Within the US corrections system, chronic hepatitis C virus (HCV) infections and their consequences in terms of morbidity and mortality are major public health concerns. It has been estimated that 12% to 31% of inmates in the United States have chronic HCV infections, whereas the rate is approximately 1.6% in the general population.1, 2 The high prevalence of HCV infections in the prison population is attributable to the frequency of a history of intravenous drug use among inmates: 20% of state inmates and 55% of federal inmates are estimated to have a history of intravenous drug use.3 In addition, up to 83% of intravenous drug users will be incarcerated at some point in their lifetime.4 Chronic HCV infections in the prisoner population result in significant morbidity and a risk of premature death. In the state of Texas, HCV-related mortality increased at a rate of 21% per year from 1994 to 2003.4
Although the treatment of HCV infections in the prisoner population provides an opportunity to make a significant improvement to public health, therapy for HCV among incarcerated patients presents several challenges that make patients in departments of corrections (DOCs) one of the difficult-to-treat groups (as discussed by Aronsohn and Jensen in the first issue of Clinical Liver Disease5). For example, psychiatric side effects were reported in up to 31% of the subjects enrolled in the registration trials of pegylated interferon-α and ribavirin.6, 7 Psychiatric side effects are of particular relevance to the prisoner population because 15% to 24% of inmates in the United States have a severe mental illness, and up to half carry at least one psychiatric diagnosis.8
Published data about the success of HCV treatment in the incarcerated population are highly variable and are limited to observational studies. Initially, standard interferon and ribavirin were used with success rates less than or similar to those reported in the community.9, 10 More recently, treatment with pegylated interferon-α and ribavirin has been reported in the setting of DOCs with sustained virological response (SVR) rates varying from 28% to 52% and with infrequent discontinuation due to medical or psychiatric issues.11–13 None of these studies compared the outcomes of incarcerated patients with the outcomes achieved for a contemporaneous nonincarcerated population.
Recently, we compared the effectiveness of HCV treatment in a cohort of incarcerated patients in the DOC of the state of Wisconsin and in a contemporaneous cohort of nonincarcerated patients in the outpatient practice at the University of Wisconsin Hospital and Clinics.14 We used a structured protocol to determine appropriateness for treatment and to monitor treatment side effects. The extensive use of telemedicine allowed the management of prisoners to continue at the DOC facility with the assistance of our clinic staff (particularly nurse practitioners and physician assistants). With this approach, 521 nonincarcerated patients and 388 incarcerated patients were evaluated for HCV treatment between January 1, 2002 and December 31, 2007. Three hundred nineteen nonincarcerated patients (61.2%) and 234 incarcerated patients (60.3%) underwent treatment with pegylated interferon-α and ribavirin. The incarcerated patients were more likely to be male and African American and to have a history of alcohol or intravenous drug use. The treated incarcerated patients were less likely to have genotype 1 virus and were less likely to have undergone previous treatment. There were similar rates of coinfection with human immunodeficiency virus in the two groups. SVR was achieved in 97 of the 226 (42.9%) incarcerated patients and 115 of the 303 (38.0%) non-incarcerated patients that folowed-up at least six months post-treatment completion. Similar proportions of patients completed the full treatment course in the two groups. According to a stepwise logistic regression, the completion of the full treatment course, a non–genotype 1 virus, a younger age at the treatment start, and a negative human immunodeficiency virus status (but not the incarceration status) were significantly associated with SVR. In summary, we found no differences between the general population and the incarcerated population in terms of the likelihood of starting HCV treatment or ultimately achieving SVR. The foregoing considered only the use of dual therapy with interferon and ribavirin to treat prisoners with HCV infections. There are no data (yet) on the use of direct acting anti-virals in an incarcerated population. The clinical complexity of these regimens, their greater side effect profiles, and their costs are going to stretch the resources of DOCs. However, we believe that our experience allows us propose the following guidelines for the successful treatment of HCV in prisoners:
- 1Good communication between the DOC medical administration, the DOC medical professionals, and the treating liver center staff is essential, and appropriate planning, including the construction of a treatment protocol, should be done before DOC patients are treated with direct-acting antivirals.
- 2The protocol should specify which inmates are eligible for treatment, the relative exclusionary criteria (e.g., major psychiatric illness and comorbid cardiac or pulmonary disease), and the stopping criteria.
- 3All potential candidates for treatment should undergo an evaluation that includes the following:
- aA review of drug interactions with current medications.
- bLaboratory tests.
- cImaging of the liver.
- dA funduscopic eye examination (for patients with hypertension, diabetes, or a history of retinal disease).
- eAn exercise stress test (for patients with cardiac risk factors: males older than 45 years, smokers, and patients with a family history of heart disease).
- 4Written approval from the patient's psychiatric health care provider must be included whenever the patient has a psychiatric history, and a plan must be established for monitoring psychiatric problems that might arise during the treatment of HCV.
- 5The protocol should include the timing of the within-treatment assessment (including laboratory tests) and the process for obtaining laboratory results on a timely basis because these data may influence treatment decisions. Follow-up appointments must be scheduled as dictated by the protocol. With a telemedicine approach, almost all these return appointments can be conducted within the DOC facility.
- 6The protocol should include stepwise responses to unwanted side effects and especially parameters for dose reduction and the use of hematopoietic growth factors.
- 7The dietary requirements of patients on direct-acting antivirals must be addressed with the DOC administration. For example, the DOC administration must be prepared to provide a snack/meal containing 20 g of fat or more every 7 to 9 hours to patients on telaprevir.
- 8Patients must be carefully educated about the treatment and especially about the requirement that no doses of the protease inhibitor should be missed. The side effects that are likely to cause significant illness (severe rash, perianal pain, anemia, malaise, and depression) must be emphasized, and patients must be told what to do if they develop these problems. The patients should be made aware of futility rules.
- 9Perhaps the most important element in a successful program is identifying and supporting a committed DOC staff that is trained in treating patients with protease inhibitors. We believe that giving assistance to the DOC providers is essential; this includes providing easy access for asking questions via phone or email, and in our program, this has been greatly facilitated by telemedicine.
In summary, the antiviral treatment of HCV-infected incarcerated patients not only is effective but also can be as successful as antiviral treatment in the general population. Because of the dismal results of outpatient HCV treatment reported for other high-risk populations in the general community, we propose that incarceration is an optimal setting for treatment, even when challenging therapies such as triple anti-HCV regimens are being used.