Skip Navigation LinksMPX-Tecovirimat-Treatment-Information-for-Providers

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EDMUND G. BROWN JR.
Governor

State of California—Health and Human Services Agency
California Department of Public Health


September 26, 2022


TO:
Healthcare Providers

SUBJECT:
MPX Tecovirimat Treatment Information for Providers


Tecovirimat Treatment   

General Information for providers

Many patients with monkeypox (MPX) have a mild, self-limited disease and recover without medical intervention. Most patients with MPX who require treatment are being managed as outpatients. However, the prognosis for MPX depends on multiple factors, including co-morbid conditions including immunosuppression, previous vaccination, and initial health status. Supportive care and treatment of symptoms (PDF) should be initiated for all patients who have MPX infection. This may include topical or systemic medications or other clinical interventions to control pain, itching, nausea and vomiting. Patients should be monitored closely to ensure resolution of illness without complications that would require further intervention. 

Patients who despite supportive care and treatment progress to severe MPX, develop MPX complications, and those at high risk for severe disease should be considered for tecovirimat treatment. Please see the Centers for Disease Control and Prevention (CDC) Guidelines for Tecovirimat Use for more detail. Per the CDC, clinicians should be aware that at this time there is a paucity of tecovirimat effectiveness data for persons with MPX, including a lack of data on which patients may benefit most from tecovirimat. Finally, clinicians should be aware of the concern for development of resistance. Studies using a variety of animal species have shown that tecovirimat is effective in treating disease caused by orthopoxviruses. Safety trials in people showed the drug was safe and with minor side effects reported. The National Institutes of Health is currently enrolling a tecovirimat effectiveness trial. 

Tecovirimat (also known as TPOXX or ST-246) is an FDA-approved antiviral medication for the treatment of human smallpox disease in adults and children. The CDC holds an expanded access Investigational New Drug (EA-IND) protocol (sometimes called "compassionate use") that allows for the use of stockpiled tecovirimat to treat MPX during an outbreak.  

Tecovirimat is available in oral and intravenous formulations. For children who weigh less than 28.6 pounds, the protocol includes instructions for opening the capsule and mixing with liquid or semi-solid food. 

Which patients should be treated with tecovirimat? 

Treatment considerations are provided in the CDC EA-IND protocol (PDF) on the CDC healthcare professionals guidance webpage. The decision to treat is at the clinical discretion of the provider. 

A positive lab result is not necessary to initiate treatment. Tecovirimat treatment may be initiated for patients with laboratory confirmed non-variola orthopoxvirus infection or suspected infection based on known exposure(s) and/or clinical manifestations of disease. 

Treatment considerations include the following taken from the CDC healthcare professionals guidance webpage: 

  • Patients with severe disease — including hemorrhagic disease; large number of lesions such that they are confluent; sepsis; encephalitis; ocular or periorbital infections; or other conditions requiring hospitalization 

  • Involvement of anatomic areas which might result in serious sequelae that include scarring or strictures — these include lesions directly involving the pharynx causing dysphagia, inability to control secretions, or need for parenteral feeding; penile foreskin, vulva, vagina, urethra, or rectum with the potential for causing strictures or requiring catheterization; anal lesions interfering with bowel movements (for example, severe pain); and severe infections (including secondary bacterial skin infections), especially those that require surgical intervention such as debridement 

Tecovirimat should also be considered for use in people who are at high risk for severe disease: 

  • People currently experiencing severe immunocompromise due to conditions such as advanced or poorly controlled human immunodeficiency virus (HIV), leukemia, lymphoma, generalized malignancy, solid organ transplantation, therapy with alkylating agents, antimetabolites, radiation, tumor necrosis factor inhibitors, or high-dose corticosteroids, being a recipient of a hematopoietic stem cell transplant <24 months post-transplant or ≥24 months but with graft-versus-host disease or disease relapse, or having autoimmune disease with immunodeficiency as a clinical component1

  • Pediatric populations, particularly patients younger than 8 years of age2 

  • Pregnant or breastfeeding people3

  • People with a condition affecting skin integrity — conditions such as atopic dermatitis, eczema, burns, impetigo, varicella zoster virus infection, herpes simplex virus infection, severe acne, severe diaper dermatitis with extensive areas of denuded skin, psoriasis, or Darier disease (keratosis follicularis)

For patients at high risk for progression to severe disease, tecovirimat should be administered early in the course of illness along with supportive care and pain control. 

What does CDC require tecovirimat providers to do?  

Providers interested in offering tecovirimat to patients should review the EA-IND protocol (PDF) and CDC requirements with their clinical facility, including the following considerations: 


1. Provider can either rely on the CDC Institutional Review Board (IRB), which serves as the central IRB for the tecovirimat EA-IND protocol (recommended by CDC), or provider can submit the protocol to their local IRB for review. This decision is at the discretion of the provider and their clinical institution. 

  • CDC IRB has determined that the TPOXX EA-IND protocol does not constitute research involving human subjects. 

  • CDC has a written reliance agreement that facilities can sign to document their reliance on CDC IRB. 

2. Provider understands CDC minimum requirements for: 

  • Obtaining Informed Consent (PDF)  (maintain in patient chart); and 

  • Submitting the FDA Form 1572 (PDF) and Curriculum Vitae to regaffairs@cdc.gov (within 7 days of the first treatment initiation, one time per facility); and 

  • Submitting the Patient Intake (PDF) Form (within 7 days of initiating treatment); and 

  • Reporting of serious adverse events using FDA Form 3500. 

3. Provider may submit required forms using any of the following methods: 

4. If a provider has a patient in urgent need of treatment, the provider may proceed with tecovirimat treatment once informed consent has been obtained. Other steps listed above can be completed after the patient has initiated treatment. 

5. All patient visits may be conducted via telemedicine. 

6. Providers are asked to inform the local health department of new treatment starts so that treatment can be recorded in the case record (CalREDIE) and local medication supply monitored. 

The CDC EA-IND provides liability coverage under the Public Readiness and Emergency Preparedness (PREP) Act for healthcare providers prescribing, administering, or dispensing the drug and for patients to seek compensation if they are seriously injured by the medication via the Countermeasure Injury Compensation Program. 

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

How do I obtain tecovirimat for my facility? 

Healthcare providers should contact their local health department. The local health department Medical Health Operational Area Coordinator (MHOAC) will submit a resource request to CDPH, and medications will be shipped to the healthcare facility. 

For information on other therapies, see CDC Monkeypox Treatment Information. 

  1. Ogoina D, Iroezindu M, James HI, Oladokun R, Yinka-Ogunleye A, Wakama P, Otike-Odibi B, Usman LM, Obazee E, Aruna O, Ihekweazu C. Clinical Course and Outcome of Human Monkeypox in Nigeria. Clin Infect Dis. 2020 Nov 5;71(8):e210-e214. doi: 10.1093/cid/ciaa143. PMID: 32052029. 

  2. Jezek Z, Szczeniowski M, Paluku KM, Mutombo M. Human monkeypox: clinical features of 282 patients. J Infect Dis. 1987 Aug;156(2):293-8. doi: 10.1093/infdis/156.2.293. PMID: 3036967. 

  3. Mbala PK, Huggins JW, Riu-Rovira T, Ahuka SM, Mulembakani P, Rimoin AW, Martin JW, Muyembe JT. Maternal and Fetal Outcomes Among Pregnant Women With Human Monkeypox Infection in the Democratic Republic of Congo. J Infect Dis. 2017 Oct 17;216(7):824-828. doi: 10.1093/infdis/jix260. PMID: 29029147. 

 


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