AbbVie’s Mavyret (glecaprevir/pibrentasvir) cured nearly all those with genotypes 5 and 6 of hepatitis C virus (HCV) in a recent trial.
Researchers from the Phase IIIb ENDURANCE-5, 6 study presented findings at the Annual Meeting of the American Association for the Study of Liver Diseases in San Francisco (The Liver Meeting) and published them in The Lancet Gastroenterology & Hepatology.
The study enrolled 23 people with genotype 5 as well as 61 people with genotype 6. The participants were treated according to Mavyret’s label: with eight weeks of the dual-drug medication if they did not have cirrhosis and 12 weeks if they had compensated cirrhosis (the milder form of the advanced liver disease). The participants were either being treated for the first time or had previously been treated with interferon-based regimens, including with that drug plus Sovaldi (sofosbuvir) and ribavirin.
Three people (13 percent) in the genotype 5 group had cirrhosis, as did six people (10 percent) in the genotype 6 group.
Twenty-two (96 percent) of those in the genotype 5 group achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), as did 60 (98 percent) of those in the genotype 6 group. This translated to an overall cure rate of 98 percent.
The treatment was well tolerated. The participants who experienced adverse health events had mostly mild symptoms. No one stopped treatment early. There were no serious adverse events that the researchers deemed related to Mavyret and no grade 3 or higher increases in ALT liver enzymes or total bilirubin.
The study’s efficacy and safety data were in line with previous major studies of Mavyret treatment among those with genotypes 5 and 6.
To read the study abstract, click here.