Gilead's Remdesivir Should Not Be Used in Hospitalized COVID-19 Patients, Says WHO

Gilead Sciences’ (Foster City, CA, USA) investigational antiviral drug remdesivir is not suggested for patients admitted to hospital with COVID-19, irrespective of how severely ill they are, as there is currently no evidence that it improves survival or the need for ventilation, according to a WHO Guideline Development Group (GDG) panel of international experts.

The recommendation is part of a living guideline, developed by the WHO with the methodological support of MAGIC Evidence Ecosystem Foundation, to provide trustworthy guidance on the management of COVID-19 and help doctors make better decisions with their patients. Living guidelines are useful in fast moving research areas like COVID-19 as they allow researchers to update previously vetted and peer reviewed evidence summaries as new information becomes available.

Remdesivir (sold under the brand name Veklury) has received worldwide attention as a potentially effective treatment for severe COVID-19 and is increasingly used to treat patients in hospital. However, its role in clinical practice has remained uncertain. The latest recommendation is based on a new evidence review comparing the effects of several drug treatments for COVID-19. It includes data from four international randomized trials involving over 7,000 patients hospitalized for COVID-19.

After thoroughly reviewing this evidence, the WHO GDG expert panel, which includes experts from around the world, including four patients who have had COVID-19, concluded that remdesivir has no meaningful effect on mortality or on other important outcomes for patients, such as the need for mechanical ventilation or time to clinical improvement. The panel acknowledged that the certainty of evidence is low and said the evidence did not prove that remdesivir has no benefit; rather, there is no evidence based on currently available data that it does improve important patient outcomes.

In response, Gilead has issued a statement expressing disappointment at the WHO guidelines which it said appeared to ignore robust evidence from multiple randomized, controlled studies published in peer-reviewed journals that demonstrate the clinical benefits of remdesivir, such as significantly faster recovery, which can free up limited hospital resources. According to Gilead, the WHO guidelines relied on data from the WHO-led Solidarity trial data. Key data from the Solidarity trial that would allow clinicians, regulators and Gilead to evaluate the quality and reliability of the interim results from the trial have not been made available and have not been peer-reviewed. Gilead claimed that the results released to date were inconsistent with more robust evidence from the NIAID trial and the company’s open-label trials, whose results have validated the clinical benefit of remdesivir.

Gilead said that the WHO guidelines were particularly disappointing because they came at a time when cases are dramatically increasing around the world and doctors are relying on remdesivir as the first and only approved antiviral treatment for patients with COVID-19 with approvals or authorizations in approximately 50 countries.

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