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Randomized Controlled Trial
. 2016 Jun;17(6):453-9.
doi: 10.1111/hiv.12363. Epub 2016 May 11.

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

G Fätkenheuer  1   2 , H Jessen  3 , A Stoehr  4 , N Jung  1 , A B Jessen  3 , T Kümmerle  1 , M Berger  5 , J R Bogner  6 , C D Spinner  7 , C Stephan  8 , O Degen  9 , R Vogelmann  10 , P Spornraft-Ragaller  11 , E Schnaitmann  12 , B Jensen  13 , A Ulmer  14 , J M Kittner  15 , G Härter  16 , P Malfertheiner  17 , J Rockstroh  18 , G Knecht  19 , S Scholten  20 , T Harrer  21 , W V Kern  22 , B Salzberger  23 , D Schürmann  24 , B Ranneberg  25
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Free article
Randomized Controlled Trial

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

G Fätkenheuer et al. HIV Med. 2016 Jun.
Free article

Abstract

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.

Keywords: darunavir; lopinavir; occupational exposure; post-exposure prophylaxis; sexual exposure.

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