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Positive Clinical Responses Reported for VIBATIV in Obese & Elderly Patients with cSSSIs

Researchers present positive new data from multiple studies of VIBATIV at the 2018 ECCMID conference in Madrid, Spain.

At the 28th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), representatives from Theravance Biopharma, Inc. presented positive new data gleaned from multiple studies involving telavancin, otherwise known as VIBATIV.

First discovered through a research program dedicated to developing new drugs in response to the growing threat of resistant bacteria and the life-threatening infections that result from them, telavancin is the only once-daily in vitro bactericidal antibiotic approved by the US Food and Drug Administration (FDA) for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), or complicated skin and skin structure infections (cSSSI), including methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (MSSA).

The data shared with conference attendees were from the Telavancin Observational Use Registry (TOUR) study, for which researchers sought to understand how telavancin is being used in real-world clinical settings by health practitioners; the fully enrolled registry consisted of 1063 patients from 45 sites throughout the United States.

In 2 presentations, representatives shared data pertaining to 2 specific patient subgroups—those who were classified as obese or elderly, as these patients are known to be at increased risk of developing complicated or serious infections. Overall, the treatment resulted in positive clinical responses, ranging from 76.5% to 78.8% in these patients.

In the first presentation, representatives presented data looking at a total of 507 patients from the TOUR study, who had been classified as obese (body mass index ≥ 30 kg/m2.)

“Obese patients are an interesting TOUR study subgroup as data show that obesity is a risk factor for developing complicated skin and skin structure infections that are associated with MRSA,” Adnan Siddiqui, MD, an infectious disease expert at BJC Christian Northeast Hospital, explained in a recent statement. Dr. Siddiqui is also a lead author of one of the TOUR presentations at ECCMID. “Highlighting this increased risk is the fact that more than half (53.6%) of the obese patients in TOUR presented with a complicated skin and skin structure infection.”

Other infection types reported for these patients included bone and joint infections (27.8%), bacteremia and endocarditis (9.9%), as well as lower respiratory tract infections (5.1%). Of these patients, a staggering 72.2% failed treatment with initial antibiotic therapy previous to receiving telavancin.

However, at end of therapy with telavancin, 78.8% of the patients were either cured or improved to step-down therapy; 9.2% still failed treatment and another 12% had an indeterminate clinical outcome. According to the press release, the median dose and treatment duration was 7.3 mg/kg and 11 days, respectively. Eighty-two (16.2%) of the patients reported an adverse event. The most common adverse event was renal failure, and it was reported in 28 (5%) of patients; the majority of the cases resolved.

“The nearly 80% positive clinical response rate achieved with telavancin therapy in the obese patient subgroup is encouraging,” Dr. Siddiqui said, “particularly considering more than 70% of obese patients in TOUR received telavancin after failing treatment with an initial antibiotic.”

The second presentation delivered at ECCMID focused on data pertaining to 312 patients in the TOUR study who were classified as elderly (≥65 years of age).

“Due to the chronic comorbidity commonly associated with the elderly population, this group is at an elevated risk of acquiring serious infections,” Jeremy Storm, an infectious disease expert at Rapid City Medical Center in South Dakota, and lead author of 1 of the TOUR presentations, is quoted as saying in a recent statement.

The infection types reported for this patient subset included complicated skin and skin structure infections (47.4%), bone and joint infections (26%), bacteremia and endocarditis (17.3%), as well as lower respiratory tract infections (9.6%). A total of 67.3% of patients failed treatment with initial antibiotic therapy before taking telavancin.

“There is significant value in using an antibiotic against challenging infections that is highly effective in either curing elderly patients or improving their condition enough to allow step-down therapy,” Storm said. “VIBATIV was able to deliver a positive clinical response rate for more than 75% of these patients against a range of challenging infection types.”

However, 11.8% of patients still failed treatment and another 11.8% had an indeterminate clinical outcome, according to the release. The median daily dose and treatment duration for these patients was 8.3 mg/kg and 10 days, respectively. A total of 55 (~18%) of patients reported experiencing an adverse event. Again, the most common adverse event reported was renal failure, which occurred in 25 (8%) of the patients studied; it was resolved in most cases.

At ECCMID, investigators also shared results from a third study which looked at in vitro activity of several antibiotics (including telavancin) against a total of 24,408 Gram-positive clinical isolates collected from medical centers all around the world between 2015 and 2017.

They found that of all the Staphylococcus aureus isolates analyzed, 100% of them proved susceptible to telavancin, “as measured by the FDA-approved breakpoint, regardless of their type or resistance profile,” the release reads. This included isolates that were considered to be resistant to multiple drugs.

Researchers reported that telavancin proved to have “greater in vitro activity” than other antibiotics such as vancomycin, daptomycin, and linezolid, against all tested S. aureus isolates, including multidrug-resistant MRSA. This was demonstrated by minimum inhibitory concentrations (MICs) that were 8 to 32 times lower than for the other antibiotics.

“We believe that this greater in vitro activity, especially against pathogens that are as challenging to treat as MDR MRSA, highlights an important competitive advantage for VIBATIV in the product’s approved indications,” Christine Slover, PharmD, director of medical affairs at Thereavance said in a recent statement.