Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.
Am J Gastroenterol. 2010 Aug;105(8):1762-9. doi: 10.1038/ajg.2010.186. Epub 2010 May 11.
Hepatitis B e antigen (HBeAg)-negative chronic hepatitis B patients are at high risk of treatment relapse after any antiviral therapy. Combining peginterferon alpha-2a with ribavirin might improve sustained response rates.
Overall, 138 HBeAg-negative chronic hepatitis B patients were randomized to receive monotherapy (peginterferon alpha-2a 180 microg weekly plus placebo) or combination therapy (peginterferon alpha-2a weekly plus ribavirin 1,000 or 1,200 mg daily, depending on body weight) for 48 weeks. Post-treatment follow-up lasted 24 weeks. Analyses were based on the modified intention-to-treat population after exclusion of five patients.
At the end of follow-up, 14 (20%) of 69 patients assigned to monotherapy and 10 (16%) of 64 assigned to combination therapy had a combined response (hepatitis B virus (HBV) DNA <10,000 copies/ml (<1,714 IU/ml) and a normal alanine aminotransferase level, P=0.49). At the end of treatment, more patients had a combined response (25 (36%) vs. 26 (41%) in the monotherapy and combination therapy group, respectively, P=0.60), but subsequently relapsed during follow-up. Serum HBV DNA and hepatitis B surface antigen (HBsAg) levels decreased during treatment (mean change at week 48 compared with baseline -3.9 vs. -2.6 log copies/ml, P<0.001 and -0.56 vs. -0.34 log IU/ml, P=0.23, respectively). HBV DNA levels relapsed after treatment discontinuation; HBsAg remained at end-of-treatment levels. In general, combination therapy was well tolerated, although it was associated with a higher risk of anemia and neutropenia.
Treatment with peginterferon alpha-2a resulted in a limited sustained response rate in HBeAg-negative chronic hepatitis B patients. Addition of ribavirin did not improve response to therapy.
乙肝 e 抗原（HBeAg）阴性慢性乙型肝炎患者在接受任何抗病毒治疗后均有较高的治疗复发风险。聚乙二醇干扰素α-2a 联合利巴韦林治疗可能会提高持续应答率。
共有 138 例 HBeAg 阴性慢性乙型肝炎患者被随机分为两组：单药治疗组（聚乙二醇干扰素α-2a 180μg，每周一次，加安慰剂）或联合治疗组（聚乙二醇干扰素α-2a 每周一次加利巴韦林 1000 或 1200mg，每日一次，根据体重而定），疗程 48 周。治疗结束后随访 24 周。分析基于排除 5 例患者后的改良意向治疗人群。
随访结束时，69 例接受单药治疗的患者中有 14 例（20%）和 64 例接受联合治疗的患者中有 10 例（16%）出现联合应答（乙型肝炎病毒（HBV）DNA<10,000 拷贝/ml（<1,714IU/ml）且丙氨酸氨基转移酶水平正常，P=0.49）。治疗结束时，更多的患者出现联合应答（单药治疗组和联合治疗组分别有 25 例（36%）和 26 例（41%），P=0.60），但随后在随访期间复发。治疗期间血清 HBV DNA 和乙型肝炎表面抗原（HBsAg）水平下降（第 48 周与基线相比，平均变化分别为-3.9 log 拷贝/ml 和-2.6 log IU/ml，P<0.001 和-0.56 vs. -0.34 log IU/ml，P=0.23）。治疗停止后 HBV DNA 水平复发；HBsAg 仍保持在治疗结束时的水平。一般来说，聚乙二醇干扰素α-2a 联合治疗具有良好的耐受性，但与贫血和中性粒细胞减少的风险增加相关。
聚乙二醇干扰素α-2a 治疗 HBeAg 阴性慢性乙型肝炎患者的持续应答率有限。加用利巴韦林并不能提高治疗应答率。
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