| Author | Molina, Jean-Michel | |
| Author | Cohen, Calvin | |
| Author | Katlama, Christine | |
| Author | Grinsztejn, Beatriz | |
| Author | Timerman, Artur | |
| Author | Pedro, Rogério de Jesus | |
| Author | Vangeneugden, Tony | |
| Author | Miralles, Diego | |
| Author | Meyer, Sandra de | |
| Author | Parys, Wim | |
| Author | Lefebvre, Eric | |
| Access date | 2019-01-17T22:14:41Z | |
| Available date | 2019-01-17T22:14:41Z | |
| Document date | 2007 | |
| Citation | MOLINA, Jean-Michel et al. Safety and efficacy of Darunavir (TMC114) with low-dose Ritonavir in treatment-experienced patients: 24-week results of POWER 3. Journal of Acquired Immune Deficiency Syndromes, v. 46, n. 1, p. 24-31, 2007. | pt_BR |
| ISSN | 1525-4135 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/31129 | |
| Description | Behalf of the TMC114-C208 and -C215 Study Groups. | |
| Language | eng | pt_BR |
| Publisher | Lippincott, Williams & Wilkins | pt_BR |
| Rights | restricted access | pt_BR |
| Title | Safety and efficacy of Darunavir (TMC114) with low-dose Ritonavir in treatment-experienced patients: 24-week results of POWER 3 | pt_BR |
| Type | Article | |
| DOI | 10.1097/QAI.0b013e3181359cfb | |
| Abstract | 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 $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 $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. | pt_BR |
| Affilliation | University of Paris. Hôpitaux de Paris. Assistance Publique. Department of Infectious Diseases. Paris, France / Hôpital Saint-Louis. Paris, France. | pt_BR |
| Affilliation | Community Research Initiative of New England. Boston, MA, USA. | pt_BR |
| Affilliation | Hôpital Pitié-Salpêtrière. Paris, France. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Pesquisa Clínica Evandro Chagas. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | PAM Heliópolis. São Paulo, SP, Brasil. | pt_BR |
| Affilliation | Universidade Estadual de Campinas. Hospital de Clínicas. Campinas, SP, Brasil. | pt_BR |
| Affilliation | Tibotec BVBA. Mechelen, Belgium. | pt_BR |
| Affilliation | Tibotec BVBA. Mechelen, Belgium. | pt_BR |
| Affilliation | Tibotec BVBA. Mechelen, Belgium. | pt_BR |
| Affilliation | Tibotec Inc. Yardley, PA, USA. | pt_BR |
| Affilliation | Tibotec Inc. Yardley, PA, USA. | pt_BR |
| Subject | Darunavir | pt_BR |
| Subject | HIV RNA < 50 copies/mL | pt_BR |
| Subject | Protease inhibitors | pt_BR |
| Subject | TMC114 | pt_BR |
| e-ISSN | 1944-7884 | |
| Embargo date | 2028-08-30 | |
