(By Dongye Han)The American Association for the Study of Liver Diseases (AASLD) will hold its 70th annual meeting in Boston this November, and has received more than 3,300 abstracts around the world. It was recently learned that the Phase II/III clinical study of the Chinese original DAA all-oral regimen for hepatitis C, which was mainly conducted by Professor Lai Wei, the Director of the Hepatobiliary and Pancreatic Center of Beijing Tsinghua Changgung Hospital, has ranked as one of the Top 10% abstracts and was selected for poster presentation by the committee of the AASLD annual meeting. The full title of this research is “ THE EFFICACY AND SAFETY OF RAVIDASVIR COMBINED WITH DANOPREVIR IN THE 12-WEEK ORAL REGIMEN FOR TREATMENT-NAÏVE HCV GENOTYPE 1 ADULT PATIENTS WITHOUT CIRRHOSIS IN CHINA: PHASE II/III CLINICAL TRIAL ”.
According to Wei Lai, this multi-centered, randomized, double-blind, placebo-controlled phase II/III trial enrolled 424 treatment-naïve, non-cirrhotic HCV GT1 adult patients from 42 centers in China. The aim of this study was to analyze the efficacy and safety of Ravidasvir (RDV) and DNVr (Ritonavir-boosted Danoprevir) combined with Ribavirin in the 12-week oral regimen for treatment-naïve HCV GT1 adult patients without cirrhosis in China. The primary efficacy endpoint was virological response (SVR12) rate.
The study concluded that RDV combined with DNVr in the 12-week oral regimen for Chinese treatment-naïve non-cirrhotic GT1 HCV adult patients can achieve high cure rates (SVR12 rates were 99%), and the efficacy is not affected by age, gender, IL28B genotype, HCV RNA levels and NS5A RAS in the baseline. There were no serious adverse events related to treatment during the study period. RDV is a new generation and pan-genotypic NS5A inhibitor with a high resistance barrier developed by Ascletis BioScience in China. RDV combined with DNVr, a Class 1 innovative anti-Hepatitis C drug, which was approved for marketing in early June 2018, composed China's native original interferon-free all-oral regimen for Hepatitis C (RDV/DNV regimen).(Reviewer Bin Shu)