Remdesivir (RDV)

Remdesivir (RDV) is a type of broad-spectrum antiviral medication called a nucleotide analog. It is currently an investigational drug and not approved in any country for any use.

COVID-19 is an RNA virus. (RNA is the molecular transcription tool organisms use to build proteins using DNA instructions.) RNA viruses are dependent on an RNA polymerase enzyme to grow the RNA chain. Remdesivir substitutes this RNA polymerase enzyme, meaning the RNA can’t develop so the virus cannot replicate itself.

Editor’s Note: Remdesivir is not FDA-approved. As a result, there is limited published information on this potential COVID-19 coronavirus treatment. The following article is sourced from Dominic Chan, a Portland, Ore. Pharm. D who specializes in medications for infectious disease in the Legacy Health hospital system.

There is only one randomized control trial for remdesivir (RDV) conducted during the last Ebola outbreak. That study was stopped before it was concluded because of a significant increase in mortality in patients taking RDV, meaning it didn’t help those Ebola patients.

The majority of clinical decisions are made based on the historical epidemics Ebola, SARS, and MERS. The outcomes of RDV use in those three disease outbreaks has not been as promising as hoped.

As of March 27, 2020:

• There are four U.S. trials.
• Two China trials are expected to complete at the beginning of April.
  • One Chinese trial is for severe COVID-19, one is for mild-to-moderate COVID-19.
    • The last day for data collection for the severe trial is April 3.
    • The last day for data collection for the mild-to-moderate one is April 10.
    • There are two or three European trials that have RDV as a comparator, meaning it’s one of the drugs they are testing in a multi-drug trial.

Once the trials are completed, there will be a short lag time as researchers crunch the data and put their paper through peer review.

In the Ebola trial, researchers noted side effects of remdesivir (RDV) that included:

• Increased liver enzyme levels that may indicate possible liver damage
  • Researchers documented similar increases in liver enzymes in three U.S. COVID-19 patients

Typical antiviral drug side effects include:

• Nausea
• Vomiting

The dosing regimen under study in the U.S. for RDV is as follows:

• An initial one-time dose of 200mg
• Followed by 100mg per day for 10 days

Remdesivir is administered intravenously by injection.

Remdesivir (RDV) itself is not believed to affect other medications, however, other medications may affect RDV. Some medications will boost the RDV level in the bloodstream, and some will reduce it. 

Some antibiotics that may do this include:

• Clarithromycin
• Rifampin

Tell your doctor all medications and supplements you use. 
 

Tell your doctor if you are pregnant or plan to become pregnant; it is unknown if remdesivir (RDV) will affect a fetus or impact a pregnancy. In rats and monkeys, RDV affected kidney development in fetuses.

It is unknown if remdesivir (RDV) passes into breast milk. Consult your doctor before breastfeeding.

Access to remdesivir (RDV) is limited because no one knows if it is an effective treatment for COVID-19.

Gilead Pharmaceuticals, the manufacturer, closed its compassionate use program. The company announced plans to open up another program similar to a clinical trial in which people can sign up to get remdesivir (RDV), but as of March 27, there is no word on how widely available that program will be.