Renal safety of tenofovir disoproxil fumarate

AIDS Reader

Volumn 17, Issue 2, 2007, Pages

  Sax, Paul E ^a,b   Gallant, Joel E ^c   Klotman, Paul E ^d  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b HARVARD MEDICAL SCHOOL   (United States)

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

^d MOUNT SINAI SCHOOL OF MEDICINE   (United States)

Author keywords

Antiretroviral therapy; HIV AIDS; Nephrotoxicity; Tenofovir

Indexed keywords

ADEFOVIR; ATAZANAVIR; CIDOFOVIR; CREATININE; EFAVIRENZ; EMTRICITABINE; LAMIVUDINE; LOPINAVIR; MULTIDRUG RESISTANCE PROTEIN 2; MULTIDRUG RESISTANCE PROTEIN 4; ORGANIC ANION TRANSPORTER 1; RITONAVIR; STAVUDINE; TENOFOVIR DISOPROXIL; ZIDOVUDINE;

ARTICLE; BACTERIAL INFECTION; CLINICAL TRIAL; COHORT ANALYSIS; DRUG APPROVAL; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEVER; GLOMERULUS FILTRATION RATE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; KIDNEY DISEASE; LYMPHOMA; MULTIDRUG RESISTANCE; NEPHROTOXICITY; PANCREATITIS; PNEUMONIA; UNITED STATES;

ADENINE; ANTI-HIV AGENTS; CLINICAL TRIALS; HIV INFECTIONS; HUMANS; KIDNEY; KIDNEY DISEASES; PHOSPHONIC ACIDS; RANDOMIZED CONTROLLED TRIALS; REVERSE TRANSCRIPTASE INHIBITORS;

EID: 33846971989     PISSN: 10530894     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (41)

1. Fisher EJ, Chaloner K, Cohn DL, et al. The safety and efficacy of adefovir dipivoxil in patients with advanced HIV disease: a randomized, placebo-controlled trial. AIDS. 2001;15:1695-1700.
2. Vandercam B, Moreau M, Goffin E, et al. Cidofovir-induced end-stage renal failure. Clin Infect Dis. 1999;29:948-949.
3. Viread (tenofovir disoproxil fumarate) Tablets [package insert]. Foster City, Calif: Gilead Sciences, Inc; May 2005.
4. Ray AS, Vela JE, Robinson KL, et al. Efflux of tenofovir by the multidrug resistance-associated protein4 (MRP4) is not affected by HIV protease inhibitors. 10th European AIDS Conference; November 17-20, 2005; Dublin. Abstract PE4.3/13.
5. Reid G, Wielinga P, Zelcer N, et al. The human multidrug resistance protein MRP4 functions as a prostaglandin efflux transporter and is inhibited by nonsteroidal antiinflammatory drugs. Proc Natl Acad Sci. 2003;100:9244-9249.
6. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31-41.
7. Levey AS, Bosch JP, Lewis JB, et al. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999;130:461-470.
8. Verhelst D, Monge M, Meynard JL, et al. Fanconi syndrome and renal failure induced by tenofovir: a first case report. Am J Kidney Dis. 2002;40:1331-1333.
9. Earle KE, Seneviratne T, Shaker J, Shoback D. Fanconi syndrome in HIV+ adults: report of three cases and literature review. J Bone Miner Res. 2004;19:714-721.
10. Schaaf B, Aries P, Kramme E, et al. Acute renal failure associated with tenofovir treatment in a patient with acquired immunodeficiency syndrome. Clin Infect Dis. 2003;37:e41-e43.
11. Peyrière H, Reynes J, Rouanet I, et al. Renal tubular dysfunction associated with tenofovir therapy: report of 7 cases. J Acquir Immune Defic Syndr Hum Retrovirol. 2004;35:269-273.
12. Lee JC, Marosok RD. Acute tubular necrosis in a patient receiving tenofovir. AIDS. 2003;17:2543-2544.
13. Izzedine H, Isnard-Bagnis C, Hulot JS, et al. Renal safety of tenofovir in HIV treatment-experienced patients. AIDS. 2004;18:1074-1076.
14. Schooley RT, Ruane P, Myers RA, et al; Study 902 Team. Tenofovir DF in antiretroviral-experienced patients: results from a 48-week, randomized, double-blind study. AIDS. 2002;16:1257-1263.
15. Squires K, Pozniak AL, Pierone G Jr, et al; Study 907 Team. Tenofovir disoproxil fumarate in nucleoside-resistant HIV-1 infection. Ann Intern Med. 2003;139:313-321.
16. Izzedine H, Hulot JS, Vittecoq D, et al; Study 903 Team. Long-term renal safety of tenofovir disoproxil fumarate in antiretroviral-naive HIV-1 infected patients. Data from a double-blind randomized active-controlled multicentre study. Nephrol Dial Transplant. 2005;20:743-746.
17. Gallant JE, Staszewski S, Pozniak AL, 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.
18. Staszewski S, Pozniak AL, Lu B, et al. Similar renal safety profile between tenofovir DF (TDF) and stavudine (d4T) using Modification of Diet in Renal Disease (MDRD) and Cockcroft-Gault (CG) estimation of glomerular filtration rate (GFR) in antiretroviral-naive patients through 144 weeks. 7th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV; November 13-16, 2005; Dublin. Abstract 93.
19. National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002;39(suppl 1):S1-S266.
20. Pozniak AL, Gallant JE, DeJesus E, et al; Study 934 Group. Tenofovir disoproxil fumarate, emtricitabine, and efavirenz versus fixed dose zidovudine/lamivudine and efavirenz in antiretroviral-naive patients: virologic, immunologic, and morphologic changes - a 96-week analysis. J Acquir Immune Defic Syndr. 2006;43:535-540.
21. Molina JM, Wilkin A, Domingo P, et al. Once-daily vs twice-daily lopinavir/ritonavir in antiretroviral-naive patients: 96-week results. 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment; July 24-27, 2005; Rio de Janeiro. Abstract WePe12.3C12.
22. Johnson M, Grinsztejn B, Rodriguez C, et al. 96-week comparison of once-daily atazanavir/ritonavir and twice-daily lopinavir/ritonavir in patients with multiple virologie failures. AIDS. 2006;20:711-718.
23. Jones R, Stebbing J, Nelson M, et al. Renal dysfunction with tenofovir disoproxil fumarate-containing highly active antiretroviral therapy regimens is not observed more frequently: a cohort and case-control study. J Acquir Immune Defic. 2004;37:1489-1495.
24. Gallant JE, Parish MA, Keruly JC, Moore RD. Changes in renal function associated with tenofovir disoproxil fumarate treatment, compared with nucleoside reverse-transcriptase inhibitor treatment. Clin Infect Dis. 2005;40:1194-1198.
25. Gallant JE, Parish M, Keruly J, Moore R. Changes in renal function in patients treated with tenofovir DF (TDF) compared to nucleoside reverse transcriptase inhibitors (NRTIs). 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment; July 24-27, 2005; Rio de Janeiro. AbstractTuPe2.3C18.
26. Gallant JE, Parish MA, Keruly JC, Moore RD. Reply to Gupta [letter] [Gupta SK. Tenofovir and changes in renal function (letter). Clin Infect Dis. 2005;41:571].
27. Clin Infect Dis. 2005;41:571.
28. Scott J, Wolfe P, Quiros J, et al. Rare occurrence of renal impairment when retrospectively evaluating the use of TDF in two clinical practices. XV International AIDS Conference; July 11-16, 2004; Bangkok, Thailand. Abstract P4632.
29. Mauss S, Berger F, Schmutz G. Antiretroviral therapy with tenofovir is associated with mild renal dysfunction. AIDS. 2005;19:93-95.
30. Antoniou T, Raboud J, Chirhin S, et al. Incidence of and risk factors for tenofovir-induced nephrotoxicity: a retrospective cohort study. HIV Med. 2005;6:284-290.
31. Kearney BP, Matthias A, Mittan A, et al. Pharmacokinetics and safety of tenofovir disoproxil fumarate on coadministration with lopinavir/ritonavir. J Acquir Immune Defic Syndr. 2006;43:278-283.
32. Nelson M, Cooper D, Schooley R, et al. The safety of tenofovir DF for the treatment of HIV infection: the first 4 years. 13th Conference on Retroviruses and Opportunistic Infections; February 5-8, 2006; Denver. Abstract 781.
33. Winston A, Amin J, Mallon PW, et al. Minor changes in calculated creatinine clearance and anion-gap are associated with tenofovir DF containing highly active antiretroviral therapy. 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment; July 24-27, 2005; Rio de Janeiro. Abstract TuPe2.3C23.
34. Padilla S, Gutierrez F, Masia M, et al. Low frequency of renal function impairment during one-year of therapy with tenofovir-containing regimens in the real-world: a case-control study. AIDS Patient Care STDs. 2005;19:421-424.
35. Gupta SK, Eustace JA, Winston JA, et al. Guidelines for the management of chronic kidney disease in HIV-infected patients: recommendations of the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2005;40:1559-1585.
36. Levey AS, Coresh J, Balk E, et al. National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification [published correction appears in Ann Intern Med. 2003;139:605]. Ann Intern Med. 2003;139:137-147.
37. Kaul S, Bassi K, Damle B, et al. Pharmacokinetic (PK) evaluation of the combination of atazanavir (ATV), enteric-coated didanosine (ddI-EC), and tenofovir disoproxil fumarate (TDF) for a once-daily antiretroviral regimen. 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy; September 14-17, 2003; Chicago. Abstract A-161.
38. Ray AS, Cihal T, Robinson KL, et al. Mechanism of active renal tubular efflux of tenofovir. Antimicrob Agents Chemother. 2006;50:3297-3304.
39. Gallant JE, Parish MA, Keruly JC, Moore RD. Changes in renal function associated with tenofovir disoproxil fumarate treatment, compared with nucleoside reverse-transcriptase inhibitor treatment. Clin Infect Dis. 2005;40:1194-1198.
40. Mauss S, Berger F, Schmutz G. Antiretroviral therapy with tenofovir is associated with mild renal dysfunction. AIDS. 2005;19:93-95.
41. Gupta SK, Eustace JA, Winston JA, et al. Guidelines for the management of chronic kidney disease in HIV-infected patients: recommendations of the HIV Medicine Association of the Infectious Diseases Society of America. Clin Infect Dis. 2005;40:1559-1585.