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NELFINAVIR AND LAMIVUDINE PHARMACOKINETICS DURING THE FIRST TWO WEEKS OF LIFE
Mirochnick, Mark et al. | Date Issued: 2011
Author
Mirochnick, Mark
Nielsen-Saines, Karin
Pilotto, José Henrique
Pinto, Jorge
Veloso, Valdiléa G.
Rossi, Steven
Moye, Jack
Bryson, Yvonne
Mofenson, Lynne
Camarca, Margaret
Watts, D. Heather
Affilliation
Boston University School of Medicine. Boston, MA, USA.
University of California. David Geffen School of Medicine. Los Angeles, CA, USA.
Hospital Geral de Nova Iguaçu. Nova Iguaçu, RJ, Brasil / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de AIDS e Imunologia Molecular. Rio de Janeiro, RJ, Brasil.
Universidade Federal de Minas Gerais. Belo Horizonte, MG, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
University of California. San Diego School of Medicine. Skaggs School of Pharmacy & Pharmaceutical Sciences. CA, USA.
NIH. NICHD. DHHS. Pediatric, Adolescent and Maternal AIDS Branch. Bethesda, MD, USA.
University of California. David Geffen School of Medicine. Los Angeles, CA, USA.
NIH. NICHD. DHHS. Pediatric, Adolescent and Maternal AIDS Branch. Bethesda, MD, USA.
Westat, Inc. Rockville, MD, USA.
NIH. NICHD. DHHS. Pediatric, Adolescent and Maternal AIDS Branch. Bethesda, MD, USA.
Abstract
Background—There are no previous data describing nelfinavir and lamivudine pharmacokinetics in neonates treated with weight band dosing regimens. Design—Pharmacokinetic study of nelfinavir and lamivudine pharmacokinetics in infants during the first 2 weeks of life treated with weight band dosing regimens. Methods—Intensive 12 hour pharmacokinetic profiles were performed between either days 4–7 or days 10–14 of life in 26 Brazilian infants. Results—Pharmacokinetic data were obtained from 26 infants who received median (range) per kg doses of 58.8 (48.4–79.0) mg/kg for nelfinavir and 2.0 (1.5 – 3.2) mg/kg for lamivudine. Median nelfinavir AUC0-12 was 25.5 (1.7 – 183.5) μg*hr/mL and median C12h was 1.09 (<0.04 – 14.44) μg/mL. AUC0-12 was less than 15 μg*hr/mL (the 10% percentile for adults) in 12 infants (46%). Median lamivudine AUC0-12 was 7.8 (2.7–15.6) μg*hr/mL and median C12h was 0.23 (<0.04 – 0.74) μg/mL. Conclusions—Lamivudine pharmacokinetic parameters observed in this study were consistent with those seen in other studies of neonates. While median nelfinavir AUC and C12h in these neonates were above the exposure targets, interindividual variability in nelfinavir exposure was large and nelfinavir exposure failed to meet the exposure targets in 46% of infants.
Keywords in Portuguese
Farmacocinética
Recém-Nascido
Nelfinavir
Lamivudina
 
Keywords
Nelfinavir
Lamivudine
Pharmacokinetics
Newborns
 
Publisher
desconhecido
Citation
MIROCHNICK, Mark et al. Nelfinavir and Lamivudine Pharmacokinetics during the First Two Weeks of Life. The Pediatric Infectious Disease Journal, v. 30, n. 9, p. 769–772, Sept. 2011.
DOI
10.1097/INF.0b013e3182242950
ISSN
0277-9730
Notes
NICHD HPTN 040/PACTG 1043 Protocol team - We 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: Belo Horizonte- Federal University of Minas Gerais: Flavia Faleiro Ferreira, Fabiana Kakehasi. Hospital Geral de Nova Iguaçu: Jorge Eurico Ribeiro. Oswaldo Cruz Foundation, Rio de Janeiro (FIOCRUZ): Francisco Inacio Bastos, Beatriz Grinsztejn, Ronaldo Ismerio, Mariza Morgado, Marilia Santini de Oliveira, Valéria Ribeiro. Westat, Inc.: Emmanuel Aluko, Jim Bethel, Yolanda Bertucci, Patty Chen, Barbara Driver, Ruby Duston, Adriana Ferreira, Priya Guyadeen, Sarah Howell, Marsha Johnson, Naomi Leshabane, Lilya Meyerson, Rita Patel, Georgine Price, Susan Raitt, Eunice Yu. NICHD: Jennifer Read, George Siberry. Other protocol team members included Ruth Dickover from the University of CA-Davis, and Elizabeth Smith and Sheryl Zwerski from the National Institute of Allergy and Infectious Diseases, Diane Holland from the University of CA-San Diego Pediatric Pharmacology Laboratory. Pharmaceutical support and representatives included Marita McDonough from Boehringer-Ingelheim Pharmaceuticals, Inc. and Helen Watson from GlaxoSmithKline. This study was supported by NICHD Contract # HHSN267200800001C (NICHD Control # N01-HD-8-0001).