1656. Incidence and Clinical Impact of Serum Creatinine Rise with Integrase Inhibitors in HIV-1-Infected Adults
Session: Poster Abstract Session: HIV: Renal Issues in HIV-Infected Patients
Saturday, October 10, 2015
Room: Poster Hall
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  • Background: Integrase inhibitors (INSTI) have gained preferred agent status in recent 2015 Department of Health and Human Services HIV treatment guidelines – usage is expected to increase significantly. Phase III/IV INSTI studies have shown excellent viral load suppression, but also potential increases in serum creatinine (SCr) of 0.1-0.2 mg/dL due to decreased tubular secretion of creatinine. The rate and clinical significance of increased SCr in real-world INSTI usage is unknown. The objective of this single-center, retrospective chart review is to determine change in SCr and creatinine clearance (CrCl) from baseline over 60 weeks after initiation of an INSTI as first or second treatment options in HIV-infected adults.

    Methods: HIV + adults (age ≥ 18 years) treated at the University of Toledo Medical Center who initiated a regimen containing raltegravir (R), dolutegravir (D), or elvitegravir coformulated with cobicistat (Ec) with a baseline CrCl > 50 mL/min, and ≥ 3 SCr draws within 60 wk of INSTI initiation were evaluated (data collected from 6/1/07–5/1/15).  Patients with an active AIDS defining illness, severe hepatic impairment, pregnancy, or HIV-associated nephropathy were excluded. Outcomes assessed include documented change SCr and CrCl from baseline within 60 wk.

    Results: Table 1 describes baseline characteristics and changes in SCr from baseline to last draw within 60 wk of INSTI initiation. SCr increased by ≥ 50% or 0.5 mg/dl in only 1 R, 1 D, and 3 Ec patients. No dose adjustments or discontinuation due to renal insufficiency were required.

    Conclusion: SCr and CrCl changes were similar to those seen in clinical trials for INTSI in patients with baseline CrCl > 50 ml/min. No serious adverse events or discontinuations due to renal insufficiency were observed.

    Table 1: Demographics and outcomes









    Age, yr mean (SD)

    46 (11)

    48 (14)

    40 (11)

    Gender (% M)




    Race (% White)




    CD4 <200 cell/μl,%




    HIV RNA ≤50 cp/ml,%




    Baseline CrCl, ml/min (median; IQR)

    85 (75,100)

    79 (70,108)

    97 (82,116)

    Baseline SCr, mg/dl (median; IQR)

    0.96 (0.85,1.09)

    0.95 (0.89, 1.03)

    0.93 (0.75, 1.0)

    Change in SCr,  mg/dl (median; IQR)

    0.04 (-0.02,0.18)

    0.1 (0.07,0.20)

    0.09 (-0.01,0.15)

    Time to last draw, mos. (median; IQR)

    12.5 (10.75,14)

    9 (8,10)

    11 (7.25,13)

    Tara Lindeman, Lindeman, PharmD1, Joan Duggan, MD, FIDSA2, Rose Jung, PharmD1 and Eric Sahloff, PharmD, AAHIVP1, (1)Pharmacy Practice, University of Toledo, Toledo, OH, (2)Department of Medicine, Division of Infectious Diseases, University of Toledo College of Medicine, Toledo, OH


    T. Lindeman, None

    J. Duggan, None

    R. Jung, None

    E. Sahloff, None

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