Can I take PrEP (emtricitabine with tenofovir disoproxil) while pregnant or breastfeeding?

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil fumarate tablets during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Data on the use of emtricitabine and tenofovir disoproxil fumarate tablets during pregnancy from observational studies have shown no increased risk of major birth defects. Available data from the APR show no significant difference in the overall risk of major birth defects with first trimester exposure for emtricitabine (FTC) (2.3%) or tenofovir disoproxil fumarate (TDF) (2.1%) compared with the background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data) . The rate of miscarriage for individual drugs is not reported in the APR. In the U.S. general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15 to 20%.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Emtricitabine and Tenofovir Disoproxil Fumarate (oral), AvKARE. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Emtricitabine has been studied relatively well during breastfeeding, and it is sometime used in treating HIV-positive mothers who are breastfeeding. Achieving and maintaining viral suppression with antiretroviral therapy decreases breastfeeding transmission risk to less than 1%, but not zero. Individuals with HIV who are on antiretroviral therapy with a sustained undetectable viral load and who choose to breastfeed should be supported in this decision. If a viral load is not suppressed, banked pasteurized donor milk or formula is recommended.[1,2]

For use in treating maternal hepatitis B, no difference exist in infection rates between breastfed and formula-fed infants born to hepatitis B-infected women, as long as the infant receives hepatitis B immune globulin and hepatitis B vaccine at birth. Mothers with hepatitis B are encouraged to breastfeed their infants after their infants receive these preventative measures.[3,4] With HIV pre-exposure prophylaxis with tenofovir 200 mg and emtricitabine 300 mg, infants receive only about 0.5% of a therapeutic dose of emtricitabine. During long-term maternal use of emtricitabine 200 mg daily, breastfed infants usually have undetectable blood concentrations.

“Summary of Use during Lactation”, LactMed record “Emtricitabine” (LM657), quoted verbatim. Everything LactMed reports about Emtricitabine while breastfeeding.

Tenofovir is available in the U.S. in two forms, tenofovir disoproxil fumarate and tenofovir alafenamide. Both release tenofovir, but tenofovir disoproxil fumarate releases tenofovir in the bloodstream whereas tenofovir alafenamide enters cells before releasing tenofovir. Most published experience is with tenofovir disoproxil fumarate in HIV therapy and prophylaxis. Exposure of the breastfed infant to tenofovir is trivial in HIV-positive mothers and in HIV-negative mothers treated for HIV prophylaxis or hepatitis B infection.[1,2] Among HIV-positive mothers who have breastfed during tenofovir disoproxil fumarate therapy no infant adverse effects have occurred up to 2 years of age. Achieving and maintaining viral suppression with antiretroviral therapy decreases breastfeeding transmission risk to less than 1%, but not zero. Individuals with HIV who are on antiretroviral therapy with a sustained undetectable viral load and who choose to breastfeed should be supported in this decision. Low tenofovir concentration in breastmilk and maternal serum and breastmilk HIV viral load are associated with a greater risk of HIV transmission from mother to infant. If a viral load is not suppressed, banked pasteurized donor milk or formula is recommended.[3,4]

In hepatitis B, expert reviews of available data and professional guidelines state that there is no justification for contraindicating the use of tenofovir during breastfeeding.[2,5-7] No differences exist in infection rates between breastfed and formula-fed infants born to hepatitis B-infected women, as long as the infant receives hepatitis B immune globulin and hepatitis B vaccine at birth.

“Summary of Use during Lactation”, LactMed record “Tenofovir Disoproxil Fumarate” (LM658), quoted verbatim. Everything LactMed reports about Tenofovir Disoproxil Fumarate while breastfeeding.

8.2 Lactation Risk Summary Based on published data, FTC and tenofovir have been shown to be present in human breast milk (see Data). It is not known if the components of emtricitabine and tenofovir disoproxil fumarate tablets affect milk production or have effects on the breastfed child. Treatment of HIV-1 Infection: The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1. Because of the potential for: (1) HIV transmission (in HIV-negative infants); (2) developing viral resistance (in HIV-positive infants); and (3) adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed if they are taking emtricitabine and tenofovir disoproxil fumarate tablets for the treatment of HIV-1.

Prescribing label, section “8.2 Lactation” (opening excerpt): Emtricitabine and Tenofovir Disoproxil Fumarate (oral), AvKARE. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.