Directly observed therapy for chronic hepatitis C: a randomized clinical trial in the prison setting

Abstract

Background: The diagnosis and treatment of chronic hepatitis C are major concerns in prisons.

Objectives: The aim of this randomized clinical trial was to determine the extent to which directly observed therapy (DOT) improved the efficacy of the standard treatment for chronic hepatitis C in the prison setting.

Patients and methods: A randomized clinical trial was carried out to evaluate the efficacy of a DOT compared with a self-administered therapy in prison inmates who underwent standard treatment for chronic hepatitis C (based on pegylated interferon alpha-2a and ribavirin).

Results: A total of 252 inmates were randomized, of which 244 were analyzed: 109 in the DOT group and 135 in the non-DOT group. The mean age was 35.88 years (SD 6.54), 94.3% were men, 72.1% reported intravenous drug use, 21.3% were HIV co-infected, and 55.3% had genotype 1 or 4. The patients received the study treatment for a median time of 33.9 weeks in the overall sample. Sustained virological response was achieved in 60.6% (95% CI, 51.17-69.22) of the DOT group and in 65.9% (95% CI, 57.59-73.38) of the standard therapy group (risk ratio=0.92; 95% CI, 0.76-1.12). The mean proportion of patients continuing the treatment was 83% (SD=31). Adverse events were reported in 93.4% of the patients, and serious adverse events were reported in 8.2%, with no significant differences between groups.

Conclusions: Sustained virological response was remarkably high, although there were no differences between groups, probably due to high treatment adherence.

Keywords: Chronic hepatitis C; Directly observed therapy; HCC; HCV; Hepatitis C crónica; Interferón pegilado; Pegylated interferon; Ribavirin; Ribavirina; Tratamiento directamente observado.