Remdesivir is the first and only drug to be approved by the Food and Drug Administration for the treatment of COVID-19. It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need.
The FDA approved the antiviral, which was previously used under an emergency use authorization, for use in hospitalized coronavirus patients who are at least 12 years old and weigh a minimum of 40 kg.
Gilead said the approval was based on data from three randomized controlled trials, including one led by the National Institutes of Health that showed the drug cut hospitalized patients' recovery times by five days.
WHO Director General Tedros Adhanom Ghebreyesus defended the so-called Solidarity Trial, which was launched to study the effectiveness of remdesivir and three other drugs in treating COVID-19, as the largest trial in the world. It included more than 11,000 coronavirus patients across 30 countries, with more than 2,700 participants given remdesivir.
Gilead also announced that FDA issued a new emergency use authorization for the use of remdesivir to treat hospitalized patients under 12 years old who meet certain weight requirements.
Did President Trump Use Remdesivir?
Yes, the drug gained widespread attention when President Trump received a five-dose course of it after he contracted the coronavirus in early October.
He was also treated with an experimental anti-body infusion and the anti-inflammatory steroid dexamethasone and recovered in Walter Reed National Military Medical Center after three days.
A Broad-spectrum Antiviral
Remdesivir, is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences.Remdesivir is approved or authorized for emergency use to treat COVID 19 in around 50 countries. Remdesivir has been authorized for emergency use in India, Singapore, and approved for use in Japan, the European Union, the United States, and Australia for people with severe symptoms. It may shorten the time it takes to recover from the infection
Earlier Studies
Earlier studies found antiviral activity against several RNA viruses including SARS coronavirus and MERS coronavirus, but it is not approved for any indication.
Remdesivir was originally developed to treat hepatitis C and was then tested against Ebola virus disease and Marburg virus disease, but was ineffective for all of these viral infections.
Remdesivir is the first treatment for COVID-19 to be approved by the U.S. Food and Drug Administration (FDA).The approval by the FDA does not include the entire population that had been authorized to use remdesivir under an Emergency Use Authorization (EUA) originally issued on 1 May 2020.
In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for remdesivir to authorize the drug's use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kilograms to less than 40 kilograms or hospitalized pediatric patients less than twelve years of age weighing at least 3.5 kilograms . Clinical trials assessing the safety and efficacy of remdesivir in this pediatric patient population are ongoing.
Medical Uses
In the European Union, remdesivir is indicated for the treatment of disease 2019 (COVID 19) in adults and adolescents (aged twelve years and older with body weight at least 40 kg) with pneumonia requiring supplemental oxygen. In the United States, remdesivir is indicated for use in adults and adolescents (aged twelve years and older with body weight at least 40 kg for the treatment of COVID-19 requiring hospitalization.
Efficacy Against COVID
Preliminary data from an international multi-center, placebo controlled double-blind randomized trial carried out by the US National Institutes of Health suggests that remdesivir is effective in reducing the recovery time from 15 to 11 days in people hospitalized with COVID 19. On 29 April 2020, the National Institute of Allergy and Infectious Diseases (NIAID) announced that remdesivir was better than a placebo in reducing time to recovery for people hospitalized with advanced COVID 19 and lung involvement. The study concluded that "given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient.
Patients given remdesivir were more likely to have improved by day 15.Remdesivir also improved mortality rates for those receiving supplemental oxygen (4% with remdesivir versus 13% with placebo at day 29 of treatment). All-cause mortality among all patients was 11% with remdesivir and 15% with placebo at day 2. The preliminary findings hadn’t shown an effect on mortality.
Remdesivir treatment may prevent patients from progressing to more severe respiratory disease. Those treated with remdesivir were less likely to need high levels of respiratory support. Remdesivir appeared to most benefit patients who were receiving supplemental oxygen.
Remdesivir is a beneficial treatment for patients with COVID-19,It may also help to conserve scarce health care resources, such as ventilators, during the COVID-19 pandemic.
The findings show that remdesivir alone isn’t a sufficient treatment for all patients but does provide some benefit. Studies are underway to evaluate remdesivir in combination with other therapies.
Adverse Effects
The most common adverse effects in studies of remdesivir for COVID 19 include respiratory failure and organ impairment, including low albumin, low potassium, low count of red blood cells, low count of platelets that help with clotting, and yellow discoloration of the skin.
Other reported side effects include gastrointestinal distress, elevated transaminase levels in the blood (liver enzymes), and infusion site reactions.
Other possible side effects of remdesivir include:infusion‐related reactions. Infusion‐related reactions have been seen during a remdesivir infusion or around the time remdesivir was given. Signs and symptoms of infusion‐related reactions may include: low blood pressure, nausea, vomiting, sweating, and shivering.
Increases in levels of liver enzymes, seen in abnormal liver blood tests. Increases in levels of liver enzymes have been seen in people who have received remdesivir, which may be a sign of inflammation or damage to cells in the liver.
Hypersensitivity
Contraindications: Hypersensitivity to drug or any ingredient.Hypersensitivity, including infusion-related reactions observed during and following administration. Signs and symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering.
Drug Interactions
Coadministration of remdesivir is not recommended with chloroquine or hydroxychloroquine. Based on in vitro data, chloroquine demonstrated an antagonistic effect on the intracellular metabolic activation and antiviral activity of remdesivir.
Remdesivir Use in Pregnant Women
Outcomes in the first 86 pregnant women who were treated with remdesivir (March 21 to June 16, 2020) have been published. Recovery rates were high among women who received remdesivir (67 while pregnant and 19 on postpartum days 0-3). No new safety signals were observed. At baseline, 40% of pregnant women (median gestational age 28 weeks) required invasive ventilation compared with 95% of postpartum women (median gestational age at delivery 30 weeks). Among pregnant women, 93% of those on mechanical ventilation were extubated, 93% recovered, and 90% were discharged.
Among postpartum women, 89% were extubated, 89% recovered, and 84% were discharged. There was 1 maternal death attributed to underlying disease and no neonatal deaths. Data continue to emerge. A case series of 5 patients describe successful treatment and monitoring throughout treatment with remdesivir in pregnant women with COVID-19.
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