Gilead Sciences’ fixed-dose combination pill of Sovaldi (sofosbuvir) and ledipasvir cured 94 percent to 99 percent of those with genotype 1 of hepatitis C virus (HCV) in two large Phase III trials, MedPage Today reports. Notably, the therapy succeeded in doing so without the need for either interferon or ribavirin. Results from the ION-1 and ION-2 trials were presented at the 49th annual meeting of the European Association for the Study of the Liver (EASL) in London and were also published in The New England Journal of Medicine.
In both studies, participants were randomly assigned to receive the combination pill of the polymerase inhibitor Sovaldi and the NS5A inhibitor ledipasvir, with or without ribavirin, for 12 or 24 weeks. ION-1 included 865 treatment-naive participants, 16 percent of whom had compensated cirrhosis. ION-2 included 440 treatment-experienced participants, 20 percent of whom had compensated cirrhosis.
In ION-1’s 12-week groups, 97 percent of those who took ribavirin and 99 percent of those who did not achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). In the 24-week groups, 99 percent of those who took ribavirin and 98 percent of those who did not achieved an SVR12.
In ION-2’s 12-week groups, 96 percent of those who took ribavirin and 94 percent of those who did not achieved an SVR12. Ninety-nine percent of everyone in the 24-week arm was cured. In the 24-week groups, 99 percent of those who took ribavirin and 98 percent of those who did not achieved an SVR12.
A total of 210 people with cirrhosis have undergone treatment in the ION program. Only nine of them have relapsed, eight of whom received just 12 weeks of therapy, suggesting that 24 weeks of therapy may be needed for this group.
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