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Gilead's Harvoni wins Japanese nod

This article was originally published in Scrip

Executive Summary

Japanese authorities have approved Gilead's once-daily single pill, Harvoni (ledipasvir plus sofosbuvir), for hepatitis C genotype 1 patients. Also approved for genotype 1 patients in Japan are Merck & Co's Vanihep (vaniprevir) and Bristol-Myers Squibb's all-oral, interferon- and ribavirin-free two-pill regimen Daklinza (daclatasvir) and Sunvepra (asunaprevir), as well as Janssen Pharmaceutical's Sovriad (simeprevir). The news comes not long after Gilead's Sovalidi was granted a price well below that set in the US for genotype 2 patients. The Harvoni approval was backed by data from the Phase III clinical trial GS-US-337-0113 with 318 treatment-naïve and treatment-experienced Japanese patients with genotype 1 HCV infection randomized to ledipasvir plus sofosbuvir or ledipasvir plus sofosbuvir plus ribavirin.



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