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.