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.
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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