背景和目的：在慢性乙型肝炎（CHB）患者中停止核苷（酸）类似物（NAs）治疗并不常见。虽然一些指南中出现了停用标准，但评估停用 NA 的指标有限，是否可以安全停用 NA 仍然是一个棘手的临床问题。我们的研究旨在探讨治疗结束（EOT）时血清前基因组 RNA（pgRNA）和乙型肝炎核心相关抗原（HBcrAg）在指导 CHB 患者安全停用 NA 中的作用。
Serum Pregenomic RNA Combined With Hepatitis B Core-Related Antigen Helps Predict the Risk of Virological Relapse After Discontinuation of Nucleos(t)ide Analogs in Patients With Chronic Hepatitis B
Fa-Da Wang 1 2 , Jing Zhou 1 , Lan-Qing Li 1 , Meng-Lan Wang 1 , Ya-Cao Tao 1 , Yong-Hong Wang 1 , Dong-Mei Zhang 1 , En-Qiang Chen 1
Affiliations
Affiliations
1
Center of Infectious Diseases, West China Hospital, Sichuan University, Chengdu, China.
2
Department of Infectious Disease, Chengdu Third People's Hospital, Chengdu, China.
Background and aim: Cessation of nucleos(t)ide analogs (NAs) therapy in patients with chronic hepatitis B (CHB) is uncommon. Although criteria for discontinuation appear in some guidelines, the indicators for assessing discontinuation of NAs are limited, whether NAs can be safely ceased remains a difficult clinical issue. Our study aimed to investigate the role of serum pregenomic RNA (pgRNA) and hepatitis B core-related antigen (HBcrAg) at the end of treatment (EOT) in guiding the safe discontinuation of NAs in CHB patients.
Methods: This is a retrospective study, clinical data of all CHB patients who discontinued NAs treatment at West China Hospital between June 2020 and January 2021 were collected, including EOT pgRNA, HBcrAg, hepatitis B surface antigen (HBsAg), etc. All patients should meet the Asian-Pacific guideline for discontinuation. Observing virological relapse (VR) rates during 1 year of NAs discontinuation and analyzing the relationship between EOT pgRNA, HBcrAg, and VR.
Results: A total of 64 patients were enrolled in this study and 33 (51.5%) patients experienced VR in 1 year. EOT pgRNA positivity (OR = 14.59, p = 0.026) and EOT higher HBcrAg levels (OR = 14.14, p = 0.001) were independent risk factors for VR. The area under the receiver-operating characteristic (AUROC) value of EOT HBcrAg for VR was 0.817 (p < 0.001), optimal cut-off value was 3.3 log10 U/mL. Patients with EOT pgRNA positivity and EOT HBcrAg >3.3 log10 U/mL were more likely to experience VR after discontinuation of NAs (88.9 vs. 45.5%, p = 0.027).
Conclusion: According to current guidelines, a higher VR rate occurs after cessation of NAs. EOT pgRNA positivity and higher HBcrAg level carries a higher risk of VR. Combining these novel markers can better help us assess whether patients can safely cease NAs treatment.