Pharmacology Rounds: Antibiotic Issues

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Nurses Edition Commentary

Kathy Garvin, RN and Lisa Chavez, RN

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jack B. -

I can appreciate the role of fidaxomicin for recurrent CDI but frankly I can't agree on using it on all comers presenting w CDI to the ED as first line blanket treatment for all. The guidelines conclude the initial cure rate and mortality is the same for vancomycin vs Fidaxomicin. Sure I might be tempted to use Fidax on someone at risk for recurrence but many can wait for trial of oral vancomycin to work given substantial price tag of Fidax ($6,204.00 for 20 tabs {source Mckesson} for Fidax vs $~180 for 10 day oral vancomycin). That is a staggering price tag for an antibiotic where old fashioned Vanco may well work for the majority of cases CDI (granted success will vary depending on risk factors). But given mortality and initial cure rates are the same, many of our uninsured or underinsured w large copays will end up on Vanc. The 2021 guidelines clearly state, "Vacomycin remains an acceptable alternative." Commentators seemed to conclude Fidax was the new, better way to go.

More importantly, the commentators should have emphasized that vanc is still the drug of choice for fulminant/severe CDI. CID Clinical Practice Guidlelines 2021 state:
"The previous iteration of the guidelines also recommends vancomycin (500 mg 4 times daily orally or by nasogastric tube) rather than fidaxomicin for treatment of fulminant (previously known as severe, complicated) CDI. This recommendation remains unchanged. Fulminant CDI is not common. Furthermore, the studies demonstrating equivalent efficacy for fidaxomicin and vancomycin in initial clinical response to therapy for CDI generally excluded patients with fulminant disease. Hence, there are no available data supporting the use of fidaxomicin for treatment of fulminant CDI."

jack B. -

Do a deeper dive on these expert guidelines- The recommendations for Fidaxo are based on RCTs HEAVILY funded and massaged by the manufacturers of Fidaxo (they helped write, revise manuscripts, fund, and or analyze statistics for most of the studies). The included RCTs studied mostly INPATIENTS. The only RCT which included about 40% outpatients in nejm was written and sponsored by the manufacturer of Fidaxo and this study showed no difference in clinical cure rate as its primary end point (like the rest of the mentioned studies). Many of the RCTs found recurrence rates of CDI higher w Vanco weeks later but no adverse event rate between vancomycin and Fidax was same / non-inferior in all studies .

These guidelines should not apply to outpatient treatment sent home from ED w Rx. Blanket statements that Fidaxo is superior for all CDIs is overly broad and not supported by the underlying studies. Perhaps Fidaxo has a role in some subset of patients / sicker inpatients. Perhaps one of the EBM gurus could chime in but the recommendations are not based on strong evidence in support of Fidaxo for all CDIs.

Would love to see a study of higher dose oral vancomycin vs Fidaxo- doubt the drug company would sponsor that !!

Tigecycline might stack up well vs FIdax in sicker inpatients as it shows good activity vs resistant strains and blocks toxin production.

Bryan H. -

Dear Jack,

Thanks for your comments and thorough review. There are two major guidelines related to C. diff, both published in 2021 - ACG and IDSA. They are in alignment on most recommendations. Our goal was to provide a brief summary of these two guidelines to answer the listener question on what they are recommending.

For non-severe, ACG recommends either vancomycin or fidaxomicin.

For severe, ACG recommends either vancomycin or fidaxomicin.

For fulminant, ACG recommends vancomycin. The 2021 iteration of IDSA does not discuss fulminant treatment. We also did not discuss fulminant cases in the segment.

IDSA discusses initial cases and recurrent episodes in the 2021 update. For both scenarios, they recommend fidaxomicin first with vanc as an acceptable alternative.

We agree with most of your statements. Cost is an important factor in choosing. The guidelines comment on this situation and say to choose the best option with available resources. We agree with their recommendation, which may mean vancomycin in our ED population (especially as outpatients). We also agree that manufacturer involvement, both in the studies of vancomycin and in the disclosure lists of authors on the two guidelines discussed, has an influence in their ultimate recommendations. This was mentioned in the segment.

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