Department of Medicine I, J.W. Goethe University Hospital, Frankfurt, Germany.
Curr Med Res Opin. 2010 Jul;26(7):1733-43. doi: 10.1185/03007995.2010.487038.
Standard treatment of chronic hepatitis C (CHC) is peginterferon alfa (PEG-IFN alfa) plus ribavirin (RBV) for 48 weeks in patients infected with genotype 1, and 24 weeks for those infected with genotype 2 or 3. However, recent studies have shown that on-treatment markers of virologic response can be used to tailor treatment duration according to each patient's response to therapy.
To discuss the rationale for assessing on-treatment markers of virologic response to PEG-IFN alfa plus RBV.
A literature search was conducted using MEDLINE and conference proceedings for clinical studies of reduced and extended treatment durations in the treatment of CHC.
Patients infected with genotype 1 and low baseline viral load who have undetectable HCV RNA by week 4 can be effectively treated for 24 weeks without any decline in efficacy. Extended treatment duration of 72 weeks has been studied in various selected patient groups with genotype 1 infection who are slow to respond to treatment; however, data are conflicting regarding the patient subgroup that may benefit most from this strategy. Finally, selected HCV genotype 2 or 3 patients with undetectable HCV RNA at week 4 and other favorable prognostic features may be effectively managed with shorter (12 to 16 weeks) treatment duration. Further work is required to determine how the findings of this review relate to patients who do not fit with the enrollment criteria of randomized clinical trials or who require dose adjustment based on adverse tolerability. Care should also be exercised when comparing data between studies because of differences in design and patient populations.
Evaluation of on-treatment markers of virologic response has revolutionized the treatment of CHC: implementation of these assessments in clinical practice is strongly supported by data from recent clinical studies, even in advance of formal recognition in treatment guidelines.
对于感染基因 1 型的慢性丙型肝炎（CHC）患者，标准治疗方案是聚乙二醇干扰素 alfa（PEG-IFN alfa）联合利巴韦林（RBV）治疗 48 周，感染基因 2 或 3 型的患者治疗 24 周。然而，最近的研究表明，可根据每位患者对治疗的反应来调整治疗时间，使用治疗中病毒学应答的标志物。
讨论评估 PEG-IFN alfa 联合 RBV 治疗中病毒学应答的治疗标志物的原理。
使用 MEDLINE 和会议记录对 CHC 缩短和延长治疗时间的临床研究进行文献检索。
基线病毒载量低且第 4 周 HCV RNA 不可检测的基因 1 型感染患者，可以有效治疗 24 周而不降低疗效。在对治疗反应缓慢的基因 1 型感染的各种特定患者组中研究了 72 周的延长治疗时间，但关于最可能从该策略中受益的患者亚组的数据存在矛盾。最后，在第 4 周 HCV RNA 不可检测且其他预后特征良好的某些 HCV 基因型 2 或 3 型患者，可能通过较短的（12-16 周）治疗时间来有效治疗。需要进一步研究来确定本综述的结果与不符合随机临床试验入组标准的患者或需要根据不良反应进行剂量调整的患者相关。由于设计和患者人群的差异，在比较研究数据时应谨慎。
评估治疗中病毒学应答的标志物彻底改变了 CHC 的治疗方法：最近的临床研究数据强烈支持在临床实践中实施这些评估，即使在治疗指南中正式认可之前也是如此。
