Is Emtricitabine Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use Emtricitabine? Is Emtricitabine safe for nursing mother and child? Does Emtricitabine extracts into breast milk? Does Emtricitabine has any long term or short term side effects on infants? Can Emtricitabine influence milk supply or can Emtricitabine decrease milk supply in lactating mothers?

Nucleoside and nucleotide analog reverse-transcriptase inhibitors (NRTI) (Ribera 2011). It is excreted in breast milk in small quantities (Mugwanya 2016, Benaboud 2011), much lower (200 times less) than the dose used in newborns and infants (Mugwanya 2016). The dosage in infants older than 3 months is 6 mg/kg/day and half from birth to that age (Ribera 2011). No problems have been observed in infants whose mothers were taking it, except for mild diarrhea in 4% of cases (Mugwanya 2016), so its use in breastfeeding mothers is considered safe for both HIV treatment and pre-exposure prophylaxis (Mugwanya 2017, Seidman 2017). The WHO recommends the so-called B+ option (highly active antiretroviral therapy - HAART) for all pregnant or breastfeeding women diagnosed with HIV, irrespective of their clinical status and CD4 count, continuing during breastfeeding and without interruption for life. Breastfeeding should be exclusive for 6 months and continue for 12 to 24 months along with complementary feeding (WHO 2016). The recommended HAART combination is tenofovir + lamivudine or emtricitabine + efavirenz daily.The infant, irrespective of the type of breastfeeding, should take nevirapine or zidovudine daily for 6 weeks (WHO 2016). Most countries in the world have adopted these recommendations which date from 2013 (Nelson 2014).

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. During long-term maternal use of emtricitabine 200 mg daily, their breastfed infants usually have undetectable blood concentrations.

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]