AbbVie’s investigational glecaprevir/pibrentasvir, known as G/P, cured very high rates in a recent trial of those with genotype 1 of hepatitis C virus (HCV) who had failed a previous cure attempt.
AbbVie applied for U.S. Food and Drug Administration (FDA) approval of G/P in December 2016. The FDA recent granted the regimen priority review.
Publishing their findings in the journal Hepatology, researchers studied the efficacy and safety of G/P with or without ribavirin in the Phase II open-label MAGELLAN-1 study. The study included 50 people without cirrhosis who had genotype 1 of hep C and had experienced virologic failure following a previous treatment for the virus.
The participants were randomized to three arms of the study: arm A received 200 milligrams of glecaprevir and 80 mg of pibrentasvir; arm B received 300 mg of glecaprevir, 120 mg of pibrentasvir and 800 mg of ribavirin; and arm C received 300 mg of glecaprevir and 120 mg of pibrentasvir. All received 12 weeks of treatment.
Among those in arms A, B and C, the respective proportion that achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure) was 100 percent (6 of 6), 95 percent (21 of 22) and 86 percent (19 or 22).
One participant in each of arms B and C experienced virologic failure. Two other people in arm C were lost to follow-up.
The majority of adverse health events among the participants were mild. There were no serious adverse health events related to HCV treatment and no relevant abnormalities in lab test results for ALT liver enzymes, total bilirubin or hemoglobin.
The researchers concluded that G/P “was highly efficacious and well-tolerated” in the study population and that the addition of ribavirin did not improve the efficacy of treatment.
To read the study, click here.