Common TitleC-EDGE Treatment-Experienced
Official Title Effectiveness of Elbasvir and Grazoprevir Combination, With or Without Ribavirin, for Treatment-Experienced Patients With Chronic Hepatitis C Infection
Purpose / DescriptionIn this randomized, open-label, phase 3 trial, 420 adults with genotype 1, 4, or 6 hepatitis C infection and a history of treatment failure with peginterferon and ribavirin received elbasvir-grazoprevir (50/100 mg), with or without ribavirin, for 12 or 16 weeks. Among participants who received a 12-week regimen, the SVR12 rate was 94% for elbasvir-grazoprevir with ribavirin and 92% for elbasvir-grazoprevir without ribavirin. In the 16-week treatment arms, the SVR12 rate was 97% and 92% for elbasvir-grazoprevir, with and without ribavirin respectively. Notably, of the 12 patients with genotype 1a who experienced viral relapse, 10 had evidence of a baseline NS5A resistance-associated variant.
Phase Phase III
ClinicalTrials.gov NCT02105701
Treatments
Elbasvir-Grazoprevir

Elbasvir-Grazoprevir
Tradename:ZepatierOther Names:EBR-GZRClass:FDA-ApprovedFunding
IndustryMerck Sharp & Dohme Corp.