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2020-06-01| COVID-19

Remdesivir Registers Middling Benefit in Patients with Moderate COVID-19

by Ruchi Jhonsa
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By Ruchi Jhonsa, Ph.D.

A month ago, Gilead Sciences revealed data from the much-awaited SIMPLE trial that tested the 5- and 10-day dosing durations of its investigational antiviral, remdesivir on hospitalized patients with severe disease. Today, it announced the topline results from the second SIMPLE trial that compared the drug versus the standard of care on hospitalized patients with moderate COVID-19 pneumonia.

The Phase 3 study demonstrated that in comparison to the standard of care alone, remdesivir treated patients were “65% more likely” to show signs of clinical improvement on Day 11. The new results support the findings from an NIH sponsored study, which showed that remdesivir enabled a more rapid recovery than the standard of care in patients who hadn’t yet needed mechanical ventilation. Despite this positive data, Gilead’s stock took a plunge since the news reflecting the modesty of the result. Besides, analysts are skeptical about whether the drug will reap any benefit at all.

Based on the NIH trial results, Remdesivir is currently authorized for emergency use by the USFDA for the treatment of adult or pediatric patients with suspected or laboratory-confirmed SARS-CoV2 infection and severe COVID-19. A patient with the severe disease has an oxygen saturation of less than 94% on room air and will require supplemental oxygen or mechanical ventilation.

 

Official Statements

“We now have three randomized, controlled clinical trials demonstrating that remdesivir improved clinical outcomes by several different measures. Today’s results showed that when treating moderate disease, a 5-day course of remdesivir led to greater clinical improvement than the standard of care, adding further evidence of remdesivir’s benefit to previously released study results,” said Merdad Parsey, MD, Ph.D., CMO of Gilead Sciences.

“The National Institute of Allergy and Infectious Diseases’ placebo-controlled study showed that remdesivir enabled the more rapid recovery and that earlier treatment improved clinical outcomes. Our 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,”

“The additional data we have in hand today will further guide our research efforts, including evaluating treatment earlier in the course of the disease, combination studies with other therapies for the most critically ill patients, pediatric studies, and the development of alternate formulations,” she added.

 

Detailed Trial Results

Hospitalized patients with evidence of pneumonia accompanied by reduced oxygen levels were randomized (1:1:1) to receive remdesivir for 5 or 10 days or standard of care alone. The primary endpoint measured several clinical parameters under the ‘7-point ordinal score’ umbrella on Day 11 that included the time of hospital discharge, change in the levels of oxygen, ventilator support, and death. The trial also noted any adverse events in these patients simultaneously.

When put on a 5-day regime, 134 patients (70%) showed greater than 2-point improvement, and 146 (76%) patients showed more than 1-point improvement as compared to 121 (61%) and 132 (66%) patients on standard of care alone respectively. Moreover, only half the patients (12) put on a 5-day remdesivir course required oxygen support in comparison to patients put on standard of care (22). In addition to this data, symptoms of 22 patients put on standard of care worsened by 1 point on the ordinal scale in comparison to just 6 patients put on a 5-day remdesivir course. However, no statistically significant improvement was observed for clinical worsening in patients. In contrast to a 5-day treatment, a 10-day treatment regime with remdesivir, although positive trending, could not achieve statistical significance.

When accessed for safety, the drug was generally well-tolerated in both the 5-day and 10-day treatment groups. The most common adverse events occurring in more than 5 percent of patients in both treatment groups were nausea, diarrhea, and headache.

“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.”

Related Article: COVID-19: Gilead’s Promising Remdesivir Data Jumps US Stocks, Hastens FDA’s Emergency Authorization Plans

References
  1. https://www.gilead.com/news-and-press/press-room/press-releases/2020/6/gilead-announces-results-from-phase-3-trial-of-remdesivir-in-patients-with-moderate-covid-19
  2. https://www.gilead.com/news-and-press/press-room/press-releases/2020/4/gilead-announces-results-from-phase-3-trial-of-investigational-antiviral-remdesivir-in-patients-with-severe-covid-19

 

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