Entecavir vs lamivudine therapy for naïve patients with spontaneous reactivation of hepatitis B presenting as acute-on-chronic liver failure

Table 1 Baseline data comparison between entecavir and lamivudine groups n (%)

Group	Entecavir (n = 65)	Lamivudine (n = 54)	t/χ2	P value
Age (yr)	42.8 ± 13.1	45.6 ± 11.4	1.230	0.221
Males	41 (63.1)	36 (66.7)	0.166	0.683
Total bilirubin (μmol/L)	331.6 ± 74.8	320.1 ± 82.4	0.797	0.427
ALT level (U/L)	352.5 ± 77.2	345.2 ± 89.5	0.478	0.634
HBeAg-positive	21 (32.3)	23 (42.6)	1.339	0.247
anti-HBc IgM	40 (61.5)	29 (53.7)	0.743	0.389
HBV DNA (log10 copies/mL)	7.0 ± 1.4	7.2 ± 1.6	0.727	0.469
Prothrombin activity (%)	24.7 ± 6.0	25.1 ± 5.7	0.370	0.712
Albumin (g/L)	28.7 ± 6.9	29.4 ± 5.3	0.611	0.543
Creatinine (μmol/L)	106.3 ± 42.1	109.7 ± 38.6	0.455	0.650
Sodium (mmol/L)	130.6 ± 11.4	127.2 ± 12.6	1.544	0.125
Ascites	52 (80.0)	45 (75.9)	0.217	0.641
Hepatic encephalopathy	17 (26.2)	15 (27.8)	0.040	0.842
I-II	14 (21.5)	13 (24.1)	0	1
III-IV	3 (4.6)	2 (3.7)	0	1
Spontaneous bacterial peritonitis	15 (23.1)	11 (20.4)	0.127	0.722
CTP points	11.2 ± 2.4	10.7 ± 2.1	1.196	0.234
MELD points	27.2 ± 6.5	26.8 ± 6.3	0.339	0.735

All values are expressed as mean ± SD or number (%). ALT: Alanine aminotransferase; HBeAg: Hepatitis B e antigen; CTP: Child-Turcotte Pugh; MELD: Model for end-stage liver disease.

Table 2 Virological, biochemical responses and severity scores

Characteristics	Entecavir (n = 65)	Lamivudine (n = 54)	t/χ2/z	P value
Virological
Serum HBV DNA level (log10 copies/mL)
Day 15	4.6 ± 1.1	5.4 ± 1.2	3.790	< 0.001
Day 30	3.9 ± 1.0	4.8 ± 1.3	4.266	< 0.001
Day 45	3.6 ± 0.8	4.5 ± 1.0	5.454	< 0.001
Day 60	3.4 ± 0.5	4.4 ± 0.9	7.653	< 0.001
Undetectable HBV DNA n (%)
Day 15	3 (4.6)	0 (0.0)	1.024	0.312
Day 30	15 (23.1)	6 (11.1)	2.906	0.088
Day 45	21 (32.3)	8 (14.8)	4.897	0.027
Day 60	24 (36.9)	9 (16.7)	6.039	0.014
Biochemical
Serum ALT level (U/L)
Day 15	187.4 ± 67.5	231.6 ± 81.1	3.231	0.002
Day 30	86.2 ± 22.4	94.7 ± 37.3	1.410	0.163
Day 45	54.4 ± 19.6	60.8 ± 28.7	1.222	0.226
Day 60	45.1 ± 20.8	51.6 ± 22.3	1.455	0.149
Severity
CTP score
Day 15	10.4 ± 2.7	10.2 ± 3.4	0.348	0.348
Day 30	8.7 ± 3.6	9.9 ± 4.2	1.678	0.096
Day 45	7.4 ± 2.1	8.5 ± 3.7	2.035	0.044
Day 60	6.6 ± 2.4	8.2 ± 3.5	2.478	0.016
MELD score
Day 15	25.2 ± 7.1	25.7 ± 8.4	0.350	0.727
Day 30	22.6 ± 6.7	24.5 ± 7.2	1.489	0.139
Day 45	17.8 ± 7.4	20.6 ± 8.2	1.956	0.052
Day 60	13.7 ± 4.6	16.1 ± 6.5	2.352	0.020

All values are expressed as mean ± SD. ALT: Alanine aminotransferase; CTP: Child-Turcotte Pugh; MELD: Model for end-stage liver disease.

Table 3 Univariate analysis of baseline predictors of 52-wk survival n (%)

Group	Survivors (n = 68)	Non-survivors (n = 51)	t/χ2/z	P value
Age (yr)	39.4 ± 11.7	43.2 ± 9.9	1.871	0.064
Males	38 (55.9)	39 (76.5)	5.409	0.020
Platelet count (103/μL)	93.5 ± 38.2	87.3 ± 34.1	0.917	0.361
ALT level (U/L)	367.3 ± 80.4	345.0 ± 72.6	1.560	0.121
HBeAg-positive	20 (29.4)	24 (47.1)	3.895	0.048
HBV DNA (log10 copies/mL)	7.2 ± 1.4	6.9 ± 1.5	1.122	0.264
HBV DNA undetectable (< 103 copies/mL)
Day 15	3 (4.4)	0 (0.0)	2.309	0.129
Day 30	17 (25.0)	5 (9.8)	4.466	0.035
Day 45	20 (29.4)	9 (17.6)	2.189	0.139
Day 60	21 (30.9)	12 (23.5)	1.020	0.313
Treatment with entecavir	42(61.8)	23 (45.1)	3.266	0.071
CTP points (> 10/< 10)	30/38	33/18	4.958	0.026
MELD points (> 25/< 25)	28/40	32/19	5.423	0.020

All values are expressed as mean ± SD or number (%). ALT: Alanine aminotransferase; HBeAg: Hepatitis B e antigen; CTP: Child-Turcotte Pugh; MELD: Model for end-stage liver disease.