Clinical trial NCT04042740: Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection
Official title: Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Infection
HIV Infection
Keywords: Acute Hepatitis C Infection
Glecaprevir
Pibrentasvir
4 weeks
Direct-acting antivirals
Lead sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Sponsor class: NETWORK
Collaborators: name: AbbVie
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2019-08-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at 12 Weeks Post Treatment Discontinuation (SVR12)
timeFrame: Week 16 (12 weeks post study treatment)
measure: Percentage of Participants Who Experienced Adverse Events (AEs)
timeFrame: From study entry to Week 8 (4 weeks post study treatment)
measure: Number of Participants Who Completed 4 Weeks of Treatment Without Discontinuation Due to AEs
timeFrame: From study entry to Week 4
Secondary outcomes:
measure: Percentage of Participants With HCV RNA Less Than LLOQ
timeFrame: Weeks 1, 2, 4, 8, 12, 28
measure: Number of Participants With HCV Virologic Failure
timeFrame: From Week 1 to Week 16
Other outcomes:
measure: Number of Participants by HCV Re-Treatment Regimen in Step 2
timeFrame: At Step 2 entry (median time of Step 2 entry was at 21 weeks after study entry.
Locations:
city: San Diego
country: United States
facility: Ucsd, Avrc Crs (701)
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco HIV/AIDS CRS (801)
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital CRS (6101)
state: Colorado
city: Washington
country: United States
facility: Whitman-Walker Institute, Inc. CRS (31791)
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Adult AIDS CRS
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital ACTG CRS (101)
state: Massachusetts
city: New York
country: United States
facility: Weill Cornell Chelsea CRS (7804)
state: New York
city: New York
country: United States
facility: Columbia Physicians and Surgeons CRS (30329)
state: New York
city: New York
country: United States
facility: Weill Cornell Upton CRS (7803)
state: New York
city: Chapel Hill
country: United States
facility: Unc Aids Crs (3201)
state: North Carolina
city: Seattle
country: United States
facility: University of Washington AIDS CRS (1401)
state: Washington
city: Rio de Janeiro
country: Brazil
facility: Instituto de Pesquisa Clinica Evandro Chagas (12101)
Study officials:
affiliation: Massachusetts General Hospital (MGH) CRS
name: Arthur Y. Kim, MD
role: STUDY_CHAIR
affiliation: Duke University Medical Center CRS
name: Susanna Naggie, MD, MHS
role: STUDY_CHAIR
affiliation: University of Colorado Hospital CRS
name: David Wyles, MD
role: STUDY_CHAIR
References: