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Dolutegravir Aces SPRING-2 Study, Now Available Via EAP

By Enid Vázquez

May/June 2012

Initial results of a large Phase 3 study of dolutegravir, an investigational secondgeneration integrase inhibitor, showed it to be non-inferior to Isentress. "Non-inferior" is a scientific designation applied to study results meaning that the drug studied is not less effective than the one it is compared to. If approved, dolutegravir may be at an advantage because it is given once a day, while Isentress is given twice daily.

The SPRING-2 study looked at about 800 individuals taking HIV therapy for the first time, half of them on a regimen with 50 mg dolutegravir once daily and half on a regimen with Isentress (400 mg twice daily). ViiV Healthcare and Shionogi & Co. reported that through 48 weeks, both groups achieved undetectable viral load (less than 50 copies per mL): 88% of the study participants given dolutegravir vs. 85% of those given Isentress.

Dolutegravir is now available through an expanded access program (EAP), which allows for drugs not yet approved by the FDA to be provided free of charge to those in great need.

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