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JAIDS Journal of Acquired Immune Deficiency Syndromes:
doi: 10.1097/QAI.0000000000000052
Epidemiology and Prevention

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

Fowler, Mary Glenn MD, MPH*; Coovadia, Hoosen MD; Herron, Casey M. MS; Maldonado, Yvonne MD§; Chipato, Tsungai MBChB; Moodley, Dhayendre PhD; Musoke, Philippa MBchB, PhD#; Aizire, Jim MBChB, MS#; Manji, Karim MBBS**; Stranix-Chibanda, Lynda MBChB, MMed††; Fawzi, Wafaie MD‡‡; Chetty, Vani B Tech; Msweli, Lindiwe BA; Kisenge, Rodrick PhD**; Brown, Elizabeth ScD; Mwatha, Anthony MS; Eshleman, Susan H. MD*; Richardson, Paul MSc*; Allen, Melissa MPH#; George, Kathleen MPH‡‡; Andrew, Philip RN§§; Zwerski, Sheryl CRNP‖‖; Mofenson, Lynne M. MD¶¶; Jackson, J. Brooks MD, MBA*; for the HPTN 046 Protocol Team

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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.

© 2014 by Lippincott Williams & Wilkins

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