A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection

Hepatitis C Virus (HCV) Clinical Trial

— VOYAGE-1  

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03222583
• Other study ID #: M15-592
• Status: Completed
• Phase: Phase 3
• Start date: October 4, 2017
• Est. completion date: February 15, 2019

Study information

• Verified date: November 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Randomization was stratified by geographic region (China, South Korea, Singapore), genotype (GT1, GT2, combined GT3 - 6), and HCV/HIV co-infection status (co-infected, not co-infected). In China, eligible participants were randomized to Arm A or Arm B (defined below) in the following ratios: 2:1 for GT1, 2:1 for GT2, and 2:1 for combined GT3-6. In South Korea and Singapore, eligible participants were randomized to Arm A or Arm B in the following ratios: 2:1 for GT1 and 2:1 for GT2.

All Primary and Secondary Outcome Measures were pre-specified to be analyzed only in Arm A.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 546
• Est. completion date: February 15, 2019
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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) viral load = 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, OR sofosbuvir with RBV with or without IFN. Previous treatment must have been completed = 8 weeks prior to screening.

• Participant must be documented as non-cirrhotic.

• 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+ percent = 29%)

• 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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Coinfection
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus (HCV)
• Hepatitis C, Chronic
• Hepatitis, Chronic
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection

Intervention

Drug:
• Placebo
Matching placebo tablet for oral administration
• Glecaprevir/Pibrentasvir
Coformulated tablet for oral administration

Locations

Country	Name	City	State
China	1st Hospital of Peking Uni /ID# 156845	Beijing
China	302 Military Hospital Of China /ID# 156841	Beijing
China	Beijing Di Tan Hospital, Capital Medical University /ID# 156847	Beijing
China	Beijing Friendship Hospital /ID# 156840	Beijing
China	Beijing Youan Hosp, Cap Med Un /ID# 163430	Beijing
China	Peking University Peoples Hospit /ID# 156846	Beijing	Beijing
China	The First Hosp of Jilin Univ /ID# 156820	Changchun	Jilin
China	Xiangya Hospital Central South University /ID# 156901	Changsha	Hunan
China	West China Hospital /ID# 156830	Chengdu	Sichuan
China	1st Affiliated Hosp 3rd Milita /ID# 156831	Chongqing
China	Dalian Sixth Peoples Hospital /ID# 163433	Dalian
China	Mengchao Hepatobiliary Hospita /ID# 156902	Fuzhou
China	Guangdong General Hospital /ID# 156822	Guangzhou	Guangdong
China	Guangzhou Eighth People's Hosp /ID# 156859	Guangzhou	Guangdong
China	Nanfang Hospital of Southern Medical University /ID# 156860	Guangzhou	Guangdong
China	The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156900	Guangzhou	Guangdong
China	Hainan General Hospital /ID# 156839	Haikou, Hainan
China	Jinan Infectious Diseases Hosp /ID# 156886	Jinan, Shandong
China	Chinese People's Liberation Army 81 Hospital /ID# 156862	Nanjing
China	Jiangsu Province People's Hospital /ID# 156861	Nanjing	Jiangsu
China	The Second Hospital of Nanjing /ID# 156863	Nanjing	Jiangsu
China	Huashan Hospital of Fudan University /ID# 156904	Shanghai	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong /ID# 157336	Shanghai	Shanghai
China	Shanghai Changzheng Hospital /ID# 158072	Shanghai	Shanghai
China	Shanghai Public Health Cli Ctr /ID# 156832	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University /ID# 156824	Shenyang
China	The Sixth People's Hospital of Shenyang /ID# 156849	Shenyang	Liaoning
China	Tianjin Third Central Hospital /ID# 156816	Tianjin
China	1st Aff Hosp Xinjiang Med Uni /ID# 156887	Urumqi
China	Tongji Hosp Tongji Med College /ID# 156885	Wuhan
China	Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 156884	Wuhan
China	First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163432	Xi'an
China	Fourth Military Medical University Tangdu Hospital, PLA /ID# 156765	Xi'an
China	Henan Provincial Peoples Hosp /ID# 157197	Zhengzhou, Henan
Korea, Republic of	Inje University Busan Paik Hospital /ID# 163329	Busan	Gyeongsangbugdo
Korea, Republic of	Pusan National University Hosp /ID# 163371	Busan	Busan Gwang Yeogsi
Korea, Republic of	Inha University Hospital /ID# 163320	Jung-gu	Incheon Gwang Yeogsi
Korea, Republic of	Yonsei University Health System, Severance Hospital /ID# 163339	Seodaemun-gu	Seoul Teugbyeolsi
Korea, Republic of	Seoul National Univ Bundang ho /ID# 163367	Seongnam	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 163336	Seoul
Korea, Republic of	Cath Univ Seoul St Mary's Hosp /ID# 163341	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Korea Universtiy Guro Hospital /ID# 163380	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 163364	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Seoul National University Hospital /ID# 163348	Seoul
Korea, Republic of	Pusan Nat Univ Yangsan Hosp /ID# 163334	Yangsan-si,	Gyeongsangnamdo
Singapore	Changi General Hospital /ID# 163270	Singapore
Singapore	National University Hospital ( /ID# 163272	Singapore
Singapore	Singapore General Hospital /ID# 163271	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

China,  Korea, Republic of,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of HCV GT1 - GT6-Infected Participants in Arm A Who Achieved Sustained Virologic Response 12 Weeks Post Treatment (SVR12)	Sustained virologic response 12 weeks post-treatment (SVR12) was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last dose of study drug.	12 weeks after the last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen.
Primary	Percentage of HCV GT1-Infected Participants in Arm A Who Achieved SVR12	SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last dose of study drug.	12 weeks after last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen
Primary	Percentage of HCV GT2-Infected Participants in Arm A Who Achieved SVR12	SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last actual dose of study drug.	12 weeks after the last dose of study drug, Week 20 or Week 28 depending on the treatment regimen.
Secondary	Percentage of Participants in Arm A 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.	8 or 16 weeks depending on the treatment regimen
Secondary	Percentage of Participants in Arm A 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.	From the end of treatment (Weeks 8 or 16) through 12 weeks after the last dose of study drug (Weeks 20 or 28 depending on the treatment regimen).
Secondary	Percentage of HCV/HIV Co-infected Participants in Arm A Who Achieved SVR12	SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last dose of study drug.	12 weeks after the last actual dose of study drug, Week 20 or 28 depending on the treatment regimen