Personality disorders do not affect treatment outcomes for chronic HCV infection in Spanish prisoners: the Perseo study.

BACKGROUND: The link between infection with hepatitis C virus (HCV) and personality disorders (PD) has not been investigated in detail. The aim of this study was to compare the effectiveness of HCV treatment in prisoners with and without PD. METHODS: We performed a prospective multicentre study in inmates from 25 Spanish prisons who had been treated with pegylated interferon alfa-2a plus ribavirin in 2011. PD diagnosis was based on the Personality Diagnostic Questionnaire-4+. We calculated adjusted Odds Ratios (AOR) and 95 % confidence intervals (95 % CI) using logistic regression. RESULTS: The sample included 236 patients (mean age: 40.3 years, 92.8 % male, 79.2 % intravenous drug users, and 26.3 % HIV-coinfected). The prevalence of PD was 72.5 %. 32.2 % of patients discontinued treatment; this percentage was higher in patients with HCV genotypes 1/4 (AOR = 3.55; CI:1.76-7.18) and those without PD (AOR = 2.51; 1.23-5.11). Treatment discontinuation was mainly for penitentiary reasons (40.3 %): release or transfer between prisons. The rate of sustained viral response (SVR) was 52.1 % by ITT and 76.9 % by observed treatment (OT). SVR was higher among patients with genotype 2 or 3, and those with low baseline HCV-RNA. We did not observe any differences between individuals with and without PD in term of SVR, HCV genotype or HIV infection. CONCLUSIONS: Our results support the safety and clinical effectiveness of the treatment of chronic HCV infection in correctional facilities, both in prisoners with PD and those without. Our data support non-discrimination between patients with and without PD when offering treatment for HCV infection to prison inmates. TRIAL REGISTRATION: Trial registration number (TRN) NCT01900886 . Date of registration: July 8, 2013.

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. 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.

Personality disorders among Spanish prisoners starting hepatitis C treatment: Prevalence and associated factors.

The purpose of this study was to assess the prevalence of personality disorders (PDs) and their associated factors in prisoners who initiate chronic hepatitis C (CHC) treatment in 25 Spanish prisons. The Personality Diagnostic Questionnaire-4 was used to diagnose PDs according to DSM-IV criteria. Factors potentially associated with a PD diagnosis were evaluated by logistic regression analysis. Two hundred and fifty-five patients were initially assessed and 62 (24.3%) were excluded due to an incomplete or invalid self-report screening questionnaire. PD prevalence was 70.5%, with antisocial PD being the most prevalent (46.1%). In terms of PD clusters, the most prevalent was cluster-B (55.4%). PD diagnosis was associated with HCV genotypes 1, 2, or 3 (odds ratio [OR] 2.14, 95% confidence interval [CI] 1.02-4.49). Patients with a cluster-B PD were more likely to be infected with HCV genotypes 1, 2, or 3 (OR 2.37, 95% CI 1.08-5.23) and be HIV-infected (OR 2.20, 95% CI 1.10-4.39), to report past-year injection drug use (OR 7.17, 95% CI 1.49-34.58), and to have stage 3 or 4 fibrosis (OR 2.16, 95% CI 1.06-4.49). The prevalence of PDs in Spanish prisoners who initiate CHC treatment is very high. PD management issues should be considered in treating CHC patients in prisons.

Multicenter study on the discontinuation and efficacy of chronic hepatitis C treatment in the Spanish penitentiary population (EPIBAND study).

OBJECTIVE: Imprisonment entails a golden opportunity for chronic hepatitis C treatment, as treatment adherence can easily be achieved in this setting. The objective of this study was to determine the proportion and causes of discontinuation of chronic hepatitis C therapy among the Spanish penitentiary population. METHODS: This is an observational, prospective multicenter study performed in 26 Spanish penitentiaries between October 2007 and December 2009. Patients with chronic hepatitis C who were undergoing treatment with pegylated interferon plus ribavirin in accordance with clinical practice were included. The primary variable in the study was the proportion of discontinuation of treatment for chronic hepatitis C. RESULTS: A total of 431 patients were included in this analysis (92.3% male; mean age, 37.9±6.3 years; 66.4% with high viral load; genotype 1, 51.0%; genotype 3, 35.7%; genotype 4, 11.8%; genotype 2, 1.4%; coinfected with HIV, 24.4%). The proportion of treatment discontinuation for chronic hepatitis C was 22.5% (n=97; 95% confidence interval: 18.65-26.75). Therapy discontinuation was more frequent during the first trimester of treatment (n=45; 46.4%), and release from prison was the most frequent cause for treatment discontinuation (n=35; 36.1% of discontinuations). Among 407 patients included in the efficacy analysis, sustained viral response was achieved in 52.1% (95% confidence interval: 47.12-57.02). CONCLUSION: Treatment discontinuation for chronic hepatitis C in the penitentiary setting is low. However, further efforts should be made to improve the coordination between penitentiary institutions and external centers to ensure treatment after the inmates are released or transferred to other prisons.