India / ICMR writes to WHO disagreeing over advisory to suspend HCQ usage for COVID-19

New Delhi: In an emailed letter addressed to the World Health Organisation, the Indian Council of Medical Research has expressed disagreement with the former’s advisory against the use of hydroxychloroquine (HCQ) for the treatment of COVID-19 patients and its decision to pause its Solidarity Trial to assess the drug.

The government agency stands by its call of using the anti-malarial drug in India, citing differences in dosage standards between Indian and international trials to justify the varying results in its efficacy, news agency ANI has reported.

As per the country’s current protocol to treat seriously ill coronavirus patients requiring ICU admission, HCQ dosages are administered in the following way: 400mg on the first day in the morning and night and 200 mg for the next four days in the morning and night, bringing the total to 2400 mg in five days.

A health ministry official told ANI that the wide gap in dosage levels explains why the ICMR disagrees with the international results. “Internationally in the 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.”

“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,”

This letter follows the statement of Dr VK Paul, a member of Niti Aayog’s empowered group 1, who had said on Thursday, 28 April, “When we see the present evidence of HCQ, there are fewer side-effects...We have studied the 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.”

This begs the question, however, that despite being part of the WHO’s Solidarity trial, why does India have different standards than the international experiments? How will a universal conclusion be reached if the dosage is different?

Conflicting Evidence on HCQ Behind WHO’s Decision

The World Health Organisation had earlier this week said it is putting its solidarity trial on HCQ and chloroquine on temporary 'pause' to review its benefits and harms.

"The executive group of the Solidarity Trial representing ten of the participating countries met on Saturday and has agreed to review a comprehensive analysis and critical appraisal of all evidence available globally. The review will consider data collected so far in the Solidarity Trials and, in particular robust randomised available data, to adequately evaluate the potential benefits and harms from this drug," WHO Director General Tedros Adhanom Ghebreyesus said on Monday, 25 May.

He said that the safety data will be reviewed by the Data Safety Monitoring Board. "The other arms of the trail are continuing."

This follows the latest global study, published in The Lancet on 22 May on HCQ. The observational study covered 671 hospitals around the world, and found that the use of HCQ or chloroquine had no benefit on the outcomes in patients when given early after the diagnosis of COVID-19. In fact, a higher risk of death and the development of irregular heart rhythms was observed in seriously ill patients.

Out of over 96,000 patients observed in the hospitals, around 15,000 were treated with HCQ, chloroquine, or a combination of either of these with an antibiotic.

“Each of the drug regimens of chloroquine or hydroxychloroquine alone or in combination with a macrolide was associated with an increased hazard for clinically significant occurrence of ventricular arrhythmias and increased risk of in-hospital death with COVID-19.”

On the other hand, the Indian Council of Medical Research (ICMR) had reiterated the use and safety of the medicine as a prophylactic in its revised advisory issued the same day as The Lancet study, causing alarm among experts.