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Jul 10, 2020

Gilead says Remdesivir linked to a reduction in mortality risk

COVID-19 vaccine could come by November: Healthcare equity strategist

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Gilead Sciences Inc.’s remdesivir may help severely ill COVID-19 patients survive the deadly infection, according to a comparison of the company’s clinical-trial results to a real-world group of people battling the disease.

Patients getting remdesivir as part of Gilead’s pivotal study, known as SIMPLE-Severe, were 62 per cent less likely to die within 14 days than a group that wasn’t part of the trial, the company said in a statement. The data were being presented at the International AIDS Society’s Virtual COVID-19 Conference.

There hasn’t yet been enough information to show definitively that remdesivir improves survival. A comparison of two groups that aren’t part of the same study isn’t considered conclusive, but the findings offer some insight into the benefits of the only drug to receive clearance from regulatory authorities worldwide to help fight the coronavirus.

Additional data from Gilead showed patients who belong to hard-hit racial and ethnic groups reap similar benefits, with signs that Black and Hispanic patients may do even better. A review of the company’s compassionate-use program found no unexpected complications for children, pregnant women or new mothers, most of whom recovered from the infection.

“This comparative analysis provides valuable additional information regarding the benefit of remdesivir compared with standard of care alone,” said Susan Olender, an infectious disease doctor at Columbia University Irving Medical Center, in Gilead’s statement. “While not as vigorous as a randomized controlled trial, this analysis importantly draws from a real-world setting and serves as an important adjunct to clinical trial data.”

Remdesivir was granted an emergency use authorization in May in the U.S. after early data showed it help hospitalized patients recover about four days faster. So far, the coronavirus pandemic has infected more than 12.3 million people and killed 555,000.

Gilead shares gained 2.1 per cent to US$76.28 at 1:54 p.m. on Friday in New York. This year, the stock has risen 17 per cent, largely powered by hopes that remdesivir will become a widely adopted drug for treating COVID-19 around the world.

Not Definitive

The findings, while intriguing, aren’t definitive.

Raymond James analyst Steven Seedhouse said Gilead has failed to demonstrate a mortality benefit in three gold-standard clinical trials, and is using the comparative analysis to “approximate” a more rigorous finding. He called the results confusing and said it’s unclear whether the company will be able to confirm the results in a new, properly designed and definitive trial. Others agreed.

“This type of analysis falls well short of the gold standard of a randomized clinical study, and is likely to be misinterpreted as proof that remdesivir improves survival,” Bloomberg Intelligence analysts Marc Engelsgjerd and Jenna Li wrote in a note.

The largest set of new data came from an analysis of 312 severely ill patients getting remdesivir for five or 10 days. Their results were compared to a separate group of 818 patients with similar characteristics who didn’t get the intravenous drug. After two weeks, 74 per cent of remdesivir patients were improving, compared with 59 per cent of those given standard care. They were also less likely to die, with a death rate of 7.6 per cent in remdesivir patients, compared with 12.5 per cent for those who didn’t get it.

Gilead calculated the 62 per cent reduction in mortality using a multivariate logistics regression model takes into account factors that impact mortality, such as age, race, medical conditions or how sick the patient was at baseline, rather than directly from the death rates of the two groups.

“It’s completely consistent with how the data are reported,” said Diana Brainard, Gilead’s senior vice president of HIV and emerging viral infections, in an interview.

The results are roughly in-line with the findings from the U.S. National Institute of Allergy and Infectious Diseases trial of remdesivir. That study found 7.1 per cent of hospitalized patients on remdesivir died, fewer than the 11.9 per cent of patients given a placebo. That result wasn’t statistically significant, which means it could have stemmed from chance, or the study simply wasn’t large enough to yield definitive results.

“What’s nice about these data is they’re very directionality consistent with data from other randomized controlled trials,” Brainard said. “They’re important because they’re offering more evidence about the benefit of remdesivir.”

Brainard said the results of the comparative analysis are in the final stages of review at a scientific journal, and will be published imminently. “We’re very looking forward to having the full picture fleshed out.”

Evolving Treatment

There is one medicine that has already been shown to improve survival in COVID-19. In June, University of Oxford researchers found that deaths among patients who needed breathing assistance were lower when they received the low-cost steroid dexamethasone. The 60-year-old treatment is the first to show life-saving promise months into the pandemic.

The addition of the generic malaria drug hydroxychloroquine didn’t boost the benefit of remdesivir and in fact seemed to lessen its potency, a blow for hopes that combining medicines may further benefit patients. Among those who got both drugs, 57 per cent recovered, compared with 69 per cent of those given remdesivir alone, Gilead said. The combination also led to more serious side effects.

Gilead is working on easier ways to administer the experimental treatment so that less severe patients can access it outside the hospital setting. On Thursday, the company announced it had launched human trials of an inhaled version of remdesivir. It’s also planning to study intravenous infusions in outpatient settings like nursing homes.

Foster City, California-based Gilead recently said it would charge U.S. hospitals roughly US$3,120 for most patients who need remdesivir. The drug’s current sales estimate for 2020 is US$1.98 billion, while the consensus sales estimate for 2021 is US$2.40 billion, according to Bloomberg Data.