Twelve weeks of Bristol-Myers Squibb’s “TRIO” combination pill cured 91 percent of people with genotype 1 of hepatitis C virus (HCV) who did not have cirrhosis in a recent trial. The UNITY-1 trial was a Phase III, open-label study of non-cirrhotic genotype 1’s in which 312 treatment-naive participants and 103 treatment-experienced participants received a fixed-dose, twice-daily combination pill of the NS5A replication complex inhibitor daclatasvir, the NS3 protease inhibitor asunaprevir and the non-nucleoside NS5B polymerase inhibitor beclabuvir for 12 weeks. Results were presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
Seventy-three percent of the participants were genotype 1a.
Ninety-one percent of the study participants achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), including 92 percent of the treatment-naive participants and 89 percent of the treatment-experienced participants.
There were seven cases of serious adverse events, none of which were considered related to the treatment, including three that led participants to discontinue treatment. The most common side effects were headache (26 percent) and fatigue (17 percent).
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