Lal Bikrant Bihari, Sood Vikrant, Khanna Rajeev, Rawat Dinesh, Verma Sanjeev, Alam Seema
Department of Pediatric Hepatology, Institute of Liver and Biliary Sciences, D-1, Acharya Shree Tulsi Marg, Vasant Kunj, New Delhi, 110 070, India.
Indian J Gastroenterol. 2018 Jul;37(4):326-334. doi: 10.1007/s12664-018-0878-1. Epub 2018 Aug 31.
Our aim was to evaluate the efficacy and safety of sequential therapy using pegylated interferon (Peg-IFN) and nucleos(t)ide analogue (NA) for treatment of children in immunoactive (IA) and immunotolerant (IT) phases of chronic hepatitis B.
It was a prospective observational study where those willing for sequential therapy were allocated to group 1 (sequential therapy) and others to group 2 (standard therapy). Sequential therapy included 8 weeks of NA followed by 44 weeks of combination of NA and Peg-IFN. In group 2, IA children received NA monotherapy, and IT children received no therapy. HBe seroconversion, HBs seroconversion, and loss of HBV DNA were the major outcome measures.
A total of 61 children (36 IA and 25 IT) were included in the analysis. Among the IA children, 17 received sequential therapy and 19 received standard therapy; whereas, among the IT children, 12 received sequential therapy and 13 did not receive any therapy. In IA phase, sequential therapy led to higher HBe seroconversion (64.7% vs. 21.05%, p = 0.017) and higher virological clearance (94.12% vs. 52.63%, p = 0.008). In IT children, there was no benefit of treatment with sequential therapy over observation alone. Baseline ALT > 100 IU/L predicted response to therapy with 100% sensitivity, 89.5% specificity, and LR of 9.52.
Sequential therapy leads to higher HBe seroconversion and virological response in children in IA phase. Children with baseline ALT > 100 IU/mL are more likely to respond to sequential therapy. There appears to be no role of sequential therapy in children in IT phase.
我们的目的是评估聚乙二醇干扰素（Peg-IFN）和核苷（酸）类似物（NA）序贯疗法治疗慢性乙型肝炎免疫活跃（IA）期和免疫耐受（IT）期儿童的疗效和安全性。
这是一项前瞻性观察性研究，愿意接受序贯疗法的患者被分配到第1组（序贯疗法），其他患者被分配到第2组（标准疗法）。序贯疗法包括8周的NA治疗，随后是44周的NA与Peg-IFN联合治疗。在第2组中，IA期儿童接受NA单药治疗，IT期儿童不接受治疗。HBe血清学转换、HBs血清学转换和HBV DNA消失是主要观察指标。
共有61名儿童（36名IA期和25名IT期）纳入分析。在IA期儿童中，17名接受序贯疗法，19名接受标准疗法；而在IT期儿童中，12名接受序贯疗法，13名未接受任何治疗。在IA期，序贯疗法导致更高的HBe血清学转换率（64.7%对21.05%，p = 0.017）和更高的病毒学清除率（94.12%对52.63%，p = 0.008）。在IT期儿童中，序贯疗法治疗相较于单纯观察并无益处。基线ALT>100 IU/L预测治疗反应的敏感度为100%，特异度为89.5%，似然比为9.52。
序贯疗法可使IA期儿童获得更高的HBe血清学转换率和病毒学反应。基线ALT>100 IU/mL的儿童更可能对序贯疗法有反应。序贯疗法在IT期儿童中似乎没有作用。
