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)

Study Overview
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Brief Summary
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Hepatitis C Virus (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.

Official Title
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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

Conditions
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Hepatitis C Virus (HCV)

Intervention / Treatment
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* Drug: Glecaprevir/Pibrentasvir (GLE/PIB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Evidence of acute Hepatitis C Virus (HCV) infection prior to enrollment, defined as a physician diagnosis of acute HCV infection, quantifiable HCV RNA at screening, and at least 1 of the following: Negative anti-HCV antibody, HCV Ribonucleic Acid (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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants Treated With Glecaprevir/Pibrentasvir for 8 weeks<br>Participants treated once daily with oral tablets of glecaprevir/pibrentasvir for 8 weeks. | Drug: Glecaprevir/Pibrentasvir (GLE/PIB)<br>* Oral tablets<br>* Other names: Mavyret;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virological 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 the study drug. | 12 weeks after last dose of study drug (Week 20) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) in the Modified ITT-Virologic Failure (mITT-VF) 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 the study drug. | 12 weeks after last dose of study drug (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 log10 IU/mL above nadir during treatment, confirmed HCV RNA >= 100 IU/mL after HCV RNA < lower limit of quantification (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 Relapse in the ITT Population | Post-treatment (PT) relapse is defined as confirmed HCV RNA >= LLOQ between the end of treatment (EOT) and 12 weeks after the last dose of study drug among participants who completed treatment as planned 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 drug (Week 20) | 
| Percentage of Participants With Post-Treatment Reinfection With HCV in the ITT Population | Post-treatment (PT) reinfection is defined as confirmed HCV RNA >= LLOQ in the PT period 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 drug (Week 20) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute HCV Infection, HCV Genotype 1-6, Hepatitis C, Glecaprevir/Pibrentasvir, ABT-493/ABT-530, Mavyret