Deciphering When to Use New Novel Agents in Clinical Practice

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

“I think these could actually 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 kind of firewall,” Hobbs said. “The 3 new ones that came out in the last year, all target [extended-spectrum beta-lactamase] ESBL infections. They're oral options for ESBL, which we already have limited options available.”

Hobbs presented at the recent ASM Microbe conference on the topic. She says all of them have potential usage and notes 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 notes other favorable aspects of the antimicrobial is that it has been approved and prescribed outside the US for a number of years, which may prove there is more data published or in the process of being studied for different indications including complicated urinary tract infections, and pivmecillinam does not need to be dose adjusted for renal dysfunction.

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

“A lot of times in these non-academic 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 around when to use these new antimicrobials, and looking at complicated infections, Hobbs suggests infectious disease teams and microbiologists work together to understand better the pathologies being seen.

“Your infectious diseases 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.”