Skip navigation
The Habeas Citebook Ineffective Counsel - Header

Bop Hepatitis Treatment Guidelines 2005

Download original document:
Brief thumbnail
This text is machine-read, and may contain errors. Check the original document to verify accuracy.
Guidelines for the Prevention and Treatment
of Viral Hepatitis
October 2005
(Federal Bureau of Prisons - Clinical Practice Guidelines)

Clinical guidelines are being made available to the public for informational purposes only.
The Federal Bureau of Prisons (BOP) does not warrant these guidelines for any other purpose,
and assumes no responsibility for any injury or damage resulting from the reliance thereof.
Proper medical practice necessitates that all cases are evaluated on an individual basis and
treatment decisions are patient-specific.

Guidelines for the Prevention and Treatment of
Viral Hepatitis
(October 2005 )
What’s New in the Document?
The following changes have been made since the February 2003 version of the guidelines:

Hepatitis A Virus (HAV)
• Incidence of new HAV infections at an historic low
• Reports of false positive IgM anti-HAV test results among persons with no recent history of
acute hepatitis

Hepatitis B Virus (HBV)
•
•
•
•
•
•

Decrease in incidence of acute HBV infections
Greater emphasis on preventing infections through vaccination
Update on treatment considerations for chronic hepatitis B
Pegylated interferon and entecavir introduced as two new treatment options
Update on management of persons with HIV/HBV co-infections
Infection control emphasis on blood-glucose monitoring practices

Hepatitis C Virus (HCV)
•
•
•
•
•
•
•
•

Update on treatment recommendations for acute hepatitis C
RIBA testing no longer recommended for chronic HCV infection
Screening for chronic HCV infection incorporated into baseline prevention visit
New use of qualitative and quantitative HCV RNA tests
Indications for liver biopsy broadened and “normal” ALT revisited
Liver biopsy options for certain inmates with genotypes 2 or 3
Abbreviated option of antiviral therapy for genotypes 2 or 3
Reordering of hepatitis C treatment algorithm

Appendices
•
•
•
•

Stepwise approach to managing chronic HBV infection deleted
Contraindications to interferon and ribavirin updated
Evaluation strategy for chronic hepatitis C updated and reordered
Antiviral medication tables updated

i

Guidelines for Prevention and Treatment of
Viral Hepatitis
October 2005
(Federal Bureau of Prisons - Clinical Practice Guidelines)

Table of Contents
1. Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2. Hepatitis A Virus

.................................... 1

Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Natural History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Vaccine administration
Vaccine indications
Infection Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Reporting
Containment
Contact investigations
Post-exposure management

1
1
2
2
2

3

3. Hepatitis B Virus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Acute Hepatitis B Infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diagnosis and Natural History
Treatment
Chronic Hepatitis B Infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Screening method
Clinical indications
Non-sentenced inmates
Sentenced inmates
Diagnosis and Counseling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Natural History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Chronic hepatitis B infection disease course
Chronic hepatitis B flares
Chronic hepatitis B complications

ii

4
5

6
6

7
8

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Evaluation and Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Baseline evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Hepatocellular carcinoma (HCC) screening . . . . . . . . . . . . . . . . . . . . . . . 10
Periodic evaluations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Treatment considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Treatment indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Antiviral options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Monitoring treated inmates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Evaluating treatment response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Decompensated cirrhosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Complicating medical conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Hepatitis B Prevention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Vaccine program and indications
Vaccine administration
Inmate workers
Hemodialysis patients
Infection Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Patient Education
Reporting
Containment
Hemodialysis
Blood glucose monitoring
Contact investigations
Ongoing assessments of transmission
Post-exposure management

4. Hepatitis C Virus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Acute Hepatitis C Infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Diagnosis
Treatment
Chronic Hepatitis C Infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Screening method
Clinical indications
Non-sentenced inmates
Sentenced inmates
Diagnosis and Counseling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Natural History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iii

20
21

22
22

23
24

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Evaluation and Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Baseline evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Preventive measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Detention center/short-term inmates . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Treatment considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Treatment contraindications and considerations . . . . . . . . . . . . . . . . . . . .
Confirmation of infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Genotype determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Identifying candidates for liver biopsy . . . . . . . . . . . . . . . . . . . . . . . . . .
Indications for antiviral therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Pretreatment evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Treatment options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Interferon/ribavirin side effects and adverse reactions . . . . . . . . . . . . . . . .
Monitoring treated inmates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Treatment duration and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . .
Managing anemia and neutropenia . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Re-treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Complicating medical conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

25
25
25
26
26
27
28
28
28
30
30
31
32
33
33
34
35
36

Infection Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Patient education
Reporting
Containment
Hemodialysis
Contact investigation
Post-exposure management

5. Hepatitis D Virus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Transmission
Natural History and Diagnosis
Treatment
Infection Control
Patient education
Reporting
Containment
Hemodialysis
Contact investigation
Post-exposure management

6. Cirrhosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Transplantation issues
Morbidity assessment
Preventive measures

iv

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Appendices
Appendix 1a.
Appendix 1b.

Contact Investigation - Acute Hepatitis A . . . . . . . . . . . . . . . . . . . . . . 51
Line Listing - Acute Hepatitis A . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Appendix 2.

Inmate Fact Sheet: Hepatitis B and C Viral Infections . . . . . . . . . . . . . . 53

Appendix 3.

Interpretation of Hepatitis B Virus Serologic Markers . . . . . . . . . . . . . . 54

Appendix 4.

Antiviral Medications for Chronic Hepatitis B . . . . . . . . . . . . . . . . . . . 55

Appendix 5.

Viral Hepatitis Vaccine Doses and Schedules . . . . . . . . . . . . . . . . . . . . 57

Appendix 6a.
Appendix 6b.

Contact Investigation - Acute Hepatitis B . . . . . . . . . . . . . . . . . . . . . . 58
Line Listing - Acute Hepatitis B . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

Appendix 7.

Management of Hepatitis B Virus Exposure . . . . . . . . . . . . . . . . . . . . 61

Appendix 8.

Step-Wise Approach for Evaluating and Treating Chronic Hepatitis C . . . . 62

Appendix 9.

Contraindications for Interferon/ Ribavirin Therapy . . . . . . . . . . . . . . . 63

Appendix 10a. Antiviral Medications for Chronic Hepatitis C - Interferon Preparations . .
Appendix 10b. Antiviral Medications for Chronic Hepatitis C - Ribavirin Preparations . . .
Appendix 10c. Antiviral Medications for Chronic Hepatitis C - Drug Dosages and
Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Appendix 10d. Antiviral Medications for Chronic Hepatitis C - Dosage Adjustments . . . .

64
65
66
67

Appendix 11a. Contact Investigation - Acute Hepatitis C . . . . . . . . . . . . . . . . . . . . . . 68
Appendix 11b. Line Listing - Acute Hepatitis C . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Appendix 12.

Resources - Prevention and Treatment of Viral Hepatitis . . . . . . . . . . . . 70

v

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

1. Purpose
The Federal Bureau of Prisons Clinical Practice Guidelines for the Prevention and Treatment
of Viral Hepatitis provide recommendations for the medical management of federal inmates
with viral hepatitis infections or who are otherwise at risk of infection.

2. Hepatitis A Virus (HAV)
Transmission
HAV is transmitted fecal-orally and is acquired either by person-to-person contact or by the
ingestion of contaminated food or water. Persons at increased risk of acquiring HAV infection
include persons consuming contaminated food or water, men who have sex with other men,
persons who inject illegal drugs, persons with clotting disorders who require clotting-factor
concentrates, and close personal contacts of infected persons. Those persons newly infected
with HAV are most contagious during the two weeks prior to the onset of jaundice. The
presence of diarrhea increases contagiousness. HAV remains viable in the environment for
weeks to months; therefore, transmission can readily occur through close personal contact such
as by sexual exposure or sharing contaminated communal surfaces such as toilets.
The prevalence of previously acquired HAV infection among inmate populations is estimated
at 22-39% and is largely determined by the risk-related behaviors of the inmate population and
their community origin. American Indians, Alaskan Natives, and many persons from Latin
America, Africa, the Middle East, China, and Southeast Asia come from communities with
endemic HAV infection, where infection by early adulthood is commonplace.
In the United States, the incidence of new HAV infections is at an historic low, but clusters of
hepatitis A cases continue to occur through community-based outbreaks. The highest rates of
new HAV infections occur in the Western United States, and in large urban areas among men
who have sex with men. Institutional outbreaks of hepatitis A are primarily limited to settings
with children and have not involved correctional facilities.

Natural History
The mean incubation period from the time of infection with HAV until the onset of symptoms
of acute hepatitis is 30 days (range: 15-50 days). Patients may present with jaundice, dark
urine, nausea, diarrhea, and severe malaise. Acute hepatitis A is usually a self-limited illness,
but a small number of patients develop fulminant hepatitis. Acute hepatitis eventually resolves
with the development of natural, lifelong immunity.

Return to Table of Contents

1

Hepatitis A

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Diagnosis
Acute hepatitis A is confirmed by a positive serum IgM anti-HAV titer that is detectable within
5-10 days after the onset of symptoms and persists up to 6 months after infection. All inmates
presenting with symptoms of acute hepatitis should be tested for the presence of IgM
anti-HAV, unless evidence of previous HAV infection exists (IgG anti-HAV-positive or total
anti-HAV-positive/IgM anti-HAV-negative). False positive IgM anti-HAV test results have
been reported among persons with no recent history of acute hepatitis. Therefore, positive
IgM anti-HAV test results in inmates without clinical or laboratory evidence of acute hepatitis
should be considered non-diagnostic.

Treatment
No effective antiviral therapies are available for acute hepatitis A. Therefore treatment efforts
are largely supportive. Fulminant acute hepatitis A may be complicated by protracted nausea
and vomiting, dehydration, high fever, impaired consciousness, and liver failure that requires
intensive care hospitalization.

Prevention
Vaccine administration: Hepatitis A vaccine is an inactivated, highly immunogenic vaccine
that is administered intramuscularly in the deltoid or gluteal (upper outer quadrant) muscle in a
two-shot series, 6-12 months apart depending on the vaccine preparation. The two brands of
hepatitis A vaccine (HAVRIX® formulated with a preservative; and VAQTA® formulated
without a preservative) are equally effective and can be considered interchangeable. A
bivalent combination vaccine, TWINRIX®, containing hepatitis A (HAVRIX®) and hepatitis B
(ENGERIX-B®) antigens, is given on a 0, 1, 6-month schedule, and is equally effective.
Vaccination of a person with previous immunity to HAV infection does not increase the risk of
adverse events. Hepatitis A vaccine should not be administered to persons with
hypersensitivity to alum or components of the vaccine. Prevaccination serologic screening for
prior immunity to HAV infection by detecting IgG or total anti-HAV may be cost-effective for
populations at high risk for previous HAV infection, such as certain Native American
populations and foreign-born inmates from Latin America, Africa, Southeast Asia, and China,
where HAV infection is endemic, as well as among inmates 50 years of age or older.
Postvaccination serologic testing for immunity is not indicated since the hepatitis A vaccine is
highly protective.
Vaccine indications: The following inmates should be considered candidates for hepatitis A
vaccination:
• Inmates with liver disease or cirrhosis;
• Inmates with chronic HBV and HCV infections (priority should be given to inmates with
underlying liver disease);
Table of Contents

2

Hepatitis A

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

• Inmates with clotting-factor disorders who are administered clotting-factor concentrates
(especially solvent-detergent-treated preparations);
• Users of injection and non-injection illegal drugs;
• Men who have sex with men; and
• Certain at-risk inmates in the context of a hepatitis A outbreak.
Hepatitis A vaccine is not routinely indicated for inmates workers who are plumbers or food
workers.

Infection Control
Reporting: Each institution should have a surveillance system for notifiable infectious
diseases in accordance with BOP policy. All cases of acute hepatitis A should be reported to
state health authorities, as required by all the states and the Commonwealth of Puerto Rico.
Acute hepatitis A cases should also be reported to the Central Office HSD in accordance with
BOP policy.
Containment: Inmates diagnosed with acute hepatitis A should be considered contagious 3
weeks before to 10 days after the onset of jaundice for containment and contact investigation
purposes. Inmates diagnosed with acute hepatitis A should be managed in accordance with the
following guidelines:
• Isolated in a single cell with separate sink and toilet (e.g., observation cell) until 10 days
after the onset of jaundice and until clinically improving without diarrhea;
• Immediately removed from any assigned duties as a food handler;
• Counseled regarding the importance of strict hand washing and other practical infection
control measures;
• Managed using standard precautions to prevent fecal-oral transmission when in contact with
contaminated body fluids, including wearing gloves or other personal protective equipment;
and
• Evaluated by a health care provider daily while acutely ill for signs and symptoms of liver
failure such as change in mental status, vomiting, and dehydration.
Contact investigations: A contact investigation, in consultation with local or state public
health authorities, is required for all inmates with acute hepatitis A who were incarcerated
during the incubation period, in order to enhance case-finding of other inmates who may be
infected with HAV. All food handlers should be evaluated as part of the contact investigation.
Public health officials should be directly involved in any potential foodborne outbreak to
Table of Contents

3

Hepatitis A

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

determine the need for broad-based immunoprophylaxis. A contact investigation tool is
attached in Appendix 1a (Contact Investigation - Acute Hepatitis A) and Appendix 1b (Line
Listing - Acute Hepatitis A).
Post-exposure management:
• Indications: The following susceptible contacts of an index case of hepatitis A are
candidates for post-exposure prophylaxis with pooled serum immunoglobulin (IG):
!
!
!
!
!

cellmate(s)
sexual contacts
persons routinely sharing toilet facilities
very close contacts such as those who have shared eating utensils and cigarettes
co-worker food handlers (if source-case was a food handler).

More broad-based immunoprophylaxis of inmates and correctional staff may be indicated if the
source-case was a food handler (in consultation with local and state health care authorities and
the Central Office).
• Administration: Post-exposure prophylaxis is provided by passive immunization with
pooled serum immunoglobulin (IG) in accordance with the following guidelines:
! IG prophylaxis is not effective unless administered within 2 weeks of exposure.
! Exposed inmates with previously documented natural immunity or hepatitis A
vaccination do not require IG prophylaxis. If the inmate’s immunity status to HAV
infection is unknown, prophylaxis should be empirically administered.
! Hepatitis A vaccination is not an effective post-exposure prophylaxis measure, but may
be indicated for inmates at risk of future exposures in the context of an investigated
outbreak.

3. Hepatitis B Virus (HBV)
Transmission
HBV is a bloodborne and sexually transmitted pathogen that is spread through percutaneous
and mucosal exposures to infected blood and body fluids. Major modes of acquiring HBV
infection include injection drug use, sexual intercourse with an infected partner, perinatal
transmission from mother to child, chronic hemodialysis, and through certain occupational
exposures. Tattooing with shared, contaminated needles or needle-like devices in jails and
prisons is another potential mode of HBV transmission that specifically affects inmate
populations. HBV is viable for at least 7 days on environmental surfaces and can be
transmitted by sharing contaminated household items such as razors and toothbrushes. HBV is
also transmitted perinatally or during childhood in parts of the world where the infection is
Return to Table of Contents

4

Hepatitis B

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

endemic and poorly controlled such as in Asia, the South Pacific, sub-Saharan Africa, and
certain populations in the Arctic, South America, and the Middle East. Persons with chronic
hepatitis B infection (HBsAg-positive) are often asymptomatic, but can still transmit their
infection to others. Contagiousness increases significantly if persons with chronic HBV
infection are also hepatitis B e antigen-positive (HBeAg-positive).
The incidence of acute hepatitis B is markedly declining in the United States, particularly
among children and adolescents. At-risk adults, such as men who have sex with men and
injection drug users, continue to be at risk for HBV infection and should be targeted for
vaccination. Outbreaks of acute hepatitis B can occur within the correctional setting among
unvaccinated inmates and may only be detected through careful contact investigations and
laboratory surveillance.

Acute Hepatitis B Infection
Diagnosis and Natural History
The incubation period of HBV infection from transmission of infection until the onset of
symptoms averages between 90-120 days (range: 45-180 days). Acute hepatitis B occurs in
approximately 30-50% of infected adults and may be mild, severe, or fulminant. Signs and
symptoms of acute hepatitis include fever, jaundice, nausea, abdominal pain, and malaise.
Arthritis, serum sickness, and a nonspecific rash may also occur with acute HBV infection
and, when present, are helpful diagnostically.
Acute HBV infection is confirmed by the serologic detection of IgM anti-HBc and HBsAg.
The detection of HBsAg alone is not diagnostic for acute HBV infection, since persons with
asymptomatic chronic HBV infection can be newly infected with other pathogens that cause
acute hepatitis. IgM anti-HBc may persist at detectable levels for up to 2 years in a small
subset of acutely infected persons.

Treatment
No effective therapies are available for acute hepatitis B, therefore treatment efforts are largely
supportive. Fulminant disease, suggested by hemodynamic instability, dehydration, delirium,
vomiting, and a rapidly receding liver edge, requires hospitalization and intensive
management. Inmates with acute hepatitis B should be monitored during convalescence and
thereafter to determine whether they develop chronic HBV infection (persistently
HBsAg-positive) or clear their infection (anti-HBs-positive).

Return to Table of Contents

5

Hepatitis B

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Chronic Hepatitis B Infection
Screening
Newly incarcerated inmates should be provided educational information on the transmission,
natural history, and medical management of HBV infection by appropriately trained personnel
in accordance with BOP policy. The BOP peer-oriented video on infectious diseases, the
attached information in Appendix 2 (Inmate Fact Sheet: Hepatitis B and C Viral Infections),
and other appropriate patient educational tools should be used to facilitate counseling efforts.
Screening method: Screening for HBV infection should be performed by measuring HBsAg
(additional HBV serologic tests may be warranted depending on the inmate's medical history).
Clinical indications: Inmates should be screened for hepatitis B regardless of sentencing
status if any of the following clinical indications exist:
• Pregnant inmates (routine screening is medically imperative, regardless of previous
screening results, due to the risk of perinatal transmission);
• Inmates on chronic hemodialysis who fail to develop antibodies after 2 series of
vaccinations should be screened monthly (i.e., measure HBsAg);
• Asymptomatic inmates with elevated ALT levels of unknown etiology; and
• As clinically indicated (e.g., inmates with signs or symptoms of acute or chronic hepatitis,
or percutaneous blood exposure, while incarcerated).
Non-sentenced inmates: In the absence of clinical indications, screening for HBV infection
is generally not indicated for non-sentenced inmates. Asymptomatic non-sentenced inmates in
BOP detention facilities with histories of injection drug use or other high-risk behaviors for
HBV infection should be counseled regarding their risk of acquiring HBV infection and the
behaviors that will reduce transmission of HBV infection to themselves and others during
incarceration and upon release. Referrals to community testing sites should be made when
appropriate. Long-term inmates in BOP detention facilities should be screened for HBV
infection in accordance with guidelines for sentenced inmates.
Sentenced inmates: The following sentenced inmates should be screened for HBV infection
within 6-12 months of incarceration at the prevention baseline visit:
• Inmates who have ever injected illegal drugs or shared equipment;
• Inmates who have received tattoos or body piercings while in jail or prison;
• Male inmates who have had sex with another man;
Return to Table of Contents

6

Hepatitis B

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

• Inmates with a history of chlamydia, gonorrhea, or syphilis;
• Inmates with HIV infection or HCV infection;
• Inmates from high-risk countries (i.e., Africa, Eastern Europe, Western Pacific, Asia, with
the exception of Japan); and
• Inmates with a history of percutaneous exposure to blood.
Sentenced inmates who have risk factors for chronic HBV infection, but who initially refuse
testing, should be counseled periodically regarding the need for testing during periodic
prevention visits.

Diagnosis and Counseling
Diagnosis: The diagnosis of chronic HBV infection is confirmed by the serologic detection
of hepatitis B surface antigen (HBsAg) on two separate occasions, 6 months apart; or the onetime detection of HBsAg, if total anti-HBc-positive/IgM anti-HBc-negative.
A complicated array of HBV serologic markers are useful, alone or in combination, in
characterizing various phases of HBV infection. Serologic markers are outlined in Appendix 3
(Interpretation of Hepatitis B Virus Serologic Markers).
Patient counseling: Inmates diagnosed with chronic HBV infection should be counseled by
a health care provider about the natural history of the infection, potential treatment options,
and specific measures for preventing transmission of HBV infection to others (during
incarceration and upon release), including the following information and recommendations:
• Most persons with HBV infection will remain healthy, but a small number of persons will
develop serious liver disease. Talk to your health care provider about your personal health
status.
• Drug treatment options for chronic hepatitis B are developing. Medications may or may not
be appropriate for you at this time. Talk to your doctor about your specific treatment plan.
• Do not shoot drugs, have sex with other inmates, or get a tattoo or body piercing while in
prison.
• Do not share personal items that might have your blood on them, such as toothbrushes,
dental appliances, nail-grooming equipment, or razors.
• Cover your cuts and skin sores to keep your blood from contacting other persons.
• Before release, talk to a health care provider about specific ways you can reduce the risk of
transmitting HBV infection to others after you are released.
Return to Table of Contents

7

Hepatitis B

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

• Upon release, markedly limit alcohol consumption or abstain altogether, and speak to a
physician prior to taking any new medications, including over-the-counter drugs such as
nonsteroidal anti-inflammatory agents and herbal remedies, that may damage your liver.
• Upon release, do not donate blood, body organs, other tissue, or semen.
• Upon release, seek medical attention so that your condition is appropriately monitored and
treated.

Natural History
The majority of adults acutely infected with HBV eventually clear HBsAg from the blood and
develop antibodies to HBsAg (anti-HBs) that confer long-term protection from re-infection. A
subset of persons acutely infected with HBV develop chronic HBV infection (HBsAg-positive
for 6 months or longer). The risk of chronic HBV infection is much greater for persons from
parts of the world where HBV is endemic and acquired perinatally, such as in Asia (with the
exception of Japan). Immunosuppressed individuals are also more likely to develop chronic
HBV infection.
Chronic hepatitis B infection disease course: Chronic HBV infection (HBsAg-positive)
may result in chronic hepatitis or asymptomatic chronic infection, or eventually resolve.
• Chronic hepatitis B is diagnosed by the following four criteria:
1) HBsAg-positive for > 6 months;
2) serum HBV DNA > 105 cps/mL;
(HBV DNA assays are poorly standardized and should be interpreted cautiously. The
diagnostic threshold of serum HBV DNA of 105 cps/mL or greater is somewhat
arbitrary, but helps to identify patients with significant infection that is usually
associated with liver inflammation.)
3) persistent or intermittent elevations in ALT levels; and
4) liver biopsy (when performed) showing necroinflammation score of Knodell $ 4.
Chronic hepatitis B can be characterized as HBeAg-positive or HBeAg-negative. Persons
with HBeAg-positive hepatitis have an increased risk of progressive liver disease. Persons
with HBeAg-negative chronic hepatitis B have elevated HBV DNA levels and
necroinflammation on liver biopsy, despite being HBeAg-negative. HBeAg-negative
chronic hepatitis has a fluctuating, less predictable course, compared to HBeAg-positive
hepatitis, and occurs more commonly in persons from Asia and Mediterranean countries.
• Chronic asymptomatic HBV infection: Certain persons with chronic HBV infection are
able to clear HBeAg, with an associated decrease in detectable serum HBV DNA, while
remaining HBsAg-positive. These persons are at low risk of developing cirrhosis and have
the following diagnostic criteria:

Return to Table of Contents

8

Hepatitis B

Federal Bureau of Prisons
Clinical Practice Guidelines

1)
2)
3)
4)
5)

Prevention and Treatment of Viral Hepatitis
October 2005

HBsAg-positive for > 6 months;
HBeAg-negative/anti-HBe-positive;
serum HBV DNA < 105 cps/mL;
persistently normal ALT levels; and
liver biopsy (when performed) confirms absence of significant necroinflammation and
Knodell score < 4.

• Resolved hepatitis B (anti-HBs-positive): A certain proportion of persons with chronic
HBV infection spontaneously clear their infection (approximately 1% yearly). Serum HBV
DNA levels decrease to undetectable levels (although very low levels may be detectable by
PCR), ALT levels normalize, and serum HBsAg disappears.
Chronic hepatitis B flares: Clinically apparent flares of hepatitis B can occur in persons
with chronic HBV infection during the following:
1)
2)
3)
4)
5)

spontaneous clearance of HBeAg with development of anti-HBe antibodies;
superinfection with HBV-HDV (hepatitis delta virus);
immunosuppression;
initiation of antiviral therapy for chronic hepatitis B; and
discontinuation of certain antiviral therapies for chronic hepatitis B or HIV infection.

Chronic hepatitis B complications: Individuals with chronic HBV infection are at
increased risk of developing decompensated cirrhosis and hepatocellular carcinoma (HCC).
Rates of progression to cirrhosis or HCC are affected by a variety of factors, including:
HBeAg positivity, history of alcoholism, co-infections with HIV, HCV, or HDV, and family
history of HCC. Non-hepatic complications of HBV infection include membranous
glomerulonephritis and polyarteritis nodosa.

Evaluation and Treatment
Baseline evaluation: A baseline clinician evaluation is indicated for inmates who have
chronic HBV infection (HBsAg-positive) and should include:
• Targeted history (assess age at initial infection, alcohol and substance abuse history, family
history of hepatocellular carcinoma and chronic HBV infection, risks for gastrointestinal
bleeding, and symptoms of decompensated cirrhosis);
• Targeted physical examination (assess for evidence of decompensated cirrhosis, such as
jaundice, ascites, encephalopathy, asterixis, and peripheral edema);
• Serum ALT, AST, bilirubin, alkaline phosphatase, albumin, prothrombin time, and further
diagnostic evaluations as clinically warranted for other potential causes of liver disease,
such as hemochromatosis, Wilson's disease, and autoimmune hepatitis;
• CBC with differential and platelet count;
Return to Table of Contents

9

Hepatitis B

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

• Renal function assessment (i.e., serum creatinine / BUN);
• HBeAg, anti-HBe;
• HBV DNA nucleic acid test (HBV DNA assays are poorly standardized; therefore data
should be interpreted cautiously);
• Screening for other bloodborne pathogens, e.g., anti-HIV, anti-HCV, and anti-HDV; and
• Hepatitis A vaccination with priority should be given to inmates with underlying liver
disease. (Prescreening for immunity to HAV, by detecting IgG (or total) anti-HAV, should
be considered prior to vaccination for Native American populations and foreign-born
inmates from Latin America, Africa, Southeast Asia, and China where HAV infection is
endemic, and for inmates 50 years of age or older).
Hepatocellular carcinoma (HCC) screening: HCC occurs in persons with chronic HBV
infection with or without cirrhosis. For patients with chronic HBV infection, both the
benefits of HCC screening and the optimal screening strategy are uncertain. Based upon
available data, the screening strategy outlined below should be considered on a case-by-case
basis. The following groups of inmates with chronic HBV infection, who are at higher risk for
HCC, should be screened periodically by obtaining a liver ultrasound or computed tomography
(CT) scan (e.g., annually) and alpha-fetoprotein (e.g., every 6 months):
• Inmates with cirrhosis
• Inmates with a family history of HCC
For male inmates who are 45 years of age or older and inmates from countries where chronic
HBV infection is endemic, obtain a baseline alpha-fetoprotein screen. Consider periodic
repeat alpha-fetoprotein screening (e.g., annually) for these inmates.
Periodic evaluations: Clinician evaluations for inmates with chronic HBV infection should
be scheduled on a case-by-case basis in consideration of the following:
• Chronic HBV infection (HBeAg-positive or HBeAg-negative/HBV DNA-positive) with
elevated ALT levels > 2 times the upper limit of normal: Refer for liver biopsy and
possible antiviral therapy, and monitor as clinically necessary.
• Chronic HBV infection (HBeAg-positive) with normal or mildly elevated ALT levels:
Monitor ALT levels every 3-6 months/HBeAg annually to determine if patient is developing
worsening liver disease or clearing HBeAg. (ALT levels may transiently increase with
clearance of HBeAg and the development of anti-HBe.)

Return to Table of Contents

10

Hepatitis B

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

• Asymptomatic chronic HBV infection (HBeAg-negative/HBsAg-positive/HBV DNA <
105 cps/ml): Monitor ALT levels every 6-12 months/HBsAg annually for spontaneous
clearance, i.e., resolution of infection (HBsAg-negative).
• Resolved chronic HBV infection (anti-HBs positive): Discontinue from chronic care
clinic.
Treatment considerations: A thoughtful, case-by-case approach to initiating antiviral
therapy for chronic hepatitis B is warranted, in consultation with a physician expert, for the
following reasons:
• The risks and benefits of long-term treatment are unknown;
• The potential for drug resistance is of concern with some treatments;
• Discontinuing therapy in some persons responding to treatment may result in relapse;
• A subset of infected persons spontaneously clear HBV infection without therapy in
placebo-controlled trials; and
• Future treatment options may be more effective, better tolerated, and more easily
administered.
The decision to recommend antiviral treatment should be based on the severity of liver disease,
the likelihood of response, existing co-morbid conditions, the potential for adverse reactions,
and other relevant patient-specific factors.
Treatment indications: Indications for treating chronic hepatitis B with antiviral therapy
should include all of the following:
• Chronic HBV infection (HBsAg-positive) documented for at least 6-12 months duration;
• Evidence of active viral replication, i.e., HBV DNA > 105 cps/ml (HBeAg-positive/HBV
DNA-positive or HBeAg-negative/HBV DNA-positive);
• Chronic liver inflammation suggested by elevated ALT levels (> 2 times the upper limit of
normal); and
• Evidence of necroinflammation on liver biopsy with a Knodell score $ 4.
Antiviral options: Approved antiviral therapies for chronic hepatitis B include interferon
alfa-2b, pegylated interferon alfa-2a, adefovir dipivoxil, entecavir, and lamivudine. Dosaging,
potential side effects, and monitoring parameters are outlined in Appendix 4 (Antiviral
Medications for Chronic Hepatitis B).

Return to Table of Contents

11

Hepatitis B

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

• Interferon preparations: Pegylated interferon alfa-2a or interferon alfa-2b can be
administered for a shorter duration (# 12 months) and are less likely to promote resistance
compared to other therapies. Disadvantages of interferon therapy include its subcutaneous
administration, the risk of hepatic decompensation when treating persons with cirrhosis, and
the potential for serious side effects including neuropsychiatric symptoms, bone marrow
suppression, and thyroid disease.
Predictors of a favorable response to interferon therapy include the following factors:
!
!
!
!
!

Short duration of disease;
High pretreatment ALT levels;
Low serum HBV DNA levels;
Liver necroinflammation on biopsy; and
Absence of renal failure, HIV infection, or other serious co-morbidity.

• Adefovir dipivoxil and entecavir are oral antiviral agents that are easy to administer, have
limited toxicities, are less likely to promote viral resistance compared to lamivudine, and
have some efficacy against lamivudine-resistant HBV mutants. The major disadvantage of
these agents is that the optimal treatment duration is very difficult to determine.
Cessation of therapy can result in viral relapse or severe hepatitis in certain patients.
Long-term therapy is likely required for many patients. Duration of therapy with these
medications should be discussed with a physician expert.
Adefovir dipivoxil is generally well tolerated at the recommended 10 mg dose without the
associated renal toxicity observed at higher doses. Persons with underlying renal
insufficiency and those on long-term therapy, however, are potentially at increased risk for
nephrotoxicity. Entecavir, although renally excreted has not been associated with
nephrotoxicity. Life threatening lactic acidosis and severe hepatomegaly are potential
adverse reactions of both adefovir dipivoxil and entecavir. Adefovir dipivoxil has weak
activity against HIV, whereas entecavir does not.
• Lamivudine is an oral antiviral agent that is an increasingly less attractive treatment option
for hepatitis B due to its lack of long term efficacy and its strong association with drugresistant mutants that may limit treatment gains or actually worsen liver disease.
Lamivudine should not be combined with interferon or other antiviral agents for hepatitis B,
since there is no proven benefit. Inmates previously started on lamivudine should not be
discontinued without consulting a physician expert due to the risk of precipitating liver
failure.
Monitoring treated inmates: Inmates receiving antiviral therapy for chronic hepatitis B
should receive clinician evaluations consistent with the following:
• Clinician evaluations weekly for one month, then monthly thereafter, to assess drug side
effects and potential disease complications;

Return to Table of Contents

12

Hepatitis B

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

• Psychiatry or psychology evaluations as clinically indicated during interferon treatments;
• ALT at weeks 1, 2, and 4, and at 4-8 week intervals thereafter;
• Periodic bilirubin, prothrombin time and other liver function studies as clinically warranted;
• Creatinine and BUN periodically (more frequently while on adefovir or tenofovir DF);
• CBC with differential and platelet count at weeks 1, 2, and 4 and at 4-8 week intervals
thereafter; and
• Thyroid function studies every 3 months during interferon therapy.
Transient increases in aminotransferase levels are common during therapy and correlate with
immune system clearance of HBV and the disappearance of HBeAg. Mild to moderate
increases in liver enzymes should not be an indication for reducing or discontinuing interferon
therapy, unless associated with deteriorating liver synthetic function or jaundice.
Evaluating treatment response: The effectiveness of antiviral therapy for chronic hepatitis
B is determined by monitoring the following parameters:
1) absence of HBeAg (if HBeAg-positive)
2) absence of HBV DNA
3) normalization of ALT
The clearance of HBeAg in persons with chronic HBe-positive hepatitis is associated with
improved clinical outcomes. HBeAg may not disappear, however, for months or longer after
the completion of effective antiviral therapy. HBsAg may remain positive and HBV DNA may
remain detectable for years after completion of treatment. The long-term clinical
consequences of persistent viremia are uncertain. Monitoring treatment response is even more
difficult in persons with HBe-negative hepatitis. Clearance of viremia and normalization of
ALT with treatment are helpful signs, but relapse is common in these patients despite an initial
favorable response.
Decompensated cirrhosis: Patients with decompensated cirrhosis have evidence of severe
liver disease such as markedly impaired synthetic function and signs of portal hypertension.
Interferon preparations are contraindicated in these patients due to an increased risk of
inducing hepatic failure. Chronic monotherapy with lamivudine, or adefovir, or entecavir can
be considered for these patients, since these agents may reduce the incidence of hepatic failure
and hepatocellular carcinoma. Once instituted, these agents should ordinarily not be
discontinued, due to the risk of precipitating hepatic failure.
Complicating medical conditions: Inmates with chronic hepatitis B and the following
complicating medical conditions warrant special consideration.

Return to Table of Contents

13

Hepatitis B

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

• HBV and HCV co-infection: Interferon preparations are effective against hepatitis B and
C, but the efficacy, optimal regimen, and indications for treating hepatitis with underlying
HBV and HCV infections are unknown. Antiviral therapy for chronic hepatitis B in
inmates co-infected with HCV should only be initiated after consultation with a physician
expert, and with great caution, due to the lack of a recommended treatment strategy and the
uncertain effects on underlying liver disease.
• HBV and HIV co-infection: Concurrent infection with HIV increases the risk of
cirrhosis in persons with HBV infection. Conversely, HBV infection does not hasten the
progression of HIV infection to AIDS. Antiviral therapy for chronic hepatitis B in inmates
co-infected with HIV can be considered on a case-by-case basis in consultation with a
physician expert, while considering the following:
! No long-term, evidence-based data are available to guide treatment decisions for these
patients.
! Interferon alfa therapy for chronic hepatitis B is less effective in persons with HIV/HBV
co-infection, compared to persons without HIV infection. The advantages of interferon
therapy, over other treatment options, include the limited duration of therapy, and the
lack of antiretroviral activity.
! Tenofovir disoproxil fumarate (DF), emtricitabine, tenofovir DF combined with
emtricitabine (Truvada®), and lamivudine are all active against both HIV and HBV.
Patients with HBV/HIV infections who are not candidates for antiretroviral therapy, but
who are candidates for treatment of chronic hepatitis B, should ordinarily not be treated
for hepatitis with these agents, since it will promote HIV resistance to these drugs that
may be needed for future HAART.
! Adefovir dipivoxil has weak activity against HIV at the doses used to treat chronic
hepatitis B. There is a theoretical risk of inducing cross resistance to tenofovir;
therefore, adefovir dipivoxil is not an optimal treatment choice for hepatitis B in persons
with HIV co-infection.
! Entecavir does not have activity against HIV infection. For this reason, it may be a
treatment option which does not compromise future HAART. However, data on use of
entecavir for treating HIV/HBV co-infected patients are limited.
! Persons with HIV/HBV co-infections who are candidates for HAART should ordinarily
be treated with a HAART regimen that includes an agent that is also active against HBV,
i.e., tenofovir DF. The degree of underlying liver disease should also be considered
when weighing the need to concurrently treat hepatitis B and HIV infection.
• Renal disease: Renal insufficiency secondary to glomerulonephritis from HBV infection
may respond to interferon therapy; however, treatment should be considered in consultation
with a physician expert making dosage adjustments made as necessary. Neither adefovir
nor lamivudine should be used to treat chronic hepatitis B in patients with renal
insufficiency.

Return to Table of Contents

14

Hepatitis B

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Hepatitis B Prevention
Vaccine program and indications: Each institution should establish a hepatitis B vaccine
program for inmates, since persons at risk of acquiring HBV infection are over represented
among inmate populations. The BOP targets the following inmates for hepatitis B vaccination,
based on risk of infection and co-morbid conditions:
• Inmates on chronic hemodialysis or inmates with evolving end-stage renal disease for whom
future hemodialysis is anticipated;
• Pregnant women (previously unvaccinated HBsAg-negative mothers);
• As a component of post-exposure prophylaxis for unprotected inmates following
percutaneous or permucosal exposures to blood, including victims of sexual assault;
• Inmate workers at risk for bloodborne pathogen exposure in accordance with the
institution's exposure control plan and applicable federal regulations;
• Contacts of inmates diagnosed with acute hepatitis B within the context of a contact
investigation;
• Recipients of clotting factor concentrates;
• Inmates with HIV infection with risk factors for acquiring HBV infection;
• Inmates with chronic HCV infection;
• Inmates with cirrhosis or liver disease;
• Inmates with history of injection drug use;
• Male inmates who have sex with men; and
• Inmates with history of syphilis, gonorrhea or chlamydia in the last 2 years.
Vaccine administration: Hepatitis B vaccine is available as ENGERIX-B® or
RECOMBIVAX HB®. These products are interchangeable, i.e., a vaccination series begun
with one product may be completed with the other. Hepatitis B vaccine is also available in a
combined formulation with hepatitis A vaccine (TWINRIX®). Viral hepatitis vaccines are
listed in Appendix 5 (Viral Hepatitis Vaccine Doses and Schedules). Hepatitis B vaccination
should be administered in accordance with the following guidelines:
• Prevaccination serologic screening for immunity to HBV infection is not routinely
recommended, but should be considered on a case-by-case basis. Serologic screening is
only cost-effective if the probability of prior immunity is high (> 25%), such as in inmates
Return to Table of Contents

15

Hepatitis B

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

who report prior hepatitis B vaccination (screen for anti-HBs), as well as in inmates from
countries and communities where HBV infection is endemic, i.e., Asia, the South Pacific,
sub-Saharan Africa, and certain populations in the Arctic, South America, and the Middle
East (screen for anti-HBc).
• A previous anaphylactic reaction to baker's yeast or to hepatitis B vaccine are
contraindications to vaccination or booster vaccination.
• Pregnancy should not be considered a contraindication to vaccination for women at risk
of acquiring HBV infection, since HBV itself poses a significant risk to the fetus or
newborn. No apparent risk exists for adverse effects to developing fetuses when hepatitis B
vaccine is administered to pregnant women. Pregnant inmates who are candidates for
vaccination should be counseled regarding the risks and benefits of vaccination during
pregnancy.
• All inmate candidates for vaccination should receive counseling by a physician or
otherwise qualified health care provider on the administration and potential adverse
reactions to hepatitis B vaccination. Counseling, consent, and declination should be
documented as per BOP policy.
• The three-dose vaccination series is ideally administered at 0, 1, and 4-6 months.
However, there is significant flexibility with the administration of the complete series with
the following guidelines: There must be at least a 1-month interval between doses #1 and
#2; and at least a 2-month interval between doses #2 and #3; and at least a 4-month interval
between doses #1 and #3. If a dose is delayed, the next dose should be administered
without restarting the entire series.
• The vaccine is administered intramuscularly in the deltoid muscle.
• Postvaccination testing (anti-HBs) to determine antibody responder status is not
routinely indicated for newly vaccinated inmates, unless future exposures to HBV are
anticipated, e.g, inmates receiving hemodialysis and inmate workers with anticipated
exposures to blood.
Inmate workers: Inmate workers with potential exposure to infectious blood or body fluids
(as determined by the institution's bloodborne pathogen exposure control plan) should be
offered hepatitis B vaccination in accordance with BOP policy. Newly vaccinated inmate
workers should have anti-HBs levels measured 1-2 months after the third dose of vaccine.
Inmates with low levels of anti-HBs (<10 mIU/mL) should receive a second 3-dose hepatitis B
vaccine series with repeat antibody testing 1-2 months after the third dose of vaccine. Inmate
workers who still have low levels of anti-HBs after receiving the second hepatitis B vaccine
series should be considered nonresponders susceptible to HBV infection. They should be
counseled regarding appropriate preventive measures and the need for post-exposure HBIG
prophylaxis despite vaccination.

Return to Table of Contents

16

Hepatitis B

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Hemodialysis patients: Inmates on chronic hemodialysis are at risk for ongoing exposures
to HBV and require hepatitis B vaccination, along with close monitoring of their immune
status in accordance with the following:
• Inmates on hemodialysis require higher doses of hepatitis B vaccine with different
administration schedules, compared to standard recommendations for hepatitis B vaccine
(Appendix 5).
• Inmates on hemodialysis who are newly vaccinated for hepatitis B should have
anti-HBs measured 1-2 months after the last dose of vaccine. Inmates with low levels of
anti-HBs (< 10 mIU/mL) should receive a second hepatitis B vaccine series with repeat
antibody testing 2 months after the last dose of vaccine. If anti-HBs levels remain low, the
inmate should be considered a nonresponder susceptible to HBV infection, and should be
counseled regarding appropriate preventive measures. Nonresponders and susceptible
inmates who refuse vaccination should be monitored for newly acquired HBV infection
while on dialysis by measuring HBsAg monthly.
• Those with adequate anti-HBs ($ 10 mIU/mL) following vaccination, but who are
anti-HBc negative (no natural immunity), should have anti-HBs monitored annually.
A booster dose of vaccine should be administered if the anti-HBs falls below 10 mIU/mL.
• Inmates on hemodialysis with a history of HBV infection (anti-HBc-positive and
anti-HBs-positive or HBsAg-positive) do not require anti-HBs monitoring or
consideration for vaccination.
• Inmates receiving hemodialysis who test positive for anti-HBc alone could have a false
positive test, low-grade chronic infection, remote infection, or resolving acute infection.
These hemodialysis patients should be evaluated in accordance with CDC guidelines (per
the algorithm in MMWR 2001;50(RR-5) to assess their status so that the appropriate
monitoring, immunization, and infection control measures can be determined.

Infection Control
Patient education: During orientation to the institution, and as appropriate during clinical
evaluations, all inmates should be counseled about the importance of preventing blood
exposures during activities of daily living, i.e., sharing toothbrushes and razors and through
unsafe behaviors such as injection drug use, tattooing, and sexual contact with other inmates.
Reporting: Each institution should have a surveillance system for notifiable infectious
diseases in accordance with BOP policy. All cases of acute hepatitis B should be reported to
state health authorities as required by all states and the Commonwealth of Puerto Rico.
Inmates with chronic HBV infection should be reported to the local and state authorities, as
required. All acute cases of hepatitis B and any HBsAg seroconversions among hemodialysis
patients should be reported to the Central Office HSD.

Return to Table of Contents

17

Hepatitis B

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Containment: Inmates with acute hepatitis B and chronic HBV infection (HBsAg-positive)
do not require isolation, but should be counseled on the specific measures necessary for
preventing further transmission of HBV to others during incarceration and upon release, and
should be managed while incarcerated using standard infection control precautions.
Non-disposable, patient-care items must be appropriately cleaned, disinfected, or sterilized
based on the use; and measures must be taken to prevent cross-contamination during patient
care, e.g., dialysis, vascular access, cauterizing, and dental procedures, in accordance with
CDC guidelines.
Hemodialysis: Infection control measures should be implemented to reduce the transmission
of HBV during hemodialysis in accordance with CDC guidelines for preventing transmission
of bloodborne pathogen infections among hemodialysis patients (MMWR 2001;50(RR-5)).
• Screening and prevention: All inmates receiving chronic hemodialysis should be screened
for prior HBV infection before admission to the hemodialysis unit by measuring the
following serologic markers: HBsAg, total anti-HBc, and anti-HBs. Those inmates found
to be susceptible to HBV infection should receive hepatitis B vaccine in accordance with
CDC guidelines. For both patient care and surveillance purposes, all hemodialysis inmates
who remain susceptible to HBV infection, i.e, nonresponders, should be screened monthly
for HBsAg seroconversion.
• Infection control measures: Institutions that provide dialysis should establish written
policies and practices and a mechanism for review, update, and training of staff to ensure
that infection control measures to reduce the transmission of HBV during hemodialysis are
implemented including the following:
! Specifically assigned stations or isolation room, chairs, medications, supplies, and
designated staff (do not care for HBV-susceptible inmates at the same time) should be
used to separate HBsAg-positive inmates from HBsAg-negative inmates.
! HBsAg-positive inmates should be dialyzed on specifically dedicated machines.
Dialyzers from HBsAg-positive inmates should not be reused.
! If it is necessary to reuse a machine used by a HBsAg-positive inmate for a
HBsAg-negative inmate, internal pathways of the machine can be disinfected using
conventional protocols and external surfaces cleaned using soap and water or a detergent
germicide.
! All machines and station areas that are used on HBsAg-positive inmates must be
terminally cleaned after each use (refer to manufacturers' instructions and CDC
recommendations).
Blood glucose monitoring: Patient-to-patient transmission of HBV can readily occur when
performing routine diabetes-care procedures, if appropriate infection control practices are not
used. CDC recommendations should be consistently implemented, including standard
precautions, strict hand hygiene practices, use of insulin preparation and glucometer
maintenance procedures that prevent cross contamination, ensuring adequate training of staff,
and promptly and thoroughly investigating any new HBV infection among diabetic inmates.
Return to Table of Contents

18

Hepatitis B

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Whenever feasible, individual inmates should be assigned their own glucometer for use. If
reused with another inmate, the glucometer must be cleansed and disinfected between each
use.
Contact investigations: An internal contact investigation is required for inmates diagnosed
with acute hepatitis B (IgM anti-HBc-positive), who were incarcerated during the 6 weeks - 6
months prior to disease onset, in order to identify other inmates acutely infected with HBV and
better target post-exposure management of asymptomatic contacts. Close contacts should be
tested for HBsAg to help identify the source case. Aggressive "ring vaccination" of close
contacts is warranted. The contact investigation should be coordinated with local and state
health departments. Contact investigation tools are attached in Appendix 6a (Contact
Investigation - Acute Hepatitis B) and Appendix 6b (Line Listing - Acute Hepatitis B).
Asymptomatic inmates with positive IgM anti-HBc serologies should be first evaluated to
assess if the inmate was symptomatic with acute hepatitis B or infected with HBV before or
after incarceration. (IgM anti-HBc can remain positive several years after acute infection.) A
contact investigation should be pursued if HBV infection was acquired while the inmate was
incarcerated. If the infection was acquired prior to incarceration, the local and state health
authorities should be notified as required.
Ongoing assessments of transmission: Inmates diagnosed with chronic HBV infection
(HBsAg-positive) should be interviewed at the time of diagnosis and periodically thereafter
during chronic care and prevention visits to determine if they have exposed other inmates to
infected blood through sharing toothbrushes and razors, through injection drug use, tattooing,
or sexual contact with other inmates. Identified contacts should be considered for
post-exposure prophylaxis.
Post-exposure management: Inmates with percutaneous (e.g., injection drug use,
tattooing, injury with needle or needle-like device contaminated with blood of unknown origin)
or mucosal (e.g., sexual contact, human bites) exposures to blood warrant emergency
evaluation for post-exposure prophylaxis. In evaluating human bites, both the person bitten
and the biter should be considered exposed to blood.
• Emergent care: Wounds and skin sites that have been in contact with blood or bloody
body fluids should be washed with soap and water. Exposed mucous membranes should be
flushed with water. Squeezing the wound and treating with topical antiseptics are not
recommended.
• Counseling: Inmates with percutaneous or mucosal exposures to blood should be assessed
by a health care provider and counseled regarding their risk of HBV infection, the natural
history of HBV infection, and the recommendations for post-exposure prophylaxis.
• Post-exposure interventions: Prompt post-exposure prophylaxis should be provided to
inmates potentially exposed to HBV in accordance with the following:

Return to Table of Contents

19

Hepatitis B

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

! Unvaccinated inmates should begin the vaccine series immediately and subsequent doses
should be administered in accordance with standard practices. Exposed inmates who
have already begun, but not completed, the vaccine series should receive subsequent
vaccine doses as previously scheduled.
! The source of the exposure should be tested for HBsAg, even if that person was
previously vaccinated.
! If the source of the exposure is HBsAg-positive, hepatitis B immunoglobulin (HBIG)
0.06 mL/kg body weight should also be administered to unvaccinated exposed inmates,
as soon as possible, but <7 days after the exposure. (When administered
simultaneously, hepatitis B vaccine and HBIG should be given intramuscularly at
separate sites, with the vaccine administered in the deltoid muscle.)
! Inmates who have been fully vaccinated prior to an exposure to HBV ordinarily do not
require post-exposure prophylaxis.
! Inmates who have been fully vaccinated prior to an exposure to HBV may warrant a
vaccine booster and/or HBIG, as outlined in Appendix 7 (Management of HBV
Exposures) if their anti-HBs responder status has previously been determined (e.g.,
hemodialysis patients, certain inmate workers), or their responder status is newly
assessed because of unique circumstances surrounding the exposure.
! In the context of a contact investigation of acute hepatitis B cases, both hepatitis B
vaccination and HBIG are indicated for inmates who have had percutaneous or mucosal
exposures to blood; whereas hepatitis B vaccination alone is indicated for other close
inmate contacts who have not had direct percutaneous or mucosal exposures.

4. Hepatitis C Virus (HCV)
Transmission
Hepatitis C virus (HCV) is a single-stranded, enveloped, RNA virus with 6 genotypes and
more than 50 subtypes. Genotype 1 is predominant in the United States. HCV is transmitted
primarily by direct percutaneous exposures to infectious blood, such as through injection drug
use or the transfusion of contaminated blood products (prior to July 1992). HCV is
inefficiently transmitted through sexual contact; however, persons with a history of sexually
transmitted diseases and/or multiple sexual partners have an increased risk of acquiring HCV
infection. HCV is transmitted from mother to child in approximately 5-6% of pregnant
women who have chronic HCV infection at the time of delivery. Breast feeding does not
transmit HCV from an infected mother to her child. Tattooing with shared, contaminated
needles or needle-like devices in jails and prisons is a potential mode of HCV transmission that
may affect inmate populations. Intranasal cocaine use may be a risk factor for acquiring HCV
infection, but its exact role in transmission remains ill-defined. HCV is not spread by kissing,
sneezing, hugging, coughing, food or water, sharing eating utensils or drinking glasses, or
other casual contact.

Return to Table of Contents

20

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Most inmates diagnosed with HCV infection have behavioral risk factors for acquiring HCV
and were infected prior to incarceration. Low levels of HCV transmission between inmates
have been documented through seroincidence studies and contact investigations; however,
large HCV outbreaks have not been reported in the correctional setting.

Acute Hepatitis C Infection
Diagnosis
Acute HCV infection is diagnosed when there is circumstantial evidence for new infection,
such as a recent exposure to a known HCV-infected inmate or clinical features of acute
hepatitis (jaundice, nausea, anorexia, and malaise) with the exclusion of other causes of
hepatitis. Acute hepatitis C rarely causes fulminant hepatic failure.
The mean incubation period from transmission of HCV infection to the onset of symptoms is
6-7 weeks (range: 2-26 weeks); however, only 20-30% of newly infected persons are
symptomatic. Serum ALT levels increase 4-12 weeks after acute HCV infection. Antibodies
to HCV (anti-HCV) may or may not be present when symptoms develop or with elevations in
ALT levels; however, after 3 months of HCV infection, anti-HCV is detectable by
immunoassay in 90% of patients.
The diagnosis of acute hepatitis C is confirmed by:
1) marked elevations in ALT (> 7 times the upper limit of normal) with or without
symptoms of acute hepatitis;
2) negative tests for acute hepatitis A (IgM anti-HAV) and acute hepatitis B (IgM
anti-HBc); and
3) a positive anti-HCV screening immunoassay (enzyme immunoassay, EIA or
chemiluminescence immunoassay, CIA) that is confirmed with either:
! an immunoassay with a signal-to-cutoff ratio predictive of a true positive for that
assay; or
! a supplemental test, e.g., recombinant immunoblot assay (RIBA®).
(HCV RNA may be detected by a qualitative viral load test in the blood 1-3
weeks after exposure, but viremia may be transient, i.e., a negative qualitative
HCV RNA does not preclude acute HCV infection.)
Testing recommendations following a known exposure:
1) nucleic acid test for HCV RNA immediately after exposure, at week 4 and at week 12;
2) anti-HCV by EIA or CIA immediately after exposure and at week 12; and
3) serum ALT and AST immediately after exposure, at week 4 and at week 12.

Return to Table of Contents

21

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Treatment
Inmates diagnosed with acute hepatitis C should be considered for antiviral therapy in
consultation with a physician with expertise in managing hepatitis. Reported data suggest that
antiviral therapy is beneficial in treating persons with acute HCV infection; however, the
timing and the optimal treatment regimen in this setting are uncertain. Therefore, treatment
decisions should be made on a case-by-case basis. In one study, 52% of symptomatic
individuals with acute hepatitis C spontaneously cleared the virus within 12 weeks. Of those
who did not clear the virus, treatment initiated within 3-6 months of infection resulted in a
sustained virological response in 81%. Thus, the American Association for the Study of Liver
Disease (AASLD) guidelines state: “In the absence of controlled study data, no definitive
recommendations can be made about the timing of treatment initiation; however, it seems
reasonable to delay treatment for 2-4 months after acute onset to allow for spontaneous
resolution.” Subsequent treatment, if indicated, should consist of pegylated interferon, with
or without ribavirin. Optimal treatment duration is unknown; if tolerated, treatment should be
given for at least 12 weeks, and then an HCV RNA test obtained to determine treatment
response.

Chronic Hepatitis C Infection
Screening
Newly incarcerated inmates should be provided educational information on the transmission,
natural history, and medical management of HCV infection by appropriately trained personnel
in accordance with BOP policy. The BOP peer-oriented video on infectious diseases, “Staying
Alive”, and the information in Appendix 2 (Inmate Fact Sheet: Hepatitis B and C Viral
Infection) and other appropriate patient educational tools should be used to facilitate counseling
efforts.
Screening method: The preferred screening test for HCV infection is an immunoassay
(e.g., EIA or CIA) that measures antibodies to HCV antigens.
Clinical indications: Inmates should be screened for hepatitis C regardless of sentencing
status if any of the following clinical indications exist:
• Inmates on chronic hemodialysis (screen ALT levels monthly and anti-HCV by
immunoassay semiannually);
• Inmates with elevated ALT levels of unknown etiology;
• As clinically indicated, e.g., inmates with signs or symptoms of acute or chronic hepatitis
or percutaneous blood exposure while incarcerated; and

Return to Table of Contents

22

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

• Evidence of extrahepatic manifestations of HCV infection such as mixed cryoglobulinemia,
membranoproliferative glomerulonephritis, or porphyria cutanea tarda.
Non-sentenced inmates: Screening by immunoassay for HCV infection in asymptomatic,
highly mobile, non-sentenced inmates should ordinarily not be pursued unless clinically
indicated. Asymptomatic non-sentenced inmates in BOP detention facilities with histories of
injection drug use or other high risk behaviors for HCV infection, should be counseled
regarding their risk for HCV infection and behaviors that will reduce transmission of HCV
infection to others during incarceration and upon release. Referrals to community HCV testing
sites should be made when appropriate. Long-term inmates in BOP detention facilities should
be screened for HCV infection in accordance with guidelines for sentenced inmates.
Sentenced inmates: An anti-HCV screening immunoassay should be considered for the
following sentenced inmates during the prevention baseline visit:
• Inmates who have ever injected illegal drugs or shared equipment;
• Inmates who have received tattoos or body piercings while in jail or prison;
• Inmates with HIV infection or chronic HBV infection;
• Inmates who received a blood transfusion/organ transplant before 1992 or received clotting
factor transfusion prior to 1987; and
• Inmates with a history of percutaneous exposure to blood.
Sentenced inmates who have risk factors for HCV infection, but initially refuse testing, should
be counseled periodically during preventive health visits on the need for testing during routine
patient encounters.

Diagnosis and Counseling
Diagnosis: The detection of anti-HCV by immunoassay in a person with risk factors for
acquiring HCV infection strongly predicts prior infection with HCV. A quantitative HCV
nucleic acid test, however, is required before initiating antiviral therapy, regardless of HCV
genotype, to both confirm chronic infection and guide therapy. If the quantitative HCV
nucleic acid test is negative, the more sensitive qualitative HCV nucleic acid test (lower limit
of detection of 50 IU/mL) should be obtained. Other important issues regarding HCV
diagnostic assays include:
• The appropriate processing of HCV nucleic acid test samples is essential, since viral RNA
is unstable and false negative tests may result from inadequate processing.
• The RIBA® supplemental test is not routinely recommended for diagnosing chronic HCV
infection.
Return to Table of Contents

23

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Patient counseling: Inmates diagnosed with chronic HCV infection should be counseled by
a health care provider about the natural history of the infection, potential treatment options,
and specific measures for preventing transmission of HCV infection to others (during
incarceration and upon release), including the following information and recommendations:
• Most persons with chronic HCV infection will remain healthy, but a small number of
persons will develop serious liver disease. Talk to your health care provider about your
personal health status and risk of liver disease.
• Current drug treatment options for chronic hepatitis C are moderately effective. Newer
medications should be available in the future that will improve treatment options.
Medications may or may not be appropriate for you at this time. Talk to your doctor about
your specific treatment plan.
• Do not inject drugs, have sex with other inmates, or get a tattoo or body piercing while in
prison. Individuals who continue to inject drugs should be counseled to avoid reusing or
sharing syringes, needles, water, and cotton or other paraphernalia.
• Do not share personal items that might have your blood on them, such as toothbrushes,
dental appliances, nail-grooming equipment or razors.
• Cover cuts and skin sores to keep blood from contacting other persons.
• Before release, talk to a health care provider about specific ways you can reduce the risk of
transmitting HCV infection to others after you are released.
• For the remainder of your life, do not drink alcohol at all, or only rarely, and speak to a
physician prior to taking any new medications, including over-the-counter medications such
as nonsteroidal anti-inflammatory drugs (NSAIDs) and herbal remedies, that may damage
your liver.
• Upon release, do not donate blood, body organs, other tissue or semen.
• Upon release, seek medical attention so that you receive appropriate monitoring and
treatment of your condition.

Natural History
An estimated 50-85% of persons infected with HCV develop chronic infection, while 15- 50%
of newly infected persons are able to clear the virus spontaneously. Chronic HCV infection
frequently results in high levels of HCV RNA in the blood, ranging from 105-107 international
units (IU)/mL, despite the presence of HCV antibodies. The majority of persons with chronic
HCV infection are asymptomatic.

Return to Table of Contents

24

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Chronic HCV infection has an unpredictable course that is frequently characterized by
fluctuations in ALT levels that may or may not be associated with significant liver disease.
Approximately one-third of persons with chronic HCV infection have no laboratory or biopsy
evidence of liver disease.
An estimated 10-15% of persons with chronic HCV infection develop progressive fibrosis of
the liver leading to cirrhosis. High levels of alcohol consumption, older age at the time of
infection, HIV infection, chronic HBV infection, and male gender increase the risk of disease
progression. The degree of viremia ("viral load") and the HCV genotype, however, do not
affect the progression of liver disease. The degree of ALT elevation does not strongly
correlate with the risk of disease progression, but persons who develop cirrhosis are more
likely to have marked elevations in serum ALT levels. Once cirrhosis develops in persons
with chronic HCV infection, the risk of hepatocellular carcinoma (HCC) is about 1-4% per
year.

Evaluation and Treatment
Baseline evaluation: A baseline clinician evaluation should be conducted for all inmates
diagnosed with HCV infection and include at least the following:
• Estimation and documentation of the earliest possible date of infection (whenever feasible);
• Targeted history and physical examination to evaluate for signs and symptoms of liver
disease, quantify prior alcohol consumption and determine risk behaviors for acquiring
HCV infection;
• Serum ALT, AST, bilirubin, alkaline phosphatase, albumin, prothrombin time, and further
diagnostic evaluations as clinically warranted, for other potential causes of liver disease
such as hemochromatosis, Wilson's disease, and autoimmune hepatitis;
• CBC with differential and platelet count;
• Renal function assessment (serum creatinine / BUN); and
• Anti-HIV by immunoassay and HBsAg.
Preventive measures: The following preventive interventions are indicated for inmates
diagnosed with chronic HCV infection:
• Hepatitis B vaccination: Serologic prescreening for immunity to HBV infection should be
considered for inmates who self-report previous, but undocumented hepatitis B vaccination
by measuring anti-HBs. It is cost-effective to screen inmates from countries where HBV
infection is endemic, e.g., Asia, the South Pacific, sub-Saharan Africa, and certain
populations in the Arctic, South America, and the Middle East, by measuring total
anti-HBc. Vaccination of inmates not in one of the above two categories should be offered
Return to Table of Contents

25

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

without prescreening for prior infection. Inmates with evidence of liver disease should be
priority candidates for vaccination.
• Hepatitis A vaccination: Serologic prescreening for immunity to HAV infection by testing
for IgG (or total) anti-HAV should be considered for Native American inmates and
foreign-born inmates from Latin America, Africa, Southeast Asia, and China where
hepatitis A is endemic, and among inmates 50 years of age or older. All other inmates
should be offered vaccination without prescreening for prior infection. Inmates with
evidence of liver disease should be priority candidates for vaccination. The combination
hepatitis A/B vaccine (Twinrix®) is a convenient and cost-effective option for inmates
requiring vaccination against both viruses.
• Pneumococcal vaccine and yearly influenza vaccination should be offered for inmates
who have developed cirrhosis.
• Hepatocellular carcinoma (HCC) screening: Inmates with chronic HCV infection are at
increased risk for HCC, but the optimal screening strategy is uncertain. Periodic
screening for HCC, with a liver ultrasound or abdominal CT-scan (e.g., annually) and
serum alpha-fetoprotein (e.g., every 6 months), should be considered for inmates with HCV
infection and cirrhosis.
• Screening for esophageal varices should be considered in any inmate with known
cirrhosis, and in those with suspected cirrhosis who may not be candidates for liver biopsy
(e.g., serum markers for impaired hepatic synthetic function, severe thrombocytopenia).
Detention center/short-term inmates: Inmate candidates for hepatitis C treatment
entering BOP short-term detention facilities, including pre-trial and nonsentenced federal
detainees, should ordinarily not be started on antiviral therapy. The potential for interrupted
antiviral therapy for hepatitis C places the inmates at risk for a number of undesirable
outcomes, including treatment failure if the course of treatment is not completed, and adverse
effects from medications if the inmate does not receive the required laboratory and clinical
monitoring upon release or transfer.
Inmates entering BOP custody who are already on treatment for hepatitis C, should be
maintained on antiviral therapy, unless treatment must be discontinued for medical reasons.
Consult with a Central Office physician if there are questions regarding continuation of
therapy.
Treatment considerations: Treating physicians should weigh the following factors in
assessing the appropriateness of treatment and the best timing for initiating treatment as they
counsel inmates with chronic HCV infection:
• Only 10-15% of persons with HCV infection develop significant long term complications of
liver disease, usually 20-30 years after initial infection.

Return to Table of Contents

26

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

• No laboratory parameters definitively predict which persons infected with HCV will
develop cirrhosis or will respond to medical therapy.
• The presence of moderate to severe fibrosis (Metavir $ stage 2 or Ishak $ stage 3) on liver
biopsy is currently the best marker for determining who should be offered antiviral therapy
for hepatitis C.
• The combination of a pegylated interferon plus ribavirin is significantly more effective in
clearing viremia and establishing sustained viral response rates (SVR) than prior treatment
regimens.
• Although current antiviral therapy is usually well tolerated, serious drug side effects may
occur.
• Future treatments for hepatitis C may be more effective and more easily tolerated.
An evidenced-based strategy for evaluating inmates for hepatitis C treatment is outlined in
Appendix 8 (Step-Wise Approach for Evaluating and Treating Chronic Hepatitis C).
Treatment contraindications and considerations: Inmates with chronic HCV infection
who are potential candidates for antiviral therapy should first be assessed for absolute or
relative treatment contraindications as listed in Appendix 9 (Contraindications to Interferon or
Ribavirin Therapy). Inmates with contraindications to antiviral therapy should not be treated
with interferon and ribavirin as long as the contraindication exists.
The following co-morbidities, although not absolute contraindications, should be carefully
evaluated prior to initiating antiviral therapy:
• Mental illness: Inmates with a history of psychiatric illness or with signs or symptoms of
mental illness should be referred to a psychologist or psychiatrist for assessment. Inmates
with serious mental illness should be treated and stabilized prior to pursuing a further
work-up for treatment.
• Alcohol: HCV-infected inmates being considered for treatment who have significant
alcohol abuse histories should receive specific counseling messages. Heavy and prolonged
alcohol use is an independent risk factor for the development of cirrhosis, and alcohol
accelerates the progression of HCV-related fibrosis. Therefore HCV treatment without
abstinence from alcohol is unlikely to be of benefit. The treatment response to
peginterferon plus ribavirin is significantly reduced in individuals who drink more than 30
grams of alcohol per day, and perhaps with lower levels of consumption, as well.
An inmate’s unwillingness to abstain from alcohol intake while incarcerated is a potential
indicator of alcoholism and should be evaluated. Effective treatment for alcoholism should
be offered to as many HCV-infected inmates as possible prior to release, whether or not
they have been administered HCV treatment or responded to such treatment.
Return to Table of Contents

27

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

• Substance abuse: Inmates with significant substance abuse other than alcohol may have a
number of issues which can indirectly affect whether HCV treatment will be successful.
Injection drug users may also be at risk for HIV, HBV, endocarditis, and possible reinfection with HCV. Amphetamine and cocaine abuse may result in cardiovascular
complications which carry morbidities in and of themselves, in addition to the additive risks
of interferon and ribavirin. Ongoing substance use in the controlled environment of a
prison or jail is, at best, an indicator that the inmate is not taking adequate responsibility for
his or her overall health. Treatment decisions must be individualized where these issues are
present.
Confirmation of infection: Inmate candidates for liver biopsy and/or antiviral therapy
should have chronic HCV infection confirmed (if not done previously) through the detection of
HCV RNA by a quantitative nucleic acid test. A single negative test should be repeated with
the more sensitive qualitative nucleic acid test to confirm infection.
Genotype determination: The HCV genotype markedly affects treatment response.
Persons with genotypes 2 or 3 have a 76-82% response rate to pegylated interferon/ribavirin
therapy, compared to persons with genotype 1 who have a 40-45% response rate. The HCV
genotype must be determined prior to pursuing treatment, since the genotype will affect patient
counseling, the evaluation strategy, the decision to treat for a subset of patients, and the
recommended drug regimen. Once the HCV genotype has been determined in a specific
patient, serial genotype testing is not indicated unless re-infection is suspected, since HCV
genotypes do not change during the course of an infection.
Identifying candidates for liver biopsy: Liver biopsy is the best means of staging liver
disease in patients with chronic hepatitis C and may identify other etiologies of chronic liver
disease, such as autoimmune hepatitis, alcoholic liver disease, Wilson’s disease, and
hemochromatosis. Determining the degree of liver disease is particularly important for those
inmates who may wish to defer treatment if they have normal liver histology or minimal
fibrosis, as well as in cases where relative contraindications to treatment exist, i.e., psychiatric
and substance abuse disorders not in full remission, and medical conditions such as diabetes or
cardiovascular disease which are not fully controlled. The following guidance should be
considered when determining the need for liver biopsy:
• ALT levels: The decision to obtain a liver biopsy should not be strongly based on ALT
levels; however, ALT levels are a relevant factor that warrant monitoring and review. The
greater the ALT level, the more likely it is that a person has significant liver disease;
therefore, inmates with markedly elevated ALT levels should be prioritized for liver biopsy.
However, even persons with normal ALT levels may have liver disease and should be
evaluated for liver biopsy since a small, but significant percentage (14-24%) of persons with
normal ALT levels have more than portal fibrosis (Metavir $ stage 2).
Inmates with persistently normal ALT levels (at least 6 normal values evenly distributed
over a 24-month period), and who have no other physical or laboratory evidence of chronic
liver disease, were infected before the age of 35, and have no history of significant alcohol
Return to Table of Contents

28

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

use, are at extremely low risk of severe liver disease. Most of these persons, when
biopsied, have normal liver histology or minimal fibrosis and are deemed “slow
progressors.” Slow progressors advance only one Metavir stage in 15-20 years or more.
Women who are slow progressors are especially unlikely to develop severe liver disease
during their lifetime.
Deferring liver biopsy is reasonable for inmates with persistently normal ALT levels when
the risk of liver disease is extremely low. Chronic HCV infection should still be confirmed
in such cases with a quantitative HCV RNA test, and if negative, should be repeated with a
qualitative nucleic acid test to diagnose resolved HCV infection. Inmates with confirmed
HCV infection and normal ALT levels should be monitored with a targeted history and
physical examination every 6-12 months, along with a platelet count, AST, ALT, alkaline
phosphatase and prothrombin time measurements.
A decreased platelet count, an increase in the AST/ALT ratio, and a prolonged prothrombin
time are the earliest indicators of cirrhosis and portal hypertension and warrant an
aggressive evaluation for liver disease.
• Genotypes 2 and 3: Liver biopsy can be deferred and antiviral therapy empirically
initiated for certain inmates with genotypes 2 and 3 due to the high response rates to
treatment for these patients. All inmates with HCV genotypes 2 or 3, however, should be
advised of the potential toxicity of interferon and ribavirin and offered liver biopsy to help
determine the urgency of therapy. Other inmates, with relative contraindications to
antiviral therapy, or in whom other causes of liver disease are suspected, or who have
evidence of severe liver disease on physical examination or laboratory testing, should have
a liver biopsy to help guide treatment decision-making.
• Genotypes 1, 4, 5, and 6: Liver biopsy is generally indicated for all inmates with these
genotypes, since treatment is less effective in these patients. Treatment without liver biopsy
may be considered for inmates with suspected compensated cirrhosis, or with certain
extrahepatic manifestations of HCV infection.
• HIV co-infection: Inmates with hepatitis C and HIV co-infection should receive a liver
biopsy regardless of ALT levels or genotype, due to the increased risk of accelerated
fibrosis and the greater potential for adverse reactions with antiviral therapy.
• Compensated cirrhosis: Inmates with compensated cirrhosis, that is suspected from
clinical and laboratory parameters, should be either referred directly for liver biopsy or
treated empirically with antiviral therapy (without biopsy confirmation) in consultation with
a specialist.
• Rebiopsies: Inmates with normal liver histology or minimal fibrosis should be rebiopsied
every 2-5 years. The timing of follow-up should be made on a case-by-case basis. Inmates
with minimal fibrosis, but with marked hepatocellular necrosis and inflammation should be

Return to Table of Contents

29

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

rebiopsied in one year or referred for treatment on a case-by-case basis, since these inmates
are at greater risk of developing progressive fibrosis.
Indications for antiviral therapy: Inmates with the following criteria are priority
candidates for antiviral therapy based on evidenced-based data and the American Association
for the Study of Liver Diseases (AASLD) recommendations:
• abnormal serum ALT values;
• liver biopsy with chronic hepatitis with significant fibrosis (more than portal fibrosis:
Metavir $ stage 2 or Ishak $ stage 3);
• compensated liver disease (total bilirubin < 1.5 g/dL; INR < 1.5; albumin > 3.4 g/dL;
platelet count > 75,000/mm3; and no evidence of hepatic encephalopathy or ascites;
• acceptable pre-treatment labs: hemoglobin > 13 g/dL in men or > 12 g/dL in women;
absolute neutrophil count > 1500/mm3; creatinine < 1.5 mg/dL; and
• inmate is willing to be treated and conform to treatment requirements, including abstinence
from alcohol and illicit drugs.
Hepatitis C treatment should be deferred in inmates with early hepatic fibrosis who have
relative contraindications to antiviral therapy, until these complicating conditions are resolved.
Conversely, antiviral therapy should be considered in inmates with stage 3 or 4 fibrosis despite
the presence of relative contraindications. If treatment is pursued for such individuals, the
inmate must be counseled on the increased risk of side effects, and/or the potential for
exacerbations in medical or psychiatric illnesses.
Pretreatment evaluation: Inmates should be evaluated by a physician and screened for
other medical conditions that may complicate antiviral therapy.
• Screening tests: The following tests should be obtained (unless completed recently):
! Serum chemistries: Obtain liver enzymes, bilirubin, CBC with differential and platelet
count, prothrombin time, TSH, renal function, anti-HIV, HBsAg, ferritin, ANA,
fundoscopy for inmates with diabetes or hypertension, and other patient-specific
diagnostic tests as medically indicated.
! Pregnancy test for all female inmates: Ribavirin may cause fetal abnormalities. All
female inmates of childbearing potential must have a pregnancy test immediately prior to
initiating therapy.
! Cardiac risk assessment: Inmates should have a basic cardiac risk assessment from a
clinician, since hemolysis from ribavirin may precipitate angina pectoris. An
electrocardiogram should be obtained in inmates with preexisting cardiac disease.
Symptomatic inmates should be carefully evaluated for cardiac disease prior to initiating
treatment.
Return to Table of Contents

30

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

! Mental health evaluation: A mental health evaluation should be performed by a
psychiatrist or a psychologist before prescribing interferon and ribavirin therapy to
determine if mental health treatment is warranted prior to antiviral therapy or if ongoing
mental health assessments are needed during treatment.
< The evaluation should include an assessment of axis I and axis II diagnoses, including
a comprehensive alcohol and substance abuse history, and a suicide risk assessment.
Interferon therapy has been associated with changes in mood and affect in most
individuals. In a small percentage, significant depression, suicide attempts and
completed suicides have resulted. The absence of a history of depression or suicide
attempts does not appear to lessen the risk of these side effects from interferon;
however, their presence should prompt heightened vigilance on the part of the treating
providers.
< Other mental illnesses or conditions, if not treated or not in remission, may adversely
affect the inmate's ability to successfully complete a course of antiviral treatment,
either due to issues of compliance or inability to tolerate even mild side effects.
! Inmates with compensated cirrhosis: Inmates with suspected or biopsy-confirmed
compensated cirrhosis should have an upper endoscopy screening for esophageal varices,
a liver ultrasound or abdominal CT-scan, and measurements of alpha-fetoprotein and
ammonia prior to treatment initiation. If HCC or decompensated cirrhosis is diagnosed,
antiviral therapy is contraindicated.
Treatment options: Pegylated interferon (alfa 2a or alfa 2b) plus ribavirin is the preferred
drug regimen for treating chronic hepatitis C in the absence of contraindications to either drug.
Pegylated interferon is available in two formulations: PEG-Intron® (alfa 2b) and Pegasys®
(alfa 2a). Ribavirin is available as: Rebetol®, Copegus®, and generic preparations that are
considered bioequivalent. Clinical studies have paired pegylated interferon alfa 2a with
Copegus®; and pegylated interferon alfa 2b with Rebetol®. Ribavirin is completely
ineffective as monotherapy and should never be prescribed without interferon.
Either a 12 or 24-week course of pegylated interferon and ribavirin is effective for patients
with genotypes 2 or 3 depending on treatment response; whereas a 48-week course of
treatment is recommended for patients with genotype 1. Patients with genotype 1 require
higher doses of ribavirin. The optimal duration of antiviral therapy is unknown for persons
with genotypes 4, 5, 6, or nontypable HCV; therefore, these patients should be treated with
the 48-week course of treatment recommended for genotype 1 patients. Inmates who have
contraindications to ribavirin, regardless of genotype, should be treated with a 48-week course
of pegylated interferon alone.
Detailed drug dosages, monitoring parameters, and potential side effects are outlined in
Appendices 10a-10d (Antiviral Medications for Chronic Hepatitis C).

Return to Table of Contents

31

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Interferon/ribavirin side effects and adverse reactions: Inmates treated for chronic
hepatitis C should be counseled by a clinician before and during treatment regarding both the
anticipated and potential side effects/adverse reactions of interferon and ribavirin.
• Interferon: An influenza-like reaction often occurs within 6-8 hours of initial treatment
with interferon. The fatigue, headache, fever, and myalgias often abate with subsequent
treatments and can be partially aborted by premedication with antipyretics. Acetaminophen
can be given safely up to 2 gm/day in divided doses. Nonsteroidal anti-inflammatory agents
(NSAIDs) should not be prescribed.
Chronic side effects of interferon can include severe fatigue, weight loss, reversible
alopecia, irritability, rage, confusion, and neuropsychiatric disorders. Severe and
incapacitating depression can occur, even in persons without previous histories of
depression. Bone marrow suppression resulting in neutropenia and thrombocytopenia are
potentially serious effects of interferon that should be anticipated and monitored closely,
particularly in patients with cirrhosis or HIV infection. Thyroid dysfunction occurs in
approximately 4% of persons treated with interferon and may result in irreversible thyroid
dysfunction, even with cessation of drug therapy. Resultant hypothyroidism can be treated
on a case-by-case basis with hormone replacement therapy, while continuing interferon;
whereas, hyperthryoidism usually necessitates discontinuation of interferon.
Pegylated interferons generally have similar side effect profiles compared to standard
interferons; however, pegylated interferons induce neutropenia to a greater degree. Inmates
with side effects to interferon should have their dosage reduced or therapy discontinued
depending on the severity of the side effects. Serious sequelae may occur in less than 1%
of persons receiving interferon treatment and can include: renal failure, pneumonitis,
severe bone marrow suppression, visual and hearing loss, retinal hemorrhage, acute
psychosis, and suicide.
• Ribavirin: Ribavirin causes a dose-related red cell hemolysis to variable degrees in nearly
all persons who are treated. A decrease in the hemoglobin of 2-3 gm/dL and a decrease in
hematocrit of 5-10% should be anticipated. Persons with a preexisting hemolysis or severe
anemia (hemoglobin < 11 g or hematocrit < 33%) or underlying cardiovascular or
cerebrovascular disease should not receive ribavirin. Persons with HIV infection or other
co-morbid conditions should be monitored closely. Anemia ordinarily develops between 1
and 4 weeks of initiating therapy. New onset of episodic chest pain during therapy should
be presumed to be angina pectoris until proven otherwise. Symptoms of sudden hemolysis
such as dyspnea, fatigue, headache, and palpitations may develop. If anemia occurs
ribavirin should be reduced in dosage or discontinued.
Clearance of ribavirin is significantly impaired in renal insufficiency; thus, the risk of
adverse effects, particularly hemolytic anemia, increase significantly with a decline in renal
function. Ribavirin dose should be reduced with impaired renal function (creatinine > 1.5
mg/dL), and ribavirin is contraindicated if the creatinine is > 2.0 mg/dL, or the creatinine
clearance is < 50 ml/min. Ribavirin is absolutely contraindicated in dialysis patients, since
Return to Table of Contents

32

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

it is not dialyzable. Ribavirin also causes histamine-like side effects such as nasal
stuffiness, itching, and skin irritations. More severe effects can include an asthma-like
syndrome or bronchitis.
Ribavirin may cause fetal abnormalities. All female inmates of childbearing
potential must have a pregnancy test prior to initiating therapy. Both women
AND men must be counseled to use adequate birth control during treatment and
for 6 months after treatment is completed. Counseling of both women AND men
regarding the risk of birth defects is particularly important for inmates awaiting release
and receiving ribavirin or who have recently completed treatment.

Monitoring treated inmates: Inmates receiving interferon and ribavirin should be monitored
as follows:
• Clinician evaluations: Clinician evaluations should occur weekly for one month, then
monthly thereafter, to assess drug side effects and potential complications. Inmates with
compensated cirrhosis, HIV infection, and other co-morbid conditions require more
frequent monitoring, as do patients who develop significant side effects or complications
while on therapy. Psychiatry and psychology consultations should be provided as clinically
indicated while inmates are taking interferon.
• Laboratory monitoring: Inmates receiving interferon and ribavirin therapy should be
monitored for drug toxicities in accordance with the following general guidance:
! ALT at weeks 1, 2, and 4, and at 8-12 week intervals thereafter;
(An unusual but serious complication of interferon or interferon and
ribavirin combination therapy is the paradoxical worsening of hepatitis. If
ALT levels increase significantly, antiviral therapy should be discontinued,
ALT levels should be monitored closely, and the inmate should be
monitored for signs and symptoms of hepatitis.)
! Periodic bilirubin, prothrombin time, and serum chemistries, including creatinine/BUN
repeated with any new elevations in ALT or symptoms or signs of liver disease;
! CBC with differential/platelet count at weeks 1, 2, and 4, and at 4-8 week intervals
thereafter; and
! Thyroid function studies every 3 months during interferon therapy.
Treatment duration and maintenance: The recommended duration of interferon and
ribavirin antiviral therapy and the assessment of treatment response varies with HCV
genotypes and is assessed by the clearance of HCV RNA. An early viral response (EVR) is
indicated by a 2 log decrease in viral load after 4-12 weeks of treatment. A sustained viral
response (SVR) is indicated by the absence of detectable HCV RNA in the serum measured by
a nucleic acid test 24 weeks after completion of antiviral therapy.
• Genotypes 1, 4, 5, and 6: Antiviral therapy for hepatitis C is administered for 12 weeks
for inmates with HCV genotypes 1, 4, 5, or 6, followed by the measurement of quantitative
Return to Table of Contents

33

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

HCV RNA. A detected EVR in persons infected with HCV genotype 1, predicts a
sustained viral response (SVR). Inmates with an EVR should be treated for another 36
weeks (total 48 weeks course of treatment). (Use the same laboratory and same type of
viral load testing when comparing pretreatment and post-treatment levels of HCV RNA.)
Failure to achieve an EVR (not suppressing HCV RNA by at least two logs from baseline)
predicts treatment failure. Antiviral therapy should be discontinued in these patients
after 12 weeks of treatment. In the absence of evidenced-based data on treatment
response for persons infected with HCV genotypes 4, 5, and 6, inmates with these
genotypes should be treated like those with HCV genotype 1.
• Genotypes 2 and 3: Patients infected with HCV genotypes 2 or 3 may be effectively
treated with 12-24 weeks of therapy. Achieving an SVR after 12 weeks of treatment has
the following potential benefits: a decreased duration and severity of medication side
effects, lower overall treatment costs, and increasing the number of inmates who could
complete antiviral therapy prior to release. The following two options should be
considered:
! Option 1
< Administer antiviral therapy for 4 weeks
(pegylated interferon alfa 2a or 2b with ribavirin)
< Check HCV RNA after 4 weeks of treatment. If undetectable or $ 2 log decrease
from baseline, complete a total of 12 weeks of treatment
< Confirm that HCV RNA is undetectable at 12 weeks, and again at 6 months posttreatment.
! If HCV RNA has not shown a $2 log decrease at 4 weeks, check the viral load
again at 12 weeks.
! Complete 24 weeks of treatment if HCV RNA is undetectable or $ 2 log decrease
from baseline.
! Discontinue treatment (nonresponder) if HCV RNA has not shown a $ 2 log
decrease at 12 weeks.
(In clinical trials, relapse rates were slightly higher in the 12 week vs. 24 week treatment
groups. If relapse is detected after a 12 week course of treatment, the same regimen of
peg-interferon and ribavirin should be continued for a full 24 weeks.)
! Option 2
< Administer antiviral therapy for 12 weeks.
< Check HCV RNA after 12 weeks of treatment.
! Complete 24 weeks of treatment if HCV RNA is undetectable or $2 log decrease
from baseline and confirm that HCV RNA is undetectable 6-months post-treatment.
! Discontinue treatment (nonresponder) if HCV RNA has not shown a $2 log
decrease at 12 weeks.
Managing anemia and neutropenia: The impact of early versus late antiviral dosage
reductions and the degree of dose reductions on sustained virologic response has been
Return to Table of Contents

34

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

evaluated in clinical trials. A significant reduction in SVR was only observed in patients who
required a reduction in the dose of ribavirin to less than 60 percent of the originally prescribed
dose within the first 20 weeks of therapy. Reducing the dose of peginterferon during the first
20 weeks of treatment had no significant impact on SVR. Furthermore, reducing the dose of
either peginterferon or ribavirin, even to less than 60 percent of the original dose, after 20
weeks of treatment, when patients had undetectable HCV RNA, had no effect on the SVR.
The routine use of erythropoietin or granulocyte colony-stimulating factor (G-CSF) to treat
anemia and neutropenia and therefore avoid or ameliorate the need for dose reduction of
peginterferon and ribavirin is not recommended due to the lack of definitive indications. Use
of these agents may be approved on a case-by-case basis in consultation with a Central Office
physician, based on individual patient characteristics and evidence of an early viral response
(EVR) to treatment. Neither of these agents will correct interferon-induced thrombocytopenia;
therefore, dose reduction or discontinuation is essential when platelet counts drop to potentially
dangerous levels. (Recombinant thrombopoietin cannot yet be recommended, due to lack of
safety and efficacy data.)
Re-treatment: Patients who do not achieve a SVR following antiviral therapy can be
categorized as nonresponders or relapsers.
• Nonresponders: These patients do not adequately respond to antiviral therapy by either:
1) developing a SVR upon the completion of antiviral therapy; or by
2) clearing viremia at a rate that predicts a SVR if treatment were continued.
• Relapsers: These patients have undetectable levels of HCV RNA at the end of treatment,
but do not attain a SVR, i.e., HCV RNA is detectable by 24 weeks after completion of
initially effective antiviral therapy.
Re-treatment of relapsers and nonresponders should be considered on a case-by-case basis with
the approval of Central Office HSD, while considering the following:
• Relapsers should not be retreated with the same regimen. Although direct comparison
studies have not been performed between the two brands of pegylated interferon, they are
considered to be equivalent. Therefore, a treatment relapser after a course of one pegylated
interferon preparation (plus ribavirin) would not necessarily be retreated with the other
brand of pegylated interferon.
• Re-treatment should be considered for those inmates who are most likely to benefit
from therapy and are at significant risk of disease progression by weighing the follow
factors in combination:
! the severity of underlying liver disease determined by liver biopsy;
! the viral genotype and other predictive factors that influence response rates;
! the previous regimen and the relative potency of the new regimen (e.g., non-pegylated
interferon, interferon monotherapy); and
Return to Table of Contents

35

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

! the previous response to therapy.
• Nonresponders to a standard pegylated interferon and ribavirin regimen will not be
retreated.
• Long-term antiviral maintenance therapy should not be prescribed because it is still
investigational and has unproven benefits.
Complicating medical conditions :
• Renal insufficiency: Persons with HCV infection have an increased risk of renal disease
that is often associated with cryoglobulinemia, and histologic findings that resemble
idiopathic membranoproliferative glomerulonephritis (MPGN). Clinical manifestations
include hematuria, proteinuria that is often in the nephrotic range, and a variable degree of
renal insufficiency. In the absence of liver disease that warrants antiviral therapy for HCV
infection, inmates with moderate to severe kidney disease (e.g., nephrotic syndrome,
elevated plasma creatinine concentration, new hypertension, fibrosis or tubulointerstitial
disease on biopsy) should still be considered for antiviral therapy for HCV infection.
Specific treatment regimens should be individualized in consultation with a Central Office
physician and available physician experts.
• Hemodialysis: The goal of treating hepatitis C in persons with end-stage renal disease is
to reduce the progression of liver disease and/or clear the HCV infection in patients who
may later undergo renal transplantation. Evaluation of these patients is complicated by
several factors: (1) ALT levels are more likely to be normal or near-normal in
hemodialysis patients, even in the presence of significant fibrosis; (2) the need for a liver
biopsy must be balanced against the increased risk of severe bleeding; and (3) since
interferon is contraindicated after renal transplantation, hepatitis C treatment should be
considered prior to referring the inmate for transplant consideration. For dialyzed patients,
the recommended dose of pegylated interferon 2a is 135 µg administered subcutaneously, as
monotherapy.
• HBV and HCV co-infections: Antiviral therapy for inmates with HBV and HCV
co-infections should be initiated with great caution, and only in consultation with a
specialist, due to the uncertainty of the risks and benefits of treatment and lack of a
recommended treatment regimen. All cases which may be candidates for treatment should
be reviewed with a Central Office physician.
• HIV and HCV co-infections: Pegylated interferon and ribavirin therapy should be
considered for all inmates with chronic hepatitis C and HIV co-infection, since HIV
increases the risk of hepatic fibrosis and end-stage liver disease. Treatment response rates,
however, are lower in HIV infected patients and the risk of serious adverse effects are
greater. The recommended duration of treatment, assuming an EVR at 12 weeks, is 48
weeks of therapy, regardless of genotype. The following treatment considerations should
also be noted for inmates with HCV/HIV co-infections:
Return to Table of Contents

36

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

! Treatment for HIV and HCV infections should not be initiated simultaneously.
! Inmates who have not been treated for either HIV infection or chronic hepatitis C should
first be treated with antiretroviral therapy if the inmate is a candidate for treatment
(AIDS or CD4+ T-cell count < 350 cells/mm3); otherwise consider antiviral therapy for
chronic hepatitis C in inmates with documented liver disease.
! Patients with HIV infection are at greater risk of hepatotoxicity with interferon/ribavirin
therapy, particularly if they are on a HAART regimen. Ritonavir and nevirapine have
been specifically implicated in some studies, although other studies suggest an increased
risk with any HAART regimen. ALT levels should be monitored every 1-2 months
while on therapy.
! Didanosine (ddI) should not be co-administered with either interferon or ribavirin due to
the increased risk of pancreatitis and lactic acidosis.
! Bone marrow suppression from HIV infection or antiretrovirals, such as zidovudine
(AZT) may complicate treatment for hepatitis C. In order to avoid severe anemia from
ribavirin-induced hemolysis, erythropoietin therapy or an alternative HAART regimen
may be warranted.
• Latent TB and chronic HCV infection: Inmates with latent TB infection and chronic
HCV infection should be considered for isoniazid treatment and should be monitored for
hepatotoxicity in accordance with the same guidelines established for patients without HCV
infection. All inmates require screening for symptoms of hepatitis while taking isoniazid.
Those inmates with baseline ALT elevations, also warrant periodic monitoring of ALT
levels. Isoniazid should be discontinued in inmates with marked elevations in ALT levels
or significant signs or symptoms of hepatitis in accordance with BOP Guidelines for the
Management of Tuberculosis.

Infection Control
Patient education: All inmates should be counseled during orientation to the institution and
when appropriate during clinical evaluations of the importance of preventing blood exposures
to others during activities of daily living such as sharing toothbrushes and razors and through
unsafe behaviors such as injection drug use, tattooing, and sexual contact with other inmates.
Reporting: Each institution should have a surveillance system for notifiable infectious
diseases in accordance with BOP policy. Acute hepatitis C is a reportable condition in many
states. Inmates with acute hepatitis C should be reported to local or state authorities where
required and to the Central Office HSD. Inmates with chronic HCV infection should be
reported to the local or state health authorities where required.
Containment: Inmates with acute hepatitis C and chronic HCV infection do not require
isolation, but should be counseled on the specific measures necessary for preventing further
transmission of HCV to others during incarceration and upon release and should be managed
while incarcerated using standard infection control precautions. Non-disposable patient-care
items must be appropriately cleaned, disinfected, or sterilized based on the use; and measures
Return to Table of Contents

37

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

must taken to prevent cross contamination during patient care, e.g., dialysis, vascular access,
cauterizing, dental procedures, etc., in accordance with CDC guidelines.
Hemodialysis:
• Screening: Inmates on hemodialysis without chronic HCV infection should have serum
ALT levels measured monthly and anti-HCV measured by an immunoassay semi-annually
to screen for newly acquired HCV infection. All inmates receiving hemodialysis with a
positive anti-HCV screening immunoassay should have a supplemental qualitative HCV
RNA performed.
• Infection control: Infection control measures to reduce HCV transmission during
hemodialysis should be implemented in accordance with CDC guidelines. Inmates with
HCV infection receiving dialysis do not need to be isolated from other patients or dialyzed
separately on dedicated machines. Dialyzers used for inmates with HCV infection can be
reused.
Contact investigation: Contact investigations should be initiated for those inmates with
acute hepatitis C who have been incarcerated during the 2 weeks to 6 months prior to disease
onset. A contact investigation tool is attached in Appendix 11a (Contact Investigation - Acute
Hepatitis C) and Appendix 11b (Line Listing - Acute Hepatitis C) In addition to documenting
medical visits or procedures during which the inmate may have had blood exposure, inmates
should be interviewed for information regarding recent drug injection, tattooing or body
piercing and sexual contacts. Enhanced case-finding, and counseling and testing for
anti-HCV, should be initiated for sexual contacts, injection partners and those who have used
the same tattooing equipment.
Post-exposure Management:
• Emergent care: Wounds and skin sites that have been in contact with blood or bloody
body fluids should be washed with soap and water. Exposed mucous membranes should be
flushed with water. Squeezing the wound and treating with topical antiseptics are not
recommended.
• Counseling: Inmates with percutaneous or mucosal exposures to blood should be assessed
by a qualified health care provider and counseled regarding their risk of acquiring HCV
infection, the natural history of HCV infection, and the recommendations for post-exposure
management.
• Post-exposure follow-up: No vaccine or passive immunization is available to prevent
acquisition of HCV infection following an exposure. The following guidelines should be
used for managing inmate exposures to HCV:
! Whenever feasible, the source of the exposure should be tested for anti-HCV, unless the
source's infection status is already known.
Return to Table of Contents

38

Hepatitis C

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

! Exposed inmates should be referred for medical evaluation and follow-up.
! Measure anti-HCV by a screening immunoassay (confirmed by HCV RNA, if positive)
in the exposed inmate immediately after exposure and at week 12.
! Measure HCV RNA by a qualitative nucleic acid test, and ALT levels in the exposed
inmate immediately after exposure, at week 4, and at week 12.
! Inmates with evidence of newly acquired HCV infection should be appropriately
counseled and referred for further medical evaluation including possible treatment for
acute hepatitis C.

5. Hepatitis D Virus (HDV)
Transmission
HDV is a defective RNA virus that requires HBsAg for structural integrity and replication.
HDV, also known as hepatitis delta virus, is transmitted through percutaneous exposures to
blood such as through injection drug usage. Sexual transmission occurs, but is much less
efficient than for HBV. Perinatal transmission is rare. Inmates at highest risk for delta
hepatitis have a history of injection drug use or have resided in areas of the world with a high
prevalence of infection such as Turkey, Egypt, Southern Italy, Spain, Russia, Romania, and
the Amazon River Basin.

Natural History and Diagnosis
Natural history: Acute HBV-HDV co-infection (concurrent infections with HBV and HDV)
results in a severe acute hepatitis more frequently than infection with HBV alone, but
progression to chronic infection is uncommon. HBV-HDV superinfection (HDV infection
acquired in a person with preexisting chronic HBV infection) results in chronic HDV infection
and a higher risk for cirrhosis and hepatocellular carcinoma compared to persons infected with
HBV alone.
Diagnosis: Serologic detection of HDV infection varies depending on whether the virus is
acquired through co-infection or superinfection. Following HBV-HDV co-infection both IgM
anti-HDV and IgG anti-HDV are detectable. IgM anti-HDV is more likely to be detectable
during the acute illness; whereas IgG anti-HDV is more like to be present during
convalescence, but there is considerable overlap. Chronic infection is uncommon. IgG
anti-HDV is usually undetectable with the disappearance of HBsAg and HDAg. Following
HBV-HDV superinfection, chronic HDV infection with detectable HDAg usually occurs. Both
IgM anti-HDV and IgG anti-HDV remain detectable.

Treatment
The treatment of acute delta hepatitis is supportive similar to that for acute hepatitis B.
Periodic clinician evaluations should be conducted for inmates with chronic HDV infection in
Return to Table of Contents

39

Hepatitis D

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

accordance with guidelines for monitoring chronic HBV infection. Inmates with chronic delta
hepatitis should be considered candidates for antiviral therapy using the same criteria as
inmates with chronic HBV infection. Antiviral therapy for delta hepatitis should be considered
in consultation with a specialist. Treatment regimens may differ from those recommended for
persons infected with HBV alone.

Infection Control
Patient education: All inmates should be counseled during orientation to the institution and
when appropriate during clinical evaluations of the importance of preventing blood exposures
to others during activities of daily living such as sharing toothbrushes and razors and through
unsafe behaviors such as injection drug use, tattooing, and sexual contact with other inmates.
Reporting: Inmates with acute delta hepatitis should be reported to state and local health
authorities as required. Acute delta hepatitis cases should also be reported to the Central
Office HSD.
Containment: Inmates with acute delta hepatitis or chronic HDV infection do not require
isolation, but should be counseled on the specific measures necessary for preventing further
transmission of HDV to others during incarceration and upon release and should be managed
while incarcerated using standard infection control precautions. Non-disposable patient-care
items must be appropriately cleaned, disinfected, or sterilized based on the use; and measures
must be taken to prevent cross contamination during patient care, e.g., dialysis, vascular
access, cauterizing, dental procedures, etc., in accordance with CDC guidelines.
Hemodialysis: Routine testing for HDV infection for inmates receiving hemodialysis is not
recommended. Inmates who are known to be infected with HDV should be isolated from all
other dialysis patients, especially those who are HBsAg-positive.
Contact investigation: A contact investigation should be conducted for all inmates
diagnosed with acute delta hepatitis using a similar approach to that recommended for acute
hepatitis C cases (i.e., evaluating potential percutaneous exposures, such as injection drug use
or tattooing). Suspected contacts should be tested for HBsAg in order to identify at-risk
persons with chronic HBV infection (HBsAg-positive).
Post-exposure management: Wounds and skin sites that have been in contact with blood or
body fluids should be washed with soap and water. Exposed mucous membranes should be
flushed with water. Squeezing the wound or treating with antiseptics is not recommended.
Prophylaxis for acute HBV infection should be provided to susceptible contacts. HDV can not
infect an individual if infection with HBV is prevented with hepatitis B immunoglobulin or
hepatitis B vaccine. Inmate contacts with chronic HBV infection should be counseled on the
risk for HBV-HDV superinfection.

Return to Table of Contents

40

Hepatitis D

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

6. Cirrhosis
Transplantation Issues
Liver transplantation is the treatment of choice for patients with hepatic failure from chronic
HBV and HCV infections; however due to the lack of available donor organs this option is
limited, not only for inmate populations, but also for persons in the community. Split liver
transplantation from living donors is a promising option that may expand transplantation
options to patients with liver failure in the foreseeable future. Even with available donor
livers, transplantation may be unsuccessful for patients with end-stage liver disease from HBV
and HCV infections, due to high rates of re-infection and progressive liver disease in the
transplanted organ.
Nevertheless, inmates with hepatic failure from viral hepatitis should be assessed on a case-bycase basis for eligibility for liver transplantation by assessing patient specific factors such as
the following: MELD scores that help predict patient mortality, medical contraindications for
transplantation, mental health stability, evidence of ongoing substance abuse, criminal history
factors that may negate successful transplantation, and patient motivation (as evidenced by
adherence to current treatment recommendations). Inmates who are potential candidates for
liver transplantation should be advised of the limited access to donor livers and, where
available, be referred for evaluations to local transplant centers. If transplantation during
incarceration is not feasible, inmates should be evaluated for early release while considering
public safety concerns, local correctional policies, and governing laws and regulations.

Morbidity Assessment
The Model for End-stage Liver Disease (MELD) predicts liver disease severity and the
risk of three month mortality based on serum creatinine, serum total bilirubin, and
prothrombin time (INR). In a recent study of patients with end-stage liver disease awaiting
liver transplantation, 3 month mortality varied with increasing MELD scores: MELD < 9,
mortality was 1.9%; MELD of 20-29, mortality was 19.6%, MELD of 30-39, mortality was
52.6%; and MELD $ 40, mortality was 71.3%.
The value of MELD as a predictor of mortality is limited by its dependency on serum
creatinine which can fluctuate with changes in fluid status. MELD is a better predictor of
mortality for different populations than of death for any given individual. Nevertheless,
MELD provides useful information for assessing the morbidity of inmates with end-stage liver
disease.
All inmates with decompensated cirrhosis should have a MELD score determined to assess
mortality risk. MELD scores should be recalculated over several weeks in inmates with
shifting fluid status.

Return to Table of Contents

41

Cirrhosis

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

The MELD score can be calculated by utilizing a calculator provided by United Network for
Organ Sharing available at http://www.unos.org/resources/MeldPeldCalculator.asp?index=98
Data required includes: date of birth, bilirubin, creatinine, INR and dialysis status.
Inmates with MELD scores of 30 or greater should be considered for Medical Referral Center
designation. (The MELD score predicts mortality independent of clinical parameters such as
hepatic encephalopathy, ascites, and variceal bleeding. These significant complications of
cirrhosis, however, should also be considered in referring patients for Medical Referral Center
designation.)

Preventive Measures
The following preventive measures should be considered for inmates with cirrhosis:
• Immunize against influenza (annually), pneumococcal pneumonia, and hepatitis A and B
(unless immune).
• Provide patient education on:
! selecting a low-salt, low fat, "heart healthy" diet;
! complete abstinence of alcohol during incarceration and after release; and
! avoidance of iron supplements and potentially hepatotoxic medications, such as
nonsteroidal inflammatory drugs (NSAIDS).
• Perform baseline endoscopy to screen for esophageal varices. (Follow-up annual
screening can be considered on a case-by-case basis, but the benefit of repeated screening is
unclear. Once esophageal varices have been identified the risk of future variceal
hemorrhage is 25-35%.)
• Prescribe nonselective beta-blocker therapy, such as propranolol or nadolol, for
inmates with large esophageal varices or red wale markings on endoscopy. (The dose
of beta-blocker should be titrated weekly to reduce the resting heart rate by 25%, but not
less than 55 beats/minute or reducing the systolic blood pressure to lower than 90 mm Hg.)
Long-acting nitrates can be added to nonselective beta-blockers in patients who do not
respond to beta-blockers alone, but long-acting nitrates should not be used alone.
• Provide primary prophylaxis for spontaneous bacterial peritonitis (SBP) with an
antibiotic, such as ciprofloxacin (generally limit to short treatment periods in high risk
patients such as those with upper gastrointestinal hemorrhage).
• Periodically screen for HCC by ultrasonography (e.g., annually) and alpha-fetoprotein
testing (e.g. semiannually), but note, the optimal screening strategy is uncertain.

Return to Table of Contents

42

Cirrhosis

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Definitions

General Definitions
Absolute contraindication is a condition or factor that in and of itself ordinarily precludes a
specific intervention.
Relative contraindication is a condition or factor that may preclude a specific intervention
when considered in conjunction with other criteria.
Qualitative viral assay is a nucleic acid test (NAT) used to detect the presence, but not the
amount of virus present.
Quantitative viral assay is a nucleic acid test (NAT) used to measure the amount of virus
present.
Standard precautions are protective measures used for all patient/inmate contacts and
situations to prevent the spread of infections transmitted by contaminated blood and body
fluids. Precautions include the wearing of gloves and other personal protective equipment
(personal protective equipment should be an impervious barrier) when soiling is likely; and
procedures for protective handling (handling includes the use of puncture-resistant devices and
leak-proof protection) of contaminated materials and equipment, and routine cleaning of all
contaminated surfaces and equipment.

Hepatitis A
Hepatitis A is an acute viral hepatitis caused by a highly infectious RNA virus that is
transmitted primarily by the fecal-oral route and close personal contact. Acute hepatitis A has
a mild to fulminant clinical presentation that resolves without progression to chronic infection
or chronic hepatitis.
HAV is hepatitis A virus, an enveloped RNA virus.
IgM anti-HAV is the antibody subclass to HAV that develops with acute infection. False
positive IgM anti-HAV serologies can occur.
IgG anti-HAV are antibodies to HAV that confer immunity.
Total anti-HAV are total antibodies to HAV that include IgG and IgM antibody subclasses.

Return to Table of Contents

43

Definitions

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Hepatitis B
Hepatitis B is an acute or chronic viral hepatitis caused by a DNA virus that is transmitted
primarily through sexual contact, exposures to blood, and perinatally.
HBV is hepatitis B virus, a double-stranded DNA virus.
HBsAg is hepatitis B surface antigen, a viral envelope antigen that is detectable during acute
or chronic HBV infection.
HBeAg is hepatitis e antigen, a secreted, viral antigen of the hepatitis B viral core that is
indicative of active viral replication and increased infectiousness.
Anti-HBs is the antibody to hepatitis B surface antigen that confers immunity to HBV
infection. Anti-HBs is usually detectable after infection with HBV and following vaccination.
IgM anti-HBc is the antibody to hepatitis B core antigen that develops with acute HBV
infection.
Total anti-HBc is the total antibody response to hepatitis B core antigen that is detectable
after acute HBV infection and remains detectable during convalescence. Measurement of total
anti-HBc is a useful screen for past HBV infection. Total anti-HBc is not detectable following
hepatitis B vaccination.
Anti-HBe is the antibody to hepatitis e antigen that develops as viral replication and active
hepatitis B begin to wane. Development of anti-HBe coincides with the loss of HBe antigen.

Hepatitis C
Hepatitis C is an acute or chronic viral hepatitis caused by an RNA virus that is transmitted
primarily by percutaneous contact with blood.
HCV is hepatitis C virus, an enveloped, single-stranded RNA virus.
Anti-HCV is the antibody to HCV core and nonstructural proteins that is detectable from
several weeks to months after clinical hepatitis.
Anti-HCV screening assay is an immunoassay such as an enzyme immunoassay (EIA) or
chemiluminescence immunoassay (CIA) used to screen for HCV infection by measuring
antibodies to HCV antigens.

Return to Table of Contents

44

Definitions

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

RIBA (anti-HCV) is the recombinant immunoblot assay that measures antibodies to HCV
antigens through immunoblot technology.
Early viral response (EVR) after treatment of chronic hepatitis C with pegylated interferon
and ribavirin is a minimum two log decrease in the level of HCV RNA after the first 12 weeks
of treatment compared to pretreatment levels, as measured by a quantitative nucleic acid test
(NAT).
Sustained viral response (SVR) after antiviral treatment of chronic hepatitis C is the
absence of detectable HCV RNA in the serum 24 weeks after treatment is completed,
measured by a qualitative NAT for HCV RNA with a lower limit of detection of 50 IU/ml or
less.

Hepatitis D
HDV is hepatitis delta virus, a defective single-stranded RNA virus that requires HBV for
structural integrity and replication.
Hepatitis D or delta hepatitis is an acute or chronic hepatitis caused by HDV.
HBV-HDV co-infection is the simultaneous infection of HBV and HDV.
HBV-HDV superinfection is acute HDV infection in a person with preexisting chronic
HBV infection (HBsAg-positive).
HDAg is hepatitis delta antigen.
IgM anti-HDV is an antibody subclass to HDV.
IgG anti-HDV is an antibody subclass to HDV.

Cirrhosis
Compensated cirrhosis is defined as: total serum bilirubin less than 1.5 g/dL; international
normalized ratio (INR) less than 1.5; albumin greater than 3.4 g/dL; platelet count greater than
75,000 k/mm3; and no evidence of the following: ascites by liver ultrasound, esophageal
varices by upper endoscopy, hepatic encephalopathy, or elevations in alfa-fetoprotein or serum
ammonia.

Return to Table of Contents

45

Definitions

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Decompensated cirrhosis is cirrhosis of the liver with evidence of significant liver disease,
such as ascites, encephalopathy, marked thrombocytopenia, bleeding esophageal varices; and
loss of liver synthetic function, e.g., albumin < 3.5 g/dL, total bilirubin > 1.5 mg/dL and
international normalized ratio (INR) > 1.5.)
MELD or Model for End-stage Liver Disease is a validated disease severity index that
uses age, creatinine, bilirubin, and prothrombin time to predict mortality.

Return to Table of Contents

46

Definitions

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

References

General
Centers for Disease Control and Prevention. Prevention and control of infections with hepatitis viruses
in correctional settings. MMWR. 2003;52(No. RR-1):1-36. Available from:
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5201a1.htm
Centers for Disease Control and Prevention. Recommendations for preventing transmission of
bloodborne pathogen infections among chronic hemodialysis patients. MMWR. 2001;50(No. RR-5):143. Available from: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm
Centers for Disease Control and Prevention. Practice recommendations for health-care facilities
implementing U.S. Public Health Service guidelines for management of occupational exposures to
bloodborne pathogens. MMWR. 2001;50(No. RR-11):1-42. Available from:
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5011a3.htm

Hepatitis A
Wasley A, Samandari T, Bell BP. Incidence of hepatitis A in the United States in the era of
vaccination. JAMA. 2005;294:246-248.
Centers for Disease Control and Prevention. Positive test results for acute hepatitis A virus infection
among persons with no recent history of acute hepatitis–United States, 2002-2004. MMWR.
2005;54:453-456.
Centers for Disease Control and Prevention. Prevention of hepatitis A through active or passive
immunization – recommendations of the Advisory Committee on Immunization Practices (ACIP).
MMWR. 1999;48(No. RR-12):1-37. Available from:
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4812a1 .htm

Hepatitis B
Thio CL, Sulkowski MS, Thomas DL. Treatment of chronic hepatitis B in HIV-infected persons:
Thinking outside the black box. Clin Infect Dis. 2005;41:1035-1040.
Centers for Disease Control and Prevention. Transmission of hepatitis B virus among persons
undergoing blood glucose monitoring in long-term–care facilities—Mississippi, North Carolina, and
Los Angeles County, California, 2003-2004. MMWR. 2005;54:220-223.
Lok AS. The maze of treatments for hepatitis B. N Engl J Med. 2005;352:2743-2746.
Lau GK, Piratvisuth T, Luo KX, et al. Peginterferon alfa-2a, lamivudine, and the combination for
HBeAg-positive chronic hepatitis B. N Engl J Med. 2005;352:2682-2695.

Return to Table of Contents

47

References

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, et al. Long-term therapy with adefovir dipivoxil for
HBeAg-negative chronic hepatitis B. N Engl J Med. 2005;352:2673-2681.
Macalino GE, Vlahov D, Dickinson BP, et al. Community incidence of hepatitis B and C among
reincarcerated women. Clin Infect Dis. 2005;41:998-1002.
Macalino GE, Vlahov D, Sanford-Colby S, et al. Prevalence and incidence of HIV, hepatitis B virus,
and hepatitis C virus infections among males in Rhode Island prisons. Am J Public Health.
2004;94:1218-1223.
Centers for Disease Control and Prevention. Transmission of hepatitis B virus in correctional
facilities—Georgia, January 1999—June 2002. MMWR. 2004;53:678-681.
Centers for Disease Control and Prevention. Incidence of hepatitis B—United States, 1990-2002.
MMWR. 2004;52:1252-1254.
Lok AS, McMahon BJ. Chronic hepatitis B: update of recommendations. Hepatology 2004;39:857-861.
Centers for Disease Control and Prevention. Hepatitis B vaccination of inmates in correctional
facilities–Texas, 2000-2002. MMWR. 2004;53:681-683.
Goldstein, ST, Alter MJ, Williams IT, et al. Incidence and risk factors for acute hepatitis B in the
United States, 1982-1998: implications for vaccination programs. J Infect Dis. 2002;185:713-719.
Charuvastra A, Stein J, Schwartzapfel B, et al. Hepatitis B vaccination practices in state and federal
prisons. Public Health Rep. 2001;116:203-209.
Centers for Disease Control and Prevention. Immunization of health-care workers – recommendations
of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control
Practices Advisory Committee (HICPAC). MMWR. 1997;46(RR-18). Available from:
http://www.cdc.gov/mmwr/preview/mmwrhtml/00050577.htm
Centers for Disease Control and Prevention. Hepatitis B virus: a comprehensive strategy for eliminating
transmission in the United States through universal childhood vaccination– recommendations of the
Advisory Committee on Immunization Practices(ACIP). MMWR. 1991;40(No. RR-13):1-25.

Hepatitis C
Fox RK, Currie SL, Evans J, et al. Hepatitis C virus infection among prisoners in the California state
correctional system. Clin Infect Dis. 2005;41:177-186.
Tien PC. Management and treatment of hepatitis C virus infection in HIV-infected adults:
recommendations from the Veterans Affairs Hepatitis C Resource Center Program and National
Hepatitis C Program Office. Am J Gastroenterol. 2005;100:2338-54.
Mangia A, Santoro R, Minerrva N, et al. Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in
HCV genotype 2 or 3. N Engl J Med. 2005;352:2609-2617.

Return to Table of Contents

48

References

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Altice FL, Bruce RD. Hepatitis C virus infection in United States correctional institutions. Current
Hepatitis Reports 2004;3:112-118.
Strader DB, Wright T, Thomas DL, et al. Diagnosis, management, and treatment of hepatitis C.
American Association for the Study of Liver Diseases (AASLD) practice guideline. Hepatology.
2004;39:1147-1171. Available from: https://www.aasld.org/eweb/docs/hepatitisc.pdf
Torriani FJ, Rodriguez-Torres M, Rockstroh JK, et al. Peginterferon alfa-2a plus ribavirin for chronic
hepatitis C infection in HIV-infected patients. N Engl J Med. 2004;351:438-450.
Pawlotsky J. Treating hepatitis C in “difficult to treat” patients. N Engl J Med. 2004;351:422-423.
Baillargeon J, Kelley WH, Grady J, et al. Hepatitis C seroprevalence among newly incarcerated
inmates in the Texas correctional system. Public Health. 2003;117:43-48.
Centers for Disease Control and Prevention. Guidelines for laboratory testing and result reporting of
antibody to hepatitis C virus. MMWR. 2003;52(No. RR-3):1-16.
Allen SA, Spaulding AC, Osei AM, et al. Treatment of chronic hepatitis C in a state correctional
facility. Ann Intern Med. 2003;138:187-190.
Sulkowski MS, Thomas DL. Hepatitis C in the HIV-infected person. Ann Intern Med 2003;138:197207.
Fernandez-Villar A, Sopena B, Vazquez R, et al. Isoniazid hepatotoxicity among drug users: The role
of hepatitis C. Clin Infect Dis 2003;36:293-298.
Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C
virus infection. N Engl J Med. 2002;347:975-982.
Seeff LB, Hoofnagle JH. National Institutes of Health Consensus Development Conference:
Management of hepatitis C: 2002. Hepatology. 2002;36:S1-S14.
Lauer GM, Walker BD. Hepatitis C infection, N Engl J Med, 2001;345:41-52.
Zeuzem SZ, Feinman SV, Rasenack J, et al. Peginterferon alfa-2a in patients with chronic hepatitis C.
N Engl J Med. 2000;343:1666-1672.
Alter MJ, Kruszon-Moran D, Nainan OV, et al. The prevalence of hepatitis C virus infection in the
United States, 1988 through 1994. N Engl J Med. 1999;341:556-562.
Centers for Disease Control and Prevention. Recommendations for prevention and control of hepatitis
C virus (HCV) infection and HCV-related chronic disease. MMWR.1998;47(No. RR-19):1-39.
National Institutes of Health Consensus Development Panel Statement: Management of hepatitis C.
Hepatology. 1997;26:2S-10S.

Return to Table of Contents

49

References

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Cirrhosis
Wiesner R, Edwards E, Freeman R, et al. Model for end-stage liver disease (MELD) and allocation of
donor livers. Gastroenterology 2003;124:91-96.
Wright TL. Treatment of patients with hepatitis C and cirrhosis. Hepatology. 2002;36:S185-S194.
Gebo KA, Chander G, Jenckes MW, et al. Screening tests for hepatocellular carcinoma in patients with
chronic hepatitis C: a systemic review. Hepatology. 2002;S84 -S92.
Sharara AI, Rockey DC. Gastroesophageal variceal hemorrhage. N Engl J Med. 2001;345:669-681.
Kamath PS, Wiesner RH, Malinchoc M, et al. A model to predict survival in patients with end-stage
liver disease. Hepatology. 2001;33:464-470.
Heathcote EJ, Shiffman ML, Cooksley WGE, et al. Peginterferon alfa-2a in patients with chronic
hepatitis C and cirrhosis. N Engl J Med. 2000;343:1673-1680.
Menon KVN, Kamath PS. Managing the complications of cirrhosis. Mayo Clin Proc. 2000;75:501-509.

Return to Table of Contents

50

References

Federal Bureau of Prisons
Clinical Practice Guidelines

Appendix 1a.

Prevention and Treatment of Viral Hepatitis
October 2005

Contact Investigation - Acute Hepatitis A

Inmate name:
Inmate number:

Date of Report:
Facility:

___/___/______

Date/Facility entry: ___/___/______

Date symptom onset: ___/___/______

Date BOP entry:

___/___/______

Reported by (name and title):
Laboratory Test

Date

Result

IgM anti-HAV
IgM anti-HBc
HBsAg
anti-HCV by ~ EIA ~ RNA ~ RIBA

1. Reported to local health department?

~ Yes ___/___/___ ~ No (reason

)

2. In the 2-6 weeks prior to illness onset, was patient in a BOP facility?
~ Yes (complete BOP investigation necessary)
~ No (local/state health department to do investigation - proceed to #7.
3. Risk factors (2-6 weeks prior to illness onset):
a) Close contact with a person with confirmed/ suspected acute hepatitis A?
~ No
~ Yes: ~ sexual partner ~ cell mate
~ dorm mate
b) Illicit drug use? ~ Yes
~ No
c) Sexual partners? ~ Yes (#____)
~ No
d) Work assignments:
4. Detection and prevention of common source outbreaks:
a) Employed in food services? ~ Yes
~ No
(If yes, enhance case-finding among persons eating at location)

b) Part of a recognized common-source foodborne outbreak? ~ Yes

~ No

5. Vaccination history: Vaccinated against hepatitis A? ~ No
~ Yes
When: Dose #1 date:___/___/______ Dose #1 date:___/___/______
6. Opportunities for prevention of this case:
Was patient a cell or dormitory mate of a person with acute hepatitis? ~ Yes

~ No

7. Contact evaluation for post-exposure prophylaxis: Susceptible inmate contacts should ordinarily
receive immunoglobulin (IG prophylaxis, 0.02 mL/kg IM in the deltoid or gluteal muscle) to prevent acute
HAV infection within 2 weeks of exposure.
Consult with local or state health department prior to administration.

8. Susceptible contacts include: cellmates, close personal contacts, injection drug use contacts, and
sexual contacts. (Establish line listing.)

Return to Table of Contents

51

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Appendix 1b.

Prevention and Treatment of Viral Hepatitis
October 2005

Line Listing - Acute Hepatitis A

(Limited Official Use)

Close contacts: cell mates, sexual contacts, persons sharing toilet facilities, etc.
#

Contact Name

Registration #

Contact Type

Date IG given

Food Service (FS) Workers screened (screen food handlers 1 as potential source in every case)
#

1

Potential Source Name

if symptomatic;

2

Registration #

IgM anti-HAV 1

Date IgG given2

if index case is a foodhandler

If foodhandler 3 has acute hepatitis A: identify housing units/dorm/etc. with inmates
eating food from location where foodhandler worked while ill and consider IG prophylaxis
for inmates from these housing units (consult first with health department)
Housing Unit /Dorm or other id’d area

3

Number

IG Given?

Foodhandler = food service workers who prepare or touch the food before it is eaten.

Return to Table of Contents

52

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Appendix 2.

Prevention and Treatment of Viral Hepatitis
October 2005

Inmate Fact Sheet: Hepatitis B and C Viral Infections

Am I at risk of infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)?
You may be at risk for HBV or HCV infection if you have ever injected drugs or had sex
with an infected partner. HBV is more easily transmitted through sex and from a mother to
her child compared to HCV. Persons receiving blood transfusions prior to 1992 may be at
risk for HCV infection. Talk to a health care provider about the risks of infection that affect
you personally.
How can I prevent getting HCV or HBV while I am in prison?

< Do not have sex with other inmates, shoot drugs, or get a tattoo or body piercing.
< Do not share tooth brushes, razors, nail clipping devices, or other personal items that
might have blood on them with other inmates.
Are these infections dangerous to my health?
Most persons infected with HBV or HCV do not develop serious problems. However, a
small but significant number develop serious liver disease. Talk to a health care provider
about your personal risks for developing liver disease.
Why should I be tested for HBV or HCV infection?
You should be tested if you are at risk so doctors can monitor your infection and assess your
need for treatment now or in the future. You should also be tested so that you can better
prevent others from getting infected, including your infant if you are pregnant.
How do I get tested for HBV or HCV?
A simple blood test can determine if you are infected.
How can I prevent giving HBV or HCV to others if I am already infected?
< First, remember that you can spread these infections even if you feel fine.
< Do not shoot drugs or have sex with other inmates.
< Do not share personal items that might have your blood on them, such as toothbrushes,
dental appliances, nail-clipping equipment or razors.
< Cover your cuts and skin sores to keep your blood from contacting other persons.
< If you are being released, talk to a health care provider about specific ways you can reduce
the risks of spreading HBV or HCV to others.

Return to Table of Contents

53

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Interpretation of Hepatitis B Virus Serologic Markers1

Appendix 3.
HBsAg

Total
Anti-HBc

IgM
Anti-HBc

Anti-HBs

Interpretation

-

-

-

-

Susceptible (never infected)

+

-

-

-

Acute infection, early incubation 2

+

+

+

-

Acute infection 3

-

+

+

-

Acute resolving infection 3

-

+

-

+

+

+

-

-

Chronic infection

-

+

-

-

Multiple interpretations 4

-

-

-

+

Past infection
(recovered & immune)

Immune from vaccination

$ 10 mIU/ml

Abbreviations:
HBsAg
Total anti-HBc
IgM anti-HBc
Anti-HBs

hepatitis B surface antigen
total antibody to hepatitis B core antigen
immunoglubulin M antibody to hepatitis B core antigen
antibody to hepatitis B surface antigen

1

Adapted from: CDC (2004). Interpretations of the Hepatitis B Panel.
www.cdc.gov/ncidod/diseases/hepatitis/b/Bserology.htm.
2

Note: Transient HBsAg positivity (lasting < 21 days) might be detected in some patients
during vaccination.
3

IgM usually wanes after 5 months post-infection, but may persist longer

4

Multiple interpretations: may be recovering from acute HBV infection; may be distantly
immune and test not sensitive enough to detect low level of anti-HBs in serum; may be
susceptible with a false positive anti-HBc; or may be undetectable level of HBsAg present in
the serum and the person is actually a carrier. Most persons positive for anti-HBc alone are
unlikely to be infectious except in certain exposures involving very large amounts of blood.

Return to Table of Contents

54

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Appendix 4.

Prevention and Treatment of Viral Hepatitis
October 2005

Antiviral Medications for Chronic Hepatitis B

Medication / Dosage

Interferon alfa 2b
(Intron A®)

Dose:
5 million units SQ daily or
10 million units SC thrice (3
x) weekly

Baseline Tests / Monitoring

Baseline Tests:

Adverse Reactions:

<
<
<
<

<
<
<
<
<

<
<

Pegylated interferon
alfa 2a
(Pegasys® )
Dose: 180 mcg SQ weekly
For HBeAg-positive 16 to
24 weeks of treatment
recommended
HBeAg-negative 1-year or
more of treatment
recommended

Adverse Reactions / Comments

<
<

anti-HIV, anti-HCV, anti-HDV
HBeAg, HBV DNA
ALT / AST, liver function
CBC with differential and
platelets
chemistry panel
calculated creatinine clearance/
BUN
thyroid function studies
mental health assessment

<
<
<
<

fever, fatigue, myalgias
nausea & diarrhea
alopecia
headache
psychiatric (depression,
anxiety, irritability)
neutropenia and
thrombocytopenia
thyroid dysfunction
renal failure
injection site irritation

Monitoring:
< Clinician evaluations every week
x 1 month then monthly

< CBC with differential and
<
<
<
<

platelets
ALT / liver function
creatinine / BUN
thyroid function studies
psychology / psychiatry
monitoring, as necessary

Comments:
< contraindicated with
decompensated cirrhosis

< Cost: high

Lamivudine

Baseline tests and monitoring: Adverse Reactions:

(Epivir-HBV®)

same as above except thyroid
studies and mental health
assessment only necessary if
clinically indicated.

Dose:
100 mg orally, daily for one
year or more (normal renal
function and HIV
seronegative)

< lactic acidosis
< hepatomegaly

Comments:
Lamivudine is less attractive
treatment option due to lack of
long term efficacy and strong
association with drug-resistant
mutants. Do not combine with
interferon or other antiviral
agents for hepatitis B.

Recommended dose for HIV
co-infection is 150 mg bid
along with other antiretroviral medications.
Optimal treatment duration
unknown.
*See warning below

*Warning: Due to the risk of precipitating liver failure, do not discontinue lamivudine,
entecavir or adefovir dipoxovil without consulting a physician expert.

Return to Table of Contents

55

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Appendix 4.

Prevention and Treatment of Viral Hepatitis
October 2005

Antiviral Medications for Chronic Hepatitis B

Medication / Dosage

Adefovir dipivoxil
Hepsera®

Dose: 10 mg orally, daily
Adjust for renal
impairment

Baseline Tests / Monitoring

Baseline Tests:

Adverse Reactions / Comments

Adverse Reactions:

Same as above except thyroid
studies and mental health
assessment only necessary if
clinically indicated.

< lactic acidosis
< hepatomegaly

Comments:
< Medications well tolerated and

Monitoring:
Optimal treatment duration
unknown. Treat for
minimum of one year.
*See warning below

(Page 2)

< ALT, liver function
< creatinine / BUN
(Discontinue if creatinine rises
more than 0.5 above baseline)

rate of developing drug
resistance is low.
< Low level activity against
HIV.
< Active against lamivudine
resistant mutants

Entecavir

Baseline Tests:

Adverse reactions:

Baraclude®

Same as above

< lactic acidosis
< hepatomegaly

Monitoring:

Comments:

< ALT, liver function function
< Clinical and laboratory follow

< Since entecavir is primarily

Dose:
< 0.5 mg orally, daily in
nucleoside-treatmentnaive adults
< 1 mg orally, daily in
lamivudine-refractory
adults
< Adjust for renal
impairment

up should continue for several
months after treatment is
stopped

Optimal treatment duration
unknown. Treat for
minimum of one year.

eliminated by the kidneys, coadministration of drugs that
reduce renal function or
compete for active tubular
secretion may increase serum
concentrations of either
entecavir or the coadministered drug.

< Effective against lamivudine
resistant HBV mutants;
activity against dual mutants is
significantly less than that of
wild-type HBV.

*See warning below

< Not active against HIV

*Warning: Due to the risk of precipitating liver failure, do not discontinue lamivudine,
entecavir or adefovir dipoxovil without consulting a physician expert.

Return to Table of Contents

56

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Appendix 5.

Viral Hepatitis Vaccine Doses and Schedules

Vaccine Type

Dose (mL)

Volume

# Doses in
series

Schedule
(months)

Hepatitis A and B Vaccines for Adults
Hepatitis A
Havrix1

1,440 EL.U 3,5

1

2

0 and between
6 - 12

VAQTA2

50 U 5

1

2

0 and between
6 - 12

Hepatitis B
Recombivax-HB2

10 mcg5

1

3

0, 1, and 6

Engerix-B1

20 mcg5

1

3

0, 1, and 6

1

3

0, 1, and 6

Hepatitis A and B combination
Twinrix1

20 mcg (B)5
720 EL.U.(A)

Source:

Adapted from CDC guidelines, MMWR 2003;52(No. RR-1)

Hepatitis B Vaccines for Hemodialysis-dependent Adults
Hepatitis B
Recombivax-HB 2

40 mcg5

1

3

0, 1, and 6

Engerix-B1

40 mcg5

2.0 4

4

0, 1, 2, and 6

Source:

Adapted from CDC guidelines, MMWR 2001;50( No. RR.- 5)

1

Manufactured by GlaxoSmithKline Biologicals

2

Manufactured by Merck & Co., Inc.

3

Enzyme linked immunosorbent assay (ELISA) units.

4

Two 1.0 mL doses administered at one site in a 4-dose schedule at 0, 1, 2, and 6 months.

5

Recommended route/site for administration is the deltoid by intramuscular injection.

Return to Table of Contents

57

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Appendix 6a.

Contact Investigation - Acute Hepatitis B

Inmate name:
Inmate number:

Facility:

Date symptom onset: ___/___/______

Date of Report:

___/___/______

Date/Facility entry:

___/___/______

Date BOP entry:

___/___/______

Reported by (name and title):

Laboratory Test

Date

Result

IgM anti-HAV
IgM anti-HBC
HBsAg
anti HCV by ~ EIA ~ RNA ~ RIBA
ALT/AST

~ Yes ___/___/___ ~ No (reason_____________)

1. Reported to local health department?

2. In the 6 weeks to 6 months prior to illness onset, was patient in a BOP facility?

~ Yes (complete BOP investigation necessary)

~ No (health department to do investigation)

3. Risk factors (6 weeks to 6 months prior to illness onset):

a) Did patient have close contact with a person with confirmed or suspected HBV infection?

~ No ~ Yes: ~ sexual partner
b) Illicit drug use?

~ Yes

~ cell mate

~ dorm mate ~ other:____________

~ No

c) Sexual partners? ~ Yes (#____)

~ No

d) Other reported contact with human blood? ~ No

~ Yes (when what circumstances:________________________________________________)
e) On dialysis? ~ Yes
f) Recent hospitalization

~ No
~ No

~ Yes (when? where?__________________________________________________________)
g) Recent IV infusions or injections received in outpatient setting?

No

~ Yes (When? Where? _______________________________________________________)
h) Recent dental work No

~ Yes (When? Where? _______________________________________________________)
i) Recent tattoo

~ Yes

j) Body piercing ~ Yes

Return to Table of Contents

~ No
~ No

58

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Appendix 6a.

Prevention and Treatment of Viral Hepatitis
October 2005

Contact Investigation - Acute Hepatitis B

(page 2)

4. Vaccination history:
Vaccinated against hepatitis B?

~ No

~ Yes When? Dose #1 date_________ Dose #2 date _________ Dose #3 date________

5. Review prior opportunities for prevention of this case:
Was patient a cell or dormitory mate of a person with acute hepatitis?
~ No

~ Yes

6. Contact evaluation: Consider total anti-HBc testing to determine contacts' susceptibility.
7. Contact management: Inmates in close contact with an inmate diagnosed with acute hepatitis
B should be considered for post-exposure prophylaxis.

NOTE: For susceptible inmate contacts with identified or suspected percutaneous or mucosal
exposures, administer post-exposure prophylaxis by initiating the first dose of hepatitis B vaccine
series IM in the deltoid muscle along with HBIG 0.06 ml/kg body weight IM at a separate site
(Give HBIG only if within 7 days of exposure).

NOTE: For susceptible inmate contacts without identified or suspected per cutaneous or mucosa
exposures, initiate the first dose of hepatitis B vaccine, but do not give HBIG.

NOTE: Contacts include: injection drug use contacts, sexual contacts, tattoo contacts, and close
personal contacts (Establish line listing).

Return to Table of Contents

59

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Appendix 6b.

Prevention and Treatment of Viral Hepatitis
October 2005

Line Listing - Acute Hepatitis B

(Limited Official Use)

Suspected percutaneous or mucosal exposure
#

Contact Name

Registration #

Date HBIG given

Date vaccinated

Close contacts (i.e., cellmates, sharing of personal items, etc.) without identified
percutaneous / mucosal exposure (i.e., ring vaccination)
#

Contact Name

Return to Table of Contents

Registration #

60

Date vaccine series initiated

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Appendix 7.

Prevention and Treatment of Viral Hepatitis
October 2005

Management of Hepatitis B Virus Exposures 1

Vaccination Status/
Antibody Status

Treatment Based on Source’s HBsAg Status
HBsAg positive

HBsAg negative

Unknown Status

Unvaccinated

HBIG 2 X 1;
Initiate HB
vaccine series

Initiate HB vaccine
series

Initiate HB vaccine
series

Vaccinated

No treatment

No treatment

No treatment

HBIG X 1 and
revaccination
series,

No treatment unless
never
revaccinated; then
begin a
revaccination
series

Treat as if source
were HBsAgpositive

known responder
(adequate anti-HBs is
10 mIU/ml)

Vaccinated
known nonresponder

or
HBIG X 23

Vaccinated
unknown response
status

Test exposed
person for antiHBs: If adequate no treatment
If inadequate -

No treatment

Test exposed
person for antiHBs: If adequate no treatment
If inadequate - give
vaccine
booster/recheck
titer in 1 - 2
months

HBIG X 1
plus
vaccine booster
1

Exposure is percutaneous (laceration, needlestick, bite) or permucosal (ocular or mucousmembrane) contact with blood.

2

HBIG dose is 0.06 mL/kg administered IM at different site than vaccine, preferably < 24
hours after exposure, but no greater than 7 days post- exposure.

3

Give 1 dose of HBIG and reinitiate vaccine series for nonresponders who have not
completed second 3-dose vaccine series; Give HBIG X 2 for nonresponders who have failed
second vaccine series.

Adapted from: CDC. Updated U.S. Public Health Service guidelines for the management of
occupational exposures to HBV, HCV, and HIV and recommendations for post-exposure
prophylaxis. MMWR 2001;50(RR-11):1-52

Return to Table of Contents

61

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Appendix 8. Step-wise Approach for Evaluating and Treating Chronic Hepatitis C
1. Screen for Hepatitis C Virus Infection
< Risk factors present: if EIA+ or CIA+, then considered infected
< No risk factors: confirm infection if EIA+ or CIA+ with a qualitative HCV RNA test

2. Baseline Evaluation
<
<
<
<
<
<

Medical history / physical examination.
Establish duration of infection by history.
CBC, serum chemistries, INR, anti-HIV, HBsAg
Evaluate other potential causes of liver disease, as appropriate
Assess contraindications to interferon and ribavirin prior to liver biopsy or consideration for tx
Evidence of decompensated cirrhosis ÷ manage without antiviral therapy

3. Review Treatment Contraindications and Considerations
< Mental health assessment to identify suicidal ideation or uncontrolled psychiatric illness
< Assess alcohol use / substance abuse history and counsel on risk reduction. Referrals as appropriate.
< Ensure that sentence length is sufficient to complete a course of treatment.

4. Determine Genotype
5. Confirm chronic HCV infection prior to liver biopsy
< Detect HCV RNA by a quantitative assay, if negative reevaluate with qualitative HCV RNA assay.

6. Liver Biopsy
< Offer liver biopsy to most inmates, regardless of genotype (see text)
< If liver biopsy is normal or shows minimal fibrosis ÷ monitor / re-biopsy in 2-5 years
< If portal or bridging fibrosis and moderate inflammation and necrosis ÷ consider antiviral therapy

7. Drug Therapy
< HCV Genotype 2 or 3:
Option 1
– Treat with pegylated interferon / ribavirin for 4 weeks; then check quantitative HCV RNA
– If viral load has decreased by 2 logs or is undetectable, complete total of 12 weeks of treatment
Option 2
– Treat with pegylated interferon / ribavirin for 12 weeks; then check quantitative HCV RNA
– Complete 24 weeks of treatment if HCV RNA is undetectable or $ 2 log decrease from baseline
– Discontinue treatment (nonresponder) if HCV RNA has not shown a $ 2 log decrease at 12 weeks

< HCV Genotype 1, 4, 5, 6, or HIV co-infected:
– Treat with pegylated interferon / ribavirin combination therapy
– Check quantitative HCV RNA after 12 weeks
– If viral levels have not decreased by 2 logs (102) at 12 weeks - discontinue therapy
– Otherwise continue therapy for 48 weeks

8. Monitor post-treatment
< Measure qualitative HCV RNA assay at completion of treatment
< Measure qualitative HCV RNA 6 months after completion of effective therapy
< Referral to drug education / treatment program if appropriate and not previously completed.
Abbreviations: EIA - enzyme immunoassay; CIA - chemiluminescence immunoassay; RIBA - recombinant
immunoblot assay; NAT - nucleic acid test; ALT - alanine aminotransferase; ULN - upper limits of normal.

Return to Table of Contents

62

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Appendix 9.

Prevention and Treatment of Viral Hepatitis
October 2005

Contraindications for Interferon / Ribavirin Therapy*

Interferon (standard and pegylated)
Absolute Contraindications
< Decompensated cirrhosis

< Potential life-threatening extrahepatic disease such as refractory AIDS, malignancy, severe
COPD, or angina
< Uncontrolled autoimmune disorders
< Poorly controlled diabetes
< Solid organ transplantation (kidney, heart, or lung)
< Untreated or uncontrolled hyperthyroidism
< Active suicidal ideation or other neuropsychiatric condition that is poorly controlled
< Ongoing alcohol or injection drug usage - refer for evaluation

Relative Contraindications
< Bone marrow dysfunction - neutropenia/thrombocytopenia
< Hepatitis B co-infection
< HIV infection that is poorly controlled with HAART
< History of recent alcohol abuse or injection drug usage - refer for evaluation

Ribavirin
Absolute Contraindications
< Pregnancy - due to risk of fetal malformations and fetal death; pregnancy test required
NOTE: women of childbearing potential AND men must use two forms of effective
contraception during treatment and during the six-months post-treatment
< Men whose female partners are pregnant
< Hemoglobinopathies (sickle cell anemia and homozygous thalassemia), hemolytic anemias
or other severe anemias
< Ischemic cardiovascular disease or cerebrovascular disease
< Renal insufficiency - creatinine clearance < 50 ml/min or serum creatinine > 2.0 mg/dL

*Refer to drug manufacturers’ warnings in addition to highlighted contraindications

Return to Table of Contents

63

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Appendix 10a. Antiviral Medications for Chronic Hepatis C - Interferon Preparations
Medications

Baseline

Monitoring

Tests
Pegylated
Interferon

< history /
physical

alfa-2b
< ALT / AST
(PEG-Intron®)

< bilirubin
< albumin

For dosing see

< alkaline
phos

Appendix 10c
< PT / INR
< CBC (diff
& plts)
< chemistry
panel

Pegylated
Interferon
alfa-2a

< creatinine /
BUN
< thyroid
function
studies

(PEGASYS®)
For dosing see

< ferritin /
ANA

Appendix 10c

Adverse
Reactions

< Clinician
< fever
evaluation every
week x 1 month,
< fatigue
then monthly.
< ALT at weeks 1, < myalgia
2, 4 and 8-12
weeks thereafter < psychiatric
(rage,
confusion,
< CBC (with diff
depression,
and plts), at
suicide)
weeks 1,2,4, and
4-8 weeks
thereafter.
< TSH every 3
months.

< bone
marrow
suppression
< thyroid
dysfunction

< Renal and liver
function studies
periodically; and < renal failure
whenever
clinically
warranted.

Comments

Pegylated
interferon in
combination with
ribavirin is the
recommended
treatment regimen
for chronic
hepatitis C for
most patients.

Patients with
compensated
cirrhosis and HIV
co-infection may
have more severe
adverse effects:
monitor
hematologic
parameters
closely.

< Screen for
depression

< anti HIV
< HBsAg
< liver
biopsy
< HCV
genotype

Return to Table of Contents

< Psychologic /
psychiatric
evaluations as
clinically
needed.

64

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October 2005

Appendix 10b. Antiviral Medications for Chronic Hepatis C - Ribavirin Preparations
Medications

Baseline Tests

Ribavirin

< CBC (with diff

with interferon
(REBETOL®)

Ribavirin

1,2

with

and plts)

< See baseline
tests for
interferon since
ribavirin
always given in
combination
with interferon
preparation.

pegylated
interferon

< Pregnancy test
for all female
inmates.

Monitoring

Adverse
Reactions

Ongoing monitoring Hemolysis:
of hemoglobin and
expect 5-10%
hematocrit for
decrease in
evidence of
hematocrit.
hemolytic anemia
which often occurs
Note: patients
between 1 and 4
with cirrhosis
weeks after
may have more
initiating therapy.
severe anemia.
Note: Women of
childbearing
potential AND men
must use two forms
of birth control
during treatment
AND during the 6
months after
antiviral therapy is
completed.

Consider monthly
pregnancy tests for
female inmates at
risk of pregnancy,
e.g., community
access.

Note: anemia
may precipitate
angina,
dyspnea, fatigue

Teratogenic counsel women
AND men
regarding the
risk of birth
defects and the
necessity of
birth control
before, during,
& 6 mos. after
treatment.

Comments
Ribavirin capsules
should be taken
with food.

Ribavirin should be
administered on
pill line to ensure
compliance and
increase efficacy.

The optimal dose of
ribavirin depends
on HCV genotype,
i.e., higher doses
are required for
genotype 1.

Ribavirin should
not be used in
patients with a
serum creatinine of
> 2 mg/dL, or a
creatinine
clearance of < 50
ml/min.

For dosing see
Counseling is
particularly
important for
inmates
awaiting release
and after
treatment is
completed.

Appendix 10c

1

COPEGUS® and REBETOL®, are formulated as tablets and capsules respectively; and are considered to
be bioequivalent by the FDA. Generic formulations are also available.

2

In clinical studies pegylated interferon alfa-2a was administered with COPEGUS ® and pegylated
interferon alfa-2b was administered with REBETOL®.

Return to Table of Contents

65

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Appendix 10c.

Prevention and Treatment of Viral Hepatitis
October 2005

Antiviral Medications for Chronic Hepatitis C
Drug Doses & Administration

Generic (Trade Name)

Recommended Dose

Peginterferon Regimens (plus Ribavirin)
Peginterferon alfa-2a (Pegasys®)

< 180 : g SQ once weekly regardless of weight

or
Peginterferon alfa-2b (Peg-Intron®) < 1.5 :g/kg SQ once weekly
plus
< Genotype 1, 4, 5, 6:

Ribavirin (Rebetol®; Copegus®)

< 75 kg: 400 mg PO every morning. and
600 mg every evening

$ 75 kg: 600 mg BID
< Genotype 2 and 3: 400 mg PO BID

Regimens Used in Certain Clinical Circumstances
Peginterferon alfa-2a (Pegasys®) as
monotherapy

< 180 : g SQ once weekly regardless of weight

Peginterferon alfa-2b (Peg-Intron®) < 1.0 :g/kg SQ once weekly
as monotherapy
Interferon alfa-2b plus ribavirin
(Rebetron®)

< Interferon alfa-2b 3 mU three times weekly SQ and
Ribavirin:
< 75 kg: 400 mg PO every morning. and
600 mg every evening

$ 75 kg: 600 mg BID

Peginterferon alfa-2a (Pegasys®) in
hemodialysis

< 135 : g SQ once weekly

From: Strader DB, Wright T, Thomas DL, Seeff LB.; Practice Guidelines Committee, American Association
for the Study of Liver Diseases (AASLD). Diagnosis Management and Treatment of Hepatitis C. Hepatology
2004; 39:1147-1171.

Return to Table of Contents

66

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October, 2005

Appendix 10d. Antiviral Medications for Chronic Hepatitis C - Dosage Adjustments
Medication

Parameter

Interferons

WBC < 1500/mm3

Adjustment
< reduce dose by 50%
3

neutrophil count < 750/mm
platelet ct < 80,000/mm3
Ribavirin

hemoglobin < 10 g/dL

< reduce dose to 200 mg per day

Ribavirin
and
Interferons

hemoglobin < 8.5 g/dL

< discontinue

WBC < 1000/mm3

< discontinue

neutrophil count < 500/mm3

< discontinue

3

< Peginterferon alfa-2a Y discontinue

3

< Peginterferon alfa-2b Y discontinue

platelet count < 50,000/mm
platelet count < 25,000/mm

History of Cardiac Disease (CHF, previous MI, angina, or known CAD by angiography)
Ribavirin
Interferon
Ribavirin
and
Interferons

2 g/dL drop in hemoglobin
during any four week period
of treatment.

reduce dose to 200 mg AM, 400 mg q HS

hemoglobin < 12 g/dL after
4 weeks at reduced dose
above

discontinue

reduce dose by 50%

History of Renal Disease
Ribavirin

creatinine clearance < 50
ml/min or

contraindicated; discontinue

serum creatinine > 2.0
mg/dL

Return to Table of Contents

67

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Prevention and Treatment of Viral Hepatitis
October, 2005

Appendix 11a.

Contact Investigation - Acute Hepatitis C
Date of Report:

Inmate name:
Facility:

Inmate num ber:

Date/Facility entry:

Date symptom onset: ___/___/______

___/___/______
___/___/______

Date BOP entry:

___/___/______

Reported by (name and title):
Laboratory Test

Date

Result

IgM anti-HAV
IgM anti-HBC
HBsAg
anti HCV by ~ EIA ~ RNA ~ RIBA
HCV RNA

~ qualitative

~ quantitative

ALT/AST

1. Reported to local health department?

~ Yes ___/___/___ ~ No (reason_____________)

2. In the 2 weeks to 6 months prior to illness onset, was patient in a BOP facility?

~ Yes (complete BOP investigation necessary)

~ No (health department to do investigation)

3. Risk factors (2 weeks to 6 months prior to illness onset):
a) Did patient have close contact with a person with confirmed or suspected HCV infection?

~ No ~ Yes: ~ sexual partner

~ cell mate

b) Injection drug use?

~ Yes

c) Sexual partners?

~ Yes (#____)

~ dorm mate ~ other:____________

~ No
~ No

d) Other reported contact with human blood? ~ No

~ Yes (when/what circumstances:________________________________________________)
e) On dialysis?

~ Yes: ~ dialysis center notified

~ No

f) Recent hospitalization ~ No
~ Yes (when? where?__________________________________________________________)
g) Recent IV infusions or injections received in outpatient setting? ~ No
~ Yes (When? Where? _______________________________________________________)
h) Recent dental work ~ No
~ Yes (When? Where? _______________________________________________________)
i) Recent tattoo

~ Yes

j) Body piercing ~ Yes

~ No
~ No

4. Prior Prevention Opportunities:
Was patient a cell or dorm mate of person with acute hepatitis?

~ Yes

~ No

5. Contact notification (HCV counseling and testing should be offered and line listing completed)

Return to Table of Contents

68

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Appendix 11b.
#

Prevention and Treatment of Viral Hepatitis
October, 2005

Line Listing - Acute Hepatitis C

Contact Name

Registration #

(Limited Official Use)

Anti HCV
status

Counseling and
Testing Date

(+ or -)

Return to Table of Contents

69

Appendices

Federal Bureau of Prisons
Clinical Practice Guidelines

Appendix 12.

Prevention and Treatment of Viral Hepatitis
October, 2005

Resources - Prevention and Treatment of Viral Hepatitis

American Association for the Study of Liver Diseases
https://www.aasld.org/eweb/StartPage.aspx
Centers for Disease Control and Prevention
National Center for Infectious Diseases - Hepatitis Branch
http://www.cdc.gov/ncidod/diseases/hepatitis/
MELD Score Calculator
The MELD score can be calculated by utilizing a calculator provided by United
Network for Organ Sharing available at:
http://www.unos.org/resources/MeldPeldCalculator.asp?index=98
National Institutes of Health
National Institute of Diabetes and Digestive Disease
http://www.niddk.nih.gov
National Clinicians' Post-Exposure Prophylaxis Hotline
(888) 448-4911
Veterans Affairs National Hepatitis C Web Site
http://hepatitis.va.gov/

Return to Table of Contents

70

Appendices

 

 

Federal Prison Handbook - Side
Advertise here
The Habeas Citebook: Prosecutorial Misconduct Side