TABLE 3.
Safety Through Week 24
B/F/TAF (n = 330) |
SBR (No Switch) (n = 165) |
|
Any adverse event | 210 (64) | 85 (52) |
Adverse events in >3% of participants | ||
Upper respiratory tract infection | 20 (6) | 6 (4) |
Diarrhea | 11 (3) | 5 (3) |
Cough | 9 (3) | 6 (4) |
Arthralgia | 11 (3) | 2 (1) |
Bronchitis | 5 (2) | 7 (4) |
Grade 3 or 4 adverse event | 17 (5) | 8 (5) |
Serious adverse event | 13 (4) | 7 (4) |
Adverse event leading to study drug discontinuation* | 7 (2) | 0 |
Treatment-related adverse event | 36 (11) | 0 |
Death | 0 | 0 |
Laboratory abnormalities | ||
Of any grade | 215 (65) | 111 (67) |
Grade 3 | 24 (7) | 10 (6) |
Grade 4 | 3 (1) | 0 |
Data are n (%).
Adverse events leading to study drug discontinuation in the B/F/TAF group included nightmare† (n = 1); headache† (n = 1); acute kidney injury (n = 1); diarrhea,† dry mouth,† psychomotor hyperactivity,† agitation,† anxiety,† and insomnia† (n = 1); abdominal distension† and flatulence† (n = 1); diarrhea† (n = 1); and migraine† (n = 1).
Reported as treatment related.