Phase III Results of Zydu’s Pegylated Interferon Alpha-2b for Treating COVID-19

The Drug Controller General of India (DCGI) has given Restricted Emergency Use Approval for the use of ‘Virafin’, Pegylated Interferon alpha-2b for treating moderate COVID-19 infection in adults. A single dose subcutaneous regimen of the antiviral Virafin will make the treatment more convenient for the patients. When administered early on during COVID, Virafin will help patients recover faster and avoid much of the complications. Virafin will be available on the prescription of a medical specialist for use in a hospital/institutional setup.

In the multicentric trial conducted in 20-25 centers across India, Virafin had shown a lesser need for supplemental oxygen, clearly indicating that it was able to control respiratory distress and failure which has been one of the major challenges in treating COVID-19. The drug has also shown efficacy against other viral infections. A single dose of the antiviral Virafin administered subcutaneously early on shows significant clinical and virological improvement in moderate COVID-19 adult patients. Around 91.15% of patients treated with PegIFN were RT PCR negative by day 7.

The treatment significantly reduces the hours of supplemental oxygen in the patients. Interferon-alpha has also been implicated as crucial in the protection against SARS-CoV-2 in the recent publications in the leading journal Science. Furthermore, ageing reduces the body’s ability to produce Interferon Alpha in response to viral infections and may be associated with the higher mortality observed with COVID-19 in elderly patients. Virafin when given early on during infection can replace this deficiency and aid in a faster recovery process.

The Phase III trials demonstrated that a higher proportion of patients in the PegIFN arm showed a two-point statistically significant clinical improvement (WHO 7-point ORDINAL SCALE) on day 8 as compared to the Standard of Care (SOC arm) (80.36% vs 68.18%). Clinically the hours of supplemental oxygen required was significantly lesser in the PegIFN arm and as well as the time to resolution of signs and symptoms as compared to the SOC arm (5 days vs 6 days).

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Ref Link: doi:10.1016/j.ijid.2021.03.015