Manuscript of the first all-oral, 12-week, direct-acting antiviral agent (DAA) HCV regimen developed by Ascletis from China was officially published, as titled “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” in the latest issue of the Journal of Clinical and Translational Hepatology (Vol. 7, No. 3, 2019). The principle investigator of the study is Professor Wei Lai, Director, Hepatobiliary and Pancreatic Center, Beijing Tsinghua Chang Gung Hospital, Chair, NAFLD and Alcoholic Liver Disease Special Interest Group (ALD SIG), Past-immediate President, Chinese Society of Hepatology of the Chinese Medical Association.
This study was the first multi-centered, randomized, double-blinded, placebo-controlled phase II/III trial, investigating the first all-oral DAA HCV regimen developed by a domestic company from China. It enrolled 424 treatment-naïve, non-cirrhotic HCV GT1 adult patients (≥18 years old) from 42 centers in China. The primary efficacy endpoint was the rate of sustained virologic response at 12 weeks after the end of treatment (SVR12) and the safety was evaluated and compared between treatment and placebo arms. The results showed that the combination of Ravidasvir Plus Ritonavir-boosted Danoprevir and Ribavirin Regimen demonstrated a cure rate of 99% (SVR12) with a short treatment duration of 12 weeks in treatment-naïve non-cirrhotic HCV genotype 1 Chinese patients, and the efficacy was not affected by baseline NS5A resistance associated substitution (RAS). The RDV/DNVr regimen was with good safety and tolerability.
Ravidasvir is a next-generation, and pan-genotypic HCV NS5A inhibitor developed by Ascletis. Ravidasvir in combination with Danoprevir is the first all-oral, interferon-free, 12-week HCV DAA regimen developed by a domestic company in China. Danoprevir (GANOVO ®, new generation of NS3/4A inhibitor) was approved on June 8, 2018.
The Journal of Clinical and Translational Hepatology （Print ISSN: 2225-0719; Online ISSN: 2310-8819）is a journal of liver disease research founded and published jointly by XIA&HE Publishing Group and the Second Affiliated Hospital of Chongqing Medical University. It focuses on liver disease researches in basic science, clinical studies, or translational medicine perspectives. The editorial board consists of 120 senior liver disease experts from 22 countries and regions, and more than 400 reviewers from 44 countries and regions.