This week, the FDA set a target date for lenacapavir’s approval, as rising cases of dengue, measles, and other emerging threats continue to spread, alongside a dairy worker transmitting avian flu to his cats.
The FDA has set a target action date of June 19, 2025, for the approval of lenacapavir as a twice-yearly HIV pre-exposure prophylaxis (PrEP), which, if approved, would be the first of its kind. Gilead’s submission is based on data from the phase 3 PURPOSE 1 and PURPOSE 2 trials, which demonstrated impressive results, showing up to a 100% risk reduction in some groups. Lenacapavir was initially developed for HIV treatment in multidrug-resistant cases and has already received FDA approval for this use. In addition to the US application, Gilead is working on strategies to make lenacapavir available globally, including through the EU-M4all process for low- and middle-income countries. While still investigational for PrEP, the drug holds significant potential for expanding HIV prevention options.
In 2024, infectious disease clinical science saw significant advancements, including new antibiotic trials and infection prevention strategies. However, the year also presented challenges, with rising concerns about emerging infections like dengue, mpox, measles, and H5N1 influenza. In an interview with Jeff Freiberg, MD, PhD he discussed the trends and findings from recent studies, emphasizing the increasing cases of dengue, particularly in Puerto Rico, and the resurgence of measles linked to lower vaccination rates. The spread of clade I mpox and the potential pandemic risk of H5N1 avian influenza also highlighted the ongoing need for vigilance and research in the field of infectious diseases.
Oliver A Cornely discusses the growing threat of Candida infections, highlighting the rise in resistance and recent taxonomic changes in Candida species. Candida infections, especially invasive forms like candidemia, are particularly dangerous for immunocompromised patients. With increasing resistance to antifungal agents like fluconazole, particularly in Candida auris and Candida parapsilosis, Cornely stresses the importance of early treatment with echinocandins for invasive infections. He also calls for microbiology labs to report both old and new species names for clarity, as recent taxonomic revisions may cause confusion. As antifungal resistance escalates, Cornely urges for new drug development and improved diagnostic tools, as well as more research into outbreaks and infection control measures to prevent further spread.
A recent post hoc analysis of the CAMERA2 clinical trial has revealed that persistent fever lasting beyond 72 hours is a stronger predictor of 90-day mortality in patients with MRSA bacteremia than traditional markers like CRP and WBC counts. The study, which involved 345 patients, found that persistent fever, particularly after day 4 of illness, was significantly associated with increased mortality. This suggests that fever is a more specific indicator of unresolved infections or ongoing source control issues. The findings emphasize the importance of clinicians focusing on persistent fever as part of risk stratification and considering personalized diagnostic and treatment strategies for MRSA bacteremia.
The CDC recently reported a case where two indoor domestic cats contracted HPAI A(H5N1), commonly known as avian influenza, in the homes of dairy workers. This marks the first instance of indoor cats testing positive for the virus, which had previously been documented in outdoor cats on dairy farms. Despite the cats showing severe symptoms, such as respiratory and neurological issues, the dairy workers declined testing, leaving uncertainty about whether they were infected. The findings raise concerns about the potential for reverse zoonotic transmission (from humans to animals) and the challenges in preventing further spread due to lack of personal protective equipment (PPE) use by the workers. The CDC emphasizes the need for veterinarians in affected areas to take precautions when treating cats with symptoms of avian influenza, including wearing PPE and reporting suspected cases to health officials.