Faetkenheuer, G. and Jessen, H. and Stoehr, A. and Jung, N. and Jessen, A. B. and Kuemmerle, T. and Berger, M. and Bogner, J. R. and Spinner, C. D. and Stephan, C. and Degen, O. and Vogelmann, R. and Spornraft-Ragaller, P. and Schnaitmann, E. and Jensen, B. and Ulmer, A. and Kittner, J. M. and Haerter, G. and Malfertheiner, P. and Rockstroh, J. and Knecht, G. and Scholten, S. and Harrer, T. and Kern, W. V. and Salzberger, B. and Schuermann, D. and Ranneberg, B. (2016) PEPDar: A randomized prospective noninferiority study of ritonavir-boosted darunavir for HIV post-exposure prophylaxis. HIV MEDICINE, 17 (6). pp. 453-459. ISSN 1464-2662, 1468-1293
Full text not available from this repository. (Request a copy)Abstract
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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | HEALTH-CARE; ANTIRETROVIRAL DRUGS; NEEDLESTICK INJURY; NAIVE; SEROCONVERSION; TOLERABILITY; INFECTION; SAFETY; LOPINAVIR/RITONAVIR; RECOMMENDATIONS; darunavir; lopinavir; occupational exposure; post-exposure prophylaxis; sexual exposure |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin I |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 15 Mar 2019 12:27 |
| Last Modified: | 15 Mar 2019 12:27 |
| URI: | https://pred.uni-regensburg.de/id/eprint/2827 |
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