AbbVie’s investigational glecaprevir/pibrentasvir, known as G/P, cured nearly all those with genotypes 4, 5 and 6 of hepatitis C virus (HCV) in a recent advanced trial. The daily, fixed-dose combination tablet will likely be approved during 2017.
Researchers from the Phase III ENDURANCE-4 trial of 121 people with hep C and no cirrhosis presented their findings at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
Seventy-six of the participants had genotype 4, 26 had genotype 5 and 19 had genotype 6. The trial excluded those with hepatitis B virus (HBV) and HIV. All the participants had previously been treated for hep C with interferon-based regimens.
Eighty-six percent of the participants had no or mild fibrosis (scarring) of the liver, 7 percent had moderate fibrosis and another 7 percent had advanced fibrosis.
Ninety-nine percent of the participants achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure).
The most common adverse health events were headache (21 percent) and fatigue (17 percent). There were no grade 3 adverse events in the participants’ lab test results.
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