Foster City, CA—With persistent concerns about drug supply, the manufacturer of the investigational antiviral remdesivir announced clinical-trial results demonstrating that COVID-19 patients receiving a shorter, 5-day course of the drug fared much better than patients receiving standard care.
Gilead Sciences, Inc. recently announced topline results from the phase lll SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia. The open-label study evaluated both 5-day and 10-day courses of the investigational antiviral remdesivir plus standard of care, versus standard of care alone.
Results suggest that patients in the 5-day remdesivir treatment group were 65% more likely to have clinical improvement at Day 11 compared with those in the standard-of-care group (OR 1.65 [95% CI, 1.09-2.48]; P = .017). The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard-of-care were also favorable, trending toward but not reaching statistical significance (OR 1.31 [95% CI, 0.88-1.95]; P = .18), according to a press release.
Gilead, which said it plans to submit the full data for publication in a peer-reviewed journal in the coming weeks, also advises that no new safety signals were identified with remdesivir across either treatment group.
“Our understanding of the spectrum of SARS-CoV-2 infection severity and presentations of COVID-19 continues to evolve,” said Francisco Marty, MD, an infectious-diseases physician at Brigham and Women’s Hospital, and associate professor of medicine at Harvard Medical School.
“These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients.”
Remdesivir is currently approved in Japan as a treatment for patients infected with SARS-CoV-2, the virus that causes COVID-19.
Outside of Japan, remdesivir is an investigational, unapproved drug. Although the FDA has granted remdesivir an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19, that authorization is temporary and does not take the place of the formal new drug application submission, review, and approval process.
In the study, hospitalized patients with confirmed COVID-19 infection and evidence of pneumonia without reduced oxygen levels were randomized (1:1:1) to receive open-label remdesivir for 5 or 10 days or standard of care alone. Defined as the primary endpoint was the clinical status as assessed by a 7-point ordinal score at Day 11, ranging from hospital discharge to increasing levels of oxygen and ventilatory support to death. The secondary study objective was the rate of adverse events in each remdesivir treatment group compared with standard of care.
Researchers report that, at Day 11, a higher proportion of patients in the 5-day treatment group achieved improvement in clinical status versus the standard-of-care group, achieving statistical significance for a ≥1-point improvement in ordinal scale (P = .026). In addition, they note, nonstatistically significant increases in clinical worsening or death were observed in the standard-of-care only group compared with the remdesivir groups.
“We now have three randomized, controlled clinical trials demonstrating that remdesivir improved clinical outcomes by several different measures,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Today’s results showed that when treating moderate disease, a 5-day course of remdesivir led to greater clinical improvement than standard of care, adding further evidence of remdesivir’s benefit to previously released study results.”
Earlier, the National Institute of Allergy and Infectious Diseases’ placebo-controlled study showed that remdesivir enabled more rapid recovery and that earlier treatment improved clinical outcomes.
Dr. Parsey said Gilead’s SIMPLE-Severe study showed that when treating patients with severe disease, 5 days of remdesivir led to similar clinical improvements as a 10-day course, adding, “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.”
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
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Gilead Sciences, Inc. recently announced topline results from the phase lll SIMPLE trial in hospitalized patients with moderate COVID-19 pneumonia. The open-label study evaluated both 5-day and 10-day courses of the investigational antiviral remdesivir plus standard of care, versus standard of care alone.
Results suggest that patients in the 5-day remdesivir treatment group were 65% more likely to have clinical improvement at Day 11 compared with those in the standard-of-care group (OR 1.65 [95% CI, 1.09-2.48]; P = .017). The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard-of-care were also favorable, trending toward but not reaching statistical significance (OR 1.31 [95% CI, 0.88-1.95]; P = .18), according to a press release.
Gilead, which said it plans to submit the full data for publication in a peer-reviewed journal in the coming weeks, also advises that no new safety signals were identified with remdesivir across either treatment group.
“Our understanding of the spectrum of SARS-CoV-2 infection severity and presentations of COVID-19 continues to evolve,” said Francisco Marty, MD, an infectious-diseases physician at Brigham and Women’s Hospital, and associate professor of medicine at Harvard Medical School.
“These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients.”
Remdesivir is currently approved in Japan as a treatment for patients infected with SARS-CoV-2, the virus that causes COVID-19.
Outside of Japan, remdesivir is an investigational, unapproved drug. Although the FDA has granted remdesivir an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19, that authorization is temporary and does not take the place of the formal new drug application submission, review, and approval process.
In the study, hospitalized patients with confirmed COVID-19 infection and evidence of pneumonia without reduced oxygen levels were randomized (1:1:1) to receive open-label remdesivir for 5 or 10 days or standard of care alone. Defined as the primary endpoint was the clinical status as assessed by a 7-point ordinal score at Day 11, ranging from hospital discharge to increasing levels of oxygen and ventilatory support to death. The secondary study objective was the rate of adverse events in each remdesivir treatment group compared with standard of care.
Researchers report that, at Day 11, a higher proportion of patients in the 5-day treatment group achieved improvement in clinical status versus the standard-of-care group, achieving statistical significance for a ≥1-point improvement in ordinal scale (P = .026). In addition, they note, nonstatistically significant increases in clinical worsening or death were observed in the standard-of-care only group compared with the remdesivir groups.
“We now have three randomized, controlled clinical trials demonstrating that remdesivir improved clinical outcomes by several different measures,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “Today’s results showed that when treating moderate disease, a 5-day course of remdesivir led to greater clinical improvement than standard of care, adding further evidence of remdesivir’s benefit to previously released study results.”
Earlier, the National Institute of Allergy and Infectious Diseases’ placebo-controlled study showed that remdesivir enabled more rapid recovery and that earlier treatment improved clinical outcomes.
Dr. Parsey said Gilead’s SIMPLE-Severe study showed that when treating patients with severe disease, 5 days of remdesivir led to similar clinical improvements as a 10-day course, adding, “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.”
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
« Click here to return to Weekly News Update.
