Favipiravir phase-3 clinical trial shows ‘faster clinical cure’ in mild to moderately ill patients

The initial findings show on an average it took three days to normalise cough, fever, oxygen-saturation levels, and the respiratory rate in mild and moderately ill patients who were given Favipiravir.

The phase-3 clinical trial of the antiviral drug Favipiravir has found “faster clinical cure” in mild to moderately ill patients. The Covid-19 patients administered with Favipiravir reported average improvement in oxygen levels, fever, and cough in three days as compared to five days among those under routine care.

The antiviral drug trial was conducted on 150 Covid-19 patients between May and July 3 across seven hospitals, five of which were in Maharashtra. In Mumbai, Kasturba and Breach Candy hospitals were a part of the trial. Government Medical Colleges in Nagpur and Aurangabad were also a part of the trial, besides AIIMS Raipur, GMERS Hospital, Vadodara, and HCG Hospital, Ahmedabad.

“Patients randomized to Favipiravir seemed to have a faster clinical cure, and more importantly, faster viral clearance than those randomized in the routine care group,” said Dr Zarir Udwadia, the principal investigator in the trial. Patients in Favipiravir arm were administered the drug for a maximum of 14 days along with standard treatment care.

Udwadia said while the drug trial results from across the globe are awaited, there is “enough evidence to consider using Favipiravir in symptomatic Covid-19 patients with mild to moderate infection”.

The initial findings show on an average it took three days to normalise cough, fever, oxygen-saturation levels, and the respiratory rate in mild and moderately ill patients who were given Favipiravir. The patients with mild illness had slight fever and cough, while the moderately ill ones had pneumonia and lung involvement.

While viral clearance was faster with Favipiravir, experts involved in the drug trial said the drug was not effective for severely ill patients. Adverse events due to Favipiravir was observed in at least 35.6 per cent (26 patients) cases as compared to eight per cent (six patients) patients who were not administered the drug.

In a statement, pharmaceutical giant Glenmark said none of the patients had to discontinue Favipiravir since adverse events were “mild to moderate”.

The study also found that 69.8 per cent of patients achieved clinical cure state by the fourth day of medication as compared to 44.9 per cent among the other group.

Favipiravir remains a concern for its high cost. Glenmark pharmaceutical launched it at Rs 103 per tablet under brand name Fabiflu. On July 19, the DCGI issued a notice to the company over the high cost of the tablets.