Reyataz+Norvir+Truvada withOUT food, strange effects

[Forever England]

I've been on this combo for a few months and have been quite happy with the comparatively modest side effects. I've taken it with my evening meal at 7pm. Sometimes I've eaten 30 minutes earlier and on one or two occassions an hour later (eg when I've been on a plane and had no option but to wait until food was available).

My doctor feels I should be undetectable by now, yet I'm still hovering above (between 50 and 150 copies/ul after a year on treatment). After exhausting other avenues (I don't smoke, drink, do drugs and I adhere 100%) he suggested trying withOUT food, so I switched to 5pm late last week.

Since then I've noticed an odd feeling about an hour after dosing. I lose focus and energy, get light-headed, feel odd and tingly in my face and hands, slightly shaky and queasy/uneasy in the pit of my stomach. It's not identical to the stoned sensation I experienced when my combo included Sustiva and it isn't debilitating, it's more flu-like. It is slightly unpleasant though.

Has anyone else experienced this? I was happier when I switched to this combo after Atripla precisely because of the better side-effect profile. Which component in the treatment is this likely cause of these effects and could dosing on an empty stomach be a contributing factor?

The doctor suggests it may be necessary to investigate other treatments if I continue to hover above undetectable as, although he feels I'm generally doing well, he wants to get me below. To me this seems arbitrary - the difference is a dozen or so copies either way and the only reason to use "undetectable" as a reference is that it's the lowest level to which current tests are able to measure.

Has anyone had similar experience or knowledge of this?

Thanks.

[newt]

I have several comments.

1. The suggestion without food is odd, since Reyataz needs an acid environment to be absorbed, and food creates this, plus is better absorbed with food according to studies, plus Norvir needs some fat really to get absorbed and tenofovir, one of the drugs in Truvada, is better absorbed with food.

2. A fair number of people need 400mg Reyataz rather than 300mg, and perhaps 200mg Norvir booster for this combo (see point 6 before looking at a higher dose).

3. Is it the latest Roche viral load test they are using? This is not so good, it's too accurate/flaky. There's not much difference between 40, 50 and 60 or 72 copies on viral load. Under 100 is probably "undetectable". However, over 100 consistently, yes I agree, this is not good enough. Forthcoming BHIVA guidelines on routine monitoring (late, very late in arriving...) will probably suggest the target is a consistently low viral load, and each clinic must decide what this means based on the type of viral load tests they choose to use (really clear eh, but accurate).

4. Lightheaded, yes, I get this if I don't eat with this combo, it can be helpful in the mornings, but is crap at bedtime. This is likely to be any or all of the drugs, and some food will lessen the effect. A little food is probably enough, like a yogurt smoothie or glass of real milk.  I suspect the queasy feeling is the Norvir. It is not necessary to take this at the same time as the rest (but this is inconvenient...). Food should have no effect on it's boosting properties (indeed, should enhance this if the studies are to be believed).

5. Took me 8 months to get below 50 copies on this combo.

6. In the UK a test called Therapeutic Drug Monitoring (TDM) will look at your drug levels for Reyataz. is available for free. It takes about a 1-2 weeks to get the results back. It's a simple blood draw. This test will settle whether you have enough of this drug in your body 24 hrs a day. If not, then perhaps a switch is a good idea, or using a higher dose to top up indicated.

Hope this helps.

- matt

[BlueMoon]

Hi Forever England, my experience with that regimen was similar to yours, except I've never taken it without food.  That seems unwise and counterproductive, as food stimulates the absorption process of the Reyataz.

I changed doctors a few months after my first regimen was prescribed, as a matter of convenience.  My new doctor was also impatient to see me get to 'undetectable' and tried to get me to change my regimen.  I felt it was not worth risking side effects over ten or fifteen copies of the virus.  If you saw the toilet at my job then you would know that diarrhea is not worth the risk.

Even so he continued to press me to change, and when I continued to resist he pulled a flank attack by recommending adding a med, while telling dire warnings of mass resistance if I didn't do something.  So I added Isentress, thinking I could drop it if it was a problem, and if not then I could drop the boosted Reyataz instead.  I did get to undetectable, but now my dilemma is that if I drop one and my viral load rises, then I may lose the use all four of the meds I'm on, and I'm already resistant to the non-nukes.

I wish that I had 'stayed the course' until there had been obvious treatment failure (I'm now back with my original doctor!).  I don't think it's necessary to make a change yet, but if you do it should be a change in meds.

[Forever England]

I have several comments.

1. The suggestion without food is odd, since Reyataz needs an acid environment to be absorbed, and food creates this, plus is better absorbed with food according to studies, plus Norvir needs some fat really to get absorbed and tenofovir, one of the drugs in Truvada, is better absorbed with food.

2. A fair number of people need 400mg Reyataz rather than 300mg, and perhaps 200mg Norvir booster for this combo (see point 6 before looking at a higher dose).

3. Is it the latest Roche viral load test they are using? This is not so good, it's too accurate/flaky. There's not much difference between 40, 50 and 60 or 72 copies on viral load. Under 100 is probably "undetectable". However, over 100 consistently, yes I agree, this is not good enough. Forthcoming BHIVA guidelines on routine monitoring (late, very late in arriving...) will probably suggest the target is a consistently low viral load, and each clinic must decide what this means based on the type of viral load tests they choose to use (really clear eh, but accurate).

4. Lightheaded, yes, I get this if I don't eat with this combo, it can be helpful in the mornings, but is crap at bedtime. This is likely to be any or all of the drugs, and some food will lessen the effect. A little food is probably enough, like a yogurt smoothie or glass of real milk.  I suspect the queasy feeling is the Norvir. It is not necessary to take this at the same time as the rest (but this is inconvenient...). Food should have no effect on it's boosting properties (indeed, should enhance this if the studies are to be believed).

5. Took me 8 months to get below 50 copies on this combo.

6. In the UK a test called Therapeutic Drug Monitoring (TDM) will look at your drug levels for Reyataz. is available for free. It takes about a 1-2 weeks to get the results back. It's a simple blood draw. This test will settle whether you have enough of this drug in your body 24 hrs a day. If not, then perhaps a switch is a good idea, or using a higher dose to top up indicated.

Hope this helps.

- matt

Thanks Matt for such a detailed and helpful response.

1) Others have said this. I trust my doctor and his intent but must confess to being concerned here.

2) Interesting. I don't like any drugs and I loathe side-effects, so I'm always happier with less rather than more but I realise this isn't a case of want.

3) I don't know but will ask.

4) I feel like I'm suddenly running on empty, all energy becomes depleted. It kicks in about 75 mins after my 5pm dose and the rest of the day's a write-off. This will be very troublesome, ongoing and I'm on the verge of calling to confirm it's OK to return to with food.

5) I started Atripla in May 2009 and switched to this about 4-5 months after.

6) I had a similar test for Efavirenz when taking Atripla, as I was not tolerating the side effects (hence the switch).  I recall the doc specifically stating there was *no* equivalent test available to him for the current meds though - I will check this as I may have misunderstood. I will also ask about dose amount. Doctor already suggested a switch, although I'm uncomfortable if there isn't a strong reason.

I come back to the feeling (based on no medical expertise) that "undetectable" seems somewhat arbitrary, given that just a few copies tips you over, but perhaps it's as much a case of proving that the treatment is working as effectively as is measurable, rather than *not quite*, which might be a cause for longer-term concern.

[Forever England]

Hi Forever England, my experience with that regimen was similar to yours, except I've never taken it without food.  That seems unwise and counterproductive, as food stimulates the absorption process of the Reyataz.

I changed doctors a few months after my first regimen was prescribed, as a matter of convenience.  My new doctor was also impatient to see me get to 'undetectable' and tried to get me to change my regimen.  I felt it was not worth risking side effects over ten or fifteen copies of the virus.  If you saw the toilet at my job then you would know that diarrhea is not worth the risk.

Even so he continued to press me to change, and when I continued to resist he pulled a flank attack by recommending adding a med, while telling dire warnings of mass resistance if I didn't do something.  So I added Isentress, thinking I could drop it if it was a problem, and if not then I could drop the boosted Reyataz instead.  I did get to undetectable, but now my dilemma is that if I drop one and my viral load rises, then I may lose the use all four of the meds I'm on, and I'm already resistant to the non-nukes.

I wish that I had 'stayed the course' until there had been obvious treatment failure (I'm now back with my original doctor!).  I don't think it's necessary to make a change yet, but if you do it should be a change in meds.

Thanks Bluemoon. Isentress looks interesting and seems well tolerated. It's fairly new and there isn't much about longer-term effects as a consequence, but I read it's well-tolerated. But I was relatively happy on the current regimen and was hopeful about the new Norvir formulation which doesn't require refrigeration. I wouldn't mind continuing without food for a period, on medical advice, were it not for the side-effects, which are of the type that prompted me to switch away from Atripla, in the first place.