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Study Says HCQ Could Harm Patients; ICMR Expands Prophylactic Use 

Study Says HCQ Could Harm Patients; ICMR Expands Prophylactic Use 

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Adding to the scepticism surrounding the use of chloroquine or hydroxychloroquine for the treatment of COVID-19 patients, a new study in The Lancet has found worrying results after giving the drug to hospitalised patients. Almost parallelly, the Indian Council of Medical Research (ICMR) has reiterated the use and safety of the medicine as a prophylactic in its revised advisory, issued the same day.

The observational study published on 22 May in The Lancet covered 671 hospitals around the world, concluded that the use of HCQ or chloroquine (when used alone or in combination with a macrolide) 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 in the hospitals, under 15,000 were treated with HCQ, chloroquine, or a combination of either of these with an antibiotic.

Speaking to CNN, Dr Mandeep Mehra, medical director of the Brigham and Women's Hospital Heart and Vascular Center and the lead author of the study, said he would suggest hospitals to stop using these drugs to treat the disease caused by the novel coronavirus.

"Our data has very convincingly shown that across the world in a real-world population that this drug combination, whichever way you slice it or dice it, does not show any evidence of benefit, and in fact, is immutably showing a signal of grave harm," he said.

Earlier, several studies had found the drugs to be of no benefit to COVID-19 patients, and concerns about its effects on the heart have been raised since it became the buzzword for the treatment and prevention of COVID-19, touted by US President Donald Trump. With this observational study, the possibility of harm from the medicine gets strengthened.

The US Food and Drug Administration (FDA) last month issued an advisory saying that hydroxychloroquine has "not been shown to be safe and effective".

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ICMR Reiterates HCQ Use As Prophylactic

The ICMR issued a revised advisory on the use of Hydroxychloroquine (HCQ) as prophylaxis for COVID-19 infection on 22 May, the same day as The Lancet study got published.

This came as a follow-up to its guidelines from 23 March, when it had allowed the use of the medicine to prevent the infection among healthcare workers treating the patients. The recommendation to use the drug had been criticised by experts even then, as FIT had reported earlier. The revised advisory has been substantiated by three studies conducted by the nodal research body, which found that the use of the anti-malarial drug HCQ helps prevent the infection.

  1. An observational prospective study of 334 healthcare workers at AIIMS, out of which 248 took HCQ prophylaxis (median 6 weeks of follow up) in New Delhi also showed that those taking HCQ prophylaxis had lower incidence of the infection than those not taking it.
  2. Another investigation from three central government hospitals in New Delhi indicates that amongst healthcare workers involved in COVID-19 care, those on HCQ prophylaxis were less likely to develop the infection, compared to those who were not on it. The benefit was less pronounced in healthcare workers caring for a general patient population.
  3. A retrospective case-control analysis at ICMR has found that there is a significant dose-response relationship between the number of prophylactic doses taken and frequency of occurrence of SARSCoV-2 infection in symptomatic healthcare workers who were tested for the illness.

In light of these observations, the use of HCQ as a prophylaxis has now been recommended for asymptomatic healthcare workers in COVID and non-COVID hospitals, asymptomatic frontline workers and asymptomatic contacts of confirmed cases. For the former category, the revised guidelines also permit an extension of the dosage of the medicine beyond the previously stipulated 8 weeks with strict monitoring.

The advisory mentions that the drug must be avoided in patients of retinopathy, hypersensitivity to HCQ, and those with existing cardiomyopathy and cardiac rhythm disorders. It must also not be given to children under 15 and to pregnant and lactating women.

“Rarely the drug causes cardiovascular side effects such as cardiomyopathy and rhythm (heart rate) disorders. In that situation, the drug needs to be discontinued. The drug can rarely cause visual disturbance including blurring of vision which is usually self- limiting and improves on discontinuation of the drug. For the above-cited reasons, the drug has to be given under strict medical supervision with an informed consent,” the ICMR adds.

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Hydroxychloroquine For COVID-19: Miracle Drug or Premature Claims?

The scientific community around the world continues to be doubtful about the use of the drug in COVID-19 patients - because of an absence of randomized control trials and any concrete evidence showing its benefits.

In an earlier report, Deepa Agashe, Scientist at National Centre For Biological Sciences, B'luru had told us, “The problem with using Hydroxychloroquine for COVID-19 is that we don’t know whether the side effects of that drug in the context of patients suffering from COVID-19 or other ailments is very high.”

The reason we don't know that yet is because of the availability of only limited scientific studies and results from clinical trials conducted on a small sample of the population. While it's true that hydroxychloroquine is not very expensive and is readily available, one big concern remains that it has not shown impressive results among critically ill patients who are receiving several other medications and have organ failure.

In fact, with emerging research showing that it may, in fact, be harmful, the ICMR’s decision, based on observational studies, will have to be looked at with scepticism. You can watch our in-depth analysis of the available evidence on HCQ here.

(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)

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