Phase 3
Completed N=230
Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1
Hepatitis C Virus (HCV)
Source: ClinicalTrials.gov NCT03212521 ↗
Enrolled (actual)
230
Serious AEs
1.7%
Results posted
Sep 2019
Primary outcomePrimary: Percentage of Participants in the Modified Intention-to-Treat Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 100.0 percentage of participants
◆ Published Evidence
Emerging
10citations · ~1 / year
Efficacy and Safety of 8 Weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve, HCV-Infected Patients with APRI ≤ 1 in a Single-Arm, Open-Label, Multicenter Study.
Summary
A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.
Linked Publications
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Efficacy and Safety of 8 Weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve, HCV-Infected Patients with APRI ≤ 1 in a Single-Arm, Open-Label, Multicenter Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in the Modified Intention-to-Treat Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
100.0 | — |
| SECONDARY Percentage of Participants in the Intention-to-Treat Population With SVR12 |
96.5 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
0.0 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse |
0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and indeterminate GT may be acceptable.
- Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or equal to 1, at time of screening.
- Does not have current active hepatitis B virus infection defined as:
- positive hepatitis B surface antigen (HBsAg), OR
- hepatitis B virus (HBV) deoxyribonucleic acid (DNA) > lower limit of quantification (LLOQ) in subjects with isolated positive anti-hepatitis B core (HBc) (i.e., negative HBsAg and anti-hepatitis B surface[HBs])
- Platelets ≥ 150,000 cells/mm³
- Albumin ≥ lower limit of normal (LLN)
- Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load ≥ 1,000 IU/mL at Screening and for at least 6 months before Screening.
- No past history/evidence of cirrhosis.
- No history of hepatocellular carcinoma.
- Hepatitis C virus treatment-naïve (had not received a single dose of any approved or investigational anti-HCV medication).
- If female, the subject must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.
Data sourced from ClinicalTrials.gov (NCT03212521) 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.