News Release

Extended-dose nevirapine could protect infants of HIV-infected mothers from contracting the virus

Peer-Reviewed Publication

The Lancet_DELETED

A regimen of extended-dose nevirapine could reduce the risk of infants of HIV-infected mothers contracting the virus, and a long course of such treatment could be effective where access to affordable and safe replacement feeding is not yet available. These are the conclusions* of authors of an Article in this week's HIV special issue of The Lancet.

UNICEF and WHO recommend that infants born to HIV-infected mothers who do not have access to safe, acceptable, and sustainable replacement feeding should be exclusively breast-fed for at least six months.

Professor Robert Bollinger along with investigators from the Johns Hopkins University in the United States, Addis Ababa University Faculty of Medicine in Ethiopia, BJ Medical College and National AIDS Research Institute in India, and Makerere University/Johns Hopkins University Research Collaboration in Uganda did three randomised trials in Ethiopia, India, and Uganda to assess whether the antiretroviral drug nevirapine given daily to breastfed infants up to six weeks of age could decrease HIV transmission via breastfeeding.

HIV-infected, breastfeeding mothers were randomised to receive either single-dose nevirapine (SDN) — nevirapine 200mg to women in labour and nevirapine 2mg/kg to newborns after birth; or 6 week extended dose nevirapine (EDN) — as with SDN plus nevirapine 5mg daily from days 8-42 for the infant. The primary endpoint was HIV infection at 6 months of age in infants who had tested HIV-negative at birth.

The analysis included 986 SDN infants and 901 EDN infants, and at six months 87 children in the SDN group were HIV-positive compared with 62 in the EDN group, which meant a 20% reduced risk of becoming HIV-positive for EDN infants. However this finding was not statistically significant. At six weeks, 54 children in the SDN group and 25 in the EDN group were HIV-positive, which meant a reduced risk of 46% of contracting HIV for EDN infants, and this finding was statistically significant.

The authors conclude: "Although a 6-week regimen of daily nevirapine might be associated with a reduction in the risk of HIV transmission at 6 weeks of age, the lack of a significant reduction in the primary endpoint — risk of HIV transmission at 6 months — suggests that a longer course of daily infant nevirapine to prevent HIV transmission via breast milk might be more effective where access to affordable and safe replacement feedings is not yet available and where the risks of replacement feeding are high."

In an accompanying Comment, Dr Jeffrey Stringer and Dr Benjamin Chi, University of Alabama at Birmingham, USA, working from The Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia, say: "Extended infant prophylaxis with nevirapine is simple enough to be implemented almost anywhere. It represents a long-awaited, if partial, solution to a mother's impossible choice. We should not delay."

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For Professor Robert Bollinger, Johns Hopkins Center for Clinical Global Health Education, Johns Hopkins School of Medicine, Baltimore, USA please contact Tim Parsons T) +1 410-955-7619 E) rcb@jhmi.edu / tmparson@jhsph.edu

Dr Jeffrey Stringer and Dr Benjamin Chi, University of Alabama at Birmingham, USA, working from The Centre for Infectious Disease Research in Zambia (CIDRZ), Lusaka, Zambia contact by e-mail only E) stringer@cidrz.org

Notes to editors: *A co-principal investigator from India involved in this study disagrees with the way the paper has been presented and interpreted; details are included in a letter from her in this week's Correspondence section. (Dr Mrudula Phadke, page 287). The various steps The Lancet took when we became aware of this dispute are also detailed in a Comment by two of our executive editors (page 269). Both of these documents, plus the general Comment which accompanies the Article, are in the link to the full Article in this week's press release e-mail.

http://multimedia.thelancet.com/pdf/press/nevirapine.pdf


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