Oral Tecovirimat for the Treatment of Smallpox.

ABSTRACT:

Background

Smallpox was declared eradicated in 1980, but variola virus (VARV), which causes smallpox, still exists. There is no known effective treatment for smallpox; therefore, tecovirimat is being developed as an oral smallpox therapy. Because clinical trials in a context of natural disease are not possible, an alternative developmental path to evaluate efficacy and safety was needed.

Methods

We investigated the efficacy of tecovirimat in nonhuman primate (monkeypox) and rabbit (rabbitpox) models in accordance with the Food and Drug Administration (FDA) Animal Efficacy Rule, which was interpreted for smallpox therapeutics by an expert advisory committee. We also conducted a placebo-controlled pharmacokinetic and safety trial involving 449 adult volunteers.

Results

SUBMITTER: Grosenbach DW 

PROVIDER: S-EPMC6086581 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature