2182. Renal and bone outcomes among HIV-infected patients exposed to EFV/TDF/FTC compared to other TDF-containing antiretroviral regimens: Findings from the Veterans Health Administration (VHA)
Session: Poster Abstract Session: HIV Renal and Bones
Saturday, October 29, 2016
Room: Poster Hall
  • 161021_IDWEEK_2016_ VA_BONE&RENAL_BMSUSS3363_v6_LEAD AU APPROVAL_FINAL.pdf (882.8 kB)
  • Background: Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) has been a recommended backbone in antiretroviral therapy (ART) regimens for treatment-naïve patients for many years. While TDF has been associated with an increased risk of renal insufficiency and bone demineralization, some data suggests that the third agent of TDF-containing combinations may affect the risk of negative outcomes relative to other TDF-containing regimens. We compared renal and bone outcomes in fixed-dose EFV/TDF/FTC versus non-EFV based TDF/FTC regimens (including rilpivirine, elvitegravir/cobicistat, boosted protease inhibitors [PIs]) in treatment-naïve HIV-infected veterans.   Methods: This cohort study used national VHA datasets and identified veterans newly initiating ART in 2003-2015 and controlled for potential bias with matching weights, an extension of inverse-probability weights. Covariates included baseline demographics, HIV laboratory measures, kidney and bone measures, and other key diagnoses/drug exposures. Cox proportional hazards regression models calculated hazard ratios (HRs) in the weighted cohort for renal and bone outcomes associated with TDF/FTC with EFV compared to TDF/FTC with non-EFV regimens (separately and overall).   Results: Of 33,048 HIV+ veterans, 13,366 received an ART regimen of interest, and it was the initial regimen in 7,236, including 4,178 EFV and 3,058 non-EFV Veterans. The mean (SD) age was 50.0 (10.1), 96% were male, and 59% and 30% were Black and Caucasian, respectively. Standardized differences between groups were less than 0.1 for all baseline characteristics following weighting. Adjusted HRs were 0.84 (95% CI 0.72, 0.99) and 0.83 (0.70, 0.98) for risk of chronic kidney disease (CKD) in EFV patients compared to all non-EFV regimens and to boosted PIs, respectively (Figure 1). For fracture, adjusted HRs were 0.52 (0.32, 0.83) and 0.51 (0.31, 0.84) for EFV versus all non-EFV and boosted PIs, respectively (Figure 2).   Conclusion: EFV/TDF/FTC was associated with a significantly lower risk for the development of CKD and osteoporotic fractures compared to other TDF-containing regimens in the VHA. The third agent in ART regimens has a significant effect on the risk of complications associated with TDF.    
    Joanne Lafleur, PharmD, MSPH1,2, Adam Bress, PharmD, MS1,2, Jacob Crook, MStat2,3, Stephen Esker, PharmD4, Heather Nyman, PharmD1, Thomas Reese, PharmD1,2, Roger Bedimo, MD5, Pablo Tebas, MD, FIDSA6 and Lisa Rosenblatt, MD, MPH4, (1)Pharmacotherapy, University of Utah, Salt Lake City, UT, (2)Salt Lake City VA Healthcare System, Salt Lake City, UT, (3)Epidemiology, University of Utah, Salt Lake City, UT, (4)Bristol-Myers Squibb, Plainsboro, NJ, (5)Medicine, VA N Texas Health Care Systems, University of Texas, Dallas, TX, (6)Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA


    J. Lafleur, Bristol Meyers Squibb: Grant Investigator and Scientific Advisor , Consulting fee and Educational grant

    A. Bress, None

    J. Crook, None

    S. Esker, Bristol Meyers Squibb: Employee , Salary

    H. Nyman, Fresenius: Independent Contractor , Consulting fee

    T. Reese, None

    R. Bedimo, Merck & Co.: Scientific Advisor , Research grant
    Theratechnologies: Scientific Advisor , Research grant
    Bristol Myers Squibb: Scientific Advisor , Research grant
    Gilead: Scientific Advisor , Consulting fee

    P. Tebas, Bristol Meyers Squibb: Scientific Advisor , Consulting fee
    Merck: Consultant , Consulting fee

    L. Rosenblatt, Bristol-Myers Squibb: Employee and Shareholder , Salary and Stock shares

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