Elimination of hepatitis C. Positioning document of the Spanish Association for the Study of the Liver (AEEH).

The Spanish Association for the Study of the Liver (AEEH) is convinced that the elimination of hepatitis C virus (HCV) in Spain is possible as long as we are able to use the resources and tools necessary for it. This document reflects the position of the AEEH regarding the elimination of HCV, establishing a wide range of recommendations that can be grouped into five categories: 1) Screening of HCV according to age, of the existence of classic acquisition risk factors of infection, active search of previously diagnosed patients and development of microelimination strategies in vulnerable populations; 2) Simplification of HCV diagnosis (one-step diagnosis and diagnosis at the point of patient care); 3) Simplification of patient treatment and improvement of care circuits; 4) Health policy measures, and, finally, 5) Establishment of HCV elimination indicators.

Elimination of hepatitis C. Positioning document of the Spanish Association for the Study of the Liver (AEEH). / Eliminación de la hepatitis C. Documento de posicionamiento de la Asociación Española para el Estudio del Hígado (AEEH).

The Spanish Association for the Study of the Liver (AEEH) is convinced that the elimination of hepatitisC virus (HCV) in Spain is possible as long as we are able to use the resources and tools necessary for it. This document reflects the position of the AEEH regarding the elimination of HCV, establishing a wide range of recommendations that can be grouped into five categories: 1)Screening of HCV according to age, of the existence of classic acquisition risk factors of infection, active search of previously diagnosed patients and development of micro-elimination strategies in vulnerable populations; 2)Simplification of HCV diagnosis (one-step diagnosis and diagnosis at the point of patient care); 3)Simplification of patient treatment and improvement of care circuits; 4)Health policy measures, and, finally, 5)Establishment of HCV elimination indicators.

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.

Dual therapy with darunavir/r plus etravirine is safe and effective as switching therapy in antiretroviral experienced HIV-patients. The BITER Study.

INTRODUCTION: Switching therapy studies are usually designed as second-line antiretroviral treatment (ART) in patients without previous virologic failures. Combined ART (cART) with DRV/r and ETR has a good pharmacokinetic profile, high genetic barrier and has been proved as rescue therapy. The aim of our study was to analyze efficacy and safety of therapy with DRV/r plus ETR in treatment experienced HIV-patients with previous therapeutic failures that need to switch ART. We present results at first 24 weeks. METHODS: Multicentre retrospective observational study. INCLUSION CRITERIA: adult HIV-patients on ART with HIV-VL <1000 cop/mL who started their ART with DRV/r (600/100 bid or 800/100 qd)+ETR by adverse events, non-adherence, tolerability or prevention of future complications. Patients with acute AIDS events, HBV, pregnancy, drug addiction or previous selected mutations to DRV or ETR were excluded. RESULTS: Ninety-nine patients were included, mean age: 47 years (r: 22-79); 70% men, 40.4% previous AIDS event and 39.3% HCV. Ninety-one patients had received ≥3 cART regimens and 45≥5, 75 patients had HIV-VL <50 cop/mL and 24 low-level viremia (LLV): 297.5±261.4 cop/mL, CD4+ 568±279 cells/µL. ART before switching: NRTI+PI/r (33%), NNRTI (17%), PI/r+NNRTI (23%), PI/r+INI (13%), other (14%). Main reason to switching was: toxicity/intolerance 50 patients (renal 32%, gastrointestinal: 14%, hyperlipidaemia 10%; osteopenia/osteoporosis: 6%); improving adherence 26 patients; prevention of complications 19 patients. Nine subjects withdrew ART during follow-up because: intolerance or new toxicity three; non-adherence two; simplification to DRV/r monotherapy two; persistence of previous toxicity one; virologic failure one. At week 24, among patients who continued with DRV/r+ETR (n=90): 81 (89%) had VL<50 cop/mL, in those with with HIV-VL<50 at baseline (67/90), 94% persisted with <50 cop., and in those with LLV (24/90), 61% (n=14) achieved a VL<50 cop. We didn't observe any significant difference in lab parameters between baseline and week 24. Estimated glomerular filtrate rate increased from 83.4±24.7 to 88.5±56.8 mL/min, p=NS. Regarding reason to switching, it improved in 42 cases, no changes: 20 cases; worsened: 4 cases, and non-applicable or unknown: 24 cases. CONCLUSIONS: Switching to dual therapy with DRV/r+ETR is an effective strategy in selected heavily experienced ART patients, even in those with LLV (<1000 cop/mL). This cART is safe and well tolerated, can reduce number of pills and improve adherence.

[Chronic hepatitis C virus infection and associated liver disease among the inmates of a Spanish prison]. / Infección crónica por el virus de la hepatitis C y enfermedad hepática asociada en una prisión española.

OBJECTIVE: The objective of this study was to determine the prevalence and genotype distribution of chronic hepatitis C virus (HCV) infection in a penitentiary population. The secondary objective was to describe histological findings in liver of the biopsied population, and identify risk factors associated with liver fibrosis and inflammatory activity. METHODS: Among 800 inmates, 730 accepted HCV antibody screening and PCR confirmation. Sociodemographic, behavioral, and incarceration-related variables were analyzed. Liver biopsy was offered to individuals with chronic HCV infection. Advanced liver disease was defined as fibrosis 3 and/or an inflammatory activity index score 8). RESULTS: HCV antibodies were found in 279 inmates. PCR confirmed HCV infection in 250 inmates, yielding a prevalence of 34.2% (95% confidence interval [CI]: 30.8-37.8). Intravenous drug use was independently associated with HCV infection, odds ratio (OR) 51.7 (95% CI: 31-86). Genotypes were 1a 32.9%, 3 29.7%, 1b 18.4% and 4 17.1%. Fifty-one liver biopsies were performed; advanced liver disease was found in 7 patients (13.7%) based on fibrosis and in 31 patients (60.7%) based on the inflammatory activity index. High AST and ALT levels were associated with advanced liver disease established on both fibrosis and inflammatory activity (P<.05). Lengthy intravenous drug use was associated with inflammatory activity (P=.02; OR 1.2; 95% CI: 1.03-1.7). CONCLUSIONS: Persistent HCV infection is highly prevalent among prison inmates and is associated with intravenous drug abuse. HCV genotype diversity is higher in prison inmates than in the general population. Higher transaminase levels are associated with advanced liver disease.

[Predictive markers of HIV and HCV infection and co-infection among inmates in a Spanish prison]. / Factores predictivos de infección por el VIH, VHC y coinfección en la población reclusa de una prisión española.

OBJECTIVE: To study the prevalence and factors associated with HIV and HCV infection among inmates of a Spanish prison. METHOD: A cross-sectional study was carried out in July 2001. We determined HCV (ELISA and RIBA-3) and HIV (ELISA and Western-blot) serology in the prison population. Study variables included age, sex, nationality and previous intravenous drug use (IDU). In IDU inmates we analyzed the age when intravenous drug use was initiated, years of consumption, age at first admission in prison and syringe sharing with other inmates. The subpopulations of Arab and Romani (gypsy) inmates were studied differentially. RESULTS: A total of 800 inmates (mean age 34.2 6 6.2 years) were evaluated; 74.3% were Spanish and 33.6% IDU. HCV serology was obtained in 730 inmates and HIV serology in 773 with the following seroprevalence results: HCV 38.2%, HIV 19.1% and HCV-HIV co-infection 18.8%. The variables associated with HCV or HIV infection in the univariate analysis were Spanish nationality, previous IDU and coinfection by the other virus. In the multivariate analysis, only coinfection and, particularly, previous IDU (HCV infection: adjusted ORp 104.8 [95% CI: 49.4-222.2]) (HIV infection adjusted ORp 45.1 [95% CI: 14.0-144.9]) maintained an association with the two infections. CONCLUSIONS: The prevalence of HIV and HCV infection and coinfection is high in Spanish prisons. Infection by either of these viruses and previous IDU were independently associated with both infections. The percentage of non-Spanish inmates with these infections is low.