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

• Status: Recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy of a fixed dose combination (FDC) of glecaprevir/pibrentasvir (G/P) given for 4 weeks in acute hepatitis C (HCV)-infected participants, with or without HIV-1 coinfection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AIDS Clinical Trials Group; National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: AbbVie; National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Ribavirin

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.