Safety and efficacy of tenofovir in chronic hepatitis B-related decompensated cirrhosis

Table 1 Baseline characteristics of the compensated and decompensated liver cirrhosis groups

	All (n = 174)	Compensated LC (n = 117)	Decompensated LC (n = 57)	P value
Male/female	114/60	73/44	41/16	0.238
Age (yr)	52.2 ± 11.0	52.3 ± 11.0	51.9 ± 11.0	0.889
HBeAg positive	78/96 (44.8%)	50/67 (42.7%)	28/29 (49.1%)	0.516
HBV DNA (log10 copies/mL)	6.49 ± 1.40	6.34 ± 1.40	6.79 ± 1.35	0.065
ALT (IU/L)	92.8 ± 165.6	77.2 ± 115.2	124.4 ± 235.5	0.014
TB (mg/dL)	1.71 ± 2.40	1.06 ± 0.97	3.04 ± 3.61	0.000
PT INR	1.27 ± 0.29	1.14 ± 0.12	1.49 ± 0.36	0.000
Albumin (g/dL)	3.9 ± 2.95	4.35 ± 3.51	3.03 ± 0.66	0.000
Platelet count(103/μL)	115.0 ± 48.5	127.7 ± 47.4	90.9 ± 41.1	0.000
Child score	6.1 ± 1.6	5.2 ± 0.5	8.0 ± 1.5	0.000
MELD score	10.1 ± 4.0	8.3 ± 1.87	13.4 ± 4.76	0.000
Ascites			20
Episode of HE			1
Episode of varix bleeding			4

LC: Liver cirrhosis.

Table 2 Virological, serological and biochemical response after 12 mo of tenofovir disoproxil fumarate therapy n (%)

	All (n = 174)	Compensated LC (n = 117)	Decompensated LC (n = 57)	P value
Virological response
Change in serum HBV DNA level
Month 6	-4.07 ± 1.39	-4.00 ± 1.42	-4.20 ± 1.32	0.581
Month 12	-4.30 ± 1.38	-4.20 ± 1.39	-4.49 ± 1.35	0.310
Serum HBV DNA undetectable1
Month 6	96 (55.2)	67 (57.3)	29 (50.9)	0.516
Month 12	144 (82.8)	104 (88.9)	40 (70.2)	0.005
Serological
HBeAg seroconversion
Month 6	6/78 (7.7)	3/50 (6.0)	3/28 (10.7)	0.664
Month 12	7/78 (8.9)	3/50 (6.0)	4/28 (14.2)	0.373
HBeAg loss
Month 6	2/78 (2.5)	2 (4.0)	0 (0)	0.427
Month 12	2/78 (2.5)	2 (4.0)	0 (0)	0.517
Biochemical
ALT normalization
Month 6	108 (62.0)	72 (61.5)	36 (63.2)	0.869
Month 12	121 (69.5)	77 (65.8)	44 (77.2)	0.161

¹HBV DNA < 116 copies/mL. LC: Liver cirrhosis. HBV: Hepatitis B virus; HBeAg: Hepatitis B e antigen.

Table 3 Virological response after 12 mo of tenofovir disoproxil fumarate therapy according to HBeAg status n (%)

	All	Compensated LC (n = 50)	Decompensated LC (n = 28)	P value
Virological response of HBeAg positive patients (n = 78)
Change in serum HBV DNA level
Month 6	-4.32 ± 1.33	-2.89	-3.18	0.926
Month 12	-4.65 ± 1.33	-4.56 ± 1.45	-4.82 ± 1.08	0.701
Serum HBV DNA undetectable
Month 6	31 (39.7)	20/50 (40)	11/17(39.2)	1.000
Month 12	54 (74.3)	40/10(80)	14/14(50)	0.010
		Compensated LC (n = 67)	Decompensated LC (n = 29)
Virological response of HBeAg negative patients (n = 96)
Change in serum HBV DNA level
Month 6	-3.86 ± 1.40	-3.78 ± 1.39	-4.04 ± 1.43	0.576
Month 12	-4.01 ± 1.37	-3.94 ± 1.30	-4.19 ± 1.51	0.534
Serum HBV DNA undetectable
Month 6	65 (67.7)	47/20 (70.1)	18/11 (62.0)	0.481
Month 12	90 (93.7)	64/3 (95.5)	26/3 (89.6)	0.362

LC: Liver cirrhosis. HBV: Hepatitis B virus; HBeAg: Hepatitis B e antigen.

Table 4 Multivariate analysis for complete virological response after 12 mo of tenofovir disoproxil fumarate therapy

	Regression coefficient	Standard error	OR (95%CI)	P value
Age (per year)	-0.018	0.022	0.982 (0.941-1.025)	0.412
Sex	0.427	0.543	1.533 (0.529-4.439)	0.431
ALT level (per 1 IU/L)	0.001	0.001	1.001 (0.999-1.003)	0.342
HBeAg	1.726	0.524	5.617 (2.011-15.689)	0.001
Positivity
Negativity
Baseline HBV DNA (per 1 log10 copies/mL)	0.117	0.184	1.124 (0.784-1.611)	0.525
Diagnosis	-1.080	0.456	0.340 (0.139-0.829)	0.018
Compensated
Decompensated

Table 5 Changes of creatinine clearance (eGFR) during tenofovir disoproxil fumarate therapy for 12 mo

	All (n = 174)	Mean eGFR (CKD-EPI equation)		P value
		Compensated LC (n = 117)	Decompensated LC (n = 57)
Baseline	95.2 ± 17.8	95.4 ± 14.8	94.8 ± 23.0	0.880
Week 12	91.1 ± 16.2	93.2 ± 13.0	86.6 ± 21.1	0.205
Week 24	91.1 ± 17.5	92.2 ± 14.2	89.2 ± 22.0	0.895
Week 36	90.6 ± 16.6	91.1 ± 14.4	89.7 ± 20.3	0.943
Week 48	90.7 ± 18.4	91.6 ± 14.9	88.9 ± 23.8	0.959

LC: Liver cirrhosis.