Juluca--the First Single Tablet two-drug Regimine

[Mightysure]

So, I've only seen one post related to this, so I wanted to get peoples input for my own curiosity and for anyone thinking about starting or switching to this.

It's a single tablet containing dolutegravir (Tivicay) and rilpivirine (Edurant). Dolutegravir is a tiny peach-colored miracle if you ask me, but I don't know of many people taking rilpivirine. For those on Complera or Odefsey, what's it like? What are the side effects?  Also, for those taking either component of Juluca now, would you consider switching to not only take fewer pills but lower costs?

The only thing I know about rilpivirine is that it is being studied along with a new integrate inhibitor for the monthly injections. It has one of the longest half lives if any HIV drug (38 hours), I can definitely see the appeal.

So what do you guys think? Is this progress or just another money grab from big pharma? 

[bmancanfly]

I think it's a great advancement in treatment.  I'm surprised it hasn't gotten more attention hear.  I think the future of treatment will contain fewer drugs, dosed less often. This is a good start.

Any regimen that can eliminate NRTI's (and the possible long term sides effects like mitochondria damage) is a big improvement in treatment.  Up until now NRTI's have been the backbone of HIV treatment and largely unavoidable.  This may change that.  Less drugs are always better in my book - so long as you can fully suppress your VL.

Unfortunately, I can't tolerate Tivicay so it's not an option for me.  Otherwise I'd give it a try.

[daveR]

I take Rilpivirine and have no problems with it. They tested my heart function before I started and a month later to make sure I did not have Long QT Syndrome and that was it. I think it is a popular drug due to it cheap price compared to some others. Only real issue is the food intake requirement. Even then everybody has to eat.

I think it is a good step forward.

[Mightysure]

@daveR that's interesting. Can it affect your heart rhythm or something? I know a lot of drugs can affect it if you have an arhythmia, like some anti depressants. But cool. It doesn't sound as bad as other NNRTI, like the main drug in Atripla.

@bmancanfly I agree. I think it's great and I'm kinda disappointed it hadn't gotten more mainstream attention, but on the other hand I think it's a testament to how treatment has advanced so much that most of is are living normal lives and we're not suffering like those in the 80s.

However I had hoped we would get to one drug sooner, but when the Tivicay trials failed, I was disappointed, but we learned stuff we didn't know before, so that's good I guess.

If you don't mind me asking, why can't you tolerate Tivicay? Is it side effects or does it not work as far as fighting the virus?


I'm curious about this drug bc I'm thinking about joining the injection trial. I'm determined to join at least one clinical trial. I've been turned down so many times I'm starting to question my life. Lmao

[daveR]

@daveR that's interesting. Can it affect your heart rhythm or something? I know a lot of drugs can affect it if you have an arhythmia, like some anti depressants. But cool. It doesn't sound as bad as other NNRTI, like the main drug in Atripla.

It was found to affect the heart rhythm in doses of 75 mg or more. The standard dose per Edurant tablet is 25 mg so well below the threshhold but they check to make sure you have no abnormalities before you start it. I am not sure the dosage of this new combo but would assume 25 mg again. I am curious how they control the dosage strength in the long lasting injections they are working on. They must be fairly sure of the slow release mechanism. It is the same as most meds, interactions exist and other medication that can affect the heart QT rate need to be taken with care. I came across antibiotics a while back for a sinus infection which had to be avoided.

I think it has less side effects than the Atripla drugs in respect to the nervous system.

[Jim Allen]

Hi

Well considering it was only approved in early November as maintenance therapy so somewhat limiting the audience (Not for newbies), and its not yet added to guidelines like DHHS added to insurances or even reached everyone's shelves yet as an option, I am personally not really surprised we have not seen many posters use it. With time the number will increase https://www.poz.com/drug/juluca

Few things to note is the dosage seems to be 50 mg of dolutegravir and 25 mg of rilpivirine. Neither drug is new at this stage with dolutegravir being the newest of the two of course and both have been well studied, and the studies of the two together showed it worked and was well tolerated.

Here is the most complete package info i could spot so far with some good information, of course the study results are available on this combo and separably there is plenty of information on both drugs

https://aidsinfo.nih.gov/drugs/588/juluca/202/professional

As I would expected at least it reads a lot like the Tivicay one, so some people might have headaches, hypersensitivity is one to watch for and things like if you have pre-existing depressive disorders this would not be a first choice

I am interested but I do not think its not a huge unknown or rather plenty is known already.

Personally I will stick with Triumeq, one really big one for me is I can take it without food, this helps manage/reduce the headaches/dreams problems I experience from the dolutegravir (Tivicay) component. Many don't have this issue of course, but Juluca has a take with meal requirement and I am not sure I could go back to taking dolutegravir (Tivicay) with food.

Jim

[Mightysure]

I knew I forgot something. @bmancanfly I wasn't aware of mitochondria damage of nucleotide  transcriptase inhibitors. They seem to be the backbone of the majority of regimines so I'm a bit surprised at that.

[bmancanfly]

If you don't mind me asking, why can't you tolerate Tivicay? Is it side effects or does it not work as far as fighting the virus?

I acquired my virus before many of the current drugs were available, so no resistance issues. Unfortunately, I'm in the minority group that has CNS/insomnia issues with the Tivicay component.  It's a good drug for many (including my partner) but not so much for me personally.

[bmancanfly]

I knew I forgot something. @bmancanfly I wasn't aware of mitochondria damage of nucleotide  transcriptase inhibitors. They seem to be the backbone of the majority of regimines so I'm a bit surprised at that.

If you google NRTI and mitochondria you'll find quite a bit of info on it.  It's been a concern that's been out there for a very long time.  But there really wasn't much you could do about it since, as you say, NRTI's have been the backbone of treatment since the very beginning of haart. 

Understandably, most people concern themselves with the initial side effects of HIV meds - which are diminishing with the introduction of newer meds.  But with very effective treatment we are going to be taking these meds (potentially) for decades. I think I'm more concerned (at this point in my treatment) with the very long term side effects.  To be clear, I don't think there is any reason to go running off like chicken little out of concern about this issue.  But it is something that is in the back of my mind and I would feel better knowing I eliminated that drug class (and potential risk) from my treatment regimen.

Any proven method that can reduce total drug exposure, without risking viral escape,  is a plus I think.

There have been anecdotal accounts here over the years of people who were having fatigue issues that resolved when they stopped taking NRTI's.  Again, totally anecdotal.  But combined with what we know about mitochondria and NRTI's effect on them, it makes one wonder.

I still take NRTI's because there hasn't been a viable option yet for me to eliminate them.  But I will eliminate them when I can.

[Jim Allen]

If you google NRTI and mitochondria you'll find quite a bit of info on it.

Come on, do provide references for health/medical/scientific information. Google it has never been sufficient.

My view is indeed there is a level of this as can be seen with certain HIV drugs that cause peripheral neuropathy as a quick example (Mostly older versions of the meds, older dosages) it is "thought" to be because they can damage to mitochondria. That said rare complications and the outcomes in patients/effects are monitored as it's the seen back in things like neuropathy & liver as example and the last one is checked.

Any proven method that can reduce total drug exposure, without risking viral escape,  is a plus I think

Totally agree and hopefully with time it will also make the options and treatments cheaper, however I suspect that will be a good while off at first.

Jim

https://www.poz.com/basics/hiv-basics/peripheral-neuropathy

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5702650/

[harleymc]

I've been on Complera for years with a switch to Odefsey scheduled in a couple of weeks when my Complera supply runs out.

I've found the rilpivirine component is not a big issue for me, we have to eat, so I just have mine with breakfast. Having it with (home based) breakfast avoids that awkward thing of making sure I'm carrying medications around for lunch or dinner it also means I have two chances at a catch up dose, it I miss breakfast.

Rilpivirine has a lot of potential medication interactions, but I just remind my doctors at prescription time and do a double check with my pharmacist. Easy.


As for me I don't think this combo will be for me I have extensive exposure to both Rilpivirine and to integrase inhibitors (Raltegravir).  But it does sound like a ripper of a combination for those who are still sensitive to these drugs.

[phenethylamine]

Any word when this will get approved in Canada?
I am really to eager to try it....75mg Juluca vs 950mg in Triumeq.
Dose reduction of 875mg!!!

[awakening]

Changes in dosing guidelines for Juluca.
https://www.empr.com/news/juluca-dolutegrair-rilpivirine-separate-dose-calcium-iron-supplements/article/738611/

[Mightysure]

I've been on Complera for years with a switch to Odefsey scheduled in a couple of weeks when my Complera supply runs out.

I've found the rilpivirine component is not a big issue for me, we have to eat, so I just have mine with breakfast. Having it with (home based) breakfast avoids that awkward thing of making sure I'm carrying medications around for lunch or dinner it also means I have two chances at a catch up dose, it I miss breakfast.

Rilpivirine has a lot of potential medication interactions, but I just remind my doctors at prescription time and do a double check with my pharmacist. Easy.


As for me I don't think this combo will be for me I have extensive exposure to both Rilpivirine and to integrase inhibitors (Raltegravir).  But it does sound like a ripper of a combination for those who are still sensitive to these drugs.

Are you saying that you don't respond to these drugs? TIVICAY has a great cross resistance profile. It's been shown to work in those who have integrase resistance.

[etaoinshrdlu]

Few things to note is the dosage seems to be 50 mg of dolutegravir and 25 mg of rilpivirine. Neither drug is new at this stage with dolutegravir being the newest of the two of course and both have been well studied, and the studies of the two together showed it worked and was well tolerated.

As I mentioned in another thread, I'm switching tomorrow from Truimeq to Juluca. I'm curious about your statement here, that its components aren't new. According to https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/21/58/fda-approved-hiv-medicines, they are the newest oral drugs on the market. Rilpiverine was approved in May 2011 and dolutegravir in August 2013. I ditched PIs some time ago and I'll be happy to ditch NRTIs finally, too.

[Jim Allen]

Newest is not new. As I said neither drug is "new" so if you say 2011 that means its going into its 7th year in real world treatment and on top of that approval + trail and study time before that.

Now lets say they never develop a new drug after this are you always going to class it as "new" even in 7 more years or 70 years time?

[etaoinshrdlu]

Well, can't argue with that, I guess. It will definitely not be new seven decades from now!