Twelve‐week ravidasvir plus ritonavir‐boosted danoprevir and ribavirin for non‐cirrhotic HCV genotype 1 patients: A phase 2 study. Issue 8 (12th March 2018)

• Record Type: Journal Article
• Authors: Kao, Jia‐Horng; Yu, Min‐Lung; Chen, Chi‐Yi; Peng, Cheng‐Yuan; Chen, Ming‐Yao; Tang, Huoling; Chen, Qiaoqiao; Wu, Jinzi J
• Is Part Of: Journal of gastroenterology and hepatology. Volume 33:Issue 8(2018)
• Page Start: 1507
• Page End: 1510
• Publication Date: 2018-03-12
• Subjects: danoprevir -- efficacy -- hepatitis C -- interferon free -- ravidasvir; Gastroenterology -- Periodicals; Digestive organs -- Diseases -- Periodicals; Liver -- Diseases -- Periodicals; Gastroenterology -- Periodicals; Liver Diseases -- Periodicals; 616.33
• DOI: 10.1111/jgh.14096
• Languages: English
• ISSNs: 0815-9319

Abstract

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‐naïve Asian HCV genotype 1 (GT1) patients without cirrhosis. Methods: A total of 38 treatment‐naïve, 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‐naïve non‐cirrhotic Asian patients with HCV GT1 infection. This interferon‐free regimen is also safe and well tolerated.