Published in:
Open Access
01-07-2018 | Original Article
Sofosbuvir–velpatasvir plus ribavirin in Japanese patients with genotype 1 or 2 hepatitis C who failed direct-acting antivirals
Authors:
Namiki Izumi, Tetsuo Takehara, Kazuaki Chayama, Hiroshi Yatsuhashi, Koichi Takaguchi, Tatsuya Ide, Masayuki Kurosaki, Yoshiyuki Ueno, Hidenori Toyoda, Satoru Kakizaki, Yasuhito Tanaka, Yoshiiku Kawakami, Hirayuki Enomoto, Fusao Ikeda, Deyuan Jiang, Shampa De-Oertel, Brian L. McNabb, Gregory Camus, Luisa M. Stamm, Diana M. Brainard, John G. McHutchison, Satoshi Mochida, Masashi Mizokami
Published in:
Hepatology International
|
Issue 4/2018
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Abstract
Background/purpose
In Japan, there is a growing population of patients with chronic hepatitis C virus (HCV) infection who failed a direct-acting antiviral (DAA)-based regimen. In this Phase 3 study, we evaluated sofosbuvir–velpatasvir plus ribavirin in Japanese patients with genotype 1 or 2 HCV infection who previously received DAAs.
Methods
Patients were randomized 1:1 to receive sofosbuvir–velpatasvir plus ribavirin for 12 or 24 weeks. Randomization was stratified by HCV genotype and presence of cirrhosis. The primary endpoint was sustained virologic response 12-week post-treatment (SVR12).
Results
Of 117 participants, 81% had HCV genotype 1 infection, 33% had cirrhosis, and 95% had NS5A resistance-associated substitutions (RAS) at baseline. Overall, SVR12 rates were 97% (58/60; 95% CI 88–100%) with 24 weeks of treatment and 82% (47/57; 95% CI 70–91%) with 12 weeks. For HCV genotype 1 and 2 infected patients, the SVR12 rates with 24 weeks of treatment were 98% and 92%, respectively. In both treatment groups, SVR12 rates in HCV genotype 1 patients were statistically superior to a historical control rate of 50% (p < 0.001). For patients with NS5A RASs at baseline, 85% (46/54) in the 12-week group and 96% (54/56) in the 24-week group achieved SVR12. The most common adverse events were upper respiratory tract viral infection, anemia, and headache. Three (2.6%) patients discontinued treatment because of adverse events.
Conclusion
Sofosbuvir–velpatasvir plus ribavirin was highly effective and well tolerated in Japanese patients who previously failed a DAA-based regimen. Baseline NS5A RASs did not affect treatment outcomes.