Common TitleMAGELLAN-1 (Part 1)
Official Title Glecaprevir and Pibrentasvir for 12 Weeks for Hepatitis C Virus Genotype 1 Infection and Prior Direct-Acting Antiviral Treatment.
Purpose / DescriptionIn this phase 2 open-label trial, 50 genotype 1 patients without cirrhosis who had previously failed a DAA-containing regimen were randomized to 3 arms: (A) glecaprevir-pibrentasvir (GLE-PIB) 200-80 mg daily, (B) GLE-PIB 300/120 mg with ribavirin 800 mg daily and (C) GLE-PIB 200/120 mg daily – all for 12 weeks. By intent-to-treat analysis, a sustained virologic response (SVR12) was achieved in 100% (6/6) of patients in arm A, 95% (21/22) of patients in arm B and 86% (19/22) of patients in arm C. SVR12 was achieved in 91% (10/11) and 93% (14/15) of patients with baseline resistance-associated substitutions (RAS) to NS5A only and both NS3 and NS5A respectively, to a 15% detection threshold. All patients without baseline RAS or with only NS3 RAS achieved an SVR12.
Phase Phase II
Treatments
Glecaprevir-Pibrentasvir

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