Common TitleEXPEDITION-5
Official Title Efficacy and Safety of glecaprevir/pibrentasvir in Renally Impaired Patients With Chronic HCV Infection
Purpose / DescriptionIn this open-label, single arm, phase 3 trial, investigators evaluated the safety and efficacy of the fixed-dose combination of glecaprevir-pibrentasvir for 8, 12 or 16 weeks in treatment-naïve and treatment-experienced participants with chronic HCV genotypes 1-6 and advanced renal insufficiency. The renal insufficiency was defined as eGFR less than 45 mL/min/1.73 m2 (Stage 3b, 4 or 5 chronic kidney disease) Most of the participants enrolled received glecaprevir-pibrentasvir for 8 weeks. Overall, 97% (97 of 101) of the participants treated with glecaprevir-pibrentasvir achieved an SRV12.
Phase Phase III
ClinicalTrials.gov NCT03069365
Treatments
Glecaprevir-Pibrentasvir

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