- Poster presentation
- Open Access
Safety analysis of darunavir/r (DRV/r): combined data from randomised Phase II and Phase III studies
© Fätkenheuer et al; licensee BioMed Central Ltd. 2008
- Published: 10 November 2008
- Lower Incidence
- Safety Profile
- Experienced Patient
DRV/r has been evaluated in a large-scale clinical program in a broad range of HIV-1-infected antiretroviral-naïve and -experienced patients (pts). This analysis examines the safety profile of DRV/r in pts in these studies administered DRV/r 600/100 mg BID or 800/100 mg QD, as part of combination therapy.
All available safety data at 48 weeks were analysed from 1,376 pts recruited to the DRV/r 600/100 mg BID and 800/100 mg QD arms of Phase IIb POWER 1 + 2 trials and Phase III ARTEMIS, TITAN and DUET trials. In ARTEMIS, treatment-naïve pts received 800/100 mg QD (n = 343) or lopinavir/r (LPV/r) 800/200 mg (total daily dose; n = 346); all pts received tenofovir/emtricitabine. In TITAN, treatment-experienced, LPV-naïve pts received DRV/r 600/100 mg BID (n = 298) or LPV/r 400/100 mg BID (n = 297) + OBR. In POWER 1 + 2, highly treatment-experienced pts who only received DRV/r 600/100 mg BID + OBR (n = 131) were included. Only pts from the control arm of DUET 1 + 2 (n = 604) receiving DRV/r 600/100 mg + OBR and etravirine (ETR) placebo were analysed.
In conclusion, DRV/r was consistently well tolerated and caused significantly less grade 2–4 diarrhoea than LPV/r. In ARTEMIS, the incidence of grade 2–4 diarrhoea and nausea with DRV/r 800/100 mg QD was half that reported with DRV/r 600/100 mg BID in TITAN; this could be related to population, background regimen and/or dosing differences.
This article is published under license to BioMed Central Ltd.