PrEP During Pregnancy: Safety and Recommendations
TDF/FTC PrEP can be continued during pregnancy for women at high risk of HIV acquisition, as current evidence indicates no increased risk of adverse pregnancy outcomes when compared to non-use. 1
Safety of TDF/FTC During Pregnancy
Data from the Antiretroviral Pregnancy Registry show no increase in the overall risk of major birth defects with first-trimester exposure to tenofovir disoproxil fumarate (2.1%) compared to the background rate of 2.7% in the general population. 2
Studies examining tenofovir and emtricitabine use in pregnant women living with HIV have not shown evidence of adverse effects among fetuses exposed to these medications. 3
A 2023 randomized trial specifically examining PrEP use in HIV-negative pregnant women found that immediate PrEP initiation during pregnancy was non-inferior to deferred PrEP for key outcomes including preterm birth and small-for-gestational-age infants. 1
Risk-Benefit Assessment
Pregnancy itself may be associated with increased risk of HIV acquisition compared to non-pregnant women, potentially indicating added value to continuing PrEP during pregnancy. 3
For women at very high risk of HIV acquisition (especially those with partners known to have HIV infection), the benefits of continuing TDF/FTC PrEP during pregnancy likely outweigh potential risks. 3
PrEP use may be particularly valuable as one of several options to help protect HIV-negative partners in serodiscordant couples during attempts to conceive. 3
Clinical Approach for Pregnant Women on PrEP
For Women Already on PrEP Who Become Pregnant:
Healthcare providers should discuss currently available information regarding potential risks and benefits of continuing PrEP so that an informed decision can be made. 3
If a woman chooses to take PrEP while pregnant, providers are encouraged to prospectively and anonymously submit information about the pregnancy to the Antiretroviral Use in Pregnancy Registry. 3
For Women Considering Starting PrEP During Pregnancy:
Document negative HIV antibody test immediately before starting PrEP medication. 3
Confirm that the woman is at ongoing, very high risk for acquiring HIV infection. 3
If any sexual partner is known to be HIV-infected, determine whether they are receiving antiretroviral therapy; assist with linkage to care if not in care or not receiving antiretroviral therapy. 3
Confirm that calculated creatinine clearance is ≥60 mL per minute. 3
Monitoring During Pregnancy
Every 2–3 months, perform an HIV antibody test and document negative result. 3
Evaluate and support PrEP medication adherence at each follow-up visit, as efficacy is highly dependent on adherence to daily doses. 3
Every 2–3 months, assess risk behaviors and provide risk-reduction counseling and condoms. 3
Every 6 months, test for bacterial STIs, even if asymptomatic, and treat as needed. 3
Three months after initiation, then every 6 months while on PrEP medication, check serum creatinine and calculate creatinine clearance. 3
Important Considerations and Caveats
The efficacy of TDF/FTC for HIV prevention is highly dependent on adherence to daily doses of medication. 3
Long-term safety data following fetal exposure to TDF/FTC as PrEP (rather than as treatment) remains limited, though current evidence is reassuring. 4
Do not prescribe PrEP to women who are breastfeeding due to limited safety data in this population. 3
Women with active hepatitis B, severe anemia, drug allergies or intolerances, or zidovudine/lamivudine-resistant HIV may be more likely to benefit from TDF/FTC despite pregnancy. 3
For women living with HIV who are pregnant, a zidovudine and lamivudine-based regimen may be preferred over tenofovir and emtricitabine (note this is for HIV treatment, not prevention). 3