Zydus Cadila approaches DCGI to use hepatitis drug for COVID-19 clinical trial

By Priyanka Sharma
New Delhi [India], May 5 (ANI): The country's top drug regulator, Drug Controller General of India (DCGI), has received an application from Zydus Cadila, the leading global pharmaceutical company in India, to conduct clinical trial using antiviral drug 'Pegylated Interferon Alpha-2b' in adult COVID-19 patients.
So far in India, the Pegylated Interferon Alpha-2b medicine has been used for the treatment of Hepatitis B and C.
It is important to note that the drug -- Pegylated Interferon Alpha-2b has been used in the treatment of COVID-19 in China and Cuba and is a part of the treatment guidelines of the Chinese government.
Zydus Cadila has also reached the central government's Department of Biotechnology to investigate the role of Pegylated Interferon Alpha-2b for COVID-19.
A senior government official told ANI, "Talks are on. Our experts' committee is examining it. Further decisions are awaited."
He added that research done in the US and a clinical study in China showed that the drug significantly improved the condition of COVID-19 patients.
A research conducted by the University of Texas Medical Branch, Galveston, showed evidence of a direct anti-viral effect of Interferon Alpha against novel coronavirus in-vitro. The study demonstrated around 10,000 fold reduction in virus titre in cells that were pre-treated with Interferon Alpha 48 hours earlier.
The second by a group of universities in China, Australia and Canada retrospectively analysed 77 moderate COVID-19 subjects in Wuhan and observed that those who received Interferon Alpha-2b showed a significant reduction in the duration of virus shedding period and even in levels of the inflammatory cytokine, IL-6.
The study suggested that if a long-acting molecule like the drug is given early on in the infection, the patient suffering from COVID 19 will have a significant benefit as the viral load is reduced, lesser IL-6 is produced and virus eliminating specific immune response is generated.
It may be noted that Zydus Cadila has been commercially manufacturing Pegylated Interferon Alpha-2b under the brand name, PegiHep, since 2011 for the treatment of Hepatitis B and C. However, PegiHep is not yet licensed or approved for the treatment of COVID-19.
The Ahmedabad-based pharmaceutical company is already manufacturing Hydroxychloroquine (HCQ) which is being used for asymptomatic healthcare workers involved in the care of suspected or confirmed cases of COVID-19, asymptomatic household contacts of laboratory-confirmed cases, and COVID-19 patients with severe disease and requiring ICU management. (ANI)