Tecovirimat (TPOXX) is an antiviral medication that is available for use to treat monkeypox under an expanded access investigational new drug (EA-IND) protocol (sometimes called “compassionate use”). It is the first-line medication to treat monkeypox in adults and children weighing 13kg or more.
The CDC IRB serves as the central IRB for the tecovirimat protocol; they have determined that its use dose not constitute research involving human subjects as defined by 45 CFR 46.102.
Studies have shown it to be effective in treating orthopox virus infection in a variety of animal species. Based on limited available data, it is felt that tecovirimat may shorten the duration of patients’ illness and viral shedding.
Clinical safety trials in people have found only minor side effects. There was a small increase in headache (12%) and nausea (5%) for patients taking tecovirimat compared to placebo (8% and 4% respectively). Significant side effects have not been reported with its use during the current outbreak.
Tecovirimat is available as a pill or IV injection, and is given as a 14 day course. Specific dosing information can be found in the package insert.
If an Orange County healthcare provider identifies a case that may require treatment, they can submit a request for tecovirimat to IAP@ochca.com mailbox or call 714-834-8180. For after office hours, please call 714-834-8180, and ask to speak to the HCA nurse on-call.
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