FDA Approval of First Two-Drug HIV Regimen

Based on the results of the Sword 1 and 2 studies, the FDA on November 21, 2017, approved the two-drug combination of dolutegravir 50 mg/rilpivirine 25 mg (Juluca) for HIV+ patients who are virally suppressed (HIV RNA <50 copies/mL of blood) for at least 6 months and who have no history of treatment failure or documented resistance to the individual drugs.

The Sword studies demonstrated that dolutegravir plus rilpivirine maintained viral suppression similar to maintaining treatment with the control regimens (26% protease inhibitor [PI], 54% nonnucleoside reverse transcriptase inhibitor, and 20% integrase based) at 48 weeks (95% and 95%, respectively). The discontinuation rate was higher in the dolutegravir/rilpivirine arm (4% vs. < 1%).