Kaewdech Apichat, Assawasuwannakit Suraphon, Sripongpun Pimsiri, Chamroonkul Naichaya, Tangkijvanich Pisit, Piratvisuth Teerha
Gastroenterology and Hepatology Unit, Division of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Thailand.
Department of Medicine, Panyananthaphikkhu Chonprathan Medical Center, Srinakharinwirot University, Nonthaburi, Thailand.
Front Med (Lausanne). 2022 Mar 24;9:859430. doi: 10.3389/fmed.2022.859430. eCollection 2022.
Discontinuation of antiviral therapy in chronic hepatitis B (CHB) patients leads to a higher hepatitis B surface antigen (HBsAg) loss; yet, clinical relapse (CR) may occur. SCALE-B score was developed to predict off-treatment CR; however, validation of SCALE-B beyond a 48-week follow-up is rare. We studied whether SCALE-B and hepatitis B virus ribonucleic acid (HBV RNA) could predict outcomes in CHB patients after a 2-year follow-up.
A total of 92 Thai CHB patients who stopped antiviral treatment were followed up; baseline characteristics, quantitative hepatitis B surface antigen (qHBsAg), hepatitis B core-related antigen (HBcrAg), and HBV RNA were collected at the time of discontinuation, and SCALE-B scores were calculated. Patients were followed up every 12 weeks for 48 weeks, and then, the intervals were upon primary doctors. Follow-up data regarding virological relapse (VR), CR, and HBsAg loss were obtained.
The median follow-up duration was 142 weeks; the cumulative incidences of VR, CR, and HBsAg loss were 65.2, 33.7, and 7.6%, respectively. After 48 weeks, VR and CR plateaued, but HBsAg loss increased from 2.2 to 7.6%. According to the SCALE-B strata, VR, CR, and HBsAg loss were significantly different. The highest stratum (≥ 320) was associated with higher VR, CR, and lesser HBsAg loss when compared to the lowest stratum, with adjusted hazard ratios of 5.0 (95% CIs: 1.8-14.4), 10.44 (95% CIs: 1.4-79.1), and 0.04 (95% CIs: 0.004-0.43), respectively.
At a median follow-up of 2.5 years after discontinuing therapy, HBsAg loss in Thai patients was found to increase over time. SCALE-B is a valuable tool for predicting CR, VR, and HBsAg loss; HBV RNA is not significantly associated with long-term outcomes.
[www.ClinicalTrials.gov], identifier [TCTR20180316007].
慢性乙型肝炎（CHB）患者停用抗病毒治疗会导致更高的乙肝表面抗原（HBsAg）消失率；然而，可能会发生临床复发（CR）。SCALE-B评分用于预测停药后的CR；然而，超过48周随访的SCALE-B验证很少见。我们研究了SCALE-B和乙肝病毒核糖核酸（HBV RNA）能否预测CHB患者2年随访后的结局。
共对92例停止抗病毒治疗的泰国CHB患者进行随访；在停药时收集基线特征、定量乙肝表面抗原（qHBsAg）、乙肝核心相关抗原（HBcrAg）和HBV RNA，并计算SCALE-B评分。患者每12周随访一次，共48周，之后随访间隔由主治医生决定。获取病毒学复发（VR）、CR和HBsAg消失的随访数据。
中位随访时间为142周；VR、CR和HBsAg消失的累积发生率分别为65.2%、33.7%和7.6%。48周后，VR和CR趋于平稳，但HBsAg消失率从2.2%升至7.6%。根据SCALE-B分层，VR、CR和HBsAg消失存在显著差异。与最低分层相比，最高分层（≥320）与更高的VR、CR以及更低的HBsAg消失相关，调整后的风险比分别为5.0（95%置信区间：1.8 - 14.4）、10.44（95%置信区间：[1.4 - 79.1]）和0.04（95%置信区间：0.004 - 0.43）。
在停药后中位随访2.5年时，发现泰国患者的HBsAg消失率随时间增加。SCALE-B是预测CR、VR和HBsAg消失的有价值工具；HBV RNA与长期结局无显著关联。
