JIA-HORNG KAOYu M.-L.Chen C.-Y.Peng C.-Y.Chen M.-Y.Tang H.Chen Q.Wu J.J.2021-09-042021-09-0420180815-9319https://www.scopus.com/inward/record.uri?eid=2-s2.0-85043576587&doi=10.1111%2fjgh.14096&partnerID=40&md5=42d64dc9e502b572facc62552c63a86fhttps://scholars.lib.ntu.edu.tw/handle/123456789/581837Background and Aim: The need for all-oral hepatitis C virus (HCV) treatments with higher response rates, improved tolerability, and lower pill burden compared with interferon-inclusive regimen has led to the development of new direct-acting antiviral agents. Ravidasvir (RDV) is a second-generation, pan-genotypic NS5A inhibitor with high barrier to resistance. The aim of this phase 2 study (EVEREST study) was to assess the efficacy and safety of interferon-free, 12-week RDV plus ritonavir-boosted danoprevir (DNVr) and ribavirin (RBV) regimen for treatment-na?ve Asian HCV genotype 1 (GT1) patients without cirrhosis. Methods: A total of 38 treatment-na?ve, non-cirrhotic adult HCV GT1 patients were enrolled in this multicenter, open-label, single-arm phase 2 study (NCT03020095). All patients received a combination of RDV 200?mg once daily (q.d.) plus DNVr 100?mg/100?mg twice daily (b.i.d.) and oral RBV 1000/1200?mg/day (body weight <?75/??75?kg) for 12?weeks. The primary endpoint was the rate of sustained virologic response 12?weeks after the end of treatment (SVR12). Results: Of 38 patients, all (100%) achieved SVR12. During the study, no treatment-related serious adverse events, no patients discontinued treatment due to adverse events, and no deaths were reported. Six of 37 (16%) patients with available sequences had HCV NS5A resistance-associated variants at baseline. All patients (6/6) with baseline NS5A resistance-associated variants achieved SVR12. Conclusions: Twelve-week RDV and DNVr in combination with RBV for 12?weeks achieves the SVR12 rate of 100% in treatment-na?ve non-cirrhotic Asian patients with HCV GT1 infection. This interferon-free regimen is also safe and well tolerated. ? 2018 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltddanoprevir; efficacy; hepatitis C; interferon free; ravidasvir[SDGs]SDG3danoprevir; ravidasvir; ribavirin; ritonavir; antivirus agent; danoprevir; lactam; ribavirin; ritonavir; sulfonamide; aged; anemia; antiviral therapy; Article; Asian; clinical article; coughing; diarrhea; drug efficacy; drug safety; drug tolerability; drug withdrawal; fatigue; female; hepatitis C; Hepatitis C virus genotype 1; human; male; multicenter study; nonhuman; open study; phase 2 clinical trial; priority journal; rash; sustained virologic response; treatment duration; upper respiratory tract infection; adult; Asian continental ancestry group; chronic hepatitis C; clinical trial; combination drug therapy; drug administration; genetics; genotype; Hepacivirus; intraocular drug administration; liver cirrhosis; middle aged; time factor; treatment outcome; very elderly; virology; Administration, Ophthalmic; Adult; Aged; Aged, 80 and over; Antiviral Agents; Asian Continental Ancestry Group; Drug Administration Schedule; Drug Therapy, Combination; Female; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Lactams; Liver Cirrhosis; Male; Middle Aged; Ribavirin; Ritonavir; Sulfonamides; Time Factors; Treatment Outcomejournal article10.1111/jgh.14096293468342-s2.0-85043576587