Positive data from the NIAID trial would be a landmark in the race to find a coronavirus treatment, where no drug has yet been proven effective. Other early data for remdesivir, including results from a Chinese trial accidentally leaked by the WHO, has been mixed. The medical journal the Lancet responded to Gilead’s news this morning by rushing to publish the inconclusive results from that Chinese study.
Gilead released its own study results this morning suggesting that severely ill patients receiving five days of remdesivir fared just as well as patients receiving a 10-day dosing regimen. More than half of both dosing groups were discharged from the hospital within two weeks of beginning their medication.
Eight percent of people in the five-day group died while 11 percent in the 10-day group died. But another 10 percent in the longer dosing arm had to discontinue treatment because of serious side effects, and the study lacked a control group.
Gilead said the data also suggests that people who received remdesivir early in their infection seemed to fare better than those that received it later. The study is not a traditional trial with a placebo arm to compare against remdesivir for effectiveness; that is how the NIAID trial whose results are expected soon is designed.
Gilead’s unusual move to announce that the NIAID trial had hit its primary endpoint — speeding patients’ time to recovery — before the agency itself released the results has ruffled some feathers, particularly because the drugmaker’s own trial was so limited.
The promise of “positive” NIAID news was likely made so that Gilead could comply with Securities and Exchange Commission policy preventing it from selectively sharing market-moving data, said Peter Bach, director of Memorial Sloan-Kettering’s Center for Health Policy and Outcomes.
“Piggybacking the severe trial release on [the incoming NIAID study] is the part which is unjustifiable,” Bach said. Calling Gilead’s results positive even though they came from a trial without a control group “has no basis in scientific inquiry,” he added.