A Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection

Sponsor
AbbVie
Study ID
NCT03219216
Phase
PHASE3
Status
Completed

Conditions

  • Hepatitis C Virus (HCV)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (GLE)/pibrentasvir (PIB) for an 8 or 12-week treatment duration in adults in Brazil with chronic hepatitis C virus (HCV) genotype (GT) 1 to GT6 infection, without cirrhosis or with compensated cirrhosis, who were HCV treatment-naïve.

Key Dates

First listed
Jul 17, 2017
Start date
Jun 6, 2018
Status verified
Mar 2020
Primary completion
Mar 11, 2019
Completion
Mar 11, 2019

Study Design

Enrollment
100 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks
    Arm A: Hepatitis C virus (HCV) genotype (GT) 1 to GT6 participants without cirrhosis (fibrosis stage F2 to F3) received glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks.
  • Experimental: Arm B: GLE/PIB for 12 Weeks
    Arm B: HCV GT1 to GT6 participants with compensated cirrhosis (F4) received GLE/PIB 300 mg/120 mg QD for 12 weeks.

Primary Outcome Measure

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after last dose of study drug (week 20 or 24 depending on treatment regimen) ]

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