Efficacy and safety of a mosaic HIV-1 vaccine regimen in men who have sex with men and transgender individuals (HVTN 706/HPX3002/Mosaico): a global, randomised, double-blind, placebo-controlled, phase
Authors: Buchbinder SP, Spinosa Guzman S, Sanchez J, Willems W, Stieh DJ, van Duijn J, van Rosmalen MGM, Hendriks J, Nijs S, Lavreys L, Paez CA, Grinzstejn B, Hutter J, Mann P, Sierra Madero JG, Cahn P, Castagna A, Truyers C, Roels S, Gilbert PB, Carone M, Luedtke A, Corey L, Pau MG, Tomaka F, HVTN 706/HPX3002/Mosaico Study Team
Journal: The lancet. HIV
mental health
psychology
open access
Abstract
Persons with traumatic brain injury (TBI) are at high risk for comorbid obstructive sleep apnea (OSA), with prevalence rates estimated between 25-66% [–]. Whether OSA precedes or follows TBI has been debated, with evidence of both directions. Studies have shown that TBI is independently associated with OSA [], and inversely that OSA patients were 1.23-fold more likely to later sustain a TBI after adjusting for demographics and comorbidities [].” However, the precise mechanisms linking OSA to TBI are poorly understood []. OSA is associated with deleterious health consequences, including cardiovascular disease [], severe cardiac events [], metabolic dysfunction [], diabetes [], and stroke []. Additionally, OSA leads to adverse outcomes such as mood disturbance, cognitive dysfunction, reduced productivity, workplace and motor vehicle accidents, and premature mortality [–]. The economic cost of OSA (i.e., health care costs; lost productivity) was estimated to exceed $149 billion in the year 2015 []. Fortunately, OSA is treatable. The American Academy of Sleep Medicine (AASM) recommends positive airway pressure (PAP) therapy as the first-line treatment for OSA []. While efficacious, adherence is poor. Approximately 42-59% of persons with OSA adhere to PAP therapy [–], with most studies using the Centers for Medicare & Medicaid Services adherence definition of ≥ 4 hours per night, ≥ 70% of the time []. Although an arbitrary cutoff, PAP use at this level has been associated with meaningful outcomes such as reduced risk of cardiac arrest [], stroke [–], and hospitalizations [] and lower health care costs []. Moreover, studies support a dose-response relationship; greater PAP use hours per night was associated with reduced daytime sleepiness and lower risk of atrial fibrillation [], hospitalization [], and cardiac events []. Also, PAP adherence has been positively associated with OSA severity []. While adherence using the conventional definition confers therapeutic benefit, PAP should be used throughout sleep duration to maximize health outcomes.