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.
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Geometric mean AUC0-24h
Timeframe: At weeks 3 & 6
Geometric mean Cmax
Timeframe: At weeks 3 & 6
Geometric mean C24h
Timeframe: At weeks 3 & 6
Percentage of pregnant/ postpartum participants who experience a grade 3 or higher adverse event assessed as related to study drug
Timeframe: Initiation of treatment to a) completion of treatment and b) latter of 10 weeks post-partum or 20 weeks post treatment initiation
Percentage of pregnant participants who experience a serious adverse event assessed as related to study drug
Timeframe: Initiation of treatment to a) completion of treatment and b) latter of 10 weeks post-partum or 20 weeks post treatment initiation