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

NCT ID: NCT03235349

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-29
• Study Completion Date: 2019-02-25

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.

Conditions

Hepatitis C Virus (HCV)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Glecaprevir/Pibrentasvir

Intervention Type: DRUG

Coformulated tablet for oral administration

Interventions

Glecaprevir/Pibrentasvir

Coformulated tablet for oral administration

Intervention Type: DRUG

Other Intervention Names

ABT-493/ABT-530; MAVYRET™

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

Peking University Peoples Hospit /ID# 156851

Beijing, Beijing Municipality, China

Guangzhou Eighth People's Hosp /ID# 156865

Guangzhou, Guangdong, China

Guangdong General Hospital /ID# 156827

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University /ID# 156866

Guangzhou, Guangdong, China

The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156905

Guangzhou, Guangdong, China

The Second Hospital of Nanjing /ID# 156869

Nanjing, Jiangsu, China

Jiangsu Province People's Hospital /ID# 156867

Nanjing, Jiangsu, China

The First Hosp of Jilin Univ /ID# 156825

Changchun, Jilin, China

The Sixth People's Hospital of Shenyang /ID# 156854

Shenyang, Liaoning, China

Ruijin Hospital, Shanghai Jiaotong /ID# 157337

Shanghai, Shanghai Municipality, China

Huashan Hospital of Fudan University /ID# 156909

Shanghai, Shanghai Municipality, China

Shanghai Public Health Cli Ctr /ID# 156837

Shanghai, Shanghai Municipality, China

West China Hospital /ID# 156835

Chengdu, Sichuan, China

Beijing Di Tan Hospital, Capital Medical University /ID# 156852

Beijing, , China

1st Hospital of Peking Uni /ID# 156850

Beijing, , China

Beijing Friendship Hospital /ID# 156843

Beijing, , China

Beijing Youan Hosp, Cap Med Un /ID# 163418

Beijing, , China

2nd Affiliated Hosp Chongqing /ID# 156838

Chongqing, , China

Mengchao Hepatobiliary Hospita /ID# 156907

Fuzhou, , China

Chinese People's Liberation Army 81 Hospital /ID# 156868

Nanjing, , China

Shengjing Hospital of China Medical University /ID# 156829

Shenyang, , China

1st Aff Hosp Xinjiang Med Uni /ID# 156891

Ürümqi, , China

Fourth Military Medical University Tangdu Hospital, PLA /ID# 156767

Xi'an, , China

First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163420

Xi'an, , China

Henan Provincial Peoples Hosp /ID# 157371

Zhengzhou, Henan, , China

Pusan National University Hosp /ID# 163411

Busan, Busan Gwang Yeogsi, South Korea

Seoul National Univ Bundang ho /ID# 163408

Seongnam, Gyeonggido, South Korea

Inje University Busan Paik Hospital /ID# 163384

Pusan, Gyeongsangbuk-do, South Korea

Pusan Nat Univ Yangsan Hosp /ID# 163385

Yangsan, Gyeongsangnam-do, South Korea

Severance Hospital /ID# 163399

Seoul, Seoul Teugbyeolsi, South Korea

Samsung Medical Center /ID# 163402

Seoul, Seoul Teugbyeolsi, South Korea

Korea University Guro Hospital /ID# 163412

Seoul, Seoul Teugbyeolsi, South Korea

Seoul National University Hospital /ID# 163401

Seoul, , South Korea

Asan Medical Center /ID# 163398

Seoul, , South Korea

Countries

China; South Korea

References

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.

Reference Type: DERIVED

PMID: 32682494 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

M15-593

Identifier Type: -

Identifier Source: org_study_id