Common TitleMAGELLAN-1 (Part 2)
Official Title Glecaprevir/Pibrentasvir in Patients with HCV Genotype 1 or 4 and Prior Direct-acting Antiviral Treatment Failure.
Purpose / DescriptionThe MAGELLAN-1 (Part 2) Trial was a an international, multicenter, randomized, open-label, phase 3 trial to evaluate the safety and efficacy of glecaprevir-pibrentasvir for 12 or 16 weeks in patients with genotype 1 or 4 chronic HCV (with or without cirrhosis) who previously experienced virologic failure with direct-acting antiviral (DAA) therapy. Among the 91 participants who enrolled, 87 had HCV genotype 1 and 4 had HCV genotype 4. Enrollment required prior treatment failure with a regimen that included at least one of the following: an NS3/4A protease inhibitor or an NS5A inhibitor. The SVR12 response rates were 89% (39 of 44) in the 12-week treatment group and 91% (43 of 47) in the 16-week group.
Phase Phase III
ClinicalTrials.gov NCT02446717
Treatments
Glecaprevir-Pibrentasvir

Glecaprevir-Pibrentasvir
Tradename:MavyretOther Names:GLE-PIBClass:FDA-ApprovedFunding
IndustryAbbVie