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)
Year: 2013
Type: article
Study design: Clinical Trial
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.
Authors: 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 George, Philip Andrew, Sheryl Zwerski, Lynne M. Mofenson, J. Brooks Jackson
Institutions: Johns Hopkins University, University of Zimbabwe, University of the Witwatersrand, Johns Hopkins Medicine, Centre for the AIDS Programme of Research in South Africa, Fred Hutch Cancer Center, Stanford Medicine, Makerere University, University of KwaZulu-Natal, Stanford University, MUJHU Research Collaboration, Muhimbili University of Health and Allied Sciences, Harvard University, Family Health International 360, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Eunice Kennedy Shriver National Institute of Child Health and Human Development
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funders: Wake Forest University, University of Washington, Strong, International Maternal Pediatric Adolescent AIDS Clinical Trials Network, National Institutes of Health, National Institute of Mental Health, National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development, Eunice Kennedy Shriver National Institute of Child Health and Human Development
Awards: HIV PREVENTION TRIALS NETWORK LEADERSHIP GROUP, G1571747198, G1597187361, G1929754733, International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group, G622809771, G7742187551, G9000014638, UZ-UCSF CTU, The Johns Hopkins University - Uganda Clinical Trials Unit, KwaZulu-Natal Clinical Trials Unit, IMPAACT Leadership Group
OpenAlex ID: W2330671666