Global health authorities have issued “strong” recommendations against the use of two antibody therapies in patients with COVID-19, reversing previous conditional recommendations that endorsed their use.
The recommendation against the use of two therapies—sotrovimab and casirivimab-imdevimab—came as part of an update to the World Health Organization’s (WHO) so-called “living guideline” on COVID-19 drugs, published in the British Medical Journal (BMJ).
The two drugs, which were developed early in the pandemic, work by binding to the SARS-CoV-2 spike protein and neutralizing the ability of the virus to infect cells. However, recent evidence shows that sotrovimab and casirivimab-imdevimab are unlikely to be effective against currently spreading COVID-19 variants.
“Today’s strong recommendation replaces previous conditional recommendations for their use and is based on emerging evidence from laboratory studies that these drugs are not likely to work against currently circulating variants, such as omicron,” BMJ said in a statement.
The recommendation to advise against the use of the two therapies in COVID-19 patients was made by the WHO Guideline Development Group of international experts.
“After weighing up all the evidence, the panel judged that almost all well informed patients would not choose to receive sotrovimab or casirivimab-imdevimab,” BMJ said.
Penny Ward, visiting professor in pharmaceutical medicine at King’s College London, told Reuters that the WHO recommendation is rather late in coming, given that that U.S. health regulators began to question the effectiveness of sotrovimab in February and pulled it from the U.S. market in April.
“Now WHO has issued this recommendation, it will be interesting to see how many other countries align with it,” she told the outlet.
In January, the FDA revised its policy on the use of casirivimab-imdevimab, limiting its use to a smaller group of patients, citing findings showing that it was less effective against Omicron.
European regulators continue to recommend the use of both therapies.
Remdesivir in Crosshairs
In the same guideline update, the WHO panel recommended against the use of antibody therapeutic remdesivir in patients with critical cases of COVID-19. At the same time, they made a conditional recommendation for the use of remdesivir in cases of severe infections with the virus.
“New trial data provided sufficiently trustworthy evidence to demonstrate benefits in patients with severe COVID-19, but not critical COVID-19,” BMJ said.
The recommendation against the use of remdesivir in critical COVID-19 infections was based on a randomised trial involving over 7,000 patients. The study found 34 more deaths per 1,000 patients in cases of critical COVID-19 when remdesivir was administered. By contrast, the trial showed 13 fewer deaths per 1,000 patients when the drug was given to patients with only a severe infection.
Meanwhile, three hospitals in California face lawsuits alleging they treated COVID-19 patients with remdesivir without receiving informed consent.
The lawsuits were filed on behalf of a dozen or so families who allege that the hospitals engaged in medical deception and failed to provide informed consent in regards to the potential side effects, such as kidney failure.