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.