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Elvitegravir/cobicistat/emtricitabine/tenofovir DF in HIV-Infected Patients with Mild to Moderate Renal Impairment.
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Download the PDF here
JAIDS Dec 2 2014
Post, Frank A MD; Winston, Jonathan MD; Andrade-Villanueva, Jaime F MD; Fisher, Martin MD; Liu, YaPei PhD; Beraud, Christophe PhD; Abram, Michael E PhD; Graham, Hiba PharmD; Rhee, Martin S MD; Cheng, Andrew K MD; Szwarcberg, Javier MD, MPH; for the Study 118 Team
(Melbourne/2014 Intl AIDS Conf) Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF (STB) in HIV-Infected Patients with Mild to Moderate Renal Impairment....... http://www.natap.org/2014/IAC/IAC_60.htm
Abstract
In HIV-1 infected treatment- naive patients with mild to moderate renal impairment (creatinine clearance [CrCl]: 50-89 mL/min), elvitegravir/cobicistat/emtricitabine/tenofovir DF (STB, n=33) achieved high rates of virologic success [78.8%; 95% CI: 61.1% to 91.0%] and was well tolerated through Week 48. Four patients discontinued study drug due to an adverse event, none due to proximal renal tubulopathy. As expected, decreases in CrCl were noted as early as Week 2, after which they stabilized. The renal safety profile of STB in patients from this study is consistent with the long-term experience in a large number of patients with CrCl >= 70 mL/min.
Four patients (12%) discontinued study drug due to an AE. One patient discontinued due to hepatitis C and Hodgkin's disease. The other three patients discontinued due to renal AEs, two of whom met the protocol-defined criterion for potential discontinuation. All three patients had baseline CrCl between 50-55 mL/min and developed CrCL < 50mL/min without evidence of PRT. Only one patient had cystatin C-based eGFR < 50 mL/min/1.73m2 at the time of
discontinuation, which was pre-existing at baseline. CrCl returned to baseline after STB discontinuation in two patients; one patient did not have any post discontinuation data available.
Increases in median values for serum creatinine were noted as early as Week 2 (0.16 mg/dL [IQR: 0.10 to 0.23]), after which they generally stabilized and were non progressive through Week 48 (0.17 mg/dL [IQR: 0.08 to 0.26]) (Figure 1a). Corresponding decreases in CrCl were also noted at Week 2 (-8.9 mL/min [IQR: -11.3 to -5.8]) and through Week 48 (-7.6 mL/min [IQR: -12.2 to -2.2]). The median changes in other creatinine-based eGFR endpoints at Week 48 were consistent with that for CrCl (eGFRMDRD: -12.1 mL/min/1.73m2 and eGFRCKD-EPI, creatinine: - 13.1 mL/min/1.73m2). There was no change in cystatin C-based eGFR from baseline (median 76.9 mL/min/1.73m2 [IQR: 61.7 to 90.1]) to Week 48 (median change +1.6 mL/min/1.73m2 [IQR: -8.0 to 6.9]). The changes from baseline at Week 48 in median values for CrCl were similar for patients in subgroups by baseline CrCl (Figure 1b). One patient had confirmed increase in serum creatinine > 0.4 mg/dL but no tubular abnormalities, and discontinued study drug due to renal AE. No patient met the laboratory definition of PRT. Three patients had confirmed new or worsening proteinuria (by dipstick), which improved while continuing study drug.
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