Long-term virological and clinical evaluation of chronic hepatitis B patients under nucleos(t)ide analogues therapy

IF 2.6 4区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY
Maria Stella Franzè , Carlo Saitta , Daniele Lombardo , Cristina Musolino , Gaia Caccamo , Roberto Filomia , Concetta Pitrone , Irene Cacciola , Teresa Pollicino , Giovanni Raimondo
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Abstract

Introduction and objectives

Identifying hepatitis B virus (HBV) patients eligible for safe nucleos(t)ide analogues (NAs) discontinuation remains challenging. Discrepant data on combined HBV DNA and quantitative HBV surface antigen (qHBsAg) assessments are available. This study aimed to identify potential predictors for safe treatment discontinuation by evaluating clinical/virological outcomes in patients on long-term NA therapy.

Patients and methods

A retrospective cohort of 139 chronic hepatitis B (CHB) patients - who consecutively started Entecavir or Tenofovir from 2007 to 2011 - was evaluated. The study population was selected based on anti-HBe positivity, absence of prior antiviral treatment, absence of non-HBV-related liver diseases or hepatocellular carcinoma (HCC), and long-term clinical/ultrasonographic/laboratory evaluations post-NA initiation. Serum samples collected before starting NA (T0) and over ten years (T1-T10) were tested for HBV DNA and qHBsAg.

Results

Twenty-two/139 (15.8 %) CHB patients (12 chronic hepatitis, 10 cirrhosis) met the inclusion criteria. All patients showed a significant decrease in liver stiffness values in the ten years of follow-up (p = 0.001), and no hepatic decompensation occurred. Three/22 (13.6 %) patients developed HCC. Ten/22 patients (45.5 %; group-A) had fluctuating HBV DNA, while other 10/22 (45.5 %; group-B) showed undetectable HBV DNA for 5–9 years with more significant qHBsAg decline (p = 0.04) than group-A. Two/22 (9.1 %) patients showed a critical qHBsAg decline up to seroconversion together with undetectable HBV DNA.

Conclusions

Persistent undetectable HBV DNA levels correlate with qHBsAg reduction and the potential HBsAg seroclearance, suggesting that long-term HBV DNA monitoring in NA-treated CHB patients might help identify candidates for treatment discontinuation.
核苷类似物治疗慢性乙型肝炎患者的长期病毒学和临床评价。
介绍和目的:确定乙型肝炎病毒(HBV)患者符合安全核苷类似物(NAs)停药的条件仍然具有挑战性。联合HBV DNA和定量HBV表面抗原(qHBsAg)评估的数据存在差异。本研究旨在通过评估长期NA治疗患者的临床/病毒学结果,确定安全停药的潜在预测因素。患者和方法:对2007年至2011年连续服用恩替卡韦或替诺福韦的139例慢性乙型肝炎(CHB)患者进行回顾性队列研究。研究人群的选择基于抗乙型肝炎病毒阳性,既往未接受抗病毒治疗,无非乙型肝炎相关肝脏疾病或肝细胞癌(HCC),以及na启动后的长期临床/超声/实验室评估。采集NA开始前(T0)和10年后(T1-T10)的血清样本,检测HBV DNA和qHBsAg。结果:22 /139例(15.8%)CHB患者(12例慢性肝炎,10例肝硬化)符合纳入标准。随访10年,所有患者肝脏硬度值均显著降低(p = 0.001),未发生肝脏失代偿。3 /22(13.6%)患者发生HCC。10 /22例(45.5%;a组有HBV DNA波动,其他10/22例(45.5%);b组5 ~ 9年未检出HBV DNA, qHBsAg下降明显高于a组(p = 0.04)。2 /22(9.1%)的患者出现严重的qHBsAg下降直至血清转化,同时HBV DNA检测不到。结论:持续检测不到的HBV DNA水平与qHBsAg降低和潜在的HBsAg血清清除率相关,表明长期监测na治疗的CHB患者的HBV DNA可能有助于确定停药的候选人。
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来源期刊
CiteScore
4.30
自引率
3.70%
发文量
198
审稿时长
42 days
期刊介绍: Clinics and Research in Hepatology and Gastroenterology publishes high-quality original research papers in the field of hepatology and gastroenterology. The editors put the accent on rapid communication of new research and clinical developments and so called "hot topic" issues. Following a clear Editorial line, besides original articles and case reports, each issue features editorials, commentaries and reviews. The journal encourages research and discussion between all those involved in the specialty on an international level. All articles are peer reviewed by international experts, the articles in press are online and indexed in the international databases (Current Contents, Pubmed, Scopus, Science Direct). Clinics and Research in Hepatology and Gastroenterology is a subscription journal (with optional open access), which allows you to publish your research without any cost to you (unless you proactively chose the open access option). Your article will be available to all researchers around the globe whose institution has a subscription to the journal.
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