1State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, China.
2State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, School of Public Health, Xiamen University, Xiamen, China.
3Department of Infectious Diseases, Ruijin Hospital, Jiaotong University School of Medicine, Shanghai, China.
4Department of Infectious Diseases, Tangdu Hospital, Xi'an, China.
5Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
6Beijing Ditan Hospital, Capital Medical University, Beijing, China.
7Department of Infectious Diseases, First Hospital of Peking University, Beijing, China.
8Department of Hepatology, First Hospital, Jilin University, Changchun, China.
9Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, China.
10Hepatology Unit, Peking University People's Hospital, Beijing, China.
11Department of Infectious Diseases, Xiangya Hospital, Central South University, Changsha, China.
12Department of Infectious Diseases, Changhai Hospital, Shanghai, China.
13Ji'nan Infectious Diseases Hospital, Ji'nan, China.
148th People's Hospital, Guangzhou, China.
15Beijing Youan Hospital, Capital Medical University, Beijing, China.
16Department of Infectious Diseases, West China Hospital, Chengdu, China.
17Department of Infectious Diseases, Zhejiang University 1st Affiliated Hospital, Hangzhou, China.
18Department of Microbiology, Health science Center, Peking University, Beijing, China.
19Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
20State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, China Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Zhejiang University, Hangzhou, China.
The investigation regarding the clinical significance of quantitative hepatitis B core antibody (anti-HBc) during chronic hepatitis B (CHB) treatment is limited. The aim of this study was to determine the performance of anti-HBc as a predictor for hepatitis B e antigen (HBeAg) seroconversion in HBeAg-positive CHB patients treated with peginterferon (Peg-IFN) or nucleos(t)ide analogues (NUCs), respectively.
This was a retrospective cohort study consisting of 231 and 560 patients enrolled in two phase IV, multicentre, randomised, controlled trials treated with Peg-IFN or NUC-based therapy for up to 2 years, respectively. Quantitative anti-HBc evaluation was conducted for all the available samples in the two trials by using a newly developed double-sandwich anti-HBc immunoassay.
At the end of trials, 99 (42.9%) and 137 (24.5%) patients achieved HBeAg seroconversion in the Peg-IFN and NUC cohorts, respectively. We defined 4.4 log10 IU/mL, with a maximum sum of sensitivity and specificity, as the optimal cut-off value of baseline anti-HBc level to predict HBeAg seroconversion for both Peg-IFN and NUC. Patients with baseline anti-HBc ≥4.4 log10 IU/mL and baseline HBV DNA <9 log10 copies/mL had 65.8% (50/76) and 37.1% (52/140) rates of HBeAg seroconversion in the Peg-IFN and NUC cohorts, respectively. In pooled analysis, other than treatment strategy, the baseline anti-HBc level was the best independent predictor for HBeAg seroconversion (OR 2.178; 95% CI 1.577 to 3.009; p<0.001).
Baseline anti-HBc titre is a useful predictor of Peg-IFN and NUC therapy efficacy in HBeAg-positive CHB patients, which could be used for optimising the antiviral therapy of CHB.