2364. Evaluation of Renal Function Changes in Patients With Prolonged Telavancin Therapy (>21 Days): Results From the Telavancin Observational Use Registry (TOUR™)

BACKGROUND: Telavancin (TLV) is a lipoglycopeptide antibacterial active against a wide range of Gram-positive organisms, including methicillin-susceptible and methicillin-resistant Staphylococcus aureus. New onset or worsening renal impairment was observed in phase 3 clinical trials. This analysis was conducted to better understand changes in renal function from real-world experience during prolonged TLV therapy. METHODS: Data from the Telavancin Observational Use Registry (TOUR™)—a multicenter chart review to characterize types of infection, pathogens, and outcomes of patients treated with TLV in clinical practice—were used to characterize a subset of patients with prolonged TLV therapy duration defined as treatment >21 days. Patient demographics, pathogens, outcomes, and adverse events (AEs) were analyzed. Clinical outcomes were determined by investigator assessment. Creatinine clearance (CrCl) was estimated by Cockcroft-Gault for all patients with serum creatinine measurements at baseline and end of TLV therapy. CrCl values were grouped as ≤30, >30–50, >50–80, and >80 mL/minute; categorical changes from baseline were classified and compared. RESULTS: A total of 308/1063 patients were treated with TLV for >21 days. At baseline, patients had a median CrCl of 113.4 mL/minute. Median TLV dose was 750 mg (range 254–1,500 mg) or 8.3 mg/kg (range 2.2–15.0 mg/kg); and median treatment duration was 38 days (range 22–185 days). The 2 most commonly treated infection types were bone and joint infections (55.2%) and complicated skin and skin structure infections (25.6%). A total of 121 (39.3%) patients had methicillin-resistant S. aureus. TLV was used as second-line or greater therapy in 235 (76%) patients, and the majority of patients (65.6%; n = 202) were treated as outpatients prior to starting TLV. Of the 308, 134 reported baseline and end of TLV therapy CrCl. CrCl was unchanged in the majority of patients (68.7%; n = 92), 9 (6.7%) improved, and CrCl decreased in 33 (24.6%) patients. A total of 25 (8.1%) patients reported renal AEs. CONCLUSION: In the subset of patients with baseline and end of TLV therapy CrCl, renal function was unchanged in the majority of patients with prolonged TLV therapy >21 days. DISCLOSURES: A. Hassoun, Theravance Biopharma, US: Speaker’s Bureau, Speaker honorarium. M. Lacy, Theravance Biopharma, US: Employee and Shareholder, Salary. C. Barnes, Theravance Biopharma, US: Employee and Shareholder, Salary. B. Castaneda-Ruiz, Theravance Biopharma, US: Employee and Shareholder, Salary.