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 3

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Arm A: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks	Glecaprevir/Pibrentasvir	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.
Arm B: GLE/PIB for 12 Weeks	Glecaprevir/Pibrentasvir	Arm B: HCV GT1 to GT6 participants with compensated cirrhosis (F4) received GLE/PIB 300 mg/120 mg QD for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	12 weeks after last dose of study drug (week 20 or 24 depending on treatment regimen)	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Post-treatment HCV Virologic Relapse	From the end of treatment (8 or 12 weeks depending on treatment regimen) through 12 weeks after the last dose of study drug	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.
Percentage of Participants With On-treatment HCV Virologic Failure	8 or 12 weeks (depending on treatment regimen)	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.

Locations (14): Hospital de Clinicas de Porto Alegre /ID# 163167
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Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Ernesto Dornelles /ID# 163171
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Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Clinicas de Porto Alegre /ID# 163166
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Porto Alegre, Rio Grande Do Sul, Brazil
Centro de Referência e Treinamento DST/AIDS /ID# 163174
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Sao Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163054
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Ribeirão Preto, Sao Paulo, Brazil
Hospital Universitário Cassiano Antônio Moraes - HCUFES /ID# 163512
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Vitoria, Espirito Santo, Brazil
Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 163066
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Botucatu, Sao Paulo, Brazil
UNIFESP/Unidade de Atendimento Pesquisa Clínica 1 /ID# 164188
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Sao Paulo, Brazil
Hospital Universitario da Universidade Federal do Maranhao - CEPEC /ID# 163169
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São Luís, Maranhao, Brazil
Universidade Estadual de Maringá /ID# 166436
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Maringá, Parana, Brazil
Instituto de Infectologia Campinas /ID# 163175
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Campinas, Sao Paulo, Brazil
Hospital Heliopolis /ID# 163063
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Sao Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC /ID# 163168
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São Paulo, Sao Paulo, Brazil
Instituto de Infectologia Emilio Ribas /ID# 163170
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São Paulo, Sao Paulo, Brazil