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

Hepatitis C Virus (HCV) Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235349
• Other study ID #: M15-593
• Status: Completed
• Phase: Phase 3
• Start date: September 29, 2017
• Est. completion date: February 25, 2019

Study information

• Verified date: August 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 25, 2019
• Est. primary completion date: November 15, 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) 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Glecaprevir/Pibrentasvir
Coformulated tablet for oral administration

Locations

Country	Name	City	State
China	1st Hospital of Peking Uni /ID# 156850	Beijing
China	Beijing Di Tan Hospital, Capital Medical University /ID# 156852	Beijing
China	Beijing Friendship Hospital /ID# 156843	Beijing
China	Beijing Youan Hosp, Cap Med Un /ID# 163418	Beijing
China	Peking University Peoples Hospit /ID# 156851	Beijing	Beijing
China	The First Hosp of Jilin Univ /ID# 156825	Changchun	Jilin
China	West China Hospital /ID# 156835	Chengdu	Sichuan
China	2nd Affiliated Hosp Chongqing /ID# 156838	Chongqing
China	Mengchao Hepatobiliary Hospita /ID# 156907	Fuzhou
China	Guangdong General Hospital /ID# 156827	Guangzhou	Guangdong
China	Guangzhou Eighth People's Hosp /ID# 156865	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	Chinese People's Liberation Army 81 Hospital /ID# 156868	Nanjing
China	Jiangsu Province People's Hospital /ID# 156867	Nanjing	Jiangsu
China	The Second Hospital of Nanjing /ID# 156869	Nanjing	Jiangsu
China	Huashan Hospital of Fudan University /ID# 156909	Shanghai	Shanghai
China	Ruijin Hospital, Shanghai Jiaotong /ID# 157337	Shanghai	Shanghai
China	Shanghai Public Health Cli Ctr /ID# 156837	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University /ID# 156829	Shenyang
China	The Sixth People's Hospital of Shenyang /ID# 156854	Shenyang	Liaoning
China	1st Aff Hosp Xinjiang Med Uni /ID# 156891	Urumqi
China	First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163420	Xi'an
China	Fourth Military Medical University Tangdu Hospital, PLA /ID# 156767	Xi'an
China	Henan Provincial Peoples Hosp /ID# 157371	Zhengzhou, Henan
Korea, Republic of	Inje University Busan Paik Hospital /ID# 163384	Busan	Gyeongsangbugdo
Korea, Republic of	Pusan National University Hosp /ID# 163411	Busan	Busan Gwang Yeogsi
Korea, Republic of	Seoul National Univ Bundang ho /ID# 163408	Seongnam	Gyeonggido
Korea, Republic of	Asan Medical Center /ID# 163398	Seoul
Korea, Republic of	Korea University Guro Hospital /ID# 163412	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center /ID# 163402	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Seoul National University Hospital /ID# 163401	Seoul
Korea, Republic of	Severance Hospital /ID# 163399	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Pusan Nat Univ Yangsan Hosp /ID# 163385	Yangsan-si,	Gyeongsangnamdo

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.
Secondary	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.	12 or 16 weeks depending on the treatment regimen
Secondary	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.	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).
Secondary	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.	12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen