Efficacy of Once Daily DarunavirRitonavir in PI-Naïve, NNRTI-Experienced Patients in the ODIN Trial

Abstract EN

Background.

An exploratory subanalysis of the ODIN trial was performed to evaluate the efficacy of darunavir/ritonavir (DRV/r) 800/100 mg OD versus 600/100 mg BID in patients who were NNRTI-experienced but PI-naïve.

Methods.

ODIN was a phase III, 48-week study comparing DRV/r OD versus BID in 590 treatment-experienced patients with no DRV resistance-associated mutations (RAMs) at screening.

Patients received DRV/r 800/100 mg OD or DRV/r 600/100 mg BID plus ≥2 NRTIs.

Of the 590 patients randomized, 272 (46%) were NNRTI-experienced but PI-naïve.

Results.

Overall, 272 patients received DRV/r OD n = 135 or BID n = 137 plus ≥2 optimised NRTIs.

The mean age was 39 years; 35% were female; 27% were Black, 24% Caucasian, 26% Oriental/Asian, and 23% other races; 17% were recruited in South Africa; and 48% had non-B HIV-1 subtypes.

Mean baseline plasma HIV-1 RNA load was 4.10 log 10 copies/mL; median CD4 cell count was 258 cells/μL.

At week 48, 111/135 (82%) of DRV/r OD and 109/137 (80%) of DRV/r BID patients achieved an HIV-1 RNA load <50 copies/mL.

No patient developed primary PI RAMs.

Conclusion.

DRV/r 800/100 mg OD in combination with ≥2 optimised NRTIs led to virological suppression <50 copies/mL in 82% of NNRTI-experienced, PI-naïve patients by week 48.