The ARTEMIS trial: once-daily darunavir/ritonavir in the management of treatment-naive, HIV-infected patients

Abstract

The potential for once-daily use of darunavir in combination with low-dose ritonavir (darunavir/ritonavir) in antiretroviral-naive patients has been evaluated in the Phase III ARTEMIS trial. This followed the demonstration of sustained efficacy and a favorable safety profile of darunavir/ritonavir 600/100 mg twice daily in patients with a broad range of treatment experience in the Phase IIb POWER and Phase III TITAN studies. The 48-week primary analysis of ARTEMIS demonstrated that once-daily darunavir/ritonavir 800/100 mg was noninferior to lopinavir/ritonavir, given either 400/100 mg twice daily or 800/200 mg every day, in treatment-naive, HIV-1-infected patients (84 vs 78% of patients, respectively, had confirmed plasma HIV-1 RNA less than 50 copies/ml by per-protocol time-to-loss of virologic response at week 48). In patients with baseline HIV RNA more than 100,000 copies/ml, darunavir/ritonavir achieved higher response rates than lopinavir/ritonavir (79 vs 67%; p <0.05). In addition to being at least as effective as lopinavir/ritonavir, once-daily darunavir/ritonavir had tolerability advantages compared with lopinavir/ritonavir, including lower incidences of grade 2–4 gastrointestinal adverse events (mainly diarrhea), and triglyceride and total cholesterol elevations. These benefits, along with the convenience of once-daily darunavir/ritonavir 800/100 mg and its low propensity to the development of resistance, suggest darunavir/ritonavir is a valuable treatment option for treatment-naive patients.