Will review use of hydroxycholroquine in Covid-19 treatment, says ICMR
NEWDELHI: The Indian Council of Medical Research (ICMR) will review whether to continue use of hydroxycholroquine (HCQ) to treat coronavirus disease (Covid-19) patients in India after the World Health Organisation (WHO) suspended human trials till it assess data on its safety and efficacy.
The use of the anti-malarial drug as a prophylaxis -- preventive medicine -- will continue in an attempt to ward off infection in people at risk, such as health care workers.
“Our experts will be meeting tomorrow (Wednesday) to assess the evidence that is before us in treating patients with a combination of HCQ and antibiotic azithromycin that is currently being used. A call will be taken after the discussion and a fresh advisory could be issued in this regard based on what experts say,” said an ICMR official, who did not wish to be identified.
On Friday, ICMR revised its March 23 advisory on approving prophylaxis use of HCQ, and expanded the pool of people who should be given the medicine to prevent infection, including asymptomatic surveillance workers deployed in containment zones and paramilitary/ police personnel involved in Covid-19-related activities.
In March, ICMR approved “restricted use” of the drug in the country after available global studies showed there was viral load reduction in Covid-19 patients who took it.
“We were always looking at the drug’s efficacy in preventing infection; not really for treatment purposes,” the ICMR official added
The medical research council also began the use of the drug under observational study mode to get proof of concept, and also did some in-vitro studies in a lab in the National Institute of Virology, Pune, to generate data on its efficacy.
“Many drugs are being repurposed for treatment and for prophylaxis purposes, of which HCQ is one. It’s a safe drug and has been in use for nearly 100 years, which provided the sense of its safety, and the lab studies showed the drug had anti-viral activity. Data generated over the past five to six weeks has shown that it may be working, with no major side-effects. The ICMR advisory is clear that it is to be taken as a prophylaxis drug for actual benefit,” said Dr Balram Bhargava, director general, ICMR .
The data on assessment of HCQ prophylaxis among 1,323 health care workers indicated adverse effects such as nausea (8.9%), abdominal pain (7.3%), vomiting (1.5%), hypoglycemia (1.7%) and cardio-vascular effects (1.9%). The data from the Pharmacovigilance programme of India reported 214 instances of adverse drug reactions associated with prophylaxis HCQ use.
The observational prospective study of 334 healthcare workers at the All India Institute of Medical Sciences, New Delhi, out of which 248 took HCQ prophylaxis also showed that those taking HCQ prophylaxis had lower incidence of the SarsCoV-2 infection than those not taking it.
“However, there are certain contraindications for not taking the drug that have been listed in the advisory, and the drug is not to be taken on an empty stomach as that could have caused nausea in maximum cases,” said Dr Bhargava.
The dosage given to people in India is 400mg, twice a day, for one day, and subsequently 400mg once a week. The course is recommended for seven weeks.
Doctors say some more evidence is required before confidence in the drug can be reinstated.
“We are not giving the drug now as enthusiastically as it was given in the beginning given the kind of evidence before us. We will have to look into all aspects of the evidence available; we will talk to experts on this,” said Dr Yatin Mehta, critical care specialist, Medanta Hospital.
THE MOVE COMES AFTER THE WORLD HEALTH ORGANIZATION SUSPENDED HUMAN TRIALS SAYING IT NEEDS TO ASSESS DATA ON ITS SAFETY AND EFFICACY