SOFOSBUVIR PHỐI HỢP RIBAVIRIN CÓ HOẶC KHÔNG CÓ PEGYLATED - INTERFERON TRONG ĐIỀU TRỊ VIÊM GAN C: NGHIÊN CỨU NGẪU NHIÊN ĐA TRUNG TÂM PHA 3B TẠI VIỆT NAM

Abstract

Sofosbuvir is a nucleotide analog inhibitor of the HCV NS5B RNA polymerase with pangenotypic potency. This Phase 3b, multicenter, open - label study evaluated for the first time the safety and efficacy of sofosbuvir + ribavirin ± pegylated - interferon (peginterferon) in Vietnamese patients infected with hepatitis C virus (HCV) genotype 1 or 6. Treatment - naïve patients (± cirrhosis) infected with HCV genotypes 1 or 6 were assigned in a 1: 1 ratio to receive sofosbuvir + peginterferon/ribavirin for 12 weeks or sofosbuvir + ribavirin for 24 weeks. The primary endpoint was sustained virologic response at 12 weeks post - treatment (SVR12). Of the 50 patients enrolled and treated, 60% were genotype 6, 58% were male and 80% had the IL28B CC allele. Three patients

(6%) had cirrhosis. SVR12 rates for patients treated with sofosbuvir + peginterferon/ribavirin for 12 weeks were 100% for both genotype 1 (95% CI, 69 - 100%) and genotype 6 (95% CI, 78 - 100%) infected patients. Treatment with sofosbuvir + ribavirin for 24 weeks resulted in SVR12 rates of 80% (95% CI, 44 - 97%) and 100% (95% CI 78 - 100%) in genotype 1 and genotype 6 patients, respectively. Both patients who did not achieve SVR12 had genotype 1 and experienced virologic relapse. All reported adverse events were mild or moderate in severity. No patients discontinued treatment due to adverse events. In conclusion, sofosbuvir - based regimens were highly effective and safe in Vietnamese patients infected with HCV genotypes 1 or 6.