Theravance Biopharma Reports Positive New Data from Multiple Studies of VIBATIV® (telavancin) at 2018 ECCMID™ Conference
The TOUR findings reported at ECCMID are based on a review of data collected from the fully enrolled registry of 1,063 patients. The Company expects future TOUR analyses to be updated as additional data become available. Details from the two TOUR-related ECCMID presentations are as follows:
Obese Patients in TOUR:
Researchers presented data reported for 507 patients in the TOUR study classified as obese (body mass index ≥ 30 kg/m2). The infection types reported for these patients included complicated skin & skin structure infections (cSSSIs) (53.6%), bone and joint infections (27.8%), bacteremia and endocarditis (9.9%), and lower respiratory tract infections (5.1%). Of these patients, 72.2% failed treatment with initial antibiotic therapy prior to receiving VIBATIV.
Among the patients who had an outcome assessment at end of therapy (EOT) with VIBATIV (n = 458), 78.8% were cured or improved to step-down therapy, 9.2% failed treatment and 12.0% had an indeterminate clinical outcome. The median VIBATIV daily dose and duration of treatment were 7.3 mg/kg and 11 days, respectively. Of the 507 patients, 82 reported an adverse event. Renal failure, the most commonly occurring adverse event, was reported in 28 of the 507 patients and resolved in the majority of these cases. There were no new safety signals identified in this patient subset.
"Obese patients are an interesting TOUR study subgroup as data show that obesity is a risk factor for developing complicated skin & skin structure infections that are associated with MRSA. Highlighting this increased risk is the fact that more than half of the obese patients in TOUR presented with a complicated skin & skin structure infection," said
Elderly Patients in TOUR:
Researchers presented data reported for 312 patients in the TOUR study classified as elderly (≥ 65 years of age). The infection types reported for these patients included cSSSIs (47.4%), bone and joint infections (26.0%), bacteremia and endocarditis (17.3%), and lower respiratory tract infections (9.6%). Of these patients, 67.3% failed treatment with initial antibiotic therapy prior to receiving VIBATIV.
Among the patients that had an outcome assessment at EOT with VIBATIV (n = 289), 76.5% were cured or improved to step-down therapy, 11.8% failed treatment and 11.8% had an indeterminate clinical outcome. The median VIBATIV daily dose and duration of treatment were 8.3 mg/kg and 10 days, respectively. Of the 312 patients, 55 reported an adverse event. Renal failure, the most commonly occurring adverse event, was reported in 25 of the 312 patients and resolved in the majority of these cases. There were no new safety signals identified in this patient subset.
"Due to the chronic comorbidity commonly associated with the elderly population, this group is at an elevated risk of acquiring serious infections such as those reported in the TOUR study. Accordingly, there is significant value in using an antibiotic against challenging infections that is highly effective at either curing elderly patients or improving their condition enough to allow step-down therapy," said
Activity Against Challenging Gram-Positive Clinical Isolates:
In addition to data collected as part of the TOUR study, researchers also presented results from a third study evaluating the in vitro activity of several antibiotics, including VIBATIV, against 24,408 Gram-positive clinical isolates collected from medical centers around the world from 2015-2017. 100% of the evaluated S. aureus isolates were susceptible to VIBATIV as measured by the
VIBATIV possessed greater in vitro activity than vancomycin, daptomycin and linezolid demonstrated by minimum inhibitory concentrations (MICs) that were 8- to 32-fold lower than for those other antibiotics against all the S. aureus isolates tested, including MDR MRSA. VIBATIV maintained potent in vitro activity against ceftaroline-nonsusceptible S. aureus, MDR coagulase-negative staphylococci, β-haemolytc streptococci and Streptococcus pneumoniae isolate subsets. MICs are a measure used to express in vitro activity of an antibiotic against a pathogen.
"Our ongoing surveillance of active global Gram-positive clinical isolates and the susceptibility of those pathogens to current antibiotic treatments continues to demonstrate that VIBATIV possesses greater in vitro potency than several well-known competitor antibiotics," said
TOUR is a multi-center, observational study that has enrolled 1,063 patients from 45 sites in the US. As a non-interventional study, all treatment decisions are at the discretion of the patient's healthcare provider. Study patients may have treatment initiated in either hospital-based settings or out-patient infusion sites. In order to qualify for enrollment in TOUR, patients must have received at least one dose of VIBATIV and meet specified inclusion criteria. By broadly collecting and examining real-world data related to VIBATIV treatment patterns, clinical effectiveness and safety outcomes in medical practice,
- Assisting in optimizing use in patients currently being treated with VIBATIV;
- Potentially highlighting subsets of patients that may be most appropriate for treatment with VIBATIV; and
- Illustrating current healthcare practitioner's patterns of VIBATIV use.
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 MSSA. VIBATIV is a once-daily, injectable lipoglycopeptide antibiotic with in vitro potency, bactericidal activity within six hours, and penetration into target infection sites. The drug is approved in the U.S. for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of S. aureus when alternative treatments are not suitable. In addition, VIBATIV is approved in the U.S. for the treatment of adult patients with complicated skin & skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including S. aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains. The product labeling also describes the use of VIBATIV in treating patients whose pneumonia or skin infection is complicated by concurrent bacteremia.
The product's proven efficacy against difficult-to-treat Gram-positive infections has been demonstrated in several large, multinational registrational studies, which involved one of the largest cohorts of patients with S. aureus infections studied to date. Importantly, these studies demonstrated significantly higher cure rates for VIBATIV as compared to vancomycin in HABP/VABP due to any single Gram-positive pathogen or S. aureus with vancomycin MIC ≥1 µg/mL. Additionally, there is extensive and well-documented evidence of the drug's in vitro potency and in vivo activity against a broad collection of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.
VIBATIV is also approved for marketing in
VIBATIV®(telavancin)Important Safety Information
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.
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.
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.
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.
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.
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.
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.
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