Two studies reveal “positive” data for Gilead’s remdesivir in hospitalised COVID-19 patients

pharmafile | April 30, 2020 | News story | Research and Development COVID-19, Gilead, coronavirus, remdesivir 

The first findings of two new studies have been revealed detailing the efficacy of Gilead’s antiviral therapy remdesivir in the treatment of patients hospitalised with COVID-19.

Gilead said that it had been made aware of “positive data” emerging from a randomised, controlled trial sponsored by the National Institute of Allergy and Infectious Diseases’ (NIAID) – the first in the US to test a therapy for the novel coronavirus – in hospitalized patients with advanced COVID-19 and lung involvement, noting that the trial had met its primary endpoint.

The study examined patients across 68 sites, 47 of which were in the US and 21 of which were in Europe and Asia.

Following a meeting between the study team and an independent data and safety monitoring board on 27 April, preliminary data from the study indicated that remdesivir patients recovered 31% faster than those receiving placebo, translating into a median time to recovery of 11 days versus 15 days respectively.

Additionally, the data indicated that remdesivir could present a survival benefit, with mortality rates recorded as 8% with Gilead’s drug compared to 11.6% with placebo. More detailed findings are to follow in an upcoming update from the NIAID.

The findings were announced by Dr Anthony Fauci, Director of the NIAID, in an Oval Office briefing on Wednesday, who later told Reuters that the Institute had moved to announce the data over fears that potential leaks of partial data could ultimately lead to more confusion around the drug’s efficacy.

“I would love to wait to present it at a scientific meeting, but it’s just not in the cards when you have a situation where the ethical concern about getting the drug to people on placebo dominates the conversation,” he told Reuters.

Dr Fauci appeared to reference the leaked findings of an earlier study into the drug’s efficacy conducted at the University of Chicago Medicine, which reported promising results at an early despite lacking a control group.

Alongside this reveal, Gilead also unveiled data from the Phase 3 SIMPLE trial, which sought to establish the efficacy of a five-day regimen of remdesivir against the standard 10-day dosing regimen in hospitalised patients with severe manifestations of COVID-19 disease.

Participants in the study showed evidence of pneumonia and reduced oxygen levels not requiring mechanical ventilation at the time they joined. The results of the study showed that both regimens demonstrated a similar clinical improvement these patients, and no new safety signals were reported.

Specifically, the five-day regimen group recorded a time to clinical improvement of 10 days for 50% of the participants, and 60% were discharged by day 14 of treatment. This compares to 11 days in the 10-day group, with 52.3% discharged by the same point. By day 14, 645% of the five-day group had achieved “clinical recovery”, compared to 53.8% in the 10-day group. Additionally, 62% of patients receiving treatment early were able to be discharged, compared to 49% of patients who were treated after the ten-day point.

“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” commented Dr Merdad Parsey, Chief Medical Officer at Gilead. “These study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir.

However, it is difficult to draw conclusions of remdesivir’s definitive efficacy as the study had no control group. Gilead confirmed plans to release full data from the study in a peer-reviewed journal “in the coming weeks”.

Matt Fellows

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