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Author Topic: Early Trial of Gileadís HIV Capsid Inhibitor Supports 3-Month Dosing  (Read 2656 times)

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Online Jim Allen

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This is an interesting initial trial of this new class of ARV, also its apparently 100x more potent than current ARV's and they are working on an oral formulation.

Poz.com write-up in full: https://www.poz.com/article/early-trial-gileads-hiv-capsid-inhibitor-supports-3month-dosing

In short:

Quote

The antiretroviral GS-6207 is injected under the skin and would need to be combined with other meds to fully suppress HIV.

Gilead Sciencesí investigational capsid inhibitor GS-6207 showed promise in an early study as a new long-acting form of HIV treatment that could be dosed only every three months. The drug proved safe and well tolerated in a small study including HIV-negative participants.

While GS-6207 was administered via subcutaneous (under the skin) injection in the study, Gilead is attempting to develop an oral formulation of the antiretroviral (ARV).

Capsid inhibitors, a new class of ARV, interfere with the breakdown of the capsid, which shelters HIVís genetic material, after the virus enters an immune cell. Medications in this classóGS-6207 is the firstóalso prevent the assembly of the capsid during the production of new viruses after HIV has incorporated its RNA into a cellís genome.
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Offline Loa111

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Re: Early Trial of Gileadís HIV Capsid Inhibitor Supports 3-Month Dosing
« Reply #1 on: March 12, 2019, 09:21:46 am »
So If all went well with this trial & full research process, in years to come, getting this placed under the skin every 3 months could be a treatment option.

Interesting the treatment is 100 times more potent than current ARV's which obviously do a very good job already. I wonder what the benefits of 100 times more potent could be for us?

Online Jim Allen

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Re: Early Trial of Gileadís HIV Capsid Inhibitor Supports 3-Month Dosing
« Reply #2 on: March 12, 2019, 09:40:05 am »
Smaller dosage, anyhow i somehow doubt they will be going down the route of 3 months under the skin initially with this as it still has to be combined with daily pills. (At least that's what I recall reading when I checked)

Maybe more down the line, I would more likely expect this to be tested in pill form combination, than trials of that opening up a new class of ARV. End of the day it hopefully means more combination possibilities and, who knows a new treatment class for people with resistance

We will see, maybe if things go well and fast we might have something in 8-15 years
That's just my thoughts on it of course.
« Last Edit: March 12, 2019, 09:58:48 am by JimDublin »
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Offline Mightysure

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Re: Early Trial of Gileadís HIV Capsid Inhibitor Supports 3-Month Dosing
« Reply #3 on: March 12, 2019, 10:25:10 am »
This is great news! I think the potency may mean lower dosing and maybe low resistance profile, like integrase inhibitors.
I think finding a target such as this is very helpful in that there isn't an analogous function of our cells so there is a much lower chance of side effects.

I could see this being combined with other injectables or being attempted as monotherapy for acute infections.


I dont see it as PrEP though.

Online Jim Allen

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Gileadís HIV Capsid Inhibitor Worked Well in 1st Human Trial
« Reply #4 on: July 24, 2019, 05:35:05 am »
A follow-up to the above posting on Gileadís HIV Capsid Inhibitor

Full write-up
https://www.poz.com/article/gileads-hiv-capsid-inhibitor-worked-1st-human-trial

In Short:
Gileadís HIV Capsid Inhibitor Worked Well in 1st Human Trial

Quote
Findings from the two studies of GS-6207 were presented in a pair of posters at the 10th International AIDS Society Conference on HIV Science in Mexico City (IAS 2019).

In an ongoing Phase Ib trial, 24 people with HIV who had not previously been treated with a capsid inhibitor received one subcutaneous injection of GS-6207. They were randomized into three even groups of six people each to receive a 50 milligram, 150 mg or 450 mg dose of the drug or a placebo.

Ten days after their injection, those who received GS-6207 experienced an average maximum reduction in viral load of 98.4% to 99.3% (1.8 to 2.2 log10). All these reductions were significantly greater than that seen among those who received the placebo.

None of the participants experienced a serious adverse health event or dropped out of the study because of adverse health events. The most common adverse events were mild to moderate reactions at the point of injection, experienced by 63% (15 of 24) of the participants.

In a separate laboratory study, researchers studied the emergence of resistance to GS-6207 in HIV-infected cells when the drug was administered at levels below the threshold considered appropriate for treating the virus. In this context, the drug prompted HIV to develop mutations related to the viral capsid known as L56I, M661, Q67H, K70N, N74D/S and T107N.

Virus that had at least one of these mutations had a diminished response to GS-6207 but had no such reduction in its susceptibility to other classes of ARVs. Such drug resistance was commonly associated with a compromised ability of HIV to infect cells as well as an impaired capacity to replicate within cells.
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