Nevirapine Safely Lowers HIV-1 Transmission by Breast-Feeding

There has long been concern about the safety of HIV-infected mothers who breast-fed their infants, with studies finding higher rates of mortality in the mothers and evidence that breast-feeding accounts for 30% to 40% of postnatal HIV transmission.^1-3 The concern about breast-feeding and viral transmission initially led to recommendations that HIV-positive women not breast-feed.

However,that changed with the introduction of antiretroviral therapy (ART) and results from several trials demonstrating that ART given women during and after pregnancy could prevent transmission.^4-6 In 2010, the World Health Organization released new guidelines on HIV and breast-feeding, recommending that HIV-infected women receive ART regardless of viral load and exclusively breast-feed for six months, then continue breast-feeding concurrent with the introduction of solid foods until the baby is one year old.⁷

Now, researchers funded by the National Institutes of Health have shown that giving infants once-daily nevirapine for up to six months after birth safely prevents mother-to-child transmission of HIV while breast-feeding.

The study, published in Lancet  in January 2012, involved 1,527 six-week-old infants of 1,505 HIV-positive women. The infants, who had received once-daily nevirapine for the first six weeks of life, were then randomized to either nevirapine or placebo for another five months.

The researchers found a 54% reduced rate of infection in treated babies, although there was no significant difference in mortality rates between the groups, or in the combined HIV infection and mortality rates. The benefit was greatest among babies born to women with relatively high CD4 counts who would not qualify for ART initiation. Those infants had a fourfold reduction in HIV transmission. Once prophylaxis ended, however, transmission rates for all infants returned to those seen in the placebo group.

The bottom line: Prophylactic nevirapine in breast-feeding infants up to six months is safe and effective in reducing viral transmission.

 

References:

1. Nduati R, Richardson BA, John G, et al. Effect of breast-feeding on mortality among HIV-1 infected women: a randomised trial. Lancet. 2001;357(9269):1651-1655.2. Coutsoudis A, Dabis F, Fawzi W, et al. Late postnatal transmission of HIV-1 in breast-fed children: an individual patient data meta-analysis. J Infect Dis. 2004;189(12):2154-2166.3. Leroy V, Karon JM, Alioum A, et al. Twenty-four month efficacy of a maternal short-course zidovudine regimen to prevent mother-to-child transmission of HIV-1 in West Africa. AIDS. 2002;16(4):631-641.4. Bedri A, Gudetta B, Isehak A, et al. Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breast-feeding in Ethiopia, India, and Uganda: an analysis of three randomised controlled trials. Lancet. 2008;372(9635):300-313.5. Kumwenda NI, Hoover DR, Mofenson LM, et al. Extended antiretroviral prophylaxis to reduce breast-milk HIV-1 transmission. N Engl J Med. 2008;359(2):119-129.6. Chasela CS, Hudgens MG, Jamieson DJ, et al. Maternal or infant antiretroviral drugs to reduce HIV-1 transmission. N Engl J Med. 2010;362(24):2271-2281.7. World Health Organization. Guidelines on HIV and Infant Feeding; 2010.