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CME / ABIM MOC / CE

Human Monkeypox Virus Infection 2022: Part 3 — Treatment and Prevention

  • Authors: Susan L. Smith, MN, PhD
  • CME / ABIM MOC / CE Released: 8/25/2022
  • Valid for credit through: 8/25/2023
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  • Credits Available

    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

    You Are Eligible For

    • Letter of Completion
    • ABIM MOC points

Target Audience and Goal Statement

This activity is intended for clinicians who work in primary care and public health settings.

The goal of this activity is that learners will be better able to determine appropriate preexposure and postexposure prophylaxis measures for human-to-human monkeypox virus infection.

Upon completion of this activity, participants will:

  • Have increased knowledge regarding the
    • Treatment of human-to-human monkeypox virus infection
    • Prevention of human-to-human monkeypox virus infection
    • Implications for the healthcare team


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Faculty

  • Susan L. Smith, MN, PhD

    Disclosures

    Owns stock (publicly traded) in: Hepion

Editor/Compliance Reviewer

  • Esther Nyarko, PharmD

    Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Esther Nyarko, PharmD, has no relevant financial relationships.

Compliance Reviewer/Nurse Planner

  • Amy Bernard, MS, BSN, RN, NPD-BC, CHCP

    Senior Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Amy Bernard, MS, BSN, RN, NPD-BC, CHCP, has no relevant financial relationships.


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CME / ABIM MOC / CE

Human Monkeypox Virus Infection 2022: Part 3 — Treatment and Prevention

Authors: Susan L. Smith, MN, PhDFaculty and Disclosures

CME / ABIM MOC / CE Released: 8/25/2022

Valid for credit through: 8/25/2023

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Note: The information on the monkeypox virus outbreak is continually evolving. The content within this activity serves as a historical reference to the information that was available at the time of this publication. We continue to add to the collection of activities on this subject as new information becomes available. It is the policy of Medscape Education to avoid the mention of brand names or specific manufacturers in accredited educational activities. However, manufacturer names related to monkeypox vaccines may be provided in this activity to promote clarity. The use of manufacturer names should not be viewed as an endorsement by Medscape of any specific product or manufacturer.

Introduction

Before April 2022, monkeypox virus (MPXV) infection in humans was seldom reported outside of the African regions where it was considered endemic.[1] Thus, few practicing health care professionals in the United States, aside from those who specialized in tropical medicine or global infectious diseases, had heard of MPXV until recently, when the Centers for Disease Control and Prevention (CDC) reported an outbreak (meaning that the number of cases is greater than expected in a geographical area) of MPXV infection in the US.[2] The first case in this outbreak was confirmed on May 17, 2022. As of August 22, 2022, there were 14,115 confirmed cases in the US, with all states except Wyoming affected,[3] and the US government had declared MPXV infection a public health emergency.[4] As of August 22, 2022, outside the US, more than 40,971 cases have been reported in 87 locations that have not historically reported MPXV, and the World Health Organization (WHO) has declared MPXV a public health emergency of international concern.[5]

Information on the outbreak is evolving, and the CDC is continually evaluating new evidence and adapting response strategies as new information and data on changing case demographics, clinical characteristics, transmission, and vaccine effectiveness become available.[6] Thus, health care professionals are encouraged to refer regularly to the CDC websites Information for Healthcare Professionals[7] and Technical Report: Multi-National Monkeypox Outbreak, United States, 2022[8] for up-to-date US and global case counts and epidemiologic parameters associated with the outbreak.

On May 23, 2022, the CDC launched an emergency response for MPXV, which includes educating providers and the public, expanding laboratory testing, outlining prevention strategies, and promoting the use of medical countermeasures for treatment and postexposure prophylaxis.[6] To support that effort, this article is the third in a 3-part series intended to help clinicians understand what MPXV is and its significance for public health. The objective of part 1 is to contrast the historic epidemiology of endemic MPXV with the epidemiology of the outbreak as it unfolds. Part 2 describes the clinical syndrome of MPXV infection, how MPXV is diagnosed, and the associated burden of disease. Part 3 summarizes options for treatment (including postexposure prophylaxis and antiviral treatments available for persons with HIV infection) and prevention of MPXV infection.

Treatment of Human Monkeypox Infection

Drugs are available that can be used to treat hMPXV infection, but none is approved by the US Food and Drug Administration (FDA) for this indication. However, countermeasures--medications that can be used to prevent or treat diseases related to chemical, biological, radiological, or nuclear threats--are available from the US Strategic National Stockpile for clinical use under an expanded-access (compassionate use) protocol for use in an outbreak.[9,10] Countermeasures for treatment are summarized in Table 1.

Table 1. Countermeasures for the Treatment of hMPXV Infection

Countermeasure*

Pertinent Information

Tecovirimat (TPOXX)

Antiviral available as an oral pill or IM injection

 

 

·   Inhibitor of the Orthopoxvirus VP37 envelope wrapping protein

·    Licensed by FDA for the treatment of human smallpox disease caused by variola virus, indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg; not approved for treatment of other Orthopoxvirus infections[11,12]

·   Efficacy data on use of tecovirimat in hMPXV infection are not available[9, 10]

Cidofovir

Antiviral available as an IV injection

 

·   Licensed by the FDA for the treatment of CMV retinitis in persons with AIDS[13]

·    Shown to be effective against orthopoxviruses in in vitro and animal studies[9]

·   Efficacy data on use of cidofovir in hMPXV infection are not available[9]

Brincidofovir†

Antiviral available as an oral tablet

·   Licensed by FDA for the treatment of human smallpox disease in adult and pediatric patients, including neonates[14]

·   Shown to be effective against orthopoxviruses in in vitro and animal studies[9]

·   Efficacy data on use of brincidofovir in hMPXV infection are not available[9]

Vaccinia immune globulin (VIGIV)

Immune globulin available as an IV infusion

·   Licensed by the FDA for the treatment of complications from smallpox (vaccinia) vaccination; may be authorized for use to treat hMPXV and other pox viruses during an outbreak[9]

CDC = Centers for Disease Control and Prevention; CMV = cytomegalovirus; FDA = US Food and Drug Administration; hMPXV = human-to-human MPXV; IM = intramuscular; IV = intravenous; NIH = National Institutes of Health; SNS = US Strategic National Stockpile

*It is unknown whether a person with severe hMPXV infection will benefit from treatment with tecovirimat, cidofovir, brincidofovir or VIGIV.

†Not available from SNS.

Prevention of Human Monkeypox Infection

Strategies for the prevention of hMPXV infection include measures to prevent disease and measures to prevent human-to-human transmission.

Prevention of Disease

There are 3 strategies to prevent disease:[15,16]

  • Postexposure prophylaxis: vaccination after known exposure
  • Expanded postexposure prophylaxis: vaccination after known or presumed exposure
  • Preexposure prophylaxis: vaccination before exposure

Two vaccines may be used for the prevention of smallpox and MPXV disease among people determined to be at high risk: ACAM2000 and JYNNEOS. ACAM2000 is a second-generation vaccine indicated for the prevention of smallpox disease available for use against MPXV in the current outbreak under an Expanded Access Investigational New Drug protocol.[17] JYNNEOS (also known as Imvamune or Imvanex)[18] is the only FDA-licensed vaccine in the US to prevent MPXV disease in people aged 18 years and older.[19] JYNNEOS is a third-generation, nonreplicating viral-vectored vaccine using Modified Vaccinia Ankara (MVA-BN). The CDC recommends that vaccination with JYNNEOS can be considered for people determined to be at high risk for infection to prevent monkeypox disease.[20] The vaccination schedule and dosing regimens for JYNNEOS are summarized in Table 2.

Table 2. Vaccination Schedule and Dosing Regimens for JYNNEOS[19,20]

Regimen

Route of Administration

Injection Volume

Recommended Number of Doses

Recommended Interval Between First and Second Doses

Alternative: People aged ≥18 years

ID

0.1 mL

2

28 days

Standard: People aged <18 years

SC

0.5 mL

2

28 days

People with history of developing keloid scars: any age

SC

0.5 mL

2

28 days

ID = intradermal; SC = subcutaneous

Administering An Intradermal Injection

To prepare to administer JYNNEOS by ID injection, use a tuberculin syringe with a 27-gauge needle (1/4" to 1/2") with a short bevel to withdraw the entire injection volume from a single vial. Do not combine residual vaccine from multiple vials to obtain a dose. Follow the steps in the order given here to administer the vaccine intradermally:

  • Select and cleanse the vaccination site 2 to 4 inches below the antecubital fossa on the volar surface (same side as palm of hand) of the forearm
  • Pull the skin taut, position the bevel of the needle to face up, and insert the needle at a 5- to 15-degree angle into the epidermis (Figure 1)
  • Slowly inject the recommended volume of vaccine

Figure 1. The traditional procedure for intradermal injection is known as the Mantoux procedure. The needle is inserted approximately 1/8 inch (3 mm) into the epidermis.

A noticeable pale elevation of the skin should appear (Figure 2). Observe patients for 15 minutes (30 minutes if patient has a history of anaphylaxis to gentamycin, ciprofloxacin, chicken, or egg) after administration of the vaccine.

Figure 2. Watch for the characteristic wheal or blister to appear as the vaccine solution is injected into the skin.

Unsafe injection practices such as reuse of syringes and misuse of medications vials put patients and healthcare personnel at risk for disease transmission and can cause outbreaks. Clinicians are encouraged to follow the CDC's injection safety guidelines (Figure 3).[21]

Figure 3. Never administer medications from the same syringe to more than 1 patient, even if the needle is changed, and never enter a vial with a used syringe or needle. Do not use medications packaged as single-dose or single-use for more than 1 patient and do not use bags of intravenous solution as a common source of supply for more than 1 patient. Limit the use of multidose vials and dedicate them to a single patient whenever possible.

Prevention of Human-to-Human Transmission

Human-to-human transmission of monkeypox virus occurs by direct contact with lesions or infected body fluids or from exposure to respiratory secretions during prolonged face-to-face contact.[22] The CDC provides guidance for clinicians on infection control in healthcare settings[23] and isolation and infection control at home.[24] Clinicians are encouraged to adhere to stay abreast of the most current guidance from CDC.

Clinical Implications

  • Drugs are available for the treatment of hMPXV infection, but none is FDA-approved for this indication. However, countermeasures are available. Tecovirimat is licensed by the FDA for the treatment of human smallpox disease caused by variola virus but not approved for treatment of other Orthopoxvirus infections, such as MPXV infection. Cidofovir is licensed by FDA for the treatment of CMV retinitis in persons with AIDS. Brincidofovir is licensed by FDA for the treatment of human smallpox disease in adult and pediatric patients, including neonates. VIVIG is licensed by the FDA for the treatment of complications from smallpox (vaccinia) vaccination.
  • Strategies for prevention of hMPXV infection include measures to prevent disease and measures to prevent human-to-human transmission. There are 3 strategies to prevent disease: postexposure prophylaxis, expanded postexposure prophylaxis, and preexposure prophylaxis. JYNNEOSis the only FDA-licensed vaccine in the US to prevent MPXV disease in people aged 18 years and older. JYNNEOS is administered by either SC or ID injection.
  • Implications to the healthcare team: To prevent transmission and to educate patients and the public, clinicians are encouraged to adhere to and stay abreast of the most current recommendations from the CDC.

 

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