ICMR writes to WHO disagreeing with HCQ assessment, officials say international HCQ trial dosages four times higher than Indian trials

After the Union Health Ministry expressed reservations about the World Health Organisation's (WHO) advisory to suspend hydroxychloroquine (HCQ) usage in treating COVID-19 patients, now, India's nodal government agency ICMR (Indian Council of Medical Research) overseeing the country's response to the coronavirus pandemic has also written to the WHO citing differences in dosage standards between Indian and international trials that could explain the efficacy issues of HCQ in treating COVID-19 patients.

After the Union Health Ministry expressed reservations about the World Health Orgsation's (WHO) advisory to suspend hydroxychloroquine (HCQ) usage in treating COVID-19 patients, now, India's nodal government agency ICMR (Indian Council of Medical Research) overseeing the country's response to the coronavirus pandemic has also written to the WHO citing differences in dosage standards between Indian and international trials that could explain the efficacy issues of HCQ in treating COVID-19 patients.

Currently, as per protocols set by the Indian government to treat severe coronavirus patients requiring ICU management, HCQ dosages are administered in the following way- 1st day a heavy dose of 400mg HCQ dose once in the morning and one at night, followed by 200 mg HCQ one in the morning and one at night to be followed for the next four days. The total dosage administered to a patient in 5 days, therefore, amounts to 2400 mg.

Speaking to on the condition of anonymity, a Health Ministry official explained the context behind the ICMR and Health Ministry disagreeing with WHO's assessment, the primary point being the wide gap in dosage levels given in India and internationally.

"Internationally in Solidarity trial COVID-19 patients are being administered with--800 mg x 2 loading doses 6 hours apart followed by 400 mg x 2 doses per day for 10 days. The total dosage given to a patient over 11 days is about 9600 mg which is four times higher than the dose we are giving to our patients," informed the official.

This indicates that in our treatment protocol, the efficacy of HCQ is good and patients are recovering quickly with less amount of dosage being administered," said the official.

Buoyed by the preliminary success observed in the treatment of COVID-19 patients through these HCQ tablets, the Indian Council of Medical Research (ICMR) has written to the WHO.

In a letter via an email, Dr Sheela Godbole, National Coordinator of the WHO-India Solidarity Trial and Head of the Division of Epidemiology, ICMR-National AIDS Research Institute has written to Dr Soumya Swaminathan, Chief Scientist at World Health Orgzation.

In a letter, Dr Godbole stated: "There was no reason to suspend the trial for safety concern," attributing her statement to the current RECOVERY data which differs significantly from the non-randomised assessment by Mehra et al, a scientific paper.

When contacted Dr Godbole, she said: "Only one arm of the Solidarity trial by WHO has temporary been paused for a time being i.e. HCQ arm, other arms of the clinical trial are still active."

On Thursday, Dr VK Paul, Member Niti Aayog and Chairman of empowered group 1 said: "When we see the present evidence of HCQ, there are fewer side-effects...We have studied HCQ drug very closely with our scientists and hence as per the latest government guidelines--HCQ drug can be given to frontline workers and severe coronavirus patients. However, these guidelines would be reviewed from time to time," said Paul.

UK's stand

A UK study into HCQ as a COVID-19 treatment is to continue despite the WHO suspending its trial, underway in several countries, due to safety concerns. HCQ is one of the drugs in Oxford's RECOVERY (Randomised Evaluation of Covid-19 therapy trial) study, Professor Peter Horby, Professor of Emerging Infectious Diseases and Global Health in the Nuffield Department of Medicine, University of Oxford, said in a statement.

"In response to that paper, we looked very carefully at our data over the weekend, to make sure we are not putting patients at risk. Since RECOVERY patients are randomised, our data are much less vulnerable to the biases that plague studies that use routine health care data," the statement read.

An independent committee has looked at our data and did not see any safety concerns. We discussed our findings with Medicines and Healthcare products Regulatory Authority, who have agreed with our interpretation that the data provide reassurance that continued enrolment into the HCQ arm is safe and that we should press ahead with getting a reliable answer on hydroxychloroquine through the RECOVERY trial," the statement further read.

( With inputs from ANI )