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

HIV Infection Clinical Trial

— PURGE-C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04042740
• Other study ID #: ACTG A5380
• Secondary ID: 38553UM1AI068636
• Status: Completed
• Phase: Phase 2
• Start date: November 15, 2019
• Est. completion date: August 22, 2023

Study information

• Verified date: March 2024
• Source: AIDS Clinical Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 22, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Infection
• HIV Infection
• Infections
• Virus Diseases

Intervention

Drug:
• Glecaprevir/Pibrentasvir (G/P)
Fixed-dose combination (FDC) tablets containing 100 mg of glecaprevir and 40 mg of pibrentasvir; administered as 3 tablets orally.
• Ribavirin (RBV)
Tablets containing 200 mg of ribavirin. RBV dosed according to weight-based and renal dosing tables in study protocol.

Locations

Country	Name	City	State
Brazil	Instituto de Pesquisa Clinica Evandro Chagas (12101)	Rio de Janeiro
United States	University of Colorado Hospital CRS (6101)	Aurora	Colorado
United States	Johns Hopkins Adult AIDS CRS	Baltimore	Maryland
United States	Massachusetts General Hospital ACTG CRS (101)	Boston	Massachusetts
United States	Unc Aids Crs (3201)	Chapel Hill	North Carolina
United States	Columbia Physicians and Surgeons CRS (30329)	New York	New York
United States	Weill Cornell Chelsea CRS (7804)	New York	New York
United States	Weill Cornell Upton CRS (7803)	New York	New York
United States	Ucsd, Avrc Crs (701)	San Diego	California
United States	University of California, San Francisco HIV/AIDS CRS (801)	San Francisco	California
United States	University of Washington AIDS CRS (1401)	Seattle	Washington
United States	Whitman-Walker Institute, Inc. CRS (31791)	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
AIDS Clinical Trials Group	AbbVie, National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with sustained virologic response at 12 weeks post-treatment (SVR12)	SVR12 defined as achieving unquantifiable HCV RNA (less than the lower limit of quantification [LLOQ] target detected [TD] or target not detected [TND]) at study visit 12 weeks post treatment. If a participant does not have any HCV RNA measurements in this time period then the participant will be considered as SVR12 failure, unless there are preceding and subsequent HCV RNA measurements that are both LLOQ (either TD or TND).	Week 16 (12 weeks post treatment)
Primary	Proportion of participants who experienced adverse events (AEs)	Study protocol required reporting of (1) AEs Grade greater than or equal to 2, (2) AEs that led to a change in study treatment regardless of grade and (3) AEs meeting ICH definition of SAE or Expedited AE (EAE) reporting requirement. DAIDS AE Grading Table (V2.1) and DAIDS EAE Manual (V2.0) are used.	From study treatment initiation to 4 weeks after study treatment discontinuation (Week 8)
Primary	Number of participants who complete 4 weeks of treatment without discontinuation due to AEs	Number of participants who complete 4 weeks of treatment without discontinuation due to AEs	From study entry to Week 4
Secondary	Proportion of participants with HCV RNA less than LLOQ	Proportion of participants with HCV RNA less than LLOQ (TD or TND)	Weeks 1, 2, 4, 8, 12, 28
Secondary	Number of participants with HCV virologic failure	Virologic failure defined as failure to achieve unquantifiable HCV RNA and confirmed increase in HCV RNA greater than 1 log10 from on-treatment nadir	Weeks 1, 2, 4