Rates of transmission of HIV from infected mothers to their newborn children are reduced if the children are given a daily oral dose of the antiretroviral drug nevirapine, a strategy that can be safely used until the child is six months old or the mother stops breastfeeding. These are findings of an Article published Online First by the Lancet, written by Professor Hoosen M Coovadia, University of Witwatersrand, Johannesburg, and Nelson Mandela School of Medicine, University of Kwazulu-Natal, Durban, South Africa, and Kathy George, Family Health International, Research Triangle Park, NC, USA, and colleagues.
Studies have shown that nevirapine given once daily for the first 6, 14, or 28 weeks of life reduces mother-to-child transmission of HIV through breast milk more than a single dose at birth or within the first few weeks of life. This new study assessed incremental safely and efficacy of extension of this prophylaxis until six months.
A total of 1527 infants took part in the trial, all of whom received nevirapine as per standard practice up to the age of six weeks. After that, the infants were randomised to receive oral nevirapine once daily, or placebo, until age six months or when the mother stopped breast feeding, whichever happened first.
The researchers found that 1.1% of infants in the extended nevirapine group became HIV-positive between ages 6 weeks and 6 months, compared to 2.4% in the placebo group, translating to a 54% reduction in transmission. However mortality (1.2% nevirapine, 1.1% placebo) did not differ between the 2 groups at 6 months. Around one in six children in both groups had serious adverse events, but frequency of adverse events, serious adverse events, and deaths did not differ significantly between the groups.
The authors conclude: "After 6 weeks of treatment with once-daily nevirapine, continued use of nevirapine to age 6 months in uninfected infants of breastfeeding mothers with HIV-1 is safe, and results in a greater than 50% reduction in mother-to-child transmission from breastfeeding compared with placebo. No other study has directly assessed the incremental benefit of extension of nevirapine from age 6 weeks until 6 months to establish whether the extended period is more efficacious and whether there are increased safety issues associated with long-term treatment with nevirapine."
Kathy George, Family Health International, Research Triangle Park, NC, USA. Please e-mail to arrange interview. E) KGeorge@fhi360.org
Note to editors: No linked Comment is being published with this Article.
Journal
The Lancet