Is Pre-Exposure Prophylaxis (PrEP) safe for use during pregnancy to prevent Human Immunodeficiency Virus (HIV) acquisition?

HIV PrEP During Pregnancy

PrEP is safe and recommended for pregnant women at substantial risk of HIV acquisition, and pregnancy should not preclude its use. 1, 2

Safety Profile and Evidence Base

The available evidence demonstrates no increased risk of adverse pregnancy outcomes with tenofovir-based PrEP. The FDA Antiretroviral Pregnancy Registry shows no increase in major birth defects with first trimester TDF exposure (2.1%) compared to the U.S. background rate of 2.7%. 3 Published data from controlled trials involving 327 pregnant women with chronic HBV receiving tenofovir from 28-32 weeks gestation through postpartum showed no new safety concerns and no increased risk of adverse pregnancy outcomes. 3

Multiple completed studies evaluating PrEP exposure during pregnancy found no differences in pregnancy or perinatal outcomes, including pregnancy loss, birth defects, congenital anomalies, preterm birth, or infant growth faltering. 4, 5 This evidence base is being expanded by nine ongoing studies that will provide data on over 6,200 additional PrEP-exposed pregnancies by 2022. 5

Clinical Rationale for Use

Pregnancy itself increases HIV acquisition risk, making PrEP particularly valuable during this period. HIV incidence more than doubles during pregnancy and the postpartum period compared to when women are not pregnant. 6, 5 Newly acquired maternal HIV infection during pregnancy, with its associated high primary viremia, substantially increases the risk of vertical transmission—accounting for up to one-third of vertical transmission cases in African settings. 6

Prescribing Approach

Initial Assessment

• Confirm HIV-negative status using a fourth-generation antigen-antibody assay before initiating PrEP. 2
• Assess for acute HIV infection symptoms (fever, headache, muscle soreness, sore throat, rash, swollen lymph nodes) or recent unprotected sex with an HIV-positive partner. 2
• Calculate creatinine clearance using Cockcroft-Gault formula; ensure ≥60 mL/min before prescribing TDF-based PrEP. 2
• Screen for pre-existing osteopenia or osteoporosis, as TDF-based PrEP is not recommended in these patients. 2, 7

Counseling and Shared Decision-Making

Engage in thorough discussion about benefits and risks specific to pregnancy. 1 Key counseling points include:

• PrEP is not 100% effective and does not prevent other STIs. 2
• Safety data for infants exposed during pregnancy is incomplete, though no harm has been reported to date. 2
• The known benefits of preventing HIV acquisition during pregnancy likely outweigh potential risks for women at substantial risk. 8
• Adherence to daily dosing is critical for effectiveness. 8

Medication Selection and Dosing

Use TDF/FTC (tenofovir disoproxil fumarate/emtricitabine) as the preferred regimen. 1, 3 The dosing is identical to non-pregnant individuals:

• TDF 300mg/FTC 200mg once daily. 1
• Pharmacokinetics and dosing appear similar in pregnant and non-pregnant women. 1

Common pitfall: Avoid cobicistat-boosted regimens during pregnancy due to lack of safety and pharmacokinetic data. 1

Monitoring During Pregnancy

• Prescribe no more than a 90-day supply, renewable only after confirming continued HIV-negative status. 2
• Schedule follow-up visits every 2-3 months for HIV testing, adherence evaluation, and STI screening. 2
• Monitor glucose levels if protease inhibitors are co-administered, as they may cause hyperglycemia during pregnancy. 8
• Close monitoring is suggested for all pregnant women receiving PrEP. 1

Special Considerations

Partner Management

Ensure HIV-positive partners initiate antiretroviral treatment and achieve viral suppression as early as possible. 1 This provides dual protection through both PrEP and treatment-as-prevention.

Breastfeeding

Breastfeeding while taking tenofovir-based PrEP is considered safe. Very low concentrations of the drug are found in breast milk. 8 The CDC 2025 guidelines confirm that breastfeeding is not a contraindication for PrEP. 1

Important caveat: The Taiwan guidelines from 2020 state that breastfeeding is an absolute contraindication to PrEP 2, but this conflicts with more recent CDC guidance and WHO recommendations that support PrEP use during breastfeeding. 1, 8 The most recent and authoritative guidance (CDC 2025) should take precedence.

Bone Health

TDF-based PrEP causes 1-1.5% bone mineral density loss at 48 weeks, which returns to baseline upon discontinuation. 7 For pregnant women with pre-existing bone disease, this is a relative concern but should be weighed against HIV acquisition risk during pregnancy.

Discontinuation

If PrEP is discontinued during pregnancy:

• Perform HIV testing to confirm whether infection has occurred. 2
• If HIV-positive, order resistance testing and establish immediate linkage to HIV care. 2
• If discontinuing all antiretrovirals during first trimester due to fetal development concerns, stop all drugs simultaneously and reintroduce together to avoid resistance development. 8

Integration with Maternal Health Systems

PrEP should be integrated into routine antenatal care. 6 Pregnancy provides a critical opportunity to assess HIV vulnerabilities, offer HIV testing, and provide comprehensive prevention options for the current pregnancy, postpartum period, and future safer conception planning. 9

Healthcare providers should register pregnant women exposed to PrEP in the Antiretroviral Pregnancy Registry by calling 1-800-258-4263 to contribute to ongoing safety surveillance. 3