VDH COVID-19 Therapeutics Bi-Weekly Updates

VDH COVID-19 Therapeutics Bi-Weekly Update

A note to readers

Welcome to the VDH COVID-19 Therapeutics newsletter!

The purpose of this newsletter is to keep you informed and up to date on all things COVID-19 therapeutics – including information related to the treatment types, patient eligibility, ordering considerations, and logistical know-how.  We want to ensure this update is valuable and meets your needs in treating patients with COVID-19. Please take a moment to complete this quick survey so we can continually improve!

For any additional information, questions, comments, or feedback, please reach out to: COVID19Therapeutics@vdh.virginia.gov.

Therapeutics in the news

EVUSHELD effectiveness

• EVUSHELD is a preventative antibody for use as a pre-exposure prophylactic treatment for patients who are high risk, immunocompromised, and/or may not be eligible for vaccination
• In a late-state pre-exposure prevention trial, EVUSHELD reduced the risk of symptomatic COVID-19 after six months by 83% compared with placebo
• The data was published in the New England Journal of Medicine on April 20, 2022 and adds to a body of evidence in support of EVUSHELD to prevent symptomatic and severe COVID-19
• The drug was well tolerated with no safety issues by all patients, and the population included those with underlying conditions that placed them at high risk for severe infection and immunocompromised patients
• Review the article here, and a statement from manufacturer AstraZeneca here

World Health Organization (WHO) recommends highly successful COVID-19 therapy

• On April 22, 2022, the WHO made strong recommendations for Paxlovid for mild and moderate cases of COVID-19 in patients with high risk for hospital admission – calling it “the best therapeutic choice for high-risk patients to date”
• This recommendation stemmed from new data from two randomized controlled trials involving over 3000 patients, demonstrating a dramatic reduction in hospitalization risk (85%) following treatment
• Please review the WHO’s living guideline for the most up-to-date recommendations on COVID-19 therapeutics. This statement from the WHO is also informative related to Paxlovid treatment

FDA approves Remdesivir to treat young children

• On Monday April 25, 2022, the U.S. Food and Drug Administration (FDA) announced that it expanded approval of remdesivir in treating patients as young as 28 days and weighing at least 7 pounds
• This is the first COVID-19 treatment approved for young children
• Eligible children must be hospitalized or have mild-moderate infection and high risk for progressing to a severe case
• Read the FDA news release here

The CDC issued a Health Advisory on use of COVID-19 therapeutics

• The Health Alert Network (HAN) outlines recommendations for healthcare Providers, including direction to prescribe therapeutics for patients when clinically indicated
• Review the Health Advisory here

Important clinical updates

Paxlovid packaging for patients with renal impairment

On April 14, 2022, the U.S. Food and Drug Administration (FDA) revised the Emergency Use Authorization (EUA) for the COVID-19 oral antiviral therapeutic, Paxlovid, to authorize an additional pack presentation with appropriate dosing for patients with moderate renal impairment (eGFR ≥30 to <60 mL/min). As a result, Paxlovid will soon be available in two package presentations: 

This new packaging presentation will make dosing and administration easier to follow for patients with renal impairment – reducing the potential for inadvertent high dosing of the nirmatrelvir component. Please note that neither the recommended dosage for renal impaired patients nor the tablet concentration have changed per the FDA EUA. The way the tablets are packaged for ease of use has changed.

{Please note that Paxlovid is not recommended in patients with severe renal impairment (eGFR <30 mL/min) and no dose adjustment is needed in patients with mild renal disease (eGFR>60).}

Paxlovid (Renal Impaired) can be requested in quantities of 5 through VaxMaX starting this past Monday, April 25, 2022 for all VaxMaX providers. Please continue to have all therapeutic requests submitted by 12pm ET on Tuesdays.

Process and logistics updates

Therapeutics locator tool is transitioning to the Federal level

Please note the locator tool for identifying places to obtain COVID-19 therapeutic treatments will be sunset at the VDH level to transition this to the Federal level.  You can now identify locations to obtain therapeutics here.  This link will now appear throughout the VDH website to ensure you can easily locate services providers.

Transferring therapeutics to other sites

• Some health center sites may order therapeutics centrally prior to dispersing to other locations. Sites are required to report in HPoP whenever product is moved to a different site
• The benefit is that this data (when accurately reported) feeds into the HHS Locator Tool that informs constituents of where they can access therapeutics
• Instructions on how to do so are in the HPoP Job Aid here

Therapeutics Usage & Inventory Reporting Requirements

• Sites with continued non-compliance with utilization and inventory reporting may not have their orders fulfilled until they regularly report
• Reporting for Sotrovimab, Regen-cov, Bam/ETE are due every Wednesday by 11:59PM ET in the U.S. Healthcare COVID-19 Portal (i.e., TeleTracking/NHSN)
• VDH has published a job aid for the U.S. Healthcare COVID-19 Portal, which can be accessed here
• Reporting courses administered and daily on-hand inventory for Paxlovid, Molnupiravir, Evusheld and Bebtelovimab are due daily by 11:59pm EDT in the HHS Health Partner Order Portal (HPoP).
• VDH has published a job aid for the HHS Health Partner Order Portal (HPoP) here
• Therapeutic wastage reporting requirements
• As part of a new feature in the Health Partner Order Portal (HPoP), providers are now able to report therapeutic wastage
• Reporting of wastage is required only if therapeutics in your inventory expire and/or will not be used at a future date
• For information regarding how to report therapeutic wastage in HPoP, please refer to the updated HPoP Job Aid here
• If you are having challenges with reporting or have questions, please contact COVID19Therapeutics@vdh.virginia.gov for assistance

Allocation data 

VDH resources

VDH Therapeutics Website for Healthcare Providers

Check out the VDH Therapeutics webpage here.  Reach out to COVID19Therapeutics@vdh.virginia.gov for questions, comments, or feedback on information you’d like to see.

COVID-19 Therapeutics Webinars and Open Forum Calls

• VDH is continuing to facilitate webinars and open forums monthly. 
  See below for links to register!

May 12 Webinar: https://vdh.zoom.us/webinar/register/WN_X0tMHmD2RRW-IxuqOXoYNg
May 25 Open Forum: https://vdh.zoom.us/webinar/register/WN_aqexxTf3QoeiONWOcJ4jKg

Additional resources and education

WHO Resources

The WHO has published this infographic (right) to help Providers make informed decisions related to COVID therapeutics.

WHO also maintains a therapeutics living guideline that is updated as changes happen to keep Providers and the public informed.

Paxlovid and drug interactions

Paxlovid has interactions with several medications – though don’t let this deter you from prescribing this medication for eligible patients. 

The University of Liverpool has developed an interaction tool which can assist providers in prescription decision making.

Information is also available in a table format: click here for the PDF  (see below for snapshot).