Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)

A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB 8-Week Treatment in Adults and Adolescents With Acute Hepatitis C Virus (HCV) Infection

HCV infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection.

GLE/PIB is an approved drug for the treatment of chronic HCV. Around 283 participants at least 12 years of age with acute HCV Infection will be enrolled in approximately 70 sites worldwide.

Participants will receive oral tablets of GLE/PIB once daily (QD) for 8 weeks and will be followed for 12 weeks after the end of treatment.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, monitoring for side effects and completing questionnaires.

Study Overview

• Status: Completed
• Conditions: Hepatitis C Virus (HCV)
• Intervention / Treatment: Drug: Glecaprevir/Pibrentasvir (GLE/PIB)

• Study Type: Interventional
• Enrollment (Actual): 286
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital /ID# 227167
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital /ID# 227169
• Austria
  • Niederoesterreich
    • Sankt Poelten, Niederoesterreich, Austria, 3100
      • Universitaetsklinikum St. Poelten /ID# 227098
  • Oberoesterreich
    • Linz, Oberoesterreich, Austria, 4010
      • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 226985
  • Wien
    • Vienna, Wien, Austria, 1090
      • Medizinische Universitaet Wien /ID# 226938
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2C7
      • Vancouver Infectious Diseases Centre /ID# 227125
    • Victoria, British Columbia, Canada, V8W 1M8
      • CoolAid Medical Clinic /ID# 239978
  • Ontario
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Charlton Medical Centre /ID# 228100
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Royal Victoria Hospital / McGill University Health Centre /ID# 227126
• France
  • Paris, France, 75012
    • AP-HP - Hopital Saint-Antoine /ID# 229070
  • Herault
    • Montpellier Cedex 5, Herault, France, 34295
      • CHU Montpellier - Hopital Saint Eloi /ID# 229083
  • Ile-de-France
    • Clichy, Ile-de-France, France, 92110
      • Hopital Beaujon /ID# 246817
  • Nord
    • TOURCOING Cedex, Nord, France, 59208
      • CH de Tourcoing /ID# 233732
  • Paris
    • Creteil, Paris, France, 94010
      • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 259111
  • Rhone
    • Lyon, Rhone, France, 69004
      • HCL - Hopital de la Croix-Rousse /ID# 229077
    • Lyon, Rhone, France, 69004
      • HCL - Hopital de la Croix-Rousse /ID# 259102
• Germany
  • Berlin, Germany, 10439
    • zibp-Zentrum fuer Infektiologie /ID# 226765
  • Hamburg, Germany, 20146
    • ICH Study Center GmbH & Co KG /ID# 228162
  • Munich, Germany, 81675
    • Klinikum rechts der Isar /ID# 226783
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60596
      • Infektiologikum /ID# 226880
  • Nordrhein-Westfalen
    • Bonn, Nordrhein-Westfalen, Germany, 53127
      • Universitaetsklinikum Bonn /ID# 226764
    • Dortmund, Nordrhein-Westfalen, Germany, 44137
      • Klinikum Dortmund gGmbH /ID# 249689
• Italy
  • Foggia, Italy, 71100
    • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia /ID# 227081
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 227080
  • Milano
    • Milan, Milano, Italy, 20162
      • ASST Grande Ospedale Metropolitano Niguarda /ID# 227079
  • Napoli
    • Naples, Napoli, Italy, 80131
      • Azienda Ospedaliera Universitaria Federico II /ID# 227183
  • Roma
    • Rome, Roma, Italy, 00133
      • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 227078
• Spain
  • Barcelona, Spain, 08003
    • Hospital Parc de Salut del Mar /ID# 226696
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona /ID# 226695
  • Madrid, Spain, 28010
    • Centro Sanitario Sandoval /ID# 226954
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor /ID# 251780
  • Valencia, Spain, 46014
    • Duplicate_Hospital General Universitario de Valencia /ID# 226709
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol /ID# 226698
• United States
  • Arizona
    • Chandler, Arizona, United States, 85225-2906
      • Arizona Health Research /ID# 233558
    • Peoria, Arizona, United States, 85381
      • The Institute for Liver Health /ID# 228427
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • Liver Wellness Center /ID# 244933
  • California
    • Beverly Hills, California, United States, 90211
      • AHF Research Center /ID# 254795
    • Chula Vista, California, United States, 91911-6658
      • Velocity Clinical Research Chula Vista /ID# 238352
    • Los Angeles, California, United States, 90027
      • AHF Healthcare Center- Hollywood /ID# 254794
    • Los Angeles, California, United States, 90048
      • TLC Clinical Research Inc /ID# 232334
    • Sacramento, California, United States, 95817
      • University of California, Davis Comprehensive Cancer Center /ID# 230814
  • Florida
    • Doral, Florida, United States, 33122-1713
      • Angels Clinical Research Institute /ID# 234090
    • Fort Lauderdale, Florida, United States, 33308
      • AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 254814
    • Fort Pierce, Florida, United States, 34982
      • Midway Immunology and Research Center /ID# 229194
    • Oakland Park, Florida, United States, 33334-4434
      • Midland Research Group, Inc /ID# 231885
    • Orlando, Florida, United States, 32803
      • Orlando Immunology Center /ID# 229839
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital /ID# 228930
    • West Palm Beach, Florida, United States, 33407-3100
      • Duplicate_Triple O Research Institute /ID# 229928
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic /ID# 233489
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Midtown Infectious Disease Clinic /ID# 229927
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics /ID# 226934
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Duplicate_University of Kentucky Chandler Medical Center /ID# 231588
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Hospital /ID# 232139
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center /ID# 226937
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital /ID# 230694
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital /ID# 226932
  • Mississippi
    • Jackson, Mississippi, United States, 39216-4500
      • University of Mississippi Medical Center /ID# 232620
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Las Vegas Research Center /ID# 255631
  • New Jersey
    • Newark, New Jersey, United States, 07103-2842
      • North Jersey Community Research Initiative (NJCRI) /ID# 245129
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College /ID# 230815
  • North Carolina
    • Fayetteville, North Carolina, United States, 28304
      • Coastal Research Institute, LLC /ID# 233233
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital /ID# 231204
    • Cincinnati, Ohio, United States, 45267-0585
      • Duplicate_University Of Cincinnati Medical Center /ID# 226922
  • Oklahoma
    • Tahlequah, Oklahoma, United States, 74464-0545
      • Cherokee Nation Outpatient Health Center /ID# 232618
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital /ID# 232624
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • University Gastroenterology /ID# 233332
  • Tennessee
    • Nashville, Tennessee, United States, 37232-0011
      • Vanderbilt University Medical Center /ID# 241282
  • Texas
    • Houston, Texas, United States, 77030-2783
      • Liver Associates of Texas, P.A /ID# 229775
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Digestive and Liver Disease Sp /ID# 232633
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Wisconsin Medical Center /ID# 230116

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Evidence of acute HCV infection prior to enrollment, defined as a physician diagnosis of acute HCV infection, quantifiable HCV ribonucleic Acid (RNA) at screening, and at least 1 of the following:

  • Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; OR
  • Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 11-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen; OR
  • Clinical signs and symptoms compatible with acute hepatitis [alanine aminotransferase (ALT) > 5 × upper limit of normal (ULN) and/or jaundice] in the absence of a history of chronic liver disease or other cause of acute hepatitis and positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen; OR
  • Negative anti-HCV antibody with a positive HCV RNA or HCV core antigen within a 5-month period prior to screening.
• Absence of hepatocellular carcinoma (HCC), for participants with cirrhosis, or with indeterminate cirrhosis status, as indicated by a negative ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to screening or a negative ultrasound at screening. Participant who has a positive ultrasound result suspicious of HCC followed by a subsequent negative CT scan or MRI or biopsy result will be eligible for the study.
• Participants documented as having no cirrhosis or as having compensated cirrhosis.

Exclusion Criteria:

• Participants with prior treatment, including interferon for this HCV infection.
• History of liver decompensation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glecaprevir/Pibrentasvir; Participants treated once daily (QD) with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.	Drug: Glecaprevir/Pibrentasvir (GLE/PIB); Oral tablets; Other Names: Mavyret; ABT-493/ABT-530

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population	SVR12 is defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study treatment. Efficacy was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants achieving SVR12 was greater than 90.5%.	12 weeks after last dose of study treatment (Week 20)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving SVR12 in the Modified ITT-Virologic Failure (mITT-VF) Population	SVR12 is defined as the HCV RNA level < LLOQ 12 weeks after the last dose of study treatment. Efficacy was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants achieving SVR12 was greater than 92.7%. This efficacy analysis was performed only if success was demonstrated for the primary efficacy analysis, following a fixed-sequence testing procedure.	12 weeks after last dose of study treatment (Week 20)
Percentage of Participants With On-Treatment Virologic Failure in the ITT Population	On-treatment virologic failure is defined as confirmed increase in HCV RNA of > 1 log^10 IU/mL above the lowest post-baseline value during treatment, confirmed HCV RNA >= 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA >= LLOQ at the end of treatment (EOT) with at least 6 weeks of treatment.	Up to Week 8
Percentage of Participants With Post-Treatment (PT) Relapse in the ITT Population	PT relapse is defined as confirmed HCV RNA >= LLOQ between the EOT and 12 weeks after the last dose of study treatment among participants who completed treatment as planned (study treatment duration >= 52 days) with HCV RNA < LLOQ at the EOT and with at least 1 PT HCV RNA value, excluding cases of reinfection.	Up to 12 weeks after the last dose of study treatment (Week 20)
Percentage of Participants With PT Reinfection With HCV in the ITT Population	PT reinfection is defined as confirmed HCV RNA >= LLOQ in the PT period in a participant who had HCV RNA < LLOQ at the final treatment visit, along with the PT detection of a different HCV genotype, subtype, or clade compared with baseline.	Up to 12 weeks after the last dose of study treatment (Week 20)

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2021
• Primary Completion (Actual): September 17, 2024
• Study Completion (Actual): September 17, 2024

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Hepatitis C; Acute HCV Infection; HCV Genotype 1-6; Mavyret; Glecaprevir; Pibrentasvir
• Additional Relevant MeSH Terms: Blood-Borne Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Communicable Diseases; Flaviviridae Infections; Hepatitis A; Hepatitis; Infections; Hepatitis C
• Other Study ID Numbers: M20-350; 2020-005777-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes