Abstract
Effective strategies are needed for the prevention of mother-to-child HIV transmission (PMTCT) in resource-limited settings. The Kisumu Breastfeeding Study was a single-arm open label trial conducted between July 2003 and February 2009. The overall aim was to investigate whether a maternal triple-antiretroviral regimen that was designed to maximally suppress viral load in late pregnancy and the first 6 mo of lactation was a safe, well-tolerated, and effective PMTCT intervention. HIV-infected pregnant women took zidovudine, lamivudine, and either nevirapine or nelfinavir from 34-36 weeks' gestation to 6 mo post partum. Infants received single-dose nevirapine at birth. Women were advised to breastfeed exclusively and wean rapidly just before 6 mo. Using Kaplan-Meier methods we estimated HIV-transmission and death rates from delivery to 24 mo. We compared HIV-transmission rates among subgroups defined by maternal risk factors, including baseline CD4 cell count and viral load. Among 487 live-born, singleton, or first-born infants, cumulative HIV-transmission rates at birth, 6 weeks, and 6, 12, and 24 mo were 2.5%, 4.2%, 5.0%, 5.7%, and 7.0%, respectively. The 24-mo HIV-transmission rates stratified by baseline maternal CD4 cell count <500 and ≥500 cells/mm(3) were 8.4% (95% confidence interval [CI] 5.8%-12.0%) and 4.1% (1.8%-8.8%), respectively (p = 0.06); the corresponding rates stratified by baseline maternal viral load <10,000 and ≥10,000 copies/ml were 3.0% (1.1%-7.8%) and 8.7% (6.1%-12.3%), respectively (p = 0.01). None of the 12 maternal and 51 infant deaths (including two second-born infants) were attributed to antiretrovirals. The cumulative HIV-transmission or death rate at 24 mo was 15.7% (95% CI 12.7%-19.4%). This trial shows that a maternal triple-antiretroviral regimen from late pregnancy through 6 months of breastfeeding for PMTCT is safe and feasible in a resource-limited setting. These findings are consistent with those from other trials using maternal triple-antiretroviral regimens during breastfeeding in comparable settings.
Highlights
UNAIDS and the World Health Organization (WHO) estimate that in 2009 there were 230,000 to 510,000 new human immunodeficiency virus (HIV) infections worldwide among children aged 0–15 y of age [1]
This trial shows that a maternal triple-antiretroviral regimen from late pregnancy through 6 months of breastfeeding for prevention of mother-to-child HIV transmission (PMTCT) is safe and feasible in a resource-limited setting
For PMTCT in late pregnancy and during breast feeding were the following: (1) to detect a 50% reduction in the mother-to-child HIV-transmission rate at 18 mo compared to the corresponding rate using the single-dose nevirapine (NVP) regimen in the HIVNET 012 study [8]; (2) to detect a 50% improvement in the infant HIV-free survival rate at 18 mo compared to the corresponding rate using the single-dose NVP regimen in the HIVNET 012 study [8]; (3) to assess safety and toxicity for the mothers with use of the maternal triple-ARV prophylaxis regarding rates of hepatic, hematologic, or dermatologic toxicities; (4) to assess adverse events or evidence of hepatic, hematologic, or dermatologic toxicity for infants exposed to low dose ARVs through maternal breast milk
Summary
UNAIDS and the World Health Organization (WHO) estimate that in 2009 there were 230,000 to 510,000 new HIV infections worldwide among children aged 0–15 y of age [1]. HIV MTCT rates in the absence of any antiretroviral (ARV) intervention among breastfeeding mothers who tested HIV antibody positive during pregnancy or delivery have ranged from 25% to 48% in various studies [2]. About half a million children become infected with human immunodeficiency virus (HIV), which causes acquired immunodeficiency syndrome (AIDS) Most these newly infected children live in resourcelimited countries and most acquire HIV from their mother, so-called mother-to-child transmission (MTCT). 25%–50% of babies born to HIV-positive mothers become infected with HIV during pregnancy, delivery, or breastfeeding. This infection rate can be reduced by treating mother and child with antiretroviral (ARV) drugs. Further reductions in risk can be achieved by giving mother and baby three ARVs—an NNRTI and two nucleoside reverse transcriptase inhibitors (NRTIs such as zidovudine and lamivudine)—during pregnancy and perinatally (around the time of birth)
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