The correctional system has unique possibilities as an appropriate environment for HCV testing and treatment. Data indicate that as many as 29% to 43% of all HCV RNA positive individuals are annual discharges from prisons or jails.8
Incarceration may be the only time that many inmates intersect with the healthcare system. Treatment in prisons occurs in controlled, directly observed settings potentially allowing for increased compliance and ability to monitor for side effects and complications.
Minimal data exists on HCV infection and treatment response with current standard therapy of PEG-IFN plus RBV in the correctional setting. summarizes all data to date of HCV treatment in this setting. Rates of virologic response to treatment in our cohort are lower than that published in clinical trials in other settings. These response rates are not significantly different from those previously published by our and other groups using non–PEG-IFN. Given the small number of patients in our study, the lower SVR may be explained in part by the number of patients (5 of 33) who were: (1) lost to follow-up after demonstrating a 12-week or 24-week response in viral load (which is highly correlated with ETR and SVR) and completing treatment or (2) lost to follow-up after demonstrating an ETR. The dropout rate was also affected by the inherent flux of the prison population and unforeseeable discharge from the prison in four patients who were initiated on IFN therapy. It is unknown if these patients completed treatment in the community. This highlights the importance of postdischarge planning, adequate community resources, and continuity of care for inmates, in whom the potential exists for successful treatment outcomes.
Summary of All Intraprison Treatment Studies to Date for Chronic HCV Infection
Lower SVR in our study may also be explained by the fact that a significant proportion of patients (37%) included in this study had previously failed standard IFN therapy (monotherapy or combination IFN/RBV therapy). SVR in retreated nonresponders and partial responders is known to be lower than in treatment-naive patients.25
It has been demonstrated that retreatment in relapsers with PEG-IFN and RBV can achieve SVR rates approaching, though still lower than, that in treatment-naive patients.26,27
Retreatment response in all groups is also known to be higher in genotype non-1 patients—a minority of patients in this study had genotype non-1 disease. Given the large dropout rate due to adverse effects to PEG-IFN and RBV (26 out of 71, or 37%), one might consider that those patients who had poor tolerability to standard IFN would also be less likely to tolerate PEG-IFN/RBV therapy. Interestingly, we found no difference in treatment response by treatment history. It is unclear if the factors affecting treatment adherence in our analysis were in the end the same for both the treatment-naive and previously treated groups. It may be that more patients in the treatment-naive group were discharged from the facility before reaching the chosen end points, or were more likely to discontinue treatment due to side effects, than those who had already failed prior treatment and had a second opportunity for treatment. Of note, the dropout rate due to side effects in this study is higher than in our previous treatment group with standard IFN (37% vs. 12%). This may reflect less of a commitment to treatment on the part of the patients in this study group, as compared with the standard IFN group. The standard IFN group was the first to be treated for chronic hepatitis C in the RIDOC. These patients were involved in the campaign for access to treatment and seemed particularly determined to complete treatment despite adverse effects. From the clinical experience of the primary treating provider, the treatment group described in this study seemed less motivated to tolerate side effects. The physical demands of incarceration may also adversely impact the ability of inmates to tolerate treatment, though this may be balanced by efforts to not demonstrate weakness in such a setting. The high dropout rate might be overcome by more aggressive management of side effects by the treating team.
Genotype and race have been independently associated with differential responses to HCV therapy—genotype 1 with lower response rates (42% to 46% vs. 76% to 82% for genotypes 2 and 3) and AA race with lower response rates (19% to 28% vs. 52%).28,29
It is unclear why AA race is associated with lower response rates—whether host or viral factors, such as higher rates of genotype 1 infection, differences in rates of obesity and concomitant nonalcoholic fatty liver or nonalcoholic steatohepatitis, differences in degree of fibrosis or pretreatment level of viremia, or inappropriate therapy (nonweight-based or genotype-based dosing of RBV). Data are limited as AA persons have been understudied in clinical trials for HCV treatment. The few studies evaluating treatment response by AA versus CA race in nonincarcerated populations demonstrate that differential treatment response persists within genotype 1 disease, with lower rates in AA patients, despite controlling for dose of medication, sex, hepatic fibrosis, and HCV-RNA levels.29–31
Although our sample size is small, our data suggest no difference in treatment response by race for genotype 1, similar to findings by Sterling et al18
at the Virginia Department of Corrections and differing from studies in nonincarcerated populations. Maru et al24
at the Connecticut Department of Corrections did not report values for treatment response by race, but found in their study that black race was not correlated with failure to achieve SVR. This raises the question of what impact the treatment environment has on HCV treatment outcomes—perhaps directly observed therapy and close physician, nursing, psychiatric, and substance treatment support can overcome differences in response rates by race, using current guidelines for PEG-IFN and RBV dosing.
Notably, in our study, the 2 AA patients who achieved SVR had multiple negative prognostic factors for treatment success—AA race, genotype 1 disease, and retreatment. Both had early stage fibrosis on liver biopsy, suggesting particular benefit to treating AA patients at earlier stage disease. In fact, most patients (70% of those with liver biopsy, 58% overall) in our study had known early stage disease, and the overall SVR in our study likely reflects successful treatment response in this subgroup. Although some guidelines recommend deferring treatment for minimal fibrosis, our experience suggests that decisions for treatment should be individualized and consider what opportunities exist for an individual to access treatment in the future and achieve treatment response. The correctional setting may present an opportunity to treat those at earlier stage of disease, when the likelihood of achieving SVR is higher. Limitations to our study include its retrospective nature, small sample size, bias in selection of patients for treatment, and limited access to data through chart review.
Our results support the limited existing data that acceptable HCV treatment outcomes can be achieved in prisons using today’s standard-of-care in HCV treatment, PEG-IFN plus weight-based RBV. The HCV-infected population inconsistently intersects with the community healthcare system and inmates bear a remarkable burden of chronic HCV infection. HCV intervention and management in the correctional setting has enormous potential for reducing the burden of disease in the greater public health community and improving health outcomes in this burgeoning population.