Treatment of HCV genotype 2 with sofosbuvir and ribavirin results in lower sustained virological response rates in real life than expected from clinical trials.

Abstract

Hepatitis C virus (HCV) infections with genotype 2 (GT2) are generally considered as easy to treat. The current standard therapy is 12weeks of sofosbuvir and ribavirin. However, sustained virological response (SVR) rates varied substantially in distinct subgroups. Therefore, re-assessing the efficacy of interferon-free therapy in cohorts with larger patient numbers is warranted. The German Hepatitis C registry is a national multicenter cohort. Patients are treated at the discretion of the physician. Data are collected by a web-based data system and confirmed by plausibility checks and on-site monitoring. A total of 265 (4.3%) of 6034 patients enrolled in the registry were infected with GT2, and 236 had initiated treatment (60% males, 98% Caucasian, median age 54years). Treatment with sofosbuvir and ribavirin for 12weeks achieved SVR at week 12 post-treatment (SVR12) in 136/164 (83%) patients. SVR12 rates for this regimen were 80% (35/44) in treatment-experienced patients, 74% (20/27) in cirrhotics and 75% (21/28) in patients with HCV-RNA ≥6 million IU/mL. The overall SVR rate in patients treated with sofosbuvir/ribavirin 12weeks per protocol (PP), excluding therapy discontinuation or lost to follow-up, was 135/151 (89%). PP SVR12 rates were 91% for treatment naïve, 83% for cirrhotic and 80% for treatment-experienced patients respectively. In this large GT2 cohort, sofosbuvir and ribavirin for 12weeks achieved lower SVR rates compared to treatment outcomes expected from phase 3 trials. These findings highlight the need for establishing alternative treatment strategies for GT2 patients, especially in patients with unfavourable outcome factors.