Study On Unboosted Reyataz--Is Norvir Really Needed?

[tednlou2]

http://www.thebody.com/content/confs/icaac2010/art58418.html

[Inchlingblue]

http://www.thebody.com/content/confs/icaac2010/art58418.html

I don't get the point of this study since it looked at whether Norvir is needed when Reyataz is combined with Epzicom. It's already known that Norvir is not needed with Reyataz/Epzicom.

Norvir is needed as a boost with Retataz/Truvada since the Viread in Truvada lowers the levels of Reyataz. There is someone on here taking unboosted Reyataz with Truvada but it's not a common or recommended approach and this study didn't look at that.

[NYCguy]

Has anyone heard of a study of Reyataz booted with Gilead's new 'booter' drug, cobicistat (sure i'm spelling it wrong...)

[Miss Philicia]

Has anyone heard of a study of Reyataz booted with Gilead's new 'booter' drug, cobicistat (sure i'm spelling it wrong...)

I inquired about this with my physician, as he's the director of the largest clinic in Philadelphia, and he already has some patients on cobicistat in a non-quad pill study, though I can't say specifically if it's Reyataz or not -- but the mechanics of this medication are the same so I'd suspect once it's approved it will be used with other regimens as a booster.

However, if you're looking to relieve any GI side effects that Norvir may cause you're going to come away disappointed from what he says.

Oh, found this: http://www.hivandhepatitis.com/2010_conference/croi/docs/0219_2010_c.html

[NYCguy]

Thanks Miss P - that's exactly what I was looking for!  I'm not having any gastro problems from the ritanavir, just that it's always better to lower your exposure to PI's, especially ones with bad lipid profiles, like norvir.  However, the kidney thing makes me a little nervous, since I was already worried about it with Truvada.  Probably best to wait a while, since nothing is 'broken' so to speak.

[Miss Philicia]

Thanks Miss P - that's exactly what I was looking for!  I'm not having any gastro problems from the ritanavir, just that it's always better to lower your exposure to PI's, especially ones with bad lipid profiles, like norvir.  However, the kidney thing makes me a little nervous, since I was already worried about it with Truvada.  Probably best to wait a while, since nothing is 'broken' so to speak.

The booster dose is so small it's not really useful to think of it the same way as when one took Norvir at those old larger doses when it was used as a primary PI.  My lipids have actually gone down on a Norvir booster, but it's relative to when they elevated (slightly, not horribly high) on Kaletra and Saquinavir years ago.

But I will probably give cobicistat a whirl once it's FDA approved just to see if my GI issues lessen.

[Assurbanipal]

The booster dose is so small it's not really useful to think of it the same way as when one took Norvir at those old larger doses when it was used as a primary PI.  My lipids have actually gone down on a Norvir booster, but it's relative to when they elevated (slightly, not horribly high) on Kaletra and Saquinavir years ago.

But I will probably give cobicistat a whirl once it's FDA approved just to see if my GI issues lessen.

The booster dose in one Norvir tab is the same amount of Norvir as in one Kaletra tab -- the usual Kaletra dose is 2 pills twice per day, so at a Norvir booster twice a day I'm at half the Norvir I used to have... and pretty close to about half the lipid problems.  They went away during the brief period without Norvir.


I'm hoping for another booster too.

  However, the kidney thing makes me a little nervous, since I was already worried about it with Truvada.  Probably best to wait a while, since nothing is 'broken' so to speak.

And just to repeat for emphasis -- on the kidney thing -- your doctor should be checking your GFR rate as part of your quarterly blood work.  Kidney problems tend to arise slowly and those due to Truvada are typically reversible if you catch them relatively early.  So.... your doctor should be on it already and you'll likely know before it is a problem.  But do get your vitamin D levels checked -- they are not part of routine bloodwork.

[Miss Philicia]

The booster dose in one Norvir tab is the same amount of Norvir as in one Kaletra tab -- the usual Kaletra dose is 2 pills twice per day, so at a Norvir booster twice a day I'm at half the Norvir I used to have... and pretty close to about half the lipid problems.  They went away during the brief period without Norvir.


I'm hoping for another booster too.

I'm not sure what you're trying to say in relation to my post -- my point was that my source of (slightly) elevated lipds wasn't Norvir, it was the lopinavir part of Kaletra (perhaps I should have more specific).  It shouldn't be a given that Norvir = bad for lipids.

But further, as far the other new booster coming on the market from what I gathered from my physician the pharmacologics/mechanics of it are the same as, or so close to, ritonavir  that he's not convinced and/or is not seeing any differences with these side effect issues with the patients he has in clinical trials.

But hey, there's such an anti-Norvir feeling out there that if Gilead can market this as a "pharmacoenhancer" then they're doing fine.  We'll see though, and I can't say off hand what number of patients he has on this.

Also, from last month:

Ritonavir (Norvir) is the only "booster" approved by the Food and Drug Administration used to increase levels of antiretrovirals, most particularly protease inhibitors. While boosting is indicated in treatment-experienced patients, ritonavir carries side effects which make it intolerable in patients, such as gastrointestinal intolerance and lipid elevations. Cobicistat (GS-9350) is a "pharmacoenhancer" that possesses no antiretroviral activity. It increases drug levels through inhibition of Cytochrome P4503A -- the same mechanism as ritonavir. Phase II trials comparing cobicistat and ritonavir saw similar gains in CD4+ cell counts and decreases in viral load in their respective arms. Side effects were comparable, albeit less frequent, in the cobicistat arm. Phase III trials will commence later this year, comparing cobicistat versus ritonavir with various combinations. One point of concern in the cobicistat arm was a decrease in estimated glomerular filtration rate (GFR), through a false elevation in serum creatinine. Fortunately, this does not occur via the same pathway as most other nephrotoxic drugs. Further investigation is warranted to better understand the mechanism by which this occurs.1

I suppose the key is how "less frequent" is in that qualifier -- if it's just slightly then it's not particularly useful really in my view.

[Assurbanipal]

I'm not sure what you're trying to say in relation to my post -- my point was that my source of (slightly) elevated lipds wasn't Norvir, it was the lopinavir part of Kaletra (perhaps I should have more specific).  It shouldn't be a given that Norvir = bad for lipids.

How would you know the lipid problems were due to the lopinavir part of Kaletra?  Were you on unboosted lopanivir at some point? 

I think Norvir is pretty strongly indicated as a problem with lipids, even at the booster doses.     That's all I was trying to get across.  It will be interesting to see if the new booster is better, as more trials go through.

So... to the OP... not all protease inhibitors have the same effect on cholesterol -- no need to be too concerned about unboosted Reyataz.

[Miss Philicia]

How would you know the lipid problems were due to the lopinavir part of Kaletra?  Were you on unboosted lopanivir at some point? 

Because they went down once I switched from lopinavir to Prezista (still with norvir as a booster) -- am I missing something?  Seems obvious to me.  It's also known that lopinavir raises lipids (as well as norvir).

[NYCguy]

The booster dose is so small it's not really useful to think of it the same way as when one took Norvir at those old larger doses when it was used as a primary PI.  My lipids have actually gone down on a Norvir booster, but it's relative to when they elevated (slightly, not horribly high) on Kaletra and Saquinavir years ago.

Even though it's a small amount (100mg/day boosting Reyataz) I guess I've been indoctrinated in the 'less Norvir is better mentality' and over time it is still a significant amount.  Too bad that cob. has similar GI side effects.

And just to repeat for emphasis -- on the kidney thing -- your doctor should be checking your GFR rate as part of your quarterly blood work.  Kidney problems tend to arise slowly and those due to Truvada are typically reversible if you catch them relatively early.  So.... your doctor should be on it already and you'll likely know before it is a problem.  But do get your vitamin D levels checked -- they are not part of routine bloodwork.

Of course I get all that checked (and I'm taking 4K vit. D/day now)  but one study I read did indicate that Truvada kidney problems may not necessarily be reversible.  It seems like a grey area to me and the fact that Truvada and Cob. both have this issue makes me nervous.  But I still think Gilead is bound to make a bundle, and I believe the quad will be an excellent alternative to Atripla, which considering the side effects, I feel has been way over-marketed to the point that many newbies think they simply can't live without the 'one pill' option and don't even know other options exist.  And doctors keep shoving it down their throats, despite the endless side effects!

For me, I would love to find a no-norvir, no-PI, no-TRUVADA option (and also no NNRTI, which I'm resistant to)  It's do-able, I think, with Selzentry and Isentress, but at this point that would still be a 2x/day deal, unless there have been developments. And that's a deal-breaker for me.

[Assurbanipal]

...
For me, I would love to find a no-norvir, no-PI, no-TRUVADA option (and also no NNRTI, which I'm resistant to)  It's do-able, I think, with Selzentry and Isentress, but at this point that would still be a 2x/day deal, unless there have been developments. And that's a deal-breaker for me.

Just curious as to why 2x/day is a dealbreaker for you?    If you don't have to take them with food and they aren't heat sensitive, 2x daily can be really pretty easy.  You just put the second dose in your pocket when you take the first one...

The convenience factor is about the only thing I miss about Kaletra/Truvada.

[NYCguy]

Just curious as to why 2x/day is a dealbreaker for you?    If you don't have to take them with food and they aren't heat sensitive, 2x daily can be really pretty easy.  You just put the second dose in your pocket when you take the first one...

You are right that not having to take with/without food is a big advantage.  Enough to counter-balance the extra time a day?  Perhaps.  I guess I'm just so used to taking the pills and vitamins with breakfast than not thinking about it again until tomorrow, that having to worry about a second dose seems like it would be a huge pain and asking for trouble in terms of missed doses.