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Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection: an open‐label, phase 3 trial
Author(s) -
Omata Masao,
Nishiguchi Shuhei,
Ueno Yoshiyuki,
Mochizuki Hitoshi,
Izumi Namiki,
Ikeda Fusao,
Toyoda Hidenori,
Yokosuka Osamu,
Nirei Kazushige,
Genda Takuya,
Umemura Takeji,
Takehara Tetsuo,
Sakamoto Naoya,
Nishigaki Yoichi,
Nakane Kunio,
Toda Nobuo,
Ide Tatsuya,
Yanase Mikio,
Hino Keisuke,
Gao Bing,
Garrison Kimberly L.,
DvorySobol Hadas,
Ishizaki Akinobu,
Omote Masa,
Brainard Diana,
Knox Steven,
Symonds William T.,
McHutchison John G.,
Yatsuhashi Hiroshi,
Mizokami Masashi
Publication year - 2014
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/jvh.12312
Subject(s) - sofosbuvir , ribavirin , medicine , adverse effect , cirrhosis , gastroenterology , hepatitis c , hepatitis c virus , dosing , clinical endpoint , clinical trial , virology , virus
Summary Genotype 2 hepatitis C virus ( HCV ) accounts for up to 30% of chronic HCV infections in Japan. The standard of care for patients with genotype 2 HCV – peginterferon and ribavirin for 24 weeks – is poorly tolerated, especially among older patients and those with advanced liver disease. We conducted a phase 3, open‐label study to assess the efficacy and safety of an all‐oral combination of the NS 5B polymerase inhibitor sofosbuvir and ribavirin in patients with chronic genotype 2 HCV infection in Japan. We enrolled 90 treatment‐naïve and 63 previously treated patients at 20 sites in Japan. All patients received sofosbuvir 400 mg plus ribavirin (weight‐based dosing) for 12 weeks. The primary endpoint was sustained virologic response at 12 weeks after therapy ( SVR 12). Of the 153 patients enrolled and treated, 60% had HCV genotype 2a, 11% had cirrhosis, and 22% were over the aged 65 or older. Overall, 148 patients (97%) achieved SVR 12. Of the 90 treatment‐naïve patients, 88 (98%) achieved SVR 12, and of the 63 previously treated patients, 60 (95%) achieved SVR 12. The rate of SVR 12 was 94% in patients with cirrhosis and in those aged 65 and older. No patients discontinued study treatment due to adverse events. The most common adverse events were nasopharyngitis, anaemia and headache. Twelve weeks of sofosbuvir and ribavirin resulted in high rates of SVR 12 in treatment‐naïve and previously treated patients with chronic genotype 2 HCV infection. The treatment was safe and well tolerated by patients, including the elderly and those with cirrhosis.