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)
Information provided by (Responsible Party)
First received: July 28, 2017
Last updated: November 4, 2019
Last Verified: August 2019
History of Changes
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.
Hepatitis C Virus (HCV)
Drug : Glecaprevir/Pibrentasvir
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|
Further study details as provided by AbbVie:
Primary Outcome Measures
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.
- 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.
- 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.
- 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.
|Study Start Date:||September 29, 2017|
|Study Completion Date:||February 25, 2019|
|Primary Completion Date:||November 15, 2018 (Final data collection date for primary outcome measure)|
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.
Coformulated tablet for oral administration
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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)
- 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.
Participants enrolled with human immunodeficiency virus (HIV)-1 and HCV co-infection must also meet the following 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
- 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.
Additional Exclusion Criteria for participants with HCV/HIV Co-Infection:
Contacts and LocationsChoosing 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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03235349
Locations Show More
|Peking University Peoples Hospit /ID# 156851|
|Beijing, Beijing, China, 100044|
|Guangzhou Eighth People's Hosp /ID# 156865|
|Guangzhou, Guangdong, China, 510060|
|Guangdong General Hospital /ID# 156827|
|Guangzhou, Guangdong, China, 510080|
|Nanfang Hospital of Southern Medical University /ID# 156866|
|Guangzhou, Guangdong, China, 510515|
|The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156905|
|Guangzhou, Guangdong, China, 510630|
|The Second Hospital of Nanjing /ID# 156869|
|Nanjing, Jiangsu, China, 210003|
|Jiangsu Province People's Hospital /ID# 156867|
|Nanjing, Jiangsu, China, 210029|
|The First Hosp of Jilin Univ /ID# 156825|
|Changchun, Jilin, China, 130021|
|The Sixth People's Hospital of Shenyang /ID# 156854|
|Shenyang, Liaoning, China, 110006|
|Ruijin Hospital, Shanghai Jiaotong /ID# 157337|
|Shanghai, Shanghai, China, 200025|
|Huashan Hospital of Fudan University /ID# 156909|
|Shanghai, Shanghai, China, 200040|
|Shanghai Public Health Cli Ctr /ID# 156837|
|Shanghai, Shanghai, China, 201508|
|West China Hospital /ID# 156835|
|Chengdu, Sichuan, China, 610041|
|Beijing Di Tan Hospital, Capital Medical University /ID# 156852|
|Beijing, China, 100015|
|1st Hospital of Peking Uni /ID# 156850|
|Beijing, China, 100034|
|Beijing Friendship Hospital /ID# 156843|
|Beijing, China, 100050|
|Beijing Youan Hosp, Cap Med Un /ID# 163418|
|Beijing, China, 100069|
|2nd Affiliated Hosp Chongqing /ID# 156838|
|Chongqing, China, 400010|
|Mengchao Hepatobiliary Hospita /ID# 156907|
|Fuzhou, China, 350025|
|Chinese People's Liberation Army 81 Hospital /ID# 156868|
|Nanjing, China, 210002|
|Shengjing Hospital of China Medical University /ID# 156829|
|Shenyang, China, 110004|
|1st Aff Hosp Xinjiang Med Uni /ID# 156891|
|Urumqi, China, 830054|
|Fourth Military Medical University Tangdu Hospital, PLA /ID# 156767|
|Xi'an, China, 710038|
|First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163420|
|Xi'an, China, 710061|
|Henan Provincial Peoples Hosp /ID# 157371|
|Zhengzhou, Henan, China, 450000|
|Korea, Republic of|
|Pusan National University Hosp /ID# 163411|
|Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739|
|Seoul National Univ Bundang ho /ID# 163408|
|Seongnam, Gyeonggido, Korea, Republic of, 13620|
|Inje University Busan Paik Hospital /ID# 163384|
|Busan, Gyeongsangbugdo, Korea, Republic of, 47392|
|Pusan Nat Univ Yangsan Hosp /ID# 163385|
|Yangsan-si,, Gyeongsangnamdo, Korea, Republic of, 50612|
|Severance Hospital /ID# 163399|
|Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722|
|Samsung Medical Center /ID# 163402|
|Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351|
|Korea University Guro Hospital /ID# 163412|
|Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308|
|Seoul National University Hospital /ID# 163401|
|Seoul, Korea, Republic of, 03080|
|Asan Medical Center /ID# 163398|
|Seoul, Korea, Republic of, 05505|
Sponsors and CollaboratorsAbbVie
|Study Director:||AbbVie Inc.||AbbVie|
|ClinicalTrials.gov Identifier:||NCT03235349 History of Changes|
|Other Study ID Numbers:||M15-593|
|Study First Received:||July 28, 2017|
|Last Updated:||November 4, 2019|
|Individual Participant Data|
|Plan to Share IPD:||Yes|
|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
Human Immunodeficiency Virus
Additional relevant MeSH terms:
Hepatitis C, Chronic
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
ClinicalTrials.gov processed this data on June 01, 2020
This information is provided by ClinicalTrials.gov.