
Methods: We conducted a multicenter, retrospective chart review of patients receiving TLV for the treatment of osteomyelitis. After institutional review board approval, data were collected from six different medical centers across the United States. The primary outcome measure was the percent of patients cured or improved at the end of therapy (EOT). Cure was resolution of signs and symptoms with no additional antibiotics required and improvement was resolution of signs and symptoms but additional antibiotic therapy was needed after TLV therapy. The secondary outcome was the percent of patients cured or improved on follow-up at three months after discontinuation of therapy
Results: There were 32 cases of osteomyelitis with a mean age of 57.9 ± 17.0 y, and 62.5 % (20/32) were male. S. aureus was the most common pathogen in 18 (17 MRSA and 1 MSSA) followed by coagulase negative staphylococci in six. 56% were considered acute, and prostheses were present in 18.8%. At EOT, 87.5% (28/32) were considered cured or improved, with 9.4% (3/32) treatment failures and one death associated with infection. Follow-up at three months revealed that 91.3% had their infection cured or improved and 8.7% were failures. The mean durations of all antibiotic therapy and TLV therapy alone were 49.8 ± 34.3 and 33.6 ± 19.7 days, respectively. Additional antibiotics were given along with TLV in 62.5%. Serum creatinine increased two fold in 6.7% of patients with the mean serum creatinine rising from 1.0 ± 0.58 mg/dl at the onset of TLV to a maximum value of 1.30 ± 0.83 mg/dl with a final creatinine of 1.12 ± 0.49 mg/dL. Rises in serum creatinine led to discontinuation of TLV in two patients. The most common side effect was nausea in 25% (8/32) which led to discontinuation in 9.4% (3/32) patients
Conclusion: When evaluated in a retrospective observational case series in clinical practice, TLV therapy for osteomyelitis demonstrated a favorable outcome but prolonged therapy may be associated with gastrointestinal adverse events.

L. Saravolatz,
Theravance Biopharma US Inc.:
Grant Investigator
and
Speaker's Bureau
,
Grant recipient
and
Speaker honorarium
TAXIS:
Research Contractor
,
Research grant
A. Hassoun, Theravance Biopharma US Inc.: Consultant and Speaker's Bureau , Consulting fee and Speaker honorarium
K. Cleveland, Theravance Biopharma: Scientific Advisor and Speaker's Bureau , Consulting fee and Speaker honorarium
K. Rikabi, None
J. Reilly, Theravance: Scientific Advisor and Speaker's Bureau , Consulting fee and Speaker honorarium
S. Szpunar, None
S. Valenti, None
L. B. Johnson, None
See more of: Poster Abstract Session