Clinical Experience with Telavancin for the Treatment of Patients with Bacteremia and Endocarditis: Real-World Results from the Telavancin Observational Use Registry (TOUR™)

Abstract

Background: Bacteremia and endocarditis caused by Staphylococcus aureus (S. aureus), particularly methicillin-resistant S. aureus (MRSA), are challenging to treat and are associated with high morbidity and mortality. Telavancin is a lipoglycopeptide antibacterial active against susceptible Gram-positive pathogens, including MRSA.

Objective: This registry study assessed the real-world use and clinical outcomes of telavancin in patients with bacteremia or endocarditis enrolled in the Telavancin Observation Use Registry (TOUR™).

Methods: The subset of patients enrolled in TOUR who were diagnosed with endocarditis and/or bacteremia with a known or unknown primary source (N = 151) were analyzed. Data including demographics, infection type, baseline pathogens, prior or concomitant antimicrobial therapy, dosing regimen, clinical response, treatment-emergent adverse events (TEAEs) of interest, and mortality were collected by retrospective medical chart review.

Results: Telavancin was primarily used as a second-line or greater therapy (n = 132, 87.4%). MRSA was present in 87 (57.6%) patients. Median telavancin dose was 740.6 mg (interquartile range (IQR) 206.0 mg) and median duration of therapy was 9.0 days (IQR 24.0 days). Of the 132/151 (87.4%) patients with an available assessment at the end of telavancin therapy, a positive clinical response was achieved in 98/132 (74.2%), while 14/132 (10.6%) failed therapy and 20/132 (15.2%) had an indeterminant outcome. TEAEs occurred in 24 (15.9%) patients. The most frequent TEAE was renal failure (n = 12, 7.9%); seven of these patients were receiving concomitant nephrotoxic medications. There was no change in creatinine clearance for 67/89 (75.3%) patients with values recorded at the beginning and the end of telavancin therapy.

Conclusions: In real-world clinical practice, overall positive clinical outcomes are observed in patients with bacteremia or endocarditis treated with telavancin, including in those patients infected with MRSA or another S. aureus pathogen. Telavancin may be an alternative treatment option for these patients.

Trial registration: This trial was registered with clinicaltrials.gov (NCT02288234) on 11 November 2014.

Conflict of interest statement

JR has served on advisory boards and speakers bureaus for Theravance Biopharma and Cumberland Pharmaceuticals Inc. MAJ has received payment for participating in speakers’ bureaus, advisory boards for Theravance Biopharma, Cumberland Pharmaceuticals Inc, and Allergan; payment for serving on speakers’ bureau for Merck & Co. (including former Cubist Pharmaceuticals); and received research support from Theravance Biopharma related to TOUR and from Allergan. BF has received payment for participating in speakers’ bureaus for Theravance Biopharma, Allergan, Melinta, Merck & Co., and La Jolla Pharmaceutical. KC has received payment for participating in speakers’ bureaus for Allergan, Merck & Co., Theravance Biopharma, and Cumberland Pharmaceuticals Inc; consulting fees for Theravance Biopharma; and grants from Theravance Biopharma for the collection of data were paid to Methodist Healthcare of Memphis. DL is an employee of Theravance Biopharma US, Inc. BC-R was an employee of Theravance Biopharma US, Inc. during the conduct of the study and owns stock in Theravance Biopharma, Inc.

Figures

Fig. 1

Duration of therapy in TOUR patients with bacteremia or endocarditis (N = 151). Due to rounding, percentages add up to 99.9%; however, all patients with bacteremia or endocarditis are represented. TLV telavancin, TOUR telavancin observational use registry

Fig. 2

Clinical outcomes for patients with available assessments. Asterisk: Positive clinical response includes patients who were cured (85/132; 64.4%) or improved to step-down oral therapy (13/132; 9.8%). Dagger: Indeterminate outcome indicates that there was insufficient information at end of telavancin therapy to determine a positive or failed response. Double dagger: Post-therapy assessment was performed 7–30 days after end of telavancin therapy

Fig. 3

Summary of change in creatinine clearance from baseline to last and worst value during telavancin therapy (n = 89). Patients on dialysis and those who were missing a baseline or last/worst CrCl value were not included in the analysis. CrCl creatinine clearance