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
- Conditions
- Hepatitis C Virus (HCV)
- Interventions
- Drug: Glecaprevir/Pibrentasvir
- Registration Number
- NCT03235349
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
-
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.
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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.
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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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Glecaprevir/Pibrentasvir 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.
- Primary Outcome Measures
Name Time Method 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. 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.
- Secondary Outcome Measures
Name Time Method 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). 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.
Percentage of Participants With On-treatment Virologic Failure 12 or 16 weeks depending on the treatment regimen 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.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 SVR12 was defined as plasma HCV RNA level less than LLOQ (15 IU/mL) 12 weeks after the last dose of study drug.
Trial Locations
- Locations (34)
Guangdong General Hospital /ID# 156827
🇨🇳Guangzhou, Guangdong, China
The First Hosp of Jilin Univ /ID# 156825
🇨🇳Changchun, Jilin, China
West China Hospital /ID# 156835
🇨🇳Chengdu, Sichuan, China
Henan Provincial Peoples Hosp /ID# 157371
🇨🇳Zhengzhou, Henan, China
Seoul National Univ Bundang ho /ID# 163408
🇰🇷Seongnam, Gyeonggido, Korea, Republic of
Seoul National University Hospital /ID# 163401
🇰🇷Seoul, Korea, Republic of
Pusan National University Hosp /ID# 163411
🇰🇷Busan, Busan Gwang Yeogsi, Korea, Republic of
1st Hospital of Peking Uni /ID# 156850
🇨🇳Beijing, China
Samsung Medical Center /ID# 163402
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Asan Medical Center /ID# 163398
🇰🇷Seoul, Korea, Republic of
Pusan Nat Univ Yangsan Hosp /ID# 163385
🇰🇷Yangsan-si,, Gyeongsangnamdo, Korea, Republic of
The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156905
🇨🇳Guangzhou, Guangdong, China
Ruijin Hospital, Shanghai Jiaotong /ID# 157337
🇨🇳Shanghai, Shanghai, China
2nd Affiliated Hosp Chongqing /ID# 156838
🇨🇳Chongqing, China
Severance Hospital /ID# 163399
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Peking University Peoples Hospit /ID# 156851
🇨🇳Beijing, Beijing, China
Guangzhou Eighth People's Hosp /ID# 156865
🇨🇳Guangzhou, Guangdong, China
Jiangsu Province People's Hospital /ID# 156867
🇨🇳Nanjing, Jiangsu, China
Huashan Hospital of Fudan University /ID# 156909
🇨🇳Shanghai, Shanghai, China
Nanfang Hospital of Southern Medical University /ID# 156866
🇨🇳Guangzhou, Guangdong, China
The Second Hospital of Nanjing /ID# 156869
🇨🇳Nanjing, Jiangsu, China
Mengchao Hepatobiliary Hospita /ID# 156907
🇨🇳Fuzhou, China
Shanghai Public Health Cli Ctr /ID# 156837
🇨🇳Shanghai, Shanghai, China
The Sixth People's Hospital of Shenyang /ID# 156854
🇨🇳Shenyang, Liaoning, 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
Shengjing Hospital of China Medical University /ID# 156829
🇨🇳Shenyang, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University /ID# 163420
🇨🇳Xi'an, China
1st Aff Hosp Xinjiang Med Uni /ID# 156891
🇨🇳Urumqi, China
Fourth Military Medical University Tangdu Hospital, PLA /ID# 156767
🇨🇳Xi'an, China
Korea University Guro Hospital /ID# 163412
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Inje University Busan Paik Hospital /ID# 163384
🇰🇷Busan, Gyeongsangbugdo, Korea, Republic of
Chinese People's Liberation Army 81 Hospital /ID# 156868
🇨🇳Nanjing, China