Hepatitis C InfectionPhase 2PURGE-CNCT04042740
Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection
A Phase 2 study testing Glecaprevir/Pibrentasvir (G/P) in people with Hepatitis C Infection and HIV Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 12 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Infection, HIV Infection
- What is being tested?
- Glecaprevir/Pibrentasvir (G/P)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 20 Nov 2019to 22 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute HCV infection (or reinfection) within 24 weeks prior to entry
- Detectable HCV RNA at the screening visit
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
University of Colorado Hospital CRS (6101)
Aurora, Colorado, 80045
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
Massachusetts General Hospital ACTG CRS (101)
Boston, Massachusetts, 02114
Unc Aids Crs (3201)
Chapel Hill, North Carolina, 27514
Weill Cornell Chelsea CRS (7804)
New York, New York, 10010
Columbia Physicians and Surgeons CRS (30329)
New York, New York, 10032
Weill Cornell Upton CRS (7803)
New York, New York, 10065
Ucsd, Avrc Crs (701)
San Diego, California, 92103
University of California, San Francisco HIV/AIDS CRS (801)
San Francisco, California, 94110
University of Washington AIDS CRS (1401)
Seattle, Washington, 98104
Whitman-Walker Institute, Inc. CRS (31791)
Washington D.C., District of Columbia, 20005
Brazil1 site
Instituto de Pesquisa Clinica Evandro Chagas (12101)
Rio de Janeiro, 21045
About this study
Official title: Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)
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.
Read the detailed description
The study was conducted in two steps. In Step 1, participants received four weeks of treatment with G/P for acute HCV infection and were 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 entered Step 2 and were offered HCV re-treatment. The remaining participants were followed in Step 1 for a total of 28 weeks. The study primary and secondary outcome measures pertain to Step 1.
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
- Hepatitis C Infection, HIV Infection
- Being tested
- Glecaprevir/Pibrentasvir (G/P)
- Keywords
- Acute Hepatitis C Infection, Glecaprevir, Pibrentasvir, 4 weeks, Direct-acting antivirals
- Medical subject headings
- Hepatitis C, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glecaprevir/Pibrentasvir (G/P)Drug
Also called Mavyret
Fixed-dose combination (FDC) tablets containing 100 mg of glecaprevir and 40 mg of pibrentasvir; administered as 3 tablets orally.
| Study group | Role | What they receive |
|---|---|---|
| Glecaprevir/Pibrentasvir (G/P) | Experimental | 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. Receives: Drug: Glecaprevir/Pibrentasvir (G/P) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Sustained Virologic Response at 12 Weeks Post Treatment Discontinuation (SVR12)
SVR12 defined as 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 (Week 16). If a participant did not have HCV RNA measurement at Week 16, the participant was considered as SVR12 failure, unless there were preceding and subsequent HCV RNA measurements that were both LLOQ (either TD or TND).
Measured: Week 16 (12 weeks post study treatment)
Percentage 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 serious AE (SAE) or Expedited AE (EAE) reporting requirement. DAIDS AE Grading Table (V2.1) and DAIDS EAE Manual (V2.0) were used.
Measured: 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
Number of participants who completed 4 weeks of treatment without discontinuation due to AEs
Measured: From study entry to Week 4
Secondary outcomes (2)
Percentage of Participants With HCV RNA Less Than LLOQ
Percentage of participants with HCV RNA less than LLOQ (TD or TND). Given the substantial amount of missing data due to the SARS-CoV-2 pandemic, the planned analysis of 90% confidence intervals for the percentage of participants with HCV RNA <LLOQ at study visits could not be conducted in a meaningful way.
Measured: Weeks 1, 2, 4, 8, 12, 28
Number of Participants With HCV Virologic Failure
Virologic failure defined as failure to achieve unquantifiable HCV RNA or confirmed increase in HCV RNA greater than 1 log10 from on-treatment nadir
Measured: From Week 1 to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start20 Nov 2019
- Primary completion18 May 2023
- Study completion22 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Arthur Y. Kim, MD, Study chair, Massachusetts General Hospital (MGH) CRSSusanna Naggie, MD, MHS, Study chair, Duke University Medical Center CRSDavid Wyles, MD, Study chair, University of Colorado Hospital CRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042740
- Sponsor's protocol ID
- ACTG A5380
- Other IDs
- 38553, UM1AI068636
- Acronym
- PURGE-C
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2019
- Last updated
- 11 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.
Publications
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. 2026 Feb 4;81(6):1083-1090. doi: 10.1093/cid/ciaf305.
PubMed 40736252
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)
- ClinicalTrials.gov ID
- NCT04042740
- Acronym / sponsor ID
- PURGE-C / ACTG A5380
- Conditions
- Hepatitis C Infection, HIV Infection
- Keywords
- Acute Hepatitis C Infection, Glecaprevir, Pibrentasvir, 4 weeks, Direct-acting antivirals
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsResearch network
- Collaborators
- AbbVie, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 22 Aug 2023 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Posted 11 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study was conducted in two steps. In Step 1, participants received four weeks of treatment with G/P for acute HCV infection and were 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 entered Step 2 and were offered HCV re-treatment. The remaining participants were followed in Step 1 for a total of 28 weeks. The study primary and secondary outcome measures pertain to Step 1.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glecaprevir/Pibrentasvir (G/P) | Experimental | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute HCV infection (or reinfection) within 24 weeks prior to entry
- Detectable HCV RNA at the screening visit
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glecaprevir/Pibrentasvir (G/P)Also: MavyretFixed-dose combination (FDC) tablets containing 100 mg of glecaprevir and 40 mg of pibrentasvir; administered as 3 tablets orally. | Drug | Glecaprevir/Pibrentasvir (G/P) |
Primary outcome
Percentage of Participants With Sustained Virologic Response at 12 Weeks Post Treatment Discontinuation (SVR12)
Time frame: Week 16 (12 weeks post study treatment)
SVR12 defined as 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 (Week 16). If a participant did not have HCV RNA measurement at Week 16, the participant was considered as SVR12 failure, unless there were preceding and subsequent HCV RNA measurements that were both LLOQ (either TD or TND).
Percentage of Participants Who Experienced Adverse Events (AEs)
Time frame: From study entry to Week 8 (4 weeks post study treatment)
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 serious AE (SAE) or Expedited AE (EAE) reporting requirement. DAIDS AE Grading Table (V2.1) and DAIDS EAE Manual (V2.0) were used.
Number of Participants Who Completed 4 Weeks of Treatment Without Discontinuation Due to AEs
Time frame: From study entry to Week 4
Number of participants who completed 4 weeks of treatment without discontinuation due to AEs
2 secondary outcomes
Percentage of Participants With HCV RNA Less Than LLOQ
Time frame: Weeks 1, 2, 4, 8, 12, 28
Number of Participants With HCV Virologic Failure
Time frame: From Week 1 to Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40736252Kim 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. 2026 Feb 4;81(6):1083-1090. doi: 10.1093/cid/ciaf305.
- Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017Link provided by the sponsor.
- Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Y. Kim, MD study chair
Massachusetts General Hospital (MGH) CRS
Susanna Naggie, MD, MHS study chair
Duke University Medical Center CRS
David Wyles, MD study chair
University of Colorado Hospital CRS
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glecaprevir/Pibrentasvir (G/P) in people with Hepatitis C Infection and HIV Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Sustained Virologic Response at 12 Weeks Post Treatment Discontinuation (SVR12) (time frame: Week 16 (12 weeks post study treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04042740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.