Pharmacokinetics, safety, and tolerability of maraviroc in HIV-negative subjects with impaired renal function

HIV Clinical Trials

Volumn 14, Issue 3, 2013, Pages 99-109

  Vourvahis, Manoli ^a   Fang, Juanzhi ^b,d   Checchio, Tina ^b   Milton, Ashley ^b,e   Weatherley, Barry ^c   McFadyen, Lynn ^c   Heera, Jayvant ^b  

^a PFIZER INC   (United States)

^b PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United States)

^c PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^d Shire Pharmaceuticals   (United States)

^e MILLENNIUM PHARMACEUTICALS INC   (United States)

Author keywords

CCR5 antagonist; HIV; Maraviroc; Pharmacokinetics; Renal impairment

Indexed keywords

MARAVIROC; RITONAVIR PLUS SAQUINAVIR;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; DIALYSATE LEVEL; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG EXPOSURE; DRUG SAFETY; DRUG TOLERABILITY; DRUG URINE LEVEL; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; KIDNEY DYSFUNCTION; KIDNEY FAILURE; KIDNEY FUNCTION; MALE; MASS SPECTROMETRY; MAXIMUM PLASMA CONCENTRATION; OPEN STUDY; PARALLEL DESIGN; PRIORITY JOURNAL; STEADY STATE;

ADULT; AGED; ANTI-HIV AGENTS; AREA UNDER CURVE; CASE-CONTROL STUDIES; CYCLOHEXANES; CYTOCHROME P-450 CYP3A; FEMALE; GENE EXPRESSION REGULATION; HALF-LIFE; HUMANS; KIDNEY FAILURE, CHRONIC; MALE; MIDDLE AGED; P-GLYCOPROTEIN; RENAL DIALYSIS; RENAL INSUFFICIENCY; SEVERITY OF ILLNESS INDEX; TRIAZOLES;

EID: 84880219118     PISSN: 15284336     EISSN: 19455771     Source Type: Journal    
DOI: 10.1310/hct1403-99     Document Type: Article

References (23)

1. Dorr P, Westby M, Dobbs S, et al. Maraviroc (UK-427,857), a potent, orally bioavailable, and selective small- molecule inhibitor of chemokine receptor CCR5 with broadspectrum anti-human immunodefi ciency virus type 1 activity. Antimicrob Agents Chemother. 2005;49:4721-4732 (Pubitemid 41552605)
2. Gulick RM, Lalezari J, Goodrich J, et al. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med. 2008;359:1429-1441
3. Cooper DA, Heera J, Goodrich J, et al. Maraviroc versus efavirenz, both in combination with zidovudinelamivudine, for the treatment of antiretroviral-naive subjects with CCR5-tropic HIV-1 infection. J Infect Dis. 2010;201:803-813
4. ViiV Healthcare. Celsentri (maraviroc) summary of product characteristics. December 15, 2011. http://www. viivhealthcare.com/products/ selzentry-celsentri.aspx#. Accessed 2012
5. European Medicines Agency. Celsentri: Summary of product characteristics. December 7, 2011. http://www. ema.europa.eu/docs/en-GB/document-library/EPAR- Product-Information/human/000811/WC500022190.pdf. Accessed April 19, 2011
6. Abel S, Russell D, Whitlock LA, et al. Assessment of the absorption, metabolism and absolute bioavailability of maraviroc in healthy male subjects. Br J Clin Pharmacol. 2008;65(suppl 1):60-67 (Pubitemid 351366540)
7. Walker DK, Abel S, Comby P, et al. Species differences in the disposition of the CCR5 antagonist, UK-427,857, a new potential treatment for HIV. Drug Metab Dispos. 2005;33:587-595 (Pubitemid 40393203)
8. Hyland R, Dickins M, Collins C, et al. Maraviroc: in vitro assessment of drug-drug interaction potential. Br J Clin Pharmacol. 2008;66:498-507
9. Weatherley B, McFadyen L. Maraviroc modelling strategy: Use of early phase 1 data to support a semi-mechanistic population pharmacokinetic model. Br J Clin Pharmacol. 2009;68:355-369
10. Huang SM, Temple R, Xiao S, et al. When to conduct a renal impairment study during drug development: US Food and Drug Administration perspective. Clin Pharmacol Ther. 2009;86:475-479
11. Abel S, Russell D, Taylor-Worth RJ, et al. Effects of CYP3A4 inhibitors on the pharmacokinetics of maraviroc in healthy volunteers. Br J Clin Pharmacol. 2008;65 (suppl 1):27-37 (Pubitemid 351366536)
12. de Silva TI, Post FA, Griffi n MD, et al. HIV-1 infection and the kidney: An evolving challenge in HIV medicine. Mayo Clin Proc. 2007;82:1103-1116 (Pubitemid 47357143)
13. Post FA, Holt SG. Recent developments in HIV and the kidney. Curr Opin Infect Dis. 2009;22:43-48
14. Abel S, Davis JD, Ridgway CE, et al. Pharmacokinetics, safety and tolerability of a single oral dose of maraviroc in HIV-negative subjects with mild and moderate hepatic impairment. Antivir Ther. 2009;14:831-837
15. Abel S, Jenkins TM, Whitlock LA, et al. Effects of CYP3A4 inducers with and without CYP3A4 inhibitors on the pharmacokinetics of maraviroc in healthy volunteers. Br J Clin Pharmacol. 2008;65(suppl 1):38-46 (Pubitemid 351366537)
16. US Food and Drug Administration. Selzentry: Prescribing information. 2011. http://media.pfi zer.com/fi les/products/ uspi-maraviroc.pdf. Accessed April 19, 2011
17. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31-41
18. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research et al. Guidance for industry: Pharmacokinetics in patients with impaired renal function - study design, data analysis and impact on dosing and labelling. 2011. http://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM072127.pdf. Accessed April 19, 2011
19. Brewer E, Felix T, Clarke P, et al. An LC-MS-MS method for quantitative determination of maraviroc (UK-427,857) in human plasma, urine and cerebrospinal fl uid. Biomed Chromatogr. 2010;24:1316-1323
20. Dreisbach AW. The infl uence of chronic renal failure on drug metabolism and transport. Clin Pharmacol Ther. 2009;86:553-556
21. US Food and Drug Administration. Crestor: Prescribing information. November 1, 2010. http://www.crestor.com/c/ home.aspx. Accessed April 19, 2011
22. Lalonde RL, Wagner JA. Drug development perspective on pharmacokinetic studies of new drugs in patients with renal impairment. Clin Pharmacol Ther. 2009;86:557-561
23. McFadyen L, Weatherley B, Vourvahis M. Population modelling of maraviroc pharmacokinetic data when administered with and without saquinavir/ritonavir in subjects with renal dysfunction. Poster presented at: 11th International Workshop on the Clinical Pharmacology of HIV Therapy; April 7-9, 2010; Sorrento, Italy