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 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 Eshleman; Paul Richardson; Melissa Allen; Kathleen George; Philip Andrew; Sheryl Zwerski; Lynne Mofenson; J Brooks Jackson

doi:10.1097/QAI.0000000000000052

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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

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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 Herron, Yvonne Maldonado, Tsungai Chipato, Dhayendre Moodley, Philippa Musoke, Jim Aizire, Karim Manji, Lynda Stranix-Chibanda, …

Journal of acquired immune deficiency syndromes (1999), Vol.65(3), pp.366-374

03/01/2014

DOI: 10.1097/QAI.0000000000000052

PMCID: PMC3945386

PMID: 24189151

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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 infectionwe 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% CI1.3% to 2.6%), P = 0.049, but not significantly lower thereafter. Eighteen-month postnatal infection rates were low2.2% (95% CI1.1% to 3.3%) versus 3.1% (95% CI1.9% 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% CI0.0% to 1.1%). However, HIV infection/death rates at 18 months were not significantly different for infants of mothers on ART (3.7%, 95% CI1.9% to 5.5%), and infants of mothers with CD4 counts of ≥350 cells per cubic millimeter not receiving ART (4.8%, 95% CI2.7% 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.

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Title: Subtitle: 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
Creators: Mary Glenn Fowler - Johns Hopkins University
Hoosen Coovadia - University of the Witwatersrand
Casey Herron - Fred Hutch Cancer Center
Yvonne Maldonado - Stanford University School of Medicine
Tsungai Chipato - National Institutes of Health
Dhayendre Moodley - University of KwaZulu-Natal
Philippa Musoke - Makerere University
Jim Aizire - Makerere University
Karim Manji - Muhimbili University of Health and Allied Sciences
Lynda Stranix-Chibanda - University of Zimbabwe
Wafaie Fawzi - University of KwaZulu-Natal
Vani Chetty - University of KwaZulu-Natal
Lindiwe Msweli - University of KwaZulu-Natal
Rodrick Kisenge - Muhimbili University of Health and Allied Sciences
Elizabeth Brown - Fred Hutch Cancer Center
Anthony Mwatha - Fred Hutch Cancer Center
Susan Eshleman - Johns Hopkins University School of Medicine
Paul Richardson - Johns Hopkins University School of Medicine
Melissa Allen - Makerere University
Kathleen George - Harvard University
Philip Andrew - Family Health International 360
Sheryl Zwerski - National Institutes of Health
Lynne Mofenson - Eunice Kennedy Shriver National Institute of Child Health and Human Development
J Brooks Jackson - Johns Hopkins University School of Medicine
Resource Type: Journal article
Publication Details: Journal of acquired immune deficiency syndromes (1999), Vol.65(3), pp.366-374
DOI: 10.1097/QAI.0000000000000052
PMID: 24189151
PMCID: PMC3945386
NLM abbreviation: J Acquir Immune Defic Syndr
ISSN: 1525-4135
eISSN: 1944-7884
Publisher: by Lippincott Williams & Wilkins
Language: English
Date published: 03/01/2014
Academic Unit: Pathology; VPMA - Administration
Record Identifier: 9984047976802771

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