Gilead Announces Remdesivir Shows Significant Benefit in Moderate COVID-19 Patients

According to Gilead Sciences’ (hereinafter referred to as “Gilead”) official WeChat account on the 2nd, the results of the Phase III trial of remdesivir in patients with moderate novel coronavirus pneumonia were announced. Compared with standard care alone, a 5-day course of remdesivir significantly improved clinical efficacy.

Gilead Sciences stated that studies showed patients receiving a 5-day course of remdesivir were more likely to experience clinical improvement by Day 11, with a 65% greater improvement compared to the standard care group. Compared with standard care, a 10-day course of remdesivir also benefited clinical outcomes, with results trending toward but not reaching statistical significance. No new safety signals for remdesivir were identified in either treatment group.

Gilead: Remdesivir May Provide Significant Benefits to Patients with Moderate COVID-19

Gilead plans to submit the complete data for publication in a peer-reviewed journal within the coming weeks.

Francisco Marty, an infectious disease specialist at Brigham and Women’s Hospital and Associate Professor of Medicine at Harvard Medical School, stated, “Our understanding of the severity of novel coronavirus infection and of coronavirus disease continues to advance.” He added, “These findings provide further encouraging data for remdesivir, indicating that a five-day course of treatment initiated early in the disease course can significantly improve clinical outcomes in these patients.”

Gilead Sciences stated that remdesivir is currently approved in Japan for the treatment of patients infected with the novel coronavirus. Outside of Japan, remdesivir remains an investigational drug that has not yet been approved. The U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for remdesivir to treat hospitalized patients with severe COVID-19; this authorization is temporary and does not replace the formal new drug application submission, review, and approval processes.

In this study, hospitalized patients with confirmed SARS-CoV-2 infection, evidence of pneumonia, and no decreased oxygen saturation were randomly assigned (1:1:1) to receive open-label remdesivir for 5 days or 10 days, or standard care alone. The primary endpoint was clinical status on day 11, assessed on a 7-point scale ranging from discharge to increasing levels of oxygen and ventilatory support to death. The secondary objective was to compare the incidence of adverse events in the remdesivir groups versus the standard care group.

On day 11, a higher proportion of patients in the group receiving a 5-day course of remdesivir achieved clinical improvement, defined as a grade improvement of ≥1 point that was statistically significant (P=0.026), compared with the standard-of-care group. Furthermore, there was no statistically significant increase in clinical deterioration or death in the standard-of-care group compared with the remdesivir-treated group.

Merdad Parsey, M.D., Chief Medical Officer of Gilead Sciences, stated, “We now have three randomized, controlled clinical trials demonstrating that remdesivir improves clinical outcomes across multiple different assessment methods. Today’s results show that, for patients with moderate disease, a 5-day course of remdesivir leads to greater clinical improvement compared with standard care, further corroborating previously published findings on the efficacy of remdesivir. A placebo-controlled study conducted by the National Institute of Allergy and Infectious Diseases showed that remdesivir accelerates patient recovery and that early treatment can improve clinical outcomes. Our SIMPLE trial in severe cases demonstrated that the clinical improvements achieved with a 5-day course of remdesivir were similar to those achieved with a 10-day course in patients with severe disease.”

Merdad Parsey also stated, “Today, we have obtained more data, which will further guide the direction of our research, including evaluating early intervention in the disease course, combination therapy with other treatments for critically ill patients, pediatric studies, and the development of different formulations.”

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