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What Works for Women and Girls

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of age. For breastfed infants, the only predictors of mother-to-child transmissionafter one month of age were high maternal viral load <strong>and</strong> low maternal CD4 count.Infant prophylaxis with zidovudine was not a significant predictor of transmission.No transmission was observed in breastfeeding mothers who had started treatmentwith HAART be<strong>for</strong>e delivery. Similarly, no transmission was observed in breastfeedingmothers who had viral loads of less than 3,500 copies/mL. Maternal treatmentwith single-dose nevirapine at delivery did not predict mother-to-child transmission(Shapiro et al., 2009). (Gray II) (PMTCT, breastfeeding, <strong>for</strong>mula feeding, treatment,Botswana)The Post-Exposure Prophylaxis of Infants (PEPI) trial in Malawi found that extendedinfant prophylaxis with nevirapine or with nevirapine <strong>and</strong> zidovudine <strong>for</strong> the first14 weeks of life significantly reduced breast-feeding acquired HIV-1 infection in9-month-old infants. Between 2004 <strong>and</strong> 2007, 3016 breastfeeding infants werer<strong>and</strong>omly assigned to one of three different drug regimens. The control group receivedsingle-dose nevirapine plus one week of zidovudine, the second group received thecontrol regimen plus daily extended prophylaxis with nevirapine (extended nevirapinegroup) <strong>and</strong> the third group received the control regime plus nevirapine <strong>and</strong>zidovudine (extended dual prophylaxis group). At nine months (the primary endpoint in the study), the estimated rate of HIV-1 infection in the control group was10.6%. The extended nevirapine group had an infection rate of 5.2% <strong>and</strong> the extendeddual prophylaxis group had a rate of 6.4%. There were no significant differencesbetween the two extended prophylaxis groups although the extended dual prophylaxisgroup had a significant increase in the number of adverse events which were thoughtrelated to a study drug. This study demonstrated a protective efficacy of more than60% <strong>for</strong> the two extended prophylaxis groups at 14 weeks. Cumulative risk of postnatalinfection between birth <strong>and</strong> 14 weeks was 8.4% in the control group <strong>and</strong> 2.8%in the extended prophylaxis groups. This net difference of approximately 5% continuedat 24 months. (Kumwenda et al., 2008) (Gray II) (breastfeeding, treatment, PMTCT,Malawi)The Six Week Extended-Dose Nevirapine (SWEN) study combined study data from sitesin Ethiopia, India <strong>and</strong> Ug<strong>and</strong>a to assess whether daily nevirapine given to breastfedinfants through six weeks of age would decrease HIV transmission from breastfeeding.HIV-positive women who were breastfeeding their infants were r<strong>and</strong>omized to receiveeither single-dose nevirapine (during labor <strong>for</strong> the mother <strong>and</strong> after birth <strong>for</strong> the baby),or six week extended dose nevirapine (during labor <strong>for</strong> the mother <strong>and</strong> after birth <strong>for</strong> thebaby) plus daily nevirapine doses <strong>for</strong> the baby from day 8 to 42. The primary goal of thestudy was to assess HIV-infection rates at six months of age <strong>for</strong> infants who were HIVPCR negative at birth. The study concluded that a six week regimen of daily nevirapinemight be associated with a reduction in the risk of HIV transmission at six weeks ofage but the lack of a significant reduction of HIV transmission at the study end pointWHAT WORKS FOR WOMEN AND GIRLS255

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