There is not yet enough information to definitively show that remdesivir improves survival. A comparison of two groups that are not part of the same study is not considered conclusive, but the results offer a glimpse of the benefits of the only drug to get regulatory approval from around the world to help fight it. coronavirus.
Additional data from Gilead showed that patients from hard-hit racial and ethnic groups reap similar benefits, with signs that black and Hispanic patients could do even better. A review of the company’s compassionate use program found no unexpected complications in children, pregnant women, or new mothers, most of whom have recovered from the infection.
“This benchmarking provides valuable additional information regarding the benefits of remdesivir versus the standard of care alone,” said Susan Olender, infectious disease physician at Columbia University Irving Medical Center, in the Gilead statement. “Although not as robust as a randomized controlled trial, this analysis relies heavily on a real environment and serves as an important adjunct to clinical trial data.”
Remdesivir obtained emergency use authorization in May in the United States after initial data showed that it helped hospital patients recover approximately four days faster. To date, the coronavirus pandemic has infected more than 12.3 million people and killed 555,000 people.
Gilead shares gained 2.1% to US $ 76.28 at 1:54 p.m. Friday in New York. This year, the stock increased by 17%, largely fueled by the hope that remdesivir will become a widely adopted drug for the treatment of COVID-19 worldwide.
The results, although intriguing, are not final.
Raymond James analyst Steven Seedhouse said that Gilead has not shown mortality benefit in three benchmark clinical trials, and uses benchmarking to “approximate” a more rigorous conclusion. He called the results confused and said it was unclear whether the company would be able to confirm the results in a new, well-designed and definitive trial. Others have accepted.
“This type of analysis is well below the gold standard of a randomized clinical study and is likely to be misinterpreted as evidence that remdesivir improves survival,” wrote Bloomberg Intelligence analysts Marc Engelsgjerd and Jenna Li, in a note.
The largest set of new data comes from an analysis of 312 critically ill patients receiving remdesivir for five or 10 days. Their results were compared to a separate group of 818 patients with similar characteristics who did not receive the drug intravenously. After two weeks, 74% of patients with remdesivir improved, compared with 59% of those with standard care. They were also less likely to die, with a mortality rate of 7.6% in remdesivir patients, compared to 12.5% for those who did not.
Gilead calculated that the 62% reduction in mortality using a multivariate logistic regression model takes into account factors that affect mortality, such as the patient’s age, race, medical condition or illness at baseline , rather than directly from the mortality rates of the two groups.
“This fits perfectly with the way the data is reported,” said Diana Brainard, Gilead’s senior vice president, HIV and emerging viral infections, in an interview.
The results are roughly consistent with the results of the US National Institute of Allergy and Infectious Diseases remdesivir trial. This study found that 7.1% of patients hospitalized with remdesivir died, less than 11.9% of patients who received a placebo. This result was not statistically significant, which means it could have come from chance, or the study was simply not large enough to give definitive results.
“The good thing about this data is that it is very directive and consistent with the data from other randomized controlled trials,” said Brainard. “They are important because they offer more evidence on the benefits of remdesivir. ”
Brainard said the results of the benchmarking are in the final stages of review in a scientific journal and will be published shortly. “We are very excited to see the full picture expanded.”
There is a drug that has already been shown to improve survival in COVID-19. In June, researchers at the University of Oxford found that deaths among patients who needed respiratory support were lower when they received low-cost steroid dexamethasone. This 60-year treatment is the first to show promising months for saving lives in the pandemic.
The addition of hydroxychloroquine, a generic antimalarial drug, did not increase the benefits of remdesivir and in fact appeared to decrease its potency, a blow to the hope that the combination of drugs could benefit patients more. Of those who received both drugs, 57% recovered, compared to 69% of those who received remdesivir alone, said Gilead. The combination also resulted in more serious side effects.
Gilead is working on simpler ways to administer the experimental treatment so that less severe patients can access it outside of the hospital. The company announced on Thursday that it had launched human trials of an inhaled version of remdesivir. He also plans to study intravenous infusions on an outpatient basis such as nursing homes.
Gilead, based in Foster City, California, recently said that he would charge US hospitals about US $ 3,120 for most patients who need remdesivir. According to Bloomberg Data, the current estimate of the drug’s sales for 2020 is US $ 1.98 billion, while the consensus sales estimate for 2021 is US $ 2.40 billion.