Methods: A subset of patients with monomicrobial infections due to S. aureus and VAN MIC ≥1 μg/mL were characterized from the Telavancin Observational Use Registry (TOUR™), a multicenter chart review to characterize infection types, pathogens, and outcomes of patients treated with TLV in clinical practice. Patient demographics, pathogens, outcomes, and adverse events (AEs) were analyzed. Clinical outcomes were determined by investigator assessment.
Results: Of 159 patients with monomicrobial S. aureus and VAN MIC ≥1 μg/mL, 25.8% were aged ≥65 years (median 54.0, range 40−65 years), 60.4% were male, and 84.9% were White. At enrollment, complicated skin and skin structure infections (45.9%), bacteremia (20.1%), and osteomyelitis (15.7%), were the most common infection types. Median TLV daily dose was 750 mg (range 285–2000 mg) or 8.5 mg/kg (range 3.5–15.7 mg/kg) and treatment duration was 8 days (range 1–185 days). TLV was used as second-line or later therapy in 77.4% patients, 73.6% failed prior therapy, and 44.0% previously received VAN. A total of 104 (65.4%) patients had VAN MIC = 1 μg/mL; 4 (2.5%) had MIC = 1.5 μg/mL, and 51 (32.1%) had MIC = 2 μg/mL. At end of treatment, 87 (77.0%) patients with available assessment had a positive clinical response, 17 (15.0%) had an indeterminate response, and 9 (8.0%) failed treatment. Assessment data from 10 (8.1%) patients were missing or undocumented, and indeterminate for 17 (13.8%) patients. AEs were reported in 17 (10.7%) patients; 9 (5.7%) reported a serious AE, and 12 (7.5%) had AEs leading to TLV discontinuation. A total of 7 (4.4%) renal AEs were reported; 5 (3.8%) patients discontinued due to renal AEs.
Conclusion: In a real-world setting, where the majority of patients had been on prior antibiotics, once-daily TLV was effective in treating a variety of infections due to S. aureus with decreased susceptibility to VAN.
Theravance Biopharma, US:
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C. Clay, 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 .