A clinical trial of Remdesivir, an experimental drug that has raised hopes for the treatment of the Coronavirus Disease 2019 – COVID-19 has suggested that it can shorten its patients’ recovery period.
Health experts in various parts of the world have argued that the results of the trial were promising for the fight against the pandemic.
The antiviral drug is manufactured by Gilead Sciences, Inc., a US research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines.
On April 29, 2020, Gilead Sciences, Inc. announced topline results from a trial evaluating 5-day and 10-day dosing durations of the investigational antiviral remdesivir in hospitalised patients with severe manifestations of COVID-19 disease.
The results were announced as the world is in a race to find a drug that can cure coronavirus.
According to a statement from the manufacturer, the study demonstrated that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course.
The company said that no new safety signals were identified with remdesivir across either treatment group, adding that it plans to submit the full data for publication in a peer-reviewed journal in the coming weeks.
"Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.
He said that these study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir.
"The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir. This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care,” he pointed out.
Remdesivir and how it works
Remdesivir was originally developed as drug against Ebola. It is Remdesivir is an investigational antiviral compound undergoing clinical trials in a number of countries as a potential treatment for COVID-19.
It works by attacking an enzyme that a virus needs in order to replicate inside human cells, hence making them non-functional.
The drug has demonstrated activity both in laboratory and in animal models against multiple emerging viral pathogens, including Ebola, Marburg, Middle East Respiratory Syndrome (MERS) and Severe acute respiratory syndrome (SARS).
Impact of earlier treatment
In an exploratory analysis, patients in the study who received remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than 10 days of symptoms.
Pooling data across treatment arms, by Day 14, 62 percent of patients treated early were able to be discharged from the hospital, compared with 49 percent of patients who were treated late.
"These data are encouraging as they indicate that patients who received a shorter, 5-day course of remdesivir experienced similar clinical improvement as patients who received a 10-day treatment course,” said Aruna Subramanian, MD, Clinical Professor of Medicine, Chief, Immunocompromised Host Infectious Diseases, Stanford University School of Medicine, and one of the lead investigators of the study.
"While additional data are still needed, these results help to bring a clearer understanding of how treatment with remdesivir may be optimized, if proven safe and effective,” he observed.
Drug side effects
Remdesivir was generally well-tolerated in both the 5-day and 10-day treatment groups, according to the trial. The most common adverse events occurring in more than 10 percent of patients in either group were nausea, and acute respiratory failure.
Higher liver enzyme (ALT) elevations occurred in 7.3 percent of patients, with 3.0 percent of patients discontinuing remdesivir treatment due to elevated liver tests.
The drug not yet licensed or approved
Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19, according to Gilead.
Globally, over 3.2 million COVID-19 cases, and more than 227,000 deaths from this pandemic were confirmed globally as of April 30, 2020, as per a tally by Johns Hopkins University.
In Rwanda, confirmed COVID-19 cases amounted to 225 on April 29, 2020, with no death, according to data from the Ministry of Health.
As vaccine against coronavirus could be available in more than a year ahead, effective medication is crucial to saving lives and preventing negative economic impact resulting from the COVID-19 pandemic.