Universität zu Köln

Faetkenheuer, G., Jessen, H., Stoehr, A., Jung, N., Jessen, A. B., Kuemmerle, 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., Haerter, G., Malfertheiner, P., Rockstroh, J., Knecht, G., Scholten, S., Harrer, T., Kern, W. V., Salzberger, B., Schuermann, D. and Ranneberg, B. (2016). PEPDar: A randomized prospective noninferiority study of ritonavir-boosted darunavir for HIV post-exposure prophylaxis. HIV Med., 17 (6). S. 453 - 460. HOBOKEN: WILEY. ISSN 1468-1293

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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:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Faetkenheuer, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jessen, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stoehr, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jung, N. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jessen, A. B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kuemmerle, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Berger, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bogner, J. R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Spinner, C. D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stephan, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Degen, O. UNSPECIFIED UNSPECIFIED UNSPECIFIED Vogelmann, R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Spornraft-Ragaller, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schnaitmann, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jensen, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ulmer, A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kittner, J. M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Haerter, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Malfertheiner, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rockstroh, J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Knecht, G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Scholten, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Harrer, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kern, W. V. UNSPECIFIED UNSPECIFIED UNSPECIFIED Salzberger, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schuermann, D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Ranneberg, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-274520
DOI:	10.1111/hiv.12363
Journal or Publication Title:	HIV Med.
Volume:	17
Number:	6
Page Range:	S. 453 - 460
Date:	2016
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1468-1293
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language HEALTH-CARE; NAIVE; SEROCONVERSION; TOLERABILITY; INFECTION; SAFETY; LOPINAVIR/RITONAVIR; RECOMMENDATIONS; EMTRICITABINE; RALTEGRAVIR Multiple languages Infectious Diseases Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/27452