Population analysis of the pregnancy-related modifications in lopinavir pharmacokinetics and their possible consequences for dose adjustment

Journal of Antimicrobial Chemotherapy

Volumn 63, Issue 6, 2009, Pages 1223-1232

  Bouillon Pichault, Marion ^a,b,c,d   Jullien, Vincent ^a,b,c   Azria, Elie ^a,b,c   Pannier, Emmanuelle ^b,c   Firtion, Ghislaine ^b,c   Krivine, Anne ^a,b,c   Compagnucci, Alexandra ^b,c   Taulera, Olivier ^b,c   Finkielsztejn, Laurent ^b,c   Chhun, Stéphanie ^a,b,c   Pons, Gérard ^a,b,c   Launay, Odile ^a,b,c,d   Treluyer, Jean Marc ^a,b,c,d  

^a UNIVERSITÉ PARIS DESCARTES   (France)

^b ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^c Institut Cochin   (France)

^d EA   (France)

Author keywords

HIV; PK; Protease inhibitors

Indexed keywords

ABACAVIR; AMPRENAVIR PHOSPHATE; DIDANOSINE; EMTRICITABINE; LAMIVUDINE; LOPINAVIR; LOPINAVIR PLUS RITONAVIR; NEVIRAPINE; RITONAVIR; SAQUINAVIR; STAVUDINE; TENOFOVIR; ZIDOVUDINE;

ARTICLE; CD4 LYMPHOCYTE COUNT; CONTROLLED STUDY; DISTRIBUTION VOLUME; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE COMPARISON; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG EXPOSURE; DRUG MONITORING; FEMALE; GESTATIONAL AGE; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; POPULATION MODEL; POPULATION RESEARCH; PREGNANCY; VIRUS LOAD;

ANTI-HIV AGENTS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; FEMALE; HIV INFECTIONS; HUMANS; METABOLIC CLEARANCE RATE; MONTE CARLO METHOD; PLASMA; PREGNANCY; PYRIMIDINONES; TISSUE DISTRIBUTION;

EID: 65749092489     PISSN: 03057453     EISSN: 14602091     Source Type: Journal    
DOI: 10.1093/jac/dkp123     Document Type: Article

References (31)

1. Cvetkovic RS, Goa KL. Lopinavir/ritonavir: A review of its use in the management of HIV infection. Drugs 2003; 63: 769-802.
2. Crommentuyn KM, Kappelhoff BS, Mulder JW et al. Population pharmacokinetics of lopinavir in combination with ritonavir in HIV-1-infected patients. Br J Clin Pharmacol 2005; 60: 378-89.
3. DHHS Guidelines for the Use of Antiretroviral Drugs in Pregnant HIV-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. 2008. http://aidsinfo.nih.gov/contentfiles/ PerinatalGL.pdf?bcsi_scan_D99544420D78AF92=0&bcsi_scan_filename= PerinatalGL.pdf (23 January 2009, date last accessed).
4. Mock PA, Shaffer N, Bhadrakom C et al. Maternal viral load and timing of mother-to-child HIV transmission, Bangkok, Thailand. Bangkok Collaborative Perinatal HIV Transmission Study Group. AIDS 1999; 13: 407-14.
5. Mofenson LM. Mother-child HIV-1 transmission: Timing and determinants. Obstet Gynecol Clin North Am 1997; 24: 759-84.
6. Kappelhoff BS, Crommentuyn KM, de Maat MM et al. Practical guidelines to interpret plasma concentrations of antiretroviral drugs. Clin Pharmacokinet 2004; 43: 845-53.
7. Ananworanich J, Kosalaraksa P, Hill A et al. Pharmacokinetics and 24-week efficacy/safety of dual boosted saquinavir/lopinavir/ritonavir in nucleoside-pretreated children. Pediatr Infect Dis J 2005; 24: 874-9.
8. Hsu A, Isaacson J, Brun S et al. Pharmacokinetic-pharmacodynamic analysis of lopinavir-ritonavir in combination with efavirenz and two nucleoside reverse transcriptase inhibitors in extensively pretreated human immunodeficiency virus-infected patients. Antimicrob Agents Chemother 2003; 47: 350-9.
9. DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. 2008. http://aidsinfo.nih.gov/ contentfiles/AdultandAdolescentGL.pdf (23 January 2009, date last accessed).
10. Breilh D, Pellegrin I, Rouzes A et al. Virological, intracellular and plasma pharmacological parameters predicting response to lopinavir/ ritonavir (KALEPHAR study). AIDS 2004; 18: 1305-10.
11. Boffito M, Arnaudo I, Raiteri R et al. Clinical use of lopinavir/ ritonavir in a salvage therapy setting: Pharmacokinetics and pharmacodynamics. AIDS 2002; 16: 2081-3.
12. Tracy TS, Venkataramanan R, Glover DD et al. Temporal changes in drug metabolism (CYP1A2, CYP2D6 and CYP3A activity) during pregnancy. Am J Obstet Gynecol 2005; 192: 633-9.
13. Gingelmaier A, Kurowski M, Kastner R et al. Placental transfer and pharmacokinetics of lopinavir and other protease inhibitors in combination with nevirapine at delivery. AIDS 2006; 20: 1737-43.
14. Lyons F, Lechelt M, De Ruiter A. Steady-state lopinavir levels in third trimester of pregnancy. AIDS 2007; 21: 1053-4.
15. Manavi K, McDonald A, Al-Sharqui A. Plasma lopinavir trough levels in a group of pregnant women on lopinavir, ritonavir, zidovudine, and lamivudine. AIDS 2007; 21: 643-5.
16. Stek AM, Mirochnick M, Capparelli E et al. Reduced lopinavir exposure during pregnancy. AIDS 2006; 20: 1931-9.
17. Best BM, Hu S, Burchett SK et al. High-dose lopinavir and standard dose emtricitabine pharmacokinetics during pregnancy and postpartum. In: Abstracts of the Fifteenth Conference on Retroviruses and Opportunistic Infections, Boston, MA, USA, 2008. Abstract 629. Foundation for Retrovirology and Human Health, Alexandria, VA, USA.
18. Mirochnick M, Stek A, Capparelli E et al. Adequate lopinavir exposure achieved with a higher dose during the third trimester of pregnancy. In: Abstracts of the Thirteenth Conference on Retroviruses and Opportunistic Infections, Denver, CO, USA, 2006. Abstract 710. Foundation for Retrovirology and Human Health, Alexandria, VA, USA.
19. Beal SL, Sheiner LB. NONMEM User's Guide. San Francisco: NONMEM Project Group, University of California at San Francisco, 1991.
20. Dailly E, Reliquet V, Raffi F et al. A population approach to study the influence of nevirapine administration on lopinavir pharmacokinetics in HIV-1 infected patients. Eur J Clin Pharmacol 2005; 61: 153-6.
21. Gonzalez de Requena D, Gallego O, Valer L et al. Prediction of virological response to lopinavir/ritonavir using the genotypic inhibitory quotient. AIDS Res Hum Retroviruses 2004; 20: 275-8.
22. Hoefnagel JG, van der Lee MJ, Koopmans PP et al. The genotypic inhibitory quotient and the (cumulative) number of mutations predict the response to lopinavir therapy. AIDS 2006; 20: 1069-71.
23. Mirochnick M, Capparelli E. Pharmacokinetics of antiretrovirals in pregnant women. Clin Pharmacokinet 2004; 43: 1071-87.
24. Benet LZ, Hoener BA. Changes in plasma protein binding have little clinical relevance. Clin Pharmacol Ther 2002; 71: 115-21.
25. Hurst M, Faulds D. Lopinavir. Drugs 2000; 60: 1371-9; discussion 1380-1.
26. Klein CE, Chiu YL, Awni W et al. The tablet formulation of lopinavir/ritonavir provides similar bioavailability to the soft-gelatin capsule formulation with less pharmacokinetic variability and diminished food effect. J Acquir Immune Defic Syndr 2007; 44: 401-10.
27. Khuong-Josses MA, Azerad D, Boussairi A et al. Comparison of lopinavir level between the two formulations (soft-gel capsule and tablet) in HIV-infected pregnant women. HIV Clin Trials 2007; 8 254-5.
28. 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: 1173-80.
29. Yeni P. Prise en charge des personnes infectées par le VIH. Recommandations du groupe d'experts. Paris: Flammarion, 2008.
30. Fowler MG, Lampe MA, Jamieson DJ et al. Reducing the risk of mother-to-child human immunodeficiency virus transmission: Past successes, current progress and challenges, and future directions. Am J Obstet Gynecol 2007; 197: S3-9.
31. Dailly E, Allavena C, Raffi F et al. Pharmacokinetic evidence for the induction of lopinavir metabolism by efavirenz. Br J Clin Pharmacol 2005; 60: 32-4.