Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak-Reference-Cited by-同舟云学术

Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak

Published:2023 Issue:1 Volume:3 Page:
ISSN:2732-494X
Container-title:Antimicrobial Stewardship & Healthcare Epidemiology
language:en
Short-container-title:ASHE

Author:

Mgbako Ofole^ORCID,Chan Justin,Pitts Robert A.,DiLorenzo Madeline A.^ORCID,Knutsen Dorothy,Mazo Dana

Abstract

Abstract During the 2022 mpox outbreak, tecovirimat was accessed through an expanded access investigational new drug (EA-IND) protocol. We leveraged a unique public/private hospital partnership in New York City to create a novel infrastructure to navigate the EA-IND’s regulatory requirements and rapidly provide tecovirimat to patients.

Publisher

Cambridge University Press (CUP)

Subject

Infectious Diseases,Microbiology (medical),Epidemiology

Reference8 articles.

1. Epidemiologic and Clinical Characteristics of Monkeypox Cases — United States, May 17–July 22, 2022

2. 4. United States Department of Health and Human Services. Administration for Strategic Preparedness and Response. ASPR Awards $21 Million to Health Facilities to Enhance Nation’s Preparedness for Special Pathogens. October 24, 2022. https://aspr.hhs.gov/newsroom/Pages/RESPTC-Prep-Award-24Oct2022.aspx. Accessed March 27, 2023.

3. 5. Mgbako, O , Ditullio, D , PaganPirallo, P , et al. Outcomes of a telehealth visit model to deliver tecovirimat. Conference on Retroviruses and Opportunistic Infections. Abstract 1102. Seattle, Washington. February 2023.

4. 1. United States Centers for Disease Control and Prevention. Mpox. 2022 U.S. Map and Case Count. https://www.cdc.gov/poxvirus/mpox/response/2022/us-map.html. Accessed March 13, 2023.

5. 2. New York City Department of Health. Mpox 2022 Summary: Cases. https://www.nyc.gov/assets/doh/downloads/pdf/monkeypox/mpox-response-data-summary.pdf. Accessed March 13, 2023.

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1. Association of Tecovirimat Therapy With Mpox Symptom Improvement: A Cross-sectional Study—King County, Washington, May–October 2022;Open Forum Infectious Diseases;2024-01-22