Table 3 Frequencies and percentages of adverse events (AEs) and laboratory abnormalities
Immediate switch B/F/TAF BL-W24 N = 33 (%) | Delayed switch bPI BL-W24 N = 39 (%) | Delayed switch B/F/TAF W24-W48 N = 39 (%) | Immediate switch B/F/TAF W24-W48 N = 33 | |
|---|---|---|---|---|
Any AE | 25 (75.8) | 24 (61.5) | 28 (71.8) | 17 (51.5) |
Drug related AE | 10 (30.3) | 1 (2.6) | 14 (35.9) | 3 (9.1) |
Serious AE | 0 (0.0) | 1 (2.6) | 0 (0.0) | 0 (0.0) |
Discontinuation due to AE | 0 | 1 (2.6)$ | 3 (7.7)# | 1* (3.0) |
AE in ≥ 5% of participants | ||||
• Headaches | 4 (12.0) | 2 (5.1) | 4 (10.3) | |
• Hypertension | 4 (12.0) | |||
• Anxiety | 3 (9.1) | 2 (5.1) | ||
• Low mood | 2 (6.1) | 2 (5.1) | ||
• Abnormal dreams | 3 (9.1) | |||
• Insomnia | 3 (9.1) | 2 (5.1) | ||
• Sleep disturbance | 3 (9.1) | |||
• Weight gain | 3 (9.1) | 2 (5.1) | 2 (6.1) | |
• Tiredness/fatigue | 3 (9.1) | 3 (7.7) | ||
• Non-diabetic hyperglycaemia | 3 (7.7) | 2 (5.1) | ||
Grade 3 or 4 laboratory abnormalities | ||||
• Amylase | 1 (3.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
• Bilirubin | 2 (6.1) | 1 (2.6) | 0 (0.0) | 0 (0.0) |
• Total cholesterol | 0 (0.0) | 1 (2.6) | 0 (0.0) | 0 (0.0) |
• LDL cholesterol | 0 (0.0) | 1 (2.6) | 2 (5.1) | 0 (0.0) |