Table 4. Flares in sSerum ALT levels During Therapy of A5127 Study Subjects.
| Week | Baseline | Max | x baseline | X ULN‡ | ||
|---|---|---|---|---|---|---|
| ADV arm* | 1 | 12 | 68 | 383 | 5.6 | 6.4 |
| 2 | 14 | 95 | 319 | 3.4 | 5.3 | |
| 3 | 24 | 49 | 168 | 3.4 | 4.2 | |
| 4 | 36 | 55 | 228 | 4.1 | 5.7 | |
| 5 | 48 | 23 | 73 | 3.2 | 1.6 | |
| TDF arm† | 1 | 8 | 39 | 621 | 15.9 | 7.9 |
| 2 | 12 | 77 | 278 | 3.6 | 6.0 | |
| 3 | 16 | 120 | 355 | 3.0 | 7.1 | |
| 4 | 51 | 70 | 214 | 3.1 | 4.7 | |
| 5 | 57 | 43 | 134 | 3.1 | 2.1 | |
| 6 | 60 | 36 | 146 | 4.1 | 2.4 |
*
Of those subjects on ADV: subjects 1, 2, 5 completed 96 weeks of treatment; subject 3 discontinued at week 35 with HCC; subject 4 discontinued at week 57 per MD request.
†
Of those subjects on TDF: subjects 1, 3, 4, and 6 completed treatment; subject 2 discontinued at week 20 per patient request and subject 5 had multiple missed doses and discontinued at week 38 per patient request.
‡
ULN: upper limit of normal: There was no central laboratory for ALT determinations. ULN were determined by each separate laboratory site with range of 33-79 U/L.