The purpose of this study is to evaluate the efficacy, safety and tolerability of Ravidasvir (ASC16) in combination with Ritonavir-boosted Danoprevir(ASC08) and Ribavirin in treatment-naive no-cirrhotic Taiwanese patients who have chronic hepatitis C genotype1.
Name: Ravidasvir
Description: Ravidasvir 200mg tablet administered orally once dailyType: DrugRavidasvir,Danoprevir/r,RBV
Name: Danoprevir
Description: Danoprevir 100mg tablet administered orally twice dailyType: DrugRavidasvir,Danoprevir/r,RBV
Name: Ritonavir
Description: Ritonavir 100mg tablet administered orally twice dailyType: DrugRavidasvir,Danoprevir/r,RBV
Name: Ribavirin
Description: Ribavirin(RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)administered orallyType: DrugRavidasvir,Danoprevir/r,RBV
Description: SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration
Measure: Proportion of participants with Sustained Virologic Response 12 weeks after end of treatment (SVR12) Time: 12 weeksDescription: SVR24, defined as undetectable HCV RNA 24 weeks after the last day of study drug administration
Measure: Proportion of participants with Sustained virologic response 24 weeks after end of treatment Time: 24 weeksSingle Group Assignment
There is one SNP
- History or presence of decompensated liver disease (history of ascites, hepatic encephalopathy, HCC, or bleeding esophageal varices) - Presence or history of non-hepatitis C chronic liver disease, including but not limited to, autoimmune hepatitis, α-1-antitrypsin deficiency, C282Y homozygous hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, and porphyria cutanea tarda causing liver pathology or requiring phlebotomy - Positive hepatitis B surface antigen or HIV antibody at screening - History or presence of liver cirrhosis - History of severe psychiatric disease, including psychosis and/or depression, who is not able to participate or able to give written informed consent and to comply with the study restrictions - History of active malignancy within the last 5 years, with the exception of localized or in situ carcinoma (e.g., basal or squamous cell carcinoma of the skin) - History of severe cardiac disease (e.g., New York Heart Association Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmia's requiring ongoing treatment, unstable angina or other unstable, uncontrolled or significant cardiovascular disease within 6 months). --- C282Y ---