标题: 48 V 96 weeks peginterferon α-2a therapy in genotype D [打印本页] 作者: 肝胆速递 时间: 2012-8-31 14:02 标题: 48 V 96 weeks peginterferon α-2a therapy in genotype D
Gut. 2012 Aug 2. [Epub ahead of print]
Randomised study comparing 48 and 96 weeks peginterferon α-2a therapy in genotype D HBeAg-negative chronic hepatitis B.
Lampertico P, Viganò M, Di Costanzo GG, Sagnelli E, Fasano M, Di Marco V, Boninsegna S, Farci P, Fargion S, Giuberti T, Iannacone C, Regep L, Massetto B, Facchetti F, Colombo M; on behalf of the PegBeLiver Study Group.
Source
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.
Abstract
OBJECTIVE:
Treatment with peginterferon α-2a (PegIFN) for 48 weeks is the standard of care for selected HBeAg-negative patients chronically infected with hepatitis B virus (HBV), but with limited treatment efficacy. A study was undertaken to investigate whether treatment extension to 96 weeks improves the outcome in this patient population.
METHODS:
128 HBeAg-negative patients (120 genotype D) were randomised to weekly 180 μg PegIFN for 48 weeks (group A, n=51), 180 μg PegIFN for 48 weeks followed by 135 μg weekly for an additional 48 weeks (group B, n=52) or 180 μg PegIFN plus lamivudine (100 mg/day) for 48 weeks then 135 μg PegIFN for 48 weeks (group C, n=25). Endpoints were alanine aminotransferase normalisation plus HBV DNA <3400 IU/ml (primary), HBV DNA <2000 IU/ml and HBsAg clearance at 48 weeks after treatment.
RESULTS:
Forty-eight weeks after treatment, six patients in group A and 13 in group B achieved alanine aminotransferase normalisation plus HBV DNA <3400 IU/ml (11.8% vs 25.0%, p=0.08), 6 vs 15 patients had HBV DNA <2000 IU/ml (11.8% vs 28.8%, p=0.03), 0 vs 3 achieved HBsAg clearance (0% vs 5.8%, p=0.24) and 0 vs 5 had HBsAg <10 IU/ml (0% vs 9.6%, p=0.06). While extended PegIFN treatment was the strongest independent predictor of response, the combination with lamivudine did not improve responses. Discontinuation rates were similar among the groups (19.6%, 23.1%, 32.0%, p=0.81) and were mostly due to PegIFN-related adverse events.
CONCLUSIONS:
In HBeAg-negative genotype D patients with chronic hepatitis B, PegIFN treatment for 96 weeks was well tolerated and the post-treatment virological response improved significantly compared with 48 weeks of treatment.
TRIAL REGISTRATION NUMBER:
128例HBeAg阴性患者（120基因型D）被随机分配到48周（A组，n = 51），180微克135微克，每周48周（B组，n PegIFN为48周，随后每周180微克PegIFN = 52）或180微克PegIFN联合拉米夫定（100 mg /天）治疗48周48周（C组，n = 25），然后135微克PegIFN。终点是谷丙转氨酶正常化，加上HBV DNA <3400 IU /毫升（主），HBV DNA <2000 IU /毫升，在治疗48周后HBsAg清除。
结果：
6组患者治疗48周后，A和B组的谷丙转氨酶正常化加HBV DNA <3400 IU /毫升（11.8％比25.0％，P = 0.08），对15例患者的HBV DNA <2000 IU /毫升（11.8％比28.8％，P = 0.03），0比3取得HBsAg清除（0％和5.8％，P = 0.24）和0比5乙肝表面抗原<10 IU /毫升（0％和9.6％， P = 0.06）。扩展PegIFN治疗是最强的独立预测因子的响应，联合拉米夫定没有改善的反应。停药率分别为各组间相似（19.6％，23.1％，32.0％，P = 0.81），这主要是由于PegIFN相关的不良事件。
结论：