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

  • STATUS
    Not Recruiting
  • End date
    Mar 2, 2023
  • participants needed
    50
  • sponsor
    AIDS Clinical Trials Group
Updated on 10 February 2021
Investigator
Pamela Poethke, R.N.
Primary Contact
The Miriam Hosp. ACTG CRS (2951) (2.3 mi away) Contact
+2 other location
hepatitis
ribavirin
pibrentasvir
glecaprevir

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.

Description

The study will be conducted in two steps. In Step 1, participants will receive four weeks of treatment with G/P for acute HCV infection and then followed 24 weeks post treatment. Participants with HCV recurrence (reinfection, suspected relapse or undefined post-treatment viremia) or HCV virologic failure before or at the Step 1 Week 16/SVR12 (sustained virologic response 12 weeks post-treatment) visit may enter Step 2 for re-treatment. The remaining participants complete the study at Week 28 of Step 1. The study primary and secondary outcome measures pertain to Step 1.

In Step 2, participants will be re-treated with G/P with or without ribavirin (RBV) for up to 16 weeks, and followed for 24 weeks post treatment. Post-treatment follow-up for Step 2 will include visits for SVR12 determination after re-treatment.

In Step 1, study visits are scheduled at study entry, weeks 1 and 2 (on-treatment), week 4 (treatment discontinuation), and weeks 8, 12, 16 and 28 (post-treatment follow-up). In Step 2, participants will have study visits during the re-treatment period, where the number of visits depends on the re-treatment, and visits at 12 and 24 weeks post treatment. Study visits may include physical examinations, clinical assessments, blood and urine collection, questionnaires, and HCV re-infection prevention counseling.

Details
Condition HIV infection, Hepatitis C
Treatment Ribavirin (RBV), Glecaprevir/Pibrentasvir (G/P)
Clinical Study IdentifierNCT04042740
SponsorAIDS Clinical Trials Group
Last Modified on10 February 2021

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