Twelve Weeks of Ledipasvir/Sofosbuvir All-oral Regimen for Patients with Chronic Hepatitis C Genotype 2 Infection: Integrated Analysis of Three Clinical Trials.

AIM The combination of ledipasvir and sofosbuvir (LDV/SOF) has been approved for the treatment of various hepatitis C (HCV) genotypes across many countries. This article presents an integrated analysis of three prospective phase 2/3 trials in the Asia-Pacific region to evaluate the efficacy and safety of 12-weeks of LDV/SOF in HCV genotype 2 patients without cirrhosis or with compensated cirrhosis. METHODS 200 patients were included in the integrated analysis. The primary endpoint was the rate of sustained viral response for 12 weeks after the end of therapy (SVR12), analyzed by fibrosis stage, treatment history, HCV genotype subtype and presence of baseline resistance associated substitutions (RASs). Safety was evaluated by adverse events (AEs) and laboratory abnormalities. RESULTS 12-week LDV/SOF was associated with high SVR12 rates (overall 98%) in patients with genotype 2 HCV, irrespective of fibrosis stage, treatment history, genotype 2 subtype and presence of baseline NS5A RAS, and LDV/SOF was well-tolerated. CONCLUSIONS LDV/SOF for 12 weeks provides a highly effective and safe treatment for patients with genotype 2 HCV, including those with advanced fibrosis. As a ribavirin-free and protease inhibitor-free regimen with minimal on-treatment monitoring requirements, LDV/SOF can potentially play a crucial role in achieving the World Health Organization's goal of HCV elimination.