Factors influencing lopinavir and atazanavir plasma concentration

Journal of Antimicrobial Chemotherapy

Volumn 65, Issue 1, 2009, Pages 129-137

  Stöhr, Wolfgang ^a   Back, David ^b   Dunn, David ^a   Sabin, Caroline ^c   Winston, Alan ^d   Gilson, Richard ^c   Pillay, Deenan ^e   Hill, Teresa ^c   Ainsworth, Jonathan ^f   Gazzard, Brian ^g   Leen, Clifford ^h   Bansi, Loveleen ^c   Fisher, Martin ⁱ   Orkin, Chloe ^j   Anderson, Jane ^k   Johnson, Margaret ^l   Easterbrook, Philippa ^m   Gibbons, Sara ^b   Khoo, Saye ^b  

^a MRC CLINICAL TRIALS UNIT   (United Kingdom)

^b UNIVERSITY OF LIVERPOOL   (United Kingdom)

^c ROYAL FREE AND UNIVERSITY COLLEGE MEDICAL SCHOOL   (United Kingdom)

^d IMPERIAL COLLEGE HEALTHCARE NHS TRUST   (United Kingdom)

^e UNIVERSITY COLLEGE LONDON   (United Kingdom)

^f NORTH MIDDLESEX UNIVERSITY HOSPITAL NHS TRUST   (United Kingdom)

^g CHELSEA AND WESTMINSTER HOSPITAL NHS FOUNDATION TRUST   (United Kingdom)

^h NHS LOTHIAN   (United Kingdom)

ⁱ UK   (United Kingdom)

^j BARTS HEALTH NHS TRUST   (United Kingdom)

^k HOMERTON UNIVERSITY HOSPITAL   (United Kingdom)

^l ROYAL FREE LONDON NHS FOUNDATION TRUST   (United Kingdom)

^m KING S COLLEGE HOSPITAL   (United Kingdom)

more..

Author keywords

Drug interactions; Pharmacokinetics; Rifabutin

Indexed keywords

ABACAVIR; ATAZANAVIR; ATAZANAVIR PLUS RITONAVIR; DIDANOSINE; EFAVIRENZ; EMTRICITABINE; FOSAMPRENAVIR; LAMIVUDINE; LOPINAVIR; LOPINAVIR PLUS RITONAVIR; NEVIRAPINE; RIFABUTIN; RIFAMPICIN; SAQUINAVIR; STAVUDINE; TENOFOVIR; ZIDOVUDINE;

ADULT; ARTICLE; BODY WEIGHT; CONTROLLED STUDY; DRUG ANTAGONISM; DRUG BLOOD LEVEL; DRUG MONITORING; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; PREDICTION; UNITED KINGDOM;

EID: 77950345853     PISSN: 03057453     EISSN: 14602091     Source Type: Journal    
DOI: 10.1093/jac/dkp408     Document Type: Article

References (41)

1. Gazzard BG. British HIV Association Guidelines for the treatment of HIV-1-infected adults with antiretroviral therapy 2008. HIV Med 2008; 9: 563-608.
2. Hammer SM, Eron JJ Jr, Reiss P et al. Antiretroviral treatment of adult HIV infection: 2008 recommendations of the International AIDS Society-USA panel. JAMA 2008; 300: 555-70.
3. Molina JM, Andrade-Villanueva J, Echevarria J et al. Once-daily atazanavir/ritonavir versus twice-daily lopinavir/ritonavir, each in combination with tenofovir and emtricitabine, for management of antiretroviral-naive HIV-1-infected patients: 48 week efficacy and safety results of the CASTLE study. Lancet 2008; 372: 646-55.
4. 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.
5. Colombo S, Buclin T, Cavassini M et al. Population pharmacokinetics of atazanavir in patients with human immunodeficiency virus infection. Antimicrob Agents Chemother 2006; 50: 3801-8.
6. van der Leur MR, Burger DM, la Porte CJ et al. A retrospective TDM database analysis of interpatient variability in the pharmacokinetics of lopinavir in HIV-infected adults. Ther Drug Monit 2006; 28: 650-3.
7. Solas C, Poizot-Martin I, Drogoul MP et al. Therapeutic drug monitoring of lopinavir/ritonavir given alone or with a non-nucleoside reverse transcriptase inhibitor. Br J Clin Pharmacol 2004; 57: 436-40.
8. Winston A, Bloch M, Carr A et al. Atazanavir trough plasma concentration monitoring in a cohort of HIV-1-positive individuals receiving highly active antiretroviral therapy. J Antimicrob Chemother 2005; 56: 380-7.
9. Kaul S, Bassi K, Damle B et al. Pharmacokinetic evaluation of the combination of atazanavir (ATV), enteric coated didanosine (ddI-EC), and tenofovir disoproxil fumarate (TDF) for a once-daily antiretroviral regimen. In: Abstracts of the Forty-third Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, USA, 2003. Abstract A-1616. American Society for Microbiology, Washington, DC, USA.
10. Taburet AM, Piketty C, Chazallon C et al. Interactions between atazanavir-ritonavir and tenofovir in heavily pretreated human immunodeficiency virus-infected patients. Antimicrob Agents Chemother 2004; 48:2091-6.
11. von Hentig N, Dauer B, Haberl A et al. Tenofovir comedication does not impair the steady-state pharmacokinetics of ritonavir-boosted atazanavir in HIV-1-infected adults. Eur J Clin Pharmacol 2007; 63: 935-40.
12. Pellegrin I, Breilh D, Ragnaud JM et al. Virological responses to atazanavir-ritonavir-based regimens: resistance-substitutions score and pharmacokinetic parameters (Reyaphar study). Antivir Ther 2006; 11: 421-9.
13. Reyataz. Prescribing Information. Princeton, NJ, USA: Bristol-Myers Squibb Company, 2008.
14. Kaletra. Prescribing Information. North Chicago, IL, USA: Abbott Laboratories, 2008.
15. The UK Collaborative HIV Cohort Steering Committee CHIC. The creation of a large UK-based multicentre cohort of HIV-infected individuals: the UK Collaborative HIV Cohort (UK CHIC) Study. HIV Med 2004; 5: 115-24.
16. Dickinson L, Robinson L, Tjia J et al. Simultaneous determination of HIV protease inhibitors amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, 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.
17. Carlin JB, Li N, Greenwood P et al. Tools for analyzing multiple imputed datasets. The Stata Journal 2003; 3: 226-44.
18. Royston P, Ambler G, Sauerbrei W. The use of fractional polynomials to model continuous risk variables in epidemiology. Int J Epidemiol 1999; 28: 964-74.
19. la Porte CJL, Back DJ, Blaschke T et al. Updated guideline to perform therapeutic drug monitoring for antiretroviral agents. Rev Antivir Ther 2006; 3: 4-14.
20. Ray JE, Marriott D, Bloch MT et al. Therapeutic drug monitoring of atazanavir: surveillance of pharmacotherapy in the clinic. Br J Clin Pharmacol 2005; 60: 291-9.
21. Cleijsen RM, van de Ende ME, Kroon FP et al. Therapeutic drug monitoring of the HIV protease inhibitor atazanavir in clinical practice. J Antimicrob Chemother 2007; 60: 897-900.
22. Rodriguez-Novoa S, Martin-Carbonero L, Barreiro P et al. Genetic factors influencing atazanavir plasma concentrations and the risk of severe hyperbilirubinemia. AIDS 2007; 21:41-6.
23. Gonzalez de Requena D, Bonora S, Canta F et al. Atazanavir Ctrough is associated with efficacy and safety: definition of therapeutic range. In: Abstracts of the Twelfth Conference on Retroviruses and Opportunistic Infections, Boston, USA, 2005. Abstract 645. Foundation for Retrovirology and Human Health, Alexandria, VA, USA.
24. 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.
25. Pozniak AL, Miller RF, Lipman MC et al. BHIVA treatment guidelines for tuberculosis (TB)/HIV infection 2005. HIV Med 2005; 6 Suppl 2: 62-83.
26. US Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL.pdf (10 July 2009, date last accessed).
27. Baciewicz AM, Chrisman CR, Finch CK et al. Update on rifampin and rifabutin drug interactions. Am J Med Sci 2008; 335: 126-36.
28. Bonora S, Boffito M, D'Avolio A et al. Pharmacokinetics (PKS) of rifabutin (RIF) coadministered with lopinavir/ritonavir (LPV/r) in HIV patients affected by tuberculosis (TB). In: Abstracts of the Second IAS Conference on HIV Pathogenesis and Treatment, Paris, France, 2003. Abstract 863. Antivir Ther 2003; 8 Suppl 1: S427-8.
29. Khachi H, O'Connell R, Ladenheim D et al. Pharmacokinetic interactions between rifabutin and lopinavir/ritonavir in HIV-infected patients with mycobacterial co-infection. J Antimicrob Chemother 2009; 64: 871-3.
30. Shallcross VL, Kwan WS, Hartkoorn R et al. Lopinavir is a substrate for SLCO1A2 but 516A>C and 38T>C polymorphisms do not influence lopinavir plasma concentrations. In: Abstracts of the Ninth International Congress on Drug Therapy in HIV Infection, Glasgow, UK, 2008. Abstract P238. J Int AIDS Soc 2008; 11 Suppl 1: P238.
31. Niemi M. Role of OATP transporters in the disposition of drugs. Pharmacogenomics 2007; 8: 787-802.
32. 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.
33. 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.
34. Solas C, Gagnieu MC, Ravaux I et al. Population pharmacokinetics of atazanavir in human immunodeficiency virus-infected patients. Ther Drug Monit 2008; 30: 670-3.
35. Poirier JM, Guiard-Schmid JB, Meynard JL et al. Critical drug interaction between ritonavir-boosted atazanavir regimen and non-nucleoside reverse transcriptase inhibitors. AIDS 2006; 20: 1087-9.
36. Bristol-Myers Squibb Pharmaceuticals Ltd. Reyataz - Summary of Product Characteristics. http://emc.medicines.org.uk/medicine/14145/SPC/Reyataz+150+mg%2c+200+mg+and+300mg+Hard+Capsules/ (10 July 2009, date last accessed).
37. Di Giambenedetto S, De Luca A, Villani P et al. Atazanavir and lopinavir with ritonavir alone or in combination: analysis of pharmacokinetic interaction and predictors of drug exposure. HIV Med 2008; 9: 239-45.
38. 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.
39. Ng J, Klein C, Xiong J et al. Lopinavir/ritonavir 500/125 mg twice-daily+efavirenz approximate the pharmacokinetic exposure of LPV/r 400/100 mg twice-daily administered alone in healthy adult subjects. In: Abstracts of the Fifteenth Conference on Retroviruses and Opportunistic Infections, Boston, USA, 2008. Abstract 765. Foundation for Retrovirology and Human Health, Alexandria, VA, USA.
40. Stohr W, Back D, Dunn D et al. Factors influencing efavirenz and nevirapine plasma concentration: effect of ethnicity, weight and co-medication. Antivir Ther 2008; 13: 675-85.
41. FDA. In Vivo Drug Metabolism/Drug Interaction Studies-Study Design, Data Analysis, and Recommendations for Dosing and Labeling. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072119.pdf (10 July 2009, date last accessed).