Real-world evidence on all-oral, interferon-free regimens with Ombitasvir/Paritaprevir/r and Dasabuvir for treatment of chronic HCV patients receiving opioid substitution therapy in the German Hepatitis C-Registry

Background: Chronic hepatitis C virus (HCV) infection is highly prevalent in patients with a history of intravenous drug abuse; however historically, implementation of HCV treatment in this patient group in real-world remained challenging. With all-oral, interferon-free HCV regimens available and the favorable setting of opiate substitution treatment (OST), conditions are now potentially more adequate for successful HCV treatment in these patients. In clinical trials with OST patients with chronic HCV genotype 1 (GT1) infection, the regimen of ombitasvir (OBV), paritaprevir (co-dosed with ritonavir [PTV/r]) with dasabuvir (DSV) and/or ribavirin (RBV) achieved a sustained virological response (SVR) rate of 96.4%. However, real-world data on this regimen in this group is currently limited.

Goals: In this analysis, we report the real-world effectiveness, safety and adherence of the treatment regimen of OBV/PTV/r ± DSV ± RBV in patients receiving OST in the German Hepatitis C-Registry (DHC-R).

Methods: The DHC-R is a non-interventional, prospective cohort study with more than 300 study sites in Germany. OST patients with HCV GT1 or GT4 infection treated with the regimen of OBV/PTV/r ± DSV ± RBV between February 1, 2014 and December 7, 2015 were analyzed. Effectiveness was assessed by SVR at post-treatment week 12 or 24 (SVR12/24), safety is reported in all patients that received at least one dose of study drug and overall adherence was assessed by quantification of medication taken.

Results: In total, 67 OST patients received OBV/PTV/r ± DSV ± RBV, with 30 patients having reached post-treatment follow-up. Among patients receiving treatment, 8/67 (12%) had cirrhosis and 31/67 (46%) were treatment-experienced, predominantly to interferon-based therapies. 39/67 (58%), 17/67 (25%) and 11/67 (16%) were infected with HCV GT1a, GT1b or GT4, respectively. All OST patients who reached post-treatment follow-up achieved SVR12/24 (100%; 30/30). Adverse events (AE), predominantly mild or moderate in severity, were reported in 43/67 (64%) of patients. Serious AE were rare (6.0%; 4/67) and treatment discontinuations due to AE were not reported. Overall adherence was very good (100% of medication taken in 27/34; 79%) or good (90 – 100% of medication taken in 6/34; 18%) in the majority of patients.

Conclusions: In this real-world cohort of HCV GT1 and GT4-infected patients, treatment of patients receiving OST with OBV/PTV/r ± DSV ± RBV was well tolerated and achieved high rates of overall adherence and SVR.