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, exclusive breastfeeding for 6 months is recommended for HIV-infected mothers to reduce the risk of HIV transmission from the mother to the infant compared with mixed feeding. In these settings, abrupt weaning at 4 months does not reduce the risk of HIV transmission or produce an overall health benefit compared to continued breastfeeding, and increases the risk of infant death in HIV-infected infants. Extended antiretroviral prophylaxis in breastfed infants with antiretroviral drugs appears to reduce the rate of HIV transmission during breastfeeding by about half, but the optimal regimen and duration of prophylaxis has not yet been defined. Limited information in this setting indicates that efavirenz produces low levels in milk and no adverse reactions in breastfed infants however, alternate antiretroviral agents are generally preferred.
Thirteen mothers who averaged 15.8 weeks (range 6 to 25 weeks) postpartum were treated with efavirenz 600 mg daily plus zidovudine and lamivudine. Milk and plasma samples were taken 3 to 4 hours after the last dose. Skimmed breastmilk efavirenz concentrations averaged 3.5 mg/L (range 1.3 to 7.4 mg/L).
Thirteen mothers who averaged 15.8 weeks (range 6 to 25 weeks) postpartum were treated with efavirenz 600 mg daily plus lamivudine and zidovudine (n = 12) or stavudine (n = 1). Plasma samples were taken from their breastfed infants 3 to 4 hours after the last dose. Infant plasma concentrations averaged 0.86 mg/L (range 0.4 to 1.5 mg/L). Infant plasma concentrations averaged 13% of maternal plasma concentrations, but there was no statistically significant correlation between them. Average plasma levels were slightly below the plasma level considered effective for suppression of HIV in adults.
Effects in Breastfed Infants:
Thirteen mothers nursed their infants while they were taking efavirenz 600 mg daily, lamivudine 150 mg and zidovudine 300 mg daily (n = 12) or stavudine 60 mg daily (n = 1) . No adverse reactions were reported in the infants after 6 months of breastfeeding, none had developed HIV infection and all were developing normally.
Possible Effects on Lactation:
Gynecomastia has been reported among men and at least one woman receiving efavirenz therapy. Efavirenz appears to be much more likely to cause gynecomastia than other antiretroviral agents. Gynecomastia is unilateral initially, but can progress to bilateral. Spontaneous resolution usually occurred within one year, even with continuation of the regimen.
The relevance of these findings to nursing mothers is not known. The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
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