CompletedPhase 2

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

United States, Brazil45 participantsStarted 2019-11-20

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Sustained Virologic Response at 12 Weeks Post Treatment Discontinuation (SVR12)

Timeframe: Week 16 (12 weeks post study treatment)

Percentage of Participants Who Experienced Adverse Events (AEs)

Timeframe: From study entry to Week 8 (4 weeks post study treatment)

Number of Participants Who Completed 4 Weeks of Treatment Without Discontinuation Due to AEs

Timeframe: From study entry to Week 4

Trial details

NCT IDNCT04042740

SponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2023-05-18

Results submitted2024-05-15

View on ClinicalTrials.gov More Hepatitis C Infection trials