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Class ⬇

Antiretroviral (Protease Inhibitor)

PREGNANCY RECOMMENDATION:*Contraindicated

BREASTFEEDING RECOMMENDATION:*Contraindicated

Pregnancy Summary ⬆ ⬇

From the January 2024 interim report of the Antiretroviral Pregnancy Registry (APR), there were 47 (3.9%) birth anomalies in 1,216 first-trimester exposures. In 2024, the updated US Department of Health and Human Services AIDS Info guidelines for the use of antiretroviral agents during pregnancy recommend that, in most cases, patients continue their regimen during pregnancy if it is tolerated, safe, and effective in suppressing viral replication. The guideline recommends that the discussion and shared decision-making process about the known and potential risks, as well as benefits to the mother and fetus, should guide the selection of which antiretrovirals to use during pregnancy. Additionally, treatment initiation should not be delayed due to concerns about teratogenicity with first-trimester exposure. See the guideline for the most updated information. management. *The guidelines note that nelfinavir should not be used during pregnancy due to inferior virologic efficacy. There is a pregnancy exposure registry that monitors pregnancy outcomes in patients using antiretroviral medicines during pregnancy. Health care providers are encouraged to call the APR at 1-800-258-4263.

Breastfeeding Summary ⬆ ⬇

A few studies were located that describe the use of nelfinavir during human lactation. The drug was found in human breast milk, so some infant exposure will occur. In 2023, the updated US Department of Health and Human Services AIDS Info guidelines state that using replacement of breast milk through formula or pasteurized donor human breast milk from a milk bank eliminates the risk of postnatal HIV transmission to the infant. Using antiretroviral therapy to achieve and maintain viral suppression during pregnancy and postpartum decreases the risk for infant transmission to less than 1% but not zero. *For patients not on therapy or those without viral load suppression during pregnancy (at a minimum throughout the third trimester) and at delivery, replacement of breast milk is recommended. Patients on antiretroviral therapy who have a sustained undetectable viral load and who choose to breastfeed or use replacement of breast milk should be supported with this decision. If the clinical decision is to use this drug while breastfeeding, the infant should be monitored for the most common reported pediatric side effects of irritability, rash, diarrhea, hepatotoxicity, and hyperbilirubinemia.

Reference ⬆

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