Dr. Anthony Fauci praises study in press conference
12:48 pm ET April 29, 2020 (Dow Jones)
By Joseph Walker
Mixed results were reported Wednesday for a Gilead Sciences Inc. drug’s effectiveness against Covid-19, adding to uncertainty whether the closely-watched medicine can help patients desperate for a treatment.
Gilead said Covid-19 patients taking its drug remdesivir had a speedier recovery than patients taking placebo in a large U.S. government-funded study. The company didn’t release detailed data showing the magnitude of the benefit, saying federal researchers would do so later.
Meantime, a separate study in China posted negative results for the drug, though researchers urged more testing, because their trial was stopped early due to problems recruiting subjects as the pandemic slowed there.
Researchers run drug trials to establish whether a drug works safely. The varying outcomes for remdesivir point to the challenges scientists face finding definitive proof while racing to come up with a treatment in the middle of a pandemic.
A spokesman for the National Institute of Allergy and Infectious Diseases, the agency overseeing the study, declined to comment but said it was planning an announcement for later on Wednesday, most likely at President Trump’s coronavirus task-force briefing.
About 1,000 patients were enrolled in the study completed last week, said the doctor leading the study, Andre Kalil of the University of Nebraska Medical Center, in a recent interview. He said an interim analysis would be completed this week or next. The study compared recovery times for hospitalized patients taking remdesivir with patients taking placebos.
The separate study in China showed that remdesivir didn’t have a statistically significant benefit over placebo, researchers said.
The median time to clinical improvement in patients taking remdesivir was 21 days, compared with 23 days for patients taking placebo in the China study, but the difference wasn’t statistically significant, according to a paper published in the Lancet, a medical journal.
The rate of death was similar in both groups, with 14% of the patients taking remdesivir dying compared with 13% of patients in the placebo group. The difference wasn’t statistically significant.
However, some experts said that the Chinese study data were inconclusive because the trial was stopped early due to a lack of patients. Researchers intended to enroll 453 patients, but had only 237 patients enrolled when the study was stopped.
“The study has not shown a statistically significant finding that confirms a remdesivir treatment benefit of at least the minimally clinically important difference, nor has it ruled such a benefit out,” wrote John David Norrie of the Usher Institute’s Edinburgh Clinical Trials Unit, in a commentary accompanying the Lancet paper.
The Lancet paper had been scheduled for publication at 6:30 p.m. New York time on Wednesday, and was shared with the media in advance on Wednesday morning. After Gilead’s announcement, however, the Lancet lifted the embargo so that the media could report on it immediately.
Gilead’s remdesivir, an antiviral drug administered intravenously and previously tested in Ebola, is among the most closely watched experimental treatments for Covid-19, and is being studied in multiple clinical trials around the world. If approved by regulators, the drug would be the first proven to be effective against Covid-19.
The drug is unlikely to prove a panacea against the new coronavirus, and it won’t prevent healthy people from being infected as a vaccine would, doctors and analysts say. As more clinical trial data are released, doctors will be looking for evidence of whether it reduces the risk of death in patients with Covid-19.
Also on Wednesday, Gilead said a separate study it funded showed that Covid-19 patients taking remdesivir for five days had similar results as patients taking a 10-day course of the drug. The study didn’t compare the drug with a control group of patients not taking the drug, making the results difficult to interpret.
The results, while positive, far from definitively demonstrate that remdesivir safely fights Covid-19. The purpose of the study was to compare the two dosing time frames, and see whether a five-day treatment course achieved similar results as a 10-day course. A shorter course would mean more patients could get the drug.
“The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir,” Chief Medical Officer Merdad Parsey said.
The company said it is conducting the study at 180 sites, including in countries with high levels of Covid-19 infection such as China, the U.S. and Italy. The study’s initial phase involved 397 patients, and the company will enroll another 5,600 patients, Gilead said.
Gilead expects data at the end of May from another study assessing the two dosing durations of remdesivir in patients with moderate Covid-19 compared with patients receiving standard treatment.
Remdesivir hasn’t been approved anywhere and has yet to be deemed safe or effective for Covid-19 treatment.
–David Sebastian contributed to this article.
Write to Joseph Walker at email@example.com
(END) Dow Jones Newswires
April 29, 2020 12:48 ET (16:48 GMT)
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