EXPEDITION-8: Mavyret nearly perfect in 8-week regimen
SAN FRANCISCO — Mavyret yielded nearly perfect SVR rates after 8 weeks of therapy in compensated cirrhosis with HCV, according to data presented at The Liver Meeting 2018.
“Excellent real-world data confirms the high SVR data,” Robert S. Brown Jr., MD, of the Center for Liver Disease and Transplantation at New York Presbyterian Hospital and Cornell Medical College Department of Medicine, said. “The idea came to us to investigate an 8-week duration in treatment-naive patients with compensated cirrhosis, so we were looking at exactly that question.”
Brown presented data for the ongoing phase 3, non-randomized, single arm, open-label, multicenter study in 280 treatment-naive patients dosed with Mavyret (glecaprevir/pibrentasvir, AbbVie). The presentation included data from patients with all HCV genotypes except genotype 3.
The study included both per-protocol and intention-to-treat (ITT) analyses. The per-protocol analysis had a non-inferiority margin of 94% SVR, while the boundary for the ITT analysis was 99%. Virologic failures, relapses, adverse events, and resistance variants comprised secondary endpoints.
Results indicated an SVR rate of 100% in the per protocol analysis and 98% in the ITT population. “There were no virologic failures,” Brown said.
Safety data showed six serious adverse events. “None were determined to be drug-related,” Brown said. No events led to discontinuation of therapies, and no events were seen in more than 10% of the population. “This was consistent with what we’ve seen in prior [glecaprevir/pibrentasvir] trials.”
Brown added that there were no alanine aminotransferase elevations above twice or three times the upper limit of normal. “There were no liver related toxicities,” he added.
Baseline data showed that patients had a mean FibroScan (Echosens) score of 23.7, according to Brown. “Bilirubin was normal,” he said. “About 20% had platelets under 100,000.”
“These results support an 8-week duration of [glecaprevir/pibrentasvir] for treatment-naive patients with HCV,” Brown said. “We eagerly await the genotype 3 data. This adds to our treatment regimen.” – by Rob Volansky
Brown RS, et al. Abstract LB-7. Presented at: The Liver Meeting 2018; Nov. 9-13, 2018; San Francisco.
Disclosure: Brown reports research support from AbbVie, Bristol-Myers Squibb, Gilead, Merck, Johnson and Johnson; and consulting for AbbVie, Bristol-Myers Squibb, Gilead, Merck, and Novartis.