World Health Organization defends data after concluding Gilead's remdesivir flopped Covid trial

Суббота, 17 Окт, 2020

The World Health Organisation has said that Gilead Sciences Inc's antiviral medication Remdesivir failed to prevent coronavirus deaths and had no effect on COVID-19 patients' length of hospital stay in a huge trial.

The study covered more than 11,000 coronavirus patients in 30 countries.

Gilead stocks slipped 1.3% following the release of the World Health Organization study. The study has not yet been peer-reviewed.

The drug was recently used to treat US President Donald Trump after he was detected with the virus. In July, the USA has bought almost all the available global stocks for the next three months of drug from drugmaker Gilead Sciences.

Earlier this month, data from a USA study of remdesivir by Gilead showed the treatment cut COVID-19 recovery time by five days compared with patients who got a placebo in a trial comprising 1,062 patients.

Several previous studies had pointed to the futility of hydroxychloroquine and lopinavir as treatments against the coronavirus.

Furthermore, the World Health Organization study tested 10 days of remdesivir, so some patients may have been hospitalised longer than they needed to be just to finish treatment, making their length of stay look bad in comparison to others getting usual care.

Gilead, which makes the drug, told the Financial Times that the data seemed "inconsistent with more robust evidence from multiple randomized, controlled studies validating the clinical benefit" of it.

The WHO declined to comment, saying the results of the study were not yet public.

The Commission's decision was made after European Union countries warned of shortages of remdesivir in their hospitals amid a new surge of COVID-19 infections across Europe.

The study said that narrower confidence intervals would be helpful, particularly for remdesivir, which is part of the national clinical management protocol in India. The trials were conducted in more than 30 countries. This led to black-marketing of the drug here and the prices shot up by five to six times.

A final analysis, published in The New England Journal of Medicine on October 8, suggested "a trend toward reduced mortality" in certain patients receiving remdesivir, according to the drug's maker, Gilead. Participants received the treatment for 10 days, with 200 mg delivered on the first day and 100 mg for the subsequent days.

U.S. government research suggested the drug improved survival odds and shortened recovery times.

President Donald Trump took remdesivir as well as a handful of other treatments after he tested positive for the coronavirus early this month.

Syngene, the contract research subsidiary of Biocon, has a licensing agreement with Gilead to manufacture and distribute Remdesivir in 127 countries including India. These companies not only supply to the Indian market but also have the license to distribute this drug to 127 countries, mostly low and medium income nations.

There was also no significant difference in mortality for interferon-β1 (RR 1.16, 95% CI 0.96-1.39, P=0.11), nor HCQ (RR 1.19, 95% CI 0.89-1.59, P=0.23) and lopinavir (RR 1.00, 95% CI 0.79-1.25, P=0.97), both of which had previously shown no benefit in other randomized trials.