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The New England Journal of Medicine published research results today from a clinical trial of a drug shown to safely reduce the viral load and clinical illness of healthy adult volunteers intranasally infected with respiratory syncytial virus (RSV).
Le Bonheur Children’s Hospital and the University of Tennessee Health Science Center researcher and infectious disease specialist John DeVincenzo, MD, is lead author of this study. DeVincenzo also serves as medical director of the Molecular and Viral Diagnostics Laboratories at Le Bonheur Children's Hospital and also serves as a professor of Pediatrics and professor of microbiology, immunology and biochemistry at the University of Tennessee College of Medicine.
RSV is the most common cause of lower respiratory tract infections in young children in the United States and worldwide. It hospitalizes 125,000 children in the United States each year, and was the cause for 1.5 million outpatient visits, according to the Centers for Disease Control and Prevention (CDC). DeVincenzo and his fellow researchers have been part of virtually every experimental therapeautic advancement, developmental pathway and antiviral therapy created to tackle the virus in the past 15 years. Learn more about his research at lebonheur.org/promise.
“No effective antiviral treatment currently exists for RSV, which is the leading cause of severe childhood respiratory infections, and is extremely dangerous for babies and children,” says DeVincenzo. “We were pleased that our study, for the first time, shows that the infection caused by the RSV virus can be effectively reduced after the infection has started. This is also the first time to prove that once we reduce the amount of virus in a patient, they begin to feel better very quickly. The next step is to explore clinical trials in naturally infected patients.”
The challenge study of Gilead Sciences Inc.’s GS-5806, an investigational oral RSV fusion inhibitor, achieved primary and secondary endpoints of lower viral load, improvements in total mucus weight and symptom diary score compared to placebo. Volunteers in the study were given the oral drug after being infected with RSV using the experimental challenge model. The model is based on a clinical isolate from an infant hospitalized with RSV bronchiolitis which can be safely used to infect adults, and that was developed by DeVincenzo in 2007 to test proof-of-concept antivirals.