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

Phase 3CompletedNCT03219216

AbbVie100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Hepatitis C Virus (HCV)

Interventions

Glecaprevir/PibrentasvirDRUG

Film-coated tablet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (14)

Hospital Universitário Cassiano Antônio Moraes - HCUFES /ID# 163512

Vitória, Espírito Santo, Brazil

Hospital Universitario da Universidade Federal do Maranhao - CEPEC /ID# 163169

São Luís, Maranhão, Brazil

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks after last dose of study drug (week 20 or 24 depending on treatment regimen)

Secondary Outcomes

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.

Time frame: 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.

Time frame: From the end of treatment (8 or 12 weeks depending on treatment regimen) through 12 weeks after the last dose of study drug

Data from ClinicalTrials.gov

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