[TuPe3.5B01] Factors Increasing the Risk of Renal Dysfunction with Tenofovir Difumarate (TDF)

3rd International AIDS Society Conference on HIV Pathogenesis and Treatment

Rio de Janeiro - July 24 - 27, 2005

FACTORS INCREASING THE RISK OF RENAL DYSFUNCTION WITH TENOFOVIR DIFUMARATE (TDF)

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. TuPe3.5B01

Louie S.¹, Ballard C.², Bi L.¹, Beringer P.¹
¹University of Southern California, Los Angeles, United States of America, ²University of California, San Diego, San Diego, United States of America

INTRODUCTION: Tenofovir(TFV) is an acyclic phosphonate where recent data suggest that TFV is associated with an increased risk of developing renal impairment. The majority of case reports associated with TFV-related renal dysfunction (RD) was in patients with pre-existing factors. We report a large surveillance study evaluating the impact of patients with normal serum creatinine (Scr<1.0) who were receiving TFV and developed renal dysfunction (RD) using calculated glomerular filtration rate (GFR) using a modified MDRD equation.

METHODS: A retrospective database study identified 1007 patients receiving TDF. Patients met entry criteria if Scr was <1.0 mg/dL at baseline (BL) and whose Scr rose >1.5 mg/dL while on TDF-containing regimens. Patient demographics, medical history, concurrent drug history and serial Scr were collected. Creatinine clearance and glomerular filtration rate (GFR) was estimated using Cockroft and Gault and the abbreviated modification of diet in renal disease (MDRD) equations, respectively.

RESULTS: A total of 89 (8.8%) patients with 1.5× or higher BL Scr increase following TDF initiation were identified. BL GFR was 107±32 mL/min/1.73 m² where the nadir GFR was 40±17 mL/min/1.73 m², after an average of 268±213 days of therapy. Forty-five (4.5%) patients with BL Scr>1.0 mg/dL were included in the analysis. In these 45 patients, all patients had a Scr increase 1.5× above BL where 26 (58%) had a Scr elevation >2× above BL. The average change of Scr was 1.9±2.5 mg/dL increase above BL. Forty (89%) patients received protease inhibitor-containing regimens, where 38 (84%) receiving RTV-containing regimens, 34 (75%) received LPV/RTV, 13 (24.5%) triple- and 5 (9.4%) quadruple-nucleoside therapy.

CONCLUSIONS: The coadministration of RTV-containing regimens and/or in combination with double or triple nucleosides may increase the risk of TDF-related RD.

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Basic | TuPe3.5B01 | Stan Louie
Pharmacovigilance

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