| Autor: |
Fätkenheuer, G, Jessen, H, Stoehr, A, Jung, N, Jessen, AB, Kümmerle, T, Berger, M, Bogner, JR, Spinner, CD, Stephan, C, Degen, O, Vogelmann, R, Spornraft‐Ragaller, P, Schnaitmann, E, Jensen, B, Ulmer, A, Kittner, JM, Härter, G, Malfertheiner, P, Rockstroh, J |
| Předmět: |
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| Zdroj: |
HIV Medicine; Jun2016, Vol. 17 Issue 6, p453-459, 7p |
| Abstrakt: |
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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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