Gilead Sciences Unveils Final Results From Remdesivir Trial Showing It Helped COVID-19 Patients

Gilead Sciences has released the final results from a late-stage trial of its investigational antiviral remdesivir, which showed that the drug helped patients improve in multiple areas compared to placebo and worked one day faster than previous data showed.

“Treatment with [remdesivir] resulted in consistent, clinically meaningful improvements across multiple outcome assessments compared with placebo in COVID-19 patients,” the company said.

The results, which come from the National Institute of Allergy and Infectious Diseases’ 1,062-patient phase 3 trial, showed that remdesivir plus standard of care shortened recovery time by four days, meeting its primary endpoint. According to the final day-29 results, patients given remdesivir achieved clinical recovery five days faster than placebo patients, with a median recovery time of 10 days for remdesivir and 15 days for placebo, a day faster than earlier results indicated (DID, April 30). Additionally, remdesivir patients saw a 29 percent increased recovery rate compared to placebo patients, according to the results published in the New England Journal of Medicine (NEJM).

The study’s key secondary endpoint of clinical status at day 15 was also met, with patients on remdesivir 50 percent more likely to have improved by day 15 compared to those given a placebo. The effect was maintained through day 29 and, while the antiviral’s benefit was greater when given within 10 days of symptoms appearing, benefit was seen “across most ranges of symptom duration.”

Remdesivir also significantly reduced mortality in patients requiring low-flow oxygen, providing a 72 percent reduction in mortality at day 15 and a 70 percent reduction at day 29.

“We now have data suggesting that giving remdesivir to patients on oxygen may significantly reduce their chances of death as compared to other subgroups,” Gilead said.

The company filed a new drug application with the FDA in August in the hopes of getting an approval for treating COVID-19, but the agency has not yet made a decided. The drug’s Emergency Use Authorization currently allows it to be used for all hospitalized coronavirus patients regardless of severity (DID, Aug. 11).

In another research development, the UK’s large-scale RECOVERY trial found that hydroxychloroquine did not help lower patient mortality rates at 28 days.

“These findings indicate that hydroxychloroquine is not an effective treatment for hospitalized patients with COVID-19 but do not address its use as prophylaxis or in patients with less severe SARS-CoV-2 infection managed in the community,” the researchers concluded in a new article published by the NEJM.

Read the NEJM remdesivir study report here: bit.ly/3iHN0LX. — James Miessler