All oral fixed-dose combination Sofosbuvir/Ledipasvir with or without Ribavirin for 12 or 24 weeks in treatment-naive genotype 1 HCV-infected patients: the phase 3 ION-1 study
P Buggisch, T Göser, AW Lohse, T Berg, P Galle, H Wedemeyer, G Gerken, S Mauss, R Thimme, P Pang, W Symonds, J McHutchison, L Gallo, T Warger, N Forestier, S Zeuzem · Zeitschrift für Gastroenterologie · 2014 · Heft 08
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Zusammenfassung
Background and aims: The Phase 3 ION-1 study is evaluating whether the fixed-dose combination of sofosbuvir 400 mg/ledipasvir 90 mg (SOF/LDV) can effectively treat a population of treatment-naïve patients with genotype 1 HCV-infection and to determine if ribavirin (RBV) or longer treatment duration is required to achieve a high SVR rate. Methods: HCV-infected patients in the United States and Europe were randomized 1:1:1:1 to receive SOF/LDV ± RBV for 12 or 24 weeks. Randomization was stratified by HCV subtype and presence of cirrhosis. The primary endpoint was SVR12. Results: 865 patients were treated; baseline…
