Treating patients with COVID-19 has proven difficult for the medical community throughout the world, as we cope with a new virus with no vaccine or known cure. Viruses are typically prevented through vaccines or treated with an antiviral drug, one of the most common being Tamiflu, used for seasonal influenza.
One antiviral drug, Remdesivir, is being tested in clinical trials in China, Europe and now the United States, for patients with COVID-19. Originally created in 2016 as a potential treatment for Ebola, today Remdesivir is showing promise for those with COVID-19.
Several weeks ago, across all Trinity Health regional health ministries in Michigan, treatment guidelines were created for COVID-19 patients, citing Remdesivir as the first drug to attempt to use for critically ill patients.
The caveat: If they can get the drug for their patients, as the drug is in short supply and in high demand.
“When we got our first critically ill COVID-19 patient at Mercy Health Saint Mary’s, we immediately moved on gathering the paperwork to obtain this drug,” said Lisa Dumkow, PharmD, BCIDP, Clinical Pharmacist, Antimicrobial Stewardship at Mercy Health.
“The process was thorough,” said Dumkow, “We had to obtain both FDA and organizational approvals, as well as clinicians’ information for the drug. We were going to obtain the drug through the ‘Compassionate Use Program’ for this patient, as Remdesivir isn’t FDA-approved for COVID-19 patients.”
Dumkow and the team of pharmacists, infectious diseases and intensive care providers worked over an entire weekend to gather the necessary paperwork and were “extremely relieved” when the drug arrived onsite a week later.
Given through an IV once daily, the patient was able to be extubated within 60 hours after receiving the first dose of the drug.
“We were thrilled to be able to help this patient, and we were excited with the response,” said Dumkow. “Typically, in order for an antiviral to be effective, the patient needs to be given it within 48 hours of onset of symptoms. With COVID-19 and Remdesivir, we wonder if based on this case that there may be a bigger window of opportunity.”
Within a couple of weeks, the patient was discharged from the hospital to continue recuperation at home.
Encouraged by their findings, Dumkow and the team published them in the peer-reviewed pharmacology journal, Pharmacotherapy, in “open access form,” free for anyone to access who may need the information.
“The journal used ‘open access format’ so that any clinician has access to this information, as soon as possible and at no cost,” said Dumkow. Pharmacotherapy joins a large list of journals allowing all COVID-19 related articles to be available to access for free in order to speed the sharing and dissemination of data.
Moving forward, with the surge of COVID-19 patients throughout the country and globe, the drug Remdesivir via compassionate use is now being reserved for pediatric or pregnant patients. Outside of these patient populations, those hospitals who are at sites hosting clinical trials or in hospitals in the hardest-hit areas of the country, which includes Southeast Michigan, may be eligible for Remdesivir via the company’s Expanded Access Program.
“The manufacturing company, Gilead, should be applauded,” said Dumkow. “They are working with the hardest-hit areas in our country to provide medication through their ‘Expanded Access Program,’ to sites such as at St. Joe’s Mercy Health System; unfortunately, though, this medication’s shortage may continue to hinder the country’s fight against COVID-19.”
As the country and state of Michigan navigate the current COVID-19 pandemic, experts are starting to see evidence that social distancing and easier access to testing are helping to suppress the number of new cases daily.
“These efforts, combined with supportive care and potentially new therapeutic options, are helping us to stomp out COVID-19,” said Dumkow. “There may still be a long road ahead, but we are all in this together.”
Thank you to Dumkow and the rest of the team who worked hard to procure this anti-viral drug and share the information related to this case: Emily Hillaker, DO, Julie Belfer, PharmD, Anamaria Bondici, MD and Hani Murad, MD.