The National Institute of Health (NIH) have released results of a Gilead remdesivir clinical trial.
A previous SMC Roundup on this same study in part can be seen here
Prof Babak Javid, Principal Investigator, Tsinghua University School of Medicine, Beijing, and Consultant in Infectious Diseases at Cambridge University Hospitals, said:
“The full data on this study looking at the efficacy of remdesivir in patients severely ill with Covid-19 aren’t yet available. However, the safety monitoring committee of this trial recommended cessation due to overwhelming evidence of benefit of remdesivir vs. placebo (‘dummy treatment’) for the primary endpoint of the study, which showed that patients receiving remdesivir, on average, recovered in 11 days compared with 15 days for those getting the placebo drug. This was a high-quality study in which neither the patients nor their doctors knew who was receiving the drug or the placebo. The study also examined benefit of remdesivir in saving lives. There was also a benefit here: 8% of the group receiving remdesivir died compared with 11.6% receiving the placebo. However, this difference did not meet the usual cut-off of ‘statistical significance’.
“Remdesivir is an investigational anti-viral drug that was initially developed for other infections, e.g. Ebola. Although it did show some benefit for treatment of Ebola, other treatments (an antibody cocktail) were shown to be superior, so it was never taken further at that time. It works by targeting an essential enzyme of the virus, needed for it to replicate its genetic material. This enzyme is not present in human cells, making the drug relatively safe. It is not yet licensed as a medicine anywhere in the world.
“These data are promising, and given that we have no proven treatments yet for Covid, it may well lead to fast-track approval of remdesivir for treatment of Covid. However, it also shows that remdesivir is not a magic bullet in this context: the overall benefit in survival was 30%. It would be interesting to see if there were differences according to underlying health conditions or other variables. Furthermore, given what we know about Covid – that viral replication is maximal early in the disease process – it may well be (but I should stress, completely unknown at this point) that remdesivir may have even greater benefits if given to patients earlier. Since it needs to be given via the vein, this isn’t entirely practical, so selecting the optimal patient population that will most likely benefit the most from remdesivir may still need to be evaluated.”
Dr Jonathan Stoye, Group Leader, Retrovirus-Host Interactions Laboratory, The Francis Crick Institute, said:
“This is a highly promising early study showing an acceleration in recovery and small reduction in mortality for patients with advanced Covid-19 disease following remdesivir treatment. Although it has too soon to call remdesivir a magic bullet, further trials are clearly warranted. It is to be hoped that the drug manufacturer, Gilead Sciences, will be able to meet the likely demand for testing.”
Prof Derek Hill, Professor of Medical Imaging, University College London (UCL), said:
“A carefully controlled clinical trial has now announced promising preliminary results for a treatment for COVID-19. Unlike many reports of effective treatments, this is a report from a carefully controlled randomized trial comparing the drug to a placebo, so the results are much more reliable than more observational studies.
“Remdesivir is not a cure for COVID-19, but it does appear to speed up recovery on average from 15 days to 11 days. This finding is statistically significant. There is some evidence remdesivir might also reduce the death rate (technically improve survival), but in this study that finding did not reach the required level to be treated as statistically significant.
“So these are promising preliminary results. In normal times this drug would still be many months or years away from being approved for use on patients. But given these extraordinary circumstances, medicine regulators may decide to provide special fast approval in the near future, provided that there are ongoing controlled studies of its safety and efficacy.”
Prof Peter Horby, Professor of Emerging Infectious Diseases and Global Health, University of Oxford, and Chair of NERVTAG, said:
“The four days shorter time to clinical improvement in COVID patients receiving remdesivir reported by Dr Fauci from the NIAID trial is similar to the five days difference we saw in our trial in Chinese patients treated within 10 days of illness onset. This suggest that this is a real effect and that remdesivir can help patients with COVID-19. We need to see the full results, but if confirmed this would be a fantastic result and great news for the fight against COVID-19. Our trial and the NIAID trial are quite similar in design and a joint-analysis of the combined data will provide even greater certainly over the effectiveness of remdesivir. The next steps are to get the full data out and work on equitable access to remdesivir.”
Source: UK SMC
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