Theravance Biopharma Reports Positive New VIBATIV® (telavancin) Data from TOUR™ Observational Patient Registry at 2017 CHEST Annual Meeting
Researchers presented preliminary data reported for 90 patients captured in the TOUR study with confirmed LRTIs. Among those patients, 80.0% had failed prior therapy, with 15.3% having failed two or more prior therapies. Eleven of the patients were considered non-evaluable due to missing or undocumented information. Of the 79 evaluable patients, positive clinical response was reported for 67.1%, with 19.0% failing to respond to treatment and 13.9% having an indeterminate outcome. Methicillin-resistant Staphylococcus aureus (S. aureus) or MRSA was the most common pathogen (52.2%) responsible for their LRTIs and 22.2% of patients had two or more pathogens associated with their infections. The median VIBATIV daily dose and duration of treatment were 690 mg and 8 days, respectively.
Among the 90 patients with LRTI, 52.2% were diagnosed as hospital-acquired bacterial pneumonia (HABP), while 8.9% were diagnosed as ventilator-associated bacterial pneumonia (VABP). For HABP, a positive clinical response was reported in 61.9% of evaluable patients, with 21.4% failing treatment and 16.7% having an indeterminate outcome. For VABP, a positive clinical response was reported in 75.0% of evaluable patients, with 12.5% failing treatment and 12.5% having an indeterminate outcome.
The data presented at CHEST included 16 patients with reported adverse events (AEs) of interest, which included renal AEs and AEs leading to discontinuation or fatal outcome. Eleven of these were deemed to be serious AEs. Twelve patients discontinued treatment with VIBATIV due to an AE of interest.
"Results from the TOUR study continue to demonstrate consistently positive clinical response rates following VIBATIV treatment across a broad range of infection types. What is striking about the positive clinical response rates seen in the LRTI patients, is that 80% of those patients had failed at least one previous antibiotic treatment regimen, suggesting that they were battling particularly difficult to treat infections," said
TOUR is a multi-center, observational study that has enrolled 1,063 patients from about 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.
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 U.S.,
In addition, we have an economic interest in future payments that may be made by
For more information, please visit www.theravance.com.
THERAVANCE®, the Cross/Star logo, and VIBATIV® are registered trademarks of the
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