Glecaprevir/pribrentasvir well-tolerated in patients with HCV genotype 1.
The results from a phase 2 trial demonstrated that glecaprevir/pribrentasvir was well-tolerated and highly efficacious in patients with hepatitis C virus (HCV) genotype 1, who previously failed treatment with direct-acting antivirals (DAAs).
The investigational pan-genotypic regimen is a combination of 300 mg of glecaprevir and 130 mg of pibrentasvir, which is administered once-daily in 3 oral tablets, according to Healio.
Included in the phase 2 open-label MAGELLAN-1 study were 50 adult patients with HCV genotype 1 without cirrhosis who previously failed DAA therapy.
The participants were randomized to receive either 200-mg glecaprevir plus 80-mg pibrentasvir (group A); 300-mg glecaprevir plus 120-mg pibrentasvir with 800-mg ribavirin (group b); or 300-mg glecaprevir plus 120-mg pibrentasvir without ribavirin (group C). Enrollment for group A was stopped at 6 patients to optimize dosing
The results of the analysis showed that 92% of all patients achieved sustained virologic response (SVR) at 12 weeks. All of the patients in group A achieved SVR12, compared with 95% in group B and 86% in group C.
None of the patients in group A experienced virologic failure, compared with 1 patient in group B and 1 patient in group C.
Common adverse events (AEs) occurring in 84% of patients included headache, fatigue, nausea, and insomnia. However, these AEs were found to be most common in the ribavirin-containing arm. No serious AEs related to the investigational drug were reported.
“The combination of glecaprevir and pibrentasvir showed potent antiviral activity, regardless of the presence of 1 or more baseline resistance-associated polymorphisms, and irrespective of previous DAA-containing treatment regimes, resulting in high SVR12 rates in non-cirrhotic patients with HCV GT1 infection,” the authors concluded, as reported by Healio. “This suggests the combination … is highly effective in this population which, currently, has limited treatment options.”
Last week the FDA accepted AbbVie’s New Drug Application for glecaprevir/pibrentasvir, granting it priority review.