Study shows a reduction in postpartum HIV-1 transmission Source: Background: In areas with no safe breastfeeding alternatives and limited resources, the World Health Organization (WHO) recommends prophylactic administration of antiretroviral therapy to HIV-infected mothers or infants throughout the breastfeeding period. Researchers evaluated the effect of 28 weeks of maternal or infant prophylactic administration of antiretroviral therapy on postpartum HIV infection at 48 weeks. METHODS: From April 21, 2004 to January 28, 2010, researchers conducted a study called the Breastfeeding, Antiretroviral and Nutrition Intervention (BAN) in Lilongwe, Malawi. 2369 HIV-infected breastfeeding mothers (with a CD4 count of at least 250 cells/μL) and their newborn infants were randomized in a variable-group design to one of three 28-week regimens: a maternal triple antiretroviral group (n=849); an infant daily nevirapine group (n=852); or a control group (n=668). Patients and local clinical staff were aware of treatment distribution, but other researchers were unaware of this information. All mothers and infants received a single dose of nevirapine (200 mg for mothers; 2 mg/kg for infants), 7 days of zidovudine (300 mg for mothers; 2 mg/kg for infants), and lamivudine (150 mg for mothers; 4 mg/kg for infants) twice daily. Mothers were advised to wean their babies between 24 and 28 weeks after birth. The primary endpoint was HIV infection by 48 weeks, in infants uninfected at week 2, and in all randomly assigned infants after exclusion of those who did not complete follow-up. This trial is registered with ClinicalTrials.gov under r NCT00164736. Outcomes: 676 mother-infant pairs completed 48 weeks of follow-up or reached endpoint in the maternal-antiretroviral group, 680 in the infant-naivirapine group, and 542 in the control group. By 32 weeks postpartum, 96% of women in the intervention group compared with 88% of women in the control group reported not breastfeeding after the 28-week visit. Between 2 and 48 weeks after birth, 30 infants in the maternal-antiretroviral group, 25 in the infant-nevirapine group, and 38 in the control group were infected with HIV; 28 (30%) infections occurred after 28 weeks (nine in the maternal-antiretroviral group, 13 in the infant-nevirapine group, and six in the control group). The cumulative risk of HIV-1 transmission by 48 weeks was significantly higher in the control group (7%, 95% CI 5-9) than in the maternal-antiretroviral group (4%, 3-6; p=0.0273) or the infant-nevirapine group (4%, 2-5; p=0.0027). The rate of serious adverse events in infants was significantly higher between 29 and 48 weeks than during the intervention period (1.1 [95% CI 1.0-1.2] vs 0.7 [0.7-0.8]/100 person weeks; p<0.0001), with increased risk of diarrhea, malaria, growth retardation, tuberculosis, and death. Between 2 and 48 weeks postpartum, nine women died (one in the maternal-antiretroviral group, two in the infant-nevirapine group, and six in the control group). Interpretation of results: Prophylactic administration of maternal or infant antiretroviral therapy may reduce HIV transmission in areas with limited resources where no suitable breastfeeding alternatives are available. Weaning at 6 months may increase infant morbidity.