CDiddy, It is a three part issue. Tropism ev
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Posted On: 01/21/2021 11:51:56 AM
CDiddy,
It is a three part issue.
Tropism evaluates whether the strain of HIV with which the patient is infected enters CD4 cells solely through CCD5 or additionally through CXCR4. Blocking the front door is not effective if HIV can enter through the back door.
RO occupancy addresses the percentage off CCR5 receptors blocked by leronlimab or other antagonist. In maraviroc trials, >99% receptor occupancy was required to achieve viral suppression. The same is likely true of leronlimab.
In the combination trial, Cytodyn was assessing whether there was better viral suppression with addition of leronlimab. The FDA likely did not require RO testing, as patients were not left functionally untreated if leronlimab failed.
In monotherapy trial, there is no backstop. If leronlimab failed, the patient would have no other antiviral to prevent unchecked viral replication.
It is a three part issue.
Tropism evaluates whether the strain of HIV with which the patient is infected enters CD4 cells solely through CCD5 or additionally through CXCR4. Blocking the front door is not effective if HIV can enter through the back door.
RO occupancy addresses the percentage off CCR5 receptors blocked by leronlimab or other antagonist. In maraviroc trials, >99% receptor occupancy was required to achieve viral suppression. The same is likely true of leronlimab.
In the combination trial, Cytodyn was assessing whether there was better viral suppression with addition of leronlimab. The FDA likely did not require RO testing, as patients were not left functionally untreated if leronlimab failed.
In monotherapy trial, there is no backstop. If leronlimab failed, the patient would have no other antiviral to prevent unchecked viral replication.
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