Re‐treatment of chronic hepatitis C patients after relapse: efficacy of peginterferon‐alpha‐2a (40 kDa) and ribavirin
Re‐treatment of chronic hepatitis C patients after relapse: efficacy of peginterferon‐alpha‐2a (40 kDa) and ribavirin
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慢性丙型肝炎患者复发后的再治疗：聚乙二醇干扰素-α-2a (40 kDa) 和利巴韦林的疗效
DOI：
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发表时间：
2006
影响因子：
2.5
通讯作者：
G. Cooksley
中科院分区：
文献类型：
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作者：
C. Berg;F. Gonçales;D. Bernstein;H. Sette;J. Rasenack;M. Diago;D. Jensen;P. Graham;G. Cooksley
总结：我们进行了一项随机多国研究，以确定在复发的慢性丙型肝炎患者中，聚乙二醇干扰素α-2a（40 kDa）联合利巴韦林重新治疗48周是否会诱导持续病毒学应答（SVR）。 在III期试验中，研究了既往在24周未治疗随访期间复发的患者，这些患者在24周的聚乙二醇干扰素-α-2a（40 kDa）/利巴韦林联合治疗后达到治疗结束病毒学应答。 尽管推荐剂量与初始试验结束时使用的剂量相同，但允许进行调整。收集严重不良事件或导致剂量降低或停药的不良事件的数据。再次治疗后，64例患者的总体SVR率为55%。感染丙型肝炎病毒（HCV）基因型1和非1基因型患者的SVR率分别为51%和63%。在39例患者（61%）中观察到早期（第12周）病毒学应答，并预测了SVR。再治疗耐受性良好。最常见的不良事件是疲劳（5%）和腹痛（3%）。聚乙二醇干扰素-α-2a（40 kDa）和/或利巴韦林的剂量分别因3%和13%的患者发生不良事件以及23%和5%的患者发生实验室异常而调整。 因此，聚乙二醇干扰素-α-2a（40 kDa）加利巴韦林48周的疗程在24周联合治疗后随访期间复发的患者中诱导了55%的SVR。 对于在最初的24周联合治疗后复发的患者，或因实验室检查异常等原因提前停止治疗的患者，医生应毫不犹豫地提供重新治疗。
Summary. We conducted a randomized multinational study to determine whether 48 weeks of re‐treatment with peginterferon‐alpha‐2a (40 kDa) plus ribavirin would induce a sustained virological response (SVR) in relapsed chronic hepatitis C patients. Patients who had previously relapsed during 24 weeks of untreated follow‐up, after having achieved an end‐of‐treatment virological response with 24 weeks of peginterferon‐alpha‐2a (40 kDa)/ribavirin combination therapy, within a phase III trial, were studied. Although the recommended dosage was the same as that used at the end of the initial trial, adjustments were permitted. Data on serious adverse events, or adverse events that resulted in dose reductions or discontinuations, were collected. Following re‐treatment, the overall SVR rate in the 64 patients was 55%. The SVR rates in patients infected with hepatitis C virus (HCV) genotype 1 and non‐1 genotypes were 51% and 63%, respectively. Early (week 12) virological responses were seen in 39 patients (61%) and were predictive of an SVR. Re‐treatment was well tolerated. The most frequent adverse events recorded were fatigue (5%) and abdominal pain (3%). Dosages of peginterferon‐alpha‐2a (40 kDa) and/or ribavirin were modified because of adverse events in 3% and 13% of patients, and because of laboratory abnormalities in 23% and 5% of patients, respectively. Thus, a 48‐week course of peginterferon‐alpha‐2a (40 kDa) plus ribavirin induces an SVR in 55% of patients who relapsed during follow‐up after 24 weeks of combination therapy. Physicians should not hesitate to offer re‐treatment to patients who relapse after an initial, 24‐week course of combination therapy, or who have prematurely stopped treatment because, for example, of laboratory abnormalities.
影响因子：
29.4
作者：
Shiffman, ML;Di Bisceglie, AM;Everhart, JE
通讯作者：
Everhart, JE
影响因子：
158.5
作者：
McHutchison, JG;Gordon, SC;Albrecht, JK
通讯作者：
Albrecht, JK