Efficacy and safety of tenofovir in chronic hepatitis B: Australian real world experience

Table 1 Baseline demographics

Baseline demographics	Total population (n = 92)	Treatment naïve (n = 55)	Treatment experienced, viraemic (n = 20)	Treatment experienced, non-viraemic (n = 17)
Age (yr)
Mean (IQR)	46 (36-54)	42 (32-53)	48 (41-57)	55 (44-60)
Gender n (%)
Male	64 (69.6)	39 (70.9)	11 (55)	14 (82.4)
Female	28 (30.4)	16 (29.1)	9 (45)	3 (17.6)
Ethnic origin n (%)
African	4 (4.3)	3 (5.5)	0	1 (5.9)
Asian	77 (83.7)	48 (87.3)	16 (80)	13 (76.5)
Caucasian	5 (5.4)	3 (5.5)	0	2 (11.8)
Mediterranean	2 (2.2)	1 (1.8)	1 (5)	0
Middle Eastern	1 (1.1)	0	1 (5)	0
Duration of therapy (mo)
Median (IQR)	24 (6-42)	24 (12-36)	24 (6-54)	24 (12-42)
HBe antigen status n (%)
HBeAg positive	30 (32.6)	19 (34.5)	10 (50)	1 (5.9)
HBeAg negative	62 (67.4)	36 (65.5)	10 (50)	16 (94.1)
Treatment history n (%)
Experienced	37 (40.2)	0	20 (100)	17 (100)
Adefovir	10 (27)		4 (20)	6 (35.3)
Adefovir/lamivudine	13 (35.1)		6 (30)	7 (41.2)
Lamivudine	6 (16.2)		4 (20)	2 (11.8)
Lamivudine/entecavir	1 (2.7)		1 (5)	0
Entecavir	5 (13.5)		4 (20)	1 (5.9)
Entecavir/adefovir	2 (5.4)		1 (5)	1 (5.9)
Naïve	55 (59.8)	55 (100)	0	0
HBV DNA load (IU/mL) n (%)
< 20	17	-	-	17 (100)
20-2000	29 (31.5)	6 (10.9)	6 (30)	0
2000-100000	11 (12)	8 (14.5)	3 (15)	0
> 100000	52 (56.5)	41 (74.5)	11 (55)	0
Median (IQR)	1.8 × 105 (302-1.6 × 107)	9.4 × 105 (9.7 × 104-3.7 × 107)	1.8 × 105 (790-4.1 × 106)	N/A
ALT (U/L) n (%)
0-20	11 (12)	2 (3.6)	4 (20)	5 (29.4)
20-40	26 (28.3)	10 (18.2)	8 (40)	8 (47.1)
40-400	51 (55.4)	39 (70.9)	8 (40)	4 (23.5)
> 400	4 (4.3)	4 (7.3)	0	0
Median (IQR)	30 (22-41.8)	73 (41-140)	34 (22.3-62.3)	24 (19-44)
Serum creatinine (IU/mL)
Median (IQR)	70 (60-81.5)	66.5 (50.8-71.5)	71 (63.5-84.5)	83 (69-93)
Pre-treatment biopsy n (%)	69 (75)	40 (72.7)	16 (80)	14 (82.4)
Fibrosis score n (%)
0	9 (9.8)	5 (9.1)	3 (15)	3 (17.6)
1	31 (33.7)	21 (38.2)	6 (30)	4 (23.5)
2	13 (14.1)	8 (14.5)	3 (15)	2 (11.8)
3	7 (7.6)	1 (1.8)	2 (10)	4 (23.5)
4	9 (9.8)	5 (9.1)	2 (10)	2 (11.8)
Genotype n (%)	35 (38)	6 (10.9)	9 (45)	12 (70.6)
A	3 (3.3)	2 (3.6)	0	1 (5.9)
B	7 (7.6)	2 (3.6)	1 (5)	4 (23.5)
C	13 (14.1)	2 (3.6)	7 (35)	4 (23.5)
D	3 (3.3)	0	0	2 (11.8)

“Treatment experience” refers to previous NA therapy. “Viraemia” refers to HBV DNA > 20 IU/mL. Liver biopsy was scored using the METAVIR scoring system. HBe: Hepatitis B “e”; HBV DNA: Hepatitis B viral deoxyribonucleic acid; ALT: Alanine aminotransferase; N/A: Not applicable.

Table 2 Virological suppression at on-treatment time-points (n = 92)

Follow-up (mo)	0	6	12	18	24	30	36
Patients with viral load n (%)	92 (100)	74 (80.4)	65 (70.7)	58 (63)	46 (50)	30 (32.6)	28 (30.4)
Virological suppression n (%)	18 (19.6)	41 (55.4)	45 (69.2)	46 (79.3)	37 (80.4)	26 (86.7)	25 (89.3)

“Patients with viral load” refers to the number of patients at each time point who had an available HBV DNA reading. “Virological suppression” refers to the number of patients with HBV DNA < 20 IU/mL. HBV: Hepatitis B virus.

Table 3 Cox regression model of predictors of end of follow-up virological suppression (n = 74¹)

Covariates	Multivariable
	Hazard ratio (95%CI)	P value
Baseline HBV DNA (log10 IU/mL)	0.897 (0.833-0.967)	0.0046
HBeAg status (HBeAg pos vs neg)	0.373 (0.183-0.762)	0.0069
Treatment experience (Naïve vs experienced)	1.189 (0.598-2.364)	0.6207
Age (yr)	1.018 (0.992-1.044)	0.1760
ALT (log10 IU/mL)	1.093 (0.816-1.465)	0.5505

¹Excludes patients who were not viraemic at baseline. HBV: Hepatitis B virus; ALT: Alanine aminotransferase.