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NEVIRAPINE CONCENTRATIONS IN NEWBORNS RECEIVING AN EXTENDED PROPHYLACTIC REGIMEN
Mirochnick, Mark et al. | Date Issued: 2008
Author
Mirochnick, Mark
Nielsen-Saines, Karin
Pilotto, José Henrique
Pinto, Jorge
Jimenéz, Eleanor
Veloso, Valdiléa G.
Parsons, Teresa
Watts, D. Heather
Moye, Jack
Mofenson, Lynne M.
Camarca, Margaret
Bryson, Yvonne
Affilliation
Boston University School of Medicine. Department of Pediatrics. Boston, MA, USA.
David Geffen University of California Los Angeles School of Medicine. Department of Pediatrics. Los Angeles, CA, USA.
Hospital Geral de Nova Iguaçu. Departamento de Doenças Sexualmente Transmissíveis. Nova Iguaçu, RJ, Brasil.
Universidade Federal de Minas Gerais. Departamento de Pediatria. Belo Horizonte, MG, Brasil.
San Juan City Hospital. Department of Pediatrics. San Juan, PR.
Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Rio de Janeiro, RJ. Brasil.
Johns Hopkins University. Division of Clinical Pharmacology. Baltimore, MD, USA.
National Institute of Child Health and Human Development (NICHD) / National Institutes of Health. Pediatric, Adolescent and Maternal AIDS Branch. Bethesda, MD, USA.
National Institute of Child Health and Human Development (NICHD) / National Institutes of Health. Pediatric, Adolescent and Maternal AIDS Branch. Bethesda, MD, USA.
National Institute of Child Health and Human Development (NICHD) / National Institutes of Health. Pediatric, Adolescent and Maternal AIDS Branch. Bethesda, MD, USA.
Westat, Inc., Rockville. MD, USA.
David Geffen University of California Los Angeles School of Medicine. Department of Pediatrics. Los Angeles, CA, USA.
Abstract
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.
Keywords in Portuguese
Transmissão de mãe para filho do HIV
Recém-nascido
Nevirapina
Farmacocinética
 
Keywords
Mother-to-child HIV transmission
Neonate
Nevirapine
Pharmacokinetics
 
Publisher
Lippincott, Williams & Wilkins
Citation
MIROCHNICK, Mark et al. Nevirapine Concentrations in Newborns Receiving an Extended Prophylactic Regimen. Journal of Acquired Immune Deficiency Syndromes, v. 47, n. 3, p. 334-337, Mar. 2008.
ISSN
1525-4135
Notes
The authors thank the patients and their families who enrolled in this trial. In addition to the authors, members of the NICHD/HPTN 040/PACTG 1043 Protocol Team include Mariza Morgado, PhD (Departmento de Immunologia–IOC/FIOCRUZ, Rio de Janeiro, Brazil), Eunice Yu (Westat, Rockville, MD), James Bethel, PhD (Westat), Elizabeth Hawkins, AA (Social and Scientific Systems, Silver Spring, MD), Elizabeth Smith, MD (National Institute of Allergy and Infectious Diseases [NIAID], Bethesda, MD), Sheryl Zwerski, RN (NIAID), Marita D. McDonough, RN (Boehringer-Ingelheim Pharmaceuticals, Ridgefield, CT), Charles T. Lancaster (GlaxoSmithKline, Research Triangle Park, NC), Cristina PharoRuth (GlaxoSmithKline), and Ruth E. Dickover, PhD (University of California Los Angeles School of Medicine, Los Angeles, CA). The following investigators also participated in this study: Fabiana Kakehasi, MD, Fla´via Ferreira, MD, Lilian Diniz, MD, and Maria Tavares, RN, Federal University of Minas Gerais, Belo Horizonte, Brazil; and Jorge Eurico Ribeiro, MD, Ivete Matins Gomes, MD, and Andrea Gouveia, RN, Hospital Geral de Nova Iguacxu, Nova Iguacxu, Brazil. Boehringer-Ingelheim Pharmaceuticals supplied the NVP used in this study.