CATIE News

7 May 2020 

The promise of remdesivir for COVID-19

  • An experimental antiviral drug reduces the time of recovery from COVID-19 by 31%
  • This clinical trial result demonstrates moderate efficacy of remdesivir, but it is not a cure
  • Further research and combination treatment may augment the effectiveness of the drug

Remdesivir is an experimental antiviral drug. The U.S. National Institute of Allergy and Infectious Diseases (NIAID) has announced promising but preliminary results from a randomized, placebo-controlled study of 1,063 people hospitalized with symptoms of COVID-19. In this study, participants received remdesivir or placebo, given via intravenous infusion. According to NIAID, the study found that remdesivir was associated with a 31% “faster time to recovery.” Specifically, about 50% of people who received remdesivir left hospital after 11 days vs. 15 days for people who received placebo. The death rate was reduced among people who received remdesivir (8%) vs. placebo (11%). This difference, while encouraging, was not statistically significant. NIAID will provide a detailed report from this study in the future.

Much is unknown

The full range of side effects associated with remdesivir has not yet been publicly released. However, some research suggests that the drug can cause temporary liver inflammation and in rare cases it may cause very low blood pressure.

There are still many unresolved issues with remdesivir, including the following:

  • What is the best time in the course of COVID-19 to initiate treatment?
  • Could it become part of combination therapy for COVID-19? If so, what other drugs could be used with remdesivir?
  • Is it safe in different populations, including pregnant women, children, older people, people with chronic liver disease?
  • Should older people, who are at increased risk of death from COVID-19, have a different duration of treatment than younger people?
  • Could remdesivir be used as a form of post-exposure prophylaxis (PEP) in people who have been recently exposed to the virus and who are at heightened risk for developing severe COVID-19-related disease?

Other studies

A trial of remdesivir in China was prematurely stopped because the study failed to recruit sufficient participants, as the first wave of the pandemic waned. Since that study did not have sufficient people, its findings are statistically inconclusive.

Other studies with remdesivir are finished or still underway and their results will be released in the months ahead.

Access

1. Approval

The manufacturer of remdesivir, Gilead Sciences, is collecting data from clinical trials to submit to regulatory authorities for approval of the drug. The timeline for approval in Canada and other countries is not known.

2. Compassionate access

Gilead Sciences will continue to review requests for compassionate access to remdesivir for “pregnant women and children less than 18 years of age with confirmed COVID-19 and severe manifestations of disease.” Physicians in Canada caring for these populations can contact Gilead Sciences to find out how to submit relevant data to the company.

3. Expanded access program

Gilead is rapidly developing an expanded access program (EAP) for remdesivir in Canada, France, Germany, Italy, Spain, Switzerland, the UK, Australia and Israel. This EAP is intended to provide remdesivir to people who are hospitalized with COVID-19 and require invasive mechanical ventilation.

A list of hospitals that will administer remdesivir as part of the EAP will become available at the following links:

Bear in mind

The interim analysis of the data released by NIAID has at least the following implications:

  • It accelerates the pathway for approval of remdesivir by regulatory authorities.
  • It sets the standard against which other potential treatments for COVID-19 can be compared.
  • Although remdesivir is promising, it does not effect a cure in all people with COVID-19 who have received it. As a result, it is possible that in the future doctors will test remdesivir in combination with other antiviral drugs or with drugs that can reduce the severe inflammation that occurs in people who have severe symptoms of COVID-19.
  • As remdesivir can cause temporary liver injury in some people, other treatments may be needed for people who have pre-existing liver injury and who develop severe COVID-19.

Resources

Coronavirus disease (COVID-19), HIV and hepatitis C: What you need to knowCATIE News

Kaletra disappointing in people severely ill with COVID-19CATIE News

Coronavirus disease (COVID-19): Outbreak update – Public Health Agency of Canada

COVID-19 resources

—Sean R. Hosein

 REFERENCES:

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