Gilead Sciences said its Covid-19 drug candidate remdesivir reduced the risk of death in severely sick Covid-19 patients by 62 percent compared with standard care.
The company revealed the result of the comparison of the phase-3 SIMPLE trial on remdesivir with real-world data at the virtual 23rd International AIDS Conference on Friday.
|Gilead Sciences said its Covid-19 drug candidate remdesivir lowered the risk of death in severely ill Covid-19 patients by 62 percent compared with standard care.|
The company’s data included data from the SIMPLE-Severe study on seriously ill Covid-19 patients and that from the real-world retrospective cohort who received standard care.
The comparison of 312 patients in the SIMPLE-Severe trial and 818 in the standard care group with similar characteristics and disease severity during the same period showed that 74.4 percent of the remdesivir group recovered by day 14, versus 59 percent of the standard care arm.
The analysis also showed that 7.6 percent of the remdesivir group died while 12.5 percent of the standard care group did so. This means that remdesivir cut the death risk by 62 percent compared with standard care.
“The analysis demonstrated that remdesivir treatment was associated with the significantly improved clinical recovery and a 62 percent reduction in the risk of mortality compared to standard of care,” the company said. It was an important finding that required confirmation in prospective clinical trials, it added.
The company also disclosed separate subgroup analyses from the SIMPLE-Severe study, saying various racial and ethnic groups treated with remdesivir received similar clinical outcomes as the overall patient population in terms of safety and efficacy.
Gilead said its compassionate use program demonstrated that 83 percent of 77 pediatric patients and 92 percent of 86 pregnant and postpartum women recovered from a broad spectrum of disease severity by day 28.
Korea has begun providing remdesivir treatment through the Ministry of Food and Drug Safety’s special import approval. Remdesivir treatment will be given free of charge with its supply under the compassionate use program until July.
However, from August, patients receiving remdesivir will have to pay the medical cost after the government and the company negotiate the treatment price.
On Friday, the food and drug ministry said local clinical trials on remdesivir have ended, hinting that it would officially review approval for remdesivir.
<© Korea Biomedical Review, All rights reserved.>