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)

Phase 3

Completed

Conditions: Hepatitis C Virus (HCV)

Interventions: Drug: Glecaprevir/Pibrentasvir (GLE/PIB)

Registration Number: NCT04903626

Lead Sponsor: AbbVie

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 286

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glecaprevir/Pibrentasvir	Glecaprevir/Pibrentasvir (GLE/PIB)	Participants treated once daily (QD) with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population	12 weeks after last dose of study treatment (Week 20)	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%.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving SVR12 in the Modified ITT-Virologic Failure (mITT-VF) Population	12 weeks after last dose of study treatment (Week 20)	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.
Percentage of Participants With Post-Treatment (PT) Relapse in the ITT Population	Up to 12 weeks after the last dose of study treatment (Week 20)	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.
Percentage of Participants With On-Treatment Virologic Failure in the ITT Population	Up to Week 8	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.
Percentage of Participants With PT Reinfection With HCV in the ITT Population	Up to 12 weeks after the last dose of study treatment (Week 20)	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.

Trial Locations

Locations (70): Duplicate_University Of Cincinnati Medical Center /ID# 226922
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Cincinnati, Ohio, United States
IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 227080
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Bologna, Emilia-Romagna, Italy
Arizona Health Research /ID# 233558
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Chandler, Arizona, United States
The Institute for Liver Health /ID# 228427
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Peoria, Arizona, United States
Liver Wellness Center /ID# 244933
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Little Rock, Arkansas, United States
AHF Research Center /ID# 254795
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Beverly Hills, California, United States
Velocity Clinical Research Chula Vista /ID# 238352
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Chula Vista, California, United States
AHF Healthcare Center- Hollywood /ID# 254794
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Los Angeles, California, United States
TLC Clinical Research Inc /ID# 232334
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Los Angeles, California, United States
University of California, Davis Comprehensive Cancer Center /ID# 230814
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Sacramento, California, United States
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Duplicate_University Of Cincinnati Medical Center /ID# 226922
🇺🇸Cincinnati, Ohio, United States