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Positive Results Reported for Sofosbuvir/Ledipasvir in Hepatitis Patients
Positive results have been reported from three phase III clinical trials (ION-1, ION-2, and ION-3) evaluating the investigational once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg and the NS5A inhibitor ledipasvir (LDV) 90 mg (Gilead Sciences, Inc.), with and without ribavirin, for the treatment of genotype-1 chronic hepatitis C virus (HCV) infection.
Across the three studies, 1,952 patients with genotype-1 HCV infection were randomly assigned to receive SOF/LDV with or without ribavirin for 8, 12, or 24 weeks. Of these patients, 1,512 were treatment-naïve; 440 were treatment-experienced; and 224 had compensated cirrhosis.
Of the 1,518 patients assigned to the 12-week arm of the ION-1 trial and to all arms of the ION-2 and ION-3 trials, a total of 1,456 patients (95.9%) achieved the primary efficacy endpoint of a sustained virologic response for 12 weeks (SVR12). Of the 62 patients (4.1%) who failed to achieve SVR12, 36 patients (2.4%) experienced virologic failure: 35 because of relapse and one because of on-treatment breakthrough (with documented noncompliance). Twenty-six patients (1.7%) were lost to follow-up or withdrew consent.
Source: Gilead Sciences, Inc.; December 18, 2013.