Common TitleEXPEDITION-4
Official Title Glecaprevir and Pibrentasvir in Patients with HCV and Severe Renal Impairment.
Purpose / DescriptionThis phase 3 single-arm open-label trial evaluated the safety and efficacy of 12 weeks of glecaprevir-pibrentasvir in 104 patients with genotype 1-6 hepatitis C infection and advanced renal insufficiency (estimated glomerular filtration rate less than 30 ml/min/1.73m2); 88% had chronic kidney disease stage 5 and 82% were on hemodialysis. Fifty-two percent of patients had genotype 1 infection; 19% had compensated cirrhosis and 42% were treatment-experienced, all but two with prior interferon-based therapy. The overall sustained virologic response rate was 98% by intent-to-treat analysis. The rate of adverse events attributable to glecaprevir-pibrentasvir (pruritus 20%, fatigue 14%, nausea 12%) were comparable to those observed in the other glecaprevir-pibrentasvir trials.
Phase Phase III
ClinicalTrials.gov NCT02651194
Treatments
Glecaprevir-Pibrentasvir

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