A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naïve Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 14
- Primary Endpoint
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Study Overview
Brief Summary
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.
Detailed Description
This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of GLE/PIB for an 8- or 12-week treatment duration in adults in Brazil with chronic HCV GT1 to GT6 infection, without cirrhosis or with compensated cirrhosis with a METAVIR System Fibrosis Score of F2 to F3 (without cirrhosis) or F4 (with compensated cirrhosis) or equivalent, who were HCV treatment-naïve.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant had positive plasma hepatitis C virus (HCV) antibody and HCV ribonucleic acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening Visit.
- •Participant must have been documented as without cirrhosis with METAVIR equivalent fibrosis stage of F2 to F3 or with compensated cirrhosis (F4) based on results of a liver biopsy, or FibroScan, or FibroTest score.
- •Participants who were known to be HCV/Human Immunodeficiency Virus (HIV) co-infected may have been enrolled if they had a positive test result for anti-HIV antibody at Screening and were: naïve to treatment with any antiretroviral therapy (ART), or on a stable, qualifying HIV ART regimen for at least 8 weeks prior to Baseline.
- •Participants with compensated cirrhosis only: Absence of hepatocellular carcinoma (HCC) within 3 months prior to Screening or a negative ultrasound at Screening.
Exclusion Criteria
- •Current hepatitis B virus (HBV) infection on screening tests.
- •Any current or past clinical evidence of Child-Pugh B or C classification (score of > 6) or clinical history of liver decompensation including ascites on physical exam, including hepatic encephalopathy or variceal bleeding.
- •Receipt of any investigational or commercially available anti-HCV agents.
Arms & Interventions
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.
Intervention: Glecaprevir/Pibrentasvir (Drug)
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.
Intervention: Glecaprevir/Pibrentasvir (Drug)
Outcomes
Primary Outcomes
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)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last dose of study drug.
Secondary Outcomes
- Percentage of Participants With Post-treatment HCV Virologic Relapse(From the end of treatment (8 or 12 weeks depending on treatment regimen) through 12 weeks after the last dose of study drug)
- Percentage of Participants With On-treatment HCV Virologic Failure(8 or 12 weeks (depending on treatment regimen))