Evaluation of fidaxomicin usage patterns and outcomes for Clostridium difficile infection across the United States Veterans Health Administration.

Abstract

Fidaxomicin was recently approved for the treatment of Clostridium difficile infection (CDI). Limited data on its use exist outside of the phase 3 trials. The purposes of this study were to assess the compliance with the Veterans Health Administration (VHA) fidaxomicin criteria for use and describe patient characteristics and outcomes following fidaxomicin treatment for CDI using real-world data within the VHA system. This was a multicentre, retrospective, observational study including all adult patients who received at least 1 dose of fidaxomicin at any Veterans Affairs Medical Center. A total of 880 unique patients received 1098 courses of fidaxomicin, resulting in an overall usage rate per C.difficile-positive laboratory test of 1.98%. The rate of fidaxomicin courses per 1000 C.difficile-positive diagnostic tests increased steadily from 2011 through 2015 and plateaued from 2015 to 2016. Compliance with the VHA criteria for use was low (9.1%). The majority of courses were given for a first recurrence (25.0%), followed by an initial episode (23.9%) of CDI. The failure and recurrence rates were 6.8% and 24.4%, respectively. Although overall use of fidaxomicin was low, compliance with the VHA criteria for use was also low, suggesting that the criteria may need to be revised. Further studies are warranted to clarify the role of fidaxomicin in clinical practice.