This is a Phase I/II, multi-site, open-label, single arm study to describe the pharmacokinetics (PK) and safety of glecaprevir/pibrentasvir (GLE/PIB) initiated during pregnancy in women with hepatitis C virus (HCV) infection (acute or chronic) with or without HIV and to evaluate safety for their infants through 10 weeks postpartum.
Of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with institutional review board/ethics committee (IRB/EC) policies and procedures
Willing and able to provide written informed consent for their own and their infant's study participation
At entry, 16-45 years of age (inclusive)
At entry, gestational age of 14-32 weeks, defined as greater than 13 weeks plus six days and less than or equal to 32 completed weeks gestation, as determined by the site investigator based on best obstetric estimate
Any previous treatment for hepatitis C, including HCV DAAs or interferon-based treatment
History of spontaneous preterm delivery at less than 34 weeks, as determined by the site investigator based on pregnant participant report and available medical records, or
Shortened cervix less than 20 mm if noted on ultrasound during the current pregnancy, as determined by the site investigator based on available medical records
Receipt of any prohibited medication, within 14 days prior to entry, as determined by the site investigator based on pregnant participant report and available medical records
Single group
Glecaprevir/pibrentasvir
Drug100 mg glecaprevir and 40 mg pibrentasvir for a total daily dose of glecaprevir 300 mg/pibrentasvir 120 mg
Geometric mean AUC0-24h
Area under the curve from start of dose to 24 hours post dose
Geometric mean Cmax
Peak concentration from start of dose to 24 hours post dose
Geometric mean C24h
Concentration at 24 hours post dose
Percentage of pregnant/ postpartum participants who experience a grade 3 or higher adverse event assessed as related to study drug
Percentage of pregnant/postpartum participants with sustained virologic response (SVR12)
defined as unquantifiable hepatitis C RNA (less than the lower limit of quantification \[\<LLOQ\])
Percentage of pregnant participants with spontaneous abortions or miscarriage
(\<20 weeks gestation)
Percentage of pregnant participants with stillbirths
(≥20 weeks gestation)
Percentage of infants small for gestational age
\<10th percentile
Click on the lead sponsor to view all of their trials.
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
AbbVie
Collaborator
