JOURNAL Research Article OF HEPATOLOGY Viral Hepatitis
Effectiveness of ravidasvir plus sofosbuvir in interferon-naïve and treated patients with chronic hepatitis C genotype-4
Graphical abstract Authors
Gamal Esmat, Tamer Elbaz, Maissa El 425 patients screened Raziky, ...,Eric Ruby, Pamela Vig, Imam
300 patients Waked randomized
150 80 70 Correspondence treatment naïve treatment treatment with and experienced experienced Safety population 300 without cirrhosis without cirrhosis with cirrhosis [email protected] 1 excluded 1 excluded RNA <10,000 IU/ml TLC <3,500/ml before first dose before first dose (T. Elbaz) [email protected]
ITT population 149 79 70 (I. Waked) 298 started started started treatment treatment treatment
90 without 59 with cirrhosis cirrhosis Lay summary This study evaluated efficacy and safety of 45 patients 30 patients 29 patients 40 patients 39 patients 35 patients 35 patients Safety 45 patients population RDV + SOF RDV + SOF + RBV RDV + SOF RDV + SOF + RBV RDV + SOF RDV + SOF + RBV RDV + SOF + RBV RDV + SOF + RBV the new oral hepatitis C drug ravidasvir in 300 12 weeks 12 weeks 12 weeks 12 weeks 12 weeks 12 weeks 12 weeks 16 weeks
1 discontinued 1 withdrew 1 died for SAE consent combination with the approved oral drug
1 withdrew consent sofosbuvir in 298 patients infected with
End of treatment 45 patients 44 patients 30 patients 29 patients 38 patients 39 patients 34 patients 35 patients 294 hepatitis C type 4. Our results showed
2 relapse 1 relapse 3 relapse 1 relapse that treatment with ravidasvir plus sofos- 1 died 1 lost to FU buvir, with or without ribavirin, was well 1 withdrew consent tolerated and associated with high SVR12 284* 45 patients 44 patients* 28 patients 26 patients 38 patients 39 patients 31 patients 33 patients* response rate in patients with and 100% 97.8% 93.3% 89.7% 95% 100% 88.6% 94.3% without cirrhosis. 1 lost to FU 1 lost to FU
SVR24 282 45 patients 43 patients 28 patients 26 patients 38 patients 39 patients 31 patients 32 patients
100% 95.6% 93.3% 89.7% 95% 100% 88.6% 91.4%
* Including one patient in each group who missed this visit but had SVR4 and SVR24 response
Highlights Ravidasvir is a new NS5A inhibitor for HCV.