Clinical trial NCT03235349: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus (HCV)
Keywords: Chronic Hepatitis C Virus (HCV)
Genotype 1 to 6
Cirrhosis
Compensated Cirrhosis
Human Immunodeficiency Virus
co-infection
Treatment-naïve
treatment-experienced
interferon
Asian
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-08-01
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.
Secondary outcomes:
measure: Percentage of Participants With On-treatment Virologic Failure
timeFrame: 12 or 16 weeks depending on the treatment regimen
measure: Percentage of Participants With Post-treatment Relapse
timeFrame: 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).
measure: Percentage of HCV/HIV Co-infected Participants Achieving SVR12
timeFrame: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Peoples Hospit /ID# 156851
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hosp /ID# 156865
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong General Hospital /ID# 156827
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University /ID# 156866
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156905
state: Guangdong
city: Nanjing
country: China
facility: The Second Hospital of Nanjing /ID# 156869
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province People's Hospital /ID# 156867
state: Jiangsu
city: Changchun
country: China
facility: The First Hosp of Jilin Univ /ID# 156825
state: Jilin
city: Shenyang
country: China
facility: The Sixth People's Hospital of Shenyang /ID# 156854
state: Liaoning
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong /ID# 157337
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University /ID# 156909
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Public Health Cli Ctr /ID# 156837
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital /ID# 156835
state: Sichuan
city: Beijing
country: China
facility: Beijing Di Tan Hospital, Capital Medical University /ID# 156852
city: Beijing
country: China
facility: 1st Hospital of Peking Uni /ID# 156850
city: Beijing
country: China
facility: Beijing Friendship Hospital /ID# 156843
city: Beijing
country: China
facility: Beijing Youan Hosp, Cap Med Un /ID# 163418
city: Chongqing
country: China
facility: 2nd Affiliated Hosp Chongqing /ID# 156838
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospita /ID# 156907
city: Nanjing
country: China
facility: Chinese People's Liberation Army 81 Hospital /ID# 156868
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University /ID# 156829
city: Urumqi
country: China
facility: 1st Aff Hosp Xinjiang Med Uni /ID# 156891
city: Xi'an
country: China
facility: Fourth Military Medical University Tangdu Hospital, PLA /ID# 156767
city: Xi'an
country: China
facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163420
city: Zhengzhou, Henan
country: China
facility: Henan Provincial Peoples Hosp /ID# 157371
city: Busan
country: Korea, Republic of
facility: Pusan National University Hosp /ID# 163411
state: Busan Gwang Yeogsi
city: Seongnam
country: Korea, Republic of
facility: Seoul National Univ Bundang ho /ID# 163408
state: Gyeonggido
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital /ID# 163384
state: Gyeongsangbugdo
city: Yangsan-si,
country: Korea, Republic of
facility: Pusan Nat Univ Yangsan Hosp /ID# 163385
state: Gyeongsangnamdo
city: Seoul
country: Korea, Republic of
facility: Severance Hospital /ID# 163399
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 163402
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital /ID# 163412
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 163401
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 163398
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: 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.