Jaime Andrade-Villanueva 1, Gisela Herrera 2, Philippe Chiliade 3, Ben Van Baelen 4, Eric Lefebvre 5, Ludo Lavreys 4
1 Hospital Civil de Guadalajara, Guadalajara, Mexico
2 Infectious Diseases Department,CIMA Hospital, San Jose, Costa Rica
3 Family Health International, Arlington, VA, USA
4 Tibotec BVBA, Mechelen, Belgium
5 Janssen-Cilag BV, Tilburg, The Netherlands
Abstract
Introduction: Once-daily DRV/r 800/l00mg is being examined in AR TEMIS (TMC114-C211; AntiRetroviral Therapy with TMC114 Examined In Naive Subjects), an ongoing, open-label, Phase III study comparing the efficacy and safety of DRV/r versus lopinavir with low-dose ritonavir (LPV/r) in treatment-na’ive, HIV-1-infected adu lt patients. The aim of the present analysis was to determine the influence of gender, age and race on the safety and efficacy at Week 48 of patients receiving DRV/r 800/ l00mg qd in the ARTEMIS trial. Methods: All patients received a fixed background regimen of tenofovir disoproxil fumarate (TDF) 300mg qd and emtricitabine (FTC) 200mg qd. Safety and efficacy asse ssments were performed at screening, baseline, Week 2 and every 4 weeks until Week 16, at Week 24 and every 12 weeks thereafter. Results: No clinically meani ngful differences were observed in the tolerability of DRV/r 800/ l00mg qd in treatment-na’ive patients at Week 48, irrespective of gender, age or race. The majority of AEs and laboratory abnor malities observed in all sub groups were of mild- to-moderate severity. These incidences were similar to those reported for the overall population and were infrequently associated with treatment discontinuation. The efficac y of DRV/r through Week 48 was simila r across the sub groups, and was comparable to the overall population. DRV/r 800/l00mg qd is an effective, well-tolerated once-daily treatment option for treatment-na’ive patients regardless of gender, age or race.