The world need more hiv drugs with —high genetic

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trding trding #9507
396
The world need more hiv drugs with
—high genetic barrier to virus resistance
—longer half-life to avoid the resistance that can develop with non-adhere sometimes in just 48 hours
—less toxic side-effects

Since Pro 140 was created in early 2000s, 200k-300k AIDS related deaths just in US.

How many lives would have been saved using leronlimab?

I like the idea of using a 2000mg loading dose of leronlimab. Just to point out an observations with IZ vs leronlimab.

1) One study, Ibalizumab used a 2000 mg loading dose on day 7 for their primary endpoint measured day 14 (Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV https://clinicaltrials.gov/ct2/show/NCT02475629 Proportion of patients achieving a >/= 0.5 log10 decrease from Day 7/Baseline Viral Load) It is really amazing the results with Pro 140 350mg given the long half-life, just one dose is basically 38% of full strength steady state but still good results with one hand tied behind the back, but a loading dose (or two doses first week) might be another option versus four week overlap with mono. Or at least it points out the difference between the two studies in unmet need group, could you imagine what a 2000mg loading dose for leronlimab would have done here?



They talked about possible loading dose in the results of the Pro 140 SQ 2008 trial, https://clinicaltrials.gov/ct2/show/NCT00642707

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2856743/

"Since trough concentrations increased following repeat SC dosing, a loading dose potentially could be used to increase the initial rate of virologic suppression. Faster initial viral decay rates have been correlated with improved long-term virologic outcomes (20;21). Following an initial loading dose, potent virologic suppression and steady-state trough concentrations of PRO 140 might be attainable with SC maintenance doses similar to those examined here."

FDA do your job!

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