Theravance's Vibativ Effective In Treating Skin Structure Infections
By Cyndi Root
Theravance announced in a press release that new studies of Vibativ (telavancin) confirmed efficacy in patients with complicated skin and skin structure infections (cSSSI), including methicillin-resistant Staphylococcus aureus (MRSA). The Food and Drug Administration (FDA) approved the drug in 2009 for cSSSI and in 2013, expanded the approval for patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus. Theravance presented the new findings at the 24th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Barcelona, Spain.
Vibativ
Vibativ (telavancin) is a lipoglycopeptide antibacterial drug discovered and developed by Theravance. The once-daily injectable antibiotic has a dual action mechanism. It inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. In Europe, the drug is used for the treatment of nosocomial pneumonia (NP) including ventilator-associated pneumonia, known or suspected to be caused by MRSA. Vibativ is not yet indicated for cSSSI or HABP/VABP in Europe.
Vibativ Studies
As Theravance states in its release, the most recent data on Vibativ shows that it is effective for MRSA and other gram-positive infections. Vibativ is not inferior to vancomycin and has positive attributes in vitro, in potency, in dosing, in its dual action mechanism, and in convenience. With its comprehensive and positive profile, Theravance recommends that health providers view it as an essential antibiotic. The company says that the growing concern over MRSA infections and antibiotic resistance makes the new data important as Vibativ has cure rates similar to vancomycin.
Additionally, a retrospective analysis showed a difference in the original Phase III analysis. The revised findings showed efficacy in patients with renal impairment, suggesting that Vibativ may not have been responsible for lower response rates in renal patients. The company intends to pay close attention to this result as it provides avenues for further research.
Another area of interest is the measurement of telavancin drug levels. The studies showed that immunoassays were not accurate or consistent in measuring telavancin plasma concentrations. Because telavancin is engineered from vancomycin, investigators are now aware that vancomycin immunoassays may not be effective for Vibativ.