Top 5 Infectious Disease News Stories Week of March 22-29

FDA Approves Gepotidacin (Blujepa) for Uncomplicated Urinary Tract Infections

The FDA has approved gepotidacin (Blujepa), a new oral antibiotic for treating uncomplicated urinary tract infections (uUTIs) in females aged 12 and older. This approval marks the first new class of oral antibiotics for uUTIs in nearly 30 years. GSK's gepotidacin was shown to be non-inferior to nitrofurantoin in the pivotal EAGLE-2 trial and superior in the EAGLE-3 trial. It offers an alternative treatment with a novel mechanism and a different side effect profile, potentially helping to reduce resistance and improve care for patients who do not respond to existing therapies. Gepotidacin’s safety profile was consistent with previous studies, with gastrointestinal issues like diarrhea and nausea being the most common adverse events. GSK plans to launch Blujepa commercially in the US in late 2025.

FDA Approves F8 Formulation of Theratechnologies' Tesamorelin for HIV-Associated Lipodystrophy

The FDA has approved Theratechnologies’ new formulation of tesamorelin, EGRIFTA WR (Tesamorelin F8), for managing excess abdominal fat in adults with HIV-associated lipodystrophy. This new formulation offers a more convenient weekly dosing regimen, replacing the previous daily reconstitution required with EGRIFTA SV, reducing patient burden and improving adherence. Tesamorelin F8 maintains the efficacy of its predecessor while using less than half the injection volume. In an interview with Christian Marsolais, PhD, Theratechnologies’ Chief Medical Officer, he emphasized that the simpler dosing schedule would enhance patient comfort and long-term treatment adherence. The approval follows a thorough review by the FDA and addresses concerns from a prior response letter. Additionally, Theratechnologies presented new data at the 2025 CROI conference highlighting the limitations of BMI in assessing cardiovascular risk in people with HIV, advocating for more accurate measures like waist circumference to better predict health outcomes.

Clinical Insights on HIV-Associated Visceral Fat Following FDA Approval of Tesamorelin F8

The FDA has approved Theratechnologies' EGRIFTA WR (Tesamorelin F8) for the treatment of excess visceral abdominal fat in adults with HIV-associated lipodystrophy. This new formulation simplifies the treatment regimen by reducing the dosing frequency from daily to weekly reconstitution. In an interview with David Wohl, MD, he discussed the complexities of diagnosing and managing ectopic fat (EFA) in HIV patients. Wohl emphasized that EFA is metabolically active and linked to adverse health outcomes such as cardiovascular disease, diabetes, and certain cancers. He also pointed out the challenges of treating EFA in HIV patients, as traditional weight-loss strategies like diet and exercise may not effectively target visceral fat without also affecting subcutaneous fat. Wohl noted that Tesamorelin (Egrifta) provides a solution by specifically targeting visceral adiposity without impacting subcutaneous fat. Additionally, he suggested using waist circumference as a more reliable measure than BMI for assessing visceral fat in HIV patients.

With the Rise of COVID-19 Vaccines, a Greater Public Mistrust of Immunizations Has Taken Hold

The rise of COVID-19 vaccines, initially seen as a scientific triumph, has led to a paradoxical increase in public mistrust of immunizations. Despite their rapid development, misinformation and disinformation campaigns surrounding the vaccines fueled vaccine hesitancy, which has since extended to other vaccines, including those for childhood diseases like measles, mumps, and rubella (MMR). This trend has resulted in declining vaccination rates in the US, raising concerns about the resurgence of diseases once nearly eradicated. Robert Hopkins Jr., MD, explains that the public's trust was fractured by both misinformation and vaccine mandates, exacerbating existing mistrust that began with earlier controversies surrounding vaccines. The growing skepticism about vaccines is contributing to an uptick in outbreaks, such as the current measles cases in several states.

Identifying Invasive Pneumococci in Pediatric Infections Utilizing Whole Genome Sequencing

Invasive pneumococcal disease (IPD), caused by Streptococcus pneumoniae, remains a leading cause of severe infections like pneumonia, sepsis, and meningitis in young children. Diagnosing this bacterium in pediatric cases is particularly challenging due to difficulties in collecting respiratory samples and the limitations of current diagnostic tests. Dr. Jose Alexander, medical director of microbiology at AdventHealth, emphasizes the importance of whole genome sequencing (WGS) as a powerful tool for improving diagnosis and treatment. WGS offers a comprehensive genetic profile of the pathogen, enabling clinicians to identify antimicrobial resistance and adjust treatments in real time, ultimately enhancing patient outcomes. This advancement is particularly valuable in low- and middle-income countries, where access to specialized microbiology labs is limited. While vaccines have significantly reduced IPD, evolving unvaccinated serotypes highlight the ongoing need for robust testing and tailored treatment strategies.