Sofosbuvir plus ribavirin with or without peginterferon for the treatment of hepatitis C virus: Results from a phase 3b study in China |
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| Authors: | Lai Wei Qing Xie Jin Lin Hou Jidong Jia Wu Li Min Xu Jun Li Shanming Wu Jun Cheng Jianning Jiang Guiqiang Wang Yongfeng Yang Zhuangbo Mou Zhi Liang Gao Guozhong Gong Jun Qi Niu Peng Hu Hong Tang Feng Lin Xiaoguang Dou Lanjuan Li Lun Li Zhang Yuemin Nan Benedetta Massetto Jenny C Yang Steven J Knox Kathryn Kersey Polina German Hongmei Mo Deyuan Jiang Diana M Brainard Jiaji Jiang Qin Ning Zhongping Duan |
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| Affiliation: | 1. Peking University People's Hospital, Beijing, China;2. Shanghai Jiaotong University Ruijin Hospital, Shanghai, China;3. Nanfang Hospital of Southern Medical University, Guangzhou, China;4. Beijing Friendship Hospital Affiliated with Capital Medical University, Beijing, China;5. The First Affiliated Hospital of Kunming Medical University, Kunming, China;6. Guangzhou Eighth People's Hospital, Guangzhou, China;7. First Affiliated Hospital, Nanjiang Medical University, Nanjing, China;8. Clinical Center of Shanghai Public Health, Shanghai, China;9. Beijing Ditan Hospital Affiliated with Capital Medical University, Beijing, China;10. The First Affiliated Hospital of Guangxi Medical University, Guangxi, China;11. Peking University First Hospital, Beijing, China;12. The Second Hospital of Nanjing, Nanjing, China;13. Jinan Infectious Disease Hospital, Jinan, China;14. The Third Affiliated Hospital of Sun Yat‐Sen University, Guangzhou, China;15. The Second Xiangya Hospital of Central South University, Changsha, China;16. The First Hospital of Jilin University, Changchun, China;17. The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China;18. West China Hospital, Sichuan University, Chengdu, China;19. Hainan General Hospital, Hainan, China;20. Shengjing Hospital of China Medical University, Shenyang, China;21. The First Affiliated Hospital Zhejiang University Medical College, Hangzhou, China;22. The First Affiliated Hospital of Nanchang University, Nanchang, China;23. The Third Hospital of Hebei Medical University, Hebei, China;24. Gilead Sciences, Inc., Foster City, CA, USA;25. First Affiliated Hospital of Fujian Medical University, Fujian, China;26. Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China;27. Beijing You'an Hospital Affiliated with Capital Medical University, Beijing, China |
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| Abstract: | ![]()
Background and Aim Sofosbuvir is a nucleotide analog inhibitor of the hepatitis C virus (HCV) NS5B RNA polymerase with pangenotypic potency. This phase 3b study evaluated the safety and efficacy of sofosbuvir + ribavirin ± peginterferon in Chinese patients infected with HCV genotype 1, 2, 3, or 6. Methods Patients with genotype 1 or 6 received sofosbuvir + peginterferon/ribavirin for 12 weeks or sofosbuvir + ribavirin for 24 weeks, depending on prior treatment and interferon eligibility. Patients with genotype 2 or 3 received sofosbuvir + ribavirin for 12 or 24 weeks, respectively. The primary endpoint was sustained virologic response at 12 weeks after the end of treatment (SVR12). Results Of 389 patients, 42% had genotype 1, 16% genotype 2, 32% genotype 3, and 9% genotype 6. Half were male, 58% were treatment‐naïve, and 15% had cirrhosis. SVR12 rates for patients receiving 12 weeks of sofosbuvir + peginterferon/ribavirin were 94% (95% confidence interval [CI], 87–98%) for HCV genotype 1 and 97% (95% CI, 84–100%) for genotype 6. SVR12 rates for those receiving sofosbuvir + ribavirin for 24 weeks were 95% (95% CI, 87–99%) for genotype 1, 100% (95% CI, 40–100%) for genotype 6, and 95% (95% CI, 90–98%) for genotype 3. For genotype 2 patients receiving sofosbuvir + ribavirin for 12 weeks, the SVR12 rate was 92% (95% CI, 83–97%). Twenty patients (5%) relapsed. Ten (3%) experienced serious adverse events. Three (< 1%) discontinued treatment because of adverse events, of whom one died because of treatment‐unrelated adverse events. Conclusions Sofosbuvir‐based regimens were highly effective and safe in Chinese patients with HCV genotype 1, 2, 3, or 6, suggesting sofosbuvir could serve as the backbone for HCV treatment in China irrespective of genotype. |
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| Keywords: | direct‐acting antiviral agents NS5B polymerase inhibitor pangenotypic SVR12 |
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