Tenofovir use while Breastfeeding
Drugs containing Tenofovir: Truvada, Atripla, Viread, Stribild, Complera, AccessPak for HIV PEP Basic, AccessPak for HIV PEP Expanded with Viracept, AccessPak for HIV PEP Expanded with Kaletra
Tenofovir Levels and Effects while Breastfeeding
Summary of Use during Lactation
Limited published experience with tenofovir during breastfeeding in HIV-positive mothers and HIV-negative mothers treated for hepatitis B infection indicates that the exposure of the infant to the drug is trivial. A few infants have been breastfed during maternal tenofovir therapy and no adverse effects have been seen. An expert review of available data concluded that there is currently no justification for contraindicating the use of tenofovir for hepatitis B during breastfeeding. 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. Mothers with hepatitis B are encouraged to breastfeed their infants after their infants receive these preventative measures. In the United States and other developed countries, HIV-infected mothers should generally not breastfeed their infants. In countries in which no acceptable, feasible, sustainable and safe replacement feeding is available, World Health Organization guidelines recommend that all women with an HIV infection who are pregnant or breastfeeding should be maintained on antiretroviral therapy for at least the duration of risk for mother-to-child transmission. Mothers should exclusively breastfeed their infants for the first 6 months of life; breastfeeding with complementary feeding should continue through 12 months of life. The first choice regimen for nursing mothers is tenofovir, efavirenz and either lamivudine or emtricitabine. If these drugs are unavailable, alternative regimens include: 1) zidovudine, lamivudine and efavirenz; 2) zidovudine, lamivudine and nevirapine; or 3) tenofovir, nevirapine and either lamivudine or emtricitabine. Exclusively breastfed infants should also receive 6 weeks of prophylaxis with nevirapine.
Tenofovir has very poor bioavailability and is available commercially as the more bioavailable tenofovir disoproxil fumarate which is metabolized intracellularly to the active metabolite tenofovir diphosphate. The bioavailabilities of tenofovir and tenofovir diphosphate from breastmilk are not known, but presumed to be very low. Maternal Levels. Five exclusively breastfeeding mothers received oral tenofovir 300 mg plus emtricitabine 200 mg and nevirapine 200 mg at the start of labor, then oral tenofovir 300 mg daily and emtricitabine 200 mg for 7 days postpartum. A total of 16 concurrent maternal blood and milk samples were collected on days 1, 2, 3, and 7 postpartum between 10 minutes and 21 hours after the mothers' doses. Median peak and trough tenofovir concentrations in breastmilk were 14.1 mcg/L and 6.8 mcg/L, respectively. The authors estimated that an exclusively breastfed infant would receive about 0.03% of the proposed infant dose for tenofovir and achieve trivial infant serum concentrations that would likely have no adverse consequences.
In a multicenter study in Malawi and Brazil, mothers were given a single dose of either 600 mg or 900 mg of tenofovir during labor. Breastmilk samples were collected from mothers at various times postpartum. Tenofovir was detected (>2.5 mcg/L) in three-fourths of samples collected from 25 mothers during the first 2 days postpartum. Levels ranged from 6.3 to 17.8 mcg/L. At 4 to 6 days postpartum, only one milk sample of 21 had a detectable tenofovir level of 15.7 mcg/L.
Women in Malawi received the option B+ regimen for prevention of mother-to-child transmission of HIV consisting of tenofovir, lamivudine and efavirenz between 6 and 8 pm daily. The tenofovir dose was not stated, but was presumably 300 mg daily. Milk samples collected in the morning from 33 women at month 1 postpartum had a median tenofovir concentration of 5 mcg/L (IQR 0 to 6.1 mcg/L). Milk samples collected in the morning from 47 women at month 12 postpartum had a median tenofovir concentration of 2.5 mcg/L (IQR 0 to 5.5 mcg/L).
Infant Levels. Five infants were exclusively breastfed by 4 mothers who took tenofovir 245 mg (presumably 300 mg of tenofovir disoproxil fumarate) daily. At an average of 1.8 months of age, infant serum tenofovir concentrations were measured. Tenofovir was undetectable (<0.005 mg/L) in the serum of 4 of the infants, and 0.0055 mg/L in the serum of one infant.
Blood samples were taken from 25 breastfed infants of mothers who were receiving option B+ regimen for prevention of mother-to-child transmission of HIV consisting of tenofovir, lamivudine and efavirenz between 6 and 8 pm daily. The tenofovir dose was not stated, but was presumably 300 mg daily. The median morning infant plasma concentration of tenofovir at 6 months of age was 24 mcg/L (IQR 0 to 51.6 mcg/L). The median morning infant plasma concentration of tenofovir at 12 months of age was 0 mcg/L.
Effects in Breastfed Infants
Two newborn infants whose mothers were treated with tenofovir 245 mg (presumably 300 mg of tenofovir disoproxil fumarate) daily were exclusively breastfed for 3 months. At 4 months of age, neither showed any adverse outcomes on standard developmental parameters.
Five women with hepatitis B infection were treated with tenofovir disoproxil fumarate 300 mg daily beginning in the third trimester of pregnancy and continuing postpartum. Although instructed not to breastfeed, 5 mothers breastfed (extent not stated) their newborn infants. No short-term adverse reactions were seen and the infants' HBsAg was negative between 28 and 36 weeks of age.
Fourteen mothers were treated with tenofovir (dosage unspecified) during pregnancy (12 beginning in the first trimester) for hepatitis B. Three of the mothers breastfed while taking tenofovir. No adverse outcomes were noted in their breastfed infants up to 1 year of age.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Alternate Drugs to Consider
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2. Visvanathan K, Dusheiko G, Giles M et al. Managing HBV in pregnancy. Prevention, prophylaxis, treatment and follow-up: Position paper produced by Australian, UK and New Zealand key opinion leaders. Gut. 2016;65:340-50. PMID: 26475631
3. Dionne-Odom J, Tita AT, Silverman NS. #38: Hepatitis B in pregnancy screening, treatment, and prevention of vertical transmission. Am J Obstet Gynecol. 2016;214:6-14. PMID: 26454123
4. World Health Organization. HIV and infant feeding: update. 2007. http://whqlibdoc.who.int/publications/2007/9789241595964_eng.pdf
5. World Health Organization. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Geneva: World Health Organization. 2013. http://www.who.int/hiv/pub/guidelines/arv2013/en/
6. Benaboud S, Pruvost A, Coffie PA et al. Concentrations of tenofovir and emtricitabine in breast milk of HIV-1-infected women in Abidjan, Cote d'Ivoire, in the ANRS 12109 TEMAA Study, step 2. Antimicrob Agents Chemother. 2011;55:1315-7. PMID: 21173182
7. Mirochnick M, Taha T, Kreitchmann R et al. Pharmacokinetics and safety of tenofovir in HIV-infected women during labor and their Infants during the first week of life. J Acquir Immune Defic Syndr. 2014;65:33-4. PMID: 23979002
8. Palombi L, Pirillo MF, Marchei E et al. Concentrations of tenofovir, lamivudine and efavirenz in mothers and children enrolled under the Option B-Plus approach in Malawi. J Antimicrob Chemother. 2016;71:1027-30. PMID: 26679247
9. Gouraud A, Millaret A, Bernard N, Bruel M, Paret N, Descotes J et al. Tenofovir exposure through breast feeding: Serum concentrations in neonates and clinical follow-up. Fundam Clin Pharmacol. 2012;26 (Suppl 1):9. Abstract. DOI: doi:10.1111/j.1472-8206.2012.01032.x
10. Pan CQ, Mi LJ, Bunchorntavakul C et al. Tenofovir disoproxil fumarate for prevention of vertical transmission of hepatitis B virus infection by highly viremic pregnant women: A case series. Dig Dis Sci. 57:2423-9. PMID: 22543886
11. Ganne-Carrie N, Causse X, Zarski JP et al. Efficacy and safety results of tenofovir DF (TDF) treatment from the first trimester in HBV pregnant women in real-life clinical practice. Hepatology. 2013;58 (Suppl 1):664A-5A. Abstract. DOI: doi:10.1002/hep.26855
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