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. 2021 May 18;88(1):86–95. doi: 10.1097/QAI.0000000000002731

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.