Phase 3
Completed N=100
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
Hepatitis C Virus (HCV)
Source: ClinicalTrials.gov NCT03219216 ↗
Enrolled (actual)
100
Serious AEs
4.0%
Results posted
Mar 2020
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 98.0 percentage of participants
◆ Published Evidence
Emerging
9citations · ~2 / year
Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1-6 in Brazil.
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.
Linked Publications (2)
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Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1-6 in Brazil.
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Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
98.0 | — |
| SECONDARY Percentage of Participants With On-treatment HCV Virologic Failure |
— | — |
| SECONDARY Percentage of Participants With Post-treatment HCV Virologic Relapse |
1.0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03219216) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.