Fascinating Take Cassandra X, Thank you.
The trial they propose won't be easy. They have their work cut out for them, but, they have at the top of command, the doctor who already has the necessary prior experience with the drug, the know how to get the NON-ambiguous result being sought for and the Truth Team of Scientific Advisory Experts, Scott Hansen, Jonah Sacha, MD as well as those at OHSU to ensure that this trial delivers the desired outcome.
"It is unfortunately a much more difficult endpoint to assess than simply following an HIV viral load but it is kind of in the wheelhouse of what we're believing leronlimab is capable of."
The fact that Lalezari says that "We know it's safe in that group." points to the fact that the FDA has accepted our aggregated data and considers it valid and that points to leronlimab's inherent safety.
PLWH People Living With HIV is a massive group, just to get a handle on the size, it is big. Like you're saying, there is NO THERAPY, so the indication is big.
I'll comment on this sentence of yours: "What he is saying in this last sentence is there is no therapy for the inflammation that results from an activated immune system that is not going back to homeostasis."
In HIV, the chronic inflammation which arises is not a result of an overactive immune state. Rather, the majority of immune cells, CD4 & CD8 are continuously devoted to warding off diseases because they do not develop in sufficient number to fully eliminate the offender. It is an immunocompromised state. So by taking ART for so long, the patient is in a chronically immunocompromised state. In full blown AIDS, it results because there is no immune state. In full blown AIDS, there are minimal CD4 & CD8 cells to even attempt mounting an immune response. Certainly, in diseases like Auto Immune dysfunction, an over active immune state does occur and in that example, inflammation increases. HIV though has reduced immune functionality, yet, because of that, other diseases creep in over time and lead to inflammation but, because of no defense against the development of those processes that take advantage of the immunocompromised state of PLWH.
"So a vaccine, a cold, a herpes outbreak, clinical or subclinical, any sort of illness can turn the virus back on." He says, "blipping occurs with any immune activation event" and that is very bad because the person becomes infectious again."
Those viral, bacterial, fungal, parasitic, whatever, etc. cause the immune system to engage the offender, leaving minimal defense against the lingering HIV within the body thereby giving HIV a chance to increase viral load until the distracting disease is overcome.
You've said this so well: "Inflammation shows that immune system components are not present and in place or are being depleted because they are actively dealing with some infectious agents. AIDS doesn't kill you - a deficient immune system kills you. AIDS means you will have Chronic Immune Activation Inflammation that will result in clots, strokes, heart attacks, liver and kidney failure, gut diseases, etc.
CD4+ and CD8+ cells are especially important to restore to homeostasis. HIV directly destroys CD4+ cells through the CCR5 receptor and CD8+ cells are depleted to exhaustion by RANTES. They work together in a certain ratio/balance. Restoring that balance is one of the most important things that LL does. I don't think inflammation can be stopped without that balance."
Inflammation occurs as a result of the immune system components being either continuously depleted (as in the case of HIV/AIDS) or continuously consumed in fighting off other targets or unnecessary targets (AutoImmune Disease).
Really you should say: HIV means you will have Chronic Immune Activation Inflammation that will result in clots, strokes, heart attacks, liver and kidney failure, gut diseases, etc. Because in AIDS, there is no immune system to even activate so disease may flourish, but in HIV, with ART, the CD4 & CD8 count are restored to livable levels and so the patient is allowed to develop some immune system, but not so sufficient to ward off all the diseases that non-immunocomprosed individuals are capable of. So they are the susceptible patients of Chronic Immune Activation Inflammation as their compromised immune systems will be chronically activated towards fighting disease indefinitely.
Superb, Thank you for your post.
The trial they propose won't be easy. They have their work cut out for them, but, they have at the top of command, the doctor who already has the necessary prior experience with the drug, the know how to get the NON-ambiguous result being sought for and the Truth Team of Scientific Advisory Experts, Scott Hansen, Jonah Sacha, MD as well as those at OHSU to ensure that this trial delivers the desired outcome.
"It is unfortunately a much more difficult endpoint to assess than simply following an HIV viral load but it is kind of in the wheelhouse of what we're believing leronlimab is capable of."
The fact that Lalezari says that "We know it's safe in that group." points to the fact that the FDA has accepted our aggregated data and considers it valid and that points to leronlimab's inherent safety.
PLWH People Living With HIV is a massive group, just to get a handle on the size, it is big. Like you're saying, there is NO THERAPY, so the indication is big.
I'll comment on this sentence of yours: "What he is saying in this last sentence is there is no therapy for the inflammation that results from an activated immune system that is not going back to homeostasis."
In HIV, the chronic inflammation which arises is not a result of an overactive immune state. Rather, the majority of immune cells, CD4 & CD8 are continuously devoted to warding off diseases because they do not develop in sufficient number to fully eliminate the offender. It is an immunocompromised state. So by taking ART for so long, the patient is in a chronically immunocompromised state. In full blown AIDS, it results because there is no immune state. In full blown AIDS, there are minimal CD4 & CD8 cells to even attempt mounting an immune response. Certainly, in diseases like Auto Immune dysfunction, an over active immune state does occur and in that example, inflammation increases. HIV though has reduced immune functionality, yet, because of that, other diseases creep in over time and lead to inflammation but, because of no defense against the development of those processes that take advantage of the immunocompromised state of PLWH.
"So a vaccine, a cold, a herpes outbreak, clinical or subclinical, any sort of illness can turn the virus back on." He says, "blipping occurs with any immune activation event" and that is very bad because the person becomes infectious again."
Those viral, bacterial, fungal, parasitic, whatever, etc. cause the immune system to engage the offender, leaving minimal defense against the lingering HIV within the body thereby giving HIV a chance to increase viral load until the distracting disease is overcome.
You've said this so well: "Inflammation shows that immune system components are not present and in place or are being depleted because they are actively dealing with some infectious agents. AIDS doesn't kill you - a deficient immune system kills you. AIDS means you will have Chronic Immune Activation Inflammation that will result in clots, strokes, heart attacks, liver and kidney failure, gut diseases, etc.
CD4+ and CD8+ cells are especially important to restore to homeostasis. HIV directly destroys CD4+ cells through the CCR5 receptor and CD8+ cells are depleted to exhaustion by RANTES. They work together in a certain ratio/balance. Restoring that balance is one of the most important things that LL does. I don't think inflammation can be stopped without that balance."
Inflammation occurs as a result of the immune system components being either continuously depleted (as in the case of HIV/AIDS) or continuously consumed in fighting off other targets or unnecessary targets (AutoImmune Disease).
Really you should say: HIV means you will have Chronic Immune Activation Inflammation that will result in clots, strokes, heart attacks, liver and kidney failure, gut diseases, etc. Because in AIDS, there is no immune system to even activate so disease may flourish, but in HIV, with ART, the CD4 & CD8 count are restored to livable levels and so the patient is allowed to develop some immune system, but not so sufficient to ward off all the diseases that non-immunocomprosed individuals are capable of. So they are the susceptible patients of Chronic Immune Activation Inflammation as their compromised immune systems will be chronically activated towards fighting disease indefinitely.
Superb, Thank you for your post.
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