In a study involving treatment-naive and treatment-experienced patients of Egyptian ancestry with chronic genotype 4 HCV infection, Sofosbuvir ( Sovaldi ) plus Ribavirin was shown to provide a simple, effective, and well-tolerated, Interferon-free regimen.
After 12 weeks of treatment with Sofosbuvir plus Ribavirin, SVR12 rates were 79% ( 11/14 ) in treatment-naïve patients and 59% ( 10/17 ) in treatment-experienced patients. Extending treatment duration to 24 weeks resulted in higher SVR12 rates in both treatment-naïve and -experienced patients: 100% ( 14/14 ) and 87% ( 13/15 ) respectively.
Relapse accounted for all virological failures except in one treatment-naïve subject receiving 12 weeks treatment who had a partial response.
Most adverse reactions were mild or moderate in severity and consistent with the known side effects of Ribavirin.
In this study, patients, born in Egypt and of Egyptian ancestry, with chronic HCV GT4 infection were randomised 1:1, stratified by prior treatment status and cirrhosis status, to receive 12 or 24 weeks Sofosbuvir ( 400 mg/day ) plus Ribavirin ( 1000-1200 mg/day ). Approximately 20% could have compensated cirrhosis.
Of the 60 patients enrolled, 28 were treatment-naïve and 32 treatment-experienced. 68% were male, 23% cirrhotic, and 17% had the IL28B CC host genotype.
Sofosbuvir is a nucleotide polymerase inhibitor with a high barrier to resistance that is taken as an oral, once-daily formulation. With activity against HCV genotypes 1-6, in-vitro activity of Sofosbuvir against genotype 4a HCV has been shown to be similar to its activity against other HCV genotypes. With more than 3000 patients treated to date, Sofosbuvir appears to be safe and well tolerated.
Source: European Association for the Study of the Liver ( EASL ), 2014