Long-Acting Injectable HIV Meds Suit Study Participants Very Well

[POZ Editors]

People with HIV participating in a recent trial of long-acting injectable cabotegravir plus Edurant (rilpivirine) were largely happy about receiving their antiretroviral (ARV) treatment only every four or eight weeks rather than taking daily pills, aidsmap reports. They found this dosing protocol more convenient and felt it allowed for greater privacy. Additionally, by not having to take pills daily they were able to avoid what they felt was a daily reminder of their HIV status .

Publishing their findings in PLOS ONE, researchers conducted a qualitative analysis of 27 participants in the LATTE-2 trial, in which HIV-positive people who were first-timers to ARV treatment were randomized to receive long-acting cabotegravir plus Edurant every four or eight weeks. The researchers also interviewed 12 health care providers for this new analysis.

By and large, the study participants were gay men in their 30s.

Most participants reported side effects; however, these symptoms were largely mild, including soreness and minor bruising at the injection site that cleared up after a day or two. A few experienced fever or impaired mobility. For the most part, the participants considered any side effects a fair trade-off given what they saw as the benefits of receiving their HIV treatment through a periodic injection rather than a daily pill.

Read more...
https://www.poz.com/article/longacting-injectable-hiv-meds-suit-study-participants

[terrymoore]

I would love to have this option. It would make my life much simpler (i think). Travel, food requirements, etc etc.

[Mightysure]

I joined this study.  I took my first dose of oral medicine yesterday. No noticable side effects as of yet. I have been randomized into the 4 week group, not tol thrilled about that but the study coordinator told me that only one person in my location was put into the 8 week cohort.

But the implications of this study will be groundbreaking. Yo get an injection monthly or bi monthly and live your life. No pills, keeping bottles out of sight,  pharmacy headaches, forgetting doses, food requirement will be a tjing of the past, although during this induction phase in which we have to take the meds orally they must be taken with food. 

And this would be the second 2-drug regimen approved by the FDA, if it happens.

How many of you would switch to this if it becomes available?

[Jim Allen]

How many of you would switch to this if it becomes available?

Not me, firstly it would not be practical in the Irish health care system and personally it would not suit my lifestyle or needs. I would stick to a pill a day but if it works in long term studies no denying it could be handy for some people.

Jim

[CaveyUK]

I'm the same. I'd prefer to regulate my own dosage via tablets.

Now, if they had some proven once every six month injection, which could coincide with clinic visits then I may be interested, but that is some distance off.

[leatherman]

How many of you would switch to this if it becomes available?

I used to take 32 pills (arvs) a day. then 28. then 8. then 5 then 3. and now I'm getting ready to drop down to 2. a shot a month? heck, I was already getting a couple b12 shots a month this past Winter. I'd love to get my treatment down to a shot a month. Wo0T!

[kentfrat1783]

Jim,

Why would it not be practical in the Irish healthcare system?  I just don't know anything about the Irish healthcare so not sure why you say that.

Hi All,

To me, the one pill a day isn't that bad but keeping my bottles up when the little kids are around can be fun at times.  I'm a person of habit so when the bottle isn't where I put it to start I get lost. 

If I had the option to do a shot every 3 months I'd give it a try.  Basically set it up when I have a normal doctors appointment.  A shot a month wouldn't be as convenient for me but if it was potentially more cost-effective could be beneficial. 

Then again I only started bottle this week so I'm still a newbie. 

Kenneth

[terrymoore]

i would do it. @Mightysure - may i know where you are located geographically? I wonder if it is available in Bangkok/Thailand/Asia?

[Jim Allen]

Jim,

Why would it not be practical in the Irish healthcare system?  I just don't know anything about the Irish healthcare so not sure why you say that.

Okay long story, but in short the lack of collaborative pharmaceutical care when it comes to HIV and dispensary challenges, limitations, insurance limitations and internal pissing matches between groups within the system over HIV care & medication, I just see adding injectable HIV Meds if it was right now as adding strain.

I know changes was being proposed to simplify things, but its not there yet but don't get me wrong if they could get themselves aligned than I am sure injectable HIV Meds would be great for some people and the more choices people have to suit their needs the better, I am all for that.  Who know what the future holds and prehaps if injectable HIV Meds do become a thing it might even give the players a push to get their act together.

Jim

[Jim Allen]

Just as a side note, not meaning to hijack but for China at least weekly injections of Albuvirtide seems to have been approved

https://forums.poz.com/index.php?topic=64841.msg

[Mightysure]

@Terrymoore. Im in the US, more specifically, North Carolina. Im not sure what your nationality is or if you're familiar with the US government, but healthcare varies from state to state.  Even being in NC, the state with the worst drug assistance program, we still have relatively decent access to treatment.

@Jim. Im still not sure why you don't think injectables would work in Ireland and why it wouldn't fit your lifestyle.  Im not trying to argue, I am just not clear on why you say rhat.

For me, having a reminder every month, but hopefully every 8 weeks, is much better than a daily pill. Statistically, daily dosing leaves more room for "error", so to speak. Things come up, insurance issues, pharmacy supplies, life in general, etc. 12 or 6 doses vs 365.  I'm not seeing the downside and how that would inconvenience anyone more.

[leatherman]

off-topic

Even being in NC, the state with the worst drug assistance program, we still have relatively decent access to treatment.

I keep mentioning this to my DHHS peeps at the quarterly NC Ryan White RQC (Regional Quality Committee). 

living in SC outside CLT (where NC Part A monies are used), I've volunteered with both the SC HIV Planning Council and the NC RQC. As hard to believe as it is, the SC ADAP program is a much more robust program - and a lot easier with consumer navigation of services. Being a NC boy, it troubles me to tell my homestate to follow SC, instead of the other way around. sigh.

back on-topic

12 or 6 doses vs 365

hot damn! 
what a far cry from the AZT days of (4pills X 4hrs X 365days)
5840 pills a year - and you were probably still dying of AIDS anyway. 

as soon as I switch over to this tivicay, I'll still be gulping down 730+ ARVs a year. 

[Jim Allen]

@Jim. Im still not sure why you don't think injectables would work in Ireland and why it wouldn't fit your lifestyle.  Im not trying to argue, I am just not clear on why you say rhat.

Lifestyle okay sure, bit of a first world problem, but why makes thing more difficult for myself than it has to be. So in the current format its mainly just the practical side of things, firstly travelling to Dublin every few weeks is not practical for me or my job because HIV meds/care is only dispensed in hospital clinics, not the pharmacy's or smaller regional hospitals. Its just equals more unpaid days off work. Next to that there are travelling reasons, I travel abroad a fair bit and as long as I can avoid having to travel with shapes i will, as it simply does not make things easier. That is presuming they come up with a self administering version once released and I say that because I am out of the state months at a time so I would have to have a supply i can bring with me.

Next to that there are the personal feelings about this, now each to their own and I respect that everyone here feels and can cope different. I know this sounds soft but I could not cope with having to see the clinc staff every 4-6 weeks again, it would be a huge step back and as I could not cope with it in the past and it did not help my dependency on alcohol I very much doubt i could cope again. I'm sober now and I would not be willing to return to the past.

On top of that a pill a day is a sense of control,  I am in control of my illness, and i choose each day to be in control of my health and HIV. Its not a negative moment or a negative reminder at all when i take my pill.

As for Ireland well a few years ago as in 2014 there was talk of working closer with the GP's for out patient services such so routine CD4/VL blood draws and repeat scripts however that never happened and in the meantime we can't get them to sort out the dispensary of the current medication, and HIV appointments in the places that do dispense them on the 1 day a week, its overbooked meaning they regularly have to turn people away.

Now if someone really needed the meds so nothing left, they give them a weeks worth of pills to bridge the gap to the next weeks clinc day.  Going to be interesting to see how that works with injections that needs dispensing every few weeks, meaning even more visits unless its going to be fully self-administering because there is no bandwidth for the clinics to do it. Now one of the issues or roadblocks is how we treat medication and treat sexual health services in general here and between unions, HSE and insurance and a lack of an integrated system, with each location having its own IT system its become a real pain.

If we could at least change it so that if its self-administering pills or injections the smaller hospitals could take care of the regular blood draws, repeat scripts and visits of people living in their catchment area it would be a lot better. 99% of the time I don't need to see a HIV consultant I just need someone to fill out the script

.... bit of a rant, sorry.

Jim

PS.

between unions, HSE and insurance and a lack of an integrated system

Just to clarify that's not the patient insurance, no its the pharmacists insurance that is the issue not covering having HIV meds on site. 

[Mightysure]

Yes leatherman, it is almost counterintuitive because you expect with the higher taxes and higher population, you would expect NC ADAP to be more accessible, so my jaw dropped when I saw the income threshold of NC and SC. NC you have to essentially be dirt poor to get anything.
I live on the SC border as well and contemplated going to Fort Mill for services.
Its sometimes hard to believe that cities like Chapel Hill, Durham and Greensboro are in such a state as NC.


Wow. The amount of doses you had to take is humbling to say the least. I told the intake nurse that Im not just joining clinical trials for my benefit, but Im also doing it to pay it forward because it is not lost on me that I'm here today not deathly afraid of this illness because the people before me who endured the early treatments,  who joined the clinical trials that culminated in the life saving medications we have today.

I stand on the shoulders of LTS such as yourself and it is not lost on me that there are so many who suffered so that I could be where I am today. 

Sorry that I got all mushy but thank you.

[Mightysure]

I don't think they're anticipating self administering injections, at least not while the drugs are still under patent because there's entirely too much at risk for insurance companies and the suppliers if someone without the proper training does something wrong. And on top of the injections have to be done in the butt, so I don't think self administration  is coming any time soon.

You must be able to at least pick up your meds months at a time, I would assume. We have specialty pharmacies here who are the only ones allowed to dispense HIV meds, so I understand the potential headache in traveling to the location. 

I just see bottles of pills being a bigger issue in travel than infrequent shots. Tablets of the same meds come woth the long acting injections, so if for some reason you're not able to be where the injections are administered, tablets are available, at least in the study. Because there is an induction period to ensure that you don't have bad reactions to them, so cabotegravir will not  only be available in injection form.


But if going clinics is triggering,  I wouldnt want to increase my contact with them either. It also sounds as if the Irish healthcare system has a lot of red tape because there aren't any unions here in NC.

And with the control of daily dosing comes higher risks for mishaps.  I dont see injections as giving up any control one has with their health.  It is a way to get 4 or 8 weeks of treatment in one sitting.

I guess the American health care system, with all its many flaws,  is more conducive to injections.

And FYI from what I was told by the study doc, the 8 week injections will likely come later. Since that is the more experimental arm, the FDA wants more data.

[MarkintheDark]

Like @Mightysure, I'm in the study, now 18 months on the 4-week rotation.  They randomized a group of us here six months ago for either the 4- or 8-week rotation.  My only complaint is the study draws, not the sticks.  Oh, I'm sore for a day or two, but ibuprofin takes care of that.  Results are decent.  My absolutes have never been that high (~150), but there's been a slight increase (>200) that remains steady and I'm undetectable.

In reading the thread, idk that I'd find the injections at a public clinic setting would be preferable to simply picking up a 30-90-day supply of meds.  My sense is this better utilized with a private GP. 

[terrymoore]

Like @Mightysure, I'm in the study, now 18 months on the 4-week rotation.  They randomized a group of us here six months ago for either the 4- or 8-week rotation.  My only complaint is the study draws, not the sticks.  Oh, I'm sore for a day or two, but ibuprofin takes care of that.  Results are decent.  My absolutes have never been that high (~150), but there's been a slight increase (>200) that remains steady and I'm undetectable.

In reading the thread, idk that I'd find the injections at a public clinic setting would be preferable to simply picking up a 30-90-day supply of meds.  My sense is this better utilized with a private GP.

@MarkintheDark - any side affects or strange feeling after the shot besides the sore arm?

[MarkintheDark]

@MarkintheDark - any side affects or strange feeling after the shot besides the sore arm?

Personally, I've found I can feel more fatigued than usual in the subsequent 24-36 hours.  I'm not discounting  that might be somewhat psychogenic.

Shots are given in the butt.  The Rilpivirine shot for some reason is the one that hurts more going in. Solution for me has been to alternate cheeks.

[Mightysure]

@Markinthedark
It's cool to meet someone else in the study and who's been doing it much longer. I was told that only one person was randomized into the 8 week cohort at my location. I'd think they'd want more in that group because that would have a greater impact on HIV treatment.
Anywho, the induction period is rough because Im rarely hungry in the morning when its time to take medicine.
Food requirement was why I stopped Genvoya, but I only have a few more weeks of the oral meds. So I'll deal with it.

My cd4s have stabilized around  1000. The highest was 1592 a month after I started meds, but my percentage was 37, so Im happy about that.

Do they do both injections in the same cheek? I would hope they alternate.  I really wanted to be in the 8 week geoup. My viral reservoir was tested and it is the lowest they ever saw, even lower than these babies that have been "cured" so I was willing to take the risk.

But have you been doing well in it other than soreness?

[MarkintheDark]

Previously, I'd been on Stribild, having started when my absolute was <ugh> 35.  IIRC, that was Pedro Zamora's reported level when he died in '94.   I'm a pre-HAART survivor, so you can imagine what my genotyping looks like.  (I assume the study will have done your genotype, as well).

I stabilized @ ~150.  I've seen an increase with the shots, stabilizing ~200-240.  From my POV, that's incredible.

The issues I have, organ inflammation and early osteoarthritis, are related to my long term status, not the shots.

And, heavens yes, one stick in each cheek.  As I mentioned, the Rilpivirine is the more painful one, so we alternate month-to-month.  Helpful hint:  Lie down for the injections instead of bending over.  Your glutes won't be tensed and it makes a considerable difference.

Of course, PM me if you have questions, too.

[wardp]

Is ripirivine injection compati ble with omeprazole or  does it  need stomach acid etc?

[Ptrk3]

Since it is an injection that would enter your bloodstream without having to be metabolized through stomach lining, I would presume no stomach acid is needed (so it would be compatible with omeprazole).

However, to be certain that there is no interaction with any medication one takes, one should always check with the prescribing healthcare professional or pharmacist when one begins a new medication regimen (now or in the future).

[Mightysure]

@@markinthedark

That's good to hear that your numbers have gone up since starting the injections.  You think it's due to the medicine being put directly into your bloodstream?
They did not do a genotype for me when joining the study. I know they can do genotypes now on UD viral loads now, but I dont think they did. They nor my PCP seem too concerned about it.

I'm glad that you're a pre-HAART survivor. You all went through all you did so that we could be here. It's also great that the meds they're coming out with today are helpful to those with resistance issues.

[MarkintheDark]

To answer a couple questions:

@wardp - The only contraindications of which I'm immediately aware are, yes, antacids, phenobarbitol (for epilepsy), and St. John's wort...and hell, I had to look the rest up. (https://markets.ft.com/data/announce/detail?dockey=1323-13445033-7QE75HUA2MOGD64MJG87VBEDV0)

@Mightysure - thank you and tbh, I never gave the oral vs. bloodstream/intramuscular comparison much thought. I'd be interested to know if you find out anything.  btw, I understand how annoying the fasting is.  It was pretty regular during the first year of the study, but in my second year study it was discontinued after week 4 and is now only every six months.  My particular beef was remembering NOT to pee in the morning so I'd have something in me when I went in. 

Oh, today was my monthly and reminded me of another Helpful Hint:  Alternate butt cheeks from month-to-month b/c the Rilpivirine stick can be painful.  For my study, yeah, doc actually makes a note of it.  Ibuprofin is your friend.  Lord, I feel like the Martha Stuart of Needle Etiquette.

[Cosmicdancer]

I wonder if a monthly or bi-monthly shot would result in lower treatment costs. I mean would it really be $2,500 per injection or something ridiculous like that?

[Mightysure]

@MarkintheDark Thanks for that! I will ask my doc on my next appointment about the injections. My semi educated guess is that injections having 100% bioavailability and not having to go through the digestive filtration process makes it more effective.
I mean there are so many variables in your stomach that could affect how much medicine you get. Stuff you eat, other meds, vitamins, etc...but that's just me being a bio nerd.
But my frustration isnt with the fasting. Thats the easy part.  My issue is the daily food requirement during this induction phase.  A big reason for me switching from Genvoya  to Tivicay + Descovy was so I wouldn't have to take my meds with food. 
Im a bit anxious about these injections if Ibuprofen is being mentioned. Lol. Ive had butt injections before, I hope it's not as bad as I'm anticipating.

@cosmicdancer that's a great question and one I asked the trial doctor.  He thinks that the cost will likely be the same for 4 weeks. He thinks it'll be a while before the 8 week is approved, but that'll be the only way to reduce costs.

[MarkintheDark]

@Mightysure:  If it will ease your mind, injections are made up towards the gluteus medius.  So, too, perhaps being in my 60s makes me more sensitive to sticks.  Oddly, this week's Rilpivirine shot wasn't painful.  I was surprised.

(yes, I know I misspelled Martha Stewart and I've accepted temporary suspension of my Queer Eye license) 

[elf]

Thanks but no thanks.
One pill a day suits me better.

I would consider it an option only if it were a one-year shot.

But, since I only need to  go to my ID clinic once or twice a year,
and they give me a 6 to 12 month supply of medicine,
why bother?

(In the field of psychiatry long-Acting Injectables,  haven't really solved the compliance problem, the compliance remains the same compared to oral options. The newest one is Trevicta, an  every-three-months shot.)

[Mightysure]

@elf

Ok. Whatever works for the individual. I'm not sure how an annual injection of a drug would work, but I only think compliance is just one issue it solves. For travelers, there could be less concern about security check points, lost luggage, and in general, going through mail order pharmacies, first pass metabolism issues, and in the event of natural disasters.

I think compliance in psychotherapy is different.  The issuss the medications are designed to treat are the primary reason there are compliance issues. HIV itself doesn't hinder compliance.