Table 1.
Summary of antiretroviral considerations for HIV-infected pregnant women and their antiretroviral exposed children
| Drug | Pregnancy pharmacokinetics |
Pregnancy dose changes | Placental and breast milk transfer |
Teratogenicity | Other considerations |
|---|---|---|---|---|---|
| FTC | Increased renal clearance with lower exposure in 3rd trimester | Modest PK changes, but not large enough to warrant dose changes during pregnancy | High placental transfer; Excreted in breast milk with biologically meaningful exposure to the infant | Sufficient data to exclude a 1.5-fold increased risk of overall birth defects | |
| 3TC | Increased renal clearance with lower exposure in 3rd trimester | Modest PK changes, but not large enough to warrant dose changes during pregnancy | High placental transfer; Excreted in breast milk with biologically meaningful exposure to the infant | Sufficient data to exclude a 1.5-fold increased risk of overall birth defects | Evidence of mitochondrial and genotoxicity in infancy |
| TDF | Increased renal clearance with lower exposure in 3rd trimester | Modest PK changes, but not large enough to warrant dose changes during pregnancy | High placental transfer; Excreted in breast milk at low levels | Sufficient data to exclude a 1.5-fold increased risk of overall birth defects | Reduced newborn bone mineral content; Evidence of genotoxicity in infancy |
| TAF | No data | No data | No data | No data | No data |
| EFV | Increased metabolism and reduced trough concentrations at standard dose (600mg daily) | Modest PK changes, but not large enough to warrant dose changes (at 600mg daily) during pregnancy | Moderate placental transfer Excreted in breast milk at low levels | Sufficient data to exclude a 2-fold increased risk of overall birth defects | |
| DRV/r | Reduced trough levels in 3rd trimester with standard once daily dosing | 600mg/100mg twice daily recommended. 800mg/100mg twice daily does not improve pregnancy DRV exposure and is not recommended | Low placental transfer; No data on breast milk excretion (LPV low to undetectable levels in breast milk) | Sufficient data to exclude a 2-fold increased risk of overall birth defects | |
| DTG | Increased metabolism and reduced exposure during pregnancy | Insufficient data to make a dosing recommendation | High placental transfer No data on breast milk excretion | Insufficient data |