Truvada/Intellence any thoughts on this?

[hereinny]

I am about to start meds.  I have seen 2 doctors who don't think Atripla would be right for me because i work in shifts at my job so taking the med before bed might not work since i have a very irregular sleep schedule.  My doctors suggestion was Truvada/Intellence.   He also said an option would be Truvada/Virimune but said if i were to break through or for some other reason i had to change meds, Truvada/Virimune would make give me a resistance so that i could not use atripla in the future.
The amount of pills is not my biggest issue at this point, I just want to know the boards thoughts on this.

[Miss Philicia]

Yes, that's correct about the Viramune issue that he related, it has a lower barrier to resistance issues and, in fact, that happened to me back in the 90's.  Basically he's trying to build up a first regimen of 1 NNRTI class med with 2 NRTI class meds (Truvada is a 2-in-1 medication).  That's fairly standard, but it need not be the only option.  Many also present a PI based regimen like Reyataz (w/Norvir booster) + Truvada to patients because the Atripla option isn't great for someone with a history of depression.

Intelence is new, having only been FDA approved for a little over a year.  The good thing with it is that if a patient had become resistant to NNRTI's previously Intelence was shown to still work.

You could also consider Isentress + Truvada, which is an integrase inhibitor class med (also new) + Truvada.  I'm on these and have found them to be great with little to no side effects.

I think most doctors will try and pair something with Truvada, as it's seen as the best from the NRTI class as having the least propensity towards any lipo issues.  Same with the others I listed.  The decision then, for you to make, is Intelence or Isentress being new-ish meds with less patient history to go on (though in my opinion by now enough) versus Reyataz which has been FDA approved since 2003.

[Inchlingblue]

I have not started meds yet and based on a lot of research, and echoing Miss Philicia's sage advice, I've come to the conclusion that Isentress and Truvada would be a very good choice. It is not yet approved for first-line treatment but I read that it is expected to be very soon, maybe even by May 2009 (a doctor can still prescribe it for first-line treatment before official FDA approval of such use).

The one minor drawback is that Isentress is to be taken two times a day but on the bright side, there are no indications as far as food, you can take it with food or without food and it doesn't matter, which I like. There are studies going on currently to determine if once daily dosing is possible and it looks like it will be at some point, maybe soon.

Here is a link on how it performed against Sustiva (both taken with Truvada) after 96 weeks:

http://www.aidsmeds.com/articles/hiv_isentress_raltegravir_2211_15051.shtml

The other option you can look into, which would  solve your insurance issues for the time being is to try to get into a clinical trial for Gilead's new Quad pill. You should check out the current threads about this. Although if you do get in, the control group will be given Atripla and there would be a chance that you might be in that group. The clinical trial looking at once daily Isentress dosing might still be open, which is another thing to look into if you wanted (clinicaltrials.gov)


Miss P: I'm curious, how do you divide your Isentress dose, what times do you take it etc? Thanks@!

[Miss Philicia]

Miss P: I'm curious, how do you divide your Isentress dose, what times do you take it etc? Thanks@!

Oh, more or less on a 10am and 10pm schedule.  I tend to eat late and, though as you noted it's not necessary to take Isentress with food, due to my resistance profile due to pre-HAART dual therapy issues in the 90's, I have to take a "super" HAART regimen with the addition of Prezista, which of course a treatment naive individual would not need to do.  So because of the norvir booster I take all of my stuff when I eat.

I've taken 17 different HIV medications since 1993 and of all of them Isentress has been the most trouble free.

btw, is Intelence actually officially approved as a first line treatment, or is still "off label" used as such?  I guess my only thought would be why begin with a medication that would work later on if you became resistant to NNRTI's when you used either Viramune or Sustiva?  Perhaps I'm missing something.

[Inchlingblue]

btw, is Intelence actually officially approved as a first line treatment, or is still "off label" used as such?  I guess my only thought would be why begin with a medication that would work later on if you became resistant to NNRTI's when you used either Viramune or Sustiva?  Perhaps I'm missing something.

Intelence has not been approved for first-line use, it's currently being tested for that. I agree with you that it doesn't make much sense, especially if someone has a sensitive strain of the virus and many options open to them, to start with something like Intelence. Not only because of what you state re: resistance to other NNRTIs and wanting to keep it on the back burner for future use but also because it simply has not been studied enough for first-line use and questions as to what to optimally combine it with etc. are still open.

With Isentress, on the other hand, there's sufficient data supporting it's use specifically with Truvada for first-line use, I wouldn't take Isentress with anything other than Truvada, for example, because there simply isn't enough data to support doing that.

I find it concerning that a doctor would recommend Intelence as an alternative for a Sustiva-based regimen for a treatment-naive patient who has no resistance issues. There are other more proven combos to choose from, apart from Isentress/Tuvada, such as what you mentioned, Rayataz/Norvir/Truvada and even Epzicom/Reyataz/Norvir and others. It makes no sense unless there are resistance issues but hereinny said he has no resistances.

[hereinny]

Can someone tell me what all this means?  lol   I dont know what "first line use" means?

[hereinny]

Ok, i read through these post a little more and here is what i have come up with:  First line treatment i assume means for treatment naive patients?   
For starters, the concern over Atripla for me is that due to my job, my sleep schedule is not consistant, sometimes i sleep in the morning and sometimes at night. I also have periods where i am on call, that means i would have to get out of bed in the middle of the night and go into work and I need to be pretty sharp.  The feeling is Atripla might create some problems in this area.  I would like to know how likely it is that i would have these side effects and how necessary it is to take this at bed time.  My history of depression is not a serious one.  It is VERY under control with 10mg of prozac.  My therapist has said that is such a small dose that it is likely it wouldn't matter if i stopped.
I have concerns about PI's, they seem to have a really bad rap.  I am very concerned about body shape changes as well as running for the toilet all the time.
Some of the recommendations here would be way too many pills, I'm trying to find a doable regimen.

[Ann]

Hi Here,

There's no reason why you couldn't try Reyataz/Norvir/Truvada instead of the Atripla. (and yes, first-line is for treatment naive)

Not all PIs are created equal. The Reyataz/Norvir portion of the combo is well-tolerated by most people with few, if any, reports of major diarrhea problems. Do a forum search on Reyataz and you'll read many testimonies of people who are very, very happy with this combo. It's also a once-daily dosing, just like Atripla, but without the potential neurological issues of the Sustiva component of Atripla.

And as for body changes, according to David Evans, in this post;

"In all the large lipoatrophy studies that have been done, Reyataz and Truvada have been found to fairly neutral in terms of fact loss and accumulation."

Personally, I plan on staying away from Sustiva, mainly because of the possible depression issue. I don't see the point in possibly making myself miserable, even for a few weeks, when there is a combo available that doesn't have this baggage attached.

Ann

[Miss Philicia]

hereinny -- EVERYONE is concerned with body shape changes and running to the toilet, which is why the above recommendations were made in a distinct manner for a treatment naive individual.  Least side effects, easiest implementation.

The easiest to do would be Atripla, which is why it's doled out to every queen.  You said you can't do it, so fine... we moved to the next alternatives.  I agree with what Ann says, which is why I suggested that as an alternative.  The main side effect for a Reyataz based regimen is that some, but not all by any stretch, people get a slightly yellow color for about a 10-14 day duration.  I've not taken this medication myself, but I've seen the yellowing on other people.  Most of the time it's not particularly noticeable, like if it's only a bit in the eyes.  I've seen other people look noticeably different skin wise but again, it last at most 2 weeks and then you're seemingly home free.  As far as HIV meds go that's pretty damn good in my book -- they ALL have potential drawbacks.

I still lean towards the Isentress based regimen for you, for the reasons I laid out above.  The number of pills is quite easy, and the side effect potential even less than Reyataz.  The difference is for you to make the decision of if you're willing to go on a med that has been FDA approved for 17 months, or for 6 years.

[Ann]

Here,

The drug Philicia mentions (Isentress) and the drug I mentioned in my PM (Raltegravir) are the same drug. (Isentress is the brand name, Raltegravir the generic name) Isentress is not yet approved for first-line therapy, although some doctors will prescribe this in what is known as "off label" prescribing. (mine probably won't)

Isentress also involves twice daily dosing, although there are trials underway looking at once-daily dosing. The results aren't in yet.

Ann

[Miss Philicia]

As far as the "off label" factor, I was keeping in mind that this person was offered Intelence, which is even more "off label" I suppose, so I found that a relative non-issue in terms of prescribing practicality.

The treatment naive issue for Isentress is in Phase 3 and as of this report from 2 months ago looks to be fine:

http://www.medicalnewstoday.com/articles/138523.php

[Ann]

Oh poo, I'd forgotten he'd been offered the Intelence. Sorry!

The thing that most interests me as far as Isentress goes is the once-daily dosing study. I hope it's successful as I know for a fact that I have trouble taking any med twice a day (or more) consistently. Once a day is no bother, but twice a day I screw up more often that not. Once-daily is a vital consideration for me.

[Assurbanipal]

Here

Just one other thing -- none of the side effects of the drugs are guaranteed to apply to everyone.  In fact, usually less than half the people taking these drugs get a side effect that continues for any extended period of time (typically a lot less than half).  And even when you have a side effect it is usually a lot easier to deal with than an opportunistic infection. 

So why not just cut a deal with your doctor that you will try out a combo for a month or two? If side effects appear for you on that one and they trouble you, you can move on to see if you are side effect free on something else.

Be well
Assurbanipal

[Inchlingblue]

The link below is an update on Isentress approval for first-line use, it says that Merck expects FDA approval by July 2009, so it's just around the proverbial corner.

http://www.fiercebiotech.com/press-releases/merck-announces-fda-acceptance-supplemental-new-drug-application-isentress-raltegravi

I would take it even if it's twice a day but it would be great if they figured out how to make it once a day and I'm pretty confident that they will, although it seems that will take a bit longer than the FDA first-line approval.

[mecch]

I have been taking this combination a few weeks.  I notice little difference to my other combos (see tag line) physically. Mentally it does seem more neutral than sustiva. 
Note, I have never had a problem swallowing pills, but Intellence pills have a poor design. They are almost pointed and not coated.  A few days a week they stick in my throat. Its annoying.  Always have a bite to eat on hand or take them with some liquid a bit fizzy or slicky (carbonated water or milk for instance). That seems to work better. 
Lets see if this combo can knock me to undetectable and get my % up. I'm waiting and waiting.