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Data in Europe confirm telavancin efficacy against ABSSSI
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Data from multiple studies released during the 2014 European Congress of Clinical Microbiology and Infectious Diseases demonstrate the in vitro potency of telavancin and its efficacy in patients with complicated skin and skin structure infections, including MRSA.
Telavancin (Vibativ, Theravance), an injectable antibiotic, is approved for use in the United States for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia caused by Staphylococcus aureus when no other treatment alternatives are suitable, and for the treatment of complicated skin and skin structure infections (cSSSI).
The first study was a retrospective analysis of Theravance Inc.’s phase 3 ATLAS trials that compared the efficacy of telavancin with vancomycin in patients with acute bacterial skin and skin structure infections (ABSSSI) using the FDA’s 2013 guidance on developing drugs for the treatment of ABSSSI. The analysis included 1,199 patients who received either a single daily dose of 10 mg telavancin or 1 g vancomycin every 12 hours. Results suggested that telavancin was noninferior to vancomycin in treating ABSSSI. However, unlike the results from the phase 3 trials, renal impairment was not associated with worse clinical response, suggesting that factors other than drug efficacy were responsible for poor clinical response in patients with severe renal impairment in the original analysis.
“In light of the medical and scientific community’s growing concern regarding the increasing prevalence of MRSA and potential for decreasing vancomycin susceptibility, having access to an antimicrobial with the efficacy of [telavancin] is important,” Samuel Wilson, MD, professor in the department of surgery, University of California, Irvine, and investigator in the ATLAS trials, said in a press release. “Furthermore, the value of [telavancin] will be enhanced if additional clinical research shows that renal impairment does not result in reduced clinical response to the treatment.”
Two additional studies presented at the congress demonstrated the potent in vitro activity of telavancin — the first against a collection of rarely isolated clinical pathogens from hospitals around the world, and the second against gram-positive organisms isolated from patients with cancer.
A fourth study evaluated whether commercially available vancomycin immunoassays can measure therapeutic drug levels of telavancin. However, researchers found that the assays were unable to reliably detect telavancin, despite the fact that telavancin is a derivative of vancomycin.
“As telavancin is re-engineered from vancomycin, there may be the assumption that vancomycin immunoassays can be effectively used to measure blood levels of telavancin,” Steve Barriere, PharmD, vice president of clinical and medical affairs at Theravance, said in the release. “However, there are currently no data to suggest the clinical utility of measuring telavancin concentrations in plasma. Furthermore, we have demonstrated with these study results that use of vancomycin immunoassays produces highly variable results. With approved dosing regimens, and appropriate adjustment for renal dysfunction, subsequently achieved concentrations of telavancin are well defined and predictable.”
For more information:
Barriere SL. Abstract #O153.
McConeghy K. Abstract #P1722.
Mendes RE. Abstract #eP201.
All presented at: European Congress of Clinical Microbiology and Infectious Diseases; May 10-13, 2014; Barcelona, Spain.