Phase 2 N=45 Treatment

Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection

Hepatitis C Infection · HIV Infection

Bottom Line

View on ClinicalTrials.gov: NCT04042740 ↗

Enrolled (actual)

Serious AEs

10.2%

Results posted

Jul 2024

Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response at 12 Weeks Post Treatment Discontinuation (SVR12) — 84.4 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Glecaprevir/Pibrentasvir (G/P) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Primary completion: May 2023

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	—

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.

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

View full record on ClinicalTrials.gov →

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.