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2028-08-30
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- INI - Artigos de Periódicos [3460]
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EFFICACY AND SAFETY OF TMC114/RITONAVIR IN TREATMENT-EXPERIENCED HIV PATIENTS: 24-WEEK RESULTS OF POWER 1
Author
Affilliation
Hôpital Pitié-Salpêtrière. Paris, France.
Policlinico di Modena. Modena, Italy.
Hospital Clinic Universitary. Barcelona, Spain.
Hôpital Universitaire Erasme. Brussels, Belgium.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Chelsea and Westminster Hospital. London, UK.
Mediz. Universitätsklinik – Immunologische Ambulanz. Bonn, Germany.
IFI-Institut im AK St. Georg. Hamburg, Germany.
Otto-Wagner-Spital, Interne Lungenabteilung. Vienna, Austria.
Hôpital Bichat Paris. Paris, France.
Tibotec BVBA. Mechelen, Belgium.
Tibotec BVBA. Mechelen, Belgium.
Policlinico di Modena. Modena, Italy.
Hospital Clinic Universitary. Barcelona, Spain.
Hôpital Universitaire Erasme. Brussels, Belgium.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.
Chelsea and Westminster Hospital. London, UK.
Mediz. Universitätsklinik – Immunologische Ambulanz. Bonn, Germany.
IFI-Institut im AK St. Georg. Hamburg, Germany.
Otto-Wagner-Spital, Interne Lungenabteilung. Vienna, Austria.
Hôpital Bichat Paris. Paris, France.
Tibotec BVBA. Mechelen, Belgium.
Tibotec BVBA. Mechelen, Belgium.
Abstract
Background: The ongoing phase IIb POWER 1 (TMC114-C213) trial is designed to assess efficacy and safety of the protease inhibitor (PI) TMC114 (darunavir) in treatmentexperienced HIV-1-infected patients. Design: This randomized, partially blinded, 24-week dose-finding study compared efficacy and safety of four doses of TMC114 plus low-dose ritonavir (TMC114/r) with
investigator-selected control PI(s) (CPI[s]). Methods: Patients with one or more primary PI mutation and HIV RNA > 1000 copies/
ml received optimized background therapy, plus TMC114/r 400/100 mg once daily, 800/100 mg once daily, 400/100 mg twice daily or 600/100 mg twice daily, or CPI(s). The primary endpoint (intent-to-treat) compared proportions of patients achieving viral load reduction 1.0 log10 copies/ml from baseline. Results: In total, 318 patients were treated. Baseline mean viral load was 4.48 log10 copies/ml; median CD4 cell count was 179 cells/ml. In the CPI arm 62% of patients discontinued (virological failure: 54%); 10% of TMC114/r patients discontinued. More TMC114/r (69–77%) than CPI patients (25%) reached the primary endpoint (P < 0.001); 43–53% of TMC114/r patients and 18% ofthe CPIarm achievedviral load< 50 copies/ml (P < 0.001). TMC114/r demonstrated greater mean CD4 cell count increases versus CPI(s) (68–124 versus 20 cells/ml; P < 0.05). TMC114/r 600/100 mg twice daily demonstrated the highest virological and immunological responses. Adverse event incidence was similar between treatments; headache and diarrhoea were more common with CPI(s). Conclusions: TMC114/r demonstrated statistically higher 24-week virological response rates and CD4 cell count increases than CPI(s). TMC114/r 600/100 mg twice daily has received regulatory approval in treatment-experienced patients.
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