Gilead trial shows five-day remdesivir course treats moderate covid-19

NEW DELHI: Gilead Sciences Inc late Monday said results from its phase-three clinical trial among hospitalised patients with mild covid-19 pneumonia showed that a five-day treatment course of remdesivir can lead to significant clinical improvement.

Patients in the five-day remdesivir treatment group were 65% more likely to have clinical improvement on day 11, compared with those in standard care group, the company said.

The Drugs Controller General of India (DCGI), VG Somani, has also approved the drug for a five-day treatment, a source at the apex Indian drug regulator told Mint, requesting anonymity. However, the approval has yet not been made public.

In India, Gilead has given voluntary licenseto produce remdesivir to Cipla Ltd, Jubilant Life Sciences Ltd, Hetero Drugs and Mylan under a royalty-free arrangement till an alternative drug is developed or until the World Health Organization (WHO) removes the designation of Public Health Emergency of International Concern’ for the coronavirus pandemic.

“We now have three randomised, controlled clinical trials demonstrating that remdesivir improved clinical outcomes by several different measures,” Merdad Parsey, the US-based firm’s chief medical officer, was quoted as saying in the release.

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

Two earlier trials--the National Institute of Allergy and Infectious Diseases’ (NIAID) placebo-controlled study and Gilead’s own study on severe patients—had shown that five days of remdesivir treatment course led to significant clinical improvement among patients by reducing the time to recovery.