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Author Topic: Islatravir (ISL) + lenacapavir (LEN) Promising results - Once Weekly Pill  (Read 7428 times)

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Offline Jim Allen

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Promising results. Will be interesting to see if these results hold up in a phase 3 study with far more participants.

POZ.com article in full: https://www.poz.com/article/first-onceweekly-oral-treatment-keeps-hiv-suppressed

In Brief:

Quote
A once-weekly oral regimen of the approved HIV capsid inhibitor lenacapavir and the experimental antiretroviral islatravir can keep the virus suppressed as well as daily pills, according to study results presented this week at the Conference on Retroviruses and Opportunistic Infections (CROI 2024) in Denver.

A Phase II clinical trial showed that more than 90% of people who switched to weekly islatravir and lenacapavir pills maintained an undetectable viral load, matching the viral suppression rate of those who stayed on daily Biktarvy (bictegravir/tenofovir alafenamide/emtricitabine). If data continue to look promising, this could become the longest-acting regimen that doesn’t involve injections.

This open-label Phase II study (NCT05052996) enrolled 104 adults with viral suppression (less than 50 copies) on daily Biktarvy, no history of virological failure, a CD4 count of at least 350 and a total lymphocyte count of at least 900.

The study participants were randomly assigned to either stay on Biktarvy once daily or switch to 2 mg islatravir and 300 mg lenacapavir pills once weekly. Islatravir plus lenacapavir was “both efficacious and well tolerated” at 24 weeks

Only one person (1.9%) in the islatravir plus lenacapavir group had a viral load above 50 at 24 weeks, and he went on to achieve viral suppression at 30 weeks. No one in the Biktarvy group had a detectable viral load at 24 weeks. The rate of viral suppression was exactly the same in the two groups (94.2%) after accounting for people with missing data. Follow-up will continue through 48 weeks.

Islatravir has had a rocky road to get to this point. Because doravirine is not suitable for longer-acting treatment, Merck paired islatravir with its experimental NNRTI MK-8507 in a once-weekly regimen, and Merck and Gilead started a study of once-weekly islatravir plus lenacapavir in 2021. Later that year, however, the Food and Drug Administration (FDA) placed a clinical hold on islatravir after HIV-positive participants in treatment trials experienced a decline in CD4 T-cell counts and HIV-negative volunteers in pre-exposure prophylaxis (PrEP) studies saw a drop in total lymphocyte counts.
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Offline leatherman

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well, I could get on board with this regimen. :D

While injections don't bother me, the cost of Cabenuva is too high for me - the costs of driving 100 miles to-and-from the doctor's office every other month and the cost of having an appointment for a medical professional to inject the medication.

Four doses a month sounds like a dream after one regimen all those years ago had 32 pills and 8 tablespoons of liquid meds every day.

Quote
(FDA) placed a clinical hold on islatravir after HIV-positive participants in treatment trials experienced a decline in CD4 T-cell counts and HIV-negative volunteers in pre-exposure prophylaxis (PrEP) studies saw a drop in total lymphocyte counts.
oops and ow!
leatherman (aka Michael)

We were standing all alone
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Acting like a mover shaker
Dancing to Madonna then you kissed me
And I think about it all the time
- Darren Hayes, "Chained to You"

Offline Jim Allen

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well, I could get on board with this regimen. :D

While injections don't bother me, the cost of Cabenuva is too high for me - the costs of driving 100 miles to-and-from the doctor's office every other month and the cost of having an appointment for a medical professional to inject the medication.

Four doses a month sounds like a dream after one regimen all those years ago had 32 pills and 8 tablespoons of liquid meds every day.

Yeah, same here. If the follow-up studies yield similar results, a once-a-week pill is something I would seriously consider.
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Offline leatherman

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once-a-week pill
take it monday morning and tell HIV to f@ck off the rest of the week. sweet!
leatherman (aka Michael)

We were standing all alone
You were leaning in to speak to me
Acting like a mover shaker
Dancing to Madonna then you kissed me
And I think about it all the time
- Darren Hayes, "Chained to You"

Offline Tonny2

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                 ojo.            It sounds good although it wouldn’t be for me 😞 even if i were to use cabenuca, accorsing to my doc, i still would be taken pills by mouth due to my resistance history 😢 but after 29 years of taking lots of meds i can’t complain, I’m still alive and, if to keep me alive the treatment were to  swallow stones, i would do it. Life is good even living in pain, legally blind and hiv. Just a thought…hugs



PS. The only thing that bothers me it’s and I don’t drive anymore and I had to depend on people to drive me around but I’m glad that I had good family and friends to do it with the complaining

Offline Matts

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I think that this Once-a-week-pill of Lenacapavir/Islatravir will be an option for me in the future. There were a bit more side effects than in Biktarvy. Some patients had nausea and dry mouth.
Lets see what the phase 3 will bring up.
https://www.aidsmap.com/news/mar-2024/islatravir-plus-lenacapavir-could-be-first-once-weekly-oral-hiv-treatment

According to the post of Tonny2: Am I right in thinking that a standard pill like Biktarvy + 2 injections a year of Sunlenca (Lenacapavir) is an option for heavily treatment experienced with resistance and mutation issues?
Thank You :)
« Last Edit: March 09, 2024, 05:26:12 am by Matts »
Dovato

Offline Jim Allen

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I think that this Once-a-week-pill of Lenacapavir/Islatravir will be an option for me in the future. There were a bit more side effects than in Biktarvy. Some patients had nausea and dry mouth.
Lets see what the phase 3 will bring up.
https://www.aidsmap.com/news/mar-2024/islatravir-plus-lenacapavir-could-be-first-once-weekly-oral-hiv-treatment

According to the post of Tonny2: Am I right in thinking that a standard pill like Biktarvy + 2 injections a year of Sunlenca (Lenacapavir) is an option for heavily treatment experienced with resistance and mutation issues?
Thank You :)

Yeah, with multidrug resistance, treatment options nowadays include optimized daily ART with six monthly injection of Lenacapavir.

https://www.poz.com/drug/sunlenca

https://forums.poz.com/index.php?topic=75017
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Offline kentfrat1783

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Once-a-week I could get used too and I think would be a good alternative.

Quote
While injections don't bother me, the cost of Cabenuva is too high for me - the costs of driving 100 miles to-and-from the doctor's office every other month and the cost of having an appointment for a medical professional to inject the medication.

Like Leatherman said, for many of us, the drive and extra cost of going to the doctors office every two months isn't cost effecitve. 

It will be interesting to see the results from the thrid phase of the trial and see what happens. 

But with anything good their are always some of us that won't be able to take the alternative, but still it's progress in the right direction.

Date - CD4 - Percent - VL
2024
06/26 - 372 - 24% - 33
02/20 - 336 - 24% - 42
2023
08/23 - 366 - 26%
06/20 - 349 - 21% - UD
04/15 - 229 - 19% - <20
2022
11/14 - 486 - 24% - 73
10/12 - 316 - 19% - <20
06/20 - 292 - 21% - <20
01/25 - 321 - 22% - <20
2021
09/22 - 278 - 19% - <20
02/02 - 225 - 19% - <20
2022
06/08 - 257 - 20% - <20
03/17 - 285 - 19% - 101 (2.00)
2019
12/17 - 290 - 20% - <20
09/17 - 218 - 16%
06/18 - 173 - 16% - <20
03/13 - 170 - 16% - <20
January 2019 - Started Triumeq
2018
12/05 - 174 - 18% - <20
08/28 - 166 - 15% - <20
05/08 - 106 - 11% - <20
03/05 - 90 - 10% - <20
2017
12/11 - 60 -   8%
09/07 - 42 -   6% - 54 (1.70)
May 2017 - Started Atripla
05/11 - 2 - 1% - 169,969 (5.23)
OI's: PCP
Dx`d May 11, 2017
Location: US

Offline Loa111

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I really like the idea of this once a week pill, sounds amazing.

So how long does Phase 3 trials last and if it the results are successful, approximately  how long before this could become available? (Obviously, it takes a long timeframe for new drugs to be approved over here in Ireland).


Offline Jim Allen

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approximately  how long before this could become available? (Obviously, it takes a long timeframe for new drugs to be approved over here in Ireland).

No exact answer but I see it as 3-4 years if they start working on it today and if all goes well and that's a big "if".
Phase three 48-96 weeks. Add time for approvals, setup & recruitment time of a year and finally time to publish findings. Then comes the approval process, pretty quick in the EU.

As for Ireland the question isn't drug approval but costs. Ireland has plenty of approved or gray area drugs but that doesn't mean the HSE will supply them or that you can buy them here.

« Last Edit: March 11, 2024, 06:15:09 am by Jim Allen »
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Offline leatherman

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the question isn't drug approval but costs.
that's probably an issue everywhere. Medicare/Medicaid and most insurance companies take some time to put new (higher priced) meds on their formularies - especially when they are currently other (lower priced) meds available with more researched successful patient results.
leatherman (aka Michael)

We were standing all alone
You were leaning in to speak to me
Acting like a mover shaker
Dancing to Madonna then you kissed me
And I think about it all the time
- Darren Hayes, "Chained to You"

Offline Jim Allen

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Re: Islatravir (ISL) + lenacapavir (LEN) Promising results - Once Weekly Pill
« Reply #11 on: October 25, 2024, 02:32:54 am »
October 23, 2024, By Liz Highleyman Weekly Oral HIV Treatment Continues to Look Promising https://www.poz.com/article/weekly-oral-hiv-treatment-continues-look-promising

In Brief:

Quote
A weekly oral regimen of Gilead Sciences’ HIV capsid inhibitor lenacapavir and Merck’s experimental antiretroviral islatravir kept the virus suppressed as well as daily pills for a year, according to study results presented at IDWeek 2024 in Los Angeles.

At IDWeek, Colson presented follow-up data showing that the weekly combination remains effective at 48 weeks. The viral suppression rate was still 94.2%, and no one who switched to lenacapavir and islatravir had a viral load of 50 or higher at this time point. The viral suppression rate in the Biktarvy group was 92.3%.

As of 48 weeks, 19.2% of participants in the lenacapavir plus islatravir group and 5.8% in the Biktarvy group experienced treatment-related adverse events, all mild to moderate. The most common adverse events in the lenacapavir plus islatravir group were dry mouth and nausea (both 3.8%).

A fixed-dose combination pill containing the two drugs is now being tested in the Phase III ISLEND-1 (NCT06630286) and ISLEND-2 (NCT06630299) trials.

https://clinicaltrials.gov/study/NCT06630286

https://clinicaltrials.gov/study/NCT06630299
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Offline Loa111

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Re: Islatravir (ISL) + lenacapavir (LEN) Promising results - Once Weekly Pill
« Reply #12 on: October 29, 2024, 07:05:17 am »
This is nice new to hear. I always keep a very cautious optimism about new treatments that are in trial.  However, it would be amazing if this treatment made it across the finish line.

If it is still in Phase II, from what I read, does this mean it could be another 5 - 7 years for Phase III to finish? Assuming the treatment successfully gets through Phase III.  Then maybe a few more years to get to the market in ones specific country? So this could be a 10+ years wait?

I'd be very happy to have the last couple of decades of my remaining life on a once a week pill. :)




Offline Jim Allen

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Re: Islatravir (ISL) + lenacapavir (LEN) Promising results - Once Weekly Pill
« Reply #13 on: October 29, 2024, 07:52:46 am »
Phase 3:

Primary Completion (Estimated)
2026-06

Study Completion (Estimated)
2030-08
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Offline Jim Allen

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Re: Islatravir (ISL) + lenacapavir (LEN) Promising results - Once Weekly Pill
« Reply #14 on: November 20, 2024, 03:44:54 am »
The 48-week results were also shared at Glasgow 2024.

https://i-base.info/htb/49326

Simon Collins, HIV i-Base

Glasgow 2024 included 48-week results from a randomised placebo-controlled phase 2 switch study comparing once-weekly islatravir plus lenacapavir (ISL+LEN) to a control group who continued on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF).

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