Promising results phase 2 - Once Weekly Pill for HIV treatment.

[Jim Allen]

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:

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.

[leatherman]

well, I could get on board with this regimen.

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.

(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!

[Jim Allen]

well, I could get on board with this regimen.

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.

[leatherman]

once-a-week pill

take it monday morning and tell HIV to f@ck off the rest of the week. sweet!

[Tonny2]

                 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

[Matts]

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

[Jim Allen]

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

[kentfrat1783]

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

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.

[Loa111]

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).

[Jim Allen]

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.

[leatherman]

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.