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New Kaletra formulation
Nov 27, 2005

Hi.

As a treatment naive, is it anticipated that the new formulation of Kaletra (200mg of lopinavir plus 50mg ritonavir x 4, once a day) will be earlier to tolerate than the older formulation (133.3mg lopinavir plus 33.3mg ritonavir x 6, once a day)? If so, why is this exactly?

I am concerned, as I have heard many scare stories about this drug, in particular chronic diarrohea. If the diarrohea arises, is it something which can be easily treated?

Also, is Kaletra the best Protease Inhibitor to commence with (High viral load, low CD4 count)? What would you combine this with? I have been recommended Truvada -is this a good combination and a better option than Truvada + Reyataz + Norvir? I am mainly thinking in terms of tolerability and the ability to affect my metabolism.

Many thanks.

O.

Response from Dr. Wohl

These are good and important questions. The new formulation of Kaletra promises to be an improvement over the older formulation. Beyond the increased convenience (less pills, once a day for treatment naive patients and more heat stable) the new tablets are made as a matrix of the drugs included in Kaletra that is more uniform in consistency than the old version. Therefore, the new formulation does away with the additives contained in the older formulation, some of which are thought to have been responsible for the gastrointestinal side effects.

Most people on the older version did not have diarrhea. But, some did. Even among these, in the majority the diarrhea was managable. Preliminary data do suggest the new formulation may be better tolerated in this regard.

As far as lipids, there is no expected difference between the formulations.

A combo of Truvada and Kaletra makes sense and is supported by clinical trial data as a potent and well tolerated regimen. Reyataz plus Norvir and Truvada is another potent option. In a head to head study of these two boosted PIs in treatment experienced patients who were switching from other regimens there was a trend favoring Kaletra. That same study demonstrated the differences between these agents with regard to lipids - this time favoring Reyataz. Although Ryataz+Norvir is becoming ever more popular as an initial regimen, there are no large clinical trial studies of this combination among treatment naive patients. (To be fair, unboosted Reyataz was found to be similar to Sustiva in patients initiating therapy in one large study).

If you already have abnormal lipids or multiple risk factors for cardiovascular disease, and are not on stomach acid reducing medications and can keep the Norvir in a cool place, I'd favor Reyataz+Norvir. If not, I think you will do fine with either.

DW



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