Theravance Biopharma Reports Positive Clinical Response Rates for Patients in TOUR™ Observational Patient Registry in Several Presentations at ECCMID 2017
The TOUR findings being reported at ECCMID are based on a review of preliminary data collected from the 593 patients that were enrolled in the registry as of
Complicated Skin and Skin Structure Infections (cSSSIs):
Researchers presented preliminary data reported for 279 patients captured in the TOUR study with confirmed cSSSIs. 62% of patients had been previously treated with other agents unsuccessfully. Positive clinical response was reported for 75.3% of these patients, with 9.3% of patients failing treatment and 15.4% considered non-evaluable. The predominant subtypes of cSSSIs included cellulitis (50.5%), abscess (22.2%), and surgical wound (15.4%), while the underlying pathogens causing the infections included methicillin-resistant Staphylococcus aureus (S. aureus) or MRSA (30.1%), methicillin-susceptible S. aureus or
Bone and Joint Infections:
Researchers presented preliminary data reported for 174 patients captured in the TOUR study with confirmed bone and joint infections. 72.4% of patients had been previously treated with other agents unsuccessfully. Positive clinical response was reported for 68.4% of these patients, with 10.3% of patients failing treatment and 21.3% considered non-evaluable. The underlying pathogens causing the infections included MRSA (40.2%),
"Bone and joint infections are one of those challenging infection types in which we are interested, particularly when those are caused by MRSA or
Lower Respiratory Tract Infections (LRTIs):
Researchers presented preliminary data reported for 36 patients captured in the TOUR study with confirmed LRTIs. 77.8% of patients had been previously treated with other agents unsuccessfully. Positive clinical response was reported for 58.3% of these patients, with 13.9% of patients failing treatment and 27.8% considered non-evaluable. The predominant subtypes of LRTIs were hospital-acquired bacterial pneumonia or HABP (44.4%) and ventilator-associated bacterial pneumonia or VABP (13.9%), while the most common underlying pathogen causing the infections was MRSA (61.1%). For these patients, the median VIBATIV daily dose and duration of treatment were 750 mg and 9 days, respectively. Of the 36 patients, eight patients had at least one adverse event and four patients had at least one serious adverse event. There were six deaths within 28 days of the first VIBATIV dose and two patients discontinued treatment due to an adverse event.
"Despite a majority of the LRTIs in the TOUR study being caused by MRSA, one of the most difficult-to-treat pathogens in the medical field, treatment with VIBATIV delivered a positive clinical response in more than 58% of all LRTI patients," stated
About TOUR
TOUR is a multi-center, observational study that has enrolled 1,000 patients from about 50 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.
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
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THERAVANCE®, the Cross/Star logo, and VIBATIV® are registered trademarks of the
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