Mean (SD) or n (%) | Week 24 | Week 48 | Week 72 | ||||||
Stop (n=45) | Continue (n=22) | P value | Stop (n=45) | Continue (n=22) | P value | Stop (n=45) | Continue (n=22) | P value | |
Virological outcome | |||||||||
HBV DNA <2000 IU/mL | 15 (33) | 20 (91) | <0.005* | 12 (27) | 21 (95) | <0.005* | 13 (29) | 20 (91) | 0.04* |
HBV DNA <200 IU/mL | 9 (20) | 20 (91) | <0.005* | 7 (16) | 21 (95) | <0.005* | 5 (11) | 20 (91) | <0.005* |
Undetectable HBV DNA (<20 IU/mL) | 6 (13) | 19 (86) | <0.005* | 4 (8.9) | 21 (95) | <0.005* | 1 (2.2) | 20 (91) | <0.005* |
Serological outcome | |||||||||
HBeAg seroreversion | 0 (0.0) | 0 (0.0) | 1.00 | 2 (4.4) | 0 (0.0) | 1.00 | 1 (2.2) | 0 (0.0) | 1.00 |
HBeAg neg+HBV DNA <2000 IU/mL +ALT ≤ULN | 15 (33) | 16 (73) | <0.005* | 12 (27) | 19 (86) | <0.005* | 13 (29) | 18 (82) | <0.005* |
HBsAg loss | 1 (2.2) | 1 (4.5) | 1.00 | 1 (2.2) | 1 (4.5) | 1.00 | 1 (2.2) | 1 (4.5) | 1.00 |
HBsAg decline >1 log IU/mL from Wk 0 | 1 (2.2) | 0 (0.0) | 1.00 | 1 (2.2) | 0 (0.0) | 1.00 | 4 (8.9) | 0 (0.0) | 0.29 |
Biochemical outcome | |||||||||
ALT normalisation (≤ULN) | 28 (62) | 16 (73) | 0.40 | 26 (58) | 19 (86) | 0.03* | 21 (47) | 18 (82) | 0.01* |
ALT ≤ULN+HBV DNA <2000 IU/mL | 15 (33) | 16 (73) | <0.005* | 12 (27) | 19 (86) | <0.005* | 13 (29) | 18 (82) | <0.005* |
Histological outcome | |||||||||
LSM (kPa) | – | – | – | 5.1 (1.6) | 5.1 (2.2) | 0.98 | 5.2 (1.6) | 5.3 (1.6) | 0.90 |
LSM change from week 0 (kPa)† | – | – | – | 0.2 (−0.7- 1.0) | 0.1 (−0.8- 0.7) | 0.53 | 0.0 (−0.9- 1.0) | 0.1 (−0.5- 0.9) | 0.83 |
Retreatment | |||||||||
Retreated | 12 (27) | – | – | 13 (29) | – | – | 17 (38) | – | – |
Data presented as mean (SD) or n (%). At the time of a missing visit (two patients in continue group) or at the time of retreatment, patients were coded as not having achieved a virological, serological or biochemical outcome. Groups with low cell frequencies (<5) were compared with Fisher’s exact test.
*P<0.05.
†Median (IQR).
ALT, alanine aminotransferase; LSM, liver stiffness measurement; ULN, upper limit of normal.