A Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection

Study Overview
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Brief Summary
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This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (GLE)/pibrentasvir (PIB) for an 8 or 12-week treatment duration in adults in Brazil with chronic hepatitis C virus (HCV) genotype (GT) 1 to GT6 infection, without cirrhosis or with compensated cirrhosis, who were HCV treatment-naïve.

Detailed Description
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This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of GLE/PIB for an 8- or 12-week treatment duration in adults in Brazil with chronic HCV GT1 to GT6 infection, without cirrhosis or with compensated cirrhosis with a METAVIR System Fibrosis Score of F2 to F3 (without cirrhosis) or F4 (with compensated cirrhosis) or equivalent, who were HCV treatment-naïve.

Official Title
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A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naïve Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection

Conditions
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Hepatitis C Virus (HCV)

Intervention / Treatment
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* Drug: Glecaprevir/Pibrentasvir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant had positive plasma hepatitis C virus (HCV) antibody and HCV ribonucleic acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening Visit. Participant must have been documented as without cirrhosis with METAVIR equivalent fibrosis stage of F2 to F3 or with compensated cirrhosis (F4) based on results of a liver biopsy, or FibroScan, or FibroTest score. Participants who were known to be HCV/Human Immunodeficiency Virus (HIV) co-infected may have been enrolled if they had a positive test result for anti-HIV antibody at Screening and were: naïve to treatment with any antiretroviral therapy (ART), or on a stable, qualifying HIV ART regimen for at least 8 weeks prior to Baseline. Participants with compensated cirrhosis only: Absence of hepatocellular carcinoma (HCC) within 3 months prior to Screening or a negative ultrasound at Screening. Exclusion Criteria: Current hepatitis B virus (HBV) infection on screening tests. Any current or past clinical evidence of Child-Pugh B or C classification (score of > 6) or clinical history of liver decompensation including ascites on physical exam, including hepatic encephalopathy or variceal bleeding. Receipt of any investigational or commercially available anti-HCV agents.

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks<br>Arm A: Hepatitis C virus (HCV) genotype (GT) 1 to GT6 participants without cirrhosis (fibrosis stage F2 to F3) received glecaprevir (GLE)/pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks. | Drug: Glecaprevir/Pibrentasvir<br>* Film-coated tablet<br>* Other names: MAVYRET;|
| Experimental: Arm B: GLE/PIB for 12 Weeks<br>Arm B: HCV GT1 to GT6 participants with compensated cirrhosis (F4) received GLE/PIB 300 mg/120 mg QD for 12 weeks. | Drug: Glecaprevir/Pibrentasvir<br>* Film-coated tablet<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 Virologic Response 12 Weeks Post-treatment (SVR12) | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last dose of study drug. | 12 weeks after last dose of study drug (week 20 or 24 depending on treatment regimen) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With On-treatment HCV Virologic Failure | On-treatment HCV virologic failure was defined as one of the following: Confirmed hepatitis C virus ribonucleic acid (HCV RNA) ≥ 100 IU/mL after HCV RNA < 15 IU/mL at any time point during treatment; or Confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) during study drug treatment; or HCV RNA ≥ 15 IU/mL at the end of treatment with at least 6 weeks of treatment. | 8 or 12 weeks (depending on treatment regimen) | 
| Percentage of Participants With Post-treatment HCV Virologic Relapse | Post-treatment HCV virologic relapse was defined as confirmed HCV RNA ≥ 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA levels < 15 IU/mL at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed. | From the end of treatment (8 or 12 weeks depending on treatment regimen) through 12 weeks after the last dose of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Hepatitis C Virus (HCV), Genotype 1 - 6, Metavir System Fibrosis Score, Glecaprevir, Pibrentasvir, Treatment naïve, Cirrhosis, Compensated cirrhosis