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

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

Sponsors

Lead sponsor: AbbVie

Source AbbVie
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.

Overall Status Completed
Start Date September 29, 2017
Completion Date February 25, 2019
Primary Completion Date November 15, 2018
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.
Secondary Outcome
Measure Time Frame
Percentage of Participants With On-treatment Virologic Failure 12 or 16 weeks depending on the treatment regimen
Percentage of Participants With Post-treatment Relapse 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).
Percentage of HCV/HIV Co-infected Participants Achieving SVR12 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen
Enrollment 160
Condition
Intervention

Intervention type: Drug

Intervention name: Glecaprevir/Pibrentasvir

Description: Coformulated tablet for oral administration

Arm group label: Glecaprevir/Pibrentasvir

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
AbbVie Inc. Study Director AbbVie
Location
facility
Peking University Peoples Hospit /ID# 156851 | Beijing, Beijing, 100044, China
Guangzhou Eighth People's Hosp /ID# 156865 | Guangzhou, Guangdong, 510060, China
Guangdong General Hospital /ID# 156827 | Guangzhou, Guangdong, 510080, China
Nanfang Hospital of Southern Medical University /ID# 156866 | Guangzhou, Guangdong, 510515, China
The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156905 | Guangzhou, Guangdong, 510630, China
The Second Hospital of Nanjing /ID# 156869 | Nanjing, Jiangsu, 210003, China
Jiangsu Province People's Hospital /ID# 156867 | Nanjing, Jiangsu, 210029, China
The First Hosp of Jilin Univ /ID# 156825 | Changchun, Jilin, 130021, China
The Sixth People's Hospital of Shenyang /ID# 156854 | Shenyang, Liaoning, 110006, China
Ruijin Hospital, Shanghai Jiaotong /ID# 157337 | Shanghai, Shanghai, 200025, China
Huashan Hospital of Fudan University /ID# 156909 | Shanghai, Shanghai, 200040, China
Shanghai Public Health Cli Ctr /ID# 156837 | Shanghai, Shanghai, 201508, China
West China Hospital /ID# 156835 | Chengdu, Sichuan, 610041, China
Beijing Di Tan Hospital, Capital Medical University /ID# 156852 | Beijing, 100015, China
1st Hospital of Peking Uni /ID# 156850 | Beijing, 100034, China
Beijing Friendship Hospital /ID# 156843 | Beijing, 100050, China
Beijing Youan Hosp, Cap Med Un /ID# 163418 | Beijing, 100069, China
2nd Affiliated Hosp Chongqing /ID# 156838 | Chongqing, 400010, China
Mengchao Hepatobiliary Hospita /ID# 156907 | Fuzhou, 350025, China
Chinese People's Liberation Army 81 Hospital /ID# 156868 | Nanjing, 210002, China
Shengjing Hospital of China Medical University /ID# 156829 | Shenyang, 110004, China
1st Aff Hosp Xinjiang Med Uni /ID# 156891 | Urumqi, 830054, China
Fourth Military Medical University Tangdu Hospital, PLA /ID# 156767 | Xi'an, 710038, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163420 | Xi'an, 710061, China
Henan Provincial Peoples Hosp /ID# 157371 | Zhengzhou, Henan, 450000, China
Pusan National University Hosp /ID# 163411 | Busan, Busan Gwang Yeogsi, 602-739, Korea, Republic of
Seoul National Univ Bundang ho /ID# 163408 | Seongnam, Gyeonggido, 13620, Korea, Republic of
Inje University Busan Paik Hospital /ID# 163384 | Busan, Gyeongsangbugdo, 47392, Korea, Republic of
Pusan Nat Univ Yangsan Hosp /ID# 163385 | Yangsan-si,, Gyeongsangnamdo, 50612, Korea, Republic of
Severance Hospital /ID# 163399 | Seoul, Seoul Teugbyeolsi, 03722, Korea, Republic of
Samsung Medical Center /ID# 163402 | Seoul, Seoul Teugbyeolsi, 06351, Korea, Republic of
Korea University Guro Hospital /ID# 163412 | Seoul, Seoul Teugbyeolsi, 08308, Korea, Republic of
Seoul National University Hospital /ID# 163401 | Seoul, 03080, Korea, Republic of
Asan Medical Center /ID# 163398 | Seoul, 05505, Korea, Republic of
Location Countries

China

Korea, Republic of

Verification Date

August 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Glecaprevir/Pibrentasvir

Arm group type: Experimental

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.

Acronym VOYAGE-2
Patient Data Yes
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov