Zydus Cadila seeks DCGI approval for clinical trial of hepatitis drug PegiHep in COVID-19

New Delhi: 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 a 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.

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