Clinical study of hepatitis B vaccine in achieving hepatitis B surface antibody seroconversion in patients with functional cure

Liu, Yisi; Ren, Shan; Ma, Lina; Lin, Xiao; Li, Hong; Lu, Junfeng; Cao, Zhenhuan; Zheng, Sujun; Hu, Zhongjie; Chen, Xinyue

doi:10.1016/j.bjid.2023.103703

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Original Article • Braz J Infect Dis 27 (6) • 2023 • https://doi.org/10.1016/j.bjid.2023.103703 linkcopy

Clinical study of hepatitis B vaccine in achieving hepatitis B surface antibody seroconversion in patients with functional cure

Authorship SCIMAGO INSTITUTIONS RANKINGS

Hepatitis B Surface Antigen (HBsAg) seroclearance is the highest treatment goal recommended by the current guidelines for hepatitis B. Levels of antibodies to HBsAg (anti-HBs) are strongly associated with HBsAg recurrence, but hepatitis B vaccination may increase the anti-HBs seroconversion rate and reduce recurrence. We conducted a retrospective clinical study to ascertain the effect of this vaccination on the seroconversion rate and levels of protective anti-HBs after HBsAg. In this retrospective study, we distributed a questionnaire through an online survey platform to collect information related to hepatitis B vaccination in patients with functional cure of hepatitis B with Interferon-α (IFNα) therapy. We enrolled 320 patients who achieved functional cure from IFNα therapy. Of these, 219 patients had received hepatitis B vaccination according to their personal preference and drug accessibility after HBsAg seroclearance, whereas the remaining 101 patients did not receive hepatitis B vaccination. The anti-HBs seroconversion rate of 78.1% in the vaccinated group was significantly greater than that in the unvaccinated group (41.6%) (p < 0.001). Stratified comparisons with anti-HBs of ≥ 100 IU/L and ≥ 300 IU/L showed that both proportions in the vaccinated group were greater than those in the unvaccinated group (71.2% vs. 32.7% and 56.2% vs. 17.8%, respectively, all p-values < 0.001). Logistic regression analysis showed that the odds ratio of vaccination was 4.427, which was the strongest influencing factor for anti-HBs, reaching 100 IU/L or higher. Hepatitis B vaccination in patients after HBsAg seroclearance not only increased the anti-HBs seroconversion rate but also significantly increased antibody levels, with good safety, indicating the clinical value of vaccine therapy for patients with functional cure.

Keywords
Hepatitis B; HBsAg seroclearance; Anti-HBs; Vaccination; Functional cure; IFNα therapy; Seroconversion rate

	Overall (n = 320)
Age, year	38.28 ± 9.68
Male, n (%)	194 (60.6%)
HBsAg level before IFN treatment, logIU/Ml	2.41±1.27
HBeAg status before IFN treatment
Positive, n (%)	203 (63.4%)
Negative, n (%)	117 (36.6%)
Median IFN treatment time, week	84
IFN consolidation therapy for more than 12-weeks after HBsAg seroclearance
Yes, n (%)	280 (87.5%)
No, n (%)	40 (12.5%)
Vaccination after HBsAg seroclearance
Yes, n (%)	219 (68.4%)
No, n (%)	101 (31.6%)

	Vaccinated group (n = 219)	Unvaccinated groups (n = 101)	p-value
anti-HBs seroconversion rate (≥10 IU/L)	78.1% (171/219)	41.6% (42/101)	< 0.001
Proportion of patients with anti-HBs of ≥100 IU/L	71.2% (156/219)	32.7% (33/101)	< 0.001
Proportion of patients with anti-HBs of ≥300 IU/L	56.2% (123/219)	17.8% (18/101)	< 0.001

	Anti-HBs ≥ 100 IU/L			Logistics analysis
	Yes (n = 189)	No (n = 131)	p-value	OR	95% CI	p-value
Sex			0.548
Male, n (%)	112 (59.3%)	82 (62.6%)		0.756	0.441‒1.295	0.308
Female, n (%)	77 (40.7%)	49 (37.4%)
Age, year	36.69 ± 8.77	40.58 ± 10.46	< 0.001	0.955	0.929‒0.982	0.001
Median IFN treatment time, week	96	72	0.173	0.999	0.994‒1.004	0.558
Proportion of IFN consolidation therapy for more than 12 weeks after HBsAg seroclearance	92.1% (174/189)	80.9% (106/131)	0.003	2.246	1.023‒4.931	0.044
Proportion of vaccination after HBsAg seroclearance	82.5% (156/189)	48.1% (63/131)	< 0.001	4.396	2.541‒7.604	< 0.001

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