The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic with compensated cirrhosis participants) who had experienced virologic failure in an AbbVie parent clinical study.
This study enrolled HCV infected adults who had experienced virologic failure following treatment with glecaprevir/pibrentasvir or paritaprevir/ritonavir/ombitasvir + dasabuvir (DSV) (3D) or paritaprevir/ritonavir/ombitasvir (2D) regimens in one of the following AbbVie hepatitis C virus parent studies: * M13-594 (NCT02640157) * M13-596 (NCT02692703) * M14-172 (NCT02642432) * M14-242 (NCT02493855) * M14-868 (NCT02243293) * M15-410 (NCT02446717) * M15-592 (NCT03222583) * M16-126 (NCT02966795) * M16-135 (NCT03089944)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Tablet for oral administration
Coformulated tablet for oral administration
Tablet for oral administration
Digestive Health Specialists of the Southeast /ID# 155719
Dothan, Alabama, United States
Ruane Clinical Research Group /ID# 155714
Los Angeles, California, United States
Digestive Disease Associates - Baltimore /ID# 155713
Baltimore, Maryland, United States
Henry Ford Health System /ID# 155720
Detroit, Michigan, United States
University of Buffalo /ID# 155721
Buffalo, New York, United States
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, and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed.
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).
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Carolinas Center For Liver Dis /ID# 155731
Statesville, North Carolina, United States
Gastro One /ID# 155729
Germantown, Tennessee, United States
TX Liver Inst, Americ Res Corp /ID# 157881
San Antonio, Texas, United States
Royal Brisbane and Women's Hospital /ID# 200944
Herston, Queensland, Australia
The Royal Melbourne Hospital /ID# 155727
Parkville, Victoria, Australia
...and 16 more locations