Table 2.
Adverse events during Weeks 144–240 (OLE)a,b
| Switch from DTG/ABC/3TC to B/F/TAF (N = 254) | Switch from DTG+F/TAF to B/F/TAF (N = 265) | |
| Any AE, n (%) | 214 (84.3) | 215 (81.1) |
| Drug-related AE, n (%) | 13 (5.1) | 8 (3.0) |
| ≥2 participants in either group or overall, n (%) | ||
| Diarrhea | 3 (1.2) | 0 |
| Weight increased | 2 (0.8) | 1 (0.4) |
| Headache | 1 (0.4) | 1 (0.4) |
| Grade 3 or 4 drug-related AE, n (%) | 0 | 1 (0.4) |
| Any SAE | 19 (7.5) | 32 (12.1) |
| Drug-related SAE | 0 | 0 |
| Discontinued B/F/TAF due to drug-related AEc | 2 (0.8) | 0 |
| Deaths | 2 (0.8) | 3 (1.1) |
AE, adverse event; B/F/TAF, bictegravir/emtricitabine/tenofovir alafenamide; DTG/ABC/3TC, dolutegravir/abacavir/lamivudine; DTG+F/TAF, dolutegravir plus emtricitabine and tenofovir alafenamide; OLE, open-label extension; SAE, serious adverse event.
a
Severity grades were defined by Gilead Grading Scale for Severity of AE and Laboratory Abnormalities.
b
Relatedness to study drug was assessed by the investigator.
c
The drug-related AE leading to B/F/TAF discontinuation were weight gain and obesity.