- 09 Jan 2021
Remdesivir is the first drug which has shown its effectiveness on novel coronavirus, causing the COVID-19. Remdesivir (GS-5734) is a nucleotide analog with broad-spectrum antiviral activity both in-vitro and in-vivo. It has inhibitory effects against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS.
Image Source: Gilead Science,Inc.
Gilead Sciences, the US biotech company on 29th April, 2020, in an open letter, announced results from phase 3 trials of investigational antiviral drug Remdesivir, on the COVID-19 patients. The company said that the drug helped patients to recover faster than standard care. The study showed 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 study said, “A total of 64.5 percent (n=129/200) of patients in the 5-day treatment group and 53.8 percent (n=106/197) of patients in the 10-day treatment group achieved clinical recovery. Outside of Italy, the overall mortality rate on Day 14 was 7 percent across both treatment groups, with 64 percent patients experiencing clinical improvement and 61 percent patients discharged from the hospital”.
The study involved 397 patients randomised in a 1:1 ratio to receive Remdesivir 200 mg on the first day, followed by Remdesivir 100 mg each day until day five or 10, administered intravenously, in addition to standard of care.
According to the study, patients who received Remdesivir within 10 days of symptom onset, had shown improved outcomes than those treated after more than 10 days of symptoms. By day 14, 62 percent of patients, who got treatment early, were able to be discharged from the hospital, compared with 49 percent of patients who were treated late.
The study revealed that, “Remdesivir was generally well-tolerated in both the 5-day and 10-day treatment groups. The most common adverse events occurring in more than 10 percent of patients in either group were nausea (5-day: 10.0%, n=20/200 vs. 10-day: 8.6%, n=17/197) and acute respiratory failure (5-day: 6.0%, n=12/200 vs. 10-day: 10.7%, n= 21/197). Grade 3 or higher liver enzyme (ALT) elevations occurred in 7.3 percent (n=28/385) of patients, with 3.0 percent (n=12/397) of patients discontinuing Remdesivir treatment due to elevated liver tests”.
Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences said that “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”.
Aruna Subramanian, MD, Clinical Professor of Medicine, Stanford University School of Medicine, and one of the lead investigators of the study said, “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. 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.”
Anthony Fauci, Director NIAID said, "The data shows that Remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery.Although a 31 percent improvement doesn't seem like a knockout 100 percent, it is a very important proof of concept because what it has proven is that a drug can block this virus."
Daniel ‘O’ Day, Chairman and CEO of Gilead Sciences in an open letter said, “There is still more work to do and Remdesivir has not been approved, but all of us at Gilead are humbled by what these promising results might mean for patients. After years of research and hard work on Remdesivir, there is relief and gratitude among our teams today that their efforts have been so worthwhile”.
The COVID-19 pandemic has so far, infected more than 31 lakh people and claimed more than 2.27 lakh lives. Remdesivir has shown a new ray of hope and whole world is watching its effect on novel coronavirus very keenly.