Pegylated Interferon alpha-2b
Pegylated interferon alpha-2b was originally developed as a biosimilar product for the treatment of Hepatitis C. During Covid period we tested whether it could be repurposed for the treatment of COVID. The in vitro virus neutralization ability of Virafin was found to be orders of magnitude better than other antivirals. Based on preclinical and clinical studies conducted in Hepatitis C, we approached DCGI for first conducting Phase II studies in moderate COVID patients. After a successful demonstration of safety and efficacy in the Phase 2 clinical trial BIRAC approved project DCGI permission was obtained to conduct a Phase 3 clinical trial in Moderate Covid-19 patients.
The Phase III clinical trial demonstrated a statistically significant P value- 0.0103 proportion of patients in Virafin arm, turned RT-PCR negative by day 7 91.15 as compared to the reference arm 78.90 indicating that Virafin clears viral load early. Further the median hours of supplemental oxygen required was significantly less 56 hrs in the Virafin arm as compared to the reference arm 84 hrs . Overall the median days of resolution of signs and symptoms was less 5 vs 6 days in Virafin arm compared to reference. Successful outcome in Phase 3 CT led to emergency use authorization and launch in April 21.
USP: Virafin is one of the best anti-virals for the treatment of COVID. Being an Indian product, it is available at a low price.