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 12-hour AUC (AUC0-12) was 25.5 (1.7-183.5) μg*h/mL and median 12-hour concentration (C12h) was 1.09 (<0.04-14.44) μg/mL. AUC0-12 was less than 15 μg*h/mL (the 10% for adults) in 12 infants (46%). Median lamivudine AUC0-12 was 7.8 (2.7-15.6) μg*h/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.
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 12-hour AUC (AUC0-12) was 25.5 (1.7-183.5) μg*h/mL and median 12-hour concentration (C12h) was 1.09 (<0.04-14.44) μg/mL. AUC0-12 was less than 15 μg*h/mL (the 10% for adults) in 12 infants (46%). Median lamivudine AUC0-12 was 7.8 (2.7-15.6) μg*h/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.
Authors: Chokechai Rongkavilit; Rolf P G van Heeswijk; Sompop Limpongsanurak; Pimolrat Thaithumyanon; Chantana Boonrod; Elly A M Hassink; Aeumporn Srigritsanapol; Theshinee Chuenyam; Sasiwimol Ubolyam; Richard M W Hoetelmans; Kiat Ruxrungtham; Joep M A Lange; David A Cooper; Praphan Phanuphak Journal: J Acquir Immune Defic Syndr Date: 2002-04-15 Impact factor: 3.731
Authors: P Krogstad; A Wiznia; K Luzuriaga; W Dankner; K Nielsen; M Gersten; B Kerr; A Hendricks; B Boczany; M Rosenberg; D Jung; S A Spector; Y Bryson Journal: Clin Infect Dis Date: 1999-05 Impact factor: 9.079
Authors: E V Capparelli; J L Sullivan; L Mofenson; E Smith; B Graham; P Britto; M I Becker; D Holland; J D Connor; K Luzuriaga Journal: Pediatr Infect Dis J Date: 2001-08 Impact factor: 2.129
Authors: D Moodley; K Pillay; K Naidoo; J Moodley; M A Johnson; K H Moore; P N Mudd; G E Pakes Journal: J Clin Pharmacol Date: 2001-07 Impact factor: 3.126
Authors: Adriana H Tremoulet; Edmund V Capparelli; Parul Patel; Edward P Acosta; Katherine Luzuriaga; Yvonne Bryson; Diane Wara; Carmen Zorrilla; Diane Holland; Mark Mirochnick Journal: Antimicrob Agents Chemother Date: 2007-09-24 Impact factor: 5.191
Authors: Ellen G Chadwick; Edmund V Capparelli; Ram Yogev; Jorge A Pinto; Brian Robbins; John H Rodman; Jie Chen; Paul Palumbo; Leslie Serchuck; Elizabeth Smith; Michael Hughes Journal: AIDS Date: 2008-01-11 Impact factor: 4.177
Authors: Mark Mirochnick; Karin Nielsen-Saines; Jose Henrique Pilotto; Jorge Pinto; Eleanor Jiménez; Valdilea G Veloso; Teresa Parsons; D Heather Watts; Jack Moye; Lynne M Mofenson; Margaret Camarca; Yvonne Bryson Journal: J Acquir Immune Defic Syndr Date: 2008-03-01 Impact factor: 3.731
Authors: Esther J H Janssen; Diane E T Bastiaans; Pyry A J Välitalo; Annemarie M C van Rossum; Evelyne Jacqz-Aigrain; Hermione Lyall; Catherijne A J Knibbe; David M Burger Journal: Br J Clin Pharmacol Date: 2017-02-14 Impact factor: 4.335
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: 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: Julia C Rosebush; Brookie M Best; Ellen G Chadwick; Kevin Butler; John Moye; Elizabeth Smith; Sarah Bradford; Christina A Reding; Sisinyana R Mathiba; Sherika Hanley; Mariam Aziz; James Homans; Edward P Acosta; William Murtaugh; Manoli Vourvahis; Lynn Mcfadyen; Katy Hayward; Mark Mirochnick; Pearl Samson Journal: AIDS Date: 2021-03-01 Impact factor: 4.632
Authors: Mark F Cotton; Sandi Holgate; Aurelie Nelson; Helena Rabie; Catherine Wedderburn; Mark Mirochnick Journal: J Int AIDS Soc Date: 2015-12-02 Impact factor: 5.396