Professor Vikas P. Sukhatme, MD, ScD: Existing affordable drugs like Ivermectin could rapidly reduce Covid-19 cases and deaths in India

The COVID-19 humanitarian calamity unfolding in India is on a scale not seen in this pandemic. This is an extraordinary situation – and it may benefit from an extraordinary response.

There exist affordable, readily available and minimally toxic drugs approved for non-COVID-19 use which show remarkable promise in preventing or treating the new coronavirus. Deploying these drugs in India is likely to rapidly reduce the number of COVID-19 patients, reduce the number requiring hospitalization, supplemental oxygen and intensive care and improve outcomes in hospitalized patients.

Some of these drugs are being tested in large-scale randomized clinical trials in the US and abroad but in most cases, definitive efficacy data is pending. With the current COVID-19 situation in India, we do not have time to wait for results of these studies. Importantly, currently available safety and outcomes data on these drugs is strong enough that it is time to incorporate them into national practice guidelines. Indian authorities should issue such guidelines on the most promising drugs for each stage of COVID-19. By so doing, physicians will be encouraged to use these interventions. The resulting real world data from a few healthcare settings in select cities should be tracked in real time and guidelines suitably revised. If such measures were adopted, we could see effects in 3-4 weeks. This strategy might be unusual but it is not unheard of: France has the Temporary Recommendation for Use, a “regulatory instrument which aims to allow, on a temporary basis, the use of a medicinal product to allow its effectiveness to be evaluated on the basis of its use.”

The choice of drugs is critical. We have worked closely with personnel at the Food and Drug Administration and have connected with the World Health Organization and the National Institutes of Health to evaluate the merits of repurposed drugs. Based on a mechanistic rationale, data in animal models, human retrospective analyses, clinical trials (some randomized, others not) and anecdotal human data, we created a prioritized list of interventions that hold the greatest promise and that could be deployed at scale.

For instance, there is strong data from a randomized trial and a real-world study that administering fluvoxamine sharply reduces the need for hospitalization in COVID-19 outpatients. Moreover, anecdotal unpublished data in over 400 acutely ill COVID-19 patients from several community practitioners suggests that administering fluvoxamine and ivermectin together may be even more efficacious.

Intervention as early as possible after symptom onset is key. Ivermectin is already listed as a “MAY DO” on the ICMR and Indian government guidelines for treatment of acute mild COVID-19 and we suggest that fluvoxamine be added in this category. Also, ivermectin in the prophylactic setting merits serious consideration. For the hospitalized, there are treatments currently used for other conditions that might reduce the need for ventilator support and lower the risk of death. These include inhaled adenosine, cyproheptadine and dipyridamole. For ideas for which there is rather limited human data, the government should offer pre-approved pilot protocols and funding for rapid implementation in select centers rather than issue a recommendation for use.

To be clear, it would be ideal to pursue large clinical trials to test the efficacy of all promising interventions. A randomized adaptive design could efficiently sift through the many possibilities. It may be possible to rapidly set up parallel protocols in India if government authorities can expedite the regulatory process and offer funding. US trial investigators can be persuaded to provide protocols and web-based data collection tools.

We hope that the Indian government will take advantage of repurposed drug research and use temporary use authorizations or guidelines to rapidly promote the most promising therapies at a national level while in parallel aggressively encourage pilot studies and large-scale clinical trials with shovel-ready protocols and funding. Given the current situation, India has little to lose in piloting these approaches: the potential gains could benefit not just the country but the world.

The views presented here reflect those of the authors and are not necessarily those of the institutions to which they are affiliated.

About the author:

http://whsc.emory.edu/about/leadership/bios/sukhatme-vikas.html

Professor Vikas Sukhatme M.D., Sc.D, is the Dean of the School of Medicine at Emory University. He also serves as Chief Academic Officer of Emory Healthcare and as Woodruff Professor.

Prior to coming to Emory, Sukhatme was Chief Academic Officer and Harvard Faculty Dean for Academic Programs at Beth Israel Deaconess Medical Center in Boston and the Victor J. Aresty Professor of Medicine at Harvard Medical School.

Sukhatme was born in India and raised in Rome, Italy. He completed a bachelor’s degree and then a doctorate (ScD) in theoretical physics at Massachusetts Institute of Technology. In 1979, he received an MD from Harvard Medical School in the Harvard-MIT program in Health Sciences and Technology. Following his residency in medicine and a clinical fellowship in nephrology at Massachusetts General Hospital, he spent two years at Stanford in immunology research.

His first faculty appointment was at the University of Chicago, where he was also appointed an assistant investigator of the Howard Hughes Medical Institute. In 1992 he moved to Harvard Medical School and Beth Israel Deaconess Medical Center (BIDMC) as chief of the renal division in the Department of Medicine, and he subsequently received an appointment in the hematology-oncology division. He was also the founding chief of the Division of Interdisciplinary Medicine and Biotechnology at BIDMC. For eight years, he was the Chief Academic Officer and Harvard Faculty Dean for Academic Programs at BIDMC.

Sukhatme’s research spans numerous areas of medicine in both fundamental science and clinical care. He has over 200 scientific publications that have been cited more than 40,000 times. His longstanding interest in cancer currently centers around tumor metabolism and tumor immunology and on “outside-of-the-box” approaches for treating advanced cancer. He has conducted studies on genes important in kidney cancer and polycystic kidney disease.

Sukhatme’s laboratory played a key role in the discovery of the cause of preeclampsia, a blood vessel disorder and a major cause of morbidity in pregnant women. His research has provided insights into how blood vessels leak in patients with severe infections, and on how new vessels form to feed growing tumors. He has elucidated mechanisms by which statins can cause muscle damage.

Sukhatme is known to be equally passionate about teaching medicine and educating communities outside of medical school. He initiated a course to bring MD/PhD students up to speed as they returned to the clinic after their graduate studies, as well as a mini-medical school series for the general public, and one for industry scientists highlighting unsolved clinical problems.

According to Alan Garber, provost of Harvard University and himself a physician, “Vikas is a superb researcher with remarkable breadth and sophistication, all in the service of improved human health. He has a deep, discerning intellect and is dedicated to the success of his colleagues and students. Emory is fortunate to have attracted him as dean.”

Sukhatme also is an entrepreneur, having cofounded several biotechnology companies based on discoveries from his laboratory. Along with his wife, Vidula Sukhatme, he is co-founder of a not-for-profit organization, GlobalCures, to conduct clinical trials on promising therapies for cancer not being pursued for lack of profitability. The GlobalCures vision has been expanded at Emory, leading to the creation of the Center for Innovative and Affordable Medicine, in which Sukhatme is founding director.

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