Antimalaria drug Hydroxychloroquine and antibacterial Azithromycin have been advised to be administered to confirmed patients of novel coronavirus in India by Ministry of Health and Family Welfare (MoHFW). The clinical guidelines were revised on March 31.

Uptil now MoHFW advisory said that only Hydroxylchoroquinine should be given as preventive treatment to healthcare workers and contacts of confirmed cases.

Also, anti-HIV drugs Lopinavir and Ritonavir were advised for patients with severe disease admitted in intensive care unit (ICU), which have now been removed.

In its expanded revised guidelines, the MoHFW states: “No specific antivirals have been proven to be effective as per currently available data. However, based on the available information (uncontrolled clinical trials), the following drugs may be considered as an off-label indication in patients with severe disease and requiring ICU management - Hydroxychloroquine 400 mg twice a day for one day, followed by 200 mg twice a day for 4 days, in combination with Azithromycin 500 mg once a day for 5 days.”

Study results

A French study published on March 20 in the New England Journal of Medicine treated 20 patients with this regimen and concluded that all six patients who were given the drug combination were 100 per cent virologically cured by end of sixth day. The study also said that of the other 14 patients who were only given the lone drug Hydroxychloroquine, only eight or 57.1 per cent were cured. This is the only limited evidence basis which India has revised its guidelines currently.

“Our preliminary results also suggest a synergistic effect of the combination of hydroxychloroquine and azithromycin. Azithromycin has been shown to be active in vitro against Zika and Ebola viruses and to prevent severe respiratory tract infections when administrated to patients suffering viral infection. This finding should be further explored to know whether a combination is more effective, especially in severe cases,” the NEJM study states.

Because the drug combo is feared to cause an erratic heart rate, the guidelines state that these drugs should be administered under close medical supervision, with monitoring for side effects including QTc interval, which is measurement of heart rate.

Children less than 12 years and pregnant or lactating women cannot be put on this regimen.

These guidelines are based on currently available information and would be reviewed from time to time as new evidence emerges,” MoHFW has stated.

On anti-HIV drugs Lopinavir and Ritonavir not being used in treatment anymore, Leena Menghaney from Doctors Without Borders said: “Data from clinical trials in China had suggested that anti-HIV drugs were in effective.” While initially two Italian patients from Jaipur were administered the anti-HIV drugs, one of them later died of heart attack. While globally doctors have said that Covid-19 leads to a weak heart, the MoHFW has maintained that the death was unrelated to the virus.

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