American biopharmaceutical company Gilead Sciences on Wednesday announced study results showing that patients receiving a 5-day treatment course of Remdesivir achieved similar clinical improvement in comparison with those taking a 10-day course.
By evaluating 5-day and 10-day dosing durations of the investigational antiviral drug in hospitalized patients with severe manifestations of COVID-19, the open-label Phase 3 SIMPLE trial sought to determine whether a 5-day course of remdesivir would achieve similar efficacy results as the 10-day treatment regimen used in multiple ongoing studies of Remdesivir, according to the company’s announcement.
The study demonstrated the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients to be treated with remdesivir, while no new safety signals were identified with remdesivir across either treatment group, Gilead said.
In this study, the time to clinical improvement for 50 percent of patients was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group. At Day 14, 64.5 percent of the 200 patients in the 5-day treatment group and 53.8 percent of the 197 patients in the 10-day treatment group achieved clinical recovery, the company said, noting that clinical outcomes varied by geography. The overall mortality rate at Day 14 was 7 percent among 320 patients across both treatment groups outside of Italy.
The most common adverse events occurring in more than 10 percent of patients in either group were nausea and acute respiratory failure. Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3 percent of patients, with 3.0 percent of patients discontinuing remdesivir treatment due to elevated liver tests, the study showed.
“Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” said Merdad Parsey, chief medical officer of Gilead Sciences.
These study results complement data from the placebo-controlled study of Remdesivir conducted by the National Institute of Allergy and Infectious Diseases and help to determine the optimal duration of treatment with Remdesivir, he said.
“While additional data are still needed, these results help to bring a clearer understanding of how treatment with Remdesivir may be optimized, if proven safe and effective,” said Aruna Subramanian, clinical professor of medicine at Stanford University School of Medicine, and one of the lead investigators of the study.
Gilead plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.