Race to find a treatment for coronavirus accelerates
Clinical trials underway; Bryan Llenas reports.
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Biotech company Gilead Sciences is expanding access to its antiviral drug remdesivir as an experimental coronavirus treatment.
In an open letter sent out Saturday, Gilead CEO Daniel O’Day said the company is carefully ramping up its efforts to make remdesivir available to coronavirus patients. The antiviral has previously been used to treat Ebola patients.
Remdesivir, which is awaiting regulatory approval as a coronavirus treatment, is being used in a number of clinical trials across the globe. In a project designed by regulators, it has also been made available, on an individual basis, to some severely ill patients who cannot participate in clinical trials.
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“When the news of the coronavirus first emerged, Gilead immediately began to investigate the potential of remdesivir, a medicine we had been studying for many years as part of our extensive research in antivirals,” O’Day explained. “Remdesivir had never been approved for use but based on what we had learned to date, we knew it might have potential with the novel coronavirus. Since then, we have been working with the greatest sense of urgency and responsibility to determine whether Remdesivir does indeed work against COVID-19.”
“The responsibility is to ensure that Remdesivir, an investigational medicine, is effective and safe before it is distributed for use worldwide,” he added. “Establishing the safety and efficacy of remdesivir, in partnership with regulatory authorities, is essential to potentially enabling the treatment of many more patients in the future.”
O’Day noted that multiple studies are ongoing and initial data is expected in the coming weeks. “If it is approved, we will work to ensure affordability and access so that Remdesivir is available to patients with the greatest need,” he wrote.
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The CEO explained, that, in the meantime, Gilead has made the investigational medicine available for severely ill patients who cannot enroll in a trial. The “compassionate use” program, which is typically reserved for a small number of cases, has provided Remdesivir to more than 1,000 patients. The program has been designed by regulatory authorities to ensure that each application has to be approved on an individual basis, O’Day explained. “This works well when there is only a limited number of requests – as is normally the case – but the system cannot support and process the overwhelming number of applications we have seen with COVID-19,” he added.
To deal with this, Gilead is shifting to “expanded access” programs. “The compassionate use program will continue for children and pregnant women only, reducing the numbers to a level where the system can cope,” O’Day said. “With expanded access, hospitals or physicians can apply for emergency use of Remdesivir for multiple severely ill patients at a time. While it will take some time to build a network of active sites, this approach will ultimately accelerate emergency access for more people.”
The CEO added that initial sites in the U.S. were up and running as of March 27 and it is expected that sites in additional countries will be activated soon.
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Drug trials to treat coronavirus patients have garnered massive attention in recent weeks, although experts have warned that people should not take drugs unless prescribed by a doctor.
In a press conference earlier this month, President Trump and FDA commissioner Dr. Stephen Hahn described several approaches under testing, such as chloroquine, a drug long used to treat malaria, and remdesivir.
The National Institutes of Health (NIH) recently began a clinical trial of remdesivir to treat COVID-19. The project at the University of Nebraska Medical Center (UNMC) in Omaha is the first clinical trial in the U.S. to evaluate an experimental treatment for the infectious disease.
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Other research into remdesivir includes two clinical trials in China’s Hubei province, according to Gilead. Results from the studies in China are expected in April.
On Feb. 26, Gilead Sciences announced the start of two Phase 3 clinical studies to evaluate the safety and effectiveness of remdesivir to treat adults diagnosed with COVID-19. “These randomized, open-label, multicenter studies will enroll approximately 1,000 patients at medical centers primarily across Asian countries, as well as other countries globally with high numbers of diagnosed cases, beginning in March,” Gilead said. “The studies will assess two dosing durations of remdesivir, administered intravenously.”
Previously, remdesivir was used to treat humans with Ebola. It had also shown promise in animal models for treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), according to the NIH.
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As of Monday morning, at least 732,153 coronavirus cases have been diagnosed worldwide, at least 143,055 of which are in the U.S. The disease has accounted for at least 34,686 deaths around the world, including 2,513 people in the U.S.
The Associated Press contributed to this article. Follow James Rogers on Twitter @jamesjrogers