Truvada During Pregnancy: Safety and Recommendations
Truvada (emtricitabine/tenofovir disoproxil fumarate) can be taken during pregnancy as the benefits generally outweigh the potential risks for women who need HIV prevention or treatment. 1
Safety Profile
Data from the Antiretroviral Pregnancy Registry show no increased risk of major birth defects with first trimester exposure to tenofovir disoproxil fumarate (2.1%) or emtricitabine (2.3%) compared to the background rate of 2.7% in the general population. 1
For pregnant women using Truvada for HIV PrEP (pre-exposure prophylaxis), observational studies of 78 HIV-seronegative women exposed to emtricitabine and tenofovir disoproxil fumarate during pregnancy showed no major malformations in live-born infants. 1
Pregnancy itself may be associated with increased risk of HIV acquisition, potentially indicating added value to continuing PrEP during pregnancy. 2
Recommendations for Different Scenarios
For HIV Prevention (PrEP)
For women at high risk of HIV acquisition, the benefits of continuing Truvada during pregnancy likely outweigh potential risks. 2
Healthcare providers should discuss available information regarding potential risks and benefits of continuing PrEP with pregnant women to enable informed decision-making. 2
Women taking Truvada for PrEP should be tested for HIV every 2-3 months during pregnancy to ensure they remain HIV-negative. 2
For HIV Treatment
For pregnant women living with HIV, tenofovir disoproxil fumarate (a component of Truvada) is recommended as a safe option during pregnancy. 3
Pregnant women with chronic HBV infection and advanced fibrosis or cirrhosis should continue treatment with tenofovir throughout pregnancy. 3
Special Considerations
Women who become pregnant while taking Truvada should be registered in the Antiretroviral Pregnancy Registry (1-800-258-4263) for ongoing safety monitoring. 1
Breastfeeding while taking tenofovir-based medications is considered safe according to some guidelines, as very low concentrations of the drug are found in breast milk. 3
Women with active hepatitis B, severe anemia, drug allergies or intolerances may particularly benefit from continuing Truvada during pregnancy. 2
Monitoring During Pregnancy
Adherence to daily dosing is critical for effectiveness, so evaluation and support for medication adherence should be provided at each follow-up visit. 2
Close monitoring of glucose levels is recommended for pregnant women receiving protease inhibitors alongside Truvada, as these medications may be associated with hyperglycemia. 3
Potential Risks and Caveats
Some studies have suggested a possible association between tenofovir/emtricitabine and increased risk of preterm delivery, particularly when combined with certain other antiretrovirals like lopinavir/ritonavir. 3
The pharmacokinetics of antiretroviral drugs may be altered during pregnancy, potentially affecting plasma concentrations, though tenofovir and emtricitabine appear to maintain adequate therapeutic levels. 4
If a woman chooses to discontinue antiretroviral therapy during the first trimester due to concerns about fetal development, all drugs should be stopped simultaneously and then reintroduced together to avoid development of drug resistance. 3
Remember that the decision to use Truvada during pregnancy should consider the individual's risk of HIV acquisition or need for HIV treatment, as well as the substantial benefit of preventing mother-to-child transmission of HIV.