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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
546
Matching placebo tablet for oral administration
Coformulated tablet for oral administration
Peking University Peoples Hospit /ID# 156846
Beijing, Beijing Municipality, China
Guangzhou Eighth People's Hosp /ID# 156859
Guangzhou, Guangdong, China
Guangdong General Hospital /ID# 156822
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
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.
Time frame: 12 weeks after the last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen.
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.
Time frame: 12 weeks after last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen
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.
Time frame: 12 weeks after the last dose of study drug, Week 20 or Week 28 depending on the treatment regimen.
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.
Time frame: 8 or 16 weeks depending on the treatment regimen
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.
Time frame: 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).
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.
Time frame: 12 weeks after the last actual dose of study drug, Week 20 or 28 depending on the treatment regimen
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Xiangya Hospital Central South University /ID# 156901
Changsha, Hunan, China
The Second Hospital of Nanjing /ID# 156863
Nanjing, Jiangsu, China
Jiangsu Province People's Hospital /ID# 156861
Nanjing, Jiangsu, China
The First Hosp of Jilin Univ /ID# 156820
Changchun, Jilin, China
The Sixth People's Hospital of Shenyang /ID# 156849
Shenyang, Liaoning, China
...and 38 more locations