Gilead Announces Positive Results From Phase 3 Remdesivir Trial

Patients on a shorter dosing regimen in Gilead’s phase 3 remdesivir trial saw clinical improvements similar to those on the 10-day treatment schedule, the drugmaker announced Wednesday, offering hope of a COVID-19 treatment.

More than half of the hospitalized COVID-19 patients in Gilead’s study in both the five-day and 10-day regimen groups were discharged from the hospital within two weeks.

Sixty-four percent of the 200 patients in the five-day treatment group achieved clinical recovery within two weeks and were discharged compared to 53.8 percent patients in the 10-day group, Gilead said.

In other good news for remdesivir, the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) announced on Wednesday that its remdesivir trial showed patients recovered faster on the drug than those who were given a placebo, according to preliminary data from the 1,063 patient study.

“Preliminary results indicate that patients who received remdesivir had a 31 percent faster time to recovery than those who received placebo,” NIAID said. Specifically, patients on remdesivir had a median time to recovery of 11 days compared to 15 days for those in the placebo group.

NIAID Director Anthony Fauci announced from the White House that the trial’s safety monitoring board said the “data shows that remdesivir has a clear-cut significant positive effect in diminishing the time to recovery” for COVID-19 patients.

“It is a very important proof of concept,” Fauci said. “What it is proving is that a drug can block this virus.”

Data from a Chinese remdesivir trial accidentally posted by the World Health Organization last week showed no benefit in COVID-19 patients, although Gilead argued the results were “inconclusive” and included “inappropriate characterizations” of the study (DID, April 24).

Results from the China trial were published by the researchers themselves in the Lancet Wednesday. — James Miessler