Table 3.
Summary of Adverse Events in the Safety Population
| Type of AE | Participants at wk 48, No. (%) | Participants at wk 96, No. (%) | Participants at wk 144, No. (%) | |||
|---|---|---|---|---|---|---|
| DTG/3TC (n = 369) | TAF-Based Regimen (n = 371a) | DTG/3TC (n = 369) | TAF-Based Regimen (n = 371a) | DTG/3TC (n = 369) | TAF-Based Regimen (n = 371a) | |
| Any AE | 295 (80) | 292 (79) | 324 (88) | 325 (88) | 336 (91) | 335 (90) |
| AEs occurring in ≥10% of either group | ||||||
| Nasopharyngitis | 43 (12) | 41 (11) | 62 (17) | 61 (16) | 63 (17) | 64 (17) |
| URTI | 31 (8) | 32 (9) | 45 (12) | 43 (12) | 50 (14) | 42 (11) |
| Diarrhea | 30 (8) | 26 (7) | 45 (12) | 38 (10) | 50 (14) | 44 (12) |
| Back pain | 21 (6) | 28 (8) | 32 (9) | 40 (11) | 43 (12) | 49 (13) |
| Syphilis | 24 (7) | 13 (4) | 34 (9) | 26 (7) | 39 (11) | 33 (9) |
| Arthralgia | 12 (3) | 13 (4) | 21 (6) | 22 (6) | 31 (8) | 39 (11) |
| Drug-related AEsb | 45 (12) | 5 (1) | 51 (14) | 12 (3) | 55 (15) | 18 (5) |
| Grade 2–5 | ||||||
| Any | 17 (5) | 3 (<1) | 21 (6) | 7 (2) | 21 (6) | 13 (4) |
| Occurring in ≥0.5% of either group | ||||||
| Depression | 0 | 1 (<1) | 3 (<1) | 1 (<1) | 2 (<1) | 1 (<1) |
| Insomnia | 4 (1) | 0 | 4 (1) | 0 | 4 (1) | 0 |
| Constipation | 2 (<1) | 1 (<1) | 2 (<1) | 1 (<1) | 2 (<1) | 1 (<1) |
| Weight increase | 1 (<1) | 0 | 2 (<1) | 1 (<1) | 3 (<1) | 3 (<1) |
| Flatulence | 2 (<1) | 0 | 2 (<1) | 0 | 2 (<1) | 0 |
| Nausea | 0 | 1 (<1) | 0 | 1 (<1) | 0 | 2 (<1) |
| Metabolism and nutrition disorders | ||||||
| Weight increase | 3 (<1) | 6 (2) | 5 (1) | 7 (2) | 17 (5) | 19 (5) |
| Hyperlipidemia | 3 (<1) | 1 (<1) | 4 (1) | 3 (<1) | 7 (2) | 7 (2) |
| Weight decrease | 1 (<1) | 1 (<1) | 2 (<1) | 1 (<1) | 3 (<1) | 4 (1) |
| Impaired glucose tolerance | 0 | 1 (<1) | 1 (<1) | 2 (<1) | 1 (<1) | 2 (<1) |
| Type 1 diabetes | 1 (<1) | 0 | 1 (<1) | 0 | 1 (<1) | 0 |
| Type 2 diabetes | 2 (<1) | 0 | 2 (<1) | 1 (<1) | 2 (<1) | 1 (<1) |
| AEs leading to study withdrawalc | ||||||
| Any | 13 (4) | 2 (<1) | 21 (6) | 4 (1) | 23 (6) | 7 (2) |
| Drug related | 9 (2) | 1 (<1) | 14 (4) | 3 (<1) | 13 (4) | 5 (1) |
| Any SAEd | 21 (6) | 16 (4) | 42 (11) | 35 (9) | 57 (15) | 44 (12) |
Abbreviations: AE, adverse event; DTG/3TC, dolutegravir/lamivudine; SAE, serious AE; TAF, tenofovir alafenamide; URTI, upper respiratory tract infection.
One participant was found to be taking a tenofovir disoproxil fumarate–based regimen and was excluded from the safety population.
All drug-related AEs through week 96 were grade 1 or 2; most drug-related AEs through week 144 were grade 1 or 2, except for 2 grade 3 events (suicidal ideation and increased transaminases in the DTG/3TC group) and 1 grade 4 event (angioedema in the TAF-based regimen group).
For summary of AEs leading to withdrawal from the study, see Supplementary Table 3.
Two drug-related SAEs occurred through week 144 (increased transaminases in the DTG/3TC and angioedema in the TAF-based regimen group). Three fatal AEs, unrelated to study treatment, occurred in the DTG/3TC group, 2 (gunshot wound [homicide] and substance abuse [acute intoxication]) through week 96 and a third (ischemic hepatitis) through week 144.