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Gilead Sciences Statement on The World Health Organization’s Updated Veklury (Remdesivir) COVID-19 Treatment Guidelines

Veklury is recognized as a standard of care for the treatment of hospitalized patients with COVID-19 in guidelines from numerous credible national organizations, including the US National Institutes of Health and Infectious Diseases Society of America, Japan, UK and Germany. These recommendations are based on the robust evidence from multiple randomized, controlled studies published in peer-reviewed journals that demonstrate the clinical benefits of Veklury, such as significantly faster recovery, which can free up limited hospital resources. We are disappointed the WHO guidelines appear to ignore this evidence at a time when cases are dramatically increasing around the world and doctors are relying on Veklury as the first and only approved antiviral treatment for patients with COVID-19 with approvals or authorizations in approximately 50 countries.


Key Facts

The benefits of Veklury have been demonstrated in three randomized, controlled clinical trials, including a randomized, double-blind, placebo-controlled clinical trial (ACTT-1) – the gold standard for evaluating the efficacy and safety of investigational drugs.

 

- The National Institute of Allergy and Infectious Diseases’ (NIAID) ACTT-1 trial showed Veklury leads to a five-day faster recovery in hospitalized patients overall, and a seven-day faster recovery in people who required oxygen support at baseline, compared with placebo.

 

The ACTT-1 data were peer-reviewed and published in the New England Journal of Medicine and have supported Veklury’s inclusion in multiple treatment guidelines. The data have also supported regulatory approvals or temporary authorizations to treat COVID-19 in approximately 50 countries worldwide.

 

The WHO guidelines rely 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to evaluate the quality and reliability of the interim results from the trial have not been made available and have not been peer-reviewed. The results released to date are inconsistent with more robust evidence from the NIAID trial and Gilead’s open-label trials, whose results have validated the clinical benefit of Veklury.

 

Treating critical illness with agents that battle the causative agent has been the cornerstone of medical care. As an antiviral, Veklury inhibits SARS CoV-2, the virus that causes COVID-19, reducing the ability of the virus to replicate in the body. Combinations of Veklury with anti-inflammatory agents are being studied to potentially enhance outcomes for patients with COVID-19.