Remdesivir (Veklury) approved for treating COVID-19 in non-hospitalized adults

Gilead Sciences has received Health Canada approval to market Veklury (remdesivir for injection) for use in the treatment of COVID-19 in non-hospitalized adults. The drug is intended for patients with a positive SARS-CoV-2 test result who are at high risk for progression to severe COVID-19, including hospitalization and death.1 Veklury was originally indicated only for use in the treatment of COVID-19 in hospitalized adults and adolescents with pneumonia requiring supplemental oxygen. For both therapeutic indications (i.e., hospitalized and non-hospitalized patients), Health Canada issued marketing authorization “with conditions,” meaning that the manufacturer is required to conduct clinical trials to verify the drug’s clinical benefit.1 Read: Moderna's promised vaccine production facility to be built in Montreal area The recommended dosage of remdesivir for non-hospitalized adults at increased risk of progressing to severe COVID-19 is 200 mg given by intravenous infusion on Day 1, followed by 100 mg once daily by intravenous infusion on Days 2 and 3. The three-day treatment course should be started as soon as possible after the diagnosis of symptomatic COVID-19 and within seven days of symptom onset. Treatment should not be initiated in patients with an eGFR < 30 mL/min or an alanine aminotransferase (ALT) level five times the upper limit of normal or higher. Outpatient settings where remdesivir is administered must be prepared to treat severe hypersensitivity reactions, including anaphylaxis.1 For mildly ill adults (in any setting, including the community, hospital or congregate care settings) who are at higher risk of progressing to severe disease, the Ontario COVID-19 Drugs and Biologics Clinical Practice Guidelines Working Group recommends either a five-day course of twice-daily oral nirmatrelvir/ritonavir (Paxlovid) or a three-day, once-daily course of intravenous remdesivir. The choice of drug will depend on availability, contraindications and ease of administration. Paxlovid must be started within five days of symptom onset, while remdesivir must be initiated within seven days after symptoms begin.2 References 1. Gilead Sciences Canada, Inc. Veklury (remdesivir for injection) product monograph. Mississauga, ON; April 22, 2022. https://pdf.hres.ca/dpd_pm/00065539.PDF (accessed April 28, 2022). 2. Ontario COVID-19 Drugs and Biologics Clinical Practice Guidelines Working Group. Therapeutic management of adult patients with COVID-19. Version 11.0. Updated April 1, 2022. https://covid19-sciencetable.ca/wp-content/uploads/2022/04/Clinical-Practice-Guidelines_Update_20220401.pdf (accessed April 28, 2022).

Remdesivir (Veklury) approved for treating COVID-19 in non-hospitalized adults

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