Wednesday, June 7, 2023
Physicians - maximum of 0.25 AMA PRA Category 1 Credit(s)™
ABIM Diplomates - maximum of 0.25 ABIM MOC points
Nurses - 0.25 ANCC Contact Hour(s) (0 contact hours are in the area of pharmacology)
Pharmacists - 0.25 Knowledge-based ACPE (0.025 CEUs)
Physician Assistant - 0.25 AAPA hour(s) of Category I credit
IPCE - 0.25 Interprofessional Continuing Education (IPCE) credit
This activity is intended for pharmacists, primary care providers, infectious disease specialists, adolescent medicine specialists, nurses, nurse practitioners, physician assistants, and other healthcare professionals who are involved in the care of patients at risk for or being treated for mpox.
The goal of this activity is for members of the healthcare team to be better able to identify appropriate treatment and prophylactic options in patient care and to engage in shared decision-making with diverse patient populations at high risk for transmission.
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CME / ABIM MOC / CE Released: 5/12/2023
Valid for credit through: 5/12/2024
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This activity includes discussion of therapeutic products that have not been approved by the US Food and Drug Administration, off-label uses of approved products, or data that were presented in abstract form. These data should be considered preliminary until published in a peer-reviewed journal. Readers should verify all information and data before treating patients or employing any therapies described in this or any educational activity. A qualified healthcare professional should be consulted before using any therapeutic product discussed herein.
Approximately 87,000 people (about the seating capacity of the Los Angeles Memorial Coliseum) around the world, spanning 110 countries, have been infected with mpox virus, previously known as monkeypox.[1] Of the 110 countries who reported cases, more than 100 have not historically reported mpox since its discovery in 1958. This unexpected spread of mpox to countries not used to managing this disease means that thorough understanding by clinicians is necessary to adequately educate patients to prevent the spread and progression of the disease.[1] However, clinician survey results assessing mpox knowledge, attitudes, and practices surrounding the 2022 outbreak reflect varying levels of awareness about managing the disease.
The viruses that cause mpox and smallpox are a part of the same genus of viruses, the Orthopoxvirus genus, which contains several species that can infect animals and humans. Because of this relationship, patient presentation, treatment options, and vaccines are similar between the 2 viruses. However, there are notable differences between them, and clinicians should be aware of these when it comes to managing mpox.
Transmission
A common misconception is that mpox is a sexually transmitted disease, primarily seen in the LGBTQ+ community through same sex (male to male) intercourse. However, alternative forms of transmission include hugging, kissing, and prolonged face-to-face contact, as well as sharing items such as towels, linens, clothing, and toys, according to the Human Rights Campaign Foundation (HRCF). Although it was previously understood that a person with mpox can only spread the virus to others when a rash is present, new data show that some individuals can transmit mpox to others 1 to 4 days before the rash appears.[2] As an important counseling point, clinicians can educate patients on these common misconceptions to help reduce the spread of mpox virus.
Diagnosis, Signs, and Symptoms
Healthcare providers who work in outpatient clinics could be the first to suspect mpox. The most common symptomatic manifestation of mpox is a rash that can present either similar to pimples or blisters that cause severe pain and itching in vulnerable anatomic sites such as the genitals and oropharynx. The severe pain is often accompanied by mucosal lesions, predominantly in the anogenital and perianal regions. These mucosal lesions are often associated with patients reporting pain out of proportion to the rash’s appearance. Symptoms often appear within 3 weeks of exposure. If a patient presents with influenza-like symptoms, a rash is likely to develop within 1 to 4 days. Of note, these symptomatic manifestations present as those of sexually transmitted infections, and both scenarios should be evaluated when diagnosing and treating patients.
Testing for mpox is only recommended for patients who have a rash consistent with mpox and can only be performed by healthcare providers. Testing usually includes specimen collection (swabbing the mucosal lesions) and sending these samples off to a laboratory. Healthcare professionals should be aware of testing facilities and resources in their area to adequately manage patients who could test positive for mpox virus.
Treatment
If left unmanaged, mpox can lead to further complications, such as pneumonia and other secondary bacterial infections in the central nervous system or eyes. Although there is no treatment approved by the Food and Drug Administration (FDA) specifically for mpox virus infection, medical countermeasures exist as options for the treatment of mpox because of its familial relationship with smallpox. These treatment options include tecovirimat, brincidofovir, and vaccinia immune globulin.
The Centers for Disease Control and Prevention (CDC) recommends tecovirimat, which is an FDA-approved treatment for smallpox in adults and children, as a first-line option in treating mpox. Data are not yet available on the effectiveness of tecovirimat in treating mpox infections in people. However, other studies have shown that tecovirimat is safe and potentially efficacious in treating smallpox infections in small animals and noninfected human volunteers.[3] In this study, tecovirimat safety profile, pharmacokinetics, and efficacy were analyzed and shown to have no safety concerns with minimal adverse events. Beyond that, this study established an adult regimen of 600 mg (3 × 200-mg capsules) twice daily for 14 days.[4] At this time, the Study of Tecovirimat for Human Monkeypox (STOMP) is an ongoing clinical trial assessing the effectiveness of tecovirimat for the treatment of mpox. In addition, the CDC holds an expanded access investigational new drug protocol that allows the use of tecovirimat to treat mpox during an outbreak.[5] Tecovirimat can also be used prophylactically in patients with a severe immunodeficiency in T cell function, for which smallpox or mpox vaccination after exposure to mpox virus is contraindicated.[5]
In certain situations, an individual might not be the right candidate for tecovirimat. Those situations include those experiencing severe disease at initial presentation to a healthcare provider or at high risk for progression to severe disease, those who develop recrudescence (initial improvement followed by worsening of disease) after an initial period of improvement on tecovirimat, severely immunocompromised persons, and people who are allergic to or otherwise unable to receive tecovirimat.[6] Under those circumstances, medical countermeasures can be considered as additive or alternative therapy.[4] Some adverse reactions to the oral formulation of tecovirimat include but are not limited to headache (12%), nausea (5%), and abdominal pain (2%).[3] If given the intravenous formulation, patients should be counseled on infusion site pain (73%) and infusion site swelling (39%) as the most common adverse reactions experienced in the Grosenbach trial.[3]
If tecovirimat is contraindicated or subtherapeutic, brincidofovir can serve as an additive or alternative treatment option. Brincidofovir is a prodrug of cidofovir that is approved by the FDA for the treatment of human smallpox disease. This treatment option is unique because of its approval in pediatric patients, including neonates.[5] Although approval of brincidofovir for the treatment of mpox has yet to be demonstrated, a clinical trial showed this option to be safe and likely effective against Orthopoxviruses both in vitro and in animal studies. One trial established brincidofovir adult regimen as 2 doses (two 100-mg tablets or 20 mL suspension) given on days 1 and 8.[4] Of note, this trial had more incidences of gastrointestinal upset and hepatotoxicity than the tecovirimat trial, and patient-specific characteristics should be considered.[4] As mentioned earlier, alternative therapies such as brincidofovir should be used in persons who have or are at high risk for progression to severe disease and meet either of the following criteria: experience recrudescence with the use of tecovirimat or are otherwise ineligible or have a contraindication to oral or intravenous tecovirimat.[5]
Vaccinia immune globulin intravenous (VIGIV) is another option available for the treatment of mpox in severe cases in which the development of robust antibody response may be impaired.[5] Similar to brincidofovir, VIGIV is not approved for treating mpox but could be used as a prophylactic option for those with known exposure and severe immunodeficiency in T cell function for which smallpox or mpox vaccination after exposure to mpox virus is contraindicated.[5]
Prevention
Because of mpox’s familial relationship with the virus that causes smallpox, vaccines already available for smallpox prevention can be used off-label to protect against mpox.[6] At this time, there are 2 vaccines approved by the FDA for smallpox and 1 investigational vaccine that may be used in an Orthopoxvirus emergency.
Vaccination against mpox has both pre- and postexposure prophylaxis indications. In other words, individuals who have already been exposed to mpox and those at high risk for exposure can receive either of the 2 FDA-approved vaccines.[6]
Health Disparities
Current data have shown disparities in mpox incidence when it comes to race, ethnicity, and gender orientation. Although overall cases have been decreasing, Black and African American people consistently account for the largest share of new cases each month. Since May 2022, Black people have consistently accounted for up to half (45%) of new cases.[7] However, the rate of new cases among Hispanic/Latinx and White people declined drastically. In fact, data show that 80% of vaccines distributed in the metropolitan Washington, DC, area were given to White, gay men.[7] These data show that proper resources and educational opportunities are not being evenly distributed to the communities that are affected most by this outbreak. Although 95% of cases were seen in men, the current data suggest that about 40% of individuals with mpox in the US also have HIV].[8] Although data are still needed to show whether having HIV increases the likelihood of getting sick with mpox if exposed, severely immunocompromised people, such as those with advanced HIV, are at increased risk for severe mpox or even death. Therefore, clinicians can play a role in adequately educating this patient population and others to mitigate these health disparities and ensure easy access to treatment or vaccine information and resources.
Implications for the Healthcare Team
Aside from educating patients on routes of transmission, healthcare professionals should still practice infection control protocols and be aware of their own risk of contracting mpox from a patient with a symptomatic mpox infection. Clinicians are at high exposure risk while being inside the patient’s room or within 6 feet of a patient during any procedure that might create aerosols from oral secretions, skin lesions, or suspension of dried exudates without wearing a N95 or equivalent respirator (or higher) and eye protection.[9] Although it is important to note ways in which clinicians can be exposed, mpox is not easily transmitted via respiratory secretions, but mainly through close, sustained physical contact.
Healthcare professionals can also play an important role in assessing patients’ medication regimens to ensure that no drug-drug interactions exist between the patients’ current therapy and the mpox treatment. Because a large proportion of patients with mpox also have HIV, as mentioned above, members of the healthcare team should make note of these concomitant treatments and identify potential interactions that could compromise patients’ ability to fight either or both infections.
The healthcare team can take several steps to help combat the mpox outbreak and better serve the LGBTQ+ community. Healthcare professionals can ensure that they provide competent care that will reach all communities at risk. They should be mindful of the disparities faced by Black, gay, bisexual, and other same-gender-loving men as it relates to vaccinations and treatment and work intentionally to deconstruct those disparities by educating themselves on the barriers and stigma faced by LGBTQ+ people in healthcare settings.
