Combination of Entecavir/Peginterferon Alfa-2a in Children With Hepatitis B e Antigen-Positive Immune Tolerant Chronic Hepatitis B Virus Infection.
Combination of Entecavir/Peginterferon Alfa-2a in Children With Hepatitis B e Antigen-Positive Immune Tolerant Chronic Hepatitis B Virus Infection.
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DOI：
10.1002/hep.30312
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发表时间：
2019-06
期刊：
影响因子：
--
通讯作者：
Hepatitis B Research Network (HBRN)
中科院分区：
文献类型：
--
作者：
Rosenthal P;Ling SC;Belle SH;Murray KF;Rodriguez-Baez N;Schwarzenberg SJ;Teckman J;Lin HS;Schwarz KB;Hepatitis B Research Network (HBRN)
免疫耐受慢性B型肝炎病毒（HBV）感染儿童的最佳管理策略仍然未知。本临床试验的目的是确定恩替卡韦和聚乙二醇干扰素治疗一组儿童在免疫耐受期的HBV感染的安全性和有效性。具有慢性B型肝炎免疫耐受特征的儿童接受恩替卡韦治疗，每日一次，剂量为0.015 mg/kg（最大剂量为0.5 mg），持续48周;在第8周结束时加入聚乙二醇干扰素α-2a（180 μg/1.73 m2皮下注射），每周一次，持续至第48周。主要终点是停止治疗后48周，HBV DNA水平≤ 1，000 IU/mL，无法检测到HBeAg。入组了60名儿童（75%为女性），中位年龄为10.9岁（范围3.4-17.9）。所有患者均为HBsAg和HBeAg阳性，HBV DNA水平高，丙氨酸氨基转移酶（ALT）水平正常或轻微升高。55名儿童完成了整个48周的治疗过程。在治疗结束后48周（第96周），2名儿童（3%）达到了主要终点，也是HBsAg阴性和抗-HBs阳性。1名儿童在第60周时HBeAg阳性但HBsAg阴性;另1名儿童在第72周时HBeAg阴性但HBsAg阳性，这是他们最后一次门诊访视。在其余儿童中，第96周的血清ALT和HBV DNA水平与基线相似。37名儿童发生了不良事件（AE），1名儿童发生了严重AE。结论：恩替卡韦和聚乙二醇干扰素联合治疗长达48周很少导致HBeAg丢失，在HBV感染的免疫耐受期儿童中持续抑制HBV DNA水平，治疗与频繁的AE相关。
The optimal management strategy for children with immune-tolerant chronic hepatitis B virus (HBV) infection remains unknown. The purpose of this clinical trial was to determine the safety and efficacy of therapy with entecavir and peginterferon in a group of children in the immune-tolerant phase of HBV infection. Children with immune-tolerant features of chronic hepatitis B received entecavir once daily in a dose of 0.015 mg/kg (0.5 mg maximum) for 48 weeks; peginterferon alfa-2a (180 μg/1.73m2 subcutaneously) once weekly was added at the end of week 8 and continued until week 48. The primary endpoint was lack of detectable HBeAg with HBV DNA levels ≤1,000 IU/mL 48 weeks after stopping therapy. Sixty children (75% female), median age 10.9 (range 3.4–17.9) years, were enrolled. All were positive for HBsAg and HBeAg and had high levels of HBV DNA with normal or minimally elevated levels of alanine aminotransferase (ALT). Fifty-five children completed the entire 48-week course of therapy. At 48 weeks after treatment ended (week 96), two children (3%) achieved the primary endpoint and were also HBsAg negative and anti-HBs positive. One child was HBeAg positive but HBsAg negative at week 60; another was HBeAg negative but HBsAg positive at week 72 which were their last clinic visits. In the remaining children, serum ALT and HBV DNA levels at week 96 were similar to baseline. Thirty-seven children experienced adverse events (AE) and one had a serious AE. Conclusion: The combination of entecavir and peginterferon for up to 48 weeks rarely led to loss of HBeAg with sustained suppression of HBV DNA levels in children in the immune-tolerant phase of HBV infection, and treatment was associated with frequent AEs.
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DOI：
10.1002/hep.23934
发表时间：
2010-12-01
期刊：
Hepatology (Baltimore, Md.)
影响因子：
--
作者：
Jonas, Maureen M;Block, Joan M;McMahon, Brian J
通讯作者：
McMahon, Brian J
影响因子：
7.6
作者：
Block TM;Alter H;Brown N;Brownstein A;Brosgart C;Chang KM;Chen PJ;Cohen C;El-Serag H;Feld J;Gish R;Glenn J;Greten TF;Guo JT;Hoshida Y;Kowdley KV;Li W;Lok AS;McMahon B;Mehta A;Perrillo R;Rice CM;Rinaudo J;Schinazi RF;Shetty K
通讯作者：
Shetty K
影响因子：
1.3
作者：
Kerkar, N
通讯作者：
Kerkar, N
具有免疫耐受特征的乙型肝炎病毒感染儿童的抗病毒治疗：一项试点开放标签随机研究
影响因子：
25.7
作者：
Zhu, Shishu;Zhang, Hongfei;Zhao, Pan
通讯作者：
Zhao, Pan
影响因子：
5.1
作者：
D'Antiga, L;Aw, M;Mieli-Vergani, G
通讯作者：
Mieli-Vergani, G