Directly observed therapy for chronic hepatitis C: a randomized clinical trial in the prison setting.
BACKGROUND
The diagnosis and treatment of chronic hepatitis C are major concerns in prisons.


OBJECTIVE
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.


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.
Servicios Médicos Centro Penitenciario Fontcalent, Alicante 1, Spain. Electronic address: pabloshz@coma.es.
Pablo
P
Saiz de la Hoya
Unidad de Enfermedades Infecciosas y Servicio de Medicina Interna, Hospital General Universitario de Alicante, Universidad Miguel Hernández, Elche, Spain.
Joaquín
J
Portilla
Servicios Médicos Centro Penitenciario Barcelona Hombres, Spain.
Andrés
A
Marco
Servicios Médicos Centro Penitenciario, Castellón 1, Spain.
Julio
J
García-Guerrero
Servicios Médicos Centro Penitenciario, Sevilla 1, Spain.
Inmaculada
I
Faraco
Servicios Médicos Centro Penitenciario Albolote, Granada, Spain.
José
J
Antón
Servicios Médicos Centro Penitenciario Córdoba, Spain.
José
J
de Juan
Servicios Médicos Centro Penitenciario Villabona, Asturias, Spain.
Edelmira
E
Pozo
D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D023801:Directly Observed Therapy; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011330:Prisons; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use
D000998:Antiviral Agents; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a
Chronic hepatitis C; Directly observed therapy; HCC; HCV; Hepatitis C crónica; Interferón pegilado; Pegylated interferon; Ribavirin; Ribavirina; Tratamiento directamente observado