Table 3.
Summary of safety by treatment phase in patients from study 211 (SAS).
| On-treatment phase | |||||
|---|---|---|---|---|---|
| Patients originating from study 201 |
Patients originating from study 202 |
||||
| Patients reporting: | VS HBeAg (-) n = 26 | VS HBeAg (+) n = 43 | Total n = 69 | TN HBeAg (+) n = 23 | Overall total n = 92 |
| TEAE | 16 (62) | 26 (60) | 42 (61) | 12 (52) | 54 (59) |
| Grade 1 | 9 (35) | 11 (26) | 20 (29) | 6 (26) | 26 (28) |
| Grade 2 | 7 (27) | 14 (33) | 21 (30) | 3 (13) | 24 (26) |
| Grade 3 | 0 | 1 (2) | 1 (1) | 3 (13) | 4 (4) |
| TEAE related to study drug | 3 (12) | 5 (12) | 8 (12) | 2 (9) | 10 (11) |
| TE SAE | 0 | 0 | 0 | 1 (4) | 1 (1) |
| TEAE leading to study drug discontinuation | 0 | 0 | 0 | 2 (9) | 2 (2) |
| TEAEs found in ≥5% of the total patient population | |||||
| Upper respiratory tract infection | 3 (12) | 6 (14) | 9 (13) | 1 (4) | 10 (11) |
| Nasopharyngitis | 1 (4) | 3 (7) | 4 (6) | 2 (9) | 6 (7) |
| Fatigue | 1 (4) | 3 (7) | 4 (6) | 1 (4) | 5 (5) |
| Discontinued both VBR + NrtI (off-treatment phase, patients originating from study 201) | |||
|---|---|---|---|
| Patients reporting: | VS HBeAg (-)n = 23 | VS HBeAg (+)n = 18 |
Total N = 41 |
| AE | 10 (43) | 7 (39) | 17 (41) |
| Grade 1 | 2 (9) | 3 (17) | 5 (12) |
| Grade 2 | 5 (22) | 3 (17) | 8 (20) |
| Grade 3 | 3 (13) | 1 (6) | 4 (10) |
| AE related to study drug | 0 | 0 | 0 |
| SAE | 2 (9) | 0 | 2 (5) |
| AEs found in ≥5% of the total patient population | |||
| ALT increased | 6 (26) | 5 (28) | 11 (27) |
| AST increased | 2 (9) | 0 | 2 (5) |
| Headache | 1 (4) | 1 (6) | 2 (5) |
| Nausea | 2 (9) | 0 | 2 (5) |
| Back pain |
2 (9) |
0 |
2 (5) |
|
Discontinued both VBR + NrtI, then restarted NrtI (NrtI-restart phase, patients originating from study 201) | |||
| Patients reporting: |
VS HBeAg (-) n = 16 |
VS HBeAg (+) n = 14 |
Total N = 30 |
| AE | 3 (19) | 6 (43) | 9 (30) |
| Grade 1 | 1 (6) | 2 (14) | 3 (10) |
| Grade 2 | 0 | 3 (21) | 3 (10) |
| Grade 4 | 2 (13) | 1 (7) | 3 (10) |
| AE related to study drug | 0 | 0 | 0 |
| SAE | 0 | 0 | 0 |
| AEs found in ≥5% of the total patient population | |||
| ALT increased |
2 (13) |
3 (21) |
5 (17) |
|
Continued NrtI/ETV (off-treatment phase) | |||
|
Patients originating from study 201 |
Patients originating from study 202 |
||
|
Patients reporting: |
VS HBeAg (+) continue NrtI only n = 18 |
TN HBeAg (-) continue ETV only n = 6 |
|
| AE | 0 | 1 (17) | |
| Grade 1 | 0 | 1 (17) | |
Data shown are n (%).
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; ETV, entecavir; NrtI, nucleos(t)ide reverse transcriptase inhibitor; SAE, serious adverse event; SAS, safety analysis set; TE, treatment-emergent; TEAE, treatment-emergent adverse event; TN, treatment-naive; VBR, vebicorvir; VS, virologically-suppressed.