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Switch to Reyataz/Truvada?
Dec 11, 2006

My doctor and I are thinking of changing regimens from Kaletra/Combivir to Reyataz/Truvada and I wanted a second view from you. In particular, I wanted to confirm that I'm appropriately evaluating the new side effects that I might be facing on this new Reyataz/Truvada regimen.

For a little history, I started on Crixivan/Combivir in 2000. I went undetectable almost immediately, with cd4 counts ranging from 500 to 700 for 6 years. I have no mutations or resistance to any PI's, NRTI's, or NNRTI's. Further, all other labs were pretty much normal (i.e., triglycerides and total cholesterol around 200, normal kidney/liver). That is, until I started experiencing severe Crixivan crystal sludge in my kidneys in May of this year. That resulted in, what appears to be, temporary kidney damage, with highly-elevated creatinine. After stopping Crixivan, the symptoms resolved, the labs turned back to normal, and I was placed on Kaletra.

The only other "side effects" I experienced under this Crixivan/Combivir regimen were an increasing feeling of anxiousness starting in 2004 that resulted in numerous episodes of tachycardia, where I thought I was having a heart attack. I only experienced this effect shortly after taking my Crixivan (which I had been on for 5 years by then). It might not have been related to Crixivan at all, but I've always wondered whether the piling up of kidney sludge might have been promoting some heartbeat abnormalities. In any case, subsequent stress echos appeared to rule out heart problems with no other high risk factors (no smoking, no family history, no overweight, and relatively normal lipids).

I have responded well to the Kaletra/Combivir regimen, with an undetectable viral load and a cd4 count ranging from 700 to 900. But I have experienced the following difficult side effects.

Consideration of the Kaletra to Reyataz switch is being prompted by continuing GI problems that have not resolved after 5 months on the drug. Further, I have experienced elevated triglycerides that went from 200 to 600 in the first 2 weeks on Kaletra, and have recently skyrocketed to 1,000 (while fasting). Digging a little more into the literature, as well as a call to Abbott, I was somewhat shocked to find that the postmarketing experience is that 30-40% of treatment-experienced patients also have suffered triglycerides over 750!

Given the high level of triglycerides I am experiencing, I have not been too excited about long-term use of another drug like Tricor (which can cause gall stones and pancreatitis) just to counteract the Kaletra--and probably still not achieve "normal" levels, even with a 60-70% reduction in triglycerides that Tricor might achieve. I know that with the Norvir boost, there is no guarantee that my lipids will respond positively to the Reyataz. However, I've seen anecdotal evidence where patients' triclycerides have dropped significantly in just a few weeks after making the switch from Kaletra. Further, if I maintain an undetectable viral load, I have read that perhaps dropping the Norvir boost might be a viable option, which could further increase the potential improvement in my lipid profile. (I realize that this option would be possible only if I ultimately decided to stay on Combivir [or switched to Epzicom instead of Truvada], since Truvada decreases too significantly the level of Reyataz in the blood, thus requiring the Norvir boost).

Consideration of the Combivir to Truvada switch is being prompted by acceleration of facial and limb lipoatrophy that I have experienced since going on Kaletra. Otherwise, however, I've tolerated Combivir very well over these past 7 years, with little or no other side effects of which I currently am aware. I believe the acceleration of lipoatrophy has been prompted by: (1) the severe GI problems I have been experiencing on Kaletra, which includes loss of 5-10 lbs (or 7% of my 150 lb body weight); (2) the complete makeover of my eating habits just to try to find something that lessens the GI effects; and, (3) the change to an extremely low-fat diet to attempt to lessen the adverse lipid impacts. My research suggests that Truvada (unlike Zerit and AZT) is less likely to promote fat loss, and may even permit slow gains back of lost facial and limb fat over time.

The above are the main reasons why I am considering a switch to Reyataz and Truvada. Are these sound reasons for considering a change?

The main concerns I have about adopting a Reyataz/Truvada regimen are the potential "new" side effects I might experience. For Reyataz, my main concerns are 2nd degree AV Block, pancreatitis, bilirubin (which probably doesn't affect liver function), and skin rash (including Stevens Johnson syndrome). How common are these in your experience? If I've had episodes of tachycardia (as described above), should I be concerned about the 2nd degree AV Block?

For Truvada, my main concerns are liver complications, lactic acidosis, bone loss and kidney problems. My labs indicate I've been exposed to HepB, but have never had any liver problems. Does this raise concerns about going on Truvada? Might going off Combivir be a problem--could it exacerbate "dormant" HepB problems?

As for kidney problems, are the potential Truvada effects (tubular compromise, creatinine clearance considerations, I think) more risky since I experienced kidney problems with Crixivan sludge? My current kidney lab numbers are fine. But might I be more susceptible to the potential Truvada effect with my prior Crixivan history?

As for lactic acidosis and bone loss, is Truvada any worse than the other NRTI's? Are these risks that are particularly notable for Truvada?

As a final note, I considered Atripla as an alternative regimen. However, since I've responded well to PI's, I thought it might be advisable to stay in this drug class, leaving the NNRTI's for later if I subsequently develop PI resistance problems. Also, I don't believe the literature demonstrates that Sustiva is as lipid neutral as Reyataz, and may, in fact, increase lipids, but perhaps by not as much as Kaletra.

Sorry for the long note, but as time wears on, all these side effects start taking their toll. Since I've seemed to keep the VL down and cd4 improving, I'm now getting increasingly concerned about adopting a long-term regimen with newer drugs that potentially will lessen the long-term impacts. Any suggestions you might have would be greatly appreciated.

Response from Dr. Wohl

Thanks for the completeness of your history. There are many things to consider when making such a switch. The main motivation for this change is a) the GI side effects of your current regimen and b) the high triglycerides you have developed on therapy.

The GI problems are almost certainly due to Kaletra. The new formulation of the drug has been reported to reduce GI side effects but some people continue to have problems. You have hung in there for 5 months - it is fair to say you gave it a shot and that this alone is reason to move on if symptoms can not be controlled with diet or simple measures like Lomotil. Reyataz with Norvir may be better tolerated by your GI tract. If even a little bit of Norvir causes you problems, then you may still experience some difficulty with this combo. You will not know until you try.

As for lipids. I am surprised by the post-marketing data you quote. In clinical trials, increases of triglycerides during Kaletra therapy have occured in less than 5% of patients. In a recent study of over 700 patients comparing Kaletra versus Sustiva, 3% on Kaletra had a triglyceride level of 750+ by week 96 compared to 6% of those on Sustiva. Interestingly, it may very well depend on what NRTIs accompany these drugs as far as lipids are concerned. In a study by Gilead Sciences, the makers of tenofovir, when tenofovir + 3TC + Sutiva were given to patients there was no increase in triglycerides seen (zero!). However, those on d4T + 3TC + Sustiva had big increases in triglycerides. AZT + 3TC + Sustiva also seems to increase teh triglycerides more so than tenofovir + 3TC (or FTC) + Sustiva, albeit to a lesser extent than d4T.

So, although skyhigh increases in triglycerides on Kaletra are uncommon, it does seem like this is what happened to you. Given your other problems with your regimen, a switch makes sense. As per above, I would not snub Atripla too quickly. It is actually pretty lipid friendly (especially for those triglycerides of yours). What about Reyataz. When boosted with Norvir, it too can raise triglycerides. Available data indicate that you might see a modest decline in triglycerides with a Kaletra to boosted Reyataz move and it might be worth a try if you are against going to Atripla.

I think Reyataz and Tenofovir are, overall safe drugs. I do not think you should expect any liver problems with the former. As far as kidney issues with tenofovir, I can not see your previous problems with Crixivan leading to your being more vulnerable to any renal problems from this drug. My experience over the past several years has been that the overwhelming majority of people do not have any clinically significant kideny related adverse effects from tenofovir.

It sounds like you are not actively infected with Hep B, but you should know that Truvada (tenofovir and FTC) are both active against HBV as well as HIV. As far as bone, again, we are not seeing this as a big issue in clinic.

All in all, if you are looking from relief from the GI upset and lipid issues, Atripla makes the most sense. You will have to sign on to the possibility of the efavirenz related side effects if you go this route. Alternatively, you could try Truvada and boosted Reyataz, first. If that does not work you can switch then to Atripla or, as you said, go to Epzicom and unboosted Reyataz.

I hope this helps.

DW



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