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