Efficacy of Once Daily Darunavir/Ritonavir in PI-Naïve, NNRTI-Experienced Patients in the ODIN Trial

Table 5

Safety results for protease inhibitor naïve patients in the ODIN trial.

Adverse event	Darunavir/ritonavir; 800/100 mg once daily	Darunavir/ritonavir; 600/100 mg twice daily
	Clinical adverse events
Any serious adverse event	5 (4%)	9 (7%)
Any adverse event leading to permanent drug discontinuation	1 (1%)	6 (4%)
Any Grades 2–4 adverse events	58 (43%)	66 (48%)
Most common Grades 1–4 adverse events
Diarrhoea	18 (13%)	34 (25%)
Nausea	14 (10%)	17 (12%)
Headache	11 (8%)	11 (8%)
Nasopharyngitis	6 (4%)	12 (9%)
Upper respiratory tract infection	6 (4%)	11 (8%)
Vomiting	3 (2%)	14 (10%)
Rash	9 (7%)	6 (4%)
Anorexia	2 (1%)	7 (5%)
Grades 3-4 lipid/glucose abnormalities
Total cholesterol	4 (3%)	4 (3%)
LDL cholesterol	5 (4%)	4 (3%)
Triglycerides	4 (3%)	3 (2%)
Hyperglycemia	2 (1%)	3 (2%)

All results shown are (%), unless otherwise stated.