Vibativ (telavancin) is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby Vibativ both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function.
Vibativ is specifically indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), or Enterococcus faecalis (vancomycin-susceptible isolates only).
Vibativ is supplied as a powder for reconstitution onto a solution designed for intravenous administration. The recommended initial dose is 10 mg/kg administered over a 60-minute period in patients >18 years of age by intravenous infusion once every 24 hours for 7 to 14 days.
The FDA approval of Vibativ was based on two identical randomized, multinational, multicenter, double-blinded trials (Trial 1 and Trial 2) comparing Vibativ (10 mg/kg IV every 24 hours) with vancomycin (1 g 590 IV every 12 hours) for 7 to 14 days. The trials enrolled 1,794 adult subjects with cSSSI with suspected or confirmed MRSA as the primary cause of infection. Of the 1,794 enrolled subjects, 1,410 (78.6%) were clinically evaluable. The primary endpoint was non-inferiority in terms of the clinical cure rate at the follow-up test-of-cure visit. Results are from the clinically evaluable population: Trial One Vibativ: 84.3% and Vancomycin: 82.8%. Trial Two Vibativ: 83.9% and Vancomycin: 87.7%.
Ongoing Study Commitments
Adverse events associated with the use of Vibativ may include, but are not limited to, the following:
Vibativ is a semisynthetic, lipoglycopeptide antibiotic. It inhibits bacterial cell wall synthesis by interfering with the polymerization and cross-linking of peptidoglycan. Telavancin binds to the bacterial membrane and disrupts membrane barrier function.
Wilson SE, O'Riordan W, Hopkins A, Friedland HD, Barriere SL, Kitt MM; ATLAS Investigators Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections associated with surgical procedures. American Journal of Surgery 2009 Jun;197(6):791-6
Stryjewski ME, Graham DR, Wilson SE, O'Riordan W, Young D, Lentnek A, Ross DP, Fowler VG, Hopkins A, Friedland HD, Barriere SL, Kitt MM, Corey GR; Assessment of Telavancin in Complicated Skin and Skin-Structure Infections Study Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections caused by gram-positive organisms. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America 2008 Jun 1;46(11):1683-93
Leonard SN, Rybak MJ Telavancin: an antimicrobial with a multifunctional mechanism of action for the treatment of serious gram-positive infections. Pharmacotherapy 2008 Apr;28(4):458-68
Stryjewski ME, Chu VH, O'Riordan WD, Warren BL, Dunbar LM, Young DM, Vallée M, Fowler VG Jr, Morganroth J, Barriere SL, Kitt MM, Corey GR; FAST 2 Investigator Group Telavancin versus standard therapy for treatment of complicated skin and skin structure infections caused by gram-positive bacteria: FAST 2 study. Antimicrobial Agents and Chemotherapy 2006 Mar;50(3):862-7
Stryjewski ME, O'Riordan WD, Lau WK, Pien FD, Dunbar LM, Vallee M, Fowler VG Jr, Chu VH, Spencer E, Barriere SL, Kitt MM, Cabell CH, Corey GR; FAST Investigator Group Telavancin versus standard therapy for treatment of complicated skin and soft-tissue infections due to gram-positive bacteria. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America 2005 Jun 1;40(11):1601-7
For additional information regarding Vibativ or complicated skin and skin structure infections due to gram positive bacteria, please visit the Vibativ web page.