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ARTEMIS: week 48 safety and efficacy of darunavir/r by gender, age and race
J. Andrade-Villanueva1, G. Hererra2, P. Chiliade3, B. Van Baelen4, E. Lefebvre5, L. Lavreys4
1Hospital Civil de Guadalajara, Guadalajara, Mexico, 2Infectious Diseases Department, CIMA Hospital, San Jose, Costa Rica, 3Family Health International, Arlington, United States, 4Tibotec BVBA, Mechelen, Belgium, 5Janssen-Cilag, Tilburg, Netherlands
Background: ARTEMIS is a controlled Phase III trial investigating efficacy and safety of once-daily darunavir/ritonavir (DRV/r) 800/100mg compared with lopinavir/r in treatment-naïve HIV patients. At Week 48, overall data show that DRV/r 800/100mg offers an effective, well tolerated once-daily treatment option for treatment-naïve patients. This analysis evaluated safety and efficacy according to gender, age and race.
Methods: Patients received DRV/r 800/100 qd (n=343) plus tenofovir/emtricitabine (fixed daily dose). All available safety data and Week 48 efficacy data (viral load <50 copies/mL) were analysed by gender (male n=239, female n=104), baseline age (£30 years n=115; 31-45 years n=175; ³46 years n=53), and race (Black n=80; Caucasian n=137; Hispanic n=77; Asian n=44) (ITT-TLOVR).
Results: Baseline characteristics were similar between the subgroups. Mean baseline viral load was 4.85 log10 copies/mL; median CD4 count was 225 cells/mm3. The most common adverse events (regardless of severity and causality) in the overall population were generally also those most frequently observed in the analysed subgroups. Comparing safety between all of the gender, age and race subgroups showed there was a lower incidence of diarrhoea in females and Asians (26% and 23%, respectively, vs 28-37%), a lower incidence of nausea in Black patients (9%, vs 13-20%), a lower incidence of headache in Asians (2%, vs 12-24%), and a higher incidence of upper respiratory tract infection in Asians (27%, vs 10-19%); these differences were not considered to be clinically relevant. Week 48 efficacy was similar across the subgroups (ranging from 80% of Caucasians to 100% of Asians) and consistent with that of the overall population (84%).
Conclusions: No clinically relevant differences were observed in the tolerability or 48-week efficacy of DRV/r 800/100mg qd in treatment-naïve patients, irrespective of gender, age or race. DRV/r 800/100mg is an effective, well-tolerated once-daily treatment option for treatment-naïve patients.
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