Prezista / Norvir -- food and temps advice?

[Assurbanipal]

Swapping out Isentress for Prezista / Norvir today.  I had read such great things about Isentress, but it looks like I'm one of that unlucky few percent that get the bad labs and potential muscle/liver/kidney problems.

So the doc has put me on Prezista / Norvir with some urgency.  Spent yesterday and today reading up on Prezista and I'm pretty hopeful about it in general.  (There's 13 pages of forums posts on Prezista.  Almost all are very positive on Prezista -- only 5 or 6 negative posts.) 

So my questions are less about people's experience with side effects than about the practicalities of taking these new drugs with the least fuss.  Two areas will be new for me with these pills -- food and keeping the Norvir cool.

Food -- I see Prezista needs some food, if not much,  but that Norvir may need greater quantities and some fat.  How much food are we talking about in terms of calories?  Will those 100 calorie snacks, or an 80 calorie applie do?  It's mainly the second dose I'm worried about.. Right now I just put the pills in my pocket and I'm ready to take them whenever the time rolls around and don't even need a glass of water.  It's unobtrusive and I can take it anywhere -- but looks like that will need to change.

So roughly how much food, and does it matter what percent is fat?  (BTW Bonus points for anyone who can point to evidence that dark chocolate is required ... in copious quantities plz  )

Temperature controls -- I see that Norvir needs to be at room temperature (and that the extended supply beyond a month needs to be refrigerated).  My only real concern here is the evening pill.  Will the evening pills be too warm in a pants  pocket all day?  How do you carry them around with you if you are often out and about?

Thanks guys

Assurbanipal  (off to the pharmacy to pick them up)

[Miss Philicia]

1) I've found that a snack is sufficient, though something that is solid.  I wouldn't take it with, say, a helping of yogurt.

2) I'd not keep Norvir in a pants pocket myself, unless it's in a small pill container.  I have a smallish flat pill container for such times, though frankly Miss P is very fond of carrying a man purse.

[Assurbanipal]

2) I'd not keep Norvir in a pants pocket myself, unless it's in a small pill container.  I have a smallish flat pill container for such times, though frankly Miss P is very fond of carrying a man purse.

Gracias Miss P

Perhaps some day I will go on a stunning diet and drop back to my PCP / hospital figure, buy 8 inch heels and a toupee and have the cojones to carry off the man purse.  But in the interim I fear I am too fat, balding and dumpy.

Speaking of ugly  I just opened the Norvir.  I haven't seen anything that repulsive looking in a pill/caplet/tab/whatever before.  I can see why a hard case would be recommended -- it looks like it might explode under any pressure and the results would be foul.  Is this part of the Abbott marketing strategy for stand-alone Norvir?  As a kid growing up in Seattle I remember baby slugs that were prettier.

Ah well ... down the hatch.

A

[jm1953]

Gracias Miss P

Perhaps some day I will go on a stunning diet and drop back to my PCP / hospital figure, buy 8 inch heels and a toupee and have the cojones to carry off the man purse.  But in the interim I fear I am too fat, balding and dumpy.

Speaking of ugly  I just opened the Norvir.  I haven't seen anything that repulsive looking in a pill/caplet/tab/whatever before.  I can see why a hard case would be recommended -- it looks like it might explode under any pressure and the results would be foul.  Is this part of the Abbott marketing strategy for stand-alone Norvir?  As a kid growing up in Seattle I remember baby slugs that were prettier.

Ah well ... down the hatch.

A

I'm on Prezista and Norvir also.  Prezista has been a good switch for me, and shows in my numbers.  And pretty well tolerated.  I just have a banana, crackers, or something like that when I take my dose.  Doesn't have to be anything really heavy I think. 

I think Miss P is right that you not keep your Norvir in your pants pocket.  If your working, perhaps get a small bag for sodas, or smaller, fill it with ice if there is no refrigerator around.  Your dose should be at a refrigerated temperature.

FYI,  I take my pills at 11 am and 11 pm which works well for me.  But I'm retired so it may not be ideal for people working.

Good luck and let me know how it goes,

Jeff

[leatherman]

Is this part of the Abbott marketing strategy for stand-alone Norvir?

many of us taking the norvir gelcap are (still) anxiously awaiting the arrival of Norvir in tablet form
(believe it or not the gelcap is 1million X better the liquid version!)

Norvir doesn't actually have to be keep refrigerated if it will be used within 30 days; but it should be kept at all times above 40f and below 80f. Depending on your climate you may have to refrigerate it portions of the year and/or store it so it doesn't freeze at other times of the year. In a warm moist environment the caps can melt together, and/or the liquid inside can leak out. In too cold of an enivronment, the liquid can develop crystals which render the med ineffective.

Abbott recommends that patients store Norvir capsules in the refrigerator; however, refrigeration is not necessary if the capsules are used within 30 days, protected from light and kept at a temperature less than 77°F.

Inside your pants pocket against your 90+ degree body is not recommended at all. Not only the temperature in your pocket is too high but can you squish the capgel.

If you have nausea with Norvir, you may need to eat more quantity or higher fat content to compensate. (I find by eating half my meal (not a snack but a full meal), taking the gelcap, then eating the rest of my meal is the best way to combat this side-effect.

[ByTheBay]

I have been on Prezista/Norvir for 11 weeks now and have few side effects to report.  I've noticed a reduced sense of smell, but cannot exactly trace that to Norvir.  For the first two weeks I had a metallic taste in my mouth, also reported by users of this combo, but it went away quickly.

I researched the "how much food" question with Prezista and found the in at least one clinical study they were taken with a meal of at least 240 calories.  I normally take mine with dinner at 6pm, which covers that requirement, however, on the times when I have later dinner plans, I take mine with a Cliff Bar.  A single Cliff Bar is 250 calories, can be carried easily in my pocket, and I like the taste.  I also find that I can eat one take my meds, and still be able to eat dinner an hour or so later. There are different flavors, so perhaps you will find one that works for you.

As for keeping Norvir cool: My perscription is only 30 days at a time so I store it at room temp with my other meds. There is a temp stable Norvir on the way, perhaps even this year, which will make taking it easier.  I carry mine in a pill container in my back pack, away from body heat, so cannot comment on keeping them in a pocket.

Good luck and let us know how you respond to this combo -- I think you will really like it and see good results.

[Assurbanipal]

Went off for labs and thought I'd update on this thread.  I appreciate all the advice from folks, especially on how much food is needed.

Have to say I'm finding adherence to this combo MUCH more difficult than prior combos.  I haven't missed a dose yet, but I have a lot of advantages when it comes to adherence right now (not the least of which is middle age  ) and I bet I would have missed a few times if my schedule were as crazy as when I started 3+ years ago.

I think it is the combination of twice a day PLUS not heat stable PLUS requiring food that makes it so much more difficult.  If I could just knock out one of those, it would get much more manageable.  For instance, if it were once a day, I could keep everything in the refrigerator since I'm almost always home for breakfast.  Or if the pills were heat stable, I could just have a pack of pills and a granola bar to take when out somewhere or driving.  (I have been on twice a day all along.) But it has been over a month and it is still a struggle to get it right each week -- and I think the key to adherence is finding a routine that makes it more or less automatic...

It's also given me a new appreciation for the advances in HAART packaging.  I've sort of intellectually known it could be much worse -- I remember a friend in the late 80's who had a pillbox with an alarm that went off every 4 hours -- but I wan't prepared for how much this relatively minor adjustment to the pills would get in the way.  It just makes everything else in life a lot more complicated than it feels like should be the case for such a minor switch.

So I'm impatiently awaiting the heat stable version of Norvir to come out (or even better the non-Norvir booster).  I saw in John's research thread that heat stable Norvir was approved in Europe.  Any idea when it will come out in the US?

[BlueMoon]

. . . Norvir may need . . . some fat.

Assurbanipal, where do you get that from?  I have read it several times in the forums but don't recall ever seeing in the official literature.  Also neither of my ID doctors have mentioned it.  The only clarification and guidance I was given on 'take with food' is that a meal is considered to be 300 calories.  Never any mention of how those calories are to be delivered.

The reason I'm interested is that I take my Reyataz and Norvir with breakfast, which is usually fat-free.  

I think it is the combination of twice a day PLUS not heat stable PLUS requiring food that makes it so much more difficult.

My doctor wanted me to switch the Reyataz for Prezista.  I didn't do it because the strain of preparing a second meal on time every day just seemed too daunting.  Breakfast is bad enough.  It's not much problem during the week when I have to get up for work.  But after two years of it, I'm very tired of getting up at 6 am on weekends.

[Hellraiser]

There is definitely some medication that must be taken with fatty foods otherwise it won't be absorbed into your system.  I didn't think it was Norvir however I could be wrong.  I remember only associating the refrigeration complication with Norvir.

[Assurbanipal]

Assurbanipal, where do you get that from?  I have read it several times in the forums but don't recall ever seeing in the official literature.  Also neither of my ID doctors have mentioned it.  The only clarification and guidance I was given on 'take with food' is that a meal is considered to be 300 calories.  Never any mention of how those calories are to be delivered.

The reason I'm interested is that I take my Reyataz and Norvir with breakfast, which is usually fat-free.  

My doctor wanted me to switch the Reyataz for Prezista.  I didn't do it because the strain of preparing a second meal on time every day just seemed too daunting.  Breakfast is bad enough.  It's not much problem during the week when I have to get up for work.  But after two years of it, I'm very tired of getting up at 6 am on weekends.

I had also seen it in the forums, coming from a usually reliable source (hello Mr. Newt    )   http://forums.poz.com/index.php?topic=24408.msg307783#msg307783

Doubting Thomas that I am, though, I did look for confirmation and the Prezista prescribing info was clear that fat was a component of the meals taken in the study (although it did not come out and say it was required. )

Effects of Food on Oral Absorption
When administered with food, the Cmax and AUC of darunavir, co-administered with ritonavir, is approximately 30% higher relative to the fasting state. Therefore, PREZISTA tablets, co-administered with ritonavir, should always be taken with food. Within the range of meals studied, darunavir exposure is similar. The total caloric content of the various meals evaluated ranged from 240 Kcal (12 gms fat) to 928 Kcal (56 gms fat).    http://www.prezista.com/prezista/documents/us_package_insert.pdf emphasis added

I haven't obsessed over it, just internalized that the fruit should move to lunch and the nuts to dosing times, figuring that there is enough fat in the low-fat milk and the granola at breakfast... (Hmmm, now I'm checking the bottle and box)

Of course the Prezista info may not matter to you if you are using Norvir to boost something else like Reyataz.

I'm with you on the additional adherence challenge in going to 2x daily with food -- as I wrote above, I didn't expect it to be nearly as difficult as it has turned out to be.

As far as the 6 am ..., if you are on once a day could you switch to lunch time?

Good luck
A

[Miss Philicia]

I've been on Prezista now for four years and haven't found this to be an issue.  Methinks you're over worrying about it.

[Assurbanipal]

Well, looks like the adherence obstacles are all getting solved pronto.  New heat stable Norvir approved last week (thanks for the update Miss P), and then a new study at CROI  that says once a day dosing is available for the treatment experienced with only half the Norvir!  http://www.poz.com/articles/HIV_prezista_dosing_761_18025.shtml

Unfortunately my ID doc says my lab numbers are screwed up (lipids, creatinine, calcium).  I still don't have copies of the results, but its off to the nephrologist in a couple of weeks. ..

 Still, if this is transient, should be much easier with once a day heat stable dosing.

[pozniceguy]

I have been on the once a day prezista/norvir combo for two yrs... usualy take it before bed with a "snack"  have been UD all that time with very slow climb in CD 's to slightly over 400    ( started at 2 when DX , 1994)    no obvious issues ,  timing is easy  , seldom vary except when traveling  ( Norvir is OK for 30 days w/o refrig?) then I have a simple pill box with a few days supply all counted out..


Nick

[Miss Philicia]

I'm sure I have some nasty mutation that will prevent me from changing to once daily, but we'll see.  I don't really care though because I still have to take Isentress twice a day.  And I've never understood why people balk at the fridge issue, as it's not really an issue except at the pharmacy for storage.