Pharmacokinetic and pharmacokinetic/pharmacodynamic characterization of the dolutegravir/rilpivirine two‐drug regimen in SWORD‐1/‐2 phase 3 studies

摘要

Aim SWORD‐1 and SWORD‐2 phase 3 studies concluded that switching virologically suppressed participants with HIV‐1 from their current three‐ or four‐drug antiretroviral regimen (CAR) to the two‐drug regimen of once‐daily dolutegravir (DTG, 50?mg) and rilpivirine (RPV, 25?mg) was safe, well tolerated and noninferior for maintaining HIV‐1 suppression at week 48 and highly efficacious to week 148. A secondary objective was to characterize drug exposure and exposure‐efficacy/safety relationships. Methods Adults with plasma HIV‐1 RNA 89. DTG or RPV C0avg showed no relationship with virologic failures or safety. Participants ≥50?years had similar C0avg and safety response to younger participants. Conclusion No clinically relevant relationship between DTG or RPV exposures and virologic or safety response was observed, confirming the DTG?+?RPV switch for participants as a safe and effective treatment.