Efficacy and safety of darunavir/ritonavir in treatment-experienced HIV type-1 patients in the POWER 1, 2 and 3 trials at week 96
| Autor: | Dushyantha Jayaweera, Patrick Yeni, Frank Tomaka, Beatriz Grinsztejn, Keikawus Arastéh, Anton Pozniak, Tony Vangeneugden, Afsoon D. Roberts, Jennifer F Hoy, Sandra De Meyer |
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| Rok vydání: | 2009 |
| Předmět: |
Oncology
medicine.medical_specialty Anti-HIV Agents HIV Infections Drug Administration Schedule Acquired immunodeficiency syndrome (AIDS) Internal medicine medicine Humans Pharmacology (medical) Protease inhibitor (pharmacology) Sida Darunavir Pharmacology Sulfonamides Ritonavir biology business.industry medicine.disease biology.organism_classification Virology Clinical trial Infectious Diseases Enzyme inhibitor HIV-1 biology.protein Viral disease business medicine.drug |
| Zdroj: | Antiviral Therapy. 14:859-864 |
| ISSN: | 2040-2058 1359-6535 |
| Popis: | 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 RNAResults 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+ 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. |
| Databáze: | OpenAIRE |
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