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FRIDAY, Dec. 23 (HealthDay News) -- Prophylactic nevirapine is safe and can reduce mother-to-child Human Immunodeficiency Virus-1 (HIV-1) transmission during breastfeeding up to 6 months of age, according to a study published online Dec. 23 in The Lancet.
Hoosen M. Coovadia, M.D., from the University of the Witwatersrand in Johannesburg, South Africa, and colleagues investigated the safety and efficacy of extending nevirapine treatment beyond 6 weeks of age up to six months of age in infants exposed to HIV-1 through breastfeeding. Between 2008 and 2010, infants without HIV infection after nevirapine treatment for the first six weeks were randomized to receive extended nevirapine (758 infants) or placebo (761 infants) until 6 months of age or breastfeeding cessation, whichever came first. HIV-1 infection at six months and adverse reactions were the primary efficacy and safety end points, respectively, and were compared between groups.
The investigators found that 1.1 percent (95 percent confidence interval [CI], 0.3 to 1.8) of infants in the extended treatment group and 2.4 percent (95 percent CI, 1.3 to 3.6) of control infants developed HIV-1 between six weeks and six months, with a 1.3 percent difference (95 percent CI, 0 to 2.6). This equaled a 54 percent transmission decrease (P = 0.049). Six month mortality and combined HIV infection and mortality rates did not differ significantly between the groups. Serious adverse events were observed in 16 and 15 percent of infants in the extended nevirapine and control groups, respectively. The groups did not differ significantly in frequency of adverse events, serious adverse events, and deaths.
"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," the authors write.
The study products were donated by Boehringer-Ingelheim.
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