The STOMP Trial is recruiting patients to learn if tecovirimat (TPOXX) is a safe and effective treatment for human mpox virus. Patients do not have to have severe mpox or be at risk of severe mpox to enroll.
Providers are encouraged to first seek access through the STOMP Trial if they want to request oral tecovirimat for their patients. Visit the STOMP Trial webpage for more information.
There is currently no treatment approved specifically for mpox virus infections. However, antivirals developed for use in patients with smallpox may prove beneficial against mpox. CDC provides Mpox Treatment Information for Healthcare Professionals and Interim Clinical Treatment Considerations for Severe Manifestations of Mpox.
Individuals with immunocompromising conditions may require early and prolonged treatment. See CDC’s Clinical Considerations for Treatment and Prophylaxis of Mpox Infection in People Who are Immunocompromised.
VDH’s Mpox Trainings for Healthcare Providers recorded in January and February 2024 are available as a resource for clinicians.
Supportive care for mpox includes pain management, skin and wound care, maintenance of fluid balance, and treatment of co-occurring sexually transmitted infections or bacterial superinfections.
Important aspects of pain control include the following:
- Use of over-the-counter medications for general pain management
- Prescription pain medications for short-term management of severe pain
- Topical steroids and anesthetics for local pain relief (use with caution on open skin or draining wounds)
Skin and wound care is critical for individuals with mpox. This should include prevention and treatment of secondary bacterial infections (and other complications), ensuring hydration and nutrition, and protecting vulnerable anatomical locations such as the eyes and genitals.
- Skin lesions should be kept clean and dry when not showering or bathing to prevent bacterial superinfection. Warm oatmeal baths can also reduce itching and pain.
- For oral lesions, patients can rinse their mouths with salt water at least four times per day. Alcohol-free oral antiseptics can be used to keep lesions clean. For pain, patients can suck on ice chips or ice pops, use compounds such as “magic” or “miracle” mouthwashes (prescription solutions used to treat mucositis), or apply patches and benzocaine or lidocaine gels.
- For painful genital and anorectal lesions, warm sitz baths lasting at least 10 minutes several times per day may be helpful. Topical benzocaine or lidocaine gels or creams may provide temporary relief.
- Proctitis can progress to become severe and debilitating. Stool softeners should be initiated early. Sitz baths are useful for proctitis and may calm inflammation.
- For itching, oral antihistamines and topical agents such as calamine lotion, petroleum jelly, or colloidal oatmeal may improve symptoms. Patients who use topical steroids for pre-existing skin conditions should avoid applying steroids to active lesions of mpox, unless directed to do so by their treating clinician.
Please refer to CDC’s CDC's Clinical Considerations for Pain Management of Mpox for specific treatment steps and tools, including detailed information on pain management for lesions in various locations.
Provider Resources
Moderate and severe immunocompromising conditions and treatments may increase the risk of severe, prolonged mpox. These include HIV infection (particularly if there is a low CD4 count (<200 cells/mm3)), primary immunodeficiency, active treatment for a solid tumor or hematologic malignancy, immunosuppressive or immunomodulating therapy, and receipt of chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic cell transplant (within 2 years of transplantation or taking immunosuppressive therapy).
Early optimization of immune function (e.g., initiation of HIV antiretroviral therapy) is critical for patient outcome.
Tecovirimat
- Should be considered as first line treatment of mpox in people who have advanced or poorly controlled HIV or are otherwise immunocompromised, as they may be at high risk for severe disease. It is important to begin tecovirimat as early as possible in such patients.
- Should be given IV if there is concern for inadequate or altered oral drug absorption or if the patient is unable to take oral therapy.
- Consider extending tecovirimat beyond the standard 14-day course on a day-by-day basis.
- Consider the addition of other therapies (e.g., cidofovir, brincidofovir, and VIGIV).
For further information on TPOXX, cidofovir (commercially available), brincidofovir, and VIGIV for the treatment of individuals with moderate or severe immunocompromise, please see CDC’s Clinical Considerations for Treatment and Prophylaxis of Mpox Infection in People Who are Immunocompromised.
Provider Resources
- Clinical Considerations for Treatment and Prophylaxis of Mpox Infection in People Who are Immunocompromised
- Interim Clinical Treatment Considerations for Severe Manifestations of Mpox — United States, February 2023 | MMWR (cdc.gov)
- CDC Health Alert: Severe Manifestations of Monkeypox among People who are Immunocompromised Due to HIV or Other Conditions
- FDA Mpox Response - Therapeutics
- TEMBEXA (brincidofovir) fact sheet
- VDH's TPOXX Information Sheet for Virginia Providers- provides guidance for referring patients, ordering, dispensing, and reporting TPOXX and required CDC documentation.
For most individuals with intact immune systems, supportive care and pain control will be sufficient for mpox management. However, prognosis can be impacted by initial health status, comorbidities, concurrent illnesses, and vaccination history. Therefore, in some patients, supportive care and pain control may not be adequate and treatment should be considered. Consider tecovirimat (TPOXX) as first-line therapy for eligible patients with mpox. CDC provides Information for Healthcare Providers: TPOXX for Treatment of Mpox, including instructions on accessing the medication for patients.
Resistance
- Viral resistance to tecovirimat has been rare, and when documented has occurred with prolonged administration and severe clinical outcomes.
- Consider testing lesion swab specimens for tecovirimat resistance and plasma pharmacokinetic sample collection for any patient who, after completing 14 days of tecovirimat treatment, experiences persistent or newly emergent mpox lesions. CDC provides detailed instructions for collecting and submitting specimens for resistance testing.
- Lab-confirmed tecovirimat resistance has been reported in U.S. patients during the current mpox outbreak, though the frequency of resistant viruses has been low (<1%). Most resistance occurred in patients with severe immunocompromise on multiple courses of tecovirimat treatment.
- There have been rare cases of transmission of tecovirimat resistance-associated mutation in California.
- Counsel patients about the critical importance of taking oral tecovirimat with fatty meals to ensure adequate gastrointestinal absorption and maximize serum levels of the drug. Inadequate serum levels could promote resistance as described above.
Provider Resources
- CDC's Clinical Guidance for Mpox
- CDC's Treatment Information for Healthcare Professionals
- CDC Health Alert: Update on Managing Mpox in Patients Receiving Therapeutics
- CDC's Guidance for Tecovirimat Use for Mpox
- CDC's Information for Healthcare Providers: Tecovirimat (TPOXX) for Treatment of Mpox
- Patient Enrollment: Study of Tecovirmat for Human Mpox Virus
- VDH's TPOXX Ordering Information for Virginia Providers and LHDs - provides guidance for referring patients, ordering, dispensing, and reporting TPOXX and required CDC documentation.
- VDH’s Mpox Trainings for Healthcare Providers recorded in January and February 2024 are available as a resource for clinicians.
STOMP Trial (Preferred)
For patients who are not eligible for STOMP, those who decline to participate, or those who require IV tecovirimat and meet protocol eligibility criteria, tecovirimat can also be provided under an expanded access investigational new drug (EA-IND) protocol.
If a provider at an LHD is requesting TPOXX through the EA-IND for a patient, they should contact Central Pharmacy for assistance with fulfilling this request.
Private providers should contact their local health department to request TPOXX through the EA-IND. The LHD may then consult with the CDC directly to facilitate TPOXX access or the LHD may reach out to Central Pharmacy to request oral TPOXX and/or additional support.
Prescribers must complete the TPOXX Inventory & Patient Initiation Survey for all new patients started on TPOXX obtained from outside the STOMP trial.
For more information, please see VDH's TPOXX Ordering Information for Virginia Providers and LHDs, which provides guidance for referring patients, ordering, dispensing, and reporting TPOXX and required CDC documentation.
TPOXX is available for the treatment of mpox under an EA-IND protocol through the CDC. A condensed version of the protocol for providers is available on the CDC website. The tecovirimat EA-IND protocol is intended to be used in concert with CDC’s guidance for treatment.
TPOXX IND Online Registry for Providers and Facilities
New providers and affiliated facilities can register online as participating providers/sites under the CDC-held EA-IND for tecovirimat through the Tecovirimat (TPOXX) IND Online Registry for Providers and Facilities. Detailed information about this registry can be found on CDC’s Tecovirimat IND webpage.
- New providers and affiliated medical facilities providing tecovirimat under the EA-IND protocol must register with the tecovirimat IND online registry starting October 28, 2022.
- Through the registry, providers can submit the following forms electronically:
- Form FDA 1572
- Patient Intake Form
- Clinical Outcome Form
- The tecovirimat IND Online Registry allows for convenient, time-efficient, and secure completion and return of EA-IND forms to CDC. View this Fact Sheet for an overview of the tecovirimat IND online registry process.
- Providers who have returned required IND forms prior to the online registry transition are grandfathered in as participating providers under the EA-IND. Any providers with valid email addresses on record should have received emails providing them access to the electronic Patient Intake and Clinical Outcome forms on October 25, 2022.
- Any questions about the registry and transition to electronic tecovirimat IND Patient Intake and Clinical Outcome forms can be directed to regaffairs@cdc.gov.
Required Documentation:
- Informed Consent Form: English [238 KB, 6 pages] Obtain prior to treatment.
- Other languages: Spanish [263 KB, 7 pages]
- Alternative Consent Forms that can be used to obtain informed consent:
- Patient Intake Form: Baseline assessment. Access the electronic form through the Tecovirimat IND Online Registry.
- FDA Form 1572: One signed 1572 and treating clinician’s CV per facility suffices for all tecovirimat treatments administered under the EA-IND at the same facility. Access the electronic form through the Tecovirimat IND Online Registry.
- Serious Adverse Events: Per FDA requirement, report life-threatening or serious adverse events associated with tecovirimat by completing a PDF MedWatch Form [956 KB, 5 pages] and returning it to CDC via email (regaffairs@cdc.gov) within 72 hours of awareness or sooner, if possible. The PDF MedWatch Form can also be downloaded from the FDA website. Note: The MedWatch Form can only be viewed on the Adobe desktop app. Please save or download the form for viewing.
Optional Documentation:
- Clinical Outcome Form: Progress and outcome information post treatment. Access the electronic form through the Tecovirimat IND Online Registry.
- Lesion samples for resistance testing: Lesion samples may be sent to CDC for tecovirimat-treated patient with persistent lesions and/or any new lesions that develop during and/or after tecovirimat treatment to assess for development of antiviral resistance mutations. See Optional Lesion Samples to CDC for Resistance Testing [147 KB, 2 pages] for instructions on collection, storage, and submission of samples.
- Pharmacokinetic samples for testing: During tecovirimat treatment, plasma samples may be collected to monitor tecovirimat levels for adequate drug exposure in patients. Optional Pharmacokinetic Samples for Testing [375 KB, 4 pages] has instructions on collection, storage, and submission of samples.
For more information about the requirements for obtaining TPOXX, please see CDC's Information for Healthcare Providers: Tecovirimat (TPOXX) for Treatment of Mpox.
Brincidofovir is a prodrug of cidofovir that is approved by the FDA for the treatment of human smallpox disease in adult and pediatric patients, including neonates. Data are not available on the effectiveness of brincidofovir in treating mpox virus infection in people. However, it has shown to be effective against orthopoxviruses in in vitro and animal studies. Brincidofovir should not be used simultaneously with cidofovir.
Brincidofovir is made available from the SNS for treatment of mpox to clinicians who request and obtain an FDA-authorized single-patient emergency use IND (e-IND). Brincidofovir can be considered for use under an e-IND for treatment of human mpox disease in adults and pediatric patients (including neonates) with positive results of human mpox viral testing who:
- Have severe disease OR are at high risk for progression to severe disease,
- AND meet either of the following:
- Experience clinically significant disease progression while receiving tecovirimat or who develop recrudescence (initial improvement followed by worsening) of disease after an initial period of improvement on tecovirimat, OR
- Are otherwise ineligible or have a contraindication for oral or intravenous tecovirimat
Clinicians with mpox patients necessitating brincidofovir treatment may submit an e-IND request to FDA by email (DDI.EIND@fda.hhs.gov) or phone 301-796-3400 or 1-855-543-3784 during normal business hours (8 am-4:30 pm ET M-F) or completing an electronic request to FDA. During after hours, call the FDA Emergency Coordinator at 1-866-300-4374 or 301-796-8240 or email CDER-EIND@fda.hhs.gov and call the CDER Emergency Coordinator at 301-796-9900.
Vaccinia Immune Globulin Intravenous (VIGIV)
VIGIV is licensed by FDA for the treatment of complications due to vaccinia vaccination. However, it is not approved for treatment of mpox. Therefore, CDC holds an expanded access IND protocol that allows the use of stockpiled VIGIV for the treatment of orthopoxviruses (including mpox) in an outbreak.
Data are not available on the effectiveness of VIGIV in treatment of mpox virus infection in people. Use of VIGIV has no proven benefit in the treatment of mpox and it is unknown whether a person with severe mpox infection will benefit from treatment with VIGIV. However, healthcare providers may consider its use in severe cases where the development of a robust antibody response may be impaired.
VIGIV is not prepositioned by the USG. It is available upon clinician request to CDC on a case-by-case basis. To request VIGIV, clinicians can contact the CDC Clinical Consultation Team by email (poxvirus@cdc.gov) during business hours, or for urgent clinical situations, contact the CDC Emergency Operations Center (770-488-7100). An informed consent must be obtained prior to administration. The remaining VIGIV IND fillable forms will be provided to clinicians requesting VIGIV.
Cidofovir
Cidofovir is an antiviral medication that is approved by the FDA for the treatment of cytomegalovirus (CMV) retinitis in patients with Acquired Immunodeficiency Syndrome (AIDS), and is commercially available as an injection. Data are not available on the effectiveness of cidofovir in treatment of mpox virus infection in people. However, it has shown to be effective against orthopoxviruses in in vitro and animal studies. It is unknown whether a person with severe mpox infection will benefit from treatment with cidofovir, although its use may be considered in such instances. Brincidofovir (a prodrug of cidofovir) may have an improved safety profile over cidofovir. Serious renal toxicity or other adverse events have not been observed during treatment of cytomegalovirus infections with brincidofovir as compared to treatment using cidofovir. Cidofovir should not be used simultaneously with brincidofovir.
Provider Resources
Page Last Updated: June 17, 2024
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