Cases and transmission of highly contagious fungal infections see dramatic increase between 2019 and 2021

1. Cases and transmission of highly contagious fungal infections see dramatic increase between 2019 and 2021
Many cases resistant to first-line treatment
Abstract: https://www.acpjournals.org/doi/10.7326/M22-3469
URL goes live when the embargo lifts
A study of national surveillance data found that cases of Candida auris, a highly contagious fungal infection, rose drastically between 2019 and 2021 reflecting increased transmission. The researchers also noted an increase in echinocandin-resistant cases and evidence of transmission, which is particularly concerning because echinocandins are first-line therapy for invasive Candida infections, including C auris. These findings emphasize that improved detection and infection control practices are urgently needed to prevent the spread of C auris. The report is published in Annals of Internal Medicine.

Since being initially reported in the United States in 2016, the emerging fungus Candida auris has continued to cause illness and death nationwide. The Centers for Disease Control and Prevention (CDC) rated C auris as an “urgent threat,” the highest level of concern, because it is often multidrug-resistant; spreads easily in health care facilities; and can cause severe, invasive infections with high mortality rates. Most transmission occurs in healthcare facilities, especially among residents of long-term care facilities or among persons with indwelling devices or mechanical ventilators.

Researchers from the Centers for Disease Control and Prevention used national surveillance data on clinical and screening C auris cases reported to state and local health departments and the CDC to describe recent changes in the U.S. epidemiology of C auris between 2019 and 2021. They also examined data from CDC's Antimicrobial Resistance Laboratory Network (AR Lab Network). The data showed that the percentage increase in clinical cases grew each year, from a 44 percent increase in 2019 to a 95 percent increase in 2021. They also report that colonization screening volume and screening cases increased in 2021 by more than 80 percent and more than 200 percent, respectively. The number of C auris cases that were resistant to first-line treatment in 2021 was about 3 times that in each of the previous 2 years. According to the authors, the timing of this increased C auris spread and findings from public health investigations suggest it may have been exacerbated by pandemic-related strain on the health care and public health systems, which included staff and equipment shortages, increased patient burden and disease severity, increased antimicrobial use, changes in patient movement patterns, and poor implementation of non–COVID-19 IPC measures.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Meghan Lyman, MD, Medical Officer, please email Katia Martinez at Pqh9@cdc.gov.
--------------------------------
2. Government-mandated drug safety program effective in reducing prenatal exposure to weight-loss drug phentermine-topiramate
Abstract: https://www.acpjournals.org/doi/10.7326/M22-1743
URL goes live when the embargo lifts
A study of nationwide automated healthcare records found that prenatal exposure to phentermine and topiramate extended-release capsules (phentermine-topiramate) was generally low under the Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) compared to prenatal exposure to comparison medications that were not subject to REMS- topiramate alone or other medications used to treat obesity. The findings are published in Annals of Internal Medicine.

In 2012, the FDA approved the use of the combination product phentermine-topiramate for long-term obesity management. Single-ingredient topiramate product, approved for treatment of epilepsy in 1996, is now used for a variety of indications, including weight loss. Its association with risks for birth defects is well established. Because of specific focus on weight loss for the new combination product, representing many persons of child-bearing age, phentermine-topiramate was approved with the requirement of a REMS aimed at preventing prenatal exposure. REMS is an FDA-mandated drug safety program implemented by the manufacturer to ensure that prescribers, pharmacists, and patients are informed about certain drug safety risks.

Researchers from the University of Florida studied insurance claim data for 156,280 treatment episodes among women aged 12 to 55 to evaluate the rate of prenatal exposure, contraceptive use, and pregnancy testing among patients initiating phentermine–topiramate compared to those who started topiramate (with birth defect risk) or other antiobesity medications (without birth defect risk). The authors found that the use of phentermine-topiramate was associated with half the risk for exposure during pregnancy compared to either of the control groups. They also found that only 1 in 5 patients used contraceptives before and during treatment overall, and only 1 in 20 patients had pregnancy tests before medication initiation. The authors note that younger patients used more contraceptives and pregnancy tests than their older counterparts, but the absolute risk for prenatal exposures was also higher. The authors note that the effectiveness of the REMS in reducing prenatal exposure is promising, but also emphasize the need for further clinical vigilance and risk mitigation, including topiramate products which do not have a REMS and exhibited higher prenatal exposure rates.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with the corresponding author, Amir Sarayani, PharmD, MPH, PhD, please email Matthew Splett at msplett@ufl.edu.
--------------------------------
Also new in this issue:
Assessing Heterogeneity of Treatment Effect in Real-World Data
Jodi B. Segal, MD, MPH*; Ravi Varadhan, PhD, PhD*; Rolf H.H. Groenwold, MD, PhD; Xiaojuan Li, PhD; Kaori Nomura, MPH, PhD; Sigal Kaplan, PhD; Shirin Ardeshirrouhanifard, PharmD, PhD; James Heyward, MHS; Fredrik Nyberg, PhD; and Mehmet Burcu, PhD
Research & Reporting Methods
Abstract: https://www.acpjournals.org/doi/10.7326/M22-1510