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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03219216
Recruitment Status : Completed
First Posted : July 17, 2017
Results First Posted : March 17, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus (HCV) Drug: Glecaprevir/Pibrentasvir Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 6, 2018
Actual Primary Completion Date : March 11, 2019
Actual Study Completion Date : March 11, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks
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
Film-coated tablet
Other Names:
  • ABT-493
  • ABT-530
  • MAVYRET
Experimental: Arm B: GLE/PIB for 12 Weeks
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
Film-coated tablet
Other Names:
  • ABT-493
  • ABT-530
  • MAVYRET


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 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 :
  1. Percentage of Participants With On-treatment HCV Virologic Failure [ Time Frame: 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.

  2. Percentage of Participants With Post-treatment HCV Virologic Relapse [ 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 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219216


Locations
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Brazil
Hospital Universitário Cassiano Antônio Moraes - HCUFES /ID# 163512
Vitoria, Espirito Santo, Brazil, 29 043-260
Hospital Universitario da Universidade Federal do Maranhao - CEPEC /ID# 163169
São Luís, Maranhao, Brazil, 65045-040
Universidade Estadual de Maringá /ID# 166436
Maringá, Parana, Brazil, 87083-068
Hospital de Clinicas de Porto Alegre /ID# 163166
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Hospital de Clinicas de Porto Alegre /ID# 163167
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Hospital Ernesto Dornelles /ID# 163171
Porto Alegre, Rio Grande Do Sul, Brazil, 90160-093
Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 163066
Botucatu, Sao Paulo, Brazil, 18618-686
Instituto de Infectologia Campinas /ID# 163175
Campinas, Sao Paulo, Brazil, 13015-080
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163054
Ribeirão Preto, Sao Paulo, Brazil, 14048-900
Instituto de Infectologia Emilio Ribas /ID# 163170
São Paulo, Sao Paulo, Brazil, 01246-900
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC /ID# 163168
São Paulo, Sao Paulo, Brazil, 05403-000
UNIFESP/Unidade de Atendimento Pesquisa Clínica 1 /ID# 164188
Sao Paulo, Brazil, 04037-003
Centro de Referência e Treinamento DST/AIDS /ID# 163174
Sao Paulo, Brazil, 04121-000
Hospital Heliopolis /ID# 163063
Sao Paulo, Brazil, 04231-030
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
  Study Documents (Full-Text)

Documents provided by AbbVie:
Study Protocol  [PDF] August 2, 2018
Statistical Analysis Plan  [PDF] January 29, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03219216    
Other Study ID Numbers: M16-156
First Posted: July 17, 2017    Key Record Dates
Results First Posted: March 17, 2020
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Chronic Hepatitis C Virus (HCV)
Genotype 1 - 6
Metavir System Fibrosis Score
Glecaprevir
 Pibrentasvir
Treatment naïve
Cirrhosis
Compensated cirrhosis
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Chronic Disease
Disease Attributes
Pathologic Processes