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Zydus Cadila Approaches DCGI To Use Hepatitis Drug For COVID-19 Clinical Trial

Drug Controller General of India, has received an application from Zydus Cadila, to conduct clinical trial using antiviral drug 'Pegylated Interferon Alpha-2b'


Country's top drug regulator, Drug Controller General of India (DCGI), has received an application from Zydus Cadila, a leading global pharmaceutical company in India, to conduct clinical trial using antiviral drug 'Pegylated Interferon Alpha-2b' in adult COVID-19 patients. The Pegylated Interferon Alpha-2b medicine has been used for the treatment of Hepatitis B and C in India.

It is vital to note that the drug Pegylated Interferon Alpha-2b has been used in the treatment of COVID-19 cases in China and Cuba and is a part of the treatment guidelines of the Chinese government.

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Zydus Cadila has also approached 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.  The research done in the US and a clinical study in China showed that the drug significantly improved the condition of COVID-19 patients".

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Research shows direct anti-viral effect of Interferon Alpha on COVID

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 research 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.

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Not yet licensed for COVID-19 treatment

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.

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(With inputs from agency)

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