“The only thing necessary for these diseases to the triumph is for good people and governments to do nothing.”
Systematic Approach to Hepatitis C for Correctional Systems: Controversies
and Emerging Consensus
By Scott Allen, M.D.*,
Medical Director, Rhode Island Department of Corrections
As guidelines for the
diagnosis, evaluation and treatment of chronic hepatitis C virus (HCV)
emerge in the community at large, correctional medical communities are
wrestling with the challenge of establishing an appropriate and consistent
response to an epidemic that disproportionately affects incarcerated
populations. Controversies regarding the management of HCV are brought to a
head in jails and prisons, where there is a high prevalence of disease
(12-35% according to Centers for Disease Control (CDC) estimates1) and a
legal obligation to provide access to medical care.
publications, the MMWR Recommendation and Report on the Prevention and
Control of Infections with Hepatitis Viruses in Correctional Settings1 and
the 2002 NIH Consensus Statement on the Management of Hepatitis C2 begin to
frame the key issues facing correctional health services. Soon after these
reports were published, several hundred correctional administrators,
correctional physicians, hepatologists, infectious disease specialists,
public health professionals and other interested parties met in San Antonio
for a conference on the management of HCV infection in corrections. In the
aftermath of the conference, data shared at the meeting and various
approaches taken by different systems have been discussed and debated. It
should be noted that most of what was discussed at this conference did not
address the unique challenges of HCV management in jail correctional
abound concerning the management of HCV in corrections, the discussion was
notable for several areas of emerging consensus. Perhaps the most noteworthy
was the agreement that all systems need to develop and establish a
systematic approach to the management of HCV infection.3
In this article, I
review existing HCV management controversies from the correctional
perspective, document an emerging consensus among correctional
practitioners, and provide suggestions for future directions in HCV care.
Impact of Disease
While the high prevalence of disease in corrections is widely accepted,
debate has centered on the clinical significance of infection to
correctional health care systems. Given that HCV appears to lead to
morbidity and mortality in only a minority of infected individuals, and for
that minority, progression to fibrosis, cirrhosis and death is expected to
take decades, some argue that the immediate impact to the clinical health of
currently incarcerated inmates should be minimal.
Despite the very recent recognition of the epidemic, available information
suggests that the HCV epidemic among the incarcerated is decades old. Data
from liver biopsies in several correctional systems (including Virginia4
and Louisiana5) show that many patients already have advanced fibrosis and
cirrhosis, consistent with longstanding infection. In other facilities, HCV
infection has emerged as a leading cause of in-custody death.6,7 End-stage
liver disease is now recognized as the leading cause of death in
HIV-positive populations, especially in those patients who are responsive to
HAART.8 Given the prevalence of HCV in corrections and considering
projections from the CDC regarding anticipated cases of cirrhosis, end-stage
liver disease and hepatocellular carcinoma, correctional communities should
anticipate rising morbidity and mortality from HCV-related disease in the
In order to better understand the HCV problem in the correctional setting,
more data need to be collected and shared. Wide variations in rates from
state to state and even from facility to facility are likely. Collecting
national and facility-specific data is essential in order to adapt national
guidelines and recommendations to local HCV management.
care systems, perhaps in conjunction with NIH, CDC, and local or regional
departments of health should consider developing a central database similar
to existing cancer and HIV/AIDS registries. Correctional health care workers
should be encouraged to report and circulate experience and outcome data,
cost-effectiveness data and novel strategies for the diagnosis and
management of HCV infection through peer-reviewed journals, correctional
newsletters, and conferences.
Given the high prevalence of HCV infection in correctional settings, some
have argued in favor of universal screening, while others believe targeted
screening of inmates is the right approach.
Both universal and targeted screening methods have been used in correctional
systems. In Indiana, the legislature recently implemented mandatory
screening of all inmates for HCV and HIV. Testing is performed by the
Indiana Department of Health and requires several blood samples from each
inmate; as a result, correctional health officials had to adjust intake
procedures after the legislation was passed.9
Those at risk for
HCV include persons who:
intravenously and shared unclean injecting equipment;
-received a clotting
factor concentrate produced before 1987;
-were on long-term
-have evidence of
chronic liver disease including persistently abnormal ALT levels; or
transfusion of blood or blood components or an organ transplant before
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Other states use
targeted approaches. In Wisconsin, an innovative risk-based assessment was
performed to target individuals for hepatitis screening.10 Using the
screening criteria of testing all inmates with a history of injection drug
use (IDU), hepatitis B virus infection, or elevated ALT, 90.8% of
individuals with HCV were identified, while only a quarter of the population
(26.8%) required testing. Comparison of expected costs based on 8,000
inmates/year at a reception center with a HCV prevalence of 13.2% (probably
a low figure compared to other states, DOC officials admit) predicted an
estimated $100,000 in savings on blood tests per year.
The new guidelines
published by the CDC suggest that all inmates be questioned regarding risk
factors (see box) for HCV infection during their entry medical evaluations,
and all inmates reporting risk factors for HCV should be tested. As the
specificity of any test is a function of prevalence, the CDC further
recommends that the sensitivity of risk-factor based screening be
periodically determined, and that expanded testing be considered (i.e. to
patients denying risk factors) when risk factor prevalence, including IDU,
is > 75% and prevalence of infection among those who deny risk factors is
also high (>20%).1
The period of incarceration provides an important window of opportunity to
diagnose and educate those at risk for hepatitis C. In addition to providing
an opportunity for the evaluation and treatment of those with HCV, the
identification of infected individuals has the potential to reduce
subsequent transmission in the community. At a minimum, correctional
facilities should have a systematic plan for screening based on risk factors
and disease prevalence in the facility.
While there is widespread agreement that liver biopsy can be a useful tool
to evaluate chronic HCV, the cost-effectiveness of offering biopsies, or
even requiring biopsies is widely debated.
There is general agreement that patients with early stage disease,
particularly those with stage 0-1 disease, can be counseled to defer
treatment. Therefore, liver biopsy may permit clinicians to defer treatment
in some cases, avoiding unnecessary treatment and reducing the overall cost
of care. In Virginia, implementing a management strategy for evaluating and
treating HCV that included liver biopsy was found to be cost-effective. All
inmates in the Virginia Department of Corrections are offered HCV testing,
and those that test positive for HCV RNA are offered liver biopsy. The
Virginia strategy of triaging patients to care or no care depending on liver
biopsy results limits treatment to inmates with "clinically significant"
disease and, according to official estimates, saves almost $125,000 per 100
I believe that liver biopsy is an essential tool in evaluating a patient for
treatment. Although remote facilities may find liver biopsy difficult to
access, biopsy is helpful in counseling the patient on the status of disease
and the relative indication or contraindication for treatment. Given the
data on its cost-effectiveness and clinical utility, biopsy of potential
candidates for treatment is recommended. In patients with infection caused
by genotypes 2 and 3, where 24-week courses of treatment are associated with
high response rates, biopsy may be less important.
Correctional health care providers and administrators worry that liberal
inclusion criteria to treatment will result in an overwhelming demand for
Legal and ethical considerations make it inadvisable to provide barriers to
treatment simply to minimize the cost impact to institutions. However,
clinically based strategies aimed at stratifying candidates for therapy is
defensible and advisable.
that take into consideration a variety of factors, including the likelihood
of progression to cirrhosis based on clinical data and risk factors, allow
for targeting high-risk patients for treatment. Most practitioners are now
selectively advising medical treatment for those HCV-infected inmates who
are clinically appropriate and who are anticipated to remain incarcerated
for the full course of treatment.
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.
clinically defensible systematic approaches - even those with liberal
inclusion criteria - end up treating only a percentage of those patients
potentially eligible for treatment. The vast majority of treatment
candidates will appropriately be deferred to treatment after release due to
short length of incarceration. Of the remainder, a great proportion will
elect to defer treatment after balanced informed consent based on
early-stage disease or documented slow progression.
All correctional health care programs should develop systematic,
evidence-based guidelines for HCV management. Such guidelines, however,
should never supplant the clinical judgement of the clinician, and decisions
should always be made in consultation with the patient. Given the superior
response rates of pegylated interferon plus ribavirin vs. standard
interferon therapy plus ribavirin for treatment of genotype 1, treatment
with pegylated interferon is recommended.11
Patients with Psychiatric Illness
and/or History of Substance Abuse
The correctional population has a high prevalence of individuals with a
history of substance abuse and mental illness - two groups who have
historically been excluded from treatment or who have been associated with
poor treatment outcome.12
Owing to the controlled
environment of the correctional setting, the traditionally challenging
patient groups - those with histories of substance abuse and/or mental
illness - may find themselves in one of the safer environments for therapy
with interferon and ribavirin.
to therapy for HCV infection in those with substance abuse was lifted in the
2002 NIH consensus statement, following a review of the published data
regarding efficacy of treatment of HCV in patients with IDU and
alcoholism.13 However, experts agree that HCV treatment should be coupled
with substance abuse counseling and referral for treatment. Sobriety is
largely enforced in the correctional setting, making it a more stable
environment in which to contemplate medical therapy for HCV infection.
Stable psychiatric illness is no longer considered an absolute
contraindication to treatment with interferon based therapies.
and in particular depression, has historically been seen as a relative
contraindication to therapy given the potential of treatment to cause
depression.14 On the order of a third of all patients treated with
interferon can be expected to develop symptoms of major depression. In
Rhode Island, in a review of 90 patients treated with standard IFN and
ribavirin, 60% of the patients had a history of mental illness, 44% had a
history of depression, 8% were diagnosed with psychosis and 4% had a
documented history of a prior suicide attempt. Patients were stabilized and
cleared by the psychiatry team prior to the initiation of therapy and
followed closely by the psychiatric team during therapy. No patient had to
discontinue therapy due to psychiatric side effects.15
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. Counseling should include discussion
of harm reduction (clean needle access through provider prescriptions,
needle exchange programs and pharmacy purchases, where available) in the
event of relapse of drug use post-treatment.
In facilities where
mental health care is available, an effort should be made to coordinate the
evaluation and treatment of candidates with both chronic HCV infection and
mental health problems. The close clinical follow up available in
correctional settings may provide a safe environment for the treatment of
HCV-infected patients who also have a psychiatric illness. While treatment
of patients with unstable psychiatric illness remains contraindicated,
patients who have clinically stable mental illness may be safely treated.
The decision should be made on a case-by-case basis with input from the
patient, the medical provider and the treating psychiatrist.
High prevalence of HCV combined with historically high utilization of
medical services among inmate patients have caused legitimate concern among
correctional health care administrators that the cost of treatment could
overwhelm already constrained correctional health care budgets.
As previously stated, systematic, clinical-based approaches (such as those
used by the Federal Bureau of Prisons) can direct medical treatment to those
most likely to progress to cirrhosis and are clinically and ethically
justifiable. Within the context of such approaches, only a minority of
patients ultimately receives treatment.16 In Rhode Island, where one of the
more inclusive treatment protocols has been established and the prevalence
of HCV infection stands at 27%, less than 5% of HCV positive patients are
receiving treatment at any given time, and the cost of HCV-related treatment
is limited to 5% of the total healthcare budget.3
Systematic approaches to screening, evaluation and treatment will mitigate
the high cost of HCV care in correctional settings. However, the high
prevalence of HCV infection - a treatable disease - in the context of an
obligation to provide access to care can still be expected to have a
significant impact on correctional budgets in the near term. Continuing
efforts to educate the legislatures, executive branches, public health
agencies and the broader community should be encouraged.
evaluation and treatment inclusion and exclusion criteria for HCV in
corrections will continue to be hotly debated, there is emerging consensus
regarding some aspects of HCV disease management. Chief among them is the
growing recognition that all correctional systems will need to develop and
implement an evidence-based systematic approach to the large numbers of
patients housed within correctional institutions in the United States. As
correctional systems move forward in responding to this challenge, it is
essential that data regarding disease prevalence, morbidity and mortality
and treatment outcomes and cost-effectiveness be collected and disseminated.
Nothing to disclose.
1. Centers for Disease
Control and Prevention. Prevention and Control of Infections with Hepatitis
Viruses in Correctional Settings. MMWR 2003; 52 (RR-1).
2. NIH Consensus
Statement. Management of Hepatitis C: 2002. June 10-12, 2002. http://www.consensus.nih.gov.
3. Hammett TM.
Adopting More Systematic Approaches to Hepatitis C Treatment in Correctional
Facilities. Ann Intern Med. 2003;138:235-236.
4. Sterling RK. Cost
Analysis of Evaluation and Treatment of HCV in the Virginia Department of
Corrections. Proceedings of the Management of Hepatitis C in Prisons
Conference; 2003 Jan 25-26; San Antonio, Texas.
5. Cassidy WM.
Treating Hepatitis C in Prisons. Proceedings of the Management of Hepatitis
C in Prisons Conference; 2003 Jan 25-26; San Antonio, Texas.
6. Allen SA. Hepatitis
C: The RI Experience. Proceedings of the Management of Hepatitis C in
Prisons Conference; 2003 Jan 25-26; San Antonio, Texas.
7. Rieger D., Medical
Director, Indiana Department of Corrections; personal communications, 2003.
8. Baham J, Bick J,
Giannoni D, Harris D, Ruiz J: Trends in an HIV Infected Incarcerated
Population: An Autopsy Review. 40th Annual Meeting of the Infectious
Diseases Society of America, October 2002.
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Targeted Testing for Hepatitis C in Wisconsin DOC. Proceedings of the
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11. Fried MW, et al.
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Infection, N Engl J Med, 347(13):975-982.
12. Falck-Ytter et al.
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13. Edlin BM, et al.
Is It Justifiable to Withhold Treatment for Hepatitis C from Illicit-Drug
Users? New England Journal of Medicine 2001; 345:211-214.
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Prospective Study of the Incidence and Open-label Treatment of
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Internal Medicine 2003;138:187-190.
16. Spaulding A, et
al. Hepatitis C in State Correctional Facilities. Prev Med. 1999;28:92-100.