Zeuzem Stefan, Pawlotsky Jean-Michel, Lukasiewicz Esther, von Wagner Michael, Goulis Ioannis, Lurie Yoav, Gianfranco Elia, Vrolijk Jan-Maarten, Esteban Juan I, Hezode Christophe, Lagging Martin, Negro Francesco, Soulier Alexandre, Verheij-Hart Elke, Hansen Bettina, Tal Ronen, Ferrari Carlo, Schalm Solko W, Neumann Avidan U
Saarland University Hospital, Homburg/Saar, Germany.
J Hepatol. 2005 Aug;43(2):250-7. doi: 10.1016/j.jhep.2005.05.016.
BACKGROUND/AIMS: The aim of this study was to increase virologic response rates by individualized treatment according to the early virologic response.
Serum HCV-RNA was frequently quantified in patients with chronic hepatitis C (n=270) treated with peginterferon alfa-2a (180 microg/week) and ribavirin (1000-1200 mg/day). After 6 weeks patients were classified as rapid (RVR), slow (SPR), flat (FPR), or null responders (NUR) and randomized within each viral kinetic class to continue therapy either with an individualized or standard regimen. Individualized therapy comprised peginterferon monotherapy (48 weeks) or shorter combination therapy (24 weeks) for RVR, triple therapy with histamine (1 mg/day) (48 weeks) or prolonged combination therapy (72 weeks) for SPR, triple therapy for FPR, and high-dose peginterferon (360 microg/week) plus ribavirin for NUR patients.
Patients were categorized as RVR (n=171), SPR (n=65), FPR (n=10), or NUR (n=22). Overall end-of-treatment and sustained virologic response rates were 77 and 60% in the individualized and 77 and 66% in the standard treatment arm, respectively. Histamine in addition to peginterferon and ribavirin and high-dose peginterferon plus ribavirin did not improve virologic response rates in patients with FPR and NUR, respectively.
An improvement in virologic efficacy was not achieved with the available individualized treatment options.
背景/目的：本研究的目的是根据早期病毒学反应进行个体化治疗，以提高病毒学反应率。
对270例接受聚乙二醇干扰素α-2a（180微克/周）和利巴韦林（1000 - 1200毫克/天）治疗的慢性丙型肝炎患者频繁检测血清HCV - RNA。6周后，患者被分为快速病毒学应答者（RVR）、缓慢病毒学应答者（SPR）、平坦病毒学应答者（FPR）或无应答者（NUR），并在每个病毒动力学类别内随机分组，继续接受个体化或标准治疗方案。个体化治疗包括RVR患者接受聚乙二醇干扰素单药治疗（48周）或较短疗程的联合治疗（24周），SPR患者接受组胺（1毫克/天）三联治疗（48周）或延长疗程的联合治疗（72周），FPR患者接受三联治疗，NUR患者接受高剂量聚乙二醇干扰素（360微克/周）加利巴韦林治疗。
患者被分类为RVR（n = 171）、SPR（n = 65）、FPR（n = 10）或NUR（n = 22）。个体化治疗组的总体治疗结束时病毒学应答率和持续病毒学应答率分别为77%和60%，标准治疗组分别为77%和66%。对于FPR和NUR患者，在聚乙二醇干扰素和利巴韦林基础上加用组胺和高剂量聚乙二醇干扰素加利巴韦林分别未提高病毒学应答率。
现有的个体化治疗方案未实现病毒学疗效的改善。
