Drug trials:
Gilead Science’s remdesivir shows promise as a treatment in two lab studies.
Gilead Sciences’ experimental coronavirus drug, remdesivir, has shown promising results in two key trials, boosting hopes of an effective treatment after published results from another study in China proved disappointing.
Dr. Anthony Fauci, the federal government’s top infectiousdisease expert, said Wednesday that remdesivir has shown it can shorten the time COVID19 patients take to recover by a few days, citing early results from a major trial sponsored by the organization he leads, the National Institute of Allergy and Infectious Diseases. He called it “quite good news.”
Fauci said in remarks at the White House that data from the international trial involving more than 1,000 hospitalized patients has found that the antiviral drug has “a clearcut, significant positive effect in diminishing the time to recovery.” His comments came after the Foster City drugmaker said that it was “aware of positive data emerging” from the federal remdesivir study that had “met its primary endpoint.”
The median recovery time was 11 days for patients who received remdesivir compared with 15 days for those who did not, according to the institute. While it’s not a “knockout hundred percent,” Fauci called the emerging results “a very important proof of concept.”
“What it has proven is that a drug can block this virus,” Fauci said, while emphasizing that the data still need to be analyzed further. President Trump said it was “a very positive event,” according to a White House pool report.
The federal trial’s preliminary results have also indicated improved survival chances for patients who receive remdesivir, with a mortality rate of 8% for the group that took the drug compared to 11.6% for the placebo group, according to a statement from Fauci’s institute. The New York Times reported that the U.S. Food and Drug Administration plans to announce an emergencyuse authorization for remdesivir. The drug is currently available on a patientbypatient basis under the FDA’s compassionate use program; a designation for emergency use would broaden access.
Dr. Peter ChinHong, a UCSF infectiousdisease specialist involved in the trial, said remdesivir doesn’t appear to cause a lot of side effects and seems to be broadly well tolerated by patients. He does not think it will be the only treatment needed for COVID19.
“This is just the beginning of investigations,” ChinHong said. “The other part of the picture is treating the inflammation and organ injury. I think that’s going to be the next phase in the studies.”
Additionally, Gilead said one of its own clinical trials showed that patients who received remdesivir within 10 days of their symptoms starting fared better than those who got the drug later. That study of 397 patients with severe cases of COVID19 also found that those who received remdesivir over 10 days of treatment had similar improvement compared with those who received the drug over five days.
Those results were “intriguing,” ChinHong said, because they suggest that doctors might be able to treat many more people with the same stock of remdesivir.
Gilead shares closed Wednesday up 5.7% at $83.14. The broader stock market rallied on the drugmaker’s reports as well.
Originally developed as a treatment for Ebola, remdesivir has emerged as a leading candidate to treat COVID19 patients, hopefully by getting in the way of how the new coronavirus replicates.
But the drug’s results have not been uniformly positive: a
Remdesivir “clearcut, significant has a positive effect in diminishing the time to recovery.”
Dr. Anthony Fauci
clinical trial in China found that it did not speed up the recovery of patients infected by the virus. Results from that study, which was terminated early because it did not enroll enough patients, were published Wednesday in the journal the Lancet, though a summary had previously leaked.
The China study of 237 patients found that the median time for those who received remdesivir to show clinical improvement was 21 days, compared with 23 days in a control group — a difference that researchers said was statistically insignificant. Gilead said when the results were leaked that the data still suggested a possible benefit.
Gilead’s latest remdesivir research involved a randomized trial of patients with severe cases of COVID19. By day 14 of the study, 62% of patients who were treated early were able to be sent home from the hospital, compared with 42% of patients who were treated later, Gilead said.
Dr. Aruna Subramanian of the Stanford University School of Medicine, one of the lead investigators in the Gilead study, was encouraged by the data’s indication that patients treated for fewer days improved similarly as those on longer treatments.
“While additional data are still needed, these results help to bring a clearer understanding of how treatment with remdesivir may be optimized, if proven safe and effective,” Subramanian said in a statement released by Gilead.
The company said its drug was “generally welltolerated” in the fiveday and 10day treatment groups. Some patients experienced nausea and some still suffered from acute respiratory failure, while 3% stopped taking remdesivir because of “elevated liver tests,” according to Gilead.
The company recently added an expansion phase to the study and plans to enroll 5,600 more patients, including people on ventilators. The study is being conducted at 180 sites in various countries, including the United States.
“It’s kind of a great psychological development to ... talk about an antivirus drug for a virus rather than talking about worm drugs or malaria drugs or disinfectant,” said ChinHong, the UCSF physician.
Another Gilead trial will evaluate remdesivir’s safety and efficacy in fiveday and 10day doses given to coronavirus patients with moderate symptoms. The company expects results from the first 600 patients in late May.