428
Views
22
CrossRef citations to date
0
Altmetric
Original Articles

Discontinuation of Tenofovir Disoproxil Fumarate for Presumed Renal Adverse Events in Treatment-Naïve HIV-1 Patients: Meta-analysis of Randomized Clinical Studies

, , , , , , , , & show all
Pages 231-245 | Published online: 22 Dec 2014

REFERENCES

  • 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/guidelines.
  • Gilead Sciences Inc. Q4 2013 earnings results: Confer-ence call and Web cast. phx.corporate-ir.net/External.File?item=UGFyZW5OSUQ9MjE4ODUxfEN0aWxkSUQ9LTF8VHIwZTOz&t=1. Accessed March 24, 2014.
  • VIREAD (tenofovir disoproxil fumarate) [prescribing infor-mation]. Foster City, CA: Gilead Sciences, Inc.
  • Cooper RD, Wiebe N, et al. Systematic review and meta-analysis: Renal safety of tenofovir disoproxil fumarate in HIV-infected patients. Clin Infect Dis. 2010;51(5):496–505.
  • Scherzer R, Estrella M, et al. Association of tenofovir exposure with kidney disease risk in HIV infection. AIDS. 2012;26(7):867–875.
  • Winston J, Deray G, et al. Kidney disease in patients with HIV infection and AIDS. Clin Infect Dis. 2008;47(11): 1449–1457.
  • Mocroft A, Kirk O, et al. Estimated glomerular filtration rate, chronic kidney disease and antiretroviral drug use in HIV-positive patients. AIDS. 2010;24(11):1667–1678.
  • Flandre P, Pugliese P, et al. Risk factors of chronic kidney disease in HIV-infected patients. Clin J Am Soc Nephrol. 2011;6(7):1700–1707.
  • Emerson J, Hoaglin D, et al. A modified random-effect pro-cedure for combining risk difference in sets of 2x2 tables from clinical trials. J Ital Statist Soc. 1993;3:269–290.
  • Emerson J, Hoaglin D, et al. Simple robust procedures for combining risk differences in sets of 2.2 tables. Stat Med. 1996;15:1465–1488.
  • Molina JM, Podsadecki TJ, et al. A lopinavir/ritonavir-based once-daily regimen results in better compliance and is non-inferior to a twice-daily regimen through 96 weeks. AIDS Res Hum Retro viruses. 2007;23(12):1505–1514.
  • Elion R, Cohen C, et al. Evaluation of efficacy, safety, pharmacokinetics, and adherence in HIV-1-infected, anti-retroviral-naive patients treated with ritonavir-boosted ata-zanavir plus fixed-dose tenofovir DF/emtricitabine given once daily. HIV Clin Trials. 2008;9(4):213–224.
  • Ortiz R, Dejesus E, et al. Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treat-ment-naive HIV-1-infected patients at week 48. AIDS. 2008;22(12):1389–1397.
  • Smith KY, Weinberg WG, et al. Fosamprenavir or atazana-vir once daily boosted with ritonavir 100 mg, plus tenofo-vir/emtricitabine, for the initial treatment of HIV infection: 48-week results of ALERT. AIDS Res Ther. 2008;5:5.
  • Gathe J, da Silva BA, et al. A once-daily lopinavir/ritonavir-based regimen is noninferior to twice-daily dosing and results in similar safety and tolerability in antiretroviral-naive subjects through 48 weeks. J Acquir Immune Defic Syndr. 2009;50(5):474–481.
  • Lennox JL, DeJesus E, et al. Safety and efficacy of ralte-gravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: A multi-centre, double-blind randomised controlled trial. Lancet. 2009;374(9692):796–806.
  • Mills AM, Nelson M, et al. Once-daily darunavir/ritonavir vs. lopinavir/ritonavir in treatment-naive, HIV-1-infected patients: 96-week analysis. AIDS. 2009;23(13)1 679–1688.
  • Walmsley S, Avihingsanon A, et al. Gemini: A noninferior-ity study of saquinavir/ritonavir versus lopinavir/ritonavir as initial HIV-1 therapy in adults. J Acquir Immune Defic Syndr. 2009;50(4):367–374.
  • Molina JM, Andrade-Villanueva J, et al. Once-daily ata-zanavir/ritonavir compared with twice-daily lopinavir/ ritonavir, each in combination with tenofovir and emtric-itabine, for management of antiretroviral-naive HIV-1-infected patients: 96-week efficacy and safety results of the CASTLE study. J Acquir Immune Defic Syndr. 2010;53(3):323–332.
  • Post FA, Moyle GJ, et al. Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lami-vudine 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(1):49–57.
  • Cohen C, Elion R, et al. Randomized, phase 2 evaluation of two single-tablet regimens elvitegravir/cobicistat/emtric-itabine/tenofovir disoproxil fumarate versus efavirenz/ emtricitabine/tenofovir disoproxil fumarate for the initial treatment of HIV infection. AIDS. 2011;25(6):F7–12.
  • Cohen CJ, Andrade-Villanueva J, et al. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): A phase 3, randomised, non-inferiority trial. Lancet. 2011;378(9787):229–237.
  • Eron JJ Jr, Rockstroh JK, et al. Raltegravir once daily or twice daily in previously untreated patients with HIV-1: A randomised, active-controlled, phase 3 non-inferiority trial. Lancet Infect Dis. 201111(12):907–915.
  • Molina JM, Cahn P, et al. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): A phase 3 ran-domised double-blind active-controlled trial. Lancet. 2011;378(9787):238–246.
  • Soriano V, Arasteh K, et al. Nevirapine versus atazanavir/ ritonavir, each combined with tenofovir disoproxil fuma-rate/emtricitabine, in antiretroviral-naive HIV-1 patients: The ARTEN Trial. Antivir Ther. 201116(3):339–348.
  • DeJesus E, Rockstroh JK, et al. Co-formulated elvite-gravir, 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, non-inferiority trial. Lancet. 2012;379(9835):2429–2438.
  • Gallant JE, Koenig E, et al. Cobicistat vs ritonavir as pharmacoenhancers in combination with atazanavir plus tenofovir disoproxil fumarate/emtricitabine: Phase 3 ran-domized, double blind, active-controlled trial, week 48 results. Presented at: XIX International AIDS Conference; July 22–27, 2012; Washington, DC.
  • Sax PE, DeJesus E, et al. Co-formulated elvitegravir, cobi-cistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treat-ment of HIV-1 infection: A randomised, double-blind, phase 3 trial, analysis of results after 48 weeks. Lancet. 2012 ;379(9835):2439–2448.
  • Cohen CJ, Molina JM, et al. Week 96 efficacy and safety of rilpivirine in treatment-naive, HIV-1 patients in two phase III randomized trials. AIDS. 2013;27(6):939–950.
  • Orkin C, DeJesus E, et al. Final 192-week efficacy and safety of once-daily darunavir/ritonavir compared with lopinavir/ritonavir in HIV-1-infected treatment-naive patients in the ARTEMIS trial. HIV Med. 2013;14(1):49–59.
  • Rockstroh JK, DeJesus E, et al. A randomized, double-blind comparison of coformulated elvitegravir/cobicistat/ emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus coformulated emtricitabine and tenofovir DF for initial treatment of HIV-1 infection: Analysis of week 96 results. J Acquir Immune Defic Syndr. 2013;62 (5):483–486.
  • Rockstroh JK, DeJesus E, et al. Durable efficacy and safety of raltegravir versus efavirenz when combined with tenofovir/emtricitabine in treatment-naive HIV-1-infected patients: Final 5-year results from STARTMRK. J Acquir Immune Defic Syndr. 2013;63(1):77–85.
  • Zolopa A, Sax PE, et al. A randomized double-blind com-parison of coformulated elvitegravir/cobicistat/emtric-itabine/tenofovir disoproxil fumarate versus efavirenz/ emtricitabine/tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: Analysis of week 96 results. J Acquir Immune Defic Syndr. 2013;63(1):96–100.
  • Gallant JE, Staszewski S, et al. Efficacy and safety of tenofovir DF vs stavudine in combination therapy in anti-retroviral-naive patients: A 3-year randomized trial. JAMA. 2004;292(2)191–201.
  • Gallant JE, DeJesus E, et al. Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med. 2006;354(3):251–260.
  • Cassetti I, Madruga JV, Suleiman JM, et al. The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral-naive HIV-1-infected patients. HIV Clin Trials. 2007;8(3):164–172.
  • Arribas JR, Pozniak AL, et al. Tenofovir disoproxil fuma-rate, emtricitabine, and efavirenz compared with zid-ovudine/lamivudine and efavirenz in treatment-naive patients: 144-week analysis. J Acquir Immune Defic Syndr. 2008;47(1):74–78.
  • Sax PE, Tierney C, et al. Supplement to: Abacavir-lami-vudine versus tenofovir-emtricitabine for initial HIV-1 therapy. N Engl J Med. 2009;361:2230–2240.
  • Smith KY, Patel P, et al. Randomized, double-blind, pla-cebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment. AIDS. 2009;23(12):1547–1556.
  • Daar ES, Tierney C, et al. Atazanavir plus ritonavir or efa-virenz as part of a 3-drug regimen for initial treatment of HIV-1. Ann Intern Med. 2011;154(7):445–456.
  • Sax PE, Tierney C, et al. Abacavir/lamivudine versus tenofovir DF/emtricitabine as part of combination regi-mens for initial treatment of HIV: Final results. J Infect Dis. 2011;204(8)1191–1201.
  • Sax PE, Tierney C, et al. Abacavir-lamivudine versus tenofovir-emtricitabine for initial HIV-1 therapy. N Engl J Med. 2009;361(23):2230–2240.
  • Jones R, Stebbing J, et al. Renal dysfunction with teno-fovir disoproxil fumarate-containing highly active antiret-roviral therapy regimens is not observed more frequently: A cohort and case-control study. J Acquir Immune Defic Syndr. 2004;37(4):1489–1495.
  • Nelson MR, Katlama C, et al. The safety of tenofovir diso-proxil fumarate for the treatment of HIV infection in adults: The first 4 years. AIDS. 2007;21(10):1273–1281.
  • World Health Organization. HIV/AIDS treatment and care. Clinical protocols for the WHO European Region. http://www.euro.who.int/__data/assets/pdf_file/0004/78106/E90840.pdf.
  • World Health Organization. Antiretroviral therapy for HIV infection in adults and adolescents. Recommendations for a public health approach: 2010 revision. http://www.who.int/hiv/pub/arv/adult2010/en/index.html.
  • Lepist El, Phan TK, et al. Cobicistat boosts the intestinal absorption of transport substrates, including HIV protease inhibitors and GS-7340, in vitro. Antimicrob Agents Che-mother. 2012;56(10):5409–5413.
  • Lepist El, Zhang X, et al. Contribution of the organic anion transporter OAT2 to the renal active tubular secretion of creatinine and mechanism for serum creatinine elevations caused by cobicistat [published online ahead of print March 19,2014). Kidney. Int.
  • Lazzarin A, Johnson M, et al. 5-year safety and efficacy of the once-daily antiretroviral regimen of efavirenz (ER))l emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF). J Int AIDS. Soc. 2010;13\(Suppl 4):P6.
  • Kalayjian RC, Lau B, et al. Risk factors for chronic kid-ney disease in a large cohort of HIV-1 infected individu-als initiating antiretroviral therapy in routine care. AIDS. 2012;26(15)1 907–1915.
  • Atta MG, Fine DM. Editorial comment: Tenofovir nephro-toxicity -the disconnect between clinical trials and real-world practice. AIDS Read. 2009;19(3):118–119.
  • Furuya-Kanamori L, Kelly MD, et al. Co-morbidity, age-ing and predicted mortality in antiretroviral treated Australian men: A quantitative analysis. PLoS One. 2013;8(10):e78403.
  • Hardy D, Ruane P, et al. Analysis of EVG/COBI/FTC/TDF compared to EFV/FTC/TDF by race in treatment naïve patients [poster 1351]. ID Week (Infectious Diseases Soci-ety of America); October 17–21, 2012; San Diego, CA.
  • Gallant JE, Koenig E, et al. Cobicistat versus ritona-vir as a pharmacoenhancer of atazanavir plus emtric-itabine/tenofovir disoproxil fumarate in treatment-naive HIV type 1-infected patients: Week 48 results. J Infect Dis. 2013;208(1):32–39.
  • Ryom L, Mocroft A, et al. Association between antiretro-viral exposure and renal impairment among HIV-positive persons with normal baseline renal function: The D:A:D study. J Infect Dis. 2013;207(9)1 359–1369.
  • Elion R, Cohen C, et al. Phase 2 study of cobicistat versus ritonavir each with once-daily atazanavir and fixed-dose emtricitabine/tenofovir df in the initial treatment of HIV infection. AIDS. 201125(15)1881-1886.
  • Greenland S, Robins JM. Estimation of a common effect parameter from sparse follow-up data. Biometrics. 1985;41(1):55–68.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.