An 8-week regimen of glecaprevir/pibrentasvir (Mavyret; AbbVie) was found to be well-tolerated and was associated with high rates of sustained virologic response 12 weeks after treatment (SVR12) in treatment-naïve patients with chronic hepatitis C virus (HCV) and compensated cirrhosis. The findings come from the ongoing, Phase 3b clinical trial, EXPEDITION-8.

Currently, a 12-week course of Mavyret is indicated for treatment-naïve HCV patients with compensated cirrhosis, while 8-weeks is recommended for those without cirrhosis. In EXPEDITION-8, 280 treatment-naïve HCV patients (genotypes 1, 2, 4, 5, and 6) with compensated cirrhosis were treated with Mavyret for 8-weeks; the primary efficacy measure was SVR12 rate.

In a press release, AbbVie stated that 100% (N=273/273) of patients with genotype 1, 2, 4, 5, and 6 (Cohort 1) achieved SVR12 per protocol analysis; Cohort 2, which includes treatment-naïve genotype 3 patients with compensated cirrhosis (N=60) is still ongoing. Full findings from the study were presented in a late breaking oral session at the AASLD Liver Meeting 2018 in San Francisco.

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To date, no patients have discontinued treatment and no virologic failures have been reported in Cohort 1. Adverse events reported in the study included pruritus (9.6%), fatigue (8.6%), headache (8.2%) and nausea (6.4%).

“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,” said Janet Hammond, MD, PhD, vice president, infectious diseases development, AbbVie.

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