Predictive factors for sustained virological response after treatment with pegylated interferon α-2a and ribavirin in patients infected with HCV genotypes 2 and 3.

BACKGROUND: Previous trials have often defined genotype 2 and 3 patients as an "easy to treat" group and guidelines recommend similar management. AIMS: The present study looks for differences between the two genotypes and analyzes predictive factors for SVR. METHODS: Prospective, community-based cohort study involving 421 physicians throughout Germany. The analysis includes 2,347 patients with untreated chronic HCV genotype 2 (n = 391) and 3 (n = 1,956) infection treated with PEG-IFN α-2a plus ribavirin between August 2007 and July 2012. RESULTS: When compared with genotype 2 patients, those with genotype 3 were younger, had a shorter duration of infection, lower values of total cholesterol, LDL cholesterol and BMI, a higher frequency of drug use as infection mode and male gender (p<0.0001, respectively), and a higher APRI score (p<0.005). SVR was higher in genotype 2 when compared with genotype 3 (64.7% vs. 56.9%, p = 0.004). By multivariate analysis of genotype 2 patients, low baseline γ -GT and RVR predicted SVR. In genotype 3 age ≤45 years, cholesterol>130 mg/dl, a low APRI score, and a γ-GT ≥3-times ULN, RVR, and RBV starting dose were associated with SVR by multivariate analysis. CONCLUSIONS: The present study corroborates that liver fibrosis is more pronounced in genotype 3 vs. 2. SVR is higher in genotype 2 versus genotype 3 partly because of follow-up problems in genotype 3 patients, in particular in those infected by drug use. Thus, subgroups of genotype 3 patients have adherence problems and need special attention also because they often have significant liver fibrosis. TRIAL REGISTRATION: Verband Forschender Arzneimittelhersteller e.V., Berlin, Germany ML21645 ClinicalTrials.gov NCT02106156.

Successful treatment of chronic hepatitis C virus infection in severely opioid-dependent patients under heroin maintenance.

BACKGROUND: Severely opioid-dependent patients are at high risk of both acquiring and spreading the hepatitis C virus (HCV). It is uncertain, however, whether these patients are possible candidates for HCV treatment. We therefore explored treatment retention and adherence as well as sustained viral response in co-morbid severely opioid-dependent subjects under heroin maintenance, who previously failed in conventional substitution treatment or were not in any drug treatment. METHODS: All patients in heroin maintenance in the German heroin trial, who received standard antiviral HCV therapy with pegylated interferon and ribavirin, were included. Co-consumption of licit and illicit drugs was tolerated as long as it did not interfere with treatment. RESULTS: Twenty-six patients in heroin maintenance were treated for chronic HCV infection. Both the Global Severity Index of the Symptom Checklist 90-R (average score 65.9) and the Opiate Treatment Index (average score 16.6) indicated relevant co-morbidity. Twenty-one patients (81%) were retained in treatment; the adherence rate was 92%. Eighteen patients (69%) achieved a sustained viral response, with a 100% response rate for genotype 2, 90% for genotype 3, and 42% for genotype 1. DISCUSSION: This is the first study that investigates the feasibility of antiviral HCV treatment in a well-defined sample of co-morbid severely opioid-dependent subjects in heroin maintenance treatment. Viral response rates are comparable to non-drug-user populations. Within a need-adapted treatment setting, HCV treatment may even be extended to difficult-to-treat opioid-dependent patients.