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Sharing Data is the Key to Unlocking Remdesivir Challenges

Critical care teams should consider using remdesivir to treat patients with severe acute SARS-CoV-2 infection, but supply of the drug is limited and best practices for maximizing its effectiveness are not completely understood.

The National Institutes of Health (NIH) COVID-19 Treatment Guidelines have been revised to recommend use of remdesivir in hospitalized patients with severe disease, defined as “SpO2 ≤94% on ambient air (at sea level), requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation.” The U.S. Food and Drug Administration issued an emergency use authorization for the investigational antiviral drug, providing one fact sheet for clinicians and another that can be distributed to patients. This approach followed preliminary results of a randomized controlled clinical trial that suggested remdesivir treatment was associated with faster recovery in patients with advanced COVID-19. 

However, these new recommendations come with challenges for the critical care clinician. First among them is the limited supply of remdesivir. The 600,000 doses available in the United States were donated by Gilead Sciences, Inc., as part of its commitment to distribute 1.5 million vials worldwide. The U.S. Department of Health and Human Services distributed a first wave of doses to select hospitals and state hospital departments. As distribution efforts continue across the country, to include the Veterans Health Administration facilities as well as the Native American hospital service, the donated supply is anticipated to run out in August.  It is not clear in what time frame new doses may be manufactured after the initial donated supply runs out. Moreover, it is possible that new and potentially complementary therapies will emerge that would decrease reliance on remdesivir to shorten intensive care unit (ICU) length of stay.

Since the indications for remdesivir use put forth are broad, it is unclear how to maximize the benefits of remdesivir treatment given the currently limited data and supply. While the best use may be for patients at an early stage of infection prior to developing critical illness, it is anticipated that – given the limited supply – remdesivir will be principally utilized for those requiring ICU care.

“We would like to know with greater certainty three aspects of remdesivir therapy: who will benefit most, when we should optimally initiate treatment, and when we should stop therapy. Our guidance is not as crisp as one might desire, but this is to be expected. We are learning how to best treat the disease while we are treating it,” said SCCM President Lewis J. Kaplan, MD, FACS, FCCP, FCCM.

Importantly, remdesivir is not a cure. It is not a therapeutic agent that will change a patient’s course from a mortality trajectory to one of survival, at least according to the results of the latest study. Even so, the drug’s use in the ICU will have an important role, as it may improve outcomes for those who are expected survive by shortening their time in the ICUIn so doing, remdesivir may also reduce post-intensive care syndrome in ICU survivors. Families can reunite with their loved one more quickly, and important ICU resources – beds, staff, and invasive and non-invasive ventilators -- can be liberated to treat new patients.

As the challenges and benefits of these new recommendations become more clear, it is essential that these uncertainties are not misinterpreted as shortcomings.

“This is simply a reflection of our reality. We are learning while we care for patients. It’s a good thing that we adjust care in response to new findings,” Dr. Kaplan said. “That we don’t have precise guidance that has a rigid rule to be followed is only to be expected.  Working together we can share data to generate clear and evidence-based therapy.”

An editorial published today ahead of print in Critical Care Medicine outlines how rapidly some COVID-19 therapies are evolving to maximize benefit. John J. Marini, MD, described coronavirus disease-associated acute respiratory distress syndrome (CARDS) and identified how traditional respiratory distress syndrome therapies might differ in this patient population, crediting “unprecedented, high-speed sharing of clinical data, experience, and ideas.” 

This widespread sharing of data is key in the evolving landscape of COVID-19. 

“It is absolutely essential that people use remdesivir within the existing guidance and that they track patient outcomes; the good and the bad need to be carefully observed, reported, and shared,” Dr. Kaplan stressed. “There is no more important time than now for data sharing. We need to learn from one another.” 

There is also no better time to ensure that your hospital joins more than 500 institutions worldwide participating in the Discovery COVID-19 VIRUS Registry to help identify trends in the use of remdesivir and other therapies. The VIRUS dashboard displays the periodic registry updates. In the next few weeks, the participants will start receiving aggregated reports on current VIRUS registry data trends,  including that for medication use. As your hospital prepares to implement updated recommendations from the NIH guidelines, contribute to the data-sharing effort that will help improve outcomes for adult and pediatric patients with COVID-19. 
 
Other updates from the NIH COVID-19 Treatment Guidelines Panel, which includes leaders from SCCM, include: 

  • A new section on antithrombotic therapy in patients with COVID-19 to address the role of thrombolytic, anticoagulant, and antiplatelet agents. Join the SCCM discussion on anticoagulants online.  
  • Recommendations against use of high-dose chloroquine (600 mg twice daily for 10 days) for the treatment of COVID-19. 
  • New information on immune-based therapy using convalescent plasma and SARS-CoV-2-specific immune globulins.  

Learn more about the NIH guidelines and SCCM’s role in this webcast and podcast




Posted: 5/15/2020 | 0 comments

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