Effect of baseline characteristics on the efficacy and safety of once-daily darunavir/ ritonavir in HIV-1-infected, treatment-naïve ARTEMIS patients at week 96.

Objectives: ARTEMIS demonstrated significantly greater efficacy of once-daily darunavir/ritonavir (DRV/r) 800/100 mg versus lopinavir/ritonavir 800/200 mg (total daily dose) in treatment-naive, HIV-1-infected patients at week 96. The influence of baseline characteristics on efficacy and safety was analyzed in DRV/r patients. Methods: Patients received once-daily DRV/r plus fixed-dose tenofovir/emtricitabine. Week 96 efficacy and safety data were analyzed by gender (males, n = 239; females, n = 104), age (<= 30, n = 115; 31-45, n = 175; >45, n = 53), race (Asian, n = 44; Black, n = 80; Caucasian/White, n = 137; Hispanic, n = 77), and hepatitis B and/or C virus coinfection (n = 43). Results: Week 96 virologic response rates (HIV-1 RNA <50 copies/mL) were as follows: gender: 79% for both males and females; age: 72% (<= 30), 81% (31-45), and 89% (>45); race: 96% (Asian), 71% (Black), 77% (Caucasian/White), and 79% (Hispanic); coinfection status: 72% (coinfected) and 80% (non-coinfected). The incidence of treatment-related adverse drug reactions (ADRs) and laboratory abnormalities were comparable across gender, age, and race subgroups. Coinfected patients had a higher incidence of liver-related ADRs than non-coinfected patients. Conclusions: DRV/r 800/100 mg qd is an effective, well-tolerated treatment option for treatment-naive patients of different gender, age, race, or coinfection status.