ABSTRACT
WHAT IS KNOWN AND OBJECTIVE: 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. METHODS: 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. RESULTS AND DISCUSSION: 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. WHAT IS NEW AND CONCLUSION: 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.
Subject(s)
Aminoglycosides/administration & dosage , Anti-Bacterial Agents/administration & dosage , Clostridium Infections/drug therapy , Practice Patterns, Physicians'/statistics & numerical data , Adult , Clostridium Infections/diagnosis , Fidaxomicin , Guideline Adherence , Humans , Practice Guidelines as Topic , Recurrence , Retrospective Studies , United States , United States Department of Veterans AffairsABSTRACT
OBJECTIVES: The increased incidence and severity of Clostridium difficile infection (CDI) are thought to result partly from the emergence of the hypervirulent BI/NAP1/027 strain. Limited recent data are available on the prevalence of BI/NAP1/027 in the United States (US). The objective of this study was to assess the recent prevalence of BI/NAP1/027 within the US Veterans Health Administration (VHA). METHODS: Patients with CDI at any Veterans Affairs Medical Center found to routinely test for the presence of BI/NAP1/027 during the study period were included between 1 June 2011 and 30 June 2016 in this retrospective, observational, nationwide study. RESULTS: In total, 7571 patients had 8224 positive C. difficile tests that had a corresponding BI/NAP1/027 test. Of those, there were 1810 (22.0%) presumptive positive for BI/NAP1/027. The overall prevalence of BI/NAP1/027 decreased from a high of 26.2% in 2013 to 16.9% in 2016. Statistically significant reductions in rates from 2012 to 2016 occurred in seven of nine US Census Bureau regions. CONCLUSIONS: The prevalence of C. difficile with the BI/NAP1/027 strain was 22.0% across the VHA between 2012 and 2016. Further studies are needed to confirm these results and for continued monitoring of the trends in BI/NAP1/027 prevalence.
