BACKGROUND: The optimal neonatal antiretroviral (ARV) regimen for prevention of HIV mother-to-child transmission (MTCT) is unknown for infants born to mothers who receive no ARVs during pregnancy. METHODS: As part of a protocol comparing the efficacy of 3 neonatal ARV regimens in preventing HIV-1 MTCT in neonates born to mothers who receive no prenatal treatment with ARVs, we devised a 3-dose nevirapine (NVP) regimen with the goal of maintaining the NVP plasma concentration >100 ng/mL (10 times the in vitro median inhibitory concentration of 10 ng/mL) during the first 2 weeks of life. NVP concentrations were measured in 14 newborns participating in a pharmacokinetics substudy during the second week of life and in single samples from 30 more newborns on day 10 to 14. RESULTS: The median NVP elimination half-life was 30.2 hours (range: 17.8 to 50.3 hours). The NVP concentration remained greater than the target of 100 ng/mL in all samples collected through day 10 of life. By day 14, more than half of the newborns in the pharmacokinetic substudy had NVP levels <100 ng/mL, although only 1 neonate had no detectable NVP. CONCLUSION: Although this regimen failed to meet our 100-ng/mL target, it did maintain detectable NVP concentrations in nearly all newborns through the end of the second week of life and is to be used in the parent efficacy protocol.
BACKGROUND: The optimal neonatal antiretroviral (ARV) regimen for prevention of HIV mother-to-child transmission (MTCT) is unknown for infants born to mothers who receive no ARVs during pregnancy. METHODS: As part of a protocol comparing the efficacy of 3 neonatal ARV regimens in preventing HIV-1 MTCT in neonates born to mothers who receive no prenatal treatment with ARVs, we devised a 3-dose nevirapine (NVP) regimen with the goal of maintaining the NVP plasma concentration >100 ng/mL (10 times the in vitro median inhibitory concentration of 10 ng/mL) during the first 2 weeks of life. NVP concentrations were measured in 14 newborns participating in a pharmacokinetics substudy during the second week of life and in single samples from 30 more newborns on day 10 to 14. RESULTS: The median NVP elimination half-life was 30.2 hours (range: 17.8 to 50.3 hours). The NVP concentration remained greater than the target of 100 ng/mL in all samples collected through day 10 of life. By day 14, more than half of the newborns in the pharmacokinetic substudy had NVP levels <100 ng/mL, although only 1 neonate had no detectable NVP. CONCLUSION: Although this regimen failed to meet our 100-ng/mL target, it did maintain detectable NVP concentrations in nearly all newborns through the end of the second week of life and is to be used in the parent efficacy protocol.
Authors: Sandra E Dross; Steve S Rossi; Ingrid A Beck; Mark A Micek; Ana Judith Blanco; Kristy D Seidel; Pablo Montoya; Edmund V Capparelli; Lisa M Frenkel Journal: AIDS Date: 2014-10-23 Impact factor: 4.177
Authors: Karin Nielsen-Saines; D Heather Watts; Valdilea G Veloso; Yvonne J Bryson; Esau C Joao; Jose Henrique Pilotto; Glenda Gray; Gerhard Theron; Breno Santos; Rosana Fonseca; Regis Kreitchmann; Jorge Pinto; Marisa M Mussi-Pinhata; Mariana Ceriotto; Daisy Machado; James Bethel; Marisa G Morgado; Ruth Dickover; Margaret Camarca; Mark Mirochnick; George Siberry; Beatriz Grinsztejn; Ronaldo I Moreira; Francisco I Bastos; Jiahong Xu; Jack Moye; Lynne M Mofenson Journal: N Engl J Med Date: 2012-06-21 Impact factor: 91.245
Authors: Patricia M Flynn; Mark Mirochnick; David E Shapiro; Arlene Bardeguez; John Rodman; Brian Robbins; Sharon Huang; Susan A Fiscus; Koen K A Van Rompay; James F Rooney; Brian Kearney; Lynne M Mofenson; D Heather Watts; Patrick Jean-Philippe; Barbara Heckman; Edwin Thorpe; Amanda Cotter; Murli Purswani Journal: Antimicrob Agents Chemother Date: 2011-09-06 Impact factor: 5.191
Authors: Sten H Vermund; José A Tique; Holly M Cassell; Megan E Pask; Philip J Ciampa; Carolyn M Audet Journal: J Acquir Immune Defic Syndr Date: 2013-06-01 Impact factor: 3.731
Authors: Theodore D Ruel; Edmund V Capparelli; Camlin Tierney; Bryan S Nelson; Anne Coletti; Yvonne Bryson; Mark F Cotton; Stephen A Spector; Mark Mirochnick; Rebecca LeBlanc; Christina Reding; Bonnie Zimmer; Deborah Persaud; Mutsa Bwakura-Dangarembizi; Kimesh L Naidoo; Rohan Hazra; Patrick Jean-Philippe; Ellen G Chadwick Journal: Lancet HIV Date: 2020-11-23 Impact factor: 12.767