Efficacy and safety of an extended nevirapine regimen in infants of breastfeeding mothers with HIV-1 infection for prevention of HIV-1 transmission (HPTN 046): 18-month results of a randomized, double-blind, placebo-controlled trial

Mary Glenn Fowler, Hoosen Coovadia, Casey M. Herron, Yvonne Maldonado, Tsungai Chipato, Dhayendre Moodley, Philippa Musoke, Jim Aizire, Karim Manji, Lynda Stranix-Chibanda, Wafaie Fawzi, Vani Chetty, Lindiwe Msweli, Rodrick Kisenge, Elizabeth Brown, Anthony Mwatha, Susan H. Eshleman, Paul Richardson, Melissa Allen, Kathleen GeorgePhilip Andrew, Sheryl Zwerski, Lynne M. Mofenson, J. Brooks Jackson

Research output: Contribution to journalArticlepeer-review

19 Scopus citations

Abstract

BACKGROUND:: HPTN 046 compared the efficacy and safety of infant nevirapine (NVP) among HIV-exposed breastfed infants randomized at 6 weeks to 6 months to t NVP or placebo to prevent postnatal infection: we report final 18-month outcomes. METHODS:: Randomized, placebo-controlled trial in 4 African countries. Infant diagnostic HIV testing was performed regularly from birth through 18 months. Kaplan-Meier analysis was used to assess 18-month cumulative infant HIV infection, HIV infection/or death, and mortality rates. RESULTS:: Between 6 weeks and 6 months, postnatal HIV infection rates were significantly lower among infants receiving daily NVP from 6 weeks to 6 months 1.1% [95% confidence interval (CI): 0.2% to 1.8%], compared with placebo 2.4% (95% CI: 1.3% to 2.6%), P = 0.049, but not significantly lower thereafter. Eighteen-month postnatal infection rates were low: 2.2% (95% CI: 1.1% to 3.3%) versus 3.1% (95% CI: 1.9% to 4.4%), respectively, P = 0.28. Mortality and HIV infection/death did not differ between arms at any age. Infants of women receiving antiretroviral therapy (ART) for their own health had the lowest 18-month postnatal infection rates (0.5%, 95% CI: 0.0% to 1.1%). However, HIV infection/death rates at 18 months were not significantly different for infants of mothers on ART (3.7%, 95% CI: 1.9% to 5.5%), and infants of mothers with CD4 counts of ≥350 cells per cubic millimeter not receiving ART (4.8%, 95% CI: 2.7% to 6.8%; P = 0.46). There were no differences in adverse events between study arms. CONCLUSIONS:: This trial demonstrated early but not late differences in postnatal HIV transmission among infants randomized at age 6 weeks to extended NVP or placebo, underscoring the importance of continued prophylaxis throughout breastfeeding.

Original languageEnglish (US)
Pages (from-to)366-374
Number of pages9
JournalJournal of Acquired Immune Deficiency Syndromes
Volume65
Issue number3
DOIs
StatePublished - Mar 1 2014

Keywords

  • PMTCT
  • infant HIV prophylaxis
  • nevirapine

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