FDA MAKES HUGE MESS AGAIN... Remdesivir
European study finds that Gilead's Covid-19 antiviral remdesivir shows no clinical benefit
September 17, 2021 07:29 AM EDTUpdated 08:17 AM Coronavirus
European study finds that Gilead's Covid-19 antiviral remdesivir shows no clinical benefit
Nicole DeFeudis
Editor
Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.
The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test a handful of treatments, including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. To participate, patients had to show symptoms for seven days and require oxygen support. A total of 429 patients were randomized to receive remdesivir plus standard of care, while 428 were assigned to standard of care alone.
Researchers measured remdesivir’s efficacy on day 15, using the World Health Organization’s seven-point scale — only to find that no clinical benefit was observed in patients who received the drug over those who got standard of care alone. And while previous studies have linked remdesivir to a faster time to recovery, that result was not seen in the DisCoVeRy trial.
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Here’s how patients were distributed on the WHO’s scale:
Not hospitalised, no limitations on activities (61 [15%] of 414 in the remdesivir group vs 73 [17%] of 418 in the control group); (2) not hospitalised, limitation on activities (129 [31%] vs 132 [32%]); (3) hospitalised, not requiring supplemental oxygen (50 [12%] vs 29 [7%]); (4) hospitalised, requiring supplemental oxygen (76 [18%] vs 67 [16%]); (5) hospitalised, on non-invasive ventilation or high flow oxygen devices (15 [4%] vs 14 [3%]); (6) hospitalised, on invasive mechanical ventilation or extracorporeal membrane oxygenation (62 [15%] vs 79 [19%]); (7) death (21 [5%] vs 24 [6%]).
The results bring into question Veklury’s approval — and also its hefty $3,000-plus price tag.
The FDA granted remdesivir full approval back in October based on three randomized control studies, including the full data from the NIAID-sponsored Phase III ACTT-1 trial published on Oct. 8, according to Gilead. That study showed a reduction in recovery time by five days in hospitalized Covid-19 patients and by seven days in patients requiring oxygen.
Gilead had previously been granted a partial EUA in early May to treat severe Covid-19, which was later expanded in August to include all hospitalized adults and children after a Gilead-led study showed modest efficacy.
But the week before remdesivir was approved, the WHO released a study showing the antiviral had no substantial effect on improving mortality rates, reducing the amount of patients needing ventilators or shortening hospital stays. In this trial, remdesivir had no material effects on ventilation initiation or time to discharge.
In an FAQ, the FDA had said that since Gilead’s ACTT-1 study was randomized, double-blinded and placebo-controlled (whereas the WHO trial was open-label), they found ACTT-1 to be “better suited” in a time to recovery endpoint.
In April, Gilead CEO Dan O’Day said about half of all hospitalized patients with Covid-19 in the US are treated with Veklury.
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