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Nevirapine for 6 Months during Breast-feeding Prevents Perinatal HIV Transmission

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Treating babies with nevirapine (Viramune) for 6 months while breast-feeding significantly reduced the risk of mother-to-child HIV transmission, though it did not alter the likelihood of infant mortality, according to a study of HIV positive African women and their babies described in the January 21, 2012, issue of The Lancet.

Research has conclusively shown that treating HIV positive mothers with antiretroviral drugs during pregnancy and delivery, and their infants immediately after birth, dramatically reduces the rate of vertical transmission. But HIV may also be transmitted through breast-feeding.

Prior studies have found that giving HIV-exposed babies once-daily nevirapine for the first 6, 14, or 28 weeks of life reduces the risk of transmission more than a single dose at birth or soon thereafter. The current analysis assessed the incremental safety and efficacy of extending nevirapine prophylaxis from 6 weeks to 6 months.

Hoosen Coovadia and fellow investigators with the HPTN 046 protocol team enrolled 1527 breast-feeding infants born to HIV positive mothers in 4 African countries within 7 days of birth.

All infants were given daily nevirapine from birth through 6 weeks. At that point (between June 2008 and March 2010), those who remained uninfected were randomly assigned to receive extended nevirapine prophylaxis or placebo through 6 months or until breast-feeding stopped (whichever came first); 5 infants were found to be HIV-infected at randomization and were excluded from the primary analysis.

Results

  • 1.1% of infants who received extended nevirapine became infected between 6 weeks and 6 months, compared with 2.4% of babies in the placebo group.
  • The difference of 1.3% -- reflecting a 54% reduction in transmission risk -- just reached statistical significance (P = 0.049).
  • Mortality rates (1.2% vs 1.1% respectively; P = 0.81), and combined HIV infection/mortality rates (2.3% vs 3.2%; P = 0.27), however, did not differ significantly between the nevirapine and placebo groups at 6 months.
  • Frequency of serious adverse events (15% vs 16%, respectively), all adverse events, and deaths did not differ significantly between the nevirapine and placebo groups.

Based on these findings, the study authors concluded, "Nevirapine prophylaxis can safely be used to provide protection from mother-to-child transmission of HIV-1 via breastfeeding for infants up to 6 months of age."

Investigator affiliations: Maternal Adolescent and Child Health, University of the Witwatersrand, Johannesburg, South Africa; Nelson Mandela School of Medicine, University of Kwazulu-Natal, Durban, South Africa; Fred Hutchinson Cancer Research Center, Seattle, WA; Johns Hopkins University School of Medicine, Baltimore, MD; University of Zimbabwe College of Medicine, Harare, Zimbabwe; Centre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu Natal, Durban, South Africa; Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania; Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda; Harvard University School of Public Health, Boston, MA; George Washington University School of Public Health and Health Services, Washington DC; Family Health International, Research Triangle Park, NC; Eunice Kennedy Shriver National Institute of Child Health and Human Development, U.S. National Institutes of Health (NIH), Rockville, MD; National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD; Stanford University School of Medicine, Stanford, CA.

1/24/12

Reference

HM Coovadia, ER Brown, MG Fowler, et al. Efficacy and safety of an extended nevirapine regimen in infant children of breastfeeding mothers with HIV-1 infection for prevention of postnatal HIV-1 transmission (HPTN 046): a randomised, double-blind, placebo-controlled trial. The Lancet 379(9812):221-228. January 21, 2012.