This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection without liver cirrhosis or with compensated liver cirrhosis and with chronic renal impairment in participants who were either HCV treatment-naïve (TN) or prior treatment-experienced (TE) with interferon (IFN) or pegylated interferon (PegIFN) with or without ribavirin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN.
The study included a 42-day screening period, a treatment period of either 8, 12, or 16 weeks, and a 24-week post-treatment period. The duration of treatment was determined by product labeling. Participants received glecaprevir/pibrentasvir (GLE/PIB) 300 mg/120 mg once daily. Participants who completed or prematurely discontinued the treatment period were followed for 24 weeks after their last dose of study drug to monitor safety, hepatitis C virus ribonucleic acid (HCV RNA), and the emergence and persistence of viral substitutions.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
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Scripps Clinic /ID# 159116
La Jolla, California, United States
Huntington Medical Foundation /ID# 160653
Pasadena, California, United States
Tampa General Medical Group /ID# 159115
Tampa, Florida, United States
Northwest Louisiana Nephrology /ID# 160652
Shreveport, Louisiana, United States
Massachusetts General Hospital /ID# 159114
Boston, Massachusetts, United States
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post Dosing (SVR12)
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
Time frame: 12 weeks after the last actual dose of study drug
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as: * Confirmed increase from nadir in hepatitis C virus ribonucleic acid (HCV RNA) defined as confirmed increase of \> 1 log (subscript)10(subscript) IU/mL above nadir during treatment; or * Confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA less than the lower limit of quantification (LLOQ) during study drug treatment; or * HCV RNA ≥ LLOQ at the end of treatment with at least 6 weeks of treatment
Time frame: Up to 16 weeks
Percentage of Participants With Post-treatment Relapse
Post-treatment relapse was defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) ≥ the lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA \< LLOQ at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be reinfected were not considered to have relapsed. .
Time frame: Up to 12 weeks after the last dose of study drug
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North Shore University Hospital /ID# 159108
New Hyde Park, New York, United States
Columbia Univ Medical Center /ID# 159112
New York, New York, United States
Carolinas Medical Center /ID# 159113
Charlotte, North Carolina, United States
University of Pennsylvania /ID# 159117
Philadelphia, Pennsylvania, United States
Thomas Jefferson University /ID# 159754
Philadelphia, Pennsylvania, United States
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