Changes in renal function associated with oral emtricitabine/tenofovir disoproxil fumarate use for HIV pre-exposure prophylaxis

AIDS

Volumn 28, Issue 6, 2014, Pages 851-859

  Solomon, Marc M ^a,b   Lama, Javier R ^d   Glidden, David V ^b   Mulligan, Kathleen ^b   McMahan, Vanessa ^a   Liu, Albert Y ^a,b   Vicente Guanira, Juan ^c   Veloso, Valdilea G ^e   Mayer, Kenneth H ^f   Chariyalertsak, Suwat ^g   Schechter, Mauro ^h   Bekker, Linda Gail ⁱ   Georges Kallás, Esper ^j,k   Burns, David N ^l   Grant, Robert M ^a,b  

^a SAN FRANCISCO DEPARTMENT OF PUBLIC HEALTH   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c Investigaciones Medicas en Salud   (Peru)

^d ASOCIACIÓN CIVIL IMPACTA SALUD Y EDUCACIÓN   (Peru)

^e Funda??o Oswaldo Cruz   (Brazil)

^f FENWAY INSTITUTE   (United States)

^g Faculty of Medicine Chiang Mai University   (Thailand)

^h FEDERAL UNIVERSITY OF RIO DE JANEIRO   (Brazil)

ⁱ UNIVERSITY OF CAPE TOWN   (South Africa)

^j UNIVERSITY OF SÃO PAULO   (Brazil)

^k Instituto de Investigação em Imunologia   (Brazil)

^l NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

more..

Author keywords

Chemoprophylaxis; HIV prevention; MSM; Pre exposure prophylaxis; Renal; Side effects; Tenofovir

Indexed keywords

BICARBONATE; CREATININE; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; NONSTEROID ANTIINFLAMMATORY AGENT; PHOSPHATE; PHOSPHORUS; PLACEBO; URIC ACID;

ADULT; ANTIVIRAL THERAPY; ARTICLE; BICARBONATE BLOOD LEVEL; CHEMOPROPHYLAXIS; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; DRUG SAFETY; FEMALE; GLUCOSURIA; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPOPHOSPHATEMIA; INFECTION PREVENTION; KIDNEY DYSFUNCTION; KIDNEY FUNCTION; KIDNEY PROXIMAL TUBULE; KIDNEY TUBULE DISORDER; MAJOR CLINICAL STUDY; MALE; MEN WHO HAVE SEX WITH MEN; PHOSPHATE BLOOD LEVEL; PREEXPOSURE PROPHYLAXIS; PRIORITY JOURNAL; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; TRANSGENDERISM; UREA NITROGEN BLOOD LEVEL;

ADENINE; ADOLESCENT; ADULT; ANTI-HIV AGENTS; CHEMOPREVENTION; CREATININE; DEOXYCYTIDINE; FEMALE; HIV INFECTIONS; HUMANS; KIDNEY; KIDNEY FUNCTION TESTS; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; ORGANOPHOSPHONATES; PHOSPHORUS; PLACEBOS; YOUNG ADULT;

EID: 84898016347     PISSN: 02699370     EISSN: 14735571     Source Type: Journal    
DOI: 10.1097/QAD.0000000000000156     Document Type: Article

References (38)

1. Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 2010; 363:2587-2599.
2. Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science 2010; 329:1168-1174.
3. Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med 2012; 367:399-410.
4. Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med 2012; 367:423-434.
5. Gallant JE, Staszewski S, Pozniak AL, DeJesus E, Suleiman JM, Miller MD, et al. Efficacy and safety of tenofovir DF vs. stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial. JAMA 2004; 292:191-201.
6. Gallant JE, DeJesus E, Arribas JR, Pozniak AL, Gazzard B, Campo RE, et al. Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV.NEngl J Med 2006; 354:251-260.
7. Izzedine H, Isnard-Bagnis C, Hulot JS, Vittecoq D, Cheng A, Jais CK, et al. Renal safety of tenofovir in HIV treatment-experienced patients. AIDS 2004; 18:1074-1076.
8. Mauss S, Berger F, Schmutz G. Antiretroviral therapy with tenofovir is associated with mild renal dysfunction. AIDS 2005; 19:93-95.
9. Fux CA, Christen A, Zgraggen S, Mohaupt MG, Furrer H. Effect of tenofovir on renal glomerular and tubular function. AIDS 2007; 21:1483-1485.
10. Fux CA, Simcock M, Wolbers M, Bucher HC, Hirschel B, Opravil M, et al. Tenofovir use is associated with a reduction in calculated glomerular filtration rates in the Swiss HIV Cohort Study. Antivir Ther 2007; 12:1165-1173.
11. Horberg M, Tang B, Towner W, Silverberg M, Bersoff-Matcha S, Hurley L, et al. Impact of tenofovir on renal function in HIV-infected, antiretroviral-naive patients. J Acquir Immune Defic Syndr 2010; 53:62-69.
12. Post FA, Moyle GJ, Stellbrink HJ, Domingo P, Podzamczer D, Fisher M, et al. Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study. J Acquir Immune Defic Syndr 2010; 55:49-57.
13. Vrouenraets SM, Fux CA, Wit FW, Garcia EF, Furrer H, Brinkman K, et al. Persistent decline in estimated but not measured glomerular filtration rate on tenofovir may reflect tubular rather than glomerular toxicity. AIDS 2011; 25:2149-2155.
14. Cooper RD, Wiebe N, Smith N, Keiser P, Naicker S, Tonelli M. Systematic review and meta-analysis: renal safety of tenofovir disoproxil fumarate in HIV-infected patients. Clin Infect Dis 2010; 51:496-505.
15. 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.
16. Rodriguez-Novoa S, Labarga P, D'Avolio A, Barreiro P, Albalate M, Vispo E, et al. Impairment in kidney tubular function in patients receiving tenofovir is associated with higher tenofovir plasma concentrations. AIDS 2010; 24:1064-1066.
17. Rodriguez-Novoa S, Labarga P, Soriano V, Egan D, Albalater M, Morello J, et al. Predictors of kidney tubular dysfunction in HIV-infected patients treated with tenofovir: a pharmacogenetic study. Clin Infect Dis 2009; 48:e108-e116.
18. Tordato F, Cozzi Lepri A, Cicconi P, De Luca A, Antinori A, Colangeli V, et al. Evaluation of glomerular filtration rate in HIV-1-infected patients before and after combined antiretroviral therapy exposure. HIV Med 2011; 12:4-13.
19. Dauchy FA, Lawson-Ayayi S, de La Faille R, Bonnet F, Rigothier C, Mehsen N, et al. Increased risk of abnormal proximal renal tubular function with HIV infection and antiretroviral therapy. Kidney Int 2011; 80:302-309.
20. Labarga P, Barreiro P, Martin-Carbonero L, Rodriguez-Novoa S, Solera C, Medrano J, et al. Kidney tubular abnormalities in the absence of impaired glomerular function in HIV patients treated with tenofovir. AIDS 2009; 23:689-696.
21. Karras A, Lafaurie M, Furco A, Bourgarit A, Droz D, Sereni D, et al. Tenofovir-related nephrotoxicity in human immunodeficiency virus-infected patients: three cases of renal failure, Fanconi syndrome, and nephrogenic diabetes insipidus. Clin Infect Dis 2003; 36:1070-1073.
22. Kinai E, Hanabusa H. Progressive renal tubular dysfunction associated with long-term use of tenofovir DF. AIDS Res Hum Retroviruses 2009; 25:387-394.
23. Wever K, van Agtmael MA, Carr A. Incomplete reversibility of tenofovir-related renal toxicity in HIV-infected men. J Acquir Immune Defic Syndr 2010; 55:78-81.
24. Woodward CL, Hall AM, Williams IG, Madge S, Copas A, Nair D, et al. Tenofovir-associated renal and bone toxicity. HIV Med 2009; 10:482-487.
25. Herlitz LC, Mohan S, Stokes MB, Radhakrishnan J, D'Agati VD, Markowitz GS. Tenofovir nephrotoxicity: acute tubular necrosis with distinctive clinical, pathological, and mitochondrial abnormalities. Kidney Int 2010; 78:1171-1177.
26. Peyriere H, Reynes J, Rouanet I, Daniel N, de Boever CM, Mauboussin JM, et al. Renal tubular dysfunction associated with tenofovir therapy: report of 7 cases. J Acquir Immune Defic Syndr 2004; 35:269-273.
27. Zimmermann AE, Pizzoferrato T, Bedford J, Morris A, Hoffman R, Braden G. Tenofovir-associated acute and chronic kidney disease: a case of multiple drug interactions. Clin Infect Dis 2006; 42:283-290.
28. Hall AM, Edwards SG, Lapsley M, Connolly JO, Chetty K, O'Farrell S, et al. Subclinical tubular injury in HIV-infected individuals on antiretroviral therapy: a cross-sectional analysis. Am J Kidney Dis 2009; 54:1034-1042.
29. Ridruejo E, Silva MO. Safety of long-term nucleos(t)ide treatment in chronic hepatitis B. Expert Opin Drug Saf 2012; 11:357-360.
30. Gish RG, Clark MD, Kane SD, Shaw RE, Mangahas MF, Baqai S. Similar risk of renal events among patients treated with tenofovir or entecavir for chronic hepatitis B. Clin Gastroenterol Hepatol 2012; 10:941-946.
31. Mauss S, Berger F, Filmann N, Hueppe D, Henke J, Hegener P, et al. Effect of HBV polymerase inhibitors on renal function in patients with chronic hepatitis B. J Hepatol 2011; 55:1235-1240.
32. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16:31-41.
33. Anderson PL, Glidden DV, Liu A, Buchbinder S, Lama JR, Guanira JV, et al. Emtricitabine-tenofovir concentrations and preexposure prophylaxis efficacy in men who have sex with men. Sci Transl Med 2012; 4:151ra125.
34. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. 2004. http://www.niaid.nih.gov/LabsAndResources/resources/ DAIDSClinRsrch/Documents/daidsaegradingtable.pdf.
35. Diggle P, Heagerty P, Kung-Yee L, Zeger S. Analysis of longitudinal data. 2nd ed. Oxford: Oxford University Press; 2002.
36. Levey AS, Coresh J, Greene T, Stevens LA, Zhang YL, Hendriksen S, et al. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med 2006; 145:247-254.
37. Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, et al. A new equation to estimate glomerular filtration rate. Ann Intern Med 2009; 150:604-612.
38. 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.