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

Coronavirus: Remdesivir has 'little effect' on death risks, says WHO

WHO defends data after concluding Gilead's remdesivir flopped Covid trial

Gilead Sciences Inc's remdesivir had little or no effect on COVID-19 patients' length of hospital stay or chances of survival, a clinical trial by the World Health Organization (WHO) has found.

The data from the ACTT-1 trial on 1,062 patients by the USA government's National Institute of Allergy and Infectious Diseases (NIAID) published in the New England Journal of Medicine (NEJM) has found that hospitalized patients with COVID-19 pneumonia who received Remdesivir recovered five days faster than patients receiving placebo at day 29, and had evidence of lower respiratory tract infection.

Gilead in a statement to the Financial Times said "the emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies validating the clinical benefit of remdesivir". They said they have submitted their findings to a medical journal.

Although originally cleared only for use in people who were sick enough to need supplemental oxygen or breathing support, remdesivir's emergency authorization was expanded in August to include all hospitalized patients, regardless of disease severity.

Syngene, the contract research subsidiary of Biocon, has a licensing agreement with Gilead to manufacture and distribute Remdesivir in 127 countries including India.

The trial recorded 301 deaths among 2,743 patients who received remdesivir and 303 deaths among 2,708 control patients who had received best standard care.

"The results are unambiguous - there is no impact on mortality", K. Srinath Reddy, president of the New Delhi-based Public Health Foundation of India and member of an worldwide group of researchers who monitored the trial, told The Telegraph.

The drug's manufacturer Gilead rejected the findings of the trial.

Remdesivir has been the frontrunner in re-purposed drugs with various studies showing a positive recovery rate in patients. The WHO trial claimed that the drug doesn't help Covid-19 patients.

"We're looking at monoclonal antibodies, we're looking at immunomodulators and some of the newer anti-viral drugs that have been developed in the last few months", she said.

"Remdesivir is an expensive medicine - it costs almost Rs 30,000 for a five-day course". Then, the authors looked at data on almost 740,000 COVID-19 patients and examined the use of drugs that work to protect these processes, asking whether patients who received them fared better - and they did, in some cases. "Simple. Hydroxychloroquine did not work". In the hydroxychloroquine arm, the death rate ratio was 1.19 (104 deaths were reported in the active group of 947 patients as against 84 in the control group of 906); in the lopinavir arm, the death rate ratio was 1 (148 deaths in the active group of 1,399, as against 146 in the control group of 1,372); and in the interferon arm, the death rate ratio was 1.16 (243 deaths in the active group of 2,050; 216 in the control group of 2,050).

What does the Solidarity trial data say? "The results increase our confidence that they are valid across large populations", he said.

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.

A senior ICMR official declined to say what implications the findings would have on India's current treatment policy that prescribes both remdesivir and hydroxychloroquine.

Health authorities in many countries have withdrawn approvals for the use of hydroxychloroquine.

Latest News