Peginterferon α-2a (40 kDa):: an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B
Peginterferon α-2a (40 kDa):: an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B
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DOI：
10.1046/j.1365-2893.2003.00450.x
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发表时间：
2003-07-01
影响因子：
2.5
通讯作者：
Pluck, N
中科院分区：
文献类型：
--
作者：
Cooksley, WGE;Piratvisuth, T;Pluck, N
目前慢性乙型肝炎（CHB）的治疗方法有许多局限性，需要更好的治疗方案。聚乙二醇干扰素α -2a （40 kDa）治疗慢性丙型肝炎优于传统干扰素α -2a。这是首次报道聚乙二醇干扰素α -2a （40 kDa）治疗慢性乙型肝炎。在这项II期研究中，194例既往未接受常规干扰素- α治疗的慢性乙型肝炎患者随机接受每周皮下剂量的聚乙二醇干扰素α -2a (40 kDa) 90、180或270 μ g，或常规干扰素α -2a 4.5 μ u，每周3次。治疗24周后进行24周无治疗随访。随访后评估所有受试者乙型肝炎e抗原（HBeAg）的丢失、乙型肝炎抗体（抗- hbe）的存在、乙型肝炎病毒（HBV） DNA的抑制以及血清丙氨酸转氨酶（ALT）的正常化。在随访结束时，接受聚乙二醇干扰素α -2a （40 kDa）、90、180和270 μ g的患者中，分别有37%、35%和29%的患者清除了HBeAg，而接受常规干扰素α -2a治疗的患者中，这一比例为25%。所有聚乙二醇干扰素α -2a （40 kDa）联合使用的综合疗效（HBeAg丧失、HBV DNA抑制和ALT正常化）是常规干扰素α -2a的两倍（24%vs 12%; P = 0.036）。所有治疗组不良事件发生的频率和严重程度相似。这些结果表明，聚乙二醇干扰素α -2a （40 kDa）在清除HBeAg、抑制HBV DNA和ALT正常化的基础上，对慢性乙型肝炎的疗效优于常规干扰素α -2a。
Current therapies for chronic hepatitis B (CHB) have a number of limitations, and better treatment options are needed. Peginterferon alpha -2a (40 kDa) is superior to conventional interferon alpha -2a in the treatment of chronic hepatitis C. This is the first report on peginterferon alpha -2a (40 kDa) in the treatment of CHB. In this phase II study, 194 patients with CHB not previously treated with conventional interferon-alpha were randomized to receive weekly subcutaneous doses of peginterferon alpha -2a (40 kDa) 90, 180 or 270 mu g, or conventional interferon alpha -2a 4.5 MIU three times weekly. Twenty-four weeks of therapy were followed by 24 weeks of treatment-free follow-up. All subjects were assessed for loss of hepatitis B e antigen (HBeAg), presence of hepatitis B antibody (anti-HBe), suppression of hepatitis B virus (HBV) DNA, and normalization of serum alanine transaminase (ALT) after follow-up.At the end of follow-up, HBeAg was cleared in 37, 35 and 29% of patients receiving peginterferon alpha -2a (40 kDa) 90, 180 and 270 mu g, respectively, compared with 25% of patients on conventional interferon alpha -2a. The combined response (HBeAg loss, HBV DNA suppression, and ALT normalization) of all peginterferon alpha -2a (40 kDa) doses combined was twice that achieved with conventional interferon alpha -2a (24%vs 12%; P = 0.036). All treatment groups were similar with respect to frequency and severity of adverse events. These results indicate that peginterferon alpha -2a (40 kDa) is superior in efficacy to conventional interferon alpha -2a in chronic hepatitis B based on clearance of HBeAg, suppression of HBV DNA, and normalization of ALT.