Common clinical conditions-age, low BMI, ritonavir use, mild renal impairment-affect tenofovir pharmacokinetics in a large cohort of HIV-infected women

AIDS

Volumn 28, Issue 1, 2014, Pages 59-66

  Baxi, Sanjiv M ^a   Greenblatt, Ruth M ^a,b,c   Bacchetti, Peter ^c   Scherzer, Rebecca ^a   Minkoff, Howard ^d   Huang, Yong ^a   Anastos, Kathryn ^e   Cohen, Mardge ^f   Gange, Stephen J ^g   Young, Mary ^h   Shlipak, Michael G ^a,i   Gandhi, Monica ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b Department of Clinical Pharmacy ^*  (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d STATE UNIVERSITY OF NEW YORK   (United States)

^e ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^f RUSH MEDICAL COLLEGE   (United States)

^g JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h GEORGETOWN UNIVERSITY MEDICAL CENTER   (United States)

ⁱ SAN FRANCISCO VETERANS AFFAIRS MEDICAL CENTER   (United States)

Author keywords

Areas under the concentration time curve; Cystatin C; Diverse populations; Exposure; Glomerular filtration rate; HIV infected women; Pharmacokinetics; Tenofovir

Indexed keywords

CREATININE; CYSTATIN C; RECREATIONAL DRUG; RITONAVIR; STEROID; TENOFOVIR DISOPROXIL; ADENINE; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; PHOSPHONIC ACID DERIVATIVE; TENOFOVIR;

ADULT; AGE; ANTIVIRAL THERAPY; AREA UNDER THE CURVE; ARTICLE; BODY MASS; BODY WEIGHT; CHRONIC KIDNEY DISEASE EPIDEMIOLOGY COLLABORATION; COHORT ANALYSIS; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EXPOSURE; DRUG USE; FEMALE; GLOMERULUS FILTRATION RATE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFECTION PREVENTION; LIVER FUNCTION; MAJOR CLINICAL STUDY; MATHEMATICAL PARAMETERS; MAXIMUM PLASMA CONCENTRATION; MENSTRUAL CYCLE; MIDDLE AGED; MILD RENAL IMPAIRMENT; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; STEADY STATE; STEROID THERAPY; TIME TO MAXIMUM PLASMA CONCENTRATION; TOBACCO; YOUNG ADULT; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; HIV INFECTIONS; KIDNEY FAILURE; MULTICENTER STUDY; PROSPECTIVE STUDY;

ADENINE; ADULT; AGE FACTORS; ANTI-HIV AGENTS; BODY MASS INDEX; COHORT STUDIES; FEMALE; GLOMERULAR FILTRATION RATE; HIV INFECTIONS; HUMANS; MIDDLE AGED; ORGANOPHOSPHONATES; PROSPECTIVE STUDIES; RENAL INSUFFICIENCY; RITONAVIR; YOUNG ADULT;

EID: 84892371096     PISSN: 02699370     EISSN: 14735571     Source Type: Journal    
DOI: 10.1097/QAD.0000000000000033     Document Type: Article

References (50)

1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services (updated 2/2/13). http://aidsinfo.nih. gov/contentfiles/lvguidelines/adultandadolescentgl.pdf [Accessed 17 September 2013].
2. Bangsberg DR, Ragland K, Monk A, Deeks SG. A single tablet regimen is associated with higher adherence and viral suppression than multiple tablet regimens in HIVR homeless and marginally housed people. AIDS 2010; 24:2835-2840.
3. Smith DK, Grant RM, Weidle PJ, Lansky A, Mermin J, Fenton KA, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC. Interim guidance: preexposure prophylaxis for the prevention of HIV infection in men who have sex with men. MMWR Morb Mortal Wkly Rep 2011; 60:65-68.
4. Smith DK, Thigpen MC, Nesheim SR, Lampe MA, Paxton LA, Samandari T, et al., National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC. Interim guidance for clinicians considering the use of preexposure prophylaxis for the prevention of HIV infection in heterosexually active adults. MMWR Morb Mortal Wkly Rep 2012; 61:586-589.
5. Scherzer R, Estrella M, Li Y, Choi AI, Deeks SG, Grunfeld C, et al. Association of tenofovir exposure with kidney disease risk in HIV infection. AIDS 2012; 26:867-875.
6. McComsey GA, Tebas P, Shane E, Yin MT, Overton ET, Huang JS, et al. Bone disease in HIV infection: a practical review and recommendations for HIV care providers. Clin Infect Dis 2010; 51:937-946.
7. McComsey GA, Kitch D, Daar ES, Tierney C, Jahed NC, Tebas P, et al. Bone mineral density and fractures in antiretroviralnaive persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a substudy of ACTG A5202. J Infect Dis 2011; 203:1791-1801.
8. Gagnieu MC, Barkil ME, Livrozet JM, Cotte L, Miailhes P, Boibieux A, et al. Population pharmacokinetics of tenofovir in AIDS patients. J Clin Pharmacol 2008; 48:1282-1288.
9. Baheti G, Kiser JJ, Havens PL, Fletcher CV. Plasma and intracellular population pharmacokinetic analysis of tenofovir in HIV-1-infected patients. Antimicrob Agents Chemother 2011; 55:5294-5299.
10. Barditch-Crovo P, Deeks SG, Collier A, Safrin S, Coakley DF, Miller M, et al. Phase i/ii trial of the pharmacokinetics, safety, and antiretroviral activity of tenofovir disoproxil fumarate in human immunodeficiency virus-infected adults. Antimicrob Agents Chemother 2001; 45:2733-2739.
11. Williams JA, Johnson K, Paulauskis J, Cook J. So many studies, too few subjects: establishing functional relevance of genetic polymorphisms on pharmacokinetics. J Clin Pharmacol 2006; 46:258-264.
12. Huang SM, Lesko LJ, Williams RL. Assessment of the quality and quantity of drug-drug interaction studies in recent NDA submissions: study design and data analysis issues. J Clin Pharmacol 1999; 39:1006-1014.
13. Gandhi M, Ameli N, Bacchetti P, Sharp GB, French AL, Young M, et al. Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols. AIDS 2005; 19:1885-1896.
14. Rising KBP, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med 2008; 5:e217.
15. Barkan SE, Melnick SL, Preston-Martin S, Weber K, Kalish LA, Miotti P, et al. The Women's Interagency HIV Study. WIHS Collaborative Study Group. Epidemiology 1998; 9:117-125.
16. Gandhi M, Benet LZ, Bacchetti P, Kalinowski A, Anastos K, Wolfe AR, et al. Nonnucleoside reverse transcriptase inhibitor pharmacokinetics in a large unselected cohort of HIV-infected women. J Acquir Immune Defic Syndr 2009; 50:482-491.
17. Gandhi M, Greenblatt RM, Bacchetti P, Jin C, Huang Y, Anastos K, et al. A single-nucleotide polymorphism in CYP2B6 leads to 3-fold increases in efavirenz concentrations in plasma and hair among HIV-infected women. J Infect Dis 2012; 206:1453-1461.
18. Delahunty T, Bushman L, Robbins B, Fletcher CV. The simultaneous assay of tenofovir and emtricitabine in plasma using LC/MS/MS and isotopically labeled internal standards. J Chromatogr B Analyt Technol Biomed Life Sci 2009; 877:1907-1914.
19. Shlipak MG, Scherzer R, Abraham A, Tien PC, Grunfeld C, Peralta CA, et al. Urinary markers of kidney injury and kidney function decline in HIV-infected women. J Acquir Immune Defic Syndr 2012; 61:565-573.
20. Inker LA, Eckfeldt J, Levey AS, Leiendecker-Foster C, Rynders G, Manzi J, et al. Expressing the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) cystatin C equations for estimating GFR with standardized serum cystatin C values. Am J Kidney Dis 2011; 58:682-684.
21. Inker LA, Schmid CH, Tighiouart H, Eckfeldt JH, Feldman HI, Greene T, et al. Estimating glomerular filtration rate from serumcreatinine and cystatin C. N Engl J Med 2012; 367: 20-29.
22. Stevens LA, Coresh J, Schmid CH, Feldman HI, Froissart M, Kusek J, et al. Estimating GFR using serum cystatin C alone and in combination with serumcreatinine: a pooled analysis of 3418 individuals with CKD. Am J Kidney Dis 2008; 51:395-406.
23. Yeh KC, Kwan KC. A comparison of numerical integrating algorithms by trapezoidal, Lagrange, and spline approximation. J Pharmacokinet Biopharm 1978; 6:79-98.
24. Schafer JL. Multiple imputation: a primer. Stat Methods Med Res 1999; 8:3-15.
25. Gilks WR RS, Spiegehalter DJ. Markov chain Monte Carlo in practice. London: Chapman & Hall; 1996.
26. Pruvost A, Negredo E, Theodoro F, Puig J, Levi M, Ayen R, et al. Pilot pharmacokinetic study of human immunodeficiency virus-infected patients receiving tenofovir disoproxil fumarate (TDF): investigation of systemic and intracellular interactions between TDF and abacavir, lamivudine, or lopinavir-ritonavir. Antimicrob Agents Chemother 2009; 53:1937-1943.
27. Kearney BP, Mathias A, Mittan A, Sayre J, Ebrahimi R, Cheng AK. Pharmacokinetics and safety of tenofovir disoproxil fumarate on coadministration with lopinavir/ritonavir. J Acquir Immune Defic Syndr 2006; 43:278-283.
28. Jimenez-Nacher I, Garcia B, Barreiro P, Rodriguez-Novoa S, Morello J, Gonzalez-Lahoz J, et al. Trends in the prescription of antiretroviral drugs and impact on plasma HIV-RNA measurements. J Antimicrob Chemother 2008; 62:816-822.
29. Mwafongo A, Nkanaunena K, Hosseinipour M, Lockman S, Hughes M, Currier J, and ACTG 5208. Renal insufficiency among women treated with tenofovir/emtricitabine/lopinavir/ritonavir or tenofovir/emtricitabine/ nevirapine. In: 20th Conference on Retroviruses and Opportunistic Infections. Atlanta, GA; 2013.
30. Huang F, Scholl P, Huang DB, MacGregor TR, Taub ME, Vinisko R, et al. Concomitant administration of BILR 355/r with emtricitabine/tenofovir disoproxil fumarate increases exposure to emtricitabine and tenofovir: a randomized, open-label, prospective study. Basic Clin Pharmacol Toxicol 2011; 108:163-170.
31. Tong L, Phan TK, Robinson KL, Babusis D, Strab R, Bhoopathy S, et al. Effects of human immunodeficiency virus protease inhibitors on the intestinal absorption of tenofovir disoproxil fumarate in vitro. Antimicrob Agents Chemother 2007; 51:3498-3504.
32. Kearney BP, Mathias A, Mittan A, Sayre J, Ebrahimi R, Cheng AK. Pharmacokinetics and safety of tenofovir disoproxil fumarate on coadministration with lopinavir/ritonavir. J Acquir Immune Defic Syndr 2006; 43:278-283.
33. Nishijima T, Komatsu H, Gatanaga H, Aoki T, Watanabe K, Kinai E, et al. Impact of small body weight on tenofovirassociated renal dysfunction in HIV-infected patients: a retrospective cohort study of Japanese patients. PloS One 2011; 6:e22661.
34. Kiser JJ, Fletcher CV, Flynn PM, Cunningham CK, Wilson CM, Kapogiannis BG, et al. Pharmacokinetics of antiretroviral regimens containing tenofovir disoproxil fumarate and atazanavir-ritonavir in adolescents and young adults with human immunodeficiency virus infection. Antimicrob Agents Chemother 2008; 52:631-637.
35. Jotwani V, Li Y, Grunfeld C, Choi AI, Shlipak MG. Risk factors for ESRD in HIV-infected individuals: traditional and HIV-related factors. Am J Kid Dis 2012; 59:628-635.
36. Odden MC, Scherzer R, Bacchetti P, Szczech LA, Sidney S, Grunfeld C, et al. Cystatin C level as a marker of kidney function in human immunodeficiency virus infection: the FRAM study. Arch Int Med 2007; 167:2213-2219.
37. Winston A, Jose S, Gibbons S, Back D, Stohr W, Post F, et al. Effects of age on antiretroviral plasma drug concentration in HIV-infected subjects undergoing routine therapeutic drug monitoring. J Antimicrob Chemother 2013; 68:1354-1359.
38. Mangoni AA. Predicting and detecting adverse drug reactions in old age: challenges and opportunities. Expert Opin Drug Metab Toxicol 2012; 8:527-530.
39. Grandison MK, Boudinot FD. Age-related changes in protein binding of drugs: implications for therapy. Clin Pharmacokinet 2000; 38:271-290.
40. Szczech LA. Renal dysfunction and tenofovir toxicity in HIV-infected patients. Top HIV Med 2008; 16:122-126.
41. Rodriguez-Novoa S, Alvarez E, Labarga P, Soriano V. Renal toxicity associated with tenofovir use. Exp Opin Drug Safety 2010; 9:545-559.
42. Hall AM, Hendry BM, Nitsch D, Connolly JO. Tenofovirassociated kidney toxicity in HIV-infected patients: a review of the evidence. Am J Kidney Dis 2011; 57:773-780.
43. Kearney BP, Yale K, Shah J, Zhong L, Flaherty JF. Pharmacokinetics and dosing recommendations of tenofovir disoproxil fumarate in hepatic or renal impairment. Clin Pharmacokinet 2006; 45:1115-1124.
44. Poizot-Martin I, Solas C, Allemand J, Obry-Roguet V, Pradel V, Bregigeon S, et al. Renal impairment in patients receiving a tenofovir-cART regimen: impact of tenofovir trough concentration. J Acquir Immune Defic Syndr 2013; 62:375-380.
45. DeJesus E, Rockstroh JK, Henry K, Molina JM, Gathe J, Ramanathan S, et al. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, noninferiority trial. Lancet 2012; 379:2429-2438.
46. Sax PE, DeJesus E, Mills A, Zolopa A, Cohen C, Wohl D, et al. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3 trial, analysis of results after 48 weeks. Lancet 2012; 379:2439-2448.
47. Kalayjian RC, Lau B, Mechekano RN, Crane HM, Rodriguez B, Salata RA, et al. Risk factors for chronic kidney disease in a large cohort of HIV-1 infected individuals initiating antiretroviral therapy in routine care. AIDS 2012; 26:1907-1915.
48. Miro JM, Cofan F, Trullas JC, Manzardo C, Cervera C, Tuset M, et al. Renal dysfunction in the setting of HIV/AIDS. Curr HIV/AIDS Rep 2012; 9:187-199.
49. Ibrahim F, Hamzah L, Jones R, Nitsch D, Sabin C, Post FA. Baseline kidney function as predictor of mortality and kidney disease progression in HIV-positive patients. Am J Kidney Dis 2012; 60:539-547.
50. Deti EK, Thiebaut R, Bonnet F, Lawson-Ayayi S, Dupon M, Neau D, et al. Prevalence and factors associated with renal impairment in HIV-infected patients, ANRS C03 Aquitaine Cohort, France. HIV Med 2010; 11:308-317.