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

Hepatitis C Virus (HCV) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03219216
• Other study ID #: M16-156
• Status: Completed
• Phase: Phase 3
• Start date: June 6, 2018
• Est. completion date: March 11, 2019

Study information

• Verified date: March 2020
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 11, 2019
• Est. primary completion date: March 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus (HCV)
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Glecaprevir/Pibrentasvir
Film-coated tablet

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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