Lopinavir/ritonavir trough concentrations with the tablet formulation in HIV-1-infected women during the third trimester of pregnancy

Scandinavian Journal of Infectious Diseases

Volumn 44, Issue 5, 2012, Pages 381-387

  Calza, Leonardo ^a   Manfredi, Roberto ^a   Trapani, Filippo ^a   Salvadori, Caterina ^a   Colangeli, Vincenzo ^a   Borderi, Marco ^a   Grossi, Gabriele ^a   Motta, Roberto ^a   Viale, Pierluigi ^a  

^a UNIVERSITY OF BOLOGNA   (Italy)

Author keywords

HIV; Lopinavir; Pharmacokinetics; Pregnancy; Ritonavir; Tablets

Indexed keywords

ATAZANAVIR PLUS RITONAVIR; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; FOSAMPRENAVIR PLUS RITONAVIR; LAMIVUDINE PLUS ZIDOVUDINE; LOPINAVIR PLUS RITONAVIR;

ADULT; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; DIARRHEA; DRUG FORMULATION; DRUG SAFETY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FEMALE; GEOMETRY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HYPERCHOLESTEROLEMIA; HYPERLIPIDEMIA; HYPERTRIGLYCERIDEMIA; IMMUNOLOGY; OBSERVATIONAL STUDY; OPEN STUDY; PHARMACOLOGICAL PARAMETERS; STEADY STATE; TABLET; TANDEM MASS SPECTROMETRY; THIRD TRIMESTER PREGNANCY; TROUGH PLASMA CONCENTRATION; VALIDATION PROCESS;

ADULT; ANTI-HIV AGENTS; DRUG COMBINATIONS; DRUG THERAPY, COMBINATION; FEMALE; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; LAMIVUDINE; LOPINAVIR; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; PREGNANCY TRIMESTER, THIRD; REVERSE TRANSCRIPTASE INHIBITORS; RITONAVIR; TABLETS; TREATMENT OUTCOME; YOUNG ADULT; ZIDOVUDINE;

EID: 84859741971     PISSN: 00365548     EISSN: 16511980     Source Type: Journal    
DOI: 10.3109/00365548.2011.642306     Document Type: Article

References (22)

1. Garcia PM, Kalish LA, Pitt J, Minkoff H, Quinn TC, Burchett SK, et al. Maternal levels of plasma human immunodefi ciency virus type 1 RNA and the risk of perinatal transmission. Women and Infants Transmission Study Group. N Engl J Med 1999;341:394-402.
2. Cooper ER, Charurat M, Mofenson L, Hanson IC, Pitt J, Diaz C, et al. Combination antiretroviral strategies for the treatment of pregnant HIV-1-infected women and prevention of perinatal HIV-1 transmission. J Acquir Immune Defic Syndr 2002;29:484-94.
3. Panel on treatment of HIV-infected pregnant women and prevention of perinatal transmission. Recommendations for use of antiretroviral drugs in pregnant HIV-1-infected women for maternal health and interventions to reduce perinatal HIV transmission in the United States, September 14, 2011. National Institutes of Health, AIDSinfo; 2011. pp. 1 - 216. Available at: http://aidsinfo.nih.gov/ContentFiles/PerinatalGL. pdf (Accessed 28 December 2011).
4. De Ruiter A, Mercey D, Anderson J, Chakraborty R, Clayden P, Foster G, et al. British HIV Association and Children's HIV Association guidelines for the management of HIV infection in pregnant women 2008. HIV Med 2008;9:452-502.
5. Frederiksen MC. Physiologic changes in pregnancy and their effect on drug disposition. Semin Perinatol 2001;25:120-3.
6. Anderson GD. Pregnancy-induced changes in pharmacokinetics: A mechanistic-based approach. Clin Pharmacokinet 2005;44:989-1008.
7. Roustit M, Jlaiel M, Leclercq P, Stanke-Labesque F. Pharmacokinetics and therapeutic drug monitoring of antiretrovirals in pregnant women. Br J Clin Pharmacol 2008;66:179-95.
8. Stek AM, Mirochnick M, Capparelli E, Best BM, Hu C, Burchett SK, et al. Reduced lopinavir exposure during pregnancy. AIDS 2006;20:1931 - 9.
9. Aweeka FT, Stek A, Best BM, Hu C, Holland D, Hermes A, et al. Lopinavir protein binding in HIV-1-infected pregnant women. HIV Med 2010;11:232-8.
10. 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.
11. Dickinson L, Boffi to M, Back D, Else L, von Hentig N, Davies G, et al. Sequential population pharmacokinetic modeling of lopinavir and ritonavir in healthy volunteers and assessment of different dosing strategies. Antimicrob Agents Chemother 2011;55:2775-82.
12. Dickinson L, Robinson L, Tjia J, Khoo S, Back D. Simultaneous determination of HIV protease inhibitors amprenavir, atazanavir, indinavir, lopinavir, nelfi navir, ritonavir and saquinavir in human plasma by high-performance liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2005;829:82-90.
13. La Porte CJ, Back DJ, Blaschke T. Updated guideline to perform therapeutic drug monitoring for antiretroviral agents. Rev Antiviral Ther 2006;3:4-14.
14. Boffi to M, Else L, Back D, Taylor J, Khoo S, Sousa M, et al. Pharmacokinetics of atazanavir/ritonavir once daily and lopinavir/ritonavir twice and once daily over 72 h following drug cessation. Antivir Ther 2008;13:901-7.
15. Wolfe R, Carlin JB. Sample-size calculation for a logtransformed outcome measure. Control Clin Trials 1999;20:547-54.
16. Mirochnick M, Best BM, Stek AM, Capparelli E, Hu C, Burchett SK, et al. Lopinavir exposure with an increased dose during pregnancy. J Acquir Immune Defic Syndr 2008;49:485-91.
17. Khuong-Josses MA, Azerad D, Boussairi A, Ekoukou D. 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.
18. Klein CE, Chiu YL, Awni W, Zhu T, Heuser RS, Doan T, 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.
19. Lambert JS, Else LJ, Jackson V, Breiden J, Gibbons S, Dickinson L, et al. Therapeutic drug monitoring of lopinavir/ritonavir in pregnancy. HIV Med 2011;12:166-73.
20. Ramautarsing RA, Van Der Lugt J, Gorowara M, Kerr SJ, Burger D, Ruxrungtham K, et al. Thai HIV-1-infected women do not require a dose increase of lopinavir/ritonavir during the third trimester of pregnancy. AIDS 2011;25: 1299-303.
21. Cressey TR, Jourdain G, Rawangban B, Varadisai S, Kongpanichkul R, Sabsanong P, et al. Pharmacokinetics and virologic response of zidovudine/lopinavir/ritonavir initiated during the third trimester of pregnancy. AIDS 2010;24:2193-200.
22. Best BM, Stek AM, Mirochnick M, Hu C, Li H, Burchett SK, et al. Lopinavir tablet pharmacokinetics with an increased dose during pregnancy. J Acquir Immune Defic Syndr 2010;54:381-8.