PEPDar: A randomized prospective noninferiority study of ritonavir-boosted darunavir for HIV post-exposure prophylaxis

Faetkenheuer G, Jessen H, Stoehr A, Jung N, Jessen AB, Kuemmerle T, Berger M, Bogner JR, Spinner CD, Stephan C, Degen O, Vogelmann R, Spornraft-Ragaller P, Schnaitmann E, Jensen B, Ulmer A, Kittner JM, Haerter G, Malfertheiner P, Rockstroh J, Knecht G, Scholten S, Harrer T, Kern WV, Salzberger B, Schuermann D, Ranneberg B (2016)

Publication Type: Journal article

Publication year: 2016

Journal

Book Volume: 17

Pages Range: 453-9

Journal Issue: 6

DOI: 10.1111/hiv.12363

Abstract

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.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.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.Noninferiority of DRV/r to SOC was demonstrated. DRV/r should be included as a standard component of recommended regimens in PEP guidelines.

Authors with CRIS profile

Involved external institutions

Universitätsklinikum Köln Germany (DE) Universitätsklinikum Hamburg-Eppendorf (UKE) Germany (DE) Ruprecht-Karls-Universität Heidelberg Germany (DE) Universitätsklinikum Carl Gustav Carus Dresden Germany (DE) Universitätsklinikum Düsseldorf Germany (DE) Universitätsmedizin der Johannes Gutenberg-Universität Mainz Germany (DE) Universität Ulm Germany (DE) Universitätsklinikum Magdeburg A.ö.R. Germany (DE) Universitätsklinikum Bonn Germany (DE) Universität Regensburg Germany (DE) Charité - Universitätsmedizin Berlin Germany (DE) Janssen-Cilag France France (FR) Universitätsklinikum Freiburg Germany (DE) Goethe-Universität Frankfurt am Main Germany (DE) Klinikum rechts der Isar Germany (DE) Klinikum der Universität München (Großhadern und Innenstadt) Germany (DE) Vivantes - Netzwerk für Gesundheit GmbH Germany (DE)

How to cite

APA:

Faetkenheuer, G., Jessen, H., Stoehr, A., Jung, N., Jessen, A.B., Kuemmerle, T.,... Ranneberg, B. (2016). PEPDar: A randomized prospective noninferiority study of ritonavir-boosted darunavir for HIV post-exposure prophylaxis. HIV Medicine, 17(6), 453-9. https://dx.doi.org/10.1111/hiv.12363

MLA:

Faetkenheuer, G., et al. "PEPDar: A randomized prospective noninferiority study of ritonavir-boosted darunavir for HIV post-exposure prophylaxis." HIV Medicine 17.6 (2016): 453-9.

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