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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

Primary Purpose

Hepatitis C Virus (HCV)

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Glecaprevir/Pibrentasvir

About this trial

This is an interventional treatment trial for Hepatitis C Virus (HCV) focused on measuring Chronic Hepatitis C Virus (HCV), Genotype 1 - 6, Metavir System Fibrosis Score, Glecaprevir, Pibrentasvir, Treatment naïve, Cirrhosis, Compensated cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks

Arm B: GLE/PIB for 12 Weeks

Arm Description

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: HCV GT1 to GT6 participants with compensated cirrhosis (F4) received GLE/PIB 300 mg/120 mg QD for 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03219216

First Posted

July 13, 2017

Last Updated

March 4, 2020

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT03219216

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

June 6, 2018 (Actual)

Primary Completion Date

March 11, 2019 (Actual)

Study Completion Date

March 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C Virus (HCV)

Keywords

Chronic Hepatitis C Virus (HCV), Genotype 1 - 6, Metavir System Fibrosis Score, Glecaprevir, Pibrentasvir, Treatment naïve, Cirrhosis, Compensated cirrhosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: Glecaprevir (GLE)/Pibrentasvir (PIB) for 8 weeks

Arm Type

Experimental

Arm Description

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 Title

Arm B: GLE/PIB for 12 Weeks

Arm Type

Experimental

Arm Description

Arm B: HCV GT1 to GT6 participants with compensated cirrhosis (F4) received GLE/PIB 300 mg/120 mg QD for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Glecaprevir/Pibrentasvir

Other Intervention Name(s)

ABT-493, ABT-530, MAVYRET

Intervention Description

Film-coated tablet

Primary Outcome Measure Information:

Title

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

Description

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 Outcome Measure Information:

Title

Percentage of Participants With On-treatment HCV Virologic Failure

Description

Time Frame

8 or 12 weeks (depending on treatment regimen)

Title

Percentage of Participants With Post-treatment HCV Virologic Relapse

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AbbVie Inc.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Hospital Universitário Cassiano Antônio Moraes - HCUFES /ID# 163512

City

Vitoria

State/Province

Espirito Santo

ZIP/Postal Code

29 043-260

Country

Brazil

Facility Name

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

City

São Luís

State/Province

Maranhao

ZIP/Postal Code

65045-040

Country

Brazil

Facility Name

Universidade Estadual de Maringá /ID# 166436

City

Maringá

State/Province

Parana

ZIP/Postal Code

87083-068

Country

Brazil

Facility Name

Hospital de Clinicas de Porto Alegre /ID# 163166

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Hospital de Clinicas de Porto Alegre /ID# 163167

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Hospital Ernesto Dornelles /ID# 163171

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90160-093

Country

Brazil

Facility Name

Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu /ID# 163066

City

Botucatu

State/Province

Sao Paulo

ZIP/Postal Code

18618-686

Country

Brazil

Facility Name

Instituto de Infectologia Campinas /ID# 163175

City

Campinas

State/Province

Sao Paulo

ZIP/Postal Code

13015-080

Country

Brazil

Facility Name

Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 163054

City

Ribeirão Preto

State/Province

Sao Paulo

ZIP/Postal Code

14048-900

Country

Brazil

Facility Name

Instituto de Infectologia Emilio Ribas /ID# 163170

City

São Paulo

State/Province

Sao Paulo

ZIP/Postal Code

01246-900

Country

Brazil

Facility Name

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HC /ID# 163168

City

São Paulo

State/Province

Sao Paulo

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

UNIFESP/Unidade de Atendimento Pesquisa Clínica 1 /ID# 164188

City

Sao Paulo

ZIP/Postal Code

04037-003

Country

Brazil

Facility Name

Centro de Referência e Treinamento DST/AIDS /ID# 163174

City

Sao Paulo

ZIP/Postal Code

04121-000

Country

Brazil

Facility Name

Hospital Heliopolis /ID# 163063

City

Sao Paulo

ZIP/Postal Code

04231-030

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing Time Frame

Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.

IPD Sharing 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.

IPD Sharing URL

https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Citations:

PubMed Identifier

35174470

Citation

Brown RS Jr, Collins MA, Strasser SI, Emmett A, Topp AS, Burroughs M, Ferreira R, Feld JJ. Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension. Infect Dis Ther. 2022 Apr;11(2):913-924. doi: 10.1007/s40121-022-00599-8. Epub 2022 Feb 17.

Results Reference

derived

PubMed Identifier

32949786

Citation

Peribanez-Gonzalez M, Cheinquer H, Rodrigues L, Lima MP, Alvares-da-Silva MR, Madruga J, Parise ER, Pessoa MG, Furtado J, Villanova M, Ferreira A, Mazzoleni F, Nascimento E, Silva GF, Fredrick L, Krishnan P, Burroughs M, Reuter T. Efficacy and safety of glecaprevir/pibrentasvir in treatment-naive adults with chronic hepatitis C virus genotypes 1-6 in Brazil. Ann Hepatol. 2021 Jan-Feb;20:100257. doi: 10.1016/j.aohep.2020.09.002. Epub 2020 Sep 17.

Results Reference

derived

Learn more about this trial

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

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