In the ODIN study, 590 patients were randomized to receive treatment with either PREZISTA/r 800/100 mg once daily or PREZISTA/r 600/100 mg twice daily. For both treatment arms, PREZISTA/r was used in combination with an optimized background regimen (OBR) of at least two nucleoside reverse transcriptase inhibitors (NRTIs). Overall, 46 percent of patients were protease inhibitor (PI)-naive and 13 percent were non-nucleoside reverse transcriptase inhibitor (NNRTI)-naive; 86 percent were susceptible to eight PIs (excluding ritonavir) and 60 percent were susceptible to at least two NRTIs in their OBR. At 48 weeks, a similar proportion of patients in both treatment arms achieved an undetectable viral load of <50 copies/mL (72 percent once-daily vs. 71 percent twice-daily). The study met its primary objective of non-inferiority.

The incidence of serious adverse events in the study was 5.4 percent in the once-daily group vs. 9.1 percent in the twice-daily group.  The incidence of grade 2 to 4 adverse events was 3.7 percent vs. 4.4 percent for nausea, 3.7 percent vs. 3.7 percent for diarrhea and 2.4 percent vs. 3.0 percent for vomiting, respectively. The incidence of grade 2 to 4 lipid and liver abnormalities with once-daily treatment vs. twice-daily treatment was 5.2 percent vs. 11.0 percent for triglycerides, 10.1 percent vs. 20.6 percent for total cholesterol, 9.8 percent vs. 16.7 percent for LDL cholesterol, and 1.7 percent/2.1 percent vs. 3.5 percent/3.5 percent for ALT/AST.

SOURCE Tibotec Therapeutics