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Excitement has been brewing about the use of once-daily raltegravir and also about the possibility that this integrase inhibitor could be paired with a highly active boosted protease inhibitor (PI) to make a solid nuke-sparing regimen. Both of these expectations were dealt a blow by data presented at CROI 2011.
In the industry-sponsored QDMRK study, 770 treatment-naive patients were randomized to receive raltegravir at either 800 mg once daily or 400 mg twice daily, each with tenofovir/FTC. At 48 weeks, 83.2% of patients in the once-daily group had viral loads <50 copies/mL, compared with 88.9% of those in the twice-daily group. Once-daily dosing was deemed inferior, and the data and safety monitoring board recommended study closure. Among p…