Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection
NCT ID: NCT04042740
Last Updated: 2024-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2019-11-20
2023-08-22
Brief Summary
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Detailed Description
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In Step 2, participants were re-treated for up to 16 weeks (G/P or alternate regimen through standard of care), and were followed for 24 weeks post treatment. This post-treatment follow-up included a visit for the determination of HCV sustained virologic response (SVR12) after re-treatment. All summaries of data captured from Step 2 are pooled across HCV re-treatment regimens, as specified in the Statistical Analysis Plan.
In Step 1, study visits were 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 had study visits during the re-treatment period, where the number of visits depended on the re-treatment regimen, and at weeks 12 and 24 post treatment. Study visits included physical examinations, clinical assessments, blood and urine collection, questionnaires, and HCV re-infection prevention counseling.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Glecaprevir/Pibrentasvir (G/P)
Participants were assigned to receive G/P FDC tablets to be taken orally once daily for 4 weeks (Step 1).
Participants who experienced HCV re-infection, suspected relapse, virologic failure, or undefined post-treatment viremia in Step 1 were offered to enter Step 2 for re-treatment. HCV re-treatment regimens may have included G/P FDC tablets orally once daily for 8-16 weeks, or alternate regimens through clinical care.
Glecaprevir/Pibrentasvir (G/P)
Fixed-dose combination (FDC) tablets containing 100 mg of glecaprevir and 40 mg of pibrentasvir; administered as 3 tablets orally.
Interventions
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Glecaprevir/Pibrentasvir (G/P)
Fixed-dose combination (FDC) tablets containing 100 mg of glecaprevir and 40 mg of pibrentasvir; administered as 3 tablets orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Detectable HCV RNA at the screening visit
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
Responsible Party
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Principal Investigators
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Arthur Y. Kim, MD
Role: STUDY_CHAIR
Massachusetts General Hospital (MGH) CRS
Susanna Naggie, MD, MHS
Role: STUDY_CHAIR
Duke University Medical Center CRS
David Wyles, MD
Role: STUDY_CHAIR
University of Colorado Hospital CRS
Locations
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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 Colorado Hospital CRS (6101)
Aurora, Colorado, United States
Whitman-Walker Institute, Inc. CRS (31791)
Washington D.C., District of Columbia, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States
Massachusetts General Hospital ACTG CRS (101)
Boston, Massachusetts, United States
Weill Cornell Chelsea CRS (7804)
New York, New York, United States
Columbia Physicians and Surgeons CRS (30329)
New York, New York, United States
Weill Cornell Upton CRS (7803)
New York, New York, United States
Unc Aids Crs (3201)
Chapel Hill, North Carolina, United States
University of Washington AIDS CRS (1401)
Seattle, Washington, United States
Instituto de Pesquisa Clinica Evandro Chagas (12101)
Rio de Janeiro, , Brazil
Countries
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References
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Kim AY, Kang M, Umbleja T, Nunes EP, Marks KM, Luetkemeyer AF, Koebele C, Wimbish C, Fierer DS, Kliemann DA, Solomon SS, Kort J, Kiser JJ, Lauer GM, Chung RT, Sowah LA, Alston-Smith BL, Wyles DL, Naggie S; A5380 Study Team. Short Course Therapy With Glecaprevir/Pibrentasvir for Early Hepatitis C Virus Infection: PURGE-C. Clin Infect Dis. 2025 Jul 30:ciaf305. doi: 10.1093/cid/ciaf305. Online ahead of print.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Document Type: Statistical Analysis Plan
Related Links
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Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017
Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010
Other Identifiers
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38553
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5380
Identifier Type: -
Identifier Source: org_study_id
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