A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
230
Glecaprevir/pibrentasvir 100 mg/40 mg co-formulated tablets taken orally as 3 tablets once a day.
Percentage of Participants in the Modified Intention-to-Treat Population 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. The 95% confidence interval (95%CI) was calculated using the Wilson's score method. Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 92.4%, based on the historical rate observed in glecaprevir/pibrentasvir registrational studies in treatment-naïve, non-cirrhotic patients (98.4%) minus a margin of 6%.
Time frame: 12 weeks after the last actual dose of study drug, Week 20
Percentage of Participants in the Intention-to-Treat Population With SVR12
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the LLOQ (15 IU/mL) 12 weeks after the last dose of study drug. The 95% confidence interval was calculated using the normal approximation to the binomial distribution. Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 91.4%, based on the mITT threshold minus an expected 1% rate of non-virological SVR failures.
Time frame: 12 weeks after the last actual dose of study drug, Week 20
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as one of the following conditions: * confirmed HCV RNA ≥ 100 IU/mL after HCV RNA \< 15 IU/mL during the Treatment Period; or * 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 * HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment, where the HCV RNA value must be collected on or after Study Drug Day 36 and study drug duration ≥ 36 days.
Time frame: Up to 8 weeks
Percentage of Participants With Post-treatment Relapse
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Parkway Medical Center /ID# 161261
Birmingham, Alabama, United States
Arkansas Gastroenterology /ID# 161266
North Little Rock, Arkansas, United States
UC Davis Medical Center /ID# 161138
Sacramento, California, United States
Yale University /ID# 161258
New Haven, Connecticut, United States
Univ Maryland School Medicine /ID# 161157
Baltimore, Maryland, United States
Digestive Disease Associates - Baltimore /ID# 161260
Baltimore, Maryland, United States
University of Michigan Hospitals /ID# 161265
Ann Arbor, Michigan, United States
Northwest Gastroenterology Cli /ID# 161257
Portland, Oregon, United States
Liver Associates of Texas, P.A /ID# 161262
Houston, Texas, United States
University of Vermont Medical Center /ID# 161263
Burlington, Vermont, United States
...and 32 more locations
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels \< LLOQ at the end of treatment.
Time frame: From the end of treatment (Week 8) through 12 weeks after the last dose of study drug (Week 20)