Phase 3
Completed N=694
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection
Chronic Hepatitis C · Hepatitis C
Source: ClinicalTrials.gov NCT02243293 ↗
Enrolled (actual)
694
Serious AEs
2.5%
Results posted
Oct 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 96.0; 100.0; 100.0; 93.3 percentage of participants
◆ Published Evidence
Highly cited
230citations · ~29 / year
Efficacy of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2, 4, 5, or 6 Infection Without Cirrhosis.
Summary
The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) in chronic HCV genotype 2 (GT2-), genotype 3 (GT3-), genotype 4 (GT4), genotype 5 (GT5-), or genotype 6 (GT6-) infected participants with or without cirrhosis.
Linked Publications (5)
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Efficacy of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2, 4, 5, or 6 Infection Without Cirrhosis.
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Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease.
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Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials.
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Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis.
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Efficacy and Pharmacokinetics of Glecaprevir and Pibrentasvir With Concurrent Use of Acid-Reducing Agents in Patients With Chronic HCV Infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
96.0; 100.0; 100.0; 93.3; 93.3; 93.5 | — |
| PRIMARY Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control |
98.5 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4) |
96.0; 100.0; 100.0; 93.3; 93.3; 93.5 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
0; 0; 0; 0; 0; 3.2 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse |
0.0; 0.0; 0.0; 3.4; 6.7; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Screening laboratory result indicating HCV Genotype 2, 3, 4, 5, or 6 infection.
- Chronic HCV infection.
- Participant had to be either HCV treatment-naïve or treatment-experienced.
- Participant had to be documented as non-cirrhotic or as having compensated cirrhosis (GT3 only).
Exclusion Criteria
- History of severe, life-threatening or other significant sensitivity to any drug.
- Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.
- Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
- Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
- HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
Data sourced from ClinicalTrials.gov (NCT02243293) 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.