The Maharashtra government may give hydroxychloroquine (HCQ) tablets to high-risk slum residents in Mumbai, as a “preventive measure”, according to media reports. Suspected patients kept in quarantine facilities in Dharavi could likely to be the first ones to get the HCQ tablets.
This, even as the Indian Council of Medical Research, the premier body authorising and issuing guidelines for management and treatment of COVID19, has yet not approved the use of HCQ in large scale population.
Chloroquine has been making headlines over the last 10 days ever since the US drug regulator granted emergency use authorisation to malaria drugs chloroquine and hydroxy-chloroquine to treat patients infected by Sars-Cov2. The USFDA has said that the drugs be prescribed "as appropriate, when a clinical trial is not available or feasible."
Maharashtra Health Minister Rajesh Tope cited the use of chloroquine in the US as a precedent to give the tablets to some of the suspected patients in Dharavi.
“HCQS is used to treat malaria and there have been instances of it being used in the US as a prophylaxis (preventive medicine) against Covid-19. We plan to use it in areas like Dharavi where the risk of infection is high,” he was quoted as saying in the report.
ICMR’s Head of Epidemiology and Communicable Diseases Dr Raman R Gangakhedkar is not convinced about the efficacy of HCQ in treating COVID-19, though ICMR has advised HCQ to be used in high risk healthcare workers and critical patients.
“We do not have enough evidence to suggest that HCQ can be used otherwise," Gangakhedkar said.
Dr Girdhar Babu, Professor and Head Lifecourse Epidemiology at the Public Health Foundation of India said, “There is no clear evidence of benefits from HCQ in COVID19 patients, while there are no reports of side effects in these small studies. But studies are very limited. In the way of helping people, we also have to use evidence. I will stick to the ICMR’s advisory of limited use.”
But there are some who feel that the government may not have much of a choice, given the difficulties in enforcing social distancing in slums.
"ICMR has permitted HCQ for healthcare workers and household contacts of cases. In a tightly packed colony like Dharavi where social distancing is not possible, it may possibly be treated as a large exposed household," a senior healthcare expert told CNBC-TV18.
"Limited studies is a concern but trial evidence will take several weeks. There may be fear that epidemic may be uncontrollable by then if nothing is done" the expert added.
Some medical experts feels Maharashtra government’s plans to start HCQ at a community level begs a rethink at a time when medical research fraternity world-over is raising concerns about the limited evidence on the drug's efficacy and the growing list of adverse health impacts. Several studies are being halted as adverse reactions are reported.
The drug taken in combination with Azithromycin increases the risks of side effects like arrhythmia or irregular heartbeat and even toxicity if taken in higher dosage.
According to a news report in the New York Times, a small study in Brazil was halted early for safety reasons after coronavirus patients taking a higher dose of chloroquine developed irregular heart rates that increased their risk of a potentially fatal heart arrhythmia.
Ongoing clinical trials in hospitals in Sweden were stopped last week when patients infected with coronavirus complained of blinding headaches, cramps and peripheral vision loss after a few days of being administered chloroquine.
The drug caused the heart to beat too fast or slow in one in 100 patients and this could lead to a fatal heart attack.
While US has approved emergency use, with President Donald Trump's endorsement, its top infectious disease expert, Dr. Anthony Fauci, who is also the government’s top scientific adviser has been wary. Fauci has said that it was too early and any “anecdotal evidence” still needs validation in randomized clinical trials to prove the prospects of HCQ.
The US, along with 30 other countries has ordered large HCQ supplies from India, which is the largest manufacturer of the drug. The first HCQ consignment has already reached the United States and 13 other export consignments to US and some other countries have already been cleared by the Indian government. Indian companies are ramping up production of the drug to handle the massive surge in demand globally.
This despite concerns being raised on the safety of the drug.
Dr Michael Ackerman, a genetic cardiologist and director of the Mayo Clinic's Windland Smith Rice Genetic Heart Rhythm Clinic told CNBC that while it could likely be safe for 90 percent of the population, HCQS could pose serious and potentially lethal risks to those susceptible to heart conditions. A recent study that Akerman quoted showed up to 11 percent of COVID19 patients on HCQS and azithromycin are in the so-called "red zone" for potential cardiac side effects.
US, China and Britain among other countries have licenced the use of the drug on seriously ill coronavirus patients. However, citing concerns on safety and limited data on efficacy, Britain has asked clinicians not to prescribe the drug until clinical trials are completed. The French government has also said that it was against prescribing hydroxychloroquine or using it for anything other than severe cases.
In the United States, a study conducted by researchers from Sinai Grace and Henry Ford Hospital in Detroit said use of hydroxychloroquine in COVID-19 patients brought no significant benefits in reducing the mortality rate, compared to those who received only supportive treatment. The study which is under review by the New England Journal of Medicine that 63 patients, 32 on HCQ and 31 on supportive therapy, says “a more judicious prescription of HCQ is recommended in the setting of SARS-CoV2 (COVID-19) before a larger analysis can be completed.”
US, however is actively engaged in more clinical trials with a set of 1100 patients in New York receiving HCQ treatment. Another research group under the National Institutes of Health have begun clinical trials in Tennessee in United States to evaluate the safety and effectiveness of hydroxychloroquine for the treatment of 500 adults hospitalized with COVID-19.
However as the perception of HCQ being effective in treatment of COVID-19 gains currency, the healthcare fraternity has been asking for more data on safety of the drug.
A review of the Canadian Medical Association Journal, published in the Science daily said, “Despite optimism (in some, even enthusiasm) for the potential of chloroquine or hydroxychloroquine in the treatment of COVID-19, little consideration has been given to the possibility that the drugs might negatively influence the course of disease.
Apart from cardiac arrhythmias (irregular heartrate) the journal listed more side effects of HCQ from hypoglycemia, to hallucinations, metabolic variability to toxicity. Dr. David Juurlink, Division of Clinical Pharmacology and Toxicology, Sunnybrook Health Sciences Centre, Canada was quoted as saying "We need a better evidence base before routinely using these drugs to treat patients with COVID-19."
First Published: IST