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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)

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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus (HCV)
Intervention Drug: Glecaprevir/Pibrentasvir
Enrollment 160
Recruitment Details The study was conducted at 34 sites in China and South Korea. Eligible participants were chronic hepatitis C (HCV) genotype (GT)1–6-infected adults with compensated cirrhosis with or without HIV co-infection who were HCV treatment-naïve or treatment-experienced with regimens containing interferon (IFN), pegylated IFN, ribavirin, and/or sofosbuvir.
Pre-assignment Details  
Arm/Group Title Glecaprevir/Pibrentasvir
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 160
Completed 158
Not Completed 2
Reason Not Completed
Adverse Event             1
Other             1
Arm/Group Title Glecaprevir/Pibrentasvir
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 160 participants
57.83  (11.27)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants
< 65 years
120
  75.0%
≥ 65 years
40
  25.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants
Female
80
  50.0%
Male
80
  50.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian Number Analyzed 160 participants
160
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants
South Korea
37
  23.1%
China
123
  76.9%
HCV Genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants
Genotype 1
85
  53.1%
Genotype 2
53
  33.1%
Genotype 3
14
   8.8%
Genotype 4
1
   0.6%
Genotype 5
0
   0.0%
Genotype 6
7
   4.4%
Prior HCV Treatment History   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants
Treatment-naive
110
  68.8%
Treatment-experienced
50
  31.3%
[1]
Measure Description: Treatment-experienced includes treatment with interferon (IFN; alpha, beta or pegylated interferon [pegIFN]) with or without ribavirin (RBV), OR sofosbuvir with RBV with or without IFN.
HCV Ribonucleic Acid (RNA) Level  
Mean (Standard Deviation)
Unit of measure:  Log₁₀ IU/mL
Number Analyzed 160 participants
6.16  (0.74)
Human Immunodeficiency Virus (HIV) Co-infection Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants
Hepatitis C infection only
160
 100.0%
HCV / HIV co-infection
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Hide Description 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.
Time Frame 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of study drug. Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backward imputation were counted as non-responders.
Arm/Group Title Glecaprevir/Pibrentasvir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 160
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
99.4
(98.2 to 100.0)
2.Secondary Outcome
Title Percentage of Participants With On-treatment Virologic Failure
Hide Description

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.
Time Frame 12 or 16 weeks depending on the treatment regimen
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of study drug.
Arm/Group Title Glecaprevir/Pibrentasvir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 160
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 2.3)
3.Secondary Outcome
Title Percentage of Participants With Post-treatment Relapse
Hide Description 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.
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).
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least one dose of study drug, with HCV RNA < 15 IU/mL at the end of treatment, at least one post-treatment HCV RNA value, and who completed the assigned treatment.
Arm/Group Title Glecaprevir/Pibrentasvir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 159
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.6
(0.1 to 3.5)
4.Secondary Outcome
Title Percentage of HCV/HIV Co-infected Participants Achieving SVR12
Hide Description SVR12 was defined as plasma HCV RNA level less than LLOQ (15 IU/mL) 12 weeks after the last dose of study drug.
Time Frame 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen
Hide Outcome Measure Data
Hide Analysis Population Description
No HCV-HIV co-infected participants were enrolled in the study
Arm/Group Title Glecaprevir/Pibrentasvir
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From initiation of study drug through 30 days after last dose; up to 16 or 20 weeks depending on the treatment regimen.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Glecaprevir/Pibrentasvir
Hide Arm/Group Description 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.
All-Cause Mortality
Glecaprevir/Pibrentasvir
Affected / at Risk (%)
Total   1/160 (0.63%)    
Hide Serious Adverse Events
Glecaprevir/Pibrentasvir
Affected / at Risk (%) # Events
Total   5/160 (3.13%)    
Gastrointestinal disorders   
UPPER GASTROINTESTINAL HAEMORRHAGE  1  1/160 (0.63%)  1
Hepatobiliary disorders   
BILE DUCT STONE  1  1/160 (0.63%)  1
HEPATIC LESION  1  1/160 (0.63%)  1
Infections and infestations   
LIVER ABSCESS  1  1/160 (0.63%)  1
Psychiatric disorders   
DEPRESSION  1  1/160 (0.63%)  1
1
Term from vocabulary, MedDRA (21.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Glecaprevir/Pibrentasvir
Affected / at Risk (%) # Events
Total   29/160 (18.13%)    
Infections and infestations   
UPPER RESPIRATORY TRACT INFECTION  1  19/160 (11.88%)  19
URINARY TRACT INFECTION  1  10/160 (6.25%)  10
1
Term from vocabulary, MedDRA (21.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03235349    
Other Study ID Numbers: M15-593
First Submitted: July 28, 2017
First Posted: August 1, 2017
Results First Submitted: November 4, 2019
Results First Posted: November 21, 2019
Last Update Posted: November 21, 2019