Eighteen-month follow-up of HIV-1-infected mothers and their children enrolled in the Kesho Bora study observational cohorts
OBJECTIVE: To assess the effectiveness and safety of antiretrovirals (ARVs) used for treatment or prophylaxis in a breastfeeding population of HIV-1-infected women (Burkina-Faso, Kenya, South Africa).
METHODS: HIV-1-infected pregnant women with <200 CD4 cells per cubic millimeter or with World Health Organization stage 4 disease (cohort A) and asymptomatic women with >500 CD4 cells per cubic millimeter (cohort B) were enrolled into 2 prospective cohorts. Women with 200-500 CD4 cells per cubic millimeter were enrolled in a parallel randomized trial. Women in cohort A initiated antiretroviral therapy. Women in cohort B received zidovudine from 34 to 36 weeks gestation until delivery, with single-dose nevirapine in labor (cohort B). All children received single-dose nevirapine.
RESULTS: Of 248 women enrolled, 111 (cohort A) and 125 (cohort B) infants alive at 24 hours after birth were analyzed. Sixty-nine percent and 42% of women had undetectable viral load at delivery, respectively. Ten children in each cohort died. The 18-month cumulative incidences of HIV-1 infection were 7.5% (95% confidence interval: 3.8% to 14.5%) (cohort A) and 5.8% (2.8% to 11.8%) (cohort B). Sixty-one percent (cohort A) and 78% (cohort B) were breastfed for a median duration of 20 weeks. Four children in cohort A and only 1 in cohort B became HIV-1 infected after 6 weeks of age.
CONCLUSIONS: Antiretroviral therapy initiated a median of 7 weeks before delivery in women with advanced HIV-1 disease was associated with a significant residual risk of HIV-1 transmission due to insufficient decrease in viral load by the time of delivery. Among women with >500 CD4 cells per cubic millimeter, the risk of breast-milk transmission was very low despite lack of postnatal prophylaxis.
Available from: Kevindra Krishna Naidu
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ABSTRACT: BACKGROUND: Breastfeeding is essential for child health and development in low-resource settings but carries a significant risk of transmission of HIV-1, especially in late stages of maternal disease. We aimed to assess the efficacy and safety of triple antiretroviral compared with zidovudine and single-dose nevirapine prophylaxis in pregnant women infected with HIV.
METHODS: Pregnant women with WHO stage 1, 2, or 3 HIV-1 infection who had CD4 cell counts of 200-500 cells per μL were enrolled at five study sites in Burkina Faso, Kenya, and South Africa to start study treatment at 28-36 weeks' gestation. Women were randomly assigned (1:1) by a computer generated random sequence to either triple antiretroviral prophylaxis (a combination of 300 mg zidovudine, 150 mg lamivudine, and 400 mg lopinavir plus 100 mg ritonavir twice daily until cessation of breastfeeding to a maximum of 6·5 months post partum) or zidovudine and single-dose nevirapine (300 mg zidovudine twice daily until delivery and a dose of 600 mg zidovudine plus 200 mg nevirapine at the onset of labour and, after a protocol amendment in December, 2006, 1 week post-partum zidovudine 300 mg twice daily and lamivudine 150 mg twice daily). All infants received a 0·6 mL dose of nevirapine at birth and, from December, 2006, 4 mg/kg twice daily of zidovudine for 1 week after birth. Patients and investigators were not masked to treatment. The primary endpoints were HIV-free infant survival at 6 weeks and 12 months; HIV-free survival at 12 months in infants who were ever breastfed; AIDS-free survival in mothers at 18 months; and serious adverse events in mothers and babies. Analysis was by intention to treat. This trial is registered with Current Controlled Trials, ISRCTN71468401.
FINDINGS: From June, 2005, to August, 2008, 882 women were enrolled, 824 of whom were randomised and gave birth to 805 singleton or first, liveborn infants. The cumulative rate of HIV transmission at 6 weeks was 3·3% (95% CI 1·9-5·6%) in the triple antiretroviral group compared with 5·0% (3·3-7·7%) in the zidovudine and single-dose nevirapine group, and at 12 months was 5·4% (3·6-8·1%) in the triple antiretroviral group compared with 9·5% (7·0-12·9%) in the zidovudine and single-dose nevirapine group (p=0·029). The cumulative rate of HIV transmission or death at 12 months was 10·2% (95% CI 7·6-13·6%) in the triple antiretroviral group compared with 16·0% (12·7-20·0%) in the zidovudine and single-dose nevirapine group (p=0·017). In infants whose mothers declared they intended to breastfeed, the cumulative rate of HIV transmission at 12 months was 5·6% (95% CI 3·4-8·9%) in the triple antiretroviral group compared with 10·7% (7·6-14·8%) in the zidovudine and single-dose nevirapine group (p=0·02). AIDS-free survival in mothers at 18 months will be reported in a different publication. The incidence of laboratory and clinical serious adverse events in both mothers and their babies was similar between groups.
INTERPRETATION: Triple antiretroviral prophylaxis during pregnancy and breastfeeding is safe and reduces the risk of HIV transmission to infants. Revised WHO guidelines now recommend antiretroviral prophylaxis (either to the mother or to the baby) during breastfeeding if the mother is not already receiving antiretroviral treatment for her own health.
The Lancet Infectious Diseases 03/2011; 11(3):171-80. · 22.43 Impact Factor
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ABSTRACT: Both the World Health Organization and the United States Department of Health and Human Services have recently substantially revised perinatal HIV treatment guidelines based on emerging data, much of it from the developing world. Management of HIV infection in pregnancy and delivery is complicated by concerns for maternal and fetal drug toxicity, acquisition of antiretroviral resistance, prior therapy, co-infections with other viruses, as well as incident opportunistic infections. Intrapartum and peripartum obstetric management, including the role of Caesarean section, continue to evolve in the setting of maternal HIV infection. Finally, new data have expanded the role of antiviral therapy in allowing safer infant feeding choices for HIV-infected mothers in resource-limited settings.
Current HIV/AIDS Reports 04/2011; 8(2):122-31. DOI:10.1007/s11904-011-0077-5 · 3.80 Impact Factor
Available from: Eveline Geubbels
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ABSTRACT: In 2008, between 129,000 and 194,000 of the 430,000 pediatric HIV infections worldwide were attributable to breastfeeding. Yet in many settings, the health, economic, and social consequences of not breastfeeding would have dire consequences for many more children. In the first part of this review we provide an overview of current knowledge about infant feeding in the context of HIV. Namely, we describe the benefits and risks of breastmilk, the evolution of recommended infant feeding modalities in high-income and low-income countries in the last two decades, and contextualize the recently revised guidelines for infant feeding in the context of HIV current knowledge. In the second section, we suggest areas for future research on the postnatal prevention of mother-to-child transmission of HIV (PMTCT) in developing and industrialized countries. We suggest two shifts in perspective. The first is to evaluate PMTCT interventions more holistically, to include the psychosocial and economic consequences as well as the biomedical ones. The second shift in perspective should be one that contextualizes postnatal PMTCT efforts in the cascade of maternal health services. We conclude by discussing basic, clinical, behavioral, and programmatic research questions pertaining to a number of PMTCT efforts, including extended postnatal ARV prophylaxis, exclusive breastfeeding promotion, counseling, breast milk pasteurization, breast milk banking, novel techniques for making breast milk safer, and optimal breastfeeding practices. We believe the research efforts outlined here will maximize the number of healthy, thriving, HIV-free children around the world.
Advances in Nutrition 05/2011; 2(3):225-43. DOI:10.3945/an.110.000224 · 4.71 Impact Factor
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