AbbVie’s MAVYRET Shows High Virologic Cure Rates in Treatment-Naïve Hepatitis C Patients with Compensated Cirrhosis

AbbVie announced new data for its pan-genotypic chronic hepatitis C virus (HCV) treatment, MAVYRET (glecaprevir/pibrentasvir), in treatment-naïve patients with compensated cirrhosis. Results from the Phase 3b EXPEDITION-8 study showed that with 8 weeks of MAVYRET, 100 percent (n=273/273) of genotype 1, 2, 4, 5 and 6 patients achieved a sustained virologic response 12 weeks after treatment (SVR₁₂) per protocol analysis.

These data are being presented today as a late-breaking, oral presentation at The Liver Meeting 2018 organized by the American Association for the Study of Liver Diseases (AASLD) in San Francisco, California.

“Current guidelines recommend a 12-week pan-genotypic regimen for people who have hepatitis C, are treatment-naïve and have compensated cirrhosis,” said Robert S. Brown, Jr., M.D., the Gladys and Roland Harriman professor of medicine, Weill Cornell Medical College. “We are interested in investigating shorter treatment options, which may simplify care for patients with compensated cirrhosis while providing high cure rates.”

This analysis is part of the ongoing Phase 3b EXPEDITION-8 study evaluating the safety and efficacy of MAVYRET in treatment-naïve chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6).¹ The study includes two cohorts; cohort one with genotype 1, 2, 4, 5, 6 chronic HCV-infected patients, and cohort two with genotype 3 (GT3) chronic HCV-infected patients.

“MAVYRET is already having a significant impact on people living with HCV. However, there are still groups of patients who may benefit from a shorter treatment option,” said Janet Hammond, M.D., Ph.D., vice president, infectious diseases development, AbbVie. “We continue to investigate and understand the value of an 8-week treatment regimen for patients, something we recognize as an important step towards HCV elimination.”

To date, no virologic failures have been reported in cohort one of the study and no patients have discontinued treatment due to adverse events. Adverse events (>5%) reported of the study populations include pruritus (9.6%), fatigue (8.6%), headache (8.2%) and nausea (6.4%). Six serious adverse events (2%) have occurred during the study, none of which were deemed to be related to glecaprevir/pibrentasvir. No new safety signals were identified in this study.

Data from the ongoing EXPEDITION-8 Phase 3b study will be presented as a late-breaking, oral presentation during the Late-breaking Abstract Oral Session II on November 13 at 8:30 a.m. PST.

MAVYRET is approved in the U.S. as a 12-week pan-genotypic treatment for treatment-naïve patients with compensated cirrhosis.