Indian Council of Medical Research (ICMR) has maintained its recommendation and approved the use of HCQ as prophylaxis based on the studies conducted in India, despite World Health Organisation (WHO) suspending the clinical trials using hydroxychloroquine (HCQ) under its Solidarity Trial.
A recent case-controlled study by ICMR has underlined the benefit of hydroxychloroquine (HCQ) as prophylaxis, showing that the sustained use of the anti-malaria drug along with the use of personal protective equipment (PPE) was associated with a significant decline in risk of Covid-19 infection rate by upto 80% among the healthcare workers.
The study findings further strengthen ICMRs stand on HCQ as prophylaxis, meaning the treatment is given or action is taken to prevent the disease.
“There is a huge difference in the (HCQ) dose which is used as therapeutic and preventive purpose. The prophylaxis HCQ is given in very small dose (400 milligrams once a week),” said Dr Arvind Kumar, Chairman, Centre for Chest Surgery and Director in Institute of Robotic Surgery at Sir Ganga Ram Hospital, who is also taking it himself.
According to the ICMR study published in the Indian Journal of Medical Research (IJMR), consumption of four or more maintenance doses was associated with a significant decline (>80%) in the risk of Covid-19 infection among the ‘participants’. The study also found that there was no significant association between HCQ and adverse drug reactions.
The growing debate on the efficacy of HCQ was sparked by study findings including a large observational study published in the medical journal The Lancet which showed that HCQ or HCQ with azithromycin had no significant therapeutic benefit, increased mortality and irregular heart rhythm in Covid-19 patients.
However, serious questions have been raised on the reliability of the findings reported in two of the world’s leading medical journals which have also expressed concern about potential flaws in their data.
Dr Arvind said, “The cardiac impact of HCQ has been overplayed. In the dosages which are used in the preventive setting the benefit outplays the risks. The heart rhythm disorder has been reported to the tune of 1.9 per cent.”
Amid the HCQ controversy, Dr Balram Bhargava, Director General (DG) of the ICMR, told that media last week that the Council found the drug very effective and having less side effects for prophylaxis consumption.
Soon ICMR expanded the use of HCQ as a preventive medication for asymptomatic healthcare workers working in non-Covid-19 hospitals, frontline staff on surveillance duty in containment zones and paramilitary/police personnel involved in coronavirus infection-related activities.
Further elaborating on the importance of HCQ as prophylaxis Dr Kumar said, “People who are normal but are at risk of getting the disease due to the high exposure level in their profession, need a higher level of a preventive measure than the average general population.”
Differentiating on the use of HCQ in a therapeutic setting, Dr Kumar said, “The dose is much higher and the Covid-19 patients in ICU are mostly 60 plus (age) and already have other co-morbidities. So, that is a different setting, whereas the healthcare workers are mostly the middle-aged people.”
Clinical Research & Drug Development, Consultant, Dr Arun Bhatt said, “Policy and judgements should be based on what the emergency situation demands as one cannot wait for 3 months to decide what will come in the trial. Currently, there is no option for the government but to recommend this drug as there is no other prophylaxis available.”
India has been independently making effective interventions and has managed to keep the coronavirus cases and fatalities low. Going by the positive results in the recent ICMR study, India will continue to push forward the prophylactic use of HCQ drug for protecting the doctor and frontline workers atleast till a more effective drug against Covid-19 is introduced.