Based on the recommendation of the Task Force for coronavirus disease (COVID-19), the Indian Council of Medical Research (ICMR) on Monday had approved the use of hydroxychloroquine as prophylaxis by healthcare workers taking care of COVID-19 cases and asymptomatic household contacts of confirmed cases. ICMR does not recommend prophylactic use of the drug for children under 15. Hydroxychloroquine is an antimalarial drug that is used for treating rheumatoid arthritis.
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However, a day later, the Council cautioned the general public against the unrestricted of the drug, stating that “it is still at experimental stage and is not recommended for public use.”
“Hydroxychloroquine is recommended only for a healthcare worker who is treating a COVID-19 patient. Secondly, it's recommended only for persons staying with and caring for a household patient who has been tested positive. They can take that only for prophylaxis — only for prevention,” the ICMR noted in its release.
“The recommendation is for empirical use of the drug based on available evidence and is restricted for use by only two categories of people and under strict supervision of a doctor,” Director-General of ICMR Balram Bhargava told The Hindu .
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The clarification comes as none of the drug approving agencies across the world, including the FDA, has cleared the drug for prophylaxis or for treating COVID-19 patients.
The available evidence of the efficacy of the drug is a small study by French researchers involving 26 COVID-19 patients. The study found “significant” reduction in viral load in over half the number of patients at end of six days of therapy.
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As the trial showed significant reduction, the results were published on March 17 in the International Journal of Antimicrobial Agents even before the 14-day follow-up was completed. The paper, which did not include the data of six patients, was published a day after it was submitted to the journal. One of the authors is an Editor-in-Chief of the journal where the paper was published.
During a White House press briefing a few days ago, asked if there was any evidence that the drug can be used as a prophylactic or as treatment for COVID-19 patients, Director of the U.S. National Institute of Allergy and Infectious Diseases Anthony Fauci, said: “The answer is ‘no’ as it is [based on] anecdotal evidence.”
He then added, “It was not done in a controlled clinical trial. So you really can’t make any definitive statement about it.”
Despite Dr. Fauci’s clarification, two Nigerians are reported to have over-dosed on the drug after hearing President Donald Trump saying the drug could help treat people with COVID-19. A man in Arizona, U.S., died and his wife was hospitalised after they self-medicated with a home remedy of hydroxychloroquine — a chemical used as fish tank additive that has the same active ingredient as the drug.
Prof. Gagandeep Kang, executive director of the Translational Health Science and Technology Institute (THSTI) in Faridabad, told The Hindu : “At this moment there is no evidence available [about its effectiveness]. There are ongoing trials. They must have waited for the results of the trials. Even the trials are for treating COVID-19 patients and not for prophylaxis.”
The Atlanta-based Centres for Disease Control and Prevention (CDC) says that based on “limited in-vitro and anecdotal data”, the drug has been recommended for treatment of COVID-19 patients in several countries. The drug is currently under investigation in clinical trials for pre-exposure or post-exposure prophylaxis and treatment.
“There are no currently available data from randomised clinical trials to inform clinical guidance on the use, dosing, or duration of hydroxychloroquine for prophylaxis or treatment of SARS-CoV-2 infection,” CDC says.
However, Dr. Navin Khattry from the department of medical oncology at the Tata Memorial Hospital, Mumbai and deputy director of ACTREC says: “Its use as prophylaxis has been extrapolated from the treatment trial. As a prophylaxis, the drug may benefit healthcare workers who are taking care of COVID-19 patients.”
“When there is no other drug available, and when the virus is highly contagious, it is best to use if there is some benefit. The same logic applies for other diseases where there are no medicines available,” Dr. Khattry said.
“With the Task Force for COVID-19 recommending the drug, it has become a standard of care even when WHO and CDC have not suggested its use as prophylaxis,” says Dr. Anant Bhan, a researcher in global health and bioethics. “Using the drug as prophylaxis may give a false sense of security to healthcare workers and they may not use personal protective equipment (PPE) or maintain hand hygiene. Good quality PPE is more important and urgent but we are already facing a shortage of PPE.”
“We don’t have a strong pharmcovigilance. So how are we going to pick up adverse effects of the drug and toxicity? Considering the rampant over-the-counter use of drugs, how are going to restrict its sale?” asks Dr. Bhan.
“We also can’t do any trial on prophylaxis when everyone is taking the drug.” He is also worried that just like hand sanitisers and masks, there will be a shortage of hydroxychloroquine for people with rheumatoid arthritis.