First, we need to establish a differentiation--the WHO is basing their opinion on a mortality benefit, which has not been demonstrated. However, that does not mean there is not a morbidity benefit.
Well, what's the difference? Mortality benefit= fewer people who take the drug die. Morbidity benefit = people who take the drug are incapacitated for a shorter period of time.
While remdesivir has not shown a mortality benefit, the fact that it has been shown to reduce hospitalization length in the ACTT-1 trial is extremely important in a time of limited resources.
Quote:
Originally Posted by Hawker007
That's weird as I have heard it has been working. I personally know someone it definitely helped while they were in the hospital. I just don't get the extreme differences in findings in the medical community around medications.
|
They generally aren't extreme differences, save for some of the hydroxychloroquine trials that came out of France and were touted by people that didn't understand the inherent flaws of those trials (and that most of the data was likely fabricated or edited for effect). What you are generally looking for is an improvement that is outside two standard deviations, meaning that 95% of the time, it's not due to chance. The original study that remdesivir based its EUA and subsequent FDA approval on showed a 33% reduction in length of hospital stay, but not a mortality benefit, and it was demonstrated to
four standard deviations (p<0.001) What that means is that if you would normally stay 15 days in the hospital with COVID, a patient treated with remdesivir would stay for 10. This is extremely important when it comes to resource allocation, as essentially every hospital in this area is on a bed hold and/or some form of diversion.
Quote:
Originally Posted by DaFace
I haven't dug deeply into the studies they used to form their recommendation, but the placebo effect is a very real and well-documented thing. It's possible that that the person you knew would have recovered just as well without it. That's why randomized, controlled trials are so important.
|
WHO is basing their information on SOLIDARITY, which is open-label. I originally hoped it would have been a blinded study, and it was the largest attempt at a multinational study treating several interventions (hydroxychloroquine, lopinavir/ritonavir) but likely due to resource allocation they left it open to ensure that more people received treatment. While this seems compassionate on its face--and people must receive *some* treatment to adhere to ethical standards in trials for diseases that are fatal without treatment (cancer)--it makes their data less robust when performing a clinical analysis.
The Infectious Disease Society of America (IDSA) Guidelines still recommend remdesivir for five days in moderate-severe COVID cases and for ten days in severe disease where patients require ventilation and/or ECMO.