Add-on pegylated interferon augments hepatitis B surface antigen clearance vs continuous nucleos(t)ide analog monotherapy in Chinese patients with chronic hepatitis B and hepatitis B surface antigen ≤ 1500 IU/mL: An observational study

Table 1 Demographic and baseline characteristics of the study population

Characteristics	Add-on, n = 91	Monotherapy, n = 104	P value
Male (%)	62 (68.1)	76 (73.1)	0.528
Age in yr, mean ± SD	38.11 ± 9.74	37.34 ± 11.01	0.529
BMI in kg/cm2, mean ± SD	21.97 ± 1.72	22.13 ± 1.05	0.157
Mode of transmission
Vertical (%)	36 (39.6)	32 (30.8)	0.229
Others (%)	55 (60.4)	72 (69.2)
HBsAg at week 0
< 500 IU/mL (%)	56 (61.5)	49 (47.1)	0.089
500-1000 IU/mL (%)	17 (18.7)	32 (30.8)
1000-1500 IU/mL (%)	18 (19.8)	23 (22.1)
HBeAg status at enrollment
Negative (%)	91 (100)	104 (100)	_
HBV DNA at enrollment
< 1.0 × 102 IU/ mL (%)	91 (100.0)	104 (100.0)	_
ALT, IU/L, median (range)	24 (8.0-73)	27 (7-66)	0.558
AST, IU/L, median (range)	23 (12-70)	26 (14-66)	0.212
NA
ADV (%)	10 (11.0)	12 (11.5)	0.395
ETV (%)	50 (54.9)	66 (63.5)
TDF (%)	31 (34.1)	26 (25.0)
FibroScan value, kPa
mean ± SD	4.2 ± 1.1	4.5 ± 1.2	0.824

SD: Standard deviation; BMI: Body mass index; HBsAg: Hepatitis B surface antigen; HBeAg: Hepatitis B e antigen; HBV DNA: Hepatitis B virus-deoxyribonucleic acid; NA: Nucleos(t)ide analog; ADV: Adefovir dipivoxil; ETV: Entecavir; TDF: Tenofovir disoproxil fumarate; ALT: Alanine aminotransferase; AST: Aspartate transaminase.

Table 2 Baseline variables and change of hepatitis B surface antigen in weeks 12 and 24 associated with hepatitis B surface antigen clearance

Predictors	Univariate analysis			Multivariate analysis
	OR	95%CI	P value	OR	95%CI	P value
Gender	2.045	(0.792-5.283)	0.149	-	-	-
ALT in IU/L	0.997	(0.968-1.027)	0.852	-	-	-
FibroScan value in kPa	0.794	(0.549-1.125)	0.803	-	-	-
BMI in kg/cm2	0.962	(0.951-1.218)	0.794	-	-	-
NA	1.790	(0.758-4.225)	0.184	-	-	-
Mode of HBV transmission	0.840	(0.298-2.372)	0.742	-	-	-
Age, yr	0.924	(0.878-0.972)	0.002	0.946	(0.833-0.981)	0.025
Baseline HBsAg as log10 IU/mL	0.371	(0.194-0.711)	0.003	0.557	(0.206-0.827)	0.019
Week 12 HBsAg as log10 IU/mL	0.273	(0.157-0.474)	< 0.001	0.542	(0.194-0.792)	0.002
Week 24 HBsAg as log10 IU/mL	0.218	(0.117-0.405)	< 0.001	0.188	(0.058-0.410)	0.004
HBsAg decline as log10 IU/mL
From baseline to week 12	10.646	(3.776-25.018)	< 0.001	8.925	(3.376-17.226)	< 0.001
From baseline to week 24	7.045	(3.223-15.400)	< 0.001	8.830	(4.553-18.213)	< 0.001
ALT ≥ 2 × ULN in the first 12 wkF1	4.182	(1.691-10.340)	0.002	5.275	(3.324-11.823)	0.014

^F1ALT ≥ 2 × ULN during the first 12 wk of therapy. ALT: Alanine aminotransferase; BMI: Body mass index; NA: Nucleoside Analogue or nucleotide analog; HBV: Hepatitis B virus; ULN: Upper limit of normal; OR: Odds ratio; CI: Confidence interval; UI: International unit.

Table 3 ROC curves of hepatitis B surface antigen levels and hepatitis B surface antigen changes on the prediction of hepatitis B surface antigen clearance

Factors	Area	SD	95%CI	Cut-off point	Sensitivityand specificity	HBsAg clearance rate
Age in yr	0.699	0.056	(0.589-0.809)	33	55.9%, 77.2%	58.1% (18/31)
Baseline HBsAg as log10 IU/mL	0.689	0.059	(0.573-0.806)	2.25	52.9%, 80.7%	62.1% (18/29)
Week 12 HBsAg as log10 IU/mL	0.877	0.04	(0.803-0.951)	1.89	85.3%, 82.5%	73.7% (28/38)
Week 24 HBsAg as log10 IU/mL	0.921	0.03	(0.861-0.980)	1.46	94.1%, 78.9%	72.7% (32/44)
HBsAg decline as log10 IU/mL
From baseline to week 12	0.901	0.032	(0.839-0.963)	0.5	85.3%, 88.7%	80.0% (28/35)
From baseline to week 24	0.924	0.031	(0.864-0.985)	1.0	91.2%, 86.0%	77.5% (31/40)

ROC: Receiver operator characteristic; SD: Standard deviation; CI: Confidence interval; HBsAg: Hepatitis B surface antigen; UI: International unit.

Table 4 Adverse events of the study population, n (%)

AEs	Add-on, n = 91	Monotherapy, n = 104	P value
Neutropenia	80 (87.9)	8 (7.7)	< 0.001
Thrombocytopenia	82 (90.1)	9 (8.7)	< 0.001
Fever	75 (82.4)	0 (0)	< 0.001
Fatigue	53 (58.2)	10 (9.6)	< 0.001
Anorexia	49 (53.8)	3 (2.9)	< 0.001
Weight loss	15 (16.5)	0 (0)	< 0.001
Alopecia	10 (11.0)	0 (0)	< 0.001
Thyroid dysfunction	6 (6.6)	0 (0)	0.009
ALT flares	7 (7.7)	0 (0)	0.004
Rash	5 (5.5)	0 (0)	0.021
HCC	0 (0)	1 (1.0)	1.000
Virological breakthrough	0 (0)	2 (1.9)	0.500

AEs: Adverse events; ALT: alanine aminotransferase; HCC: Hepatocellular carcinoma.