June 1, 2020 - Gilead Sciences, which created the antiviral drug remdesivir, said the drug improved symptoms among moderately ill, hospitalized COVID-19 patients who took it for five days, the company announced Monday.
The company presented the “topline” results for the phase 3 trial in humans and said full results would be published in a medical journal in upcoming weeks, according to The Associated Press.
“The additional data we have in hand today will further guide our research efforts, including evaluating treatment earlier in the course of disease, combination studies with other therapies for the most critically ill patients, pediatric studies and the development of alternate formulations,” said Merdad Parsey, MD, the company’s chief medical officer, in the news release.
The study evaluated 5- and 10-day courses of the drug versus standard care among 600 COVID-19 patients who had pneumonia but didn’t need oxygen support. Interestingly, patients in the 5-day group showed improvements, but the 10-day group had similar results to those who didn’t take the drug.
About 76% of patients who received the 5-day course of the drug improved by at least one point on a 7-point scale, as compared to 66% of those who received standard of care. At the same time, 70% of the patients who received the 10-day course showed an improvement, according to Bloomberg News.
There were no deaths in the 5-day group, two in the 10-day group, and four among the standard of care group. The most common side effects were nausea, diarrhea and headache. Gilead also said Monday that no new safety risks were identified in either treatment group.
Gilead’s new data likely indicates that remdesivir is somewhat effective, but scientists will continue to research how effective, according to STAT.
“For most clinicians when we see this, it’s heartening,” Nahid Bhadelia, medical director of the special pathogens unit at Boston Medical Center, told the news outlet. “But at the same time it’s frustrating to get the data through a press release rather than to see the data.”
Doctors still view remdesivir as an important option for COVID-19, according to STAT, but they need more data to understand what the results mean, including the benefits and side effects.
The FDA issued an emergency use authorization for remdesivir on May 1, which allows hospitals to use the drug for patients with severe cases of COVID-19. The authorization was based on early results from an NIH study that showed patients recovered faster when they received the drug.
Remdesivir is approved as a treatment for COVID-19 in Japan, but in the U.S. and other countries it is considered an investigational drug that is still undergoing the formal drug review and approval process.