Opioid Maintenance Therapy Is Not Associated With Treatment Failure to Hepatitis C Therapy in a Large German Multicenter Cohort

The largest group of newly infected individuals with chronic hepatitis C in the Western World are intravenous drug users. Emerging data support treating individuals with peginterferon and ribavirin for chronic hepatitis C after stabilisation on opioid maintenance therapy (methadone or buprenorphine). However these data are based on small cohorts or substrata from trials with small patient numbers. Here we report data from a cohort of 2422 patients including 333 patients on opioid maintenance therapy. Methods: A total of 3547 patients treated with at least one dose of peginterferon alfa-2b and weight based ribavirin are currently included in a German multicentre cohort. Only patients included in this cohort beyond 72 weeks of baseline were included in this analysis (n = 2422). Patients with missing data at week 72 were counted as treatment failures. Univariate analysis was performed for comparison of demographics in patients on opioid maintenance vs. remaining patients (age, sex, ALT, BMI, HCV-RNA, genotype, ribavirin dose, peginterferon dose). For logistic regression analysis sex, age, baseline HCV-RNA, HCV-genotype, BMI and opioid maintenance were used as independent variables. The dependent variable being HCV-RNA negative (<400 IU/mL) or positive at week 72 (SVR). Results: Patients on opioid maintenance were younger (35.0 ± 9 vs. 42.2 ± 12 years, P < 0.001), and more had genotype 3 (46.0% vs. 31.4%, P < 0.001). HCV-RNA levels were lower (45.8% vs. 61.2% <400,000 IU/mL, P < 0.001). SVR in all patients on opioid maintenance (n = 333) was 64.1% vs. 56.0% in the remaining patients (n = 2089) (P < 0.05, univariate). In logistic regression analysis, variables positively associated with SVR were younger age, HCV-genotype 2/3 and baseline HCV-RNA <400,000 IU/mL (all P < 0.001). Female sex showed a trend for SVR (P = 0.055). Opioid maintenance therapy was not associated with treatment outcomes in the logistic regression analysis. Conclusion: Efficacy of peginterferon and ribavirin was not different for patients on opioid maintenance therapy. Due to favourable factors for SVR such as HCV-genotype 3, younger age, and lower HCV-RNA, patients on opioid maintenance therapy showed a better unadjusted SVR compared to patients not on this therapy. Treatment of patients on opioid maintenance therapy in daily practice is feasible and success rates are not inferior to results from prospective, controlled studies. Background Intravenous (IV) drug users are the largest group of individuals newly infected with the hepatitis C virus (HCV) in the Western World. Emerging data support treating these individuals with peginterferon (PEG-IFN) plus ribavirin (RBV) for chronic hepatitis C after stabilization using opioid maintenance therapy (methadone or buprenorphine). However, these data are based on small cohorts or substrata from clinical trials with small patient numbers.