Marcellin Patrick, Lau George K K, Zeuzem Stefan, Heathcote E Jenny, Pockros Paul J, Reddy K Rajender, Piratvisuth Teerha, Farci Patrizia, Chow Wan-Cheng, Jia Ji-Dong, Paik Woon, Wintfeld Neil, Pluck Nigel
Service d'Hépatologie & INSERM CRB3, University of Paris, Hôpital Beaujon, Clichy, France.
Liver Int. 2008 Apr;28(4):477-85. doi: 10.1111/j.1478-3231.2008.01696.x.
BACKGROUND/AIMS: Hepatitis B and C viruses (HBV and HCV) are two clinically distinct but related diseases. Pooled data from five studies of peginterferon alpha-2a in patients with chronic HCV infection (CHC) were compared with two studies of the drug in patients with chronic HBV infection (CHB).
The HBV studies included both hepatitis B e antigen (HBeAg)-positive (n=271) and HBeAg-negative (n=177) patients; 791 patients took part in the HCV trials. In all studies, patients were treated with 180 microg peginterferon alpha-2a monotherapy once weekly for 48 weeks. The number of adverse events (AEs), discontinuations and dose modifications were documented. Health-related quality of life (HRQL) was assessed using the Short-Form 36 questionnaire. Safety was assessed throughout the treatment period. A 24-week treatment-free follow-up period was also included.
Differences (HBV vs HCV) were observed in the incidence of AEs (88-89 vs 96-100%), serious AEs (4-5 vs 7-16%) and treatment withdrawals (6-8 vs 17-33%). The frequency of depression-related events was lower in CHB patients (4 vs 22%, P<0.001), as was the impact of treatment on HRQL.
The safety and tolerability of peginterferon alpha-2a in patients with CHB compares favourably with that observed in CHC patients, with a lower incidence of common interferon-related AEs and a significantly lower incidence of depression.
背景/目的：乙型肝炎病毒（HBV）和丙型肝炎病毒（HCV）是两种临床特征不同但相关的疾病。将五项聚乙二醇化干扰素α-2a治疗慢性丙型肝炎（CHC）患者的研究汇总数据，与两项该药物治疗慢性乙型肝炎（CHB）患者的研究进行比较。
HBV研究纳入了乙肝e抗原（HBeAg）阳性患者（n = 271）和HBeAg阴性患者（n = 177）；791例患者参与了HCV试验。在所有研究中，患者接受180μg聚乙二醇化干扰素α-2a单药治疗，每周一次，共48周。记录不良事件（AE）、停药和剂量调整的数量。使用简短健康调查问卷（Short-Form 36 questionnaire）评估健康相关生活质量（HRQL）。在整个治疗期间评估安全性。还包括24周的无治疗随访期。
观察到AE发生率（88 - 89% 对 96 - 100%）、严重AE发生率（4 - 5% 对 7 - 16%）和治疗中断率（6 - 8% 对 17 - 33%）存在差异（HBV对HCV）。CHB患者中与抑郁相关事件的发生率较低（4%对22%，P < 0.001），治疗对HRQL的影响也较低。
聚乙二醇化干扰素α-2a在CHB患者中的安全性和耐受性优于CHC患者，常见的干扰素相关AE发生率较低，抑郁发生率显著更低。
