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of results 69 patients (pts) commenced OD DRV/RTV and have reached a median of 23 weeks of therapy (range 4–83; IQR 12–31); 15 pts started DRV/RTV as their first PI-based regimen. Others changed for: ART simplification/move to OD ART (n = 17), GI side-effects (n = 15), low level viraemia (n = 6), jaundice (n = 6), lipid abnormalities (n = 6), perceived potency (n = 4). PI-based regimens changed from were: LPV/r (n = 25), ATZ/r (n = 20), FAPV/r (n = 2), double-boosted PI (n = 7). 51 trough [DRV] were obtained. Twenty-nine pts provided actual trough samples (23–26.5 hrs post-drug; median = 24 hrs). Median trough [DRV] was 1,738 ng/ml (range 414–3,582; IQR 1085–2497); this was 31× the PCEC50 for WT HIV. A further 22 pts provided blood samples a median of 15 hrs (range 12.5–21 hrs) post-drug ingestion. Using a t1/2 of 15 hrs the projected C24 was 2026 ng/ml (range 772– 4,558; IQR 1420–2638), representing 37× the PCEC50 for WT HIV. Furthermore 50/51 samples were above the PCEC50 for Res HIV. No patients have exhibited virological failure to date. All six swapping for low level viraemia reached an HIV viral load of <40 copies/ml. There was no incidence of rash and only one grade 1 LFT abnormality. Multivariate analysis of factors affecting DRV concentrations, and metabolic parameters, will be presented.

journal of the international aids society

Once-daily darunavir (DRV) used in routine clinical care produces trough DRV drug concentrations in excess of 30× the protein-corrected (PC) EC50 for wild-type HIV