Twelve-week ravidasvir plus ritonavir-boosted danoprevir and ribavirin for non-cirrhotic HCV genotype 1 patients: A phase 2 study
Journal
Journal of Gastroenterology and Hepatology (Australia)
Journal Volume
33
Journal Issue
8
Pages
1507-1510
Date Issued
2018
Author(s)
Abstract
Background 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
Subjects
danoprevir; efficacy; hepatitis C; interferon free; ravidasvir
SDGs
Other Subjects
danoprevir; 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 Outcome
Publisher
Blackwell Publishing
Type
journal article