OUT OF LINE:
Hepatitis C Treatment Protocols in the California Department of
Corrections
California Prison Focus
2940 16th Street #B-5
San Francisco, CA 94103
www.prisons.org
March 9, 2005
CONTENTS
Executive Summary…………………………………………………………………...1
I. Background on HCV………………………………………………………………..2
II. CDC Protocols for Prisoners with Hepatitis C……………………………………..3
A. HCCMP Phase I: Screening and Initial Diagnosis…………………………….5
B. HCCMP Phase II: Initial Management After Diagnosis of HCV………………6
Problem #1: Denying Diagnosis and Treatment to Patients with Normal ALT
Levels…………………………………………………………………………..7
Problem #2: Withholding Treatment from Patients with Substance Abuse
Histories………………………………………………………………………..9
C. HCCMP Phase III: Staging by Liver Biopsy and Combination Therapy………10
Problem #3: Denying Treatment to Patients with Stage 1 or 2 Fibrosis………11
Problem #4: Denying Re-treatment to Relapsers and Non-responders………..14
Conclusion…………………………………………………………………………….16
Sources………………………………………………………………………………..17

Author:
Scott D. Handleman, Esq.
Charles F.A. Carbone, Esq.

0

Attorneys-at-Law

1

Executive Summary
California Prison Focus1 presents this report to assess the present treatment
offered by the California Department of Corrections (CDC) to the estimated 68,000
prisoners suffering with hepatitis C in this state.
The hepatitis C protocols of the CDC, developed in response to the Plata v. Davis
and Madrid v. Gomez litigation, deviate in several important regards from the current
medical standard of care for hepatitis C. This paper discusses the CDC’s hepatitis C
management protocols, identifies their principal deficiencies, and makes
recommendations for improvements. While the CDC provides medical treatment at the
ordinary standard of care to select inmates, the CDC falls below the ordinary standard of
care in its systematic use of exclusionary categories to deny care to patients who would
be eligible, and who would receive individualized consideration for treatment, if they
were outside the prison gates. The most serious deviations from the medical consensus
on care for hepatitis C patients are:
(1) The CDC excludes HIV-negative patients with stage 1 or 2 fibrosis
from receiving combination therapy. In the outside world, a liver biopsy
with stage 2 fibrosis is a strong indicator that a patient should receive
therapy. Patients with stage 1 fibrosis should be considered for therapy on
an individual basis.
(2) The CDC denies biopsies to patients with normal liver enzyme levels,
despite a NIH finding that the diagnostic value of liver enzyme tests has
not been well documented. The AASLD agrees that therapy is proper in
some cases for patients with persistently normal enzyme levels.
(3) The CDC denies therapy to individuals with a history of substance
abuse in the past 6-12 months, despite the NIH’s endorsement of treatment
for current drinkers and drug users. According to the NIH, treatment of
injection drug users is especially valuable because of its potential to
reduce disease transmission.
1

California Prison Focus is a fifteen-year-old non-profit organization dedicated to defending and advancing
the human and civil rights of prisoners.

2

(4) CDC protocols refuse re-treatment to patients who have not responded
to an initial course of therapy, despite an NIH finding that re-treatment is
proper in at least some instances.
CPF’s key recommendations:
The CDC should amend its policies so that stage 2 fibrosis is a strong
factor in favor of treatment.
The CDC should provide individualized consultations for patients with
stage 1 fibrosis, normal ALT levels, substance abuse problems, and
previous nonresponders. These patients, like all patients with hepatitis C,
should receive individualized treatment decisions based on the condition
of the liver, the potential side effects of treatment, the likelihood that
treatment will be effective, and the presence of comorbid conditions.
I. Background on HCV
Hepatitis C is an inflammation of the liver caused by the Hepatitis C Virus
(HCV). The disease has infected approximately 4 millions persons in the United States,
of whom 2.7 million are chronically infected. Left untreated, hepatitis C can lead to
cirrhosis, decompensated liver disease, liver cancer, and death.2 It is presently the
number-one cause of liver transplantation in the United States and causes 10,000 to
12,000 deaths every year.3
According to the Bureau of Justice Statistics, between 27 and 33 percent of state
prison inmates are infected with hepatitis C nationwide.4 In California, a UCSF study
found that the HCV incidence among new parolees is 41.5%.5 This indicates that, out of
California’s prison population of 163,939, approximately 68,000 have hepatitis C. Since
2

Salomon, Weinstein, Hammitt and Goldie, Cost-effectiveness of Treatment forChronic Hepatitis C
Infection in an Evolving Patient Population, in Journal of the American Medical Association [JAMA] (vol.
290, no. 2), July 9, 2003.
3
Management of Hepatitis C: 2002. NIH Consens State Sci Statements. 2002 Jun 10-12; 19(3) 1-46, 11.
4
The Inmate Healthcare Challenge: Fixing a Broken System in Light of the Deukmejian Report.
Background Briefing Paper for a Joint Hearing of the Senate Select Committee on the California
Correctional System (September 29, 2004), p. 2.
5
Page-Shafer, Wright, Fox, Currie, Gobidas and Tracy, HEPCAP II: Hepatitis C in the California Prisons
Project. Center for AIDS Prevention Studies (2004). www.caps.ucsf.edu/pdfs/2004portfolio/Hepcap2.pdf

3

105,298 CDC prisoners are expected to be paroled from July 2004 to June 2005,6 this
translates into 43,700 prisoners returned to society with hepatitis C this year.
Hepatitis C infection can be acute or chronic. An acute infection disappears in a
patient without any treatment a short time after infection, for unknown reasons. When
HCV genetic material is detected in a patient’s blood for a period of six months that
person is diagnosed with chronic HCV infection. Approximately 60 to 85 percent of
HCV-infected persons develop chronic infection.7 It is chronic hepatitis C infection
which endangers a patient’s health and requires monitoring and treatment.
Even chronic HCV usually progresses very slowly in causing liver damage.
Twenty years after infection, approximately 10 to 15 percent of patients will develop
liver cirrhosis, a dangerous and often fatal condition. However, many factors increase the
risk of cirrhosis, including older age at time of infection, male gender, concurrent
infection with HIV or hepatitis B, alcohol use equivalent to 2 beers per day, toxic
environmental conditions, taking medications toxic to the liver, and various medical
conditions.
HCV manifests six major variations in its genetic code, which are known as
genotypes 1 through 6. Genotype 1 accounts for 70 to 75 percent of HCV infections and
is the most difficult to treat.8
II. CDC Protocols for Prisoners with Hepatitis C
Because of the prevalence of hepatitis in prisons, many states and the federal
Bureau of Prisons have adopted written protocols for hepatitis treatment. In March 2004,

6

CDC Population Projections Unit, Population Projections 2004-2009 (Spring 2004), Tables 13-14.
www.corr.ca.gov/OffenderInfoServices/Reports/Projections/S04Pub.pdf
7
Inmate Healthcare Challenge, supra note 4, p. 10.
8
Management of Hepatitis C: 2002, supra note 3.

4

pursuant to the requirements of a federal lawsuit—Plata v. Davis—CDC’s Health Care
Services Division published policies and procedures for the diagnosis, monitoring and
treatment of hepatitis C, in a document titled Hepatitis C Clinical Management Program
(HCCMP). HCCMP’s stated purpose is to ensure “a consistent, appropriate, effective,
and efficient approach to the clinical management of persons infected with HCV.”9 The
Program divides management of HCV into three phases, corresponding to screening and
initial diagnosis (phase I); initial management after diagnosis (phase II); and staging by
liver biopsy and combination therapy (phase III). Its policies and procedures govern all
prisoners under custody of the CDC, except for those at Pelican Bay State Prison.
Prisoners at Pelican Bay are subject to the Madrid v. Gomez litigation rather than
Plata, and they are covered by a separate document, the Pelican Bay Hepatitis C Program
Policy (PBHCPP). The Pelican Bay policy, which resembles the HCCMP in many
respects, was approved by Judge Thelton Henderson on June 27, 2002.10
The hepatitis C protocols of the California Department of Corrections developed
in response to the Plata and Madrid litigation deviate in several important regards from
the current medical standard of care for hepatitis C. While the CDC provides medical
treatment at the ordinary standard of care to the inmates whom it decides to treat, the
CDC falls below the ordinary standard of care in its systematic use of categories of
exclusion to deny care to patients who would be eligible, and who would receive
individualized consideration for treatment, if they were outside the prison gates. The
most notable deviations from the medical consensus on care for hepatitis C patients are as
follows:
9

California Department of Corrections, Health Care Services, Hepatitis C Clinical Management Program
(March 2004), p. 1.
10
Hagar, John. Special Master’s Notice to Inmates Concerning Hepatitis C Disease (July 2, 2002), p. 7.

5

(1) the denial of treatment to HIV-negative patients with Stage 2 fibrosis;
(2) the denial of biopsy or treatment to patients under 45 who lack elevated ALT
levels;
(3) the denial of treatment to patients with current or recent substance abuse
histories;
(4) the denial of retreatment to nonresponders.
A. HCCMP Phase I: Screening and Initial Diagnosis
Various tools are available to diagnose and monitor HCV infections. A gateway
test is the enzyme immunoassay (EIA) test, which detects antibodies to HCV. Positive
EIA results indicate that a person has been exposed to the virus at some time. Next,
various blood tests are available to detect the presence and quantity of the virus itself
(viral load tests) and healthy liver function (ALT tests). The ALT test measures levels of
alanine aminotransferase, a liver enzyme whose presence at elevated levels in the
bloodstream indicates liver damage. A biopsy—the extraction of a small piece of liver
for testing—is more invasive, but it is the best method for detecting structural changes to
the liver caused by hepatitis.11
CDC protocols require that HCV screening be made available to patients who
request it, and that HCV screening be offered to patients with a history of intravenous
drug use or other risk factors. The screening begins with hepatitis antibody tests and
ALT liver function tests. No copayment is assessed for the screening. All patients who
test positive for HCV antibodies are then given viral load tests and, sometimes, a second
ALT test. The anticipated time period for a prisoner to complete screening and initial
diagnosis is three months.12

11
12

Management of Hepatitis C: 2002, supra note 3, pp. 12-15.
Hepatitis C Clinical Management Program, supra note 9, pp. 1-2.

6

The selectiveness of CDC’s screening procedure for HCV is controversial.
Because of the high prevalence of hepatitis among prison inmates, some states subject all
incoming prisoners to hepatitis C testing. Indiana, for example, requires mandatory
screening of all incoming prisoners for HCV and HIV.13 The Centers for Disease Control
recommends expanded or universal testing of inmates when the prevalence of risk factors
for infection is greater than 75%, and a high prevalence of HCV exists among inmates
who deny risk factors.14
B. HCCMP Phase II: Initial Management After Diagnosis of HCV
After a patient has been diagnosed with hepatitis C, s/he enters phase II of the
HCCMP. In phase II, the patient receives information about hepatitis C, receives
vaccinations against hepatitis A and B, and is evaluated to determine whether s/he
qualifies for a liver biopsy. Qualifying patients are counseled about the biopsy
requirement, available medical treatments, possible side effects, and likelihood of
treatment success. Phase II generally lasts for approximately two months.15
During phase II, several categories of patients are disqualified for liver biopsy and
treatment. For example, patients under 45 years of age are subjected to monthly ALT
tests for three months; if none of the tests show ALT levels at least two times normal,
they are not eligible for treatment. Other patients ineligible for biopsy and treatment
include patients who will be unable to complete a course of therapy prior to their release
date. Because the length of medical treatment depends on the genotype of hepatitis C
with which a patient is afflicted, patients with genotype 2 or 3 HCV are ineligible for
13

Allen, Scott. Developing a Systematic Approach to Hepatitis C for Correctional Systems: Controversies
and Emerging Consensus (April 2003). www.idcronline.org/archives/april03/mainarticle.html
14
Centers for Disease Control and Prevention. Prevention and Control of Infections with Hepatitis Viruses
in Correctional Settings. MMWR 2003; 52 (No. RR-1): 1-34, 24.
15
Hepatitis C Clinical Management Program, supra note 9, pp. 2-4.

7

treatment if they will be released within ten months of referral for biopsy. Patients with
genotype 1, 4 or 6 HCV are ineligible for treatment if they will be released within sixteen
months of biopsy referral. Patients are also ineligible for treatment if they have various
medical or psychological conditions, if they have a recent history of high-risk behaviors,
if they are unable to cooperate with treatment or give informed consent, if they are
greater than 60 years old, or if they are pregnant.16
Problem #1: Denying Diagnosis and Treatment to Patients with Normal ALT Levels
CDC Deviation from the Ordinary Standard of Care: The blanket
exclusion from treatment of patients under 45 without elevated ALT
levels is not supported by current medical literature, which recommends
individualized therapy decisions that look to ALT levels as only one
factor in making a therapy decision.
CPF Recommendation: Because CDC’s policy of denying biopsy to
patients with normal or slightly elevated ALT levels does not conform
with the current medical consensus on treatment of hepatitis C, the
policy should be abolished.
The blanket exclusion from treatment of patients under 45 without elevated ALT
levels is not supported by current medical literature, which recommends individualized
therapy decisions that look to ALT levels as only one factor in making a therapy decision.
According to the National Institutes of Health 2002 Consensus Statement on
Management of Hepatitis C, ALT levels are a “relatively insensitive” means of assessing
disease activity:
A single determination of ALT level gives limited
information about the severity of the underlying liver
disease. In most studies, a weak association exists between
the degree of ALT elevation and severity of the
histopathological findings on liver biopsy. Serial
determinations of ALT levels over time may provide a

16

Id., Attachment C: Exclusion Criteria for Combination Therapy.

8

better means of assessing liver injury, but the accuracy of
this approach has not been well documented.17
Even for patients with normal levels of ALT liver enzymes, the NIH recommends liver
biopsy as an invaluable source of information for making informed treatment decisions:
Liver biopsy provides a unique source of information on
fibrosis and assessment of histology. Liver enzymes have
shown little value in predicting fibrosis. . . . Moreover, only
liver biopsy provides information on possible contributions
of iron, steatosis, and concurrent alcoholic liver disease to
the progression of chronic hepatitis C toward cirrhosis.
Although unexpected etiologies of liver disease are rarely
discovered on liver biopsies from patients undergoing
evaluation of chronic hepatitis C, the information obtained
on liver biopsy allows affected individuals to make more
informed choices about the initiation or postponement of
antiviral treatment. Thus, the liver biopsy is a useful part
of the informed consent process.18
The American Association for the Study of Liver Diseases (AASLD) concurs that ALT
levels should not be used to withhold a biopsy or therapy, making the recommendation
that
Regardless of the serum aminotransferase levels, the
decision to initiate therapy with interferon and ribavirin
should be individualized based on the severity of liver
disease by liver biopsy, the potential of serious side effects,
the likelihood of response, and the presence of comorbid
conditions.19
Because CDC’s policy of denying biopsy to patients with normal or slightly elevated
ALT levels does not conform with the current medical consensus on treatment of
hepatitis C, the policy should be abolished.

17

Management of Hepatitis C: 2002, supra note 3, p. 14.
Id., p. 15.
19
Strader, Wright, Thomas, and Seeff, Diagnosis, Management, and Treatment of Hepatitis C. Hepatology
(vol. 39, no. 4) April 2004, 1147, 1157.
18

9

Problem #2: Withholding Treatment from Patients with Substance Abuse Histories
CDC Deviation from the Ordinary Standard of Care: Patients with a
history of substance abuse within the past 6-12 months are excluded
from treatment.
CPF Recommendation: Because the denial of HCV treatment to patients
with substance abuse problems has no therapeutic justification, CDC
should abolish the policy of excluding such patients from antiviral
treatment, while ensuring that those patients enjoy access to substance
abuse treatment.
CDC’s hepatitis C policies are deficient because the policies exclude persons with
substance abuse problems from treatment. The HCCMP denies biopsy or treatment to
prisoners with “[h]istory of illicit drug use, alcohol or other substance abuse, or other
high risk behaviors currently active or within the past 6-12 months.”20 This denial of care
has no medical basis, according to the NIH Consensus Statement:
Recent, albeit limited, experience has demonstrated the
feasibility and effectiveness of treating chronic hepatitis C
in people who use illicit injection drugs, known as injection
drug users (IDUs). This is potentially important because
injection drug use is the most common risk factor for new
HCV infections in the United States, and successful
treatment may reduce transmission. . . . HCV therapy has
been successful even when the patients have not abstained
from continued drug or alcohol use or are on daily
methadone. . . . Thus, it is recommended that treatment of
active injection drug use be considered on a case-by-case
basis, and that active injection drug use in and of itself not
be used to exclude such patients from antiviral therapy.21
Indeed, there is an emerging consensus in correctional medicine that prison is a relatively
promising environment for hepatitis C treatment for substance abusers and the mentally
ill:

20
21

Hepatitis C Clinical Management Program, supra note 9, Attachment C.
Management of Hepatitis C: 2002, supra note 3, p. 25.

10

Sobriety is largely enforced in the correctional setting,
making it a more stable environment in which to
contemplate medical therapy for HCV infection. . . .
A history of substance abuse is no longer a contraindication
for treatment of chronic HCV infection. Linking medical
therapy with referral to substance abuse treatment,
however, is a good idea. Still, the absence of available
substance abuse treatment programs in a correctional
setting should not be used to justify withholding
treatment.22
Because the denial of HCV treatment to patients with substance abuse problems has no
therapeutic justification, CDC should abolish the policy of excluding such patients from
treatment.
C. HCCMP Phase III: Staging by Liver Biopsy and Combination Therapy
Phase III of the HCCMP begins after a qualifying patient signs a liver biopsy
authorization. The patient’s case is reviewed by the Medical Authorization Review
(MAR) HCV sub-committee for approval of the biopsy. Following biopsy, the MAR
sub-committee reviews a patient’s file for a second time, to make a determination of
whether the patient qualifies for medical treatment, in light of the biopsy results. HIVnegative patients qualify for treatment only if their biopsy results show fibrosis greater
than stage 2. HIV-positive patients qualify for treatment if their biopsy results show
stage 2 fibrosis or greater.23
The prevailing standard of care for patients with HCV genotype 1 is combination
therapy with pegylated interferon and ribavirin for 48 weeks. For patients with HCV
genotypes 2 or 3, the prevailing standard of care is combination therapy with standard

22
23

Developing a Systematic Approach to Hepatitis C for Correctional Systems, supra note 13.
Hepatitis C Clinical Management Program, supra note 9, pp. 4-7.

11

interferon and ribavirin for 24 weeks.24 The CDC follows the prevailing standard of care
in administering these medicines to those whom it treats.
Both interferon and ribavirin commonly cause adverse side effects. Interferon’s
effects include fatigue, headache, myalgias, fever and chills, insomnia, nausea, anorexia,
weight loss, alopecia, irritability, depression, injection site reaction, autoimmune disease
exacerbation, neutropenia, and thrombocytopenia. The effects of ribavirin include cough,
shortness of breath, rash, nausea, anorexia, weight loss, hemolytic anemia, and
teratogenicity. HCV treatment is not recommended for patients with decompensated
liver disease, pregnancy, active autoimmune disease, severe psychiatric disease
(particularly depression), hemolytic anemia, uncontrolled medical disease, poorly
controlled diabetes mellitus, seizures, coronary artery disease, chronic obstructive
pulmonary disease, or a history of heart failure.25 CDC policy excludes such
contraindicated persons from receiving treatment.
Problem #3: Denying Treatment to Patients with Stage 1 or 2 Fibrosis
CDC Deviation from the Ordinary Standard of Care: Patients with stage
1 or 2 fibrosis are not allowed to receive treatment unless they have
stage 2 fibrosis and are HIV-positive.
CPF Recommendation: Patients with stage 2 fibrosis should be eligible
for combination therapy, and a finding that a patient has stage 2 fibrosis
should weigh in favor of receiving such therapy. Patients with stage 1
fibrosis should be considered for therapy on an individualized basis.
The Metavir scoring system identifies four stages in the liver deterioration of a
patient with Hepatitis C. These stages are based on the extent of fibrous scarring, known
as fibrosis. In stage 1, a patient’s liver is starting to show fibrosis within the portal

24

Management of Hepatitis C: 2002, supra note 3, pp. 17-18.
Flamm, Steven. Chronic Hepatitis C Virus Infection. Journal of the American Medical Association (vol.
289, no. 18), May 14, 2003, 2413, 2416.
25

12

regions. In stage 2, fibrous bridges known as septae have developed between portal
regions of the liver (so-called “bridging fibrosis”). In stage 3, the fibrous septae connect
portal regions of the liver to central regions. In stage 4, fibrosis has proceeded to such an
extent that the liver has developed cirrhosis, a condition in which the liver is no longer
able to perform its usual functions. In lay terms, these four stages of liver decay
correspond to mild fibrosis, moderate fibrosis, severe fibrosis, and cirrhosis. Treatment is
advised where a patient’s liver has developed bridging fibrosis—in other words, where
the patient’s liver has reached stage 2 in the Metavir system.26
According to CDC’s Hepatitis C Clinical Management Program, “Inmatepatients whose liver biopsy results are consistent with stage 2 fibrosis or less, and inmatepatients who are HIV infected and whose liver biopsy results are consistent with less than
stage 2 fibrosis, are currently not eligible for combination therapy. . . .” 27 Similarly,
under the Pelican Bay program, “patients with Stage 1 or Stage 2 liver biopsy results are
not offered medicine for HCV.”28
The denial of medicine to patients with stage 2 fibrosis deviates from the current
medical consensus. According to the Practice Guideline of the American Association for
the Study of Liver Diseases, for example, “[m]ore-than-portal fibrosis on liver biopsy
(Metavir > 2 or Ishak > 3) is an important predictor of future progression of liver disease
and the need for HCV treatment.”29 Writing in the Journal of the American Medical
Association, Dr. Steven Flamm argued in 2003 that
Improvements in sustained response rates and better
adverse effect management have increased the indications
26

Diagnosis, Management, and Treatment of Hepatitis C, supra note 19, 1150.
Hepatitis C Clinical Management Program, supra note 9, p. 5.
28
Special Master’s Notice to Inmates Concerning Hepatitis C Disease, supra note 10, p. 5.
29
Diagnosis, Management, and Treatment of Hepatitis C, supra note 19, p. 1151.
27

13

for therapeutic intervention. Patients without
contraindications should be considered for therapy. . . .
individuals who should strongly be considered for therapy
include patients with fibrosis or cirrhosis identified on liver
biopsy, patients with genotype 2 or 3, patients with
symptoms (eg, fatigue), and those with extrahepatic
manifestations.30
According to Flamm, therapy should even be contemplated “on an individual basis” for
asympomatic patients with genotype 1 and no fibrosis, “particularly in young adults or in
highly motivated individuals.”31
According to the Practice Guideline of the AASLD, treatment of patients with
stage 2 fibrosis is “widely accepted.”32 Where a liver biopsy indicates no fibrosis or mild
stage 1 fibrosis, treatment may still be appropriate, but the decision to treat should be
made on an individual basis.33 Although the dangers to the liver of a patient with stage 0
or 1 fibrosis are relatively remote, treatment is more likely to be successful the earlier it is
undertaken.
At least one leading practitioner of correctional medicine has gone on the record
to state that treatment is appropriate for prisoner-patients with stage 2 fibrosis caused by
HCV. According to Scott Allen, Medical Director of the Rhode Island Department of
Corrections,
“Clinically appropriate” patients include those with stage 2,
3, and compensated stage 4 liver disease. Stage 1 rapid
fibrosers (as determined by serial liver biopsies) may also
be considered for treatment. Treatment can safely be
deferred in patients with stage 0-1 fibrosis, although the
decision should be individualized and based on an informed
consultation with the patient.34
30

Chronic Hepatitis C Virus Infection, supra note 25, p. 2416.
Id.
32
Diagnosis, Management, and Treatment of Hepatitis C, supra note 19, p. 1155.
33
Id.
34
Developing a Systematic Approach to Hepatitis C for Correctional Systems, supra note 13.
31

14

Other state prison systems provide treatment for patients with Stage 2 fibrosis. In the
Hawaii prison system, for example, a patient with HCV genotype 1 qualifies for
treatment if his liver biopsy shows “portal or bridging fibrosis and at least moderate
inflammation and necrosis (Stage 2 or 3).”35 Patients with HCV genotypes 2 or 3 receive
treatment regardless of the stage of their fibrosis.
Problem #4: Denying Re-treatment to Relapsers and Non-responders
CDC Deviation from the Ordinary Standard of Care: Patients who do
not respond to an initial course of combination therapy are withdrawn
from therapy and categorically excluded from later treatment.
CPF Recommendation: Nonresponding and relapsing patients should be
considered for retreatment on a case-by-case basis, in accord with the
findings of the NIH Consensus Statement.
Although treatment for HCV genotype 1 lasts for 48 weeks, the efficacy of
treatment can be predicted from the decrease in viral levels in a patient’s bloodstream at
week 12. The goal of treatment is for a patient to achieve a sustained virologic response
(SVR), defined as the absence of HCV in the bloodstream at the end of treatment and six
months later. Patients with HCV genotype 1 who achieve an SVR almost always first
experience a dramatic reduction in the amount of virus in their blood at week 12. This
reduction is known as an early virologic response (EVR). Of those patients who do not
have an EVR by week 12, 97% will not achieve an SVR at the end of treatment.36 Thus,
it is standard medical practice to test genotype 1 patients at week 12 to see if they have
had an EVR. For patients who have not had an EVR, known as non-responders, therapy

35

State of Hawaii Department of Public Safety, Health Care Division, Hepatitis C Screening and
Treatment Guidelines (11/04 update).
36
Diagnosis, Management, and Treatment of Hepatitis C, supra note 19, p. 1154.

15

is often discontinued. Patients who achieve an SVR at the end of treatment but show
HCV in the bloodstream six months later are known as relapsers.
The CDC follows the practice of testing genotype 1 patients three months into
combination therapy to determine virologic response. Those patients who do not
demonstrate an EVR are thereafter excluded from treatment. According to the HCCMP,
“[i]nmate-patients who previously received appropriate combination therapy for HCV but
relapsed, or who did not respond to the therapy are currently not candidates for retreatment.”37
The CDC’s exclusion from re-treatment of relapsers and non-responders does not
conform to the ordinary standard of care. According to the NIH Consensus Statement,
Selected patients who fail to achieve an SVR may benefit
from re-treatment with pegylated interferon-based
regimens. Decisions regarding re-treatment should be based
on (1) previous type of response, (2) the previous therapy
and the difference in potency of the new therapy, (3) the
severity of the underlying liver disease, (4) viral genotype
and other predictive factors for response, and (5) tolerance
of previous therapy and adherence.38
For example, a patient with HCV genotype 2 or 3 who did not respond to standard
interferon plus ribavirin is apparently excluded from retreatment under the HCCMP. The
American Association for the Study of Liver Diseases recommends that such patients
receive individualized consideration to determine whether they might benefit from an
additional course of treatment.39

37

Hepatitis C Clinical Management Program, supra note 9, p. 3.
Management of Hepatitis C: 2002, supra note 3, p. 19.
39
Diagnosis, Management, and Treatment of Hepatitis C, supra note 19, pp. 1155, 1156.
38

16

Conclusion
CDC medical protocols deviate from the current standard of care for treatment of
patients with hepatitis C in four crucial respects relating to exclusion from diagnosis
and/or treatment. All four failures wrongfully deny treatment on a categorical basis
instead of providing the individualized treatment that is required. Equally disturbingly,
under the current medical consensus the presence of stage 2 fibrosis in a patient’s liver
should be a strong factor in favor of administering medical treatment—not a basis for
excluding a patient, as it is under CDC protocols.
Persons with stage 1 or 2 fibrosis, substance abusers, persons with normal ALT
levels, and non-responders may all benefit from treatment, in light of the totality of the
factors in their medical charts. Like all patients with hepatitis C, they are entitled to
individualized treatment decisions based on the progression of their liver disease, the
potential for side effects, the likelihood that they will respond to treatment, and the
presense of co-morbid conditions. To deny these people individual attention is to deprive
them of the minimally-acceptable standard of medical care, as articulated in the National
Institutes of Health Consensus Statement and the Practice Guideline of the American
Association for the Study of Liver Diseases. Not only does this denial infringe on
prisoners’ fundamental right to medical care, it endangers public health in the entire
community.

17

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California Department of Corrections, Health Care Services Division. Hepatitis C
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California Department of Corrections, Population Projections Unit. Population
Projections 2004-2009. Spring 2004.
Centers for Disease Control and Prevention. “Prevention and Control of Infections with
Hepatitis Viruses in Correctional Settings.” Morbidity and Mortality Weekly
Report (vol. 52, no. RR-1), January 24, 2003.
Flamm, Steven. “Chronic Hepatitis C Virus Infection.” Journal of the American
Medical Association (vol. 289, no. 18) May 14, 2003, 2413-2417.
Hagar, John. Special Master’s Notice to Inmates Concerning Hepatitis C Disease. July
2, 2002.
The Inmate Healthcare Challenge: Fixing a Broken System in Light of the Deukmejian
Report. Background Briefing Paper for a Joint Hearing of the Senate Select
Committee on the California Correctional System and Senate Select Committee
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12, 2002, 1-46.
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Tracy. HEPCAP II: Hepatitis C in the California Prisons Project. Center for
AIDS Prevention Studies, Spring 2004.
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Patient Population.” Journal of the American Medical Assocation (vol. 290, no.
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Strader, Doris, Teresa Wright, David Thomas, and Leonard Seef. “AASLD Practice
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18