Influence of demographic and disease parameters on virological response to once- vs twice-daily darunavir/ritonavir (DRV/r) at week 48 in ODIN

Background

ODIN was a Phase IIIb, randomised, open-label trial showing non-inferiority of DRV/r 800/100mg qd vs 600/100mg bid (+ ≥2 NRTIs) in treatment-experienced HIV-1-infected adults with no DRV resistance-associated mutations at screening. We evaluated the effect of demographic and baseline (BL) disease parameters on virological response (VR) of qd vs bid DRV/r at Week 48.

Methods

Week 48 VR (HIV-1 RNA <50 copies/mL; ITT-TLOVR) was analysed by subgroups including gender, age, race, HIV clade, BL HIV-1 RNA and CD4 count.

Results

Week 48 VR was 72.1% for DRV/r qd vs 70.9% for bid (95% CI = -6.1 to 8.5%). Week 48 VR by gender, age, race, HIV clade, BL CD4 count and HIV-1 RNA is reported (Table 1).

Table 1 % patients with HIV-1 RNA <50 copies/mL at Week 48

Conclusions

VR was comparable with DRV/r qd and bid regardless of subgroup analysed. As the trial was not powered for treatment comparisons in subgroups, and as numbers were small for some subgroups, these exploratory findings should be interpreted with caution.