The optimal strategy for chronic hepatitis B virus (HBV) infected patients with negative hepatitis B e-antigen (HBeAg) and normal alanine aminotransferase (ALT) remains uncertain. This study aimed to evaluate the safety and efficacy of tenofovir alafenamide fumarate (TAF) treatment in this patient population. This prospective, open-label, randomised controlled trial enrolled HBeAg-negative patients with normal ALT and randomised them 1:1 to either the treatment group (TAF) or the control group (no treatment). The primary endpoint was the reduction in hepatitis B surface antigen (HBsAg) levels from baseline to week 48. A total of 62 patients were enrolled and followed up by 48 weeks (n = 31 per group). No serious adverse events were reported. At week 48, there was no significant difference in the change in HBsAg between the treatment and control groups [0.01 (−0.06, 0.05) vs. −0.05 (−0.12, 0.06) log10 IU/mL, p = 0.354]. However, HBV DNA levels were significantly lower in the treatment group (0 vs. 2.86 log10 IU/mL, p < 0.001). All patients achieved HBV DNA below 20 IU/mL after treatment. Additionally, chitinase-3-like protein 1 level was lower in the treatment group (23.8 vs. 44.8 ng/mL, p = 0.019). TAF was well-tolerated in HBeAg-negative patients with normal ALT and low-level HBV DNA viremia. Treatment for 48 weeks led to a high rate of HBV DNA suppression and may potentially delay liver fibrosis progression. Accordingly, early antiviral treatment may benefit this patient population.
对于乙型肝炎e抗原(HBeAg)阴性、丙氨酸转氨酶(ALT)正常的慢性乙型肝炎病毒(HBV)感染患者的最佳治疗策略仍不确定。本研究旨在评估富马酸替诺福韦(TAF)治疗该患者群体的安全性和有效性。这项前瞻性、开放标签、随机对照试验招募了ALT正常的hbeag阴性患者,并将他们1:1随机分为治疗组(TAF)和对照组(未治疗)。主要终点是乙肝表面抗原(HBsAg)水平从基线到第48周的降低。共纳入62例患者,随访48周(每组31例)。无严重不良事件报告。48周时,治疗组与对照组HBsAg变化差异无统计学意义[0.01(-0.06,0.05)比-0.05 (-0.12,0.06)log10 IU/mL, p = 0.354]。然而,治疗组的HBV DNA水平明显降低(0 vs. 2.86 log10 IU/mL, p
{"title":"Tenofovir Alafenamide Fumarate Reduces Virological Replication in HBeAg-Negative Patients With Normal Alanine Aminotransferase: A 48-Week Randomised Controlled Trial","authors":"Qiumin Luo, Wenxiong Xu, Yeqiong Zhang, Xiangyong Li, Jing Lai, Jianguo Li, Xingrong Zheng, Hong Deng, Lubiao Chen, Xiang Zhu, Chan Xie, Liang Peng","doi":"10.1111/jvh.70141","DOIUrl":"10.1111/jvh.70141","url":null,"abstract":"<p>The optimal strategy for chronic hepatitis B virus (HBV) infected patients with negative hepatitis B e-antigen (HBeAg) and normal alanine aminotransferase (ALT) remains uncertain. This study aimed to evaluate the safety and efficacy of tenofovir alafenamide fumarate (TAF) treatment in this patient population. This prospective, open-label, randomised controlled trial enrolled HBeAg-negative patients with normal ALT and randomised them 1:1 to either the treatment group (TAF) or the control group (no treatment). The primary endpoint was the reduction in hepatitis B surface antigen (HBsAg) levels from baseline to week 48. A total of 62 patients were enrolled and followed up by 48 weeks (<i>n</i> = 31 per group). No serious adverse events were reported. At week 48, there was no significant difference in the change in HBsAg between the treatment and control groups [0.01 (−0.06, 0.05) vs. −0.05 (−0.12, 0.06) log<sub>10</sub> IU/mL, <i>p</i> = 0.354]. However, HBV DNA levels were significantly lower in the treatment group (0 vs. 2.86 log<sub>10</sub> IU/mL, <i>p</i> < 0.001). All patients achieved HBV DNA below 20 IU/mL after treatment. Additionally, chitinase-3-like protein 1 level was lower in the treatment group (23.8 vs. 44.8 ng/mL, <i>p</i> = 0.019). TAF was well-tolerated in HBeAg-negative patients with normal ALT and low-level HBV DNA viremia. Treatment for 48 weeks led to a high rate of HBV DNA suppression and may potentially delay liver fibrosis progression. Accordingly, early antiviral treatment may benefit this patient population.</p><p><b>Trial Registration:</b> Clinical trial number: NCT 04231565</p>","PeriodicalId":17762,"journal":{"name":"Journal of Viral Hepatitis","volume":"33 3","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12853233/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146093347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Igor Boechat Silveira, Gustavo Procópio Silva, Arthur Victor de Holanda Sampaio, Milena Ramos Tomé, Jingying Elena Chen, Alana Vitória Santos de Jesus, Guilherme Grossi Lopes Cançado
Inequitable access to HCV treatment persists, particularly for rural and marginalised populations. Synchronous telemedicine (TM) could mitigate access barriers, but its comparative effectiveness versus in-person care is uncertain. We performed a systematic review and meta-analysis comparing synchronous TM with in-person care for HCV. The primary outcome was sustained virologic response (SVR); secondary outcomes were treatment initiation and completion. Subgroup analyses examined study design, therapy era (interferon vs. direct-acting antivirals [DAAs]), and setting (rural vs. non-rural). Narrative synthesis addressed people who use drugs (PWUD), incarcerated populations, pandemic-era cohorts, and economic evaluations. Fifteen studies involving 7.459 patients (2 RCTs, 13 observational) were included (13 meta-analysed). For SVR, the pooled effect showed no significant difference between interventions (odds ratio [OR] 1.60, 95% CI 0.69–3.68). Treatment initiation and completion were also not significantly different overall (initiation OR 7.59, 95% CI 0.79–72.81; completion OR 2.50, 95% CI 0.76–8.25), although exclusion of single influential studies yielded significant benefits for TM in sensitivity analyses. Subgroups suggested context-specific advantages: TM favoured SVR in rural settings (OR = 4.19, 95% CI 1.28–13.73) and in RCTs (OR = 10.42, 95% CI 7.41–14.67). Narrative evidence indicated that TM improved linkage and cure among PWUD and incarcerated individuals, preserved efficacy during COVID-19, and reduced costs. Overall, synchronous TM seems comparable to in-person care overall and may be superior in rural and marginalised populations.
丙型肝炎病毒治疗的不公平获取仍然存在,特别是对农村和边缘化人群而言。同步远程医疗(TM)可以减轻获取障碍,但其相对于面对面护理的有效性尚不确定。我们进行了一项系统综述和荟萃分析,比较同步TM与丙型肝炎患者的现场护理。主要终点是持续病毒学应答(SVR);次要结局是治疗开始和完成。亚组分析检查了研究设计、治疗时代(干扰素vs直接作用抗病毒药物[DAAs])和环境(农村vs非农村)。叙事综合涉及吸毒者(PWUD)、被监禁人群、大流行时期的人群和经济评估。纳入15项研究,涉及7.459例患者(2项随机对照试验,13项观察性研究)(13项荟萃分析)。对于SVR,合并效应显示干预之间无显著差异(优势比[OR] 1.60, 95% CI 0.69-3.68)。尽管在敏感性分析中排除了单一影响研究,但治疗开始和完成总体上也没有显著差异(开始OR 7.59, 95% CI 0.79-72.81;完成OR 2.50, 95% CI 0.76-8.25)。亚组显示了特定环境的优势:TM有利于农村环境的SVR (OR = 4.19, 95% CI 1.28-13.73)和rct (OR = 10.42, 95% CI 7.41-14.67)。叙事证据表明,TM改善了PWUD和监禁个体之间的联系和治愈,在COVID-19期间保持了疗效,并降低了成本。总体而言,同步TM似乎与面对面护理相当,在农村和边缘人群中可能更优越。
{"title":"Synchronous Telemedicine Versus In-Person Care in Hepatitis C Treatment: A Systematic Review and Meta-Analysis","authors":"Igor Boechat Silveira, Gustavo Procópio Silva, Arthur Victor de Holanda Sampaio, Milena Ramos Tomé, Jingying Elena Chen, Alana Vitória Santos de Jesus, Guilherme Grossi Lopes Cançado","doi":"10.1111/jvh.70144","DOIUrl":"10.1111/jvh.70144","url":null,"abstract":"<p>Inequitable access to HCV treatment persists, particularly for rural and marginalised populations. Synchronous telemedicine (TM) could mitigate access barriers, but its comparative effectiveness versus in-person care is uncertain. We performed a systematic review and meta-analysis comparing synchronous TM with in-person care for HCV. The primary outcome was sustained virologic response (SVR); secondary outcomes were treatment initiation and completion. Subgroup analyses examined study design, therapy era (interferon vs. direct-acting antivirals [DAAs]), and setting (rural vs. non-rural). Narrative synthesis addressed people who use drugs (PWUD), incarcerated populations, pandemic-era cohorts, and economic evaluations. Fifteen studies involving 7.459 patients (2 RCTs, 13 observational) were included (13 meta-analysed). For SVR, the pooled effect showed no significant difference between interventions (odds ratio [OR] 1.60, 95% CI 0.69–3.68). Treatment initiation and completion were also not significantly different overall (initiation OR 7.59, 95% CI 0.79–72.81; completion OR 2.50, 95% CI 0.76–8.25), although exclusion of single influential studies yielded significant benefits for TM in sensitivity analyses. Subgroups suggested context-specific advantages: TM favoured SVR in rural settings (OR = 4.19, 95% CI 1.28–13.73) and in RCTs (OR = 10.42, 95% CI 7.41–14.67). Narrative evidence indicated that TM improved linkage and cure among PWUD and incarcerated individuals, preserved efficacy during COVID-19, and reduced costs. Overall, synchronous TM seems comparable to in-person care overall and may be superior in rural and marginalised populations.</p>","PeriodicalId":17762,"journal":{"name":"Journal of Viral Hepatitis","volume":"33 3","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12848981/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146064481","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}