Information for Healthcare Providers on Obtaining and Using TPOXX (Tecovirimat) for Treatment of Monkeypox

[Mary Wilson]

Updated July 22, 2022

CDC, in partnership with FDA, has made it easier for healthcare providers to provide tecovirimat (TPOXX) treatment to patients with monkeypox under the expanded access investigational new drug (EA-IND).

The streamlined process allows healthcare providers to start treatment before the paperwork is submitted, and reduces the number of required forms, patient samples, photos, and gives patients the option to see their doctor virtually.

How to obtain TPOXX

• TPOXX is available through the Strategic National Stockpile. To request TPOXX, clinicians and care facility pharmacists can contact their state/territorial health department or CDC (Emergency Operations Center 770-488-7100; Poxvirus@cdc.gov)
• Treatment with TPOXX can begin upon receipt of the medication and after obtaining informed consent. No pre-registration is required for clinicians or facilities.
• Forms requested under the EA-IND can all be returned to CDC after treatment begins.

Protocols

• CDC holds an intermediate-size patient population EA-IND(IND 116,039/Protocol 6402) to allow access to and use of TPOXX for treatment of orthopoxvirus infections, including monkeypox. The EA-IND provides an umbrella regulatory coverage so that clinicians and facilities do not need to request and obtain their own INDs. The EA-IND also provides liability coverage under the PREP Act for compensation to patients if injured via the Countermeasure Injury Compensation Program (CICP).
• On July 21, 2022, CDC IRB approved an amendment [123KB, 1 page]and continuation [105KB, 1 page] of Protocol 6402 [430KB, 21 pages]. Clinicians, care facilities, hospitals providing TPOXX can immediately transition to the revised protocol and forms.
• CDC IRB serves as the central IRB for review and approval of the TPOXX EA-IND protocol and determined that its use does not constitute research involving human subjects as defined by 45 CFR 46.102. Since this EA-IND protocol for TPOXX is solely for treatment use and not considered human subjects research, federal-wide assurance requirements do not apply.
• For facilities requiring a reliance agreement, CDC IRB will provide a pre-signed reliance agreement for facilities to sign documenting reliance on CDC IRB (huma@cdc.gov).
• Healthcare providers should complete the following forms:

https://www.cdc.gov/poxvirus/monkeypox/clinicians/obtaining-tecovirimat.html

 

[Mary Wilson]

IDSA/HIVMA Support Rapid CDC Response to Monkeypox Treatment Access Issues

7/21/2022

Medical societies urge further work on vaccination, testing, treatment and data collection

IDSA and HIVMA appreciate the Centers for Disease Control and Prevention’s swift action in responding to health care provider concerns regarding the significant procedural barriers required to obtain tecovirimat, or TPOXX, through the Expanded Access for Investigational New Drug program. The original process created significant obstacles and delays in treating severely ill patients with the monkeypox virus.

... We call on the National Institutes of Health, in collaboration with other federal agencies, clinicians and scientists, to fund clinical trials to collect data to further inform the use of tecovirimat in tandem to it being made available in as streamlined a fashion as possible, such as through an early or expanded access program.

In addition to expanding access to treatment, we welcome and urge continued partnership with the federal government to expand access to testing and vaccination as we collectively work to control the monkeypox outbreak.

Daniel P. McQuillen, MD, FIDSA – President, Infectious Diseases Society of America

Marwan Haddad, MD, MPH – Chair, HIV Medicine Association

https://www.idsociety.org/news--pub...esponse-to-monkeypox-treatment-access-issues/