Ravidasvir/Sovaldi yields high SVR12 in Egyptian genotype 4 patients

SAN FRANCISCO — A novel combination of ravidasvir and Sovaldi was associated with encouraging sustained viral response rates in a large registrational study in genotype 4 HCV in Egypt, according to findings presented at The Liver Meeting 2015.

“Ravidasvir and sofosbuvir is a promising new once-daily oral treatment,” Gamal Esmat, MD, of Cairo University in Egypt, said during his presentation.

Esmat said genotype 4 HCV accounts for 90% of the disease burden in Egypt. Ravidasvir (Pharco Pharmaceuticals) is an NS5A inhibitor that was administered at a dosage of 200 mg daily along with Sovaldi (sofosbuvir, Gilead) 400 mg daily with or without weight-based ribavirin.

SVR12 served as the primary endpoint and there were 300 patients enrolled in the study.

The study included three primary groups. Group 1a included 90 patients who were treatment-naive without cirrhosis and 60 patients who were treatment-naive with cirrhosis. Group 2 included 80 patients who did not have cirrhosis and were interferon-experienced. Group 3 included 70 patients with cirrhosis who were interferon-experienced. Patients in groups 1 and 2 were randomly assigned ribavirin or no ribavirin in a 1:1 ratio. Patients in group 3 all received ribavirin and were randomly assigned to 12 or 16 weeks of treatment.

Excluding discontinuations unrelated to treatment efficacy or safety, the total SVR12 rate to date was 98% (255/261). The rates were 100% among those without cirrhosis and 94% among those with cirrhosis. While there have been no virologic breakthroughs in the study, there were six relapses, all patients with cirrhosis, with none occurring in the 16-week treatment cohort, Esmat said. The addition of ribavirin had no significant impact on efficacy in patients without cirrhosis or those who were treatment-naive.

“All patients were undetectable by week 8,” Esmat said.

There were five treatment discontinuations.

Safety data indicated that headache, abdominal discomfort, fatigue, pruritis and diarrhea were the most frequently reported

“There was a low incidence of adverse events overall,” Esmat said. “We observed no obvious difference among patient groups.” – by Rob Volansky

Reference:

Esmat G, et al. Abstract LB-4. Presented at: The Liver Meeting; Nov. 13-17, 2015; San Francisco.

Disclosures: Esmat reports no relevant financial disclosures. This study was conducted by Pharco Pharmaceuticals.