Vibativ (telavancin) - 2 indications

Scroll down for more information on each indication:

• for the treatment of complicated skin and skin structure infections; approved September 2009
• for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by staph aureus; approved June 2013

General Information

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 following:

• 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).
• for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and -resistant isolates). Vibativ should be reserved for use when alternative treatments are not suitable.

Vibativ is supplied as a solution for intravenous infusion. The recommended dose is 10 mg/kg by IV infusion over 60 minutes every 24 hours for 7 to 14 days for cSSSI and for 7 to 21 days for HABP/VABP.

Mechanism of Action

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.

Side Effects

Adverse events associated with the use of Vibativ may include, but are not limited to, the following:

• taste disturbance
• nausea
• vomiting
• foamy urine
• diarrhea
• pruritus

Indication 1 - for the treatment of complicated skin and skin structure infections

approved September 2009

Clinical Trial Results

The FDA approval of Vibativ for cSSSI 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%.

Indication 2 - for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia caused by staph aureus

approved June 2013

Clinical Trial Results

The FDA approval of Vibativ for hospital-acquired and ventilator-associated pneumonia was based on two randomized, parallel-group, multinational, multicenter, double-blinded trials of identical design comparing Vibativ (10 mg/kg IV every 24 hours) with vancomycin (1 g IV every 12 hours) for 7 to 21 days. The subjects were premitted concomitant medication for gram-negative infections. All subjects had known or suspected infections due to methicillin-resistant Staphylococcus aureus. A total of 1,532 subjects were enrolled. The trials measured the percentage of subjects who died from any cause (all-cause mortality) 28 days after the initiation of treatment. Mortality rates were comparable between the Vibativ and vancomycin treatment arms, except for subjects who had pre-existing kidney problems. During clinical trials, more subjects with pre-existing kidney problems treated with Vibativ died compared to those treated with vancomycin.