Deciphering When to Use Novel Agents in Clinical Practice

Since 2024, 3 antimicrobials—gepotidacin (Blujepa), sulopenem etzadroxil and probenecid (Orlynvah), and pivmecillinam (Pivya)—have all been FDA approved and indicated to treat uncomplicated urinary tract infections (UTIs). Interestingly, Athena Hobbs, PharmD, BCIDP, clinical pharmacy manager and infectious diseases specialist at Cardinal Health, points out the utility to prescribe them now.

“I think these could be used in the outpatient setting quite frequently. This might be an opportunity for us to use a lot of new agents as opposed to keeping them behind that antimicrobial stewardship firewall,” Hobbs said. “The 3 new ones that came out in the last year all target ESBL [extended-spectrum β-lactamase] infections. They're oral options for ESBL, which we already have limited options available [for].”

Hobbs presented at the recent American Society for Microbiology Microbe conference on the topic. She said all of them have potential usage and noted the novelty and potential utility of pivmecillinam.

“Pivmecillinam is really interesting in that it's a very narrow-spectrum agent that targets ESBL infections and uncomplicated urinary tract infections,” Hobbs said.

She noted another favorable aspect of the antimicrobial is that it has been approved and prescribed outside the US for a number of years, which may prove there are more data published or in the process of being studied for different indications, including complicated UTIs, and pivmecillinam does not need to be dose-adjusted for renal dysfunction.

She did acknowledge there is a whole host of challenges to using new antimicrobials, including costs, limited clinical data, and the diagnostic capabilities of the individual institutions.

“A lot of times in these nonacademic medical facilities, they don't necessarily have that kind of testing ability, and so it's a concern. When you get a susceptibility profile, all you have is the phenotypic results, and you see it's resistant to a carbapenem. What do you do next?" Hobbs asked. “In the clinical world, you don't always have the right tools to be able to tell what you need to use.”

In terms of concerns about when to use these new antimicrobials and looking at complicated infections, Hobbs suggested infectious disease teams and microbiologists work together to better understand the pathologies being seen.

“Your infectious diseases [ID] physician [can] partner with your microbiologist to help identify the organism and figure out what are the mechanisms of resistance,” Hobbs said. “Your ID pharmacist can look at the pharmacokinetics and pharmacodynamics of the agents and figure out where we anticipate the agent to be able to get in the body and what kind of infections they might be able to treat.”