Sofosbuvir plus ribavirin for 12 16 or 24 weeks results in sustained virologic response over 97% in genotype 1 and 6 HCV infection in Hong Kong

Abstract

BACKGROUND & AIMS: In Hong Kong, most patients with hepatitis C virus (HCV) have genotype (GT) 1b or 6a infection. We evaluated the efficacy and safety of sofosbuvir (SOF) 400 mg plus weight-based ribavirin (RBV) 1000-1200 mg in treatment-naı¨ve, HCV genotype 1 or 6-infected patients in Hong Kong. METHODS: Patients in an open-label, Phase 3 study were randomized 1: 1: 1 to SOF + RBV for 12, 16, or 24 weeks. Randomization was stratified by HCV subtype and presence of cirrhosis. The primary endpoint was SVR12 (HCV RNAlower limit of quantitation (LLOQ = 25 IU/mL; COBAS TaqMan HCV Test Version 2.0) 12 weeks after completion of treatment). RESULTS: 31 patients were enrolled. Baseline characteristics are tabulated below. Most patients had favorable predictors of response: 90 % age65 years, 71 % BMI25 kg/m2, 65 % GT1b, 87 % non-cirrhotic, and 87 % IL28B CC genotype. All patients had HCV RNALLOQ by Week 4 and maintained through end-of-treatment. Overall SVR12 was 97 % (30/31); 1 patient in the 24-week group relapsed. Frequent adverse events (AE) reported in C 10 % were malaise, upper respiratory tract infection (URTI), and anemia. No Grade 3 or 4 adverse events (AE) or serious AEs were reported. One patient discontinued SOF + RBV early due to AE of URTI. Three (10 %) patients had treatment-emergent hemoglobin (Hgb)10 g/ dL; no patients had Hgb8.5 g/dL. CONCLUSIONS: The IFN-free SOF + RBV regimen for 12, 16 or 24 weeks was well-tolerated and highly effective in treatment-naı¨ve, HCV GT1b and GT6-infected patients with favorable predictors of response.