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news.AbbVie’s Mavyret (glecaprevir/pibrentasvir) has showed high virologic cure rates in treatment-naïve patients with compensated cirrhosis in the phase 3b Expedition-8 study.
Image: AbbVie US headquarters. (Credit: AbbVie)
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The analysis, which is part of the 3b Expedition-8 study, assessed the safety and efficacy of Mavyret in treatment-naïve chronic hepatitis C virus (HCV) patients with compensated cirrhosis across all major genotypes (GT1-6).
The patients with compensated cirrhosis showed a 100% cure rate (SVR12) in genotype 1,2,4,5 and 6 patients after 12 weeks of treatment.
AbbVie’s study is comprised of two cohorts, including cohort one with genotype 1, 2, 4, 5, 6 chronic HCV-infected patients and cohort two with genotype 3 (GT3) chronic HCV-infected patients.
Expedition-8 is an ongoing non-randomized, single arm, open-label and multicenter phase 3b study assessing
According to the company, the primary endpoint is the percentage of patients achieving SVR12 in a per-protocol analysis and the secondary endpoints are on-treatment virologic failure and relapse rates.
The company enrolled 280 patients in the cohort one and excluded seven patients from the SVR12 per-protocol analysis. Five patients have been lost to follow up and two patients secured less than 8 weeks of treatment.
The US Food and Drug Administration approved Mavyret to treat virus HCV infection in adults across all major genotypes (GT1-6).
Mavyret is a pan-genotypic, once-daily and ribavirin-free treatment, which aggregates glecaprevir 100mg and pibrentasvir 40mg. They are dosed once-daily as three oral tablets and taken with food.
Glecaprevir is an NS3/4A protease inhibitor, while pibrentasvir is an NS5A inhibitor.
Mavyret is an eight-week and pan-genotypic option for patients without cirrhosis and who are new to treatment. It is a pan-genotypic treatment approved for use in patients across all stages of CKD.
AbbVie infectious diseases development vice president Dr Janet Hammond said: “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.
“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.”
