OBJECTIVE: In POWER 1 and POWER 2, darunavir (TMC114) with low-dose ritonavir (darunavir/r) demonstrated greater efficacy versus control protease inhibitors (PIs). To examine the efficacy and safety of the selected darunavir/r dose further, additional patients were analyzed. METHODS: Treatment-experienced HIV-1-infected patients received darunavir/r at a dose of 600/100 mg twice daily plus an optimized background regimen. The primary intent-to-treat analysis was the proportion of patients with an HIV-1 RNA reduction >or=1 log10 at week 24. RESULTS: Three hundred twenty-seven patients were treated; the baseline mean HIV-1 RNA was 4.6 log10 copies/mL, and the median CD4 count was 115 cells/mm3 (median primary PI mutations = 3, PI resistance-associated mutations = 9). Two hundred forty-six patients reached week 24 by the cutoff date and were included in the efficacy analysis: 65% and 40% achieved HIV-1 RNA reductions of >or=1 log10 and <50 copies/mL, respectively, at week 24. The mean CD4 count increase was 80 cells/mm3. The most common adverse events (AEs) were diarrhea (14%), nasopharyngitis (11%), and nausea (10%). Nine (3%) patients discontinued treatment because of AEs or HIV-1-related events. Six treatment-unrelated deaths (2%) were reported. CONCLUSIONS: These results corroborate POWER 1 and POWER 2. In this larger set of treatment-experienced patients, darunavir/r at a dose of 600/100 mg twice daily provided substantial virologic and immunologic responses and was generally safe and well tolerated.
OBJECTIVE: In POWER 1 and POWER 2, darunavir (TMC114) with low-dose ritonavir (darunavir/r) demonstrated greater efficacy versus control protease inhibitors (PIs). To examine the efficacy and safety of the selected darunavir/r dose further, additional patients were analyzed. METHODS: Treatment-experienced HIV-1-infectedpatients received darunavir/r at a dose of 600/100 mg twice daily plus an optimized background regimen. The primary intent-to-treat analysis was the proportion of patients with an HIV-1 RNA reduction >or=1 log10 at week 24. RESULTS: Three hundred twenty-seven patients were treated; the baseline mean HIV-1 RNA was 4.6 log10 copies/mL, and the median CD4 count was 115 cells/mm3 (median primary PI mutations = 3, PI resistance-associated mutations = 9). Two hundred forty-six patients reached week 24 by the cutoff date and were included in the efficacy analysis: 65% and 40% achieved HIV-1 RNA reductions of >or=1 log10 and <50 copies/mL, respectively, at week 24. The mean CD4 count increase was 80 cells/mm3. The most common adverse events (AEs) were diarrhea (14%), nasopharyngitis (11%), and nausea (10%). Nine (3%) patients discontinued treatment because of AEs or HIV-1-related events. Six treatment-unrelated deaths (2%) were reported. CONCLUSIONS: These results corroborate POWER 1 and POWER 2. In this larger set of treatment-experienced patients, darunavir/r at a dose of 600/100 mg twice daily provided substantial virologic and immunologic responses and was generally safe and well tolerated.
Authors: Regina B Osih; Patrick Taffé; Martin Rickenbach; Angèle Gayet-Ageron; Luigia Elzi; Christoph Fux; Milos Opravil; Enos Bernasconi; Patrick Schmid; Huldrych F Günthard; Matthias Cavassini Journal: AIDS Res Hum Retroviruses Date: 2010-10-07 Impact factor: 2.205
Authors: Ahmed M Bayoumi; Paul G Barnett; Vilija R Joyce; Susan C Griffin; Huiying Sun; Nick J Bansback; Mark Holodniy; Gillian Sanders; Sheldon T Brown; Tassos C Kyriakides; Brian Angus; D William Cameron; Aslam H Anis; Mark Sculpher; Douglas K Owens Journal: J Acquir Immune Defic Syndr Date: 2013-12-01 Impact factor: 3.731
Authors: Lu Zheng; Susan L Rosenkranz; Babafemi Taiwo; Michael F Para; Joseph J Eron; Michael D Hughes Journal: AIDS Res Hum Retroviruses Date: 2013-01-09 Impact factor: 2.205