Zydus Cadila has received emergency use approval from the Indian regulator (DCGI) for the use of its anti-viral drug ‘Virafin’. At a time when India’s healthcare infrastructure is reeling under tremendous pressure, Virafin is being presented as a drug that can reduce the need for oxygen support and improve recovery time among moderate cases of Covid-19.
Pharma giant Zydus says 91.15 per cent of adult patients treated with Virafin tested negative for coronavirus using RT-PCR negative in seven days. A Pegylated Interferon alpha-2b drug, Virafin, is to be administered in a single dose subcutaneous (under the skin) regimen.
When administered early on during Covid-19, Virafin will help patients recover faster and avoid many complications, Zydus says. The pharma company also adds that Virafin will be available on the prescription of a medical specialist for use in hospital/institutional setups.
Zydus also says there is evidence to show that Virafin is reducing respiratory distress.
#Oxygenshortage across #Delhi hospitals. Here’s a report by @milan_reports and @KunalKumarMedia#ITVideo #COVID19India #COVID19 pic.twitter.com/CjWR14Oao4— IndiaToday (@IndiaToday) April 23, 2021
In the multicentric trial conducted in 20-25 centers across India, Virafin showed lesser need for supplemental oxygen, 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.
Speaking on the development, Dr Sharvil Patel, Managing Director, Cadila Healthcare Limited said, “The fact that we are able to offer a therapy which significantly reduces viral load when given early on can help in better disease management.”
“It comes at a much-needed time for patients and we will continue to provide them with access to critical therapies in this battle against Covid-19,” Dr Patel went on to add.
Virafin helps body cope with Interferon Alpha deficiency
In its Phase III clinical trials, researchers found that a higher proportion of patients administered Virafin tested negative for the infection by the seventh day.
“The drug ensures faster viral clearance and has several add-on advantages compared to other anti-viral agents,” says Zydus Cadila.
#Virafin#Atmanirbharbharat#EUA#DCGI#ZydusGroup#COVID-19#treatmentformoderateCovidpatients pic.twitter.com/EYLbSOs1rc— Zydus Cadila (@ZydusUniverse) April 23, 2021
Virafin, when administered in the early phases of Covid-19, can replace the deficiency of Interferon Alpha in the body. Type-1 interferons are the body’s first line of defence against a number of viral infections.
With aging, the body’s ability to produce Interferon Alpha in response to viral infections weakens. This, says Zydus, can be associated with higher mortality observed among elderly Covid-19 patients.
What does clinical trial data for Virafin says
It was found during the Phase III clinical trials of Virafin that patients administered the anti-viral drug showed considerable improvement on day 8 as compared to the existing treatment for Covid-19.
Zydus Cadila says there is an 80.36 per cent chance of a patient recovering from coronavirus in seven days, as compared to 68.18 per cent in the case of existing modes of treatment.
In the Phase II clinical trials, Zydus found that there was a significant reduction of the viral load among Covid-19 patients treated with Virafin.
Lesser oxygen required
According to pharma giant Zydus, the hours of supplemental oxygen required to treat Covid-19 patients administered Virafin was significantly less.
Relatives of patients suffering from #COVID19 line up outside an oxygen refilling plant in Madhya Pradesh’s Bhopal.
More #ReporterDiary: https://t.co/FAHzdk9TO8#COVID19 #CoronavirusPandemic #MadhyaPradesh #Bhopal pic.twitter.com/iEjXIO36tQ— IndiaToday (@IndiaToday) April 23, 2021
Similarly, it was found during the clinical trials of the anti-viral drug that signs and symptoms of patients treated with Virafin remained for five days as compared to six days for patients treated using existing modes of treatment.
Findings of the Phase III trials have been published in the Nature journal titled ‘Lu et al, Signal Transduction and Targeted Therapy (2021) 6:107’. On the other hand, the findings of Phase II clinical trials of Virafin have been published in the International Journal of Infectious Diseases titled ‘Efficacy and safety of pegylated interferon alfa-2b in moderate COVID-19: A phase II, randomized, controlled, open-label study’.