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

Background and Aims Hepatitis C virus ( HCV ) infections with genotype 2 ( GT 2) are generally considered as easy to treat. The current standard therapy is 12 weeks 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. Methods 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. Results A total of 265 (4.3%) of 6034 patients enrolled in the registry were infected with GT 2, and 236 had initiated treatment (60% males, 98% Caucasian, median age 54 years). Treatment with sofosbuvir and ribavirin for 12 weeks achieved SVR at week 12 post‐treatment ( SVR 12) in 136/164 (83%) patients. SVR 12 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 12 weeks per protocol ( PP ), excluding therapy discontinuation or lost to follow‐up, was 135/151 (89%). PP SVR 12 rates were 91% for treatment naïve, 83% for cirrhotic and 80% for treatment‐experienced patients respectively. Conclusions In this large GT 2 cohort, sofosbuvir and ribavirin for 12 weeks achieved lower SVR rates compared to treatment outcomes expected from phase 3 trials. These findings highlight the need for establishing alternative treatment strategies for GT 2 patients, especially in patients with unfavourable outcome factors.