| Author | Arastéh, Keikawus | pt_BR |
| Author | Yeni, Patrick | pt_BR |
| Author | Pozniak, Anton | pt_BR |
| Author | Grinsztejn, Beatriz | pt_BR |
| Author | Jayaweera, Dushyantha | pt_BR |
| Author | Roberts, Afsoon | pt_BR |
| Author | Hoy, Jennifer | pt_BR |
| Author | Meyer, Sandra de | pt_BR |
| Author | Vangeneugden, Tony | pt_BR |
| Author | Tomaka, Frank | pt_BR |
| Access date | 2018-11-29T14:04:31Z | |
| Available date | 2018-11-29T14:04:31Z | |
| Document date | 2009 | |
| Citation | ARASTÉH, Keikawus et al. Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96. Antiviral Therapy, v. 14, n. 6, p. 859-864, 5 Oct. 2009. | pt_BR |
| ISSN | 1359-6535 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/30317 | |
| Language | eng | pt_BR |
| Publisher | International Medical Press | pt_BR |
| Rights | restricted access | pt_BR |
| Title | Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96 | en_US |
| Type | Article | |
| DOI | 10.3851/IMP1301 | pt_BR |
| Abstract | Background: Long-term (96-week) efficacy and safety of the protease inhibitor (PI) darunavir coadministered with low-dose ritonavir (DRV/r) was evaluated in HIV type-1 (HIV-1)-infected patients with extensive prior treatment experience in the POWER 1, 2 and 3 trials. Methods: Patients with HIV-1 RNA≥1,000 copies/ml and ≥1 primary PI mutation were randomized to receive either DRV/r 600/100 mg twice daily plus an optimized background regimen (OBR), or an investigator-selected control PI (CPI) plus OBR (POWER 3 was a DRV/r 600/100 mg twice daily single-arm study). The proportion of patients with HIV-1 RNA<50 copies/ml at week 96 was assessed (intent-to-treat [ITT], time-to-loss of virological response algorithm). Results: In total, 467 patients received DRV/r 600/100 mg twice daily; 124 patients received CPI(s). At week 96, 39% of DRV/r patients in POWER 1 and 2 (pooled analysis) versus 9% of CPI patients achieved HIV-1 RNA<50 copies/ml (ITT, time-to-loss of virological response algorithm; P<0.001). A similar proportion of DRV/r patients (42%) in POWER 3 achieved HIV-1 RNA<50 copies/ml at week 96. Mean absolute CD4+ T-cell count increase for DRV/r at 96 weeks was 133 cells/mm3 in POWER 1 and 2 and 103 cells/mm3 in POWER 3. Grade 2–4 treatment-emergent adverse events at least possibly related to DRV/r (≥2% incidence, excluding laboratory abnormalities) were diarrhoea (3%), vomiting (3%), nausea (2%) and headache (2%). Conclusions: Treatment with DRV/r 600/100 mg twice daily was well tolerated and led to sustained virological and immunological responses in treatment-experienced HIV-1-infected patients over 96 weeks. | en |
| Affilliation | EPIMED. Vivantes Auguste-Viktoria-Klinikum. Berlin, Deutschland. | pt_BR |
| Affilliation | Université de Paris. Hôspital Bichat. Paris, France. | pt_BR |
| Affilliation | Chelsea and Westminster Hospital. London, UK. | pt_BR |
| Affilliation | Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil. | pt_BR |
| Affilliation | University of Miami. Miami, FL, USA. | pt_BR |
| Affilliation | George Washington University Medical Center. Washington, DC, USA. | pt_BR |
| Affilliation | The Alfred Hospital. Melbourne, VIC, Australia. | pt_BR |
| Affilliation | Tibotec BVBA. Mechelen, Belgium. | pt_BR |
| Affilliation | Tibotec BVBA. Mechelen, Belgium. | pt_BR |
| Affilliation | Tibotec Inc. Yardley, Pennsylvania, USA. | pt_BR |
| Subject | HIV-1 | en |
| Subject | Darunavir | en |
| Subject | Ritonavir | en |
| Subject | Drug Administration Schedule | en |
| Subject | Sulfonamides | en |
| e-ISSN | 2040-2058 | pt_BR |
| Embargo date | 2025-08-30 | |
