AIDS Research and Treatment / 2015 / Article / Tab 5

Research Article

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 eventDarunavir/ritonavir
800/100 mg once daily
Darunavir/ritonavir
600/100 mg twice daily

Clinical adverse events
 Any serious adverse event5 (4%) 9 (7%)
 Any adverse event leading to permanent drug discontinuation1 (1%)6 (4%)
 Any Grades 2–4 adverse events58 (43%)66 (48%)

Most common Grades 1–4 adverse events
 Diarrhoea18 (13%)34 (25%)
 Nausea14 (10%)17 (12%)
 Headache11 (8%)11 (8%)
 Nasopharyngitis6 (4%) 12 (9%)
 Upper respiratory tract infection6 (4%)11 (8%)
 Vomiting3 (2%)14 (10%)
 Rash9 (7%)6 (4%)
 Anorexia2 (1%)7 (5%)

Grades 3-4 lipid/glucose abnormalities
 Total cholesterol4 (3%)4 (3%)
 LDL cholesterol5 (4%)4 (3%)
 Triglycerides4 (3%)3 (2%)
 Hyperglycemia2 (1%)3 (2%)

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

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