High exposure to zidovudine during the first 2 weeks of life and concentration - Toxicity relationships

Journal of Acquired Immune Deficiency Syndromes

Volumn 63, Issue 5, 2013, Pages 555-562

  Hirt, Déborah ^a,b,c   Warszawski, Josiane ^d,e,f   Firtion, Ghislaine ^c   Giraud, Carole ^a,b,c,g   Chappuy, Hélène ^a,g,h   Lechenadec, Jérôme ^d   Benaboud, Sihem ^a,g   Urien, Saïk ^a,b,g   Blanche, Stéphane ^g,h   Tréluyer, Jean Marc ^a,b,c,g  

^a Paris Descartes University   (France)

^b INSERM   (France)

^c Institut Cochin   (France)

^d CENTRE FOR RESEARCH IN EPIDEMIOLOGY AND POPULATION HEALTH   (France)

^e UNIVERSITÉ PARIS SACLAY   (France)

^f BICÊTRE HOSPITAL   (France)

^g UNIVERSITÉ PARIS DESCARTES   (France)

^h HÔPITAL NECKER ENFANTS MALADES   (France)

Author keywords

Dose optimization; HIV; Neonates; Population pharmacokinetics; Prevention of mother to child transmission; Toxicity; Zidovudine

Indexed keywords

HEMOGLOBIN; LACTIC ACID; ZIDOVUDINE;

ARTICLE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG INTOXICATION; FEMALE; GESTATIONAL AGE; HEMOGLOBIN BLOOD LEVEL; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; NEWBORN; PRENATAL EXPOSURE; PRIORITY JOURNAL; SIMULATION;

ANTI-HIV AGENTS; BLOOD CHEMICAL ANALYSIS; DISEASE TRANSMISSION, INFECTIOUS; FEMALE; HEMOGLOBINS; HIV INFECTIONS; HUMANS; INFANT, NEWBORN; LACTATES; MALE; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; ZIDOVUDINE;

EID: 84883456512     PISSN: 15254135     EISSN: 10779450     Source Type: Journal    
DOI: 10.1097/QAI.0b013e3182908c00     Document Type: Article

References (37)

1. Mirochnick M, Capparelli E, Connor J. Pharmacokinetics of zidovudine in infants: a population analysis across studies. Clin Pharmacol Ther. 1999;66:16-24.
2. Durand-Gasselin L, Pruvost A, Dehee A, et al. High levels of zidovudine (AZT) and its intracellular phosphate metabolites in AZTand AZT-lamivudine- treated newborns of human immunodeficiency virus-infected mothers. Antimicrob Agents Chemother. 2008;52: 2555-2563.
3. Moodley D, Pillay K, Naidoo K, et al. Pharmacokinetics of zidovudine and lamivudine in neonates following coadministration of oral doses every 12 hours. J Clin Pharmacol. 2001;41:732-741.
4. Soler-Palacin P, Martin-Nalda A, Martinez-Gomez X, et al. Hyperlactatemia and in utero exposure to antiretrovirals: is the control group the clue? AIDS Res Hum Retroviruses. 2012;28:752-758.
5. Sperling RS, Shapiro DE, McSherry GD, et al. Safety of the maternalinfant zidovudine regimen utilized in the Pediatric AIDS Clinical Trial Group 076 Study. AIDS. 1998;12:1805-1813.
6. Alimenti A, Burdge DR, Ogilvie GS, et al. Lactic acidemia in human immunodeficiency virus-uninfected infants exposed to perinatal antiretroviral therapy. Pediatr Infect Dis J. 2003;22:782-789.
7. Crain MJ, Williams PL, Griner R, et al. Point-of-care capillary blood lactate measurements in human immunodeficiency virus-uninfected children with in utero exposure to human immunodeficiency virus and antiretroviral medications. Pediatr Infect Dis J. 2011;30: 1069-1074.
8. Fernandez Ibieta M, Cano JM, Amador JT, et al. In-utero antiretroviral exposure and mitochondrial toxicity in a cohort of uninfected infants born to HIV-1-infected women. An Pediatr (Barc). 2010;73: 180-188.
9. Giaquinto C, De Romeo A, Giacomet V, et al. Lactic acid levels in children perinatally treated with antiretroviral agents to prevent HIV transmission. AIDS. 2001;15:1074-1075.
10. Noguera A, Fortuny C, Munoz-Almagro C, et al. Hyperlactatemia in human immunodeficiency virus-uninfected infants who are exposed to antiretrovirals. Pediatrics. 2004;114:e598-e603.
11. Moyle G. Toxicity of antiretroviral nucleoside and nucleotide analogues: is mitochondrial toxicity the only mechanism? Drug Saf. 2000;23:467-481.
12. Ross AC, Leong T, Avery A, et al. Effects of in utero antiretroviral exposure on mitochondrial DNA levels, mitochondrial function and oxidative stress. HIV Med. 2012;13:98-106.
13. Dryden-Peterson S, Shapiro RL, Hughes MD, et al. Increased risk of severe infant anemia after exposure to maternal HAART, Botswana. J Acquir Immune Defic Syndr. 2011;56:428-436.
14. Mandelbrot L, Landreau-Mascaro A, Rekacewicz C, et al. Lamivudinezidovudine combination for prevention of maternal-infant transmission of HIV-1. JAMA. 2001;285:2083-2093.
15. Koh MT. Unrecognized near-fatal hyperlactatemia in an HIV-infected infant exposed to nucleoside reverse transcriptase inhibitors. Int J Infect Dis. 2007;11:85-86.
16. Scalfaro P, Chesaux JJ, Buchwalder PA, et al. Severe transient neonatal lactic acidosis during prophylactic zidovudine treatment. Intensive Care Med. 1998;24:247-250.
17. Chappuy H, Treluyer JM, Jullien V, et al. Maternal-fetal transfer and amniotic fluid accumulation of nucleoside analogue reverse transcriptase inhibitors in human immunodeficiency virus-infected pregnant women. Antimicrob Agents Chemother. 2004;48:4332-4336.
18. Hirt D, Urien S, Ekouevi DK, et al. Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS 12109). Clin Pharmacol Ther. 2009;85:182-189.
19. Bazzoli C, Benech H, Rey E, et al. Joint population pharmacokinetic analysis of zidovudine, lamivudine, and their active intracellular metabolites in HIV patients. Antimicrob Agents Chemother. 2011; 55:3423-3431.
20. Bergshoeff AS, Fraaij PL, Verweij C, et al. Plasma levels of zidovudine twice daily compared with three times daily in six HIV-1-infected children. J Antimicrob Chemother. 2004;54:1152-1154.
21. Cremieux AC, Katlama C, Gillotin C, et al. A comparison of the steady-state pharmacokinetics and safety of abacavir, lamivudine, and zidovudine taken as a triple combination tablet and as abacavir plus a lamivudine-zidovudine double combination tablet by HIV-1-infected adults. Pharmacotherapy. 2001;21:424-430.
22. Dumond JB, Reddy YS, Troiani L, et al. Differential extracellular and intracellular concentrations of zidovudine and lamivudine in semen and plasma of HIV-1-infected men. J Acquir Immune Defic Syndr. 2008;48: 156-162.
23. Vanhove GF, Kastrissios H, Gries JM, et al. Pharmacokinetics of saquinavir, zidovudine, and zalcitabine in combination therapy. Antimicrob Agents Chemother. 1997;41:2428-2432.
24. Jopling J, Henry E, Wiedmeier SE, et al. Reference ranges for hematocrit and blood hemoglobin concentration during the neonatal period: data from a multihospital health care system. Pediatrics. 2009;123:e333-e337.
25. Ekouevi DK, Toure R, Becquet R, et al. Serum lactate levels in infants exposed peripartum to antiretroviral agents to prevent mother-to-child transmission of HIV: Agence Nationale de Recherches Sur le SIDA et les Hepatites Virales 1209 study, Abidjan, Ivory Coast. Pediatrics. 2006; 118:e1071-e1077.
26. Mirochnick M, Capparelli E, Dankner W, et al. Zidovudine pharmacokinetics in premature infants exposed to human immunodeficiency virus. Antimicrob Agents Chemother. 1998;42:808-812.
27. Boucher FD, Modlin JF, Weller S, et al. Phase I evaluation of zidovudine administered to infants exposed at birth to the human immunodeficiency virus. J Pediatr. 1993;122:137-144.
28. Kearns GL, Abdel-Rahman SM, Alander SW, et al. Developmental pharmacology-drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;349:1157-1167.
29. Cade WT, Waggoner AD, Hubert S, et al. Reduced diastolic function and left ventricular mass in HIV-negative preadolescent children exposed to antiretroviral therapy in utero. AIDS. 2012;26:2053-2058.
30. Lipshultz SE, Shearer WT, Thompson B, et al. Cardiac effects of antiretroviral therapy in HIV-negative infants born to HIV-positive mothers: NHLBI CHAART-1 (National Heart, Lung, and Blood Institute Cardiovascular Status of HAART Therapy in HIV-Exposed Infants and Children cohort study). J Am Coll Cardiol. 2011;57:76-85.
31. Barret B, Tardieu M, Rustin P, et al. Persistent mitochondrial dysfunction in HIV-1-exposed but uninfected infants: clinical screening in a large prospective cohort. AIDS. 2003;17:1769-1785.
32. Crain MJ, Chernoff MC, Oleske JM, et al. Possible mitochondrial dysfunction and its association with antiretroviral therapy use in children perinatally infected with HIV. J Infect Dis. 2010;202:291-301.
33. Levels and patterns of neutrophil cell counts over the first 8 years of life in children of HIV-1-infected mothers. AIDS. 2004;18:2009-2017.
34. Le Chenadec J, Mayaux MJ, Guihenneuc-Jouyaux C, et al. Perinatal antiretroviral treatment and hematopoiesis in HIV-uninfected infants. AIDS. 2003;17:2053-2061.
35. Pacheco SE, McIntosh K, Lu M, et al. Effect of perinatal antiretroviral drug exposure on hematologic values in HIV-uninfected children: an analysis of the women and infants transmission study. J Infect Dis. 2006;194:1089-1097.
36. Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994;331:1173-1180.
37. Capparelli EV, Englund JA, Connor JD, et al. Population pharmacokinetics and pharmacodynamics of zidovudine in HIV-infected infants and children. J Clin Pharmacol. 2003;43:133-140.