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.
Two recent publications, the MMWR "Recommendation and Report on the Prevention and Control of Infections with Hepatitis Viruses in Correctional Settings"1 and the "2002 NIH Consensus Statement on the Management of Hepatitis C"2 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 settings.
While controversies 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
Controversy: 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.
Emerging Consensus: 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 near term.
Recommendation: 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.
Correctional health 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.
Controversy: 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.
Emerging Consensus: 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:|
- injected drugs intravenously and shared unclean injecting equipment;
- received a clotting factor concentrate produced before 1987;
- were on long-term hemodialysis;
- have evidence of chronic liver disease including persistently abnormal ALT levels; or
- received a transfusion of blood or blood components or an organ transplant before July 1992.
To read the complete report, go to www.cdc.gov/mmwr/preview/mmwrhtml/rr5201a1.htm.
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 table, above) 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
Recommendation: 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.
Controversy: 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.
Emerging Consensus: 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 patients.4
Recommendation: 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.
Controversy: Correctional health care providers and administrators worry that liberal inclusion criteria to treatment will result in an overwhelming demand for therapy.
Emerging Consensus: 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.
Systematic approaches 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.
"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.
Institutions with 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.
Recommendation: 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
Controversy: 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
Emerging Consensus: 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.
The contraindication 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.
Psychiatric illness, 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
Recommendation: 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.
Controversy: 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.
Emerging Consensus: 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
Recommendation: 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.
While screening, 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.
Scott Allen, M.D. is Medical Director at Rhode Island Department of Corrections.
* Disclosure: Nothing to disclose.
Centers for Disease Control and Prevention. Prevention and Control of Infections with Hepatitis Viruses in Correctional Settings. MMWR 2003; 52 (RR-1).
NIH Consensus Statement. Management of Hepatitis C: 2002. June 10-12, 2002. www.consensus.nih.gov.
Hammett T.M. Adopting More Systematic Approaches to Hepatitis C Treatment in Correctional Facilities. Ann Intern Med. 2003;138:235-236.
Sterling R.K. 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.
Cassidy W.M. Treating Hepatitis C in Prisons. Proceedings of the Management of Hepatitis C in Prisons Conference; 2003 Jan 25-26; San Antonio, Texas.
Allen S.A. Hepatitis C: The RI Experience. Proceedings of the Management of Hepatitis C in Prisons Conference; 2003 Jan 25-26; San Antonio, Texas.
Rieger D., Medical Director, Indiana Department of Corrections; personal communications, 2003.
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.
Rieger D. Universal HCV Testing in Indiana: Pros and Cons. Proceedings of the Management of Hepatitis C in Prisons Conference; 2003 Jan 25-26; San Antonio, Texas.
Burnett D. Targeted Testing for Hepatitis C in Wisconsin DOC. Proceedings of the Management of Hepatitis C in Prisons Conference; 2003 Jan 25-26; San Antonio, Texas.
Fried M.W., et al. Peginterferon alfa-2a plus Ribavirin for Chronic Hepatitis C Virus Infection, N Engl J Med, 347(13):975-982.
Falck-Ytter et al. Surprisingly Small Effect of Antiviral Treatment in Patients with Hepatitis C. Ann Intern Med 2002; 136:288-92.
Edlin B.M., et al. Is It Justifiable to Withhold Treatment for Hepatitis C from Illicit-Drug Users? New England Journal of Medicine 2001; 345:211-214.
Hauser P. A Prospective Study of the Incidence and Open-label Treatment of Interferon-induced Major Depressive Disorder in Patients With Hepatitis C. Molecular Psychiatry 2002;7:942-947.
Allen S.A., et al. Treatment of Chronic Hepatitis C in a State Correctional Facility. Ann Intern Med 2003;138:187-190.
Spaulding A., et al. Hepatitis C in State Correctional Facilities. Prev Med. 1999;28:92-100.
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