期刊
EXPERT OPINION ON DRUG DISCOVERY
卷 6, 期 3, 页码 233-250出版社
TAYLOR & FRANCIS LTD
DOI: 10.1517/17460441.2011.554815
关键词
animal model; antiviral; cynomolgus; ebolavirus; FDA Animal Efficacy rule; filoviruses; hemorrhagic fever; in vivo; nonhuman primate; prophylaxis; rhesus; therapeutics; therapy; treatment
资金
- US Defense Threat Reduction Agency [1.1C003_08_RD_B]
- Transformational Medical Technologies [TMTIO048_09_RD_T]
Introduction: Ebolaviruses are human pathogenic Category A priority pathogens for which no vaccines or therapeutics are currently licensed; however, several therapeutic agents have shown promising efficacy in nonhuman primate models of infection and are potential candidates for use in humans. Demonstration of efficacy in nonhuman primate models of ebolavirus infection will probably be central to the development and eventual licensure of ebolavirus medical countermeasures given the ethical and feasibility constraints of human efficacy assessments. Areas covered: The authors describe ebolavirus hemorrhagic fever (EHF), with an emphasis on comparing human and nonhuman primate pathophysiology. Published data examining human and animal clinical disease parameters, histopathological findings, and immune responses in fatal and nonfatal cases are synthesized and evaluated. Importantly, the authors also introduce and describe the FDA Animal Efficacy Rule as well as recent advances in antiviral drug development strategies for the treatment of EHF. Expert opinion: Well-characterized models of ebolavirus infection are currently under development and scrutiny as to their accuracy and utility for modeling fatal infection in humans. The advanced development and eventual licensure of therapeutic agents will require demonstration that mechanisms conferring protection in nonhuman primate models of infection are predictive of protective responses in humans.
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