Efficacy and Safety of All-oral, 12-week Ravidasvir Plus Ritonavir-boosted Danoprevir and Ribavirin in Treatment-naive Noncirrhotic HCV Genotype 1 Patients: Results from a Phase 2/3 Clinical Trial in China
单位：[1]Peking University First Hospital, Beijing, China[2]Peking University People’s Hospital, Beijing, China[3]Guangzhou Eighth People’s Hospital, Guangzhou, China[4]Beijing YouAn Hospital, Capital Medical University, Beijing, China[5]The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou, China浙江大学医学院附属第一医院[6]Sichuan Provincial People’s Hospital, Chengdu, China四川省人民医院[7]West China Hospital, Sichuan University, Chengdu, China四川大学华西医院[8]Xiangya Hospital, Central South University, Changsha, China[9]Henan Provincial People’s Hospital, Zhengzhou, China[10]Liuzhou People’s Hospital, Liuzhou, China[11]Jiangsu Province Hospital, Nanjing, China江苏省人民医院[12]Zhenjiang No.3 People’s Hospital, Zhenjiang, China[13]The Third People’s Hospital of Shenzhen, Shenzhen, China[14]Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China[15]People’s Liberation Army Bayi Hospital, Nanjing, China[16]Shenyang Sixth People’s Hospital, Shenyang, China[17]The 2nd Xiangya Hospital of Central South University, Changsha, China[18]Xixi Hospital of Hangzhou, Hangzhou, China[19]Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China[20]The First Hospital of Jilin University, Changchun, China[21]Baoji Center Hospital, Baoji, China[22]Beijing Ditan Hospital, Beijing, China[23]Huashan Hospital Affiliated to Fudan University, Shanghai, China[24]Chongqing Medical University No.1 Affiliated Hospital, Chongqing, China重庆医科大学附属第一医院[25]The Second Hospital of Nanjing, Nanjing, China[26]Fujian Fuzhou Municipal Infectious Disease Hospital, Fuzhou, China[27]No.1 Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China[28]The First Affiliated Hospital of Guangxi Medical University, Nanning, China[29]Beijing Friendship Hospital, Capital Medical University, Beijing, China首都医科大学附属北京友谊医院[30]Wuhan Union Hospital, Wuhan, China华中科技大学同济医学院附属协和医院[31]Shanghai Public Health Clinical Center, Shanghai, China[32]Foshan No.1 People’s Hospital, Foshan, China[33]The Third Hospital of Hebei Medical University, Shijiazhuang, China[34]Wuhan University Renmin Hospital, Wuhan, China[35]The Affiliated Hospital of Guizhou Medical University, Guiyang, China[36]The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China[37]PLA 302 Hospital, Beijing, China[38]The First Affiliated Hospital of Harbin Medical University, Harbin, China[39]Fuzhou General Hospital of Nanjing Military Command, Fuzhou, China[40]Tang Du Hospital, Fourth military Medical University, Xi’an, China[41]Nanfang Hospital, Nanfang Medical University, Guangzhou, China[42]The 85 branch of the Chinese People’s Liberation Army Hospital, Shanghai, China[43]Ascletis BioScience Co., Ltd. Hangzhou, China[44]Tsinghua Changgeng Hospital, Beijing, China
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-naive 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-naive, 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-naive, 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.
Xiaoyuan Xu,Bo Feng,Yujuan Guan,et al.Efficacy and Safety of All-oral, 12-week Ravidasvir Plus Ritonavir-boosted Danoprevir and Ribavirin in Treatment-naive Noncirrhotic HCV Genotype 1 Patients: Results from a Phase 2/3 Clinical Trial in China[J].JOURNAL of CLINICAL and TRANSLATIONAL HEPATOLOGY.2019,7(3):213-220.doi:10.14218/JCTH.2019.00033.
APA：
Xiaoyuan Xu,Bo Feng,Yujuan Guan,Sujun Zheng,Jifang Sheng...&Lai Wei.(2019).Efficacy and Safety of All-oral, 12-week Ravidasvir Plus Ritonavir-boosted Danoprevir and Ribavirin in Treatment-naive Noncirrhotic HCV Genotype 1 Patients: Results from a Phase 2/3 Clinical Trial in China.JOURNAL of CLINICAL and TRANSLATIONAL HEPATOLOGY,7,(3)
MLA：
Xiaoyuan Xu,et al."Efficacy and Safety of All-oral, 12-week Ravidasvir Plus Ritonavir-boosted Danoprevir and Ribavirin in Treatment-naive Noncirrhotic HCV Genotype 1 Patients: Results from a Phase 2/3 Clinical Trial in China".JOURNAL of CLINICAL and TRANSLATIONAL HEPATOLOGY 7..3(2019):213-220
