Lok Nayak Hospital is the national capital’s first COVID-19 only facility. Although Favipiravir was recently embraced in India by Glenmark Pharmaceuticals in the form of Fabiflu, this Delhi hospital has discontinued the use of the drug for COVID-19 patients. The well-known hospital has approved off label use of Ivermectin for early-stage COVID-19 patients, as well as Remdesivir, Tocilizumab, and plasma therapy.
Lok Nayak Hospital
A public hospital in the nation’s capital (Delhi), Lok Nayak Hospital, is now one of at least four providers in Delhi that only administers care to COVID-19 patients. The hospital has had some controversy in terms of reporting numbers of deaths and consequently sacked its director recently. By March, Lok Nayak Hospital had already established a 34-bed isolation ward for suspected COVID-19 patients as well as 11 isolation wards for confirmed cases. By the spring, it was one of the 27 hospitals in Delhi with COVID-19 isolation facilities.
Favipiravir In India
The oral antiviral has been approved for influenza in Japan since 2014 and is now approved for COVID-19 in Russia, China, and India. The drug is known to block a viral enzyme in RNA polymerase, necessary for viral replication. Glenmark Pharmaceuticals secured government approval for the production and marketing of the drug in India under the brand name Fabiflu for mild to moderate COVID-19 cases.
In India, the drug was approved the third week of June under an accelerated process post a recommendation of special Subject Expert Committee (SEC) on COVID-19. Glenmark charges about $46.87 for a pack of 34 tablets—expensive for the standard working class in India.
Clinical Trial Supporting the Decision
Glenmark reports that the actual study that justified the decision to approve (and to greenlight the company’s investment) was a study involving 150 hospitalized patients with mild and moderate COVID-19. Glenmark was involved in the study, which is quite standard but nonetheless raises the question if there were other studies not sponsor funded. This research was undertaken at Navi Mumbai, and the drug is manufactured at Glenmark’s Ankleshwar plant in Gujarat.
The company warned against certain patients using drugs such as those with severe renal, hepatic impairment, and pregnant and lactating women. Moreover, any patients with a history of abnormalities in the metabolism of uric acid or those with gout shouldn’t take the drug.
Lok Nayak Hospital had approved the use of Favipiravir for mild to moderate COVID-19 cases, but the side effects, including lower appetite, diarrhea, increased uric acid levels, and lower white blood cell counts can impact the ability to health damaged tissues (neutrophil counts) and increased liver enzymes reports National Herald India. Moreover, doctors at Lok Nayak Hospital observed that the use of the drug was correlated with QT prolongation (the heart muscle takes longer than normal to recharge between beats). The uric acid concentration was of concern as well. Lead doctors in the decision were Dr. Urmila Jhamb, Dr. Munisha Agarwal, and the COVID-19 nodal officer Dr. Sandeep Garg. The hospital’s medical director, Dr. Suresh Kumar, approved the changes. The hospital decision-making body ultimately questioned whether there was enough data available on the effectiveness of Favipiravir.
Decision markers understanding some political fault lines in India suggested they would not recommend the drug because they don’t get mild cases, and that is what the drug is intended for. Nodal officer Dr. Sandeep Garg commented, “There are better drugs to treat COVID-19 patients. Moreover, LN Hospital does not get mild cases.” The cost was undoubtedly a factor.
Economics of Favipiravir in India
Perhaps an underlying issue is the economics where a full course runs $335 when factoring in the full course required. This is a lot of money for most people in India for a drug regimen. Hence for the cost, Dr. Kush Sharma, a senior resident working at LN Hospital’s intensive care unit, suggests, “There are better treatment protocols available.”
Other Drugs now Approved
The Lok Nayak Hospital committee has approved the use of three other drugs, including Remdesivir, Tocilizumab, and Ivermectin, as well as plasma therapy for COVID-19 treatment. What follows is a breakdown of the hospital’s four-member committee rationale for its decisions.
Remdesivir was approved for moderate cases of COVID-19 if the patient exhibits no response to steroids and oxygen therapy. They suggested not to mix Hydroxychloroquine with Remdesivir as it could interfere with the antiviral’s action. They do have reported Remdesivir side effects such as nausea and high liver enzymes. Of course, caution is recommended on renal patients, children, and pregnant and lactating women.
This immunosuppressive is used for moderate to severe COVID-19 patients, particularly if there involves a hyperactive immune response (cytokine storm) in the body. Should TB patients be involved, the committee recommends caution, in addition to those with systemic bacterial and fungal infection and those on a differing immunosuppressive therapy such as for some form of cancer. Also, doctors there in India warn against using Tocilizumab if tests indicate higher levels of liver enzymes.
Although the hospital’s committee acknowledged that the only true evidence for Ivermectin comes from laboratory evidence as an inhibitor of the COVID-19 causative virus, it should be considered for hospitalized patients as it is A) cheap, B) available, and C) known to be safer than other drugs. Approved by the US FDA for parasitic infections, it’s only side effects are fever and skin rash. The hospital undoubtedly has been monitoring all the Ivermectin clinical trials now off the ground plus the significant building observational evidence from multiple countries. Lok Nayak Hospital suggests Ivermectin can help in limiting viral load and prevent severe disease progression.
Lok Nayak Hospital will continue with plasma therapy, but the exclusionary list will grow larger. For example, patients with cardio-pulmonary comorbid diseases, liver disease patients, chronic kidney patients, patients under 18 and older than 60, those that are obese, pregnant patients, and others, will be excluded.