HCV infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection. GLE/PIB is an approved drug for the treatment of chronic HCV. Around 283 participants at least 12 years of age with acute HCV Infection will be enrolled in approximately 70 sites worldwide. Participants will receive oral tablets of GLE/PIB once daily (QD) for 8 weeks and will be followed for 12 weeks after the end of treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, monitoring for side effects and completing questionnaires.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
286
Oral tablets
Arizona Health Research /ID# 233558
Chandler, Arizona, United States
The Institute for Liver Health /ID# 228427
Peoria, Arizona, United States
Liver Wellness Center /ID# 244933
Little Rock, Arkansas, United States
AHF Research Center /ID# 254795
Beverly Hills, California, United States
Velocity Clinical Research Chula Vista /ID# 238352
Chula Vista, California, United States
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population
SVR12 is defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (\< LLOQ) 12 weeks after the last dose of study treatment. Efficacy was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants achieving SVR12 was greater than 90.5%.
Time frame: 12 weeks after last dose of study treatment (Week 20)
Percentage of Participants Achieving SVR12 in the Modified ITT-Virologic Failure (mITT-VF) Population
SVR12 is defined as the HCV RNA level \< LLOQ 12 weeks after the last dose of study treatment. Efficacy was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants achieving SVR12 was greater than 92.7%. This efficacy analysis was performed only if success was demonstrated for the primary efficacy analysis, following a fixed-sequence testing procedure.
Time frame: 12 weeks after last dose of study treatment (Week 20)
Percentage of Participants With On-Treatment Virologic Failure in the ITT Population
On-treatment virologic failure is defined as confirmed increase in HCV RNA of \> 1 log\^10 IU/mL above the lowest post-baseline value during treatment, confirmed HCV RNA \>= 100 IU/mL after HCV RNA \< LLOQ during treatment, or HCV RNA \>= LLOQ at the end of treatment (EOT) with at least 6 weeks of treatment.
Time frame: Up to Week 8
Percentage of Participants With Post-Treatment (PT) Relapse in the ITT Population
PT relapse is defined as confirmed HCV RNA \>= LLOQ between the EOT and 12 weeks after the last dose of study treatment among participants who completed treatment as planned (study treatment duration \>= 52 days) with HCV RNA \< LLOQ at the EOT and with at least 1 PT HCV RNA value, excluding cases of reinfection.
Time frame: Up to 12 weeks after the last dose of study treatment (Week 20)
Percentage of Participants With PT Reinfection With HCV in the ITT Population
PT reinfection is defined as confirmed HCV RNA \>= LLOQ in the PT period in a participant who had HCV RNA \< LLOQ at the final treatment visit, along with the PT detection of a different HCV genotype, subtype, or clade compared with baseline.
Time frame: Up to 12 weeks after the last dose of study treatment (Week 20)
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AHF Healthcare Center- Hollywood /ID# 254794
Los Angeles, California, United States
TLC Clinical Research Inc /ID# 232334
Los Angeles, California, United States
University of California, Davis Comprehensive Cancer Center /ID# 230814
Sacramento, California, United States
Angels Clinical Research Institute /ID# 234090
Doral, Florida, United States
AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 254814
Fort Lauderdale, Florida, United States
...and 60 more locations