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

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 characteristics and SVR rates will be presented. In the 12-Week groups combined (n = 431), a total of 11 (2.5%) patients failed to achieve SVR, with only 1 patient that relapsed and 10 patients that were lost to follow-up. Efficacy from the 24 Week groups (n = 434) will be presented. The most frequent AEs reported for SOF/LDV were headache (25%), fatigue (23%), and nausea (12%). Thirty-two patients (4%) had treatment-emergent SAEs. No patients receiving 12-Weeks of treatment and 10 patients receiving 24-Weeks of treatment, discontinued therapy due to an AE. No AE leading to discontinuation occurred in > 1 patient. Hemoglobin < 10 g/dL occurred in 8% of patients taking SOF/LDV+RBV and no patients taking SOF/LDV. No other significant laboratory abnormalities were observed.

Conclusions: A single tablet regimen of sofosbuvir/ledipasvir administered once daily for 12 weeks is highly effective and well tolerated in treatment-naïve, genotype 1, HCV-infected patients, including those with cirrhosis. The addition of RBV did not enhance the SVR rate.

Interferonfreie Therapie der Hepatitis C

Freitag, 19. September 2014/10:00 – 11:30/Saal 1