To my knowledge, the RO requirement for combo HIV
Post# of 148183
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Posted On: 01/21/2021 2:36:42 PM
Re: Cassandra X #73646
To my knowledge, the RO requirement for combo HIV BLA has not been fully addressed publicly which is why the questions continue to be asked.
I am not sure if you misunderstood my response or I am misunderstanding yours, but I was addressing RO as it pertains to the combo HIV trial and impacts on the BLA status. You seem to be discussing RO in COVID. IMO these are two completely separate discussions as leronlimab has a direct impact on R5 tropic HIV by not allowing it to enter the cell, whereas CCR5 has in indirect innate immune response in COVID. I could be wrong, but I view RO less critical in COVID simply due to if 80% RO, then the patient's innate immune response likely improves some degree and allow them to recover (granted the closer to 100% and faster the better), but in HIV 80% RO likely results in a failed result given the virus is likely at a detectable level. Everyone's CCR5 density is different, so a 350mg dose works for some HIV patients while others had detectible levels of HIV at 700mg dose. The RO test would simply best identify what CCR5 densities would respond to what dose level based on the individual's CCR5 density (personalized, precision medicine).
I think we agree on the reasons for trials, but the RO was never part of the combo or mono HIV trial protocol, so that is why so many are concerned and confused when it is mentioned as a reason for the combo HIV BLA delay. If a RO extension trial is needed, then by all means do one, but IMO it should be done as a label expansion trial vs holding up the initial combo HIV BLA and approval that met its PE over two years ago and is much safer and had twice the efficacy as the current drugs approved for MDR2+ patients.
But to circle back around, do we know whether RO is required for combo HIV BLA or not......To my knowledge, the RO requirement for combo HIV BLA has not been fully addressed publicly which is why the questions continue to be asked.
I am not sure if you misunderstood my response or I am misunderstanding yours, but I was addressing RO as it pertains to the combo HIV trial and impacts on the BLA status. You seem to be discussing RO in COVID. IMO these are two completely separate discussions as leronlimab has a direct impact on R5 tropic HIV by not allowing it to enter the cell, whereas CCR5 has in indirect innate immune response in COVID. I could be wrong, but I view RO less critical in COVID simply due to if 80% RO, then the patient's innate immune response likely improves some degree and allow them to recover (granted the closer to 100% and faster the better), but in HIV 80% RO likely results in a failed result given the virus is likely at a detectable level. Everyone's CCR5 density is different, so a 350mg dose works for some HIV patients while others had detectible levels of HIV at 700mg dose. The RO test would simply best identify what CCR5 densities would respond to what dose level based on the individual's CCR5 density (personalized, precision medicine).
I think we agree on the reasons for trials, but the RO was never part of the combo or mono HIV trial protocol, so that is why so many are concerned and confused when it is mentioned as a reason for the combo HIV BLA delay. If a RO extension trial is needed, then by all means do one, but IMO it should be done as a label expansion trial vs holding up the initial combo HIV BLA and approval that met its PE over two years ago and is much safer and had twice the efficacy as the current drugs approved for MDR2+ patients.
But to circle back around, do we know whether RO is required for combo HIV BLA or not......To my knowledge, the RO requirement for combo HIV BLA has not been fully addressed publicly which is why the questions continue to be asked.
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