Theme: Clinical Research Year: 2017
Background: Data from real world cohorts confirmed the high cure rates (SVR 12) achieved with new direct acting antivirals (DAAs) in clinical trials. Nevertheless, real-world evidence confirming DAA mediated cure rates in OST patients are rare. Aim of this analysis was to evaluate the SVR12 rates for patients with and without OST.
Methods: The DHC-R is a national, multicenter register study in Germany. Patients are treated at physicians’ discretion and the data is collected using a web based system. This preliminary analysis is based on the dataset of 4061 patients (3719 Non-OST and 342 OST patients) which were treated with IFN-free SOF-based regimens between February 1st 2014 and June 30 2016.
Results: Majority of patients was male (OST: 55%, Non-OST: 77.5%). Although OST patients were younger (OST: 46.6 years, Non-OST: 54.5 years), the proportion of cirrhosis was similar (OST: 32.5%, Non-OST: 29.9%). The patients were predominantly GT1 infected (68.4% OST, 81.5% Non-OST). In OST patients GT1a (77.8%) and GT3 (23.4%) were more prevalent compared to Non-OST group (4.1% and 9.4% respectively). Psychiatric comorbidities were more often reported in OST patients (e.g. depression OST: 23.4%, Non-OST: 14.1%). In both groups cannabis was consumed, however the proportion of consuming patients was higher in the OST group (15.2 % versus 2.7 % in Non-OST). More OST patients consumed alcohol (OST 16.4%, Non-OST 11.9%) in general with a higher percentage (22.9%) of an increased alcohol intake > 40 g/d for men or > 30 g/d for women compared to Non-OST (12.6%). Nevertheless both patient groups achieved high SVR12 rates (Non-OST 97.8%, OST 95.6%, per protocol, Intention-To-Treat: Non-OST 92.5% and OST 87.5%) and durable ALT improvement in the follow-up phase.
Conclusion: In our cohort OST patients achieved comparable high SVR12 rates to Non-OST patients despite an increased consumption rate of cannabis and/or alcohol.