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Author Topic: Lenacapavir capsid inhibitor (GS-6207) - CAPELLA trial  (Read 2920 times)

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Online Jim Allen

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Lenacapavir capsid inhibitor (GS-6207) - CAPELLA trial
« on: February 10, 2021, 10:16:40 pm »
An update and good results from the Lenacapavir Capella trial.

POZ.com full writeup https://www.poz.com/article/lenacapavir-shows-promise-longacting-hiv-treatment-prevention

In Short:
Quote
Lenacapavir, the first HIV capsid inhibitor, led to viral load reductions in 88% of people who had received several prior antiretroviral medications and had multidrug-resistant virus, according to Gilead Sciences.

Researchers are also evaluating lenacapavir as a twice-yearly injectable for HIV pre-exposure prophylaxis (PrEP), which could expand the armamentarium of long-acting prevention options.

The Phase II/III CAPELLA trial included 36 adults with resistance to multiple antiretroviral drug classes who had a detectable viral load on their current treatment regimen. About two thirds of those who received lenacapavir had advanced immune suppression with a CD4 count below 200.

The participants were randomly assigned to add either lenacapavir or a placebo given by subcutaneous injection to their failing regimens for 14 days—that is, lenacapavir was essentially functioning as monotherapy. At that point, all participants were offered open-label lenacapavir plus an optimized background regimen designed to work as well as possible based on resistance testing. They will receive lenacapavir injections every six months as maintenance therapy.

At the end of the two-week period, 88% of those assigned to lenacapavir experienced at least a half-log reduction in viral load, compared with just 17% in the placebo group. Despite the small numbers, the difference was highly statistically significant, meaning it was probably not attributable to chance. What’s more, people in the lenacapavir group saw a significantly greater average change in viral load compared with the placebo group (-1.93 versus -0.29 log).

A previous posting on phase 1 safety testing: Early Trial of Gilead’s HIV Capsid Inhibitor Supports 3-Month https://forums.poz.com/index.php?topic=71933
« Last Edit: February 18, 2022, 02:57:11 pm by Jim Allen »
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Offline MitchMiller

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Re: Lenacapavir capsid inhibitor (GS-6207) - CAPELLA trial
« Reply #1 on: February 17, 2022, 03:16:19 am »
FOSTER CITY, Calif.Gilead Sciences, Inc. (Nasdaq: GILD) today announced new one-year results from the ongoing Phase 2/3 CAPELLA trial evaluating lenacapavir, the company’s investigational, long-acting HIV-1 capsid inhibitor, in heavily treatment-experienced people living with multi-drug resistant HIV. The findings demonstrated that lenacapavir, administered subcutaneously every six months in combination with other antiretrovirals, achieved high rates of virologic suppression and clinically meaningful increases in CD4 counts in people living with HIV whose virus was no longer effectively responding to their current therapy.

https://www.stonkmoon.com/news/GILD/7197c1205c666e64df304145dcd98cdc

Offline Da2020

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Re: Lenacapavir capsid inhibitor (GS-6207) - CAPELLA trial
« Reply #2 on: February 20, 2022, 08:01:37 pm »
I read they also fid some other trails on treatment naive patients with other drugs and found the results to be good. Hoping they can find something to use in combination to lencapavir, so that we can get to twice a year dosing instead of daily pills

Online Jim Allen

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Re: Lenacapavir capsid inhibitor (GS-6207) - CAPELLA trial
« Reply #3 on: May 14, 2022, 04:11:01 pm »
May 12th 2022 - In full: I-base: https://i-base.info/htb/42883
Lenacapavir in MDR HIV: phase 3 results of CAPELLA study published

In Brief:
Quote
Notably, lenacapavir is given by subcutaneous injection every six months, but it still needs to be used in combination with other active drugs. This is likely to include oral dosing, until other long-acting options become available.

Without this support, resistance to lenacapavir can develop easily if viral load remains unsuppressed or if adherence to other drugs in the combination is not high Viral failure was reported in 8/72 participants in CAPELLA, generally early, and with 4/8 linked to low adherence.

Lenacapavir has so far been associated with few side effects, other than injection site reactions which are generally mild; only two participants reported grade 3 events, both of which resolved. None of the serious events reported in seven participants were judged related to lenacapavir.
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Online Jim Allen

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Re: Lenacapavir capsid inhibitor (GS-6207) - CAPELLA trial
« Reply #4 on: May 20, 2022, 03:13:09 am »
The Phase III CAPELLA + CALIBRATE II trial & FDA Lifts Clinical Hold on Long-Acting Lenacapavir

https://www.poz.com/article/fda-lifts-clinical-hold-longacting-lenacapavir

In Brief:

Quote
Clinical Hold

In late December 2021, Gilead announced that the FDA had put a clinical hold on trials of lenacapavir due to concerns about the type of glass vial used for the injectable formulation, which resulted in tiny glass particles in the medication.

This week, Gilead announced that the FDA has lifted the clinical hold on the company’s Investigational New Drug application, allowing trials of injectable lenacapavir for treatment and PrEP to continue.
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Offline Da2020

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Re: Lenacapavir capsid inhibitor (GS-6207) - CAPELLA trial
« Reply #5 on: May 22, 2022, 04:38:15 pm »
Hopefully, it gets approved soon and I am eager to switch to  twice a year injections opposed to daily pills. :)

Online Jim Allen

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Re: Lenacapavir capsid inhibitor (GS-6207) - CAPELLA trial
« Reply #6 on: May 22, 2022, 05:00:54 pm »
Hopefully, it gets approved soon and I am eager to switch to  twice a year injections opposed to daily pills. :)

From what I read and the results, Initial approve and that's a "if" that happens I think will be in combination of daily oral drugs for viral suppression.

If it was just 6 monthly injection and done, then I would also be interested as well but we're not there yet
« Last Edit: May 22, 2022, 05:06:43 pm by Jim Allen »
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Offline Loa111

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Re: Lenacapavir capsid inhibitor (GS-6207) - CAPELLA trial
« Reply #7 on: May 24, 2022, 05:03:00 am »
From what I read and the results, Initial approve and that's a "if" that happens I think will be in combination of daily oral drugs for viral suppression.


So if with the 6 month injection and if daily oral drugs are still required anyway, is the benefit that one is taking less drugs on a daily basis?

Online Jim Allen

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Re: Lenacapavir capsid inhibitor (GS-6207) - CAPELLA trial
« Reply #8 on: May 24, 2022, 05:50:40 am »
Well... The way I look at it is if it works then it's a first and, should there be any additional 6 monthly treatments in the future then prehaps a combination of those could truly provide an alternative to daily pills.

The current benefits that CAPELLA trial phase 3 is looking into is suppressing the VL in those with HIV that has become multidrug-resistant. These injections and an optimized daily meds will hopefully suppress the virus and the results so far are promising.

The Phase II CALIBRATE trial, is looking into 6 monthly injections with the daily combinations for those without resistance.

lenacapavir +  daily alafenamide/emtricitabine
Or;
lenacapavir +  daily bictegravir
Or;
lenacapavir +  daily bictegravir/TAF/emtricitabine
Or;
lenacapavir +  daily TAF

I would be more interested if it was in combination with DTG or 3TC but even then it's not for me, However, hopefully it will provide other people with more treatment options to choose from.

(Sorry for any spelling issues, walking around Kilkenny today and only have this tiny phone with me)
« Last Edit: May 24, 2022, 05:54:47 am by Jim Allen »
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Offline Loa111

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Re: Lenacapavir capsid inhibitor (GS-6207) - CAPELLA trial
« Reply #9 on: May 24, 2022, 08:15:12 am »
Interesting...I'm on a 2 pill combo, so I would be open to the idea if this worked, of just taking of one my daily pills if the 6 monthly injection took care of the rest.

Thanks for the insight Jim & enjoy your walk around Kilkenny.

Online Jim Allen

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Re: Lenacapavir capsid inhibitor (GS-6207) - CAPELLA trial
« Reply #10 on: May 24, 2022, 10:35:10 am »
Thanks.
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