Directly observed therapy for chronic hepatitis C: A randomized clinical trial in the prison setting / Tratamiento directamente observado de la hepatitis C crónica: un ensayo clínico aleatorizado en el ámbito penitenciario

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

RESUMEN

ANTECEDENTES El diagnóstico y tratamiento de la hepatitis C crónica son una preocupación importante en los centros penitenciarios. OBJETIVOS: El propósito de este ensayo clínico aleatorizado fue determinar hasta qué punto el tratamiento directamente observado (TDO) mejoraba la eficacia del tratamiento estándar para la hepatitis C crónica en el ámbito penitenciario. PACIENTES Y MÉTODOS: Ensayo clínico aleatorizado para evaluar la eficacia del TDO comparado con el tratamiento auto-administrado en internos que reciben régimen estándar para la hepatitis C crónica (interferón pegilado alfa-2a y ribavirina). RESULTADOS: Se aleatorizaron un total de 252 sujetos, de los cuales se analizaron 244 109 el grupo TDO y 135 en el grupo no-TDO. La media de edad fue 35,88 (DE 6,54), 94,3% eran hombres,72,1% eran usuarios de drogas intravenosas, 21,3% co-infectados con HIV y 55,3% tenían genotipo1 o 4. En la muestra global, los pacientes recibieron el tratamiento del estudio durante una mediana de tiempo de 33,9 semanas. La respuesta virológica sostenida fue llamativamente elevada, aunque no hubo diferencias entre grupos, probablemente debido a la elevada adherencia al tratamiento en las dos ramas (AU)