On June 21st, the Hyderabad based pharmaceutical company Hetero announced in a press release that it has got approval from the Drug Controller of India to make and market a generic version of the antiviral drug remdesivir in India under the name Covifor. The same day, Cipla, the Mumbai-based pharmaceutical firm also announced their own version of remdesivir, called Cipremi.
Remdesivir is originally owned by the American Biotechnology firm Gilead Sciences. The drug had got emergency use authorisation for severe COVID-19 cases (suspected or confirmed) by the US Food and Drug Administration in May on the basis of the existing evidence for its efficiency in the management of the infection.
Even in India, the drug is under restricted emergency use, which supposedly means that doctors will need patient consent before giving them the drug and patients will need a doctor to prescribe and administer the drug.
As per media reports, Maharastra and Delhi (two of the worst-hit states in the country) will be the first receive a batch of Covifor in the country along with Hyderabad, Gujarat and Telangana.
Given the recent developments, you may have a few questions about the drug. Here are the answers to the five most common queries:What is Covifor?
Covifor is the generic version of remdesivir being marketed by Hetero in India. Remdesivir is a nucleoside analogue which was developed in 2010 to fight the Ebola outbreak in Africa. Though it was well-tolerated in ebola patients, it wasn’t as effective as some other therapies. Later, the drug was found to be effective against SARS and MERS, two diseases caused by coronaviruses that are closely related to the COVID-19 causing coronavirus.
Nucleosides are made from sugar and nitrogenous base and are the building blocks of DNA and RNA. Nucleoside analogues look like nucleosides and interfere with viral replication and keep new viruses from being formed inside the body.
Nucleoside analogues are currently being used to treat other conditions such as cytomegalovirus, HIV and hepatitis B.How does remdesivir work?
Remdesivir is an inactivated version of a nucleoside called adenosine - there are four nucleoside bases in the body: adenosine, guanosine, cytosine and thymine. Once, it gets inside the body, it is metabolized and activated. This activated remdesivir then inhibits the function of the RNA polymerase of SARS-CoV-2. RNA polymerase is an enzyme that is responsible for creating multiple copies of the viral RNA inside cells.What is the scientific evidence for remdesivir’s effects?
Various trials have been conducted to study the effects of remdesivir against COVID-19. One such trial conducted by the National Institute of Health, USA suggested that remdesivir can improve the recovery time of COVID-19 patients by 31% and the patients are able to leave the hospital on day 11 as compared to day 15 when they got standard treatment.
Results from the clinical trials conducted by Gilead Sciences show that severe COVID-19 patients showed improvement in symptoms within 10 and 11 days when they were given remdesivir for 5 and 10 days respectively. About 65% of people with moderate disease show improvement by day 11 with a 5-day treatment as compared to those who got standard care.Does Covifor have any side effects?
The FDA suggests that remdesivir may cause an increase in live enzymes, a sign of liver injury.
Remdesivir is currently only authorised to be given intravenously. There is a risk that it can cause an infusion-related reaction (hypersensitivity to the drug administration) in patients. An infusion-related reaction shows up as nausea, vomiting, sweating and shivering.Can every severe COVID-19 patient be given Covifor?
As per the guidelines of the Government of India, remdesivir will not be given to pregnant or breastfeeding women, children under the age of 12 years, those with severe kidney damage, those who need hemodialysis, and people who have 5 times the normal level of liver enzymes alanine aminotransferase and aspartate aminotransferase.For more information, see Covifor.
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