Gilead: Short Course Remdesivir Tops Standard COVID-19 Tx

— Modest efficacy, good safety in moderately ill patients in phase III study

by Molly Walker, Associate Editor, ľ��ֱ�� June 1, 2020

Hospitalized patients with moderate COVID-19 pneumonia treated with antiviral remdesivir plus standard of care were modestly more likely to show clinical improvement in a specified period than patients treated with standard of care alone, topline results from a randomized phase III open-label trial found.

In COVID-19 patients receiving treatment with intravenous remdesivir for 5 days in addition to standard treatment, odds of showing clinical improvement at day 11 were 65% higher (95% CI 9%-148%, P=0.017) versus those receiving standard of care, on Monday.

This difference in improvement was only significant in the group receiving 5 days of remdesivir, with a non-significant difference among patients receiving 10 days of the drug (OR 1.31, 95% CI 0.88-1.95, P=0.18).

On day 11, a significantly higher proportion of patients in the 5-day group achieved at least a 1-point improvement in the ordinal scale (76% vs 66%). In the 10-day group, 70% achieved this endpoint.

Two-point improvements were achieved by 70% and 65% of the 5- and 10-day remdesivir groups, respectively, compared with 61% with standard care.

Rates of clinical worsening or death trended higher in controls (11%) versus both remdesivir groups (3% and 6% for 5 and 10 days, respectively).

Remdesivir is currently approved for emergency use authorization by the FDA to treat hospitalized patients with severe COVID-19. Recently, data from the ACTT-1 trial, which was sponsored by the National Institute of Allergy and Infectious Diseases, also found the drug was associated with shorter time to recovery compared to standard of care.

In the SIMPLE Moderate trial, 584 patients were randomized 1:1:1 into three groups: remdesivir for either 5 or 10 days, or standard of care alone. Primary endpoint was clinical status, which was assessed on a 7-point ordinal scale on day 11.

Similar to prior trials, remdesivir was well-tolerated, with nausea being the most common side effect, followed by diarrhea and headache, all of which occurred in more than 5% of patients in both treatment groups.

Gilead says they plan to submit these results to a peer-reviewed journal in the upcoming weeks.

Molly Walker is deputy managing editor and covers infectious diseases for ľ��ֱ��. She is a 2020 J2 Achievement Award winner for her COVID-19 coverage.