India must consider ways to get access to remdesivir: Nirmal K Ganguly
The antiviral drug, remdesivir, emerged as the first successful treatment against the coronavirus disease (Covid-19) after a US government-funded trial on 1,063 people found it could effectively block the virus and boost recovery. “The data shows remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery,” said US National Institute of Allergy and Infectious Diseases (NIAID) director Dr Anthony Fauci, who likened the finding to the first retrovirals that worked with modest success against HIV in the 1980s.The US Food and Drug Administration (USFDA) is expected to announce an emergency-use authorization for use of remdesivir to treat patients.
Remdesivir is an experimental antiviral drug developed by the US-based pharma major Gilead Sciences. It failed in trials against the Ebola virus and was found to have limited effects among patients in Wuhan, China, where the illness was first detected last year.
Dr Nirmal K Ganguly, emeritus scientist and former director general of Indian Council of Medical Research, has gone through the findings of the soon to be published NIAID trial. He spoke to Sanchita Sharma over the phone on what these finding means for India.
Remdesivir has failed several trials in the past. How effective is it against Covid-19?
The world finally has a drug against Covid-19, but it will not be a public health tool as it has to be given intravenously to hospitalized patients to hasten recovery.
The drug was originally created as a pan-viral drug to treat RNA viruses, Marburg and Ebola, but it was not successful. In later trials, it has also been investigated for action against all coronaviruses, including those that cause Sars [Severe Acute Respiratory Syndrome], Mers (Middle Eastern Respiratory Syndrome), and now Covid-19 as well as it worked against animal coronaviruses. It was found to be clinically fulfilling Lipinski’s Rule [which give the probability of the success of a drug] and was found to work on viral replication in respiratory epithelial cells, which are the first target of infection. It does not promote mutation.
The NIAID study has confirmed its effectiveness in hastening recovery, and Gilead now plans to expand trials to include 5,600 patients in seven countries. India does not figure in the list.
However, it was not licensed in any country in the world. The USFDA has now recommended its use as an emergency drug. A small study done by Dr Aruna Subramanian, a clinical professor of medicine and infectious diseases at Stanford University School of Medicine in California, also found 50% patients given 5 mg of the drug improved in 10 days, and 60.6% were discharged in 14 days.
If remdesivir gets the USFDA nod, will India consider using it to treat Covid-19 patients?
Results from the NIAID preliminary trial show remdesivir reduced recovery time for Covid-19 patients from 15 to 11 days, which is similar to the effect that influenza drugs like Tamiflu, which don’t cure patients quickly, but help them recover.
The NIAID trial used the drug for five days and 10 days in patients with pneumonia who needed oxygen, but did not need ventilator support at that given moment. The impact on death give a trend of 4% advantage, but this result was not statistically significant, the trend was visible.
The first dose was 200 mg, followed 100 mg a day, give intravenously to hospitalised patients, with one group given the drug for five days and the other for 10 days. A significant number of patients given remdesivir did not have to go on ventilator support, and at least 30% fewer patients needed ventilation. There was clear advantage of reduction in hospital stay, with patients given the drug being discharged in 10-14 days. Five days of therapy was as effective as 10 days, which is a critical advantage in terms of reducing hospital stay, cost of medication and risk of severe adverse events [side effects].
Should India consider using remdesivir to treat patients?
Gilead Sciences is reported to have drugs to treat 1.2 lakh patients, and now plans to expand trials to many countries, excluding India. Available data shows it is one of the foremost potential drugs against the disease, and since the supply is limited, according to Gilead, India must plan to get access remdesivir.
In this emergency situation, the USFDA has announced emergency use authorisation. India must consider ways to make this drug available to its population. In the past, India saved millions by providing affordable and effective anti-retroviral drugs to treat HIV and AIDS, not just to its own population, but also to other countries who needed them, including to many countries in Africa.