Hope, finally: Green light to drug combo

Inclusion and exclusion criteria have been given in the protocol to show which patients can and cannot take the drugs.

BENGALURU: Finally, there is some hope of treating the dreaded Coronavirus Disease 2019 (COVID-19). The Drugs Controller General of India (DCGI) has approved a protocol for restricted public health emergency for the use of  the drugs Lopinavir and Ritonavir to treat patients suffering from COVID-19.

An excerpt of the protocol reads: “In view of the earlier evidence about the effectiveness of lopinavir/ritonavir against SARS and MERS-CoV, the Indian Council of Medical Research (ICMR) has suggested off-label emergency use of lopinavir/ritonavir combination for symptomatic COVID-19 patients detected in the country.”

Dr Tarun Bhatnagar, scientist E from School of Public Health, ICMR-National Institute of Epidemiology, and one of the seven authors of the protocol, told The New Indian Express,

“Studies have shown that the structure of coronavirus has protein and nucleotides (RNA and DNA) against which these drugs (lopinavir/ritonavir combination) are effective. There are reports that show it was used for SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome). Trials for Lopinavir and Ritonavir are being done for coronavirus in other countries. As we do not have time during this emergency situation, it has been approved by DCGI for restricted public health emergency use.”Dr Bhatnagar explained that these drugs are anti-retroviral and are to be consumed orally.

The retrovirus are a family of virus, to which HIV belongs. These drugs are routinely used for HIV treatment and can now off-label be used for treating coronavirus.

Used in Jaipur, Gurugram
“It has been used to treat three COVID-19 patients in Jaipur and two in Gurugram. It is still in an experimental phase,” said Dr Bhatnagar.Clinical data will be collated with its use to see if people are becoming better because of the drugs.“Right now if COVID-19 patients become better, we cannot say it is because of these drugs or not, as there is no comparison. Clinical trials will be done after the emergency is over wherein the drug will be given to one group and not to the other,” explained Dr Bhatnagar.

“From the trials, if it is seen to be effective and shows reduction in complications, then we get the idea that it could work. It can then go on the market for treating coronavirus specifically,” Dr Bhatnagar added.The approval of the protocol is based on studies done abroad and docking studies done in National Institute of Virology, Pune.

Post approval from DCGI, it was published in Indian Journal of Medical Research, a peer-reviewed online open-access medical journal published on behalf of the Indian Council of Medical Research, titled ‘Lopinavir/ritonavir combination therapy amongst symptomatic coronavirus disease 2019 patients in India: Protocol for restricted public health emergency use’.

Inclusion and exclusion criteria have been given in the protocol to show which patients can and cannot take the drugs.

The protocol was developed by a team of doctors and scientists from the School of Public Health, ICMR-National Institute of Epidemiology in Chennai, Department of Medicine, All India Institute of Medical Sciences and Division of Epidemiology & Communicable Diseases, ICMR, Delhi.

Exclusion criteria (patients who can’t be given the drugs)
Patients with hepatic impairment, use of medications that are contraindicated with lopinavir/ritonavir and can’t be replaced or stopped, and known HIV-infected individuals receiving other protease inhibitors containing regimens that can’t be replaced by lopinavir/ritonavir.

INCLUSION CRITERIA
(PATIENTS WHO CAN BE GIVEN THE DRUGS)
Includes patients associated with higher risk of mortality, age more than 60 years, hypertension, diabetes mellitus, renal failure, chronic lung disease and immunocompromised persons

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