Treatment of Chronic Hepatitis C in a State Correctional Facility

Context Hepatitis C virus (HCV), the most common bloodborne virus in the United States, causes chronic hepatitis, cirrhosis, and hepatocellular carcinoma. Hepatitis C virus is particularly prevalent among inmates of correctional facilities, but evidence regarding treatment of inmates is sparse. Contribution This observational study describes 90 HCV-infected inmates with sentences of 15 months or greater who were treated with antiviral therapy. Fifty of 79 who were treated for at least 6 months achieved viral clearance. Ten discontinued treatment because of side effects. One died of liver failure. Implications Antiviral therapy for chronic HCV is feasible in correctional settings, but costs and long-term outcomes are unknown. The Editors Over the past decade, chronic hepatitis due to hepatitis C virus (HCV) has emerged as a substantial public health concern. The estimated prevalence of hepatitis C among the entire U.S. population is 1.8% (1). Rates are considerably higher in state and federal correctional facilities (16% to 41%) (2, 3) because of individuals who are at greater risk for having been exposed to the virus, most commonly through shared needles (4). Nearly one third of all Americans infected with HCV pass through correctional facilities annually (5). The challenge of evaluating and caring for as many as one third of all incarcerated individuals with hepatitis C is daunting and has been undertaken despite limited clinical experience relevant to this special population. There are tremendous clinical, financial, and public health implications of evaluation and treatment models for the incarcerated population. Factors that might adversely affect treatment outcomes in patients with HCV in correctional settingssuch as history of substance abuse, psychiatric illness, and poor adherenceare often used to justify withholding treatment. We report on our clinical experience in the evaluation and treatment of 93 individuals at the Rhode Island Department of Corrections, Cranston, Rhode Island, between 1997 and 2001. Methods Background The Rhode Island Department of Corrections is both a jail and a prison. In 2001, the average daily census was 3348, with 16 892 admissions. Cases of chronic hepatitis C were first identified there in the early 1990s. With increased awareness of the disease in the following years, the number of identified patients rapidly exceeded the system's capacity to provide timely off-site subspecialty evaluation. Faced with this challenge, two primary care internists, under the guidance of the infectious diseasestrained medical director, learned to evaluate and treat uncomplicated hepatitis C cases on site. Screening Despite the high prevalence of hepatitis C in this population, universal screening was not performed. Hepatitis C tests were ordered for some patients because of patient request, known risk factors, or elevated aminotransferase levels. A small number of patients were identified through a voluntary seroprevalence study at the facility. Preliminary data from that study indicate that the prevalence of hepatitis C in the facility is roughly 27% (6). Initial Evaluation Given that hepatitis C progresses slowly, the Department of Corrections adopted guidelines requiring that patients have an expected length of stay of at least 15 months for evaluation and uninterrupted treatment in the facility. Patients with a history of addiction were strongly encouraged to enroll in prison substance abuse treatment programs as the foundation of their comprehensive hepatitis C treatment. For the few patients resistant to drug and alcohol rehabilitation, a documented 1-year period of sobriety before initiation of therapy was required. Candidates with a history of depression and other psychiatric disease were referred to a psychiatrist for evaluation and clearance. Treatment was closely coordinated with the psychiatric team, with more frequent follow-up during therapy. Standard blood work and, initially, liver biopsy were required before initiation of treatment. However, with changing community standards, the biopsy requirement was lifted but still recommended (7). Treatment Treatment was individualized for each patient, but standard guidelines were generally followed (8). This report summarizes our experience using standard interferon-2b (3 MU subcutaneously three times a week) with ribavirin (dosage based on weight). Written, informed consent was obtained before the initiation of therapy. Efficacy was determined by measurement of hepatitis C RNA 6 months into treatment. The Department of Corrections' medical budget funded the entire project. Results From 1997 to 2001, 349 patients tested positive for antibody to HCV. Ninety-three patients (27%) were eligible for treatment (Figure). The remainder were not treated because of duration of sentence criteria (43 women, 153 men), spontaneous clearance of the virus (5 women, 25 men), or decision to decline or defer therapy after informed consent discussions (30 men). Figure. Outcome in 93 patients treated for hepatitis C at the Rhode Island Department of Corrections, 19972001. Patient characteristics are summarized in the Table. For the 62 patients in whom genotype was determined, nearly 70% had HCV genotype 1. None of the patients described in this report were co-infected with HIV. Table. Characteristics of 93 Inmates Eligible for Hepatitis C Treatment, Rhode Island Department of Corrections, 19972001 Treatment outcomes are summarized in the Figure. Of all patients who completed treatment and had data available 6 months after treatment, the response rate was 46% (26 of 57). A few patients developed new symptoms or exacerbation of depression and were treated with antidepressant medications and close follow-up by the psychiatric team. No patient had treatment discontinued for psychiatric reasons. No suicidal ideation or attempts were reported. The most common adverse reactions reported by the patients included fatigue; flu-like symptoms, particularly at the initiation of treatment (usually improved with exercise); anorexia; and dry skin. Some patients required dosage adjustment for hematologic abnormalities, but none required discontinuation of therapy for that reason. Therapy was essentially directly observed, with nurses administering all injections and some ribavirin doses. Self-administered ribavirin dosing was monitored by random spot checks of medications kept by the patient. Adherence to therapy exceeded 90%. Discussion This is the first comprehensive description of hepatitis C treatment in a correctional setting. We found that primary care physicians can appropriately manage uncomplicated hepatitis C disease in the correctional setting with results similar to those achieved in the community. With the advent of the more effective pegylated interferon products, even greater benefits should be possible (9). The potential for depression and suicide from interferon has been well documented (10). In the community, many patients with hepatitis C who also have coexisting psychiatric illness are commonly excluded from treatment. In our population, 56 of 93 (60%) patients received psychiatric services at some time during their incarceration. This number includes both those with depression and psychosis and 4 patients with history of suicide attempt. By working closely with our psychiatric team, we have demonstrated that the correctional setting, with its closely monitored environment and well-coordinated team model, provides a unique opportunity to treat patients with hepatitis C in a secure setting that may be a safer environment than other community settings. Most patients we treated have drug dependence histories. Correctional settings allow for the opportunity to treat during a period of forced sobriety. Substance abuse relapse rates may be high in this group; however, with the advent of legal syringe access in Rhode Island through needle exchange, physician syringe prescription, and legal over-the-counter pharmacy sales of syringes, relapse of injection drug use may not necessarily be associated with re-exposure to virus (11). Linking antiviral treatment to substance abuse referral and treatment appears to be a promising strategy. Cost is often cited as a major consideration in formulating treatment protocols in correctional facilities. Although the implications for a correctional health care budget are considerable, models of cost-effectiveness have justified treatment of this disease in the community, even among individuals with histologically mild disease (12). Well-constructed protocols can be developed with a measured effect on correctional health care budgets (4). Dramatically modifying standard treatment protocols to limit access to effective treatment for this high-risk population because of cost considerations alone is neither ethical nor justified from a public health cost perspective. The correctional setting, where a large group of infected patients have gathered, presents one of the most attractive opportunities to affect the reservoir of disease in the larger community. The average length of incarceration in Rhode Island is less than 1 year, and most incarcerated individuals return to their communities. Cost to the Rhode Island Department of Corrections for 48 weeks of interferon with ribavirin was roughly $8000 per patient; laboratory costs were roughly $1500 per patient. The study is limited because it was retrospective, was from a single state, had a small sample size, changed recruitment and treatment protocols over time, and had a limited duration of follow-up. There is also a potential for selection bias given the small percentage of infected inmates treated. Although one patient died in the group, the patient had been excluded from the treatment protocol because of decompensated liver disease and was treated upon the recommendation of a consulting gastroenterologist. This death was not unexpected (10). Our experience in treating prisone