Is HSDB 6515 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use HSDB 6515? Is HSDB 6515 safe for nursing mother and child? Does HSDB 6515 extracts into breast milk? Does HSDB 6515 has any long term or short term side effects on infants? Can HSDB 6515 influence milk supply or can HSDB 6515 decrease milk supply in lactating mothers?

Anti-HIV drug. It is used to decrease the risk of vertical transmission in newborns. Mothers must be adviced that transmission of HIV infection through breastfeeding has been documented.

In the United States and other developed countries, HIV-infected mothers should generally not breastfeed their infants. HSDB 6515 has been well studied during breastfeeding. 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) HSDB 6515, lamivudine and efavirenz; 2) HSDB 6515, 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] Breastfed infants whose mothers receive a highly active antiretroviral (HAART) regimen containing HSDB 6515 have higher rates of neutropenia during the first month and severe anemia during the first 6 months of life.

A study assigned pregnant women to HSDB 6515 alone or highly-active antiretroviral therapy (HAART: HSDB 6515, lamivudine and nevirapine) to prevent maternal-to-child transmission of HIV infection. After delivery, All infants received one month of HSDB 6515 prophylaxis; some infants were breastfed and others were formula fed. A higher percentage of infants in the HAART-exposed group had neutropenia than those in the unexposed group at 1 month of age (15.9 and 3.7%, respectively). Hematologic toxicity was transient and asymptomatic. From 2 to 6 months postpartum, no differences in hematologic toxicity were seen between breastfed and formula-fed infants. No statistical difference in hepatic toxicity was seen between the breastfed and formula-fed infants.[12] A study compared the rates of severe anemia in 3 groups of infants who received postpartum prophylaxis with HSDB 6515 for prevention of maternal-to-child transmission of HIV infection. Through 6 months of age, breastfed infants whose mothers received HAART had a higher rate of severe anemia (7.4%) than breastfed infants whose mothers received only HSDB 6515 (5.3%). Formula-fed infants had the lowest rate of severe anemia (2.5%). The anemia generally responded well to iron and multivitamin supplementation, and discontinuation of HSDB 6515.[13]