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Dolutegravir is a potent, once-daily integrase inhibitor that was approved by the FDA earlier this year based on the results of three phase III clinical trials. In one of these trials (SINGLE), sponsored by the makers of dolutegravir, an abacavir/3TC plus dolutegravir regimen was compared with coformulated tenofovir/FTC/efavirenz.
The study was conducted in North America, Europe, and Australia; 844 treatment-naive, HLA*B5701-negative patients were randomized to receive the dolutegravir- or efavirenz-based regimen, along with matching placebos. The study population was well matched (overall, 84% men, 24% black; median viral load, 4.68 log copies/mL; median CD4 count, 338 cells/mm3).
At week 48, 88% of the dolutegravir group and 81% of the efav…