Paul E. Sax, MD

Disclosures

September 26, 2013

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Hello. This is Dr. Paul Sax from Brigham and Women's Hospital and Harvard Medical School.

The Interscience Conference on Antimicrobial Agents and Chemotherapy(ICAAC) just completed in Denver. The most important HIV study presented at the conference this year was the FLAMINGO study.[1]

The FLAMINGO study was a randomized clinical trial comparing dolutegravir, a recently approved once-daily integrase inhibitor vs ritonavir-boosted darunavir in treatment-naive patients. The patients also received nucleosides, of course, either tenofovir/FTC or abacavir/3TC. About 250 patients per study arm were enrolled, and the 48-week results were presented.

I should emphasize, before I give you the results, that this was an open-label study, so it is different from the previous 2 treatment-naive studies of dolutegravir. Those were blinded studies, one that compared it with tenofovir/FTC/efavirenz[2] and one that compared it with raltegravir.[3]

In this open-label study, at week 48, 90% of those in the dolutegravir arm and 83% of those in the darunavir/ritonavir arm met the criteria for virologic success by the snapshot algorithm, with an HIV RNA < 50 cells/mL. This difference not only met the protocol’s prespecified noninferiority criteria, but it also met the criteria for superiority, so dolutegravir was superior to darunavir.

Like in the SINGLE study,[2] which also showed dolutegravir's superiority, the superiority here came from fewer patients discontinuing their randomized drug in the dolutegravir vs the darunavir/ritonavir arm.

There was an equal number of virologic failures in both arms, and I should emphasize that, in this treatment-naive study, there were no cases of emergent resistance in patients who had virologic failure.

So we now have 3 studies of dolutegravir in treatment-naive patients, all compared with preferred regimens -- one vs tenofovir/FTC/efavirenz, one vs nucleosides plus raltegravir, and one vs nucleosides plus boosted darunavir -- and they all show that dolutegravir is either noninferior or superior to those comparisons.

Those are the results of the FLAMINGO trial presented at ICAAC in Denver. Thanks very much.

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