In this episode, I’ll discuss the recent reports by the NIH and Gilead on the efficacy of remdesivir.
Back in episode 486 when discussing medications with in vitro but otherwise unproven efficacy against COVID-19, I mentioned that efficacy data for remdesivir was expected in April 2020. The NIH met that deadline by 1 day with their recent press release. The data safety and monitoring board of the NIH’s adaptive trial of potential COVID-19 therapies found that remdesivir had a positive result. Full study details have yet to be published but the NIH says that:
Preliminary results indicate that patients who received remdesivir had a 31% faster time to recovery than those who received placebo (p<0.001). Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group (p=0.059).
Strengthening this data, Gilead also gave a preliminary report on April 29, 2020 of results of their Phase 3 SIMPLE trial in patients with severe COVID-19 disease, which found that 5 days of treatment with remdesivir appeared to have the same effect as 10 days.
This information by Gilead is a manufacturer funded study that has yet to be published but they reported:
In this study, the time to clinical improvement for 50 percent of patients was 10 days in the 5-day treatment group and 11 days in the 10-day treatment group. More than half of patients in both treatment groups were discharged from the hospital by Day 14 (5-day: 60.0%, n=120/200 vs.10-day: 52.3% n=103/197; p=0.14). At Day 14, 64.5 percent (n=129/200) of patients in the 5-day treatment group and 53.8 percent (n=106/197) of patients in the 10-day treatment group achieved clinical recovery.
In an exploratory analysis, patients in the study who received remdesivir within 10 days of symptom onset had improved outcomes compared with those treated after more than 10 days of symptoms. Pooling data across treatment arms, by Day 14, 62 percent of patients treated early were able to be discharged from the hospital, compared with 49 percent of patients who were treated late.
Media reports are that the FDA will follow this information with an emergency use authorization for remdesivir to treat COVID-19 but as of this writing, nothing has been published by the FDA yet.
This preliminary data is strikingly similar to that of oseltamivir – a reduction in time to recovery, 5 days of treatment is adequate, earlier treatment may be associated with better outcomes, and mortality benefits are not quite at the level of statistical significance. Hopefully the full data for remdesivir will be available in a peer-reviewed format soon.
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