Emtricitabine use while Breastfeeding
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Medically reviewed on Oct 3, 2018
Emtricitabine Levels and Effects while Breastfeeding
Summary of Use during Lactation
In the United States and other developed countries, HIV-infected mothers should generally not breastfeed their infants. Published experience with emtricitabine during breastfeeding is limited. 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 at least 12 months of life up to 24 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.
For use in treating maternal hepatitis B, no difference exist in infection rates between breast-fed 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. 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, their breastfed infants usually have undetectable blood concentrations.
Maternal Levels. Five exclusively breastfeeding mothers received oral emtricitabine 200 mg plus tenofovir 300 mg and nevirapine 200 mg at the start of labor, then oral emtricitabine 200 mg and tenofovir 300 mg daily 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 emtricitabine concentrations in breastmilk were 679 mcg/L and 177 mcg/L, respectively. The authors estimated that an exclusively breastfed infant would receive about 2% of the proposed infant dose for emtricitabine and achieve infant serum concentrations that might result in the emergence of viral resistance to emtricitabine.
Fifty HIV-negative women who were nursing their infants were given pre-exposure prophylaxis daily with the combination of tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg by directly observed therapy for 10 days. On days 7 and 10 of therapy, peak milk samples were obtained 1 to 2 hours after a dose and trough samples were obtained 23 to 24 hours after the previous dose. The median peak milk emtricitabine concentration was 212.5 mcg/L and the trough concentration was 183 mcg/L. These values represent an estimated daily dosage of 27.5 to 31.5 mcg/kg, which is approximately 0.5% of the proposed infant therapeutic dosage.
Emtricitabine was measured in 6 HIV-positive nursing mothers after a 300 mg dose during ongoing therapy. The peak breastmilk level was 872 mcg/L (range 696 to 1063 mcg/L) at a median of 3 hours.
Sixteen Nigerian women took emtricitabine 200 mg once daily as part of a combination therapy for HIV. Expressed milk samples were taken before the dose and at 0.5, 1, 2, 4, 8 and 12 hours after the dose. The median peak breastmilk concentration from dried breastmilk spots was 843 mcg/L (IQR 702 to 1132 mcg/L) at a median of 4 hours after the dose (IQR 2 to 8 hours).
Infant Levels. Fifty HIV-negative women who were nursing their infants were given pre-exposure prophylaxis daily with the combination of tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg by directly observed therapy for 10 days. A single infant blood sample was obtained after the mother's 7th dose. Of 49 infant blood samples collected, 47 had detectable concentrations of emtricitabine, with a median plasma concentration of 13.2 mcg/L. Infants under 13 weeks of age had a statistically significant lower plasma concentration than those who were 13 weeks of age or older, 16.6 mcg/L and 10.5 mcg/L, respectively.
Emtricitabine 300 mg daily was given to 6 HIV-positive nursing mothers. One breastfed infant had a detectable emtricitabine serum level of 17.5 mcg/L.
Sixteen Nigerian women took emtricitabine 200 mg once daily as part of a combination therapy for HIV. Their exclusively breastfed infants were fed on demand and had blood samples taken at 2 and 8 hours after the dose. Dried blood spots were analyzed and only 3 samples contained quantifiable (>16.6 mcg/L) blood levels of 17.5, 18.8, and 19.4 mcg/L.
Effects in Breastfed Infants
In a study of 50 infants breastfed by HIV-negative women who were given pre-exposure prophylaxis daily with the combination of tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg by directly observed therapy for 10 days, 2 infants reportedly had diarrhea lasting 2 to 3 days. No other side effects were reported.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Alternate Drugs to Consider
1. Anon. Guideline: Updates on HIV and infant feeding: The duration of breastfeeding, and support from health services to improve feeding practices among mothers living with HIV. Geneva: World Health Organization. 2016. PMID: 27583316
2. World Health Organization. HIV and infant feeding: update. 2007. http://whqlibdoc.who.int/publications/2007/9789241595964_eng.pdf
3. 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/
4. 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
5. 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
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. Mugwanya KK, Hendrix CW, Mugo NR et al. Pre-exposure prophylaxis use by breastfeeding HIV-uninfected women: A prospective short-term study of antiretroviral excretion in breast milk and infant absorption. PLoS Med. 2016;13:e1002132. PMID: 27676257
8. Waitt C, Diliiy Penchala S, Olagunju A et al. Development, validation and clinical application of a method for the simultaneous quantification of lamivudine, emtricitabine and tenofovir in dried blood and dried breast milk spots using LC-MS/MS. J Chromatogr B Anal Technol Biomed Life Sci. 2017;1060:300-37. PMID: 28651173
9. Waitt C, Olagunju A, Nakalema S et al. Plasma and breast milk pharmacokinetics of emtricitabine, tenofovir and lamivudine using dried blood and breast milk spots in nursing African mother-infant pairs. J Antimicrob Chemother.2018;73:1013-9. PMID: 29309634
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