Back to resultsEfficacy 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)
Primary Purpose
Hepatitis C Virus (HCV)
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Glecaprevir/Pibrentasvir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus (HCV) focused on measuring Chronic Hepatitis C Virus (HCV), Genotype 1 to 6, Cirrhosis, Compensated Cirrhosis, Human Immunodeficiency Virus, co-infection, Treatment-naïve, treatment-experienced, interferon, Asian
Eligibility 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.
Sites / Locations
- Peking University Peoples Hospit /ID# 156851
- Guangzhou Eighth People's Hosp /ID# 156865
- Guangdong General Hospital /ID# 156827
- Nanfang Hospital of Southern Medical University /ID# 156866
- The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156905
- The Second Hospital of Nanjing /ID# 156869
- Jiangsu Province People's Hospital /ID# 156867
- The First Hosp of Jilin Univ /ID# 156825
- The Sixth People's Hospital of Shenyang /ID# 156854
- Ruijin Hospital, Shanghai Jiaotong /ID# 157337
- Huashan Hospital of Fudan University /ID# 156909
- Shanghai Public Health Cli Ctr /ID# 156837
- West China Hospital /ID# 156835
- Beijing Di Tan Hospital, Capital Medical University /ID# 156852
- 1st Hospital of Peking Uni /ID# 156850
- Beijing Friendship Hospital /ID# 156843
- Beijing Youan Hosp, Cap Med Un /ID# 163418
- 2nd Affiliated Hosp Chongqing /ID# 156838
- Mengchao Hepatobiliary Hospita /ID# 156907
- Chinese People's Liberation Army 81 Hospital /ID# 156868
- Shengjing Hospital of China Medical University /ID# 156829
- 1st Aff Hosp Xinjiang Med Uni /ID# 156891
- Fourth Military Medical University Tangdu Hospital, PLA /ID# 156767
- First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163420
- Henan Provincial Peoples Hosp /ID# 157371
- Pusan National University Hosp /ID# 163411
- Seoul National Univ Bundang ho /ID# 163408
- Inje University Busan Paik Hospital /ID# 163384
- Pusan Nat Univ Yangsan Hosp /ID# 163385
- Severance Hospital /ID# 163399
- Samsung Medical Center /ID# 163402
- Korea University Guro Hospital /ID# 163412
- Seoul National University Hospital /ID# 163401
- Asan Medical Center /ID# 163398
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Glecaprevir/Pibrentasvir
Arm 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.
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; 15 IU/mL) 12 weeks after the last dose of study drug.
Secondary Outcome Measures
Percentage of Participants With On-treatment Virologic Failure
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.
Percentage of Participants With Post-treatment Relapse
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.
Percentage of HCV/HIV Co-infected Participants Achieving SVR12
SVR12 was defined as plasma HCV RNA level less than LLOQ (15 IU/mL) 12 weeks after the last dose of study drug.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03235349
Brief Title
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
Acronym
VOYAGE-2
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
February 25, 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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
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 to 6, Cirrhosis, Compensated Cirrhosis, Human Immunodeficiency Virus, co-infection, Treatment-naïve, treatment-experienced, interferon, Asian
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glecaprevir/Pibrentasvir
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Glecaprevir/Pibrentasvir
Other Intervention Name(s)
ABT-493/ABT-530, MAVYRET™
Intervention Description
Coformulated tablet for oral administration
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; 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.
Secondary Outcome Measure Information:
Title
Percentage of Participants With On-treatment Virologic Failure
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
Title
Percentage of Participants With Post-treatment Relapse
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).
Title
Percentage of HCV/HIV Co-infected Participants Achieving SVR12
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Peoples Hospit /ID# 156851
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Guangzhou Eighth People's Hosp /ID# 156865
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Guangdong General Hospital /ID# 156827
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Nanfang Hospital of Southern Medical University /ID# 156866
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156905
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
The Second Hospital of Nanjing /ID# 156869
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210003
Country
China
Facility Name
Jiangsu Province People's Hospital /ID# 156867
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The First Hosp of Jilin Univ /ID# 156825
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
The Sixth People's Hospital of Shenyang /ID# 156854
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110006
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong /ID# 157337
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Huashan Hospital of Fudan University /ID# 156909
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai Public Health Cli Ctr /ID# 156837
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201508
Country
China
Facility Name
West China Hospital /ID# 156835
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Beijing Di Tan Hospital, Capital Medical University /ID# 156852
City
Beijing
ZIP/Postal Code
100015
Country
China
Facility Name
1st Hospital of Peking Uni /ID# 156850
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Friendship Hospital /ID# 156843
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Youan Hosp, Cap Med Un /ID# 163418
City
Beijing
ZIP/Postal Code
100069
Country
China
Facility Name
2nd Affiliated Hosp Chongqing /ID# 156838
City
Chongqing
ZIP/Postal Code
400010
Country
China
Facility Name
Mengchao Hepatobiliary Hospita /ID# 156907
City
Fuzhou
ZIP/Postal Code
350025
Country
China
Facility Name
Chinese People's Liberation Army 81 Hospital /ID# 156868
City
Nanjing
ZIP/Postal Code
210002
Country
China
Facility Name
Shengjing Hospital of China Medical University /ID# 156829
City
Shenyang
ZIP/Postal Code
110004
Country
China
Facility Name
1st Aff Hosp Xinjiang Med Uni /ID# 156891
City
Urumqi
ZIP/Postal Code
830054
Country
China
Facility Name
Fourth Military Medical University Tangdu Hospital, PLA /ID# 156767
City
Xi'an
ZIP/Postal Code
710038
Country
China
Facility Name
First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163420
City
Xi'an
ZIP/Postal Code
710061
Country
China
Facility Name
Henan Provincial Peoples Hosp /ID# 157371
City
Zhengzhou, Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Pusan National University Hosp /ID# 163411
City
Busan
State/Province
Busan Gwang Yeogsi
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Seoul National Univ Bundang ho /ID# 163408
City
Seongnam
State/Province
Gyeonggido
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital /ID# 163384
City
Busan
State/Province
Gyeongsangbugdo
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Pusan Nat Univ Yangsan Hosp /ID# 163385
City
Yangsan-si,
State/Province
Gyeongsangnamdo
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Severance Hospital /ID# 163399
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 163402
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital /ID# 163412
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Seoul National University Hospital /ID# 163401
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 163398
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
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
32682494
Citation
Wei L, Wang G, Alami NN, Xie W, Heo J, Xie Q, Zhang M, Kim YJ, Lim SG, Fredrick LM, Lu W, Liu W, Kalluri HV, Krishnan P, Tripathi R, Mobashery N, Burroughs M, Asatryan A, Jia J, Hou J. Glecaprevir-pibrentasvir to treat chronic hepatitis C virus infection in Asia: two multicentre, phase 3 studies- a randomised, double-blind study (VOYAGE-1) and an open-label, single-arm study (VOYAGE-2). Lancet Gastroenterol Hepatol. 2020 Sep;5(9):839-849. doi: 10.1016/S2468-1253(20)30086-8. Epub 2020 Jul 16.
Results Reference
derived
Learn more about this trial
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
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