Clinical data from patients treated under an investigational protocol for TPOXX (tecovirimat) support continuing to make the smallpox antiviral drug available to treat U.S. patients with monkeypox during the current outbreak, according to a report released today by the Centers for Disease Control and Prevention. The CDC protocol includes patient treatment and adverse event reporting forms to monitor safety and ensure intended clinical use.
“Initial findings indicate that tecovirimat is likely well tolerated; among reported adverse events, most were not serious, and it is not known whether tecovirimat caused the adverse events reported,” the report notes. “… However, no control group was available for comparison; therefore, no conclusions can be drawn regarding the effectiveness of tecovirimat to treat monkeypox based on these data.”
In related news, the National Institutes of Health today announced it is enrolling U.S. adults and children with monkeypox infection in a Phase 3 clinical trial to evaluate the antiviral drug.