کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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6105496 | 1211149 | 2013 | 6 صفحه PDF | دانلود رایگان |
![عکس صفحه اول مقاله: Sofosbuvir (GS-7977) plus peginterferon/ribavirin in treatment-naïve patients with HCV genotype 1: A randomized, 28-day, dose-ranging trial Sofosbuvir (GS-7977) plus peginterferon/ribavirin in treatment-naïve patients with HCV genotype 1: A randomized, 28-day, dose-ranging trial](/preview/png/6105496.png)
Background & AimsSofosbuvir (formerly GS-7977) is a pyrimidine nucleotide analog inhibitor of the hepatitis C virus (HCV) NS5B polymerase. We assessed the safety, tolerability, antiviral activity, and pharmacokinetics of sofosbuvir plus pegylated-interferon (PegIFN)/ribavirin (RBV) in a 28-day, dose-ranging trial in treatment-naïve patients infected with genotype 1 HCV.MethodsIn this double-blind study, 64 patients were randomized (1:1:1:1) to receive one of three once-daily doses of oral sofosbuvir (100, 200, or 400Â mg) or placebo plus PegIFN/RBV for 28Â days, after which all patients continued to receive PegIFN/RBV alone for a further 44Â weeks.ResultsPatients in the sofosbuvir/PegIFN/RBV groups experienced mean reductions in HCV RNA >5Â log10Â IU/ml (â5.3 for 100Â mg, â5.1 for 200Â mg and â5.3 for 400Â mg) vs. â2.8Â log10Â IU/ml for placebo/PegIFN/RBV after 28Â days. Rapid virologic response (RVR) rates were markedly higher after sofosbuvir treatment (88-94%) than placebo (21%), as were rates of sustained virologic response (SVR) at post-treatment Week 24 (56%, 83%, and 80% for sofosbuvir 100, 200, and 400Â mg, respectively, vs. 43% for placebo). The number of patients experiencing virologic breakthrough and post-treatment relapse was higher in the sofosbuvir 100Â mg group than sofosbuvir 200 and 400Â mg groups. Sofosbuvir was well tolerated; the most frequent adverse events were fatigue and nausea.ConclusionsThese results support further studies with sofosbuvir at 200Â mg and 400Â mg to determine the optimal dose and treatment duration of sofosbuvir in HCV genotype 1.
Journal: Journal of Hepatology - Volume 58, Issue 4, April 2013, Pages 663-668