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Issentress Not Non-Inferior/
Feb 28, 2009

I am considering going on Issentress and so I am following closely the data that's released. Merck just released results (at CROI) of a study comparing patients on Issentress with those on lopinavir/ritonavir (Kaletra) and said the following; "Switching from Lopinavir/Ritonavir-Based to ISENTRESS-Based Combination Antiretroviral Therapy did not Demonstrate Non-Inferior Virologic Efficacy"

Does this mean that Issentress was in fact found to be inferior (to Kaletra) at viral suppression? If so, I guess it must have been statistically significant since they "discontinued" the study based on that finding. What is your opinion on this finding? Please help@! Thanks very much.

Response from Dr. McGowan

The study that you are referring to was not in treatment naive patients. In treatment naive patients, to date, Isentress (or raltegravir)has been as effective as efavirenz in terms of achieving virologic suppression. However, the switch study showed that Isentress was not equal to Kaletra. This speaks to the following: that Isentress has a lower genetic barrier to resistance than boosted PIs like Kaletra and that if you are planning to switch off Kaletra to Isentress one has to be certain that the background medications are sufficiently active. Thanks, Joe



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