Gilead’s Antiviral Shows Promise as a Potential COVID-19 TreatmentBy
Gilead Sciences reported this week (April 29, 2020) promising results from a Phase III clinical trial evaluating its investigational antiviral drug, remdesivir, as a treatment for hospitalized patients with severe COVID-19.
The study evaluated five-day and 10-day dosing durations of remdesivir to determine whether the durations would achieve similar efficacy results. The data from the study showed similar clinical improvements in patients with severe symptoms of COVID-19, regardless of whether they received five or 10 days of treatment. The study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases to help determine the optimal duration of treatment with remdesivir.
“The results from the global, placebo-controlled trial run by the National Institute of Allergy and Infectious Diseases (NIAID) are positive,” said Daniel O’Day, Chairman and CEO of Gilead Sciences, in an April 29, 2020 statement. “They show that patients with COVID-19 who received remdesivir recovered faster than similar patients who received placebo.”
The preliminary results from the NIAID study indicate that patients who received remdesivir had a 31% faster time to recovery than those who received placebo. Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group.
“The question of duration is important because the possibility of a shorter treatment course is beneficial in many respects,” said O’Day in his statement. “Patients can return home earlier from the hospital, families can be reunited, healthcare resources are freed up, and more medicine is available for other patients in need.”
O’Day said that the company has been ramping up production since January (January 2020) and that its existing supply, including finished product ready for distribution as well as materials in the final stages of production, amounts to 1.5 million individual doses. “We had estimated that this would be 140,000 treatment courses based on a 10-day treatment duration,” said O’Day in the company’s statement. “The ability to shorten duration for severely ill patients means we can significantly increase the number of courses available, all of which Gilead has committed for donation.”
Going forward, O’Day says that on the supply side, the company is working to build a global consortium of pharmaceutical and chemical manufacturers to expand global capacity and production. On the clinical side, Gilead says it will continue to discuss with regulatory authorities the growing data set regarding remdesivir as a potential treatment for COVID-19. The NIAID said this week (April 29, 2020) that more detailed information about its trial results, including more comprehensive data, will be available in a forthcoming report.
Source: Gilead Sciences (clinical trial results), Gilead Sciences (Statement by Chairman and CEO) and National Institute of Allergy and Infectious Diseases