Quantitation of HBsAg predicts response to entecavir therapy in HBV genotype C patients

doi:10.3748/wjg.v18.i39.5570

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Oct 21, 2012 (publication date) through May 3, 2024

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World Journal of Gastroenterology

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1007-9327

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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World J Gastroenterol. Oct 21, 2012; 18(39): 5570-5575
Published online Oct 21, 2012. doi: 10.3748/wjg.v18.i39.5570

Table 1 Baseline characteristics of the patients with hepatitis B virus genotype C

	HBeAg-negative group	HBeAg-positive group	P value
No.	26	24	NS
Age (yr)	57.2 (35-80)	44.2 (35-71)	< 0.01
Gender, M:F	15:16	16:11	NS
Diseases, CH:LC/HCC	21:5	23:1	NS
ALT (IU/mL)	38 (13-950)	102 (812-602)	< 0.01
Platelet counts (× 10⁴/mL)	18.6 (3.4-4.9)	18.0 (8.4-26.8)	NS
Albumin (mg/dL)	4.3 (3.4-4.9)	4.2 (2.3-5.0)	NS
Serum HBV DNA level	5.1 (3.9-8.8)	7.6 (5.6-8.8)	< 0.01
(log copies/mL)	5.1 (3.9-8.8)	7.6 (5.6-8.8)	< 0.01

All data are shown by median (range). HBeAg: Hepatitis B e antigen; HBV: Hepatitis B virus; ALT: Alanine aminotransferase; CH: Chronic hepatitis; LC: Liver cirrhosis; HCC: Hepatocellular carcinoma; NS: Not significant.

Table 2 Clinical and virological results among the hepatitis B e antigen-negative group, the rapid-responders, and the slow-responders in the hepatitis B e antigen-positive group during 2 years of entecavir therapy

Characteristics	HBeAg-negative group	HBeAg-positive group		P value
Characteristics	(n = 26)	RR (n = 14)	SR (n = 10)	RR vs SR
<Baseline data>
Age	58 (35-80)	45 (34-68)	43 (31-71)	NS
Gender (male:female)	13:13	9:5	6:4	NS
Disease (CH:LC/HCC)	21:5	13:1	6:4	NS
ALT (IU/L)	38 (13-950)	131 (12-602)	31 (13-108)	0.02
Platelet count (× 10⁴/mL)	18.6 (3.4-35.1)	17.1 (8.4-22.4)	20.0 (11.0-26.8)	NS
Albumin (mg/dL)	4.3 (3.4-4.9)	4.0 (2.3-5.0)	4.4 (3.7-4.6)	NS
HBV genotype C	100%	100%	100%	NS
HBV DNA (log copies/mL)	5.1 (3.9-8.8)	7.4 (5.6-8.8)	8.3 (7.1-8.8)	NS
qHBsAg (log IU/mL)	3.17 (0.70-4.58)	3.63 (1.68-4.34)	4.57 (4.35-4.76)	< 0.01
HBcrAg (log U/mL)	3.6 (3.0-> 6.8)	> 6.8 (6-> 6.8)	> 6.8 (> 6.8-> 6.8)	NS
Pre-C mutation (%)	83.3	0	0	NS
Core promoter mutation (%)	58.3	57.1	50.0	NS
<At year 2 during therapy>
HBV DNA (log copies/mL)	0.0 (0.0-2.7)	2.1 (0.0-2.1)	3.5 (3.1-6.9)	-
ALT (IU/L)	18 (9-75)	17.5 (10-31)	23 (13-37)	NS
HBeAg seroconversion	-	23.50%	0%	NS
HBsAg seroclearance	0%	0%	0%	NS
qHBsAg (log IU/mL)	2.91 (0.62-3.9)	3.25 (1.70-3.92)	4.12 (3.23-4.47)	0.01
HBcrAg (log U/mL)	3.0 (3.0-5.4)	5.9 (4.0-> 6.8)	> 6.8 (5.2-> 6.8)	< 0.01
Resistant mutations against entecavir	UDL	UDL	0%	-

HBeAg: Hepatitis B e antigen; ALT: Alanine aminotransferase; CH: Chronic hepatitis; LC: Liver cirrhosis; HCC: Hepatocellular carcinoma; UDL: Under the detection limit; HBV: Hepatitis B virus; HBsAg: Hepatitis B surface antigen; qHBsAg: Quantitation of HBsAg level; HBcrAg: HBV core-related antigen; NS: Not significant; RR: Rapid-responder; SR: Slow-responder.

Table 3 Drug resistant mutations in the slow-responders at year 2

Patient	Age (yr)	Gender	Previous therapy	HBV genotype	Drug resistant mutations against
					Lam	Lam	Lam/Ade	Ade	Ent	Ent	Ent
					L180	M204	A181	N236	T184	S202	M205
1	52	Male	No	C	Wild	Wild	Wild	Wild	Wild	Wild	Wild
2	35	Male	No	C	Wild	Wild	Wild	Wild	Wild	Wild	Wild
3	68	Male	No	C	Wild	Wild	Wild	Wild	Wild	Wild	Wild
4	56	Female	No	C	Wild	M204I	Wild	Wild	Wild	Wild	Wild
5	36	Female	No	C	Wild	M204I	Wild	Wild	Wild	Wild	Wild
6	45	Male	No	C	Wild	M204I	Wild	Wild	Wild	Wild	Wild
7	35	Male	No	C	Wild	Wild	Wild	Wild	Wild	Wild	Wild
8	67	Female	No	C	Wild	Wild	Wild	Wild	Wild	Wild	Wild
9	39	Male	No	C	Wild	Wild	Wild	Wild	Wild	Wild	Wild
10	44	Female	No	C	Wild	Wild	Wild	Wild	Wild	Wild	Wild

Lam: Lamivudine; Ade: Adefovir; Ent: Entecavir; HBV: Hepatitis B virus.

Table 4 Pretreatment clinical and virological characteristics between hepatitis B virus DNA-negative and -positive group at year 2 during entecavir therapy

Characteristics	HBV DNA-negative group	HBV DNA-positive group	P value
Characteristics	(n = 19)	(n = 31)	Univariate analysis	Multivariate analysis
Age	51 (31-73)	52 (32-80)	NS
Gender (male:female)	12:7	20:11	NS
Disease (CH:LC/HCC)	17:2	27:4	NS
ALT (IU/L)	36 (12-366)	108 (13-602)	0.03	NS
Platelet counts (× 10⁴/mL)	19.0 (8.8-35.1)	17.8 (3.4-26.8)	NS
Albumin (mg/dL)	4.35 (3.84-4.85)	4.14 (2.28-4.72)	NS
HBV genotype (B:C:others)	0:19:0	0:31:	NS
HBeAg status (positive:negative)	3:16	21:10	< 0.01	NS
HBV DNA (log copies/mL)	5.1 (3.1-7.4)	7.6 (3.7-8.8)	< 0.01	NS
qHBsAg level (log IU/mL)	3.31 (1.90-4.08)	4.20 (3.06-4.87)	< 0.01	0.03
HBcrAg level (log U/mL)	3.45 (3.0-> 6.8)	> 6.8 (3.0-> 6.8)	NS
Pre-C mutation (%)	75.0	43.3	NS
Core promoter mutation (%)	37.5	60.0	NS

CH: Chronic hepatitis; LC: Liver cirrhosis; HCC: Hepatocellular carcinoma; ALT: Alanine aminotransferase; HBV: Hepatitis B virus; HBeAg: Hepatitis B e antigen; qHBsAg: Quantitation of hepatitis B surface antigen level; HBcrAg: HBV core-related antigen; NS: Not significant.

Citation: Orito E, Fujiwara K, Kanie H, Ban T, Yamada T, Hayashi K. Quantitation of HBsAg predicts response to entecavir therapy in HBV genotype C patients. World J Gastroenterol 2012; 18(39): 5570-5575
URL: https://www.wjgnet.com/1007-9327/full/v18/i39/5570.htm
DOI: https://dx.doi.org/10.3748/wjg.v18.i39.5570