Frank J. Palella, MD: A one pill fixed dose combination of the protease inhibitor darunavir, and the more metabolic friendly pharmacoenhancer cobicistat, along with tenofovir alafenamide and FTC is available. It is the only complete single-table regimen, fixed-dose combination based upon a protease inhibitor, which also happens to be our best protease inhibitor in terms of potency, as a genetic barrier to emergence of resistance, and for its tolerability. I think the availability of such therapy is extremely important for a number of reasons. For one, it includes people who might be extensively treatment experienced and might have archived transmitted or archived resistance mutations. We know that over the last 15 or 16 years that darunavir has been available, it has been highly effective against viral isolates that already possess resistance to other drugs.
In light of our conversation regarding the potential adverse weight gain that has been most notably associated with second-generation integrase inhibitors, it is very important that we have convenient complete, single-tablet regimens based upon a protease inhibitor available to our patients as alternatives to integrase inhibitors if those patients have demonstrated weight gain or if they are at very great risk for weight gain. Likewise, the only currently recommended therapy by our guidelines generating body, the Department of Health and Human Services (DHSS), for rapid initiation scenarios is the single-table regimen, fixed-dose combination that is based on darunavir: the darunavir cobicistat tenofovir alafenamide, FTC. So, both in terms of rapid initiation and of availability for patients who have extensive treatment histories, including resistance, and patients who have demonstrated or are at risk for weight gain and its metabolic complications, the availability of the darunavir-based combination is very valuable.
Transcript edited for clarity.