Expert om remdesivir. Inte blockbuster.
Luciana Borio, MD
@llborio
·
5h
THREAD: 1. There has been a lot of back and forth on the conduct of the #Remdesivir study for #COVID19 conducted by the @NIH
and several academic centers across the U.S., Europe and Asia. I thought I would share my assessment.
Luciana Borio, MD
@llborio
·
5h
2. The amount of suspicion is understandable given the rapid growth of ill-conceived clinical studies and regulatory actions that have occurred recently.
Luciana Borio, MD
@llborio
·
5h
3. The @NIH
#
Remdesivir study is not industry-sponsored. It was
led by NIH & several academic partners. The investigators involved have a stellar record of scientific integrity & tremendous depth of experience in conducting & analyzing clinical trials & their ensuing data.
Luciana Borio, MD
@llborio
·
5h
4. People are frustrated b/c they received topline results without study details. That is to be expected during a public health emergency. I’m sure everyone is working as fast as possible to produce a clear manuscript with all of the data, but it still takes time...
Luciana Borio, MD
@llborio
·
5h
5....It wouldn’t be right to wait to share this type of information when so many patients stand to benefit. In a pandemic, every day matters.
Luciana Borio, MD
@llborio
·
5h
6. Everyone wants the perfect study & they want it fast. The only way to do that in a pandemic is to be flexible. I’m not talking about pandemic exceptionalism, as some have advocated. We still need to adhere to the highest scientific and ethical standards.
Luciana Borio, MD
@llborio
·
5h
7. We must realize that moving quickly means moving with some degree of uncertainty. Little was known about the natural course of #covid19 when the trial was designed & launched. Adapting endpoints in the face of new information is perfectly acceptable...
Luciana Borio, MD
@llborio
·
5h
8....as long as the investigators were not aware of the data – in this case, they were still blinded to the outcomes. Again, the endpoint change was was made without knowledge of data from the trial & before interim data was available to the DSMB.
Luciana Borio, MD
@llborio
·
5h
9.
The findings are clinical meaningful. Shortened duration of illness for patients with advanced disease is clinically meaningful. The endpoint matters to patients.
Luciana Borio, MD
@llborio
·
5h
10. What this is not: Some have compared #Remdesivir to Tamiflu. This isn't like Tamiflu, which shortens duration of illness in patients with uncomplicated flu if given v. early after disease onset.#Remdesivir shortens duration of illness by 4 days in pts with advanced disease!
Luciana Borio, MD
@llborio
11. What this is not: #Remdesivir is not a blockbuster.
It will likely be superseded by more effective drugs under evaluation. But until then, it adds benefit to our patients when added to a backbone of meticulous supportive care. And they deserve it.
https://twitter.com/llborio/status/1256728914568843265