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Efficacy and Safety of All-oral, 12-week Ravidasvir Plus Ritonavir-boosted Danoprevir and Ribavirin in Treatment-naïve Noncirrhotic HCV Genotype 1 Patients: Results from a Phase 2/3 Clinical Trial in China.

Xiaoyuan Xu, Bo Feng, Yujuan Guan, Sujun Zheng, Jifang Sheng, Xingxiang Yang, Yuanji Ma, Yan Huang, Yi Kang, Xiaofeng Wen, Jun Li, Youwen Tan, Qing He, Qing Xie, Maorong Wang, Ping An, Guozhong Gong, Huimin Liu, Qin Ning, Rui Hua, Bo Ning, Wen Xie, Jiming Zhang, Wenxiang Huang, Yongfeng Yang, Minghua Lin, Yingren Zhao, Yanhong Yu, Jidong Jia, Ngliang Yang, Liang Chen, Yinong Ye, Yuemin Nan, Zuojiong Gong, Quan Zhang, Peng Hu, Fusheng Wang, Yongguo Li, Ngliang Li, Zhansheng Jia, Jinlin Hou, Chengwei Chen, Jinzi J. Wu, Lai Wei
Journal of Clinical and Translational Hepatology , Volume 7, pp 213-220; doi:10.14218/JCTH.2019.00033

Abstract: Background and Aims: Ravidasvir (RDV) is a new generation pangenotypic hepatitis C virus (HCV) NS5A inhibitor, with high barrier to baseline resistance-associated species. This is the first phase 2/3 study conducted in Mainland China confirming the efficacy and safety of RDV + ritonavir-boosted danoprevir + ribavirin for 12 weeks in treatment-naïve noncirrhotic patients with genotype 1 infection in a large population. Methods: In this multicenter, randomized, double-blinded, placebo-controlled phase 2/3 trial (NCT03362814), we enrolled 424 treatment-naïve, noncirrhotic adult HCV genotype 1 patients. All patients were randomized at 3:1 ratio to receive a combination of RDV 200mg once daily plus ritonavir-boosted danoprevir 100mg/100mg twice daily and oral ribavirin 1000/1200mg/day (body weight <75/≥75 kg) (n = 318) or placebo (n = 106) for 12 weeks. The primary end-point was the rate of sustained virologic response 12 weeks after the end of treatment, and the safety was evaluated and compared between treatment and placebo groups. Results: The overall rate of sustained virological response at 12 weeks after treatment is 99% (306/309, 95%, CI: 97%-100%) under per protocol set analysis. All patients harboring baseline NS5A resistance-associated species in the treatment group (76/76, per protocol set) achieved sustained virological response at 12 weeks after treatment. No treatment-related serious adverse events were reported. Laboratory abnormalities showed mild or moderate severity (grade 1 and grade 2) in liver function tests. Conclusions: In treatment-naïve, noncirrhotic HCV Chinese patients infected with HCV genotype 1, all-oral regimen of RDV + ritonavir-boosted danoprevir + ribavirin for 12 weeks was highly efficacious, safe, and well tolerated.
Keywords: HCV / noncirrhotic / SVR / Danoprevir / Gt1 / Ravidasvir / treatment-naïve

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