Table 2.
Summary of AEs in the pooled safety population from GEMINI-1 and GEMINI-2 through week 144.
| n (%) | DTG + 3TC (N = 716) | DTG + TDF/FTC (N = 717) |
| Any AE | 613 (86) | 625 (87) |
| AEs occurring in ≥7% of participants in either group through week 144 | ||
| Diarrhea | 99 (14) | 106 (15) |
| Nasopharyngitis | 93 (13) | 127 (18) |
| Headache | 84 (12) | 91 (13) |
| Upper respiratory tract infection | 84 (12) | 61 (9) |
| Syphilis | 64 (9) | 70 (10) |
| Pharyngitis | 62 (9) | 64 (9) |
| Vitamin D deficiency | 53 (7) | 42 (6) |
| Back pain | 49 (7) | 48 (7) |
| Insomnia | 46 (6) | 59 (8) |
| Nausea | 29 (4) | 63 (9) |
| Arthralgia | 24 (3) | 47 (7) |
| Drug-related AEs | 146 (20) | 192 (27) |
| Grade 2–5 drug-related AEs | 58 (8) | 69 (10) |
| Grade 2–5 drug-related AEs occurring in ≥1% of participants | ||
| Headache | 8 (1) | 8 (1) |
| Serious AEs | 76 (11) | 85 (12) |
| AEs leading to withdrawal from study | 31 (4) | 33 (5) |
| AEs of interest leading to withdrawal from study | ||
| Psychiatric | 11 (2) | 8 (1) |
| Renal-relateda | 2 (<1) | 12 (2) |
| Osteoporosis | 0 | 2 (<1) |
3TC, lamivudine; AE, adverse event; DTG, dolutegravir; FTC, emtricitabine; TDF, tenofovir disoproxil fumarate.
a
Includes events of renal impairment, renal failure, chronic kidney disease, renal tubular disorder, glomerular filtration rate decreased, blood creatinine increased, and creatinine renal clearance decreased.