Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2023 Jun 29;3(1):e110.
doi: 10.1017/ash.2023.194. eCollection 2023.

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

Ofole Mgbako  1   2 , Justin Chan  1   2 , Robert A Pitts  1   2 , Madeline A DiLorenzo  1 , Dorothy Knutsen  1   2 , Dana Mazo  1
Affiliations
Editorial

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

Ofole Mgbako et al. Antimicrob Steward Healthc Epidemiol. .

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.

PubMed Disclaimer

Conflict of interest statement

All authors report no conflicts of interest relevant to this article.

Figures

Figure 1.
Figure 1.
Steps involved in obtaining and delivering tecovirimat at Bellevue and NYULH.
Figure 2.
Figure 2.
Epidemiological curve of mpox outbreak in NYC and timeline of the tecovirimat (TPOXX) roll-out at NYULH and Bellevue.
Figure 3.
Figure 3.
Strike team members at NYULH and Bellevue for mpox outbreak focused on clinical care delivery, vaccinations, therapeutics and monitoring, and health equity. ID, infectious diseases; IM, internal medicine; NP, nurse practitioners.
See this image and copyright information in PMC

References

    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.
    1. New York City Department of Health. Mpox 2022 Summary: Cases. https://www.nyc.gov/assets/doh/downloads/pdf/monkeypox/mpox-response-dat.... Accessed March 13, 2023.
    1. United States Centers for Disease Control and Prevention. October 24, 2022. Expanded Access IND Protocol: Use of Tecovirimat (TPOXX®) for Treatment of Human Non-Variola Orthopoxvirus Infections in Adults and Children IND No. 116,039, CDC IRB No. 6402, Version 6.2. https://www.cdc.gov/poxvirus/mpox/pdf/Tecovirimat-IND-Protocol-CDC-IRB.pdf. Accessed March 13, 2023.
    1. 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.
    1. 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.

Publication types

LinkOut - more resources