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JAIDS Journal of Acquired Immune Deficiency Syndromes:
doi: 10.1097/QAI.0000000000000245
Original Article: PDF Only

Changes in Proteinuria and Albuminuria with Initiation of Antiretroviral Therapy: Data from a Randomized Trial Comparing Tenofovir Disoproxil Fumarate/ Emtricitabine versus Abacavir/ Lamivudine.

Wyatt, Christina M MD; Kitch, Douglas MS; Gupta, Samir K MD; Tierney, Camlin PhD; Daar, Eric S MD; Sax, Paul E MD; Ha, Belinda PhD; Melbourne, Kathleen PharmD; McComsey, Grace A MD; for the AIDS Clinical Trials Group Study A5224s Team

Published Ahead-of-Print
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Abstract

: Antiretroviral therapy (ART) is associated with improved kidney function; however, the nucleotide reverse transcriptase inhibitor (NRTI) tenofovir disoproxil fumarate (TDF) has been associated with decreased kidney function and proteinuria.

Methods: We examined changes in urine protein:creatinine (UPCR) and albumin:creatinine (UACR) ratios in 245 ART-naive participants in A5202 randomized in a substudy to blinded NRTI (abacavir/lamivudine, ABC/3TC, n=124 or TDF/emtricitabine, TDF/FTC, n=121) with open-label protease inhibitor (PI) atazanavir/ritonavir (ATV/r) or non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV).

Results: At baseline, 18% of participants had clinically significant proteinuria (UPCR >= 200 mg/g) and 11% had clinically significant albuminuria (UACR >= 30 mg/g). The prevalence of clinically significant proteinuria and albuminuria decreased from baseline to week 96 in all treatment groups. In intention-to-treat analyses, there was a significant effect of NRTI component on fold-change in UPCR (p=0.011) and UACR (p=0.018) from baseline to week 96, with greater improvements in participants randomized to ABC/3TC. There was no significant effect of NNRTI/PI component on fold-change in UPCR (p=0.23) or UACR (p=0.88), and no significant interactions between NRTI and NNRTI/PI components.

Conclusion: In this pre-specified secondary analysis, ART initiation was associated with improvements in proteinuria and albuminuria, with significantly greater improvements in participants randomized to ABC/3TC versus TDF/FTC. These are the first data from a randomized trial to suggest that initiation of TDF/FTC may not be associated with the same degree of improvement in proteinuria and albuminuria that have been reported with other regimens. Future studies should consider the long-term clinical significance of these findings.

(C) 2014 by Lippincott Williams & Wilkins

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