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Emtricitabine use while Breastfeeding

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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.[1] 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.[2][3]

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.[4][5] 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.

Drug Levels

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.[6]

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.[7]

Forty-eight HIV+ mothers from Uganda and Nigeria were taking emtricitabine, tenofovir, and lamivudine and exclusively nursing their infants. The dosage of emtricitabine was not stated, but presumably 200 mg daily. The median peak level of emtricitabine in breastmilk was 933 mcg/L at 5.1 hours after the dose.[8]

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.[7]

Forty-eight HIV+ mothers from Uganda and Nigeria were taking emtricitabine, tenofovir, and lamivudine and exclusively nursing their infants. The dosage of emtricitabine was not stated, but presumably 200 mg daily. Their infants had an average age of 100 days. Emtricitabine was detectable in 19% of the infants at a median concentration of 18.5 mcg/L.[8]

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.[7]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

(Hepatitis B) Lamivudine, Tenofovir

References

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 CJ, Olagunju A, Nakalema S et al. PK of FTC, TFV and 3TC in Ugandan and Nigerian breastfeeding mother-infant pairs. Top Antiviral Med. 2016;24 (E1):449. Abstract

Emtricitabine Identification

Substance Name

Emtricitabine

CAS Registry Number

143491-57-0

Drug Class

Antiinfective Agents

Anti-HIV Agents

Antiviral Agents

Anti-Retroviral Agents

Reverse Transcriptase Inhibitors

Administrative Information

LactMed Record Number

657

Last Revision Date

20170411

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