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PEPDar: A randomized prospective noninferiority study of ritonavir-boosted darunavir for HIV post-exposure prophylaxis.
Fätkenheuer, G; Jessen, H; Stoehr, A; Jung, N; Jessen, A B; Kümmerle, T; Berger, M; Bogner, J R; Spinner, C D; Stephan, C; Degen, O; Vogelmann, R; Spornraft-Ragaller, P; Schnaitmann, E; Jensen, B; Ulmer, A; Kittner, J M; Härter, G; Malfertheiner, P; Rockstroh, J; Knecht, G; Scholten, S; Harrer, T; Kern, W V; Salzberger, B; Schürmann, D; Ranneberg, B.
Afiliación
  • Fätkenheuer G; Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.
  • Jessen H; German Centre for Infection Research, partner site Bonn-Cologne, Cologne, Germany.
  • Stoehr A; Praxis Jessen2 + Kollegen, Berlin, Germany.
  • Jung N; ifi - Institute for Interdisciplinary Medicine, Study Centre St. Georg, Hamburg, Germany.
  • Jessen AB; Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.
  • Kümmerle T; Praxis Jessen2 + Kollegen, Berlin, Germany.
  • Berger M; Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.
  • Bogner JR; Immunology Outpatient Clinic, Vivantes Auguste Viktoria Hospital, Berlin, Germany.
  • Spinner CD; Section Infectcious Diseases, Med IV, University Hospital of Munich, Munich, Germany.
  • Stephan C; Department of Medicine II, University Hospital Klinikum rechts der Isar, Munich, Germany.
  • Degen O; Department of Medicine, Center for Internal Medicine, J. W. Goethe-University Frankfurt, Frankfurt am Main, Germany.
  • Vogelmann R; Outpatient Infectious Diseases Unit, University Center Hamburg Eppendorf, Hamburg, Germany.
  • Spornraft-Ragaller P; Department of Internal Medicine, Medical Clinic II, Ruprecht-Karls-University Heidelberg, Mannheim, Germany.
  • Schnaitmann E; University Hospital Karl Gustav Carus, Dresden, Germany.
  • Jensen B; Infectomed, Stuttgart, Germany.
  • Ulmer A; Department of Gastroenterology, Hepatology and Infectiology, University Hospital Düsseldorf, Düsseldorf, Germany.
  • Kittner JM; Group Practice Ulmer/Frietsch/Müller/Roll, Stuttgart, Germany.
  • Härter G; Medical Clinic and Outpatient Clinic I, University Hospital Mainz, Mainz, Germany.
  • Malfertheiner P; Clinic for Internal Medizin III, Ulm University Medical Center, Ulm, Germany.
  • Rockstroh J; Clinic for Gastroenterology, Hepatology and Infectiology, University Hospital Magdeburg, Magdeburg, Germany.
  • Knecht G; Internal Medicine I, Gastroenterology, Infectious Diseases, University Hospital Bonn, Bonn, Germany.
  • Scholten S; Internal Medicine Specialist Center Stresemannallee, Frankfurt am Main, Germany.
  • Harrer T; Practice Hohenstaufenring, Cologne, Germany.
  • Kern WV; Department of Medicine 3, University Medicine Erlangen, Erlangen, Germany.
  • Salzberger B; Division of Infectious Diseases, University Hospital, Freiburg, Germany.
  • Schürmann D; Department Internal Medicine I, University Regensburg, Regensburg, Germany.
  • Ranneberg B; Division of Infectiology and Pneumonology, Medical Department, Charité-University Medicine Berlin, Berlin, Germany.
HIV Med ; 17(6): 453-9, 2016 06.
Article en En | MEDLINE | ID: mdl-27166295
OBJECTIVES: PEPDar compared the tolerability and safety of ritonavir-boosted darunavir (DRV/r)-based post-exposure prophylaxis (PEP) with the tolerability and safety of standard of care (SOC). The primary endpoint was the early discontinuation rate among the per-protocol population. METHODS: PEPDar was an open-label, randomized, multicentre, prospective, noninferiority safety study. Subjects were stratified by type of event (occupational vs. nonoccupational, i.e. sexual) and were randomized to receive DRV/r plus two nucleoside reverse transcriptase inhibitors (NRTIs) or SOC PEP. Twenty-two private or university HIV clinics in Germany participated. Subjects were ≥ 18 years old and had documented or potential HIV exposure and indication for HIV PEP. They initiated PEP not later than 72 h after the event and were HIV negative. RESULTS: A total of 324 subjects were screened, the per-protocol population was 305, and 273 subjects completed the study. One hundred and fifty-five subjects received DRV/r-based PEP and 150 subjects received ritonavir-boosted lopinavir (LPV/r)-based PEP for 28-30 days; 298 subjects also received tenofovir/emtricitabine. The early discontinuation rate in the DRV/r arm was 6.5% compared with 10.0% in the SOC arm (P = 0.243). Adverse drug reactions (ADRs) were reported in 68% of DRV/r subjects and 75% of SOC subjects (P = 0.169). Fewer DRV/r subjects (16.1%) had at least one grade 2 or 3 ADR compared with SOC subjects (29.3%) (P = 0.006). All grades of diarrhoea, nausea, and sleep disorders were significantly less frequent with DRV/r, while headache was significantly more frequent. No HIV seroconversion was reported during follow-up. CONCLUSIONS: Noninferiority of DRV/r to SOC was demonstrated. DRV/r should be included as a standard component of recommended regimens in PEP guidelines.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ritonavir / Fármacos Anti-VIH / Profilaxis Posexposición / Darunavir Tipo de estudio: Clinical_trials / Guideline / Observational_studies Límite: Adult / Female / Humans / Male País/Región como asunto: Europa Idioma: En Revista: HIV Med Asunto de la revista: SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS) Año: 2016 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ritonavir / Fármacos Anti-VIH / Profilaxis Posexposición / Darunavir Tipo de estudio: Clinical_trials / Guideline / Observational_studies Límite: Adult / Female / Humans / Male País/Región como asunto: Europa Idioma: En Revista: HIV Med Asunto de la revista: SINDROME DA IMUNODEFICIENCIA ADQUIRIDA (AIDS) Año: 2016 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido