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ARTEMIS: week 96 safety and efficacy of darunavir/r by gender, age and race
J. Fourie1, J. Flamm2, A. Rodriguez-French3, D. Kilby4, B. Van Baelen5, V. Sekar6, L. Lavreys5
1Chronic Diseases of Lifestyle Unit, Tygerberg, South Africa, 2Kaiser Permanente Medical Group, Sacramento, United States, 3Hospital Santo Tomas, Panama City, Panama, 4University of Ottawa Health Services, Ottawa, Canada, 5Tibotec BVBA, Mechelen, Belgium, 6Tibotec Inc., Yardley, PA, United States
Background: ARTEMIS is a controlled Phase III trial, which showed superior efficacy of once-daily darunavir/ritonavir (DRV/r) 800/100mg versus lopinavir/r 800/200mg total daily dose, and good tolerability in treatment-naïve HIV patients at Week 96. This analysis evaluated the influence of gender, age and race on the efficacy and tolerability of DRV/r in ARTEMIS at Week 96.
Methods: Patients received DRV/r 800/100 qd (n=343) plus tenofovir/emtricitabine (fixed daily dose). All available Week 96 efficacy (viral load < 50 copies/mL) and safety data were analysed by gender (male n=239, female n=104), baseline age (≤30 years n=115; 31-45 years n=175; ≥46 years n=53), and race (Black n=80; Caucasian n=137; Hispanic n=77; Asian n=44) (ITT-TLOVR).
Results: Baseline characteristics were similar across the subgroups. Mean baseline viral load was 4.86 log10 copies/mL; median CD4 count was 228 cells/mm3. Week 96 efficacy was similar between the subgroups (ranging from: 71.3-100% [race], 72.2-100% [age] and 78.8-79.1 [gender]) and was consistent with that of the overall population (79%). The most common adverse events (regardless of severity and causality) in the analysed subgroups were generally also those most frequently observed in the overall population. Comparison of safety data across all subgroups revealed a lower incidence of: diarrhoea in Asians (23% vs 30-42%); nausea in Black patients (9% vs 14-22%); headache in Asians (4.5% vs 14-26%); and a higher incidence of upper respiratory tract infection in Asians (34% vs 14-24.5%); all differences were considered by expert opinion not clinically relevant. The majority of treatment-emergent laboratory abnormalities in subgroups were Grade 1 or 2.
Conclusions: No clinically relevant differences in tolerability and efficacy of DRV/r 800/100mg qd were observed across subgroups in treatment-naïve patients. DRV/r 800/100mg is an effective, well-tolerated once-daily treatment option for all treatment-naïve patients, regardless of their gender, age or race.
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