Favipiravir Approval for COVID in India: Docs Share Their Concerns

Favipiravir Approval for COVID in India: Docs Share Their Concerns

Published22 Jun 2020, 12:27 PM IST
Fit
5 min read

Glenmark Pharmaceuticals on Saturday, 20 June, launched antiviral drug Favipiravir for the treatment of mild-to-moderate COVID-19 cases after it received approval from the Drug Controller General of India to manufacture and market the medicine, IANS reported.

What do we know about the drug and what research is the approval based on? FIT explains.

What is Favipiravir?

The antiviral drug Favipiravir is approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. It works by inhibiting viral replication and reducing the viral load in a patient.

It is an experimental medicine being repurposed for COVID-19.

The drug FabiFlu will be available as a prescription-based medication for Rs 103 per tablet, with the recommended dose being 1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14.

The drug is not recommended in patients with severe renal, hepatic impairment, and in pregnant and lactating women.

What Does Research Say?

Glenmark was the first company in India to receive the drug regulator's approval to conduct phase-3 clinical trial of Favipiravir antiviral tablets for COVID-19 patients.

The company has claimed that Favipiravir shows clinical improvements of up to 88% in COVID-19 disease, with a rapid reduction in viral load by 4 days.

A randomized multi-centric study was initiated in 150 patients in India to evaluate the efficacy and safety of the drug used with standard care in comparison to the group that received only supportive care. The study’s details are yet to be published in a peer-reviewed paper.

Glenmark has referred to four studies to substantiate the drug’s efficiency; A Russian clinical trial, an observational study in Japan on over 2,000 patients and two Chinese studies that compared it with antiretroviral drugs, finding it safer and faster in reducing time to relief than antiviral umifenovir.

Favipiravir is being studied in at least 18 trials around the world as a potential treatment for COVID-19. Earlier last month, Glenmark also announced that it is conducting another clinical trial to evaluate the efficacy of two antivirals Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult COVID-19 patients in India.

Insufficient Evidence, No Real Requirement: Doctors

Dr Manoj Goel, Director, Pulmonology, Fortis Memorial Research Institute, tells FIT, “There are several issues here. It’s an experimental drug for which we don’t have much evidence. If you also look at the recommended dosage, it amounts to too many tablets over the course of 14 days. And most importantly, the section of infected people it is being advised for - those with mild or moderate illness - have a high chance of recovery even otherwise. They will anyway recover.”

In conversation with FIT, Dr Sumit Ray, a critical care specialist in Delhi also pointed towards the weak evidence and the fact that there is no actual need for a specific antiviral drug for mild to moderate COVID patients.

“The most damage that the disease causes is the way it triggers the immune response in critical patients or the body’s clotting ability. The drug doesn’t help improve any of these real outcomes of COVID-19. So how does it really benefit? Most of the mild patients will recover anyway. Such medicines based on poor quality studies would just end up putting pressure on doctors. Families will get desperate to ask for the prescription even when there is no need and despite the risk of side-effects that accompanies any drug,” he says.

Dr Sahaj Rathi, Hepatologist and researcher and Dr SP Kalantri. Professor of medicine and medical superintendent, MGIMS Sevagram, shed light on the lack of randomized controlled trials (RCT) and the insufficient data to establish any benefit of the drug for COVID-19 treatment. “For any drug to enter the market in India, it needs to go through a series of approvals which are granted on the basis of trials that have proven its safety and efficacy in patients. The best way to know that is through randomized controlled trials in which every participant has the opportunity to be given or not given the drug. All things being equal, the benefit, as well as side-effects of the drug, can be estimated.”

Even the RCT being conducted by Glenmark is still ongoing, they add, and the sample size of 150 patients across major hospitals in the country is too small for a country of billions. The trial is still on and the data is yet to be released.

“Yes, these are desperate times. But we should not abandon scientific reasoning and lower the guard. There needs to be a healthy respect for science and research during such times too,” they add.

The Economics and Financial Strain

Dr Kalantri and Dr Rathi also point towards the unnecessary expense that the use of this medicine could lead to for patients who would have a high chance of recovery even without it.

“This would create pressure and guilt among families of COVID-19 patients. There is so much panic and fear around the disease that they will be forced to arrange for the medicine even if they have no funds - when in reality, a mild COVID case may recover either without medication, or with medicines costing no more than Rs 10.”

(With inputs from IANS)

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