Gilead Sciences Statement on The World Health Organization’s Updated Veklury® (Remdesivir) COVID-19 Treatment Guidelines
Foster City, Calif., November 19, 2020 –Veklury® (remdesivir) 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.
- 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to evaluate the quality and reliability of the interim results from the trial have not been made available and have not been peer-reviewed.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.
In the United States, Veklury is indicated for the treatment of adults and pediatric patients at least 12 years of age and weighing at least 40 kg requiring hospitalization for COVID-19. Veklury should only be administered in a hospital or healthcare setting capable of providing acute care comparable to inpatient hospital care. Please see below for Important Safety Information for Veklury.
U.S. Important Safety Information
- Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components.
Warnings and precautions
- Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of Veklury. Monitor patients under close medical supervision for hypersensitivity reactions during and following administration of Veklury. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time ≤120 minutes) can potentially prevent these reactions. If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue Veklury and initiate appropriate treatment (see Contraindications).
- Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received Veklury; these elevations have also been reported as a clinical feature of COVID-19. Perform hepatic laboratory testing in all patients (see Dosage and administration). Consider discontinuing Veklury if ALT levels increase to >10x ULN. Discontinue Veklury if ALT elevation is accompanied by signs or symptoms of liver inflammation.
- Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of Veklury with chloroquine phosphate or hydroxychloroquine sulfate is not recommended due to antagonism observed in cell culture, which may lead to a decrease in antiviral activity of Veklury.
- The most common adverse reaction (≥5% all grades) was nausea.
- The most common lab abnormalities (≥5% all grades) were increases in ALT and AST.
- Drug interaction trials of Veklury and other concomitant medications have not been conducted in humans.
Dosage and administration
- Dosage: For adults and pediatric patients ≥12 years old and weighing ≥40 kg: 200 mg on Day 1, followed by once-daily maintenance doses of 100 mg from Day 2 administered only via intravenous infusion over 30 to 120 minutes.
- Treatment duration: For patients not requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO): 5 days; may be extended up to 5 additional days (10 days total) if clinical improvement is not observed. For patients requiring invasive mechanical ventilation and/or ECMO: 10 days.
- Testing prior to and during treatment: Perform eGFR, hepatic laboratory, and prothrombin time testing prior to initiating Veklury and during use as clinically appropriate.
- Renal impairment: Veklury is not recommended in individuals with eGFR <30 mL/min.
- Dose preparation and administration: See full Prescribing Information.
Pregnancy and lactation
- Pregnancy: There are insufficient human data on the use of Veklury during pregnancy. Pregnant women hospitalized with COVID-19 are at risk for serious morbidity and mortality. Veklury should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus.
- Lactation: It is not known whether Veklury can pass into breast milk. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.
For more information, please see the full Prescribing Information, available at www.gilead.com.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
For more information on Gilead’s response to the coronavirus outbreak please visit the company’s dedicated page: https://www.gilead.com/purpose/advancing-global-health/covid-19.