Phase 2
Completed N=45
Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection
Hepatitis C Infection · HIV
Source: ClinicalTrials.gov NCT04042740 ↗
Enrolled (actual)
45
Serious AEs
10.2%
Results posted
Jul 2024
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response at 12 Weeks Post Treatment Discontinuation (SVR12) — 84.4 percentage of participants
Summary
The purpose of this study was to assess the efficacy of a fixed dose combination (FDC) of glecaprevir/pibrentasvir (G/P) given for 4 weeks for treatment of acute hepatitis C (HCV), with or without HIV-1 coinfection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response at 12 Weeks Post Treatment Discontinuation (SVR12) |
84.4 | — |
| PRIMARY Percentage of Participants Who Experienced Adverse Events (AEs) |
60.0 | — |
| PRIMARY Number of Participants Who Completed 4 Weeks of Treatment Without Discontinuation Due to AEs |
45 | — |
| SECONDARY Percentage of Participants With HCV RNA Less Than LLOQ |
51.4; 70.7; 97.6; 97.2; 88.2; 81.0 | — |
| SECONDARY Number of Participants With HCV Virologic Failure |
6 | — |
Eligibility Criteria
Inclusion Criteria
- Acute HCV infection (or reinfection) within 24 weeks prior to entry
- Detectable HCV RNA at the screening visit
Exclusion Criteria
- Any HCV treatment during the current acute HCV infection episode
- Known preexisting cirrhosis
- Acute HIV-1 infection
- Presence of active or acute AIDS-defining opportunistic infections, active serious infection (other than HIV-1 or HCV), active hepatitis B virus (HBV) or active hepatitis A virus (HAV)
- Chronic use of systemically administered immunosuppressive agents
- History of solid organ transplantation
- History of conditions that could interfere with the absorption of the study drug
- Concurrent use of prohibited medications
- Known hypersensitivity to glecaprevir or pibrentasvir, the metabolites, or parts of the formulation
- Females who are pregnant or breastfeeding
- Males with pregnant female partner
Data sourced from ClinicalTrials.gov (NCT04042740). 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.