Chou Roger, Blazina Ian, Bougatsos Christina, Holmes Rebecca, Selph Shelley, Grusing Sara, Jou Janice
Pacific Northwest Evidence-based Practice Center, Department of Medical Informatics and Clinical Epidemiology; Oregon Health & Science University, Portland.
Division of General Internal Medicine and Geriatrics; Oregon Health & Science University, Portland.
JAMA. 2020 Dec 15;324(23):2423-2436. doi: 10.1001/jama.2020.19750.
A 2014 review for the US Preventive Services Task Force (USPSTF) found antiviral therapy for hepatitis B virus (HBV) infection associated with improved intermediate outcomes, although evidence on clinical outcomes was limited.
To update the 2014 HBV screening review in nonpregnant adolescents and adults to inform the USPSTF.
Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and Ovid MEDLINE (2014 to August 2019); with surveillance through July 24, 2020.
Randomized clinical trials (RCTs) on screening and antiviral therapy; cohort studies on screening, antiviral therapy clinical outcomes, and the association between achieving intermediate outcomes after antiviral therapy and clinical outcomes.
One investigator abstracted data; a second investigator checked accuracy. Two investigators independently assessed study quality. Random-effects profile likelihood meta-analysis was performed.
Thirty trials and 20 cohort studies, with a total of 94 168 participants, were included. No study directly evaluated the effects of screening for HBV infection vs no screening on clinical outcomes such as mortality, hepatocellular carcinoma, or cirrhosis. Screening strategies that focused on risk factors such as ever having immigrated from high-prevalence countries and demographic and behavioral risk factors would identify nearly all HBV infection cases. In 1 study (n = 21 008), only screening immigrants from high-prevalence countries would miss approximately two-thirds of infected persons. Based on 18 trials (n = 2972), antiviral therapy compared with placebo or no treatment was associated with greater likelihood of achieving intermediate outcomes, such as virologic suppression and hepatitis B e-antigen (HBeAg) or hepatitis B surface antigen loss or seroconversion; the numbers needed to treat ranged from 2.6 for virologic suppression to 17 for HBeAg seroconversion. Based on 12 trials (n = 4127), first-line antiviral therapies were at least as likely as nonpreferred therapies to achieve intermediate outcomes. Based on 16 trials (n = 4809), antiviral therapy might be associated with improved clinical outcomes, but data were sparse and imprecise. Nine cohort studies (n = 3893) indicated an association between achieving an intermediate outcome following antiviral therapy and improved clinical outcomes but were heterogeneous (hazard ratios ranged from 0.07 to 0.87). Antiviral therapy was associated with higher risk of withdrawal due to adverse events vs placebo or no antiviral therapy.
There was no direct evidence for the clinical benefits and harms of HBV screening vs no screening. Antiviral therapy for HBV infection was associated with improved intermediate outcomes and may improve clinical outcomes.
2014年美国预防服务工作组（USPSTF）的一项综述发现，乙型肝炎病毒（HBV）感染的抗病毒治疗与改善中期结局相关，尽管关于临床结局的证据有限。
更新2014年关于非妊娠青少年和成年人HBV筛查的综述，为USPSTF提供信息。
Cochrane对照试验中心注册库、Cochrane系统评价数据库和Ovid MEDLINE（2014年至2019年8月）；截至2020年7月24日进行监测。
关于筛查和抗病毒治疗的随机临床试验（RCT）；关于筛查、抗病毒治疗临床结局以及抗病毒治疗后实现中期结局与临床结局之间关联的队列研究。
一名研究人员提取数据；另一名研究人员检查准确性。两名研究人员独立评估研究质量。进行随机效应轮廓似然荟萃分析。
纳入了30项试验和20项队列研究，共94168名参与者。没有研究直接评估HBV感染筛查与不筛查对死亡率、肝细胞癌或肝硬化等临床结局的影响。侧重于曾从高流行国家移民等危险因素以及人口统计学和行为危险因素的筛查策略几乎可以识别所有HBV感染病例。在1项研究（n = 21008）中，仅筛查来自高流行国家的移民会遗漏约三分之二的感染者。基于18项试验（n = 2972），与安慰剂或不治疗相比，抗病毒治疗实现病毒学抑制和乙肝e抗原（HBeAg）或乙肝表面抗原消失或血清学转换等中期结局的可能性更大；治疗所需人数从病毒学抑制的2.6到HBeAg血清学转换的17不等。基于12项试验（n = 4127），一线抗病毒治疗实现中期结局的可能性至少与非首选治疗相同。基于16项试验（n = 4809），抗病毒治疗可能与改善临床结局相关，但数据稀少且不精确。9项队列研究（n = 3893）表明，抗病毒治疗后实现中期结局与改善临床结局之间存在关联，但研究结果异质性较大（风险比范围为0.07至0.87）。与安慰剂或不进行抗病毒治疗相比，抗病毒治疗因不良事件停药的风险更高。
没有直接证据表明HBV筛查与不筛查的临床益处和危害。HBV感染的抗病毒治疗与改善中期结局相关，可能改善临床结局。
