Lrp Treatment
Geri Cutcher
Patients who are severely immunocompromised or have certain skin conditions, such as eczema, are at particular risk of uncontrolled viral spread, a severe manifestation of mpox that can be life-threatening.
Tecovirimat is a novel antiviral that was made available for treatment of certain patients with mpox under the CDC-held Expanded Access-Investigational New Drug (EA-IND) protocol during the global outbreak of mpox that began in 2022.
Data are not yet available on the effectiveness of tecovirimat in treating mpox infections in people. Based on the animal efficacy data that showed survival benefit over placebo in lethal animal models, it may be reasonable to anticipate tecovirimat may provide benefit in treating some people with disease caused by orthopoxviruses, including the virus that causes mpox. However, whether and how the efficacy in animals may translate to humans with active disease, the patients who might benefit from tecovirimat, and what specific clinical benefits might occur with tecovirimat are unknown currently. There are ongoing clinical trials to determine the efficacy and safety of tecovirimat in people with mpox.
The National Institute of Allergy and Infectious Disease is conducting the Study of Tecovirimat for Mpox (STOMP) clinical trial to assess the efficacy of tecovirimat. STOMP has an open-label TPOXX arm for patients who are severely immunocompromised, have certain active skin conditions or severe disease, for pregnant or lactating people and children under 18 years of age. All patients in this arm of the trial will receive oral TPOXX.
Data from this trial will help scientists learn which patients get the most benefit from this therapeutic and guide regulators who decide whether to approve its use for mpox. Patients should be informed about STOMP and encouraged to consider enrollment.
CDC holds an Expanded Access-Investigational New Drug (EA-IND) protocol that allows for the use of stockpiled tecovirimat to treat patients with mpox who meet EA-IND eligibility criteria. Tecovirimat is available orally or intravenously for certain patients with (or who are at high risk for) protracted or life-threatening illness, including severely immunocompromised patients, people with atopic dermatitis and other conditions affecting skin integrity, children and pregnant or breastfeeding adults.
Tecovirimat is typically the first therapeutic that should be considered if patients with mpox require more than supportive care. Brincidofovir and Vaccinia Immune Globulin (VIGIV) are additional therapeutics, available from the Strategic National Stockpile (SNS), that can be considered for treatment of mpox in certain patients who necessitate an additional or alternative treatment to tecovirimat. Cidofovir is a commercially available antiviral that has the same mechanism of action as brincidofovir and could also be considered. For patients with eye infections involving mpox, trifluridine ophthalmic solution might also be considered after consultation with ophthalmologists.
Decisions on whether and when to use these additional or alternative therapeutics must be made individually for each person and can depend on a variety of clinical and other parameters. Healthcare providers preferring a clinical consultation with CDC or who have patient management questions may contact the CDC during regular business hours at poxv...@cdc.gov and after hours via the CDC Emergency Operations Center [EOC] at (770) 488-7100.
Brincidofovir is a prodrug of cidofovir that is approved by the FDA [670 KB, 21 pages] 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.
Nearly all patients who receive brincidofovir are severely immunocompromised and require brincidofovir in combination with tecovirimat. Brincidofovir should not be used simultaneously with cidofovir. Clinicians can switch patients between IV cidofovir and brincidofovir right away without a drug holiday.
VIGIV is licensed by FDA [196 KB, 18 pages] 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 [581 KB, 24 pages] 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 in which the development of a robust antibody response may be impaired.
VIGIV can be considered for prophylactic use in an exposed person with severe immunodeficiency in T-cell function for which smallpox or mpox vaccination following exposure to mpox virus is contraindicated. Patients who receive VIGIV typically are concomitantly receiving both tecovirimat and either brincidofovir or cidofovir.
VIGIV 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 (poxv...@cdc.gov) during business hours, or for urgent clinical situations, contact the CDC Emergency Operations Center (770-488-7100). Informed consent [293 KB, 6 pages] must be obtained prior to administration. The remaining VIGIV IND fillable forms will be provided to clinicians requesting VIGIV.
Cidofovir is an antiviral medication that is approved by the FDA [ 828 KB, 6 pages] 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. Clinicians can switch patients between IV cidofovir and brincidofovir right away without a drug holiday. Nearly all patients who receive cidofovir for mpox are severely immunocompromised and require cidofovir in combination with tecovirimat.
The study will include U.S. residents 18 years of age or older who have HIV with CD4 counts of < 200 cells/mm3 and are hospitalized with probable or confirmed mpox. During hospitalization, clinicians will collect physical exam data and samples for further analysis.
Clinicians whose patients meet the above criteria and are interested in participating in the study may contact the study investigators by emailing poxv...@cdc.gov. For more information about the study, see our VIRISMAP Presentation [ 543 KB, 28 pages] and Informational Sheet.
The emergency and referral resources listed above are available to individuals located in the United States and are not operated by the National Institute on Drug Abuse (NIDA). NIDA is a biomedical research organization and does not provide personalized medical advice, treatment, counseling, or legal consultation. Information provided by NIDA is not a substitute for professional medical care or legal consultation.
There are many types of cancer treatment. The types of treatment that you have will depend on the type of cancer you have and how advanced it is. Some people with cancer will have only one treatment. But most people have a combination of treatments, such as surgery with chemotherapy and/or radiation therapy. You may also have immunotherapy, targeted therapy, or hormone therapy.
Clinical trials might also be an option for you. Clinical trials are research studies that involve people. Understanding what they are and how they work can help you decide if taking part in a trial is a good option for you.
When you need treatment for cancer, you have a lot to learn and think about. It is normal to feel overwhelmed and confused. But, talking with your doctor and learning all you can about all your treatment options, including clinical trials, can help you make a decision you feel good about. Our Questions to Ask Your Doctor About Treatment may help.
Many people struggle with controlling their drinking at some point in their lives. Millions of adults in the United States have alcohol use disorder (AUD), and approximately 1 in 10 children live in a home with a parent who has AUD.
The good news is that no matter how severe the problem may seem, most people with AUD can benefit from some form of treatment. Many others substantially reduce their drinking and report fewer alcohol-related problems.
AUD is characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. Health care providers diagnose AUD when a person has two or more of the symptoms listed below. AUD can be mild (the presence of two to three symptoms), moderate (the presence of four to five symptoms), or severe (the presence of six or more symptoms).
More than once gotten into situations while or after drinking that increased your chances of getting hurt (such as driving, swimming, using machinery, walking in a dangerous area, or engaging in unsafe sexual behavior)?
Continued to drink even though it was making you feel depressed or anxious or adding to another health problem? Or after having had an alcohol-related memory blackout?
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