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Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection (VOYAGE-2)

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: NCT03235349
Recruitment Status : Completed
First Posted : August 1, 2017
Results First Posted : November 21, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with compensated cirrhosis with or without human immunodeficiency virus (HIV) co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN) (alpha, beta or pegylated interferon [pegIFN]) with or without ribavirin (RBV) OR sofosbuvir with RBV with or without IFN.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naïve and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection
Actual Study Start Date : September 29, 2017
Actual Primary Completion Date : November 15, 2018
Actual Study Completion Date : February 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Glecaprevir/Pibrentasvir
Participants received oral glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 12 or 16 weeks. Participants received treatment for 12 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
Drug: Glecaprevir/Pibrentasvir
Coformulated tablet for oral administration
Other Names:
  • ABT-493/ABT-530
  • MAVYRET™




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen. ]
    SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.


Secondary Outcome Measures :
  1. Percentage of Participants With On-treatment Virologic Failure [ Time Frame: 12 or 16 weeks depending on the treatment regimen ]

    On-treatment virologic failure was defined as meeting one of the following:

    • confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log₁₀ IU/mL above nadir) at any time point during the treatment period; or
    • confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA < 15 IU/mL during the treatment period, or
    • HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment.

  2. Percentage of Participants With Post-treatment Relapse [ Time Frame: From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen). ]
    Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < 15 IU/mL at the end of treatment, excluding re-infection.

  3. Percentage of HCV/HIV Co-infected Participants Achieving SVR12 [ Time Frame: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen ]
    SVR12 was defined as plasma HCV RNA level less than LLOQ (15 IU/mL) 12 weeks after the last dose of study drug.



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:

  • Must be of Asian descent.
  • Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5 or 6 infection.
  • Positive anti-HCV antibody (Ab) and HCV ribonucleic acid (RNA) greater than or equal to 1000 IU/ mL at Screening Visit.
  • Chronic HCV infection defined as one of the following:

    • Positive for anti-HCV Ab or HCV RNA at least 6 months before Screening; or
    • A liver biopsy consistent with chronic HCV infection;
  • HCV treatment-naïve to any approved or investigational HCV treatment or treatment-experienced with interferon (IFN) (alpha, beta or pegylated interferon [pegIFN] with or without ribavirin (RBV) OR sofosbuvir with RBV with or without IFN. Previous treatment must have been completed >= 8 weeks prior to screening.
  • Compensated cirrhosis defined as Child-Pugh score of ≤ 6 at Screening and no current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites noted on physical exam, bleeding varices, use of diuretics for ascites, or hepatic encephalopathy.
  • Absence of hepatocellular carcinoma (HCC)

Participants enrolled with human immunodeficiency virus (HIV)-1 and HCV co-infection must also meet the following criteria:

  • Positive test result for human immunodeficiency virus antibody (HIV Ab) at Screening.
  • Naïve to treatment with any antiretroviral therapy (ART) with a cluster of differentiation (CD)4+ count greater than or equal to 500 cells/mm³ (or CD4+ % >= 29%), or
  • On a stable, qualifying HIV-1 ART regimen with CD4+ count >= 200 cells/mm³ (or CD4+ % >= 14%) at Screening; and plasma HIV-1 RNA below lower limit of quantification (LLOQ) by an approved plasma HIV-1 RNA quantitative assay at Screening and at least once during the 12 months prior to Screening.

Exclusion Criteria:

  • Positive test result for hepatitis B surface antigen (HbsAg) or positive test result for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) if HBsAg is negative.
  • Any cause of liver disease other than chronic HCV-infection.
  • HCV genotype performed during screening indicating co-infection with more than one HCV genotype
  • Clinically significant abnormalities, other than HCV infection or HCV/HIV co-infection
  • Chronic human immunodeficiency virus, type 2 (HIV-2) infection

Additional Exclusion Criteria for participants with HCV/HIV Co-Infection:

  • For participants on stable ART, taking anti-retroviral agent(s) other than those permitted
  • Treatment for an acquired immunodeficiency syndrome (AIDS)-associated opportunistic infection within 12 months of Screening or prophylaxis for an AIDS-associated opportunistic infection within 6 months of screening
  • Diagnosis of any clinical AIDS-defining event within 12 months prior to Screening.

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): NCT03235349


Locations
Show Show 34 study locations
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] April 3, 2017
Statistical Analysis Plan  [PDF] January 18, 2018

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03235349    
Other Study ID Numbers: M15-593
First Posted: August 1, 2017    Key Record Dates
Results First Posted: November 21, 2019
Last Update Posted: November 21, 2019
Last Verified: August 2019
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 to 6
Cirrhosis
Compensated Cirrhosis
Human Immunodeficiency Virus
co-infection
Treatment-naïve
treatment-experienced
interferon
Asian
Additional relevant MeSH terms:
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Infection
Coinfection
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Acquired Immunodeficiency Syndrome
HIV Infections
Hepatitis
Hepatitis, Chronic
Liver Cirrhosis
Immunologic Deficiency Syndromes
Fibrosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Parasitic Diseases