New Data for VIBATIV® (telavancin) Reported in Presentations at IDWeek™ 2016
Retrospective Study of Osteomyelitis Patients
Reports from a retrospective chart review of 32 osteomyelitis patients treated with VIBATIV in clinical settings in six
"Although osteomyelitis is not currently an approved indication for VIBATIV, these encouraging study results merit further investigation and may suggest that osteomyelitis, particularly when caused by MRSA, is another serious infection type against which VIBATIV appears to have had positive clinical outcomes," stated
Highlights from other VIBATIV data presentations at IDWeek 2016 include:
Findings Related to in vitro Potency
Results of a study showed that VIBATIV possessed significant in vitro activity that was greater than the other antibiotics evaluated in an assessment against difficult-to-treat MRSA pathogens collected from a community hospital in the Mid-Michigan area. This in vitro potency was seen even though VIBATIV was tested at only 50% of its peak clinical levels, while the other antibiotics were tested at 100% of peak clinical levels. Even at 50% peak clinical levels, researchers observed VIBATIV to be bactericidal, exhibiting a rapid and prolonged decrease in pathogen levels. The other antibiotics tested were vancomycin, daptomycin, linezolid and ceftaroline.
Healthcare Cost and Renal Function Impact
Two company-sponsored retrospective analyses of data from the previously completed Phase 3 ATTAIN (Assessment of Telavancin for Treatment of Hospital-Acquired Pneumonia) studies were conducted to compare VIBATIV to vancomycin in terms of overall healthcare costs and outcomes, as well as renal function impact. The ATTAIN studies were registrational trials which supported the regulatory approval of telavancin (marketed as VIBATIV) for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
• Results from one analysis showed that overall healthcare costs were similar for the population of patients with HABP caused by S. aureus (SA-HABP) that were treated with either VIBATIV or vancomycin. VIBATIV was associated with higher drug and nephrotoxicity costs, which were offset by lower intensive care unit and ventilator costs. Overall, the clinical cure rate for VIBATIV-treated patients was 5.9% higher than for vancomycin-treated patients.
For patients with monomicrobial SA-HABP, a population for which VIBATIV has previously demonstrated statistically significant improvements in clinical cure rates as compared to vancomycin, the analysis showed that VIBATIV led to higher clinical cure rates by 10.1% and net cost savings of
• Results from a second analysis demonstrated that renal shift tables may provide a useful assessment of the timing and magnitude of antibiotic-associated renal function changes. Shift tables were created by grouping patients in the ATTAIN studies based on creatinine clearance levels and researchers evaluated whether patients shifted between these groups (either positively or negatively) at specified treatment time points.
Findings showed that a comparable majority of VIBATIV-treated patients (67%) and vancomycin-treated patients (63%) experienced no categorical shifts in creatinine clearance, suggesting little to no change in their renal function as a result of treatment. Regardless of treatment received, at each time point analyzed approximately 25% of patients had a Grade 1 shift (one category shift in a positive or negative direction) in creatinine clearance. Negative shifts in creatinine clearance categories during the course of the study were observed in similar proportions for patients treated with VIBATIV (25.1%) and vancomycin (21.2%).
"Interestingly, our retrospective analytical modeling of data from the ATTAIN studies highlights a specific patient population that not only achieved better clinical outcomes with VIBATIV but also incurred lower overall healthcare costs as compared to vancomycin," said
About VIBATIV® (telavancin)
VIBATIV® was discovered internally in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus (S. aureus) and other Gram-positive bacteria, including MRSA and
VIBATIV is also approved for marketing in
VIBATIV® Important Safety Information
Mortality
Patients with pre-existing moderate/severe renal impairment (CrCl ≤50 mL/min) who were treated with VIBATIV® for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia had increased mortality observed versus vancomycin. Use of VIBATIV in patients with pre-existing moderate/severe renal impairment (CrCl ≤50 mL/min) should be considered only when the anticipated benefit to the patient outweighs the potential risk.
Nephrotoxicity
New onset or worsening renal impairment occurred in patients who received VIBATIV. Renal adverse events were more likely to occur in patients with baseline comorbidities known to predispose patients to kidney dysfunction and in patients who received concomitant medications known to affect kidney function. Monitor renal function in all patients receiving VIBATIV prior to initiation of treatment, during treatment, and at the end of therapy. If renal function decreases, the benefit of continuing VIBATIV versus discontinuing and initiating therapy with an alternative agent should be assessed.
Fetal Risk
Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV. Avoid use of VIBATIV during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. Adverse developmental outcomes observed in three animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans. If not already pregnant, women of childbearing potential should use effective contraception during VIBATIV treatment.
Contraindication
Intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after VIBATIV administration.
VIBATIV is contraindicated in patients with a known hypersensitivity to the drug.
Hypersensitivity Reactions
Serious and potentially fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses. VIBATIV should be used with caution in patients with known hypersensitivity to vancomycin.
Geriatric Use
Telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group.
Infusion Related Reactions
VIBATIV is a lipoglycopeptide antibacterial agent and should be administered over a period of 60 minutes to reduce the risk of infusion-related reactions. Rapid intravenous infusions of the glycopeptide class of antimicrobial agents can cause "Red-man Syndrome" like reactions including: flushing of the upper body, urticaria, pruritus, or rash.
QTc Prolongation
Caution is warranted when prescribing VIBATIV to patients taking drugs known to prolong the QT interval. In a study involving healthy volunteers, VIBATIV prolonged the QTc interval. Use of VIBATIV should be avoided in patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy.
Most Common Adverse Reactions
The most common adverse reactions (greater than or equal to 10% of patients treated with VIBATIV) were diarrhea, taste disturbance, nausea, vomiting, and foamy urine.
Full Prescribing Information, including Boxed Warning and Medication Guide in the
About
Our pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions primarily in the acute care setting. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the
In addition, we have an economic interest in future payments that may be made by
For more information, please visit www.theravance.com.
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