Patient’s Guide to Mpox Treatment with Tecovirimat (TPOXX)
- There are no treatments approved by the Food and Drug Administration (FDA) specifically for mpox. Antiviral drugs approved for treatment of smallpox may help to treat mpox because the viruses that cause mpox and smallpox are similar.
- The antiviral drug tecovirimat (TPOXX) has been used to treat mpox through an expanded access (sometimes called compassionate use) program during the outbreak that began in 2022. The compassionate use of tecovirimat is for people with severe mpox disease or who are likely to get severely ill (those with weakened immune systems, such as people with HIV that is not controlled, or who have skin conditions like eczema).
- Tecovirimat may help treat severe mpox disease involving the eyes, mouth, throat, genitals, and anus (butthole). However, it is currently unknown whether tecovirimat works or how well it works to treat mpox.
- Researchers are now testing the safety and effectiveness of tecovirimat for all people with mpox. If you have mpox, your healthcare provider might ask you to consider taking part in this research, known as the STOMP trial.
- How ill someone gets can depend on their immune system. For most people without weakened immune systems, supportive care and pain control are usually enough.
- If you have mpox symptoms, visit a healthcare provider, even if you’ve had the mpox vaccine. If you think you might benefit from tecovirimat, ask your provider.
- You can also contact the STOMP trial for more information about enrolling. Oral tecovirimat for treatment of mpox is available through STOMP.
- Tecovirimat (TPOXX) is prescribed most often for people with severe mpox or people who are likely to get severely ill.
- Tecovirimat can reduce the amount of the virus in the body. It may help treat severe mpox disease affecting the eyes, mouth, throat, genitals, and anus (butthole).
- Studies show tecovirimat can be an effective treatment for orthopoxviruses (such as the virus that causes mpox) in animals, and that it is safe when taken by healthy people without the virus.
- However, because there are not enough data to say whether tecovirimat is safe and effective for treating people who have mpox, tecovirimat is still considered an investigational drug for mpox. Investigational means the drug is still being tested to determine whether it is safe and effective to treat a specific disease.
- If you are prescribed tecovirimat, you will be asked to sign a consent form stating you understand tecovirimat is an investigational drug that has not yet been approved by the FDA for treatment of mpox.
- Conducting studies to assess tecovirimat’s safety and effectiveness in people with mpox is essential. If your healthcare provider thinks you have mpox, they may ask you to consider taking part in a clinical trial called the Study of Tecovirimat for Human Monkeypox Virus (STOMP).
- STOMP is trying to find out how well tecovirimat works against mpox infection in people. Researchers are looking for people who may have mpox to participate in studies that give them more data.
- Participation in STOMP is voluntary. You have no obligation to enroll in the trial. If you decide not to take part, your provider might still prescribe tecovirimat for you if you are severely ill or are likely to become severely ill.
- If you are part of the STOMP trial, you may be part of a group that receives either the medication or a placebo, and you won’t know which one. Or you could be part of a group in which everyone gets tecovirimat.
- During the trial, you’ll fill out a diary to keep track of your symptoms and do daily skin checks at home. If you live near a trial site, you will get check-ups there. If you don’t live near a trial site, you can enroll remotely and get check-ups remotely.
- If you think you might benefit from tecovirimat, ask your provider. You can also contact the STOMP trial for more information about enrolling.
- The trial is being conducted by the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health.
- Healthcare providers can only prescribe tecovirimat to people with mpox symptoms under special permission from the FDA, known as expanded access or compassionate use.
- When tecovirimat is prescribed too often to people with milder mpox symptoms, it may increase the chance that the virus that causes mpox will develop resistance to the medication. This means the drug might no longer work for mpox.
- The CDC and FDA are taking steps to reduce the possibility of resistance from happening by recommending that tecovirimat only be prescribed to people with severe illness or who are likely to become severely ill.
- However, patients do not have to have severe disease or be at high risk of severe illness to enroll in the STOMP trial.
Most people without weakened immune systems who get mpox recover fully within 2 to 4 weeks without the need for medical treatment.
Treatment for mpox should also include efforts to manage your symptoms. Medicines like ibuprofen (Advil, Motrin) and acetaminophen (Tylenol) can help you feel better. Learn more about taking care of yourself.
A healthcare provider may prescribe tecovirimat for:
- People with severe mpox symptoms, such as:
- bleeding or infected sores or rash
- lesions that have merged into larger lesions
- any other conditions that require hospitalization
- People with immunocompromising conditions, such as HIV that is not controlled, leukemia, lymphoma, or autoimmune diseases; or who are undergoing chemotherapy or had an organ transplant
- People with rash or lesions in areas such as the eyes, mouth, throat, genitals, and anus (butthole) that are at risk for severe disease in both the short-term (pain, swelling, pockets of pus, etc.) and the long-term (scarring, etc.)
- People with an active disease or condition that affects the skin, such as atopic dermatitis, eczema, psoriasis, impetigo, severe acne, herpes, or burns
- Children, especially if they’re younger than 1 year of age
- People who are pregnant or breastfeeding