Table 3. Safety during 3 years of double-blind treatment.
| n (%) or n/N (%) | TAF 25 mg (N = 227) | TDF 300 mg (N = 107) |
|---|---|---|
| Any AE | 199 (88) | 98 (92) |
| Proportional difference (95% CI) | –3.9% (–10.7%–2.9%) | |
| Any AE related to study | 50 (22) | 37 (35) |
| AE that lead to study drug discontinuation | 0 | 1 (<1)* |
| Any Grade 3 or 4 AE | 16 (7) | 4 (4) |
| Any Grade 3 or 4 AE related to study drug | 1 (<1) | 1 (<1) |
| Any SAE | 17 (7) | 10 (9) |
| Any SAE related to study drug | 0 | 1 (<1)* |
| Deaths | 0 | 0 |
| AEs that occurred in ≥5% of patients in any treatment group | ||
| Nasopharyngitis | 72 (32) | 24 (22) |
| Upper respiratory tract infection | 52 (23) | 27 (25) |
| Cough | 21 (9) | 5 (5) |
| Oropharyngeal pain | 16 (7) | 7 (7) |
| Pharyngitis | 13 (6) | 5 (5) |
| Influenza | 8 (4) | 7 (7) |
| Diarrhea | 14 (6) | 7 (7) |
| Nausea | 4 (2) | 7 (7) |
| Abdominal distension | 8 (4) | 6 (6) |
| Upper abdominal pain | 13 (6) | 7 (7) |
| Hepatic steatosis | 12 (5) | 6 (6) |
| Urinary tract infection | 13 (6) | 8 (7) |
| Increased amylase | 2 (<1)) | 6 (6) |
| Osteopenia | 1 (<1) | 6 (6) |
| Increased blood parathyroid hormone | 7 (3) | 8 (7) |
| Weight decreased | 4 (2) | 7 (7) |
| Toothache | 7 (3) | 6 (6) |
| Grade 3 or 4 laboratory abnormalities that occurred in ≥3% of patients in any treatment group† | ||
| Any Grade 3 or 4 laboratory abnormality | 72/225 (32) | 36/107 (34) |
| Proportional difference (95% CI) | –1.9% (–12.7%–8.9%) | |
| Alanine aminotransferase >5 × ULN | 16 (7) | 10 (9) |
| Aspartate aminotransferase >5 × ULN | 5 (2)‡ | 4 (4)‡ |
| Creatine kinase ≥10 × ULN | 9 (4) | 4 (4) |
| Fasting LDL cholesterol >190 mg/dL | 9/224 (4)‡ | 0/106 |
| Hemoglobin <9 g/dL | 2 (<1)‡ | 5 (5)‡ |
| Urine glucose (by dipstick) 4+ | 7 (3)‖ | 1 (1)‖ |
| Occult blood | 24 (11)‖ | 13 (12)‖ |
| Urine erythrocytes | 14/114 (14)‖ | 8/46 (17)‡ |
All AEs and Grade 3 or 4 laboratory abnormalities were treatment-emergent. ULN, upper limit of normal range; CI, confidence interval. *64 yr-old woman had study treatment discontinued for an AE of Grade 2 renal impairment on Day 290 that was an SAE and related to study drug. †Laboratory results are based on 225 patients for TAF 25 mg, and 107 patients for TDF 300 mg, unless otherwise noted. ‡Only Grade 3 abnormalities were observed for these parameters. ‖Grade 3 was the highest grade for these parameters.