AbbVie’s investigational fixed-dose combination tablet glecaprevir/pibrentasvir, known as G/P, cured nearly all those with the historically hard-to-treat genotype 3 of hepatitis C virus (HCV) in a recent trial, aidsmap reports. Twelve or 16 weeks of treatment performed very well, even among those treated before and those with cirrhosis.
Researchers conducted a Phase II SURVEYOR-II trial of G/P among 131 people with genotype 3 of hep C. Results were presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.
The 44 participants who did not have cirrhosis and had been treated before—with Sovaldi (sofosbuvir)-based regimens only—were randomized into two even groups to receive either 12 or 16 weeks of treatment with G/P. Among those with cirrhosis, the 40 who were being treated for the first time were given 12 weeks of G/P while the 47 who had been treated before, also with Sovaldi-based regimens only, received 16 weeks of G/P.
The study excluded those with hepatitis B virus (HBV) and HIV.
Among those treated before who did not have cirrhosis, 96 percent of those treated with G/P for 16 weeks achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), compared with 91 percent among those treated for 12 weeks. Among those with cirrhosis, the cure rates were 98 percent for those who had been treated before and who received 12 weeks of G/P and 96 percent for those who had been treated before and who received 16 weeks of G/P.
The participants experienced six serious adverse health events during the trial, although the researchers judged that none were related to G/P. The most commonly experienced adverse health events were fatigue (13 to 34 percent, depending on the study subgroup) and headache (13 to 25 percent). Participants experienced three grade 3 liver enzyme elevations and one grade 3 total bilirubin elevation.
To read the aidsmap article, click here.