Gilead Says Remdesivir Reduced Mortality in COVID-19 Patients

New data on Gilead Sciences’ remdesivir showed that the antiviral reduced the risk of mortality for severe COVID-19 patients by 62 percent.

The new data emerged from  a phase 3 trial of 312 patients treated with remdesivir compared with a results from a retrospective study of 818 patients given only the standard of care. The analysis found that 74.4 percent of remdesivir patients recovered by day 14 compared to 59 percent of those who received the standard of care alone.

Patients treated with remdesivir also demonstrated a 7.6 percent mortality rate compared with 12.5 percent among those not given the drug, the company said.

Gilead also noted that the rates and likelihood of recovery were lower in patients given remdesivir in combination with hydroxychloroquine, compared to those given remdesivir alone. The antimalarial drug was not associated with increased mortality, but there was a higher rate of adverse events in the group taking the combination.

In addition, Gilead released data from its compassionate use program for remdesivir showing that 83 percent of pediatric patients and 92 percent of pregnant and postpartum patients recovered by day 28. The company is collaborating on a separate study of remdesivir in pregnant women and is conducting a phase 2/3 clinical trial of the antiviral in pediatric patients (DID, June 19).

In other remdesivir news, Australia’s Therapeutic Goods Administration has issued a conditional approval for use of the drug, marketed as Veklury, for hospitalized COVID-19 patients who are severely sick and require oxygen or ventilation to breathe.

The conditional approval is good for up to six years, but Gilead can apply for full approval when it has more data to confirm the drug’s safety and efficacy. — Jordan Williams