PEPDar: A randomized prospective noninferiority study of ritonavir-boosted darunavir for HIV post-exposure prophylaxis
Autor: | Johannes R. Bogner, T Harrer, Juergen K. Rockstroh, Georg Härter, WV Kern, Stefan Scholten, Norma Jung, Olaf Degen, B Salzberger, B. Ranneberg, E Schnaitmann, Peter Malfertheiner, Dirk Schürmann, A Ulmer, Heiko Jessen, Björn-Erik Ole Jensen, Albrecht Stoehr, G Knecht, JM Kittner, Tim Kümmerle, R. Vogelmann, Gerd Fätkenheuer, Petra Spornraft-Ragaller, Mathias Berger, Arne Jessen, Christoph Stephan, Christoph D. Spinner |
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Rok vydání: | 2015 |
Předmět: |
0301 basic medicine
Adult Male Pediatrics medicine.medical_specialty Anti-HIV Agents 030106 microbiology Population Emtricitabine 03 medical and health sciences 0302 clinical medicine Germany medicine Humans Pharmacology (medical) 030212 general & internal medicine Prospective Studies Adverse effect education Prospective cohort study Darunavir education.field_of_study Ritonavir business.industry Health Policy Lopinavir Infectious Diseases Treatment Outcome Tolerability Withholding Treatment Female business Post-Exposure Prophylaxis medicine.drug |
Zdroj: | HIV medicine. 17(6) |
ISSN: | 1468-1293 |
Popis: | ObjectivesPEPDar 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. MethodsPEPDar 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. ResultsA 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. ConclusionsNoninferiority of DRV/r to SOC was demonstrated. DRV/r should be included as a standard component of recommended regimens in PEP guidelines. |
Databáze: | OpenAIRE |
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