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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Coformulated tablet for oral administration
Peking University Peoples Hospit /ID# 156851
Beijing, Beijing Municipality, China
Guangzhou Eighth People's Hosp /ID# 156865
Guangzhou, Guangdong, China
Guangdong General Hospital /ID# 156827
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
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.
Time frame: 12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.
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.
Time frame: 12 or 16 weeks depending on the treatment regimen
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.
Time frame: 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
SVR12 was defined as plasma HCV RNA level less than LLOQ (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 24 or Week 28 depending on the treatment regimen
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The Second Hospital of Nanjing /ID# 156869
Nanjing, Jiangsu, China
Jiangsu Province People's Hospital /ID# 156867
Nanjing, Jiangsu, China
The First Hosp of Jilin Univ /ID# 156825
Changchun, Jilin, China
The Sixth People's Hospital of Shenyang /ID# 156854
Shenyang, Liaoning, China
Ruijin Hospital, Shanghai Jiaotong /ID# 157337
Shanghai, Shanghai Municipality, China
...and 24 more locations