Treating precancerous anal lesions reduces risk of cancer in people with HIV
More than 10,723 people, age 35 years or older, living with HIV were surveyed. Patients diagnosed with HSIL (n=4,459) were randomly selected to receive treatment or active monitoring with no treatment. After a median follow-up of just over two years, among the patients who had received active monitoring and no treatment, 21 people were diagnosed with anal cancer. Of the patients who had received treatment for the HSIL diagnosis, nine people were diagnosed with anal cancer – a 57% reduction.
The study authors note that their findings could also lead to an increase in recommendations for HSIL screenings for people living with HIV, as well as change the standard of care for people with a lower but still increased risk of developing anal cancer. As for next steps in the study, researchers will use a recently developed biorepository of tissue samples, collected by the study participants, in the hopes of identifying biomarkers that may explain how HSIL develops into anal cancer.
Moderna and Pfizer COVID-19 vaccinations approved for children 6 months and older
The U.S. Food and Drug Administration (FDA) recently approved emergency use of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine in children 6 months or older. The FDA amended the emergency use authorization (EUA) for the Moderna and Pfizer COVID-19 vaccines in June 2022. For the Moderna vaccination, which has been approved for use in adults 18 years and older, the EUA has been amended to include all children ages 6 months to 17 years. For the Pfizer vaccination, which has been approved for use in children and adults 5 years and older, the EUA has been amended to include all children ages 6 months to 4 years.
According to the FDA, the benefits of vaccinating children 6 months and older outweighs the known health threats and potential risks posed by these COVID-19 vaccines. This is not to say that the FDA’s evaluation and analysis of the safety, effectiveness, and manufacturing data were not rigorous and comprehensive. All evaluation of these vaccines supports the amended EUAs for the Moderna and Pfizer COVID-19 vaccinations. The amended EUAs were also supported by the FDA’s independent Vaccines and Related Biological Products Advisory Committee.
The first systemic treatment for alopecia areata approved by FDA
The Olumiant (baricitinib) oral tablet is the first systemic treatment approved by the FDA to treat alopecia areata, an autoimmune disease that causes hair loss. A JAK inhibitor, this agent blocks multiple enzymes that cause inflammation, which leads to hair loss in patients with alopecia. To ensure the safety and effectiveness of this treatment, researchers conducted two randomized, double-blind, placebo-controlled trials over a six-month period.
During these trials, which included individuals who were determined to have at least 50% scalp hair loss according to the Severity of Alopecia Tool, patients were divided into three groups and received either a placebo, 2 mg of Olumiant, or 4 mg of the drug. At the end of the first trial, 22% of the 184 patients who received 2 mg and 35% of the 281 patients who received 4 mg had achieved adequate hair growth, compared to the 5% of 189 patients who received a placebo. Similar results were observed after the second trial, with 17% of 156 patients who received 2 mg of Olumiant and 32% of the 234 patients who received 4 mg achieving adequate hair growth, compared to the 3% of 156 patients who received a placebo.
Study estimates prevalence of Alzheimer’s-like brain disorder
The National Institute on Aging (NIA), a part of the NIH, conducted a study that showed the prevalence of brain changes related to limbic-predominant age-related TDP-43 Encephalopathy (LATE) is roughly 40% in older adults and as high as 50% in people living with Alzheimer’s disease. The study, recently published in Acta Neurophathologica, used autopsy, genetic, and clinical data collected from 6,196 patients to determine the prevalence of LATE in older adults (Acta Neuropathol 2022;144:27-44). This discovery contributes to the mounting evidence suggesting that a variety of brain disorders and disease processes contribute to dementia. LATE, a recently recognized brain disorder, mimics symptoms of Alzheimer’s, the most common form of dementia. Most people living with LATE are living with other brain disorders, such as Alzheimer’s, which can worsen symptoms.
Program addresses mental health and addiction among LGBTQ+ patients
In June 2022, the River Oaks Treatment Center, located in Riverview, Florida, implemented a treatment track specific to LGBTQ+ people that will directly address the unique needs of this community. The LGBTQ+ community often has difficulty accessing care for a variety of health issues, including addiction. These individuals are also at a greater risk of drug addiction than the overall population; therefore, doctors at River Oaks are determined to provide this vulnerable population with a nurturing environment to care for their needs.
Treatments specific to this program will be offered to members of the LGBTQ+ community as well as those close with members of this community. Besides treating drug addiction in LGBTQ+ patients, River Oaks will use this program to address LGBTQ+ specific issues, such as coming out, family dynamics, self-worth, internalized oppression, and other barriers threatening this community.
FDA grants Breakthrough Device designation for Zenith Thoraco+ Endovascular System
Cook Medical has announced that the Zenith Thoraco+ Endovascular System (Thorac+) has received FDA Breakthrough Device designation. The Thoraco+ is designed for the endovascular treatment of patients with thoracoabdominal aneurysms (Crawford Classification I-IV) and represents the latest innovations in endovascular grafts. The device incorporates four side branches for the celiac artery, superior mesenteric artery, left renal artery, and right renal artery. The Thoraco+ will be available in a range of diameters and lengths to accommodate varied patient anatomy. The designation will provide priority review from the FDA, as well as interactive and timely communication with the FDA during clinical trials and pre-market review phases, to help expedite the availability of this device.