Parise E, Cheinquer H, Crespo D, Meirelles A, Martinelli A, Sette H, Gallizi J, Silva R, Lacet C, Correa E, Cotrim H, Fonseca J, Paraná R, Spinelli V, Amorim W, Tatsch F, Pessoa M
Federal University of São Paulo, São Paulo, SP, Brazil.
Braz J Infect Dis. 2006 Feb;10(1):11-6. doi: 10.1590/s1413-86702006000100003. Epub 2006 Jun 2.
Peginterferon alfa plus ribavirin is currently the treatment of choice for chronic hepatitis C. Peginterferon alfa-2a (40KD) plus ribavirin has given an overall sustained virological response of 18% in F3/F4 previous nonresponder US patients. We evaluated the effectiveness of peginterferon alfa-2a (40KD) plus ribavirin in Brazilian patients who were relapsers or nonresponders to previous interferon-based therapy. One-hundred-thirty-four patients with biopsy-proven chronic hepatitis C, HCV RNA positive, elevated ALT and who were either relapsers (n=37) or nonresponders (n=97) to at least 24 weeks of conventional interferon/ribavirin therapy were retreated with peginterferon alfa-2a (40KD) 180mg/qw and ribavirin 800 mg bid for 48 weeks. Efficacy was assessed as virological response (defined as undetectable HCV RNA) at the end of treatment (EoT) and at the end of follow-up (SVR - Sustained Virological Response). Safety assessments consisted of clinical and laboratory evaluations. In the patient sample, 72% were genotype 1 and 34% were cirrhotic. In an intention-to-treat analysis, relapser patients showed 78% EoT response and 51% SVR. Nonresponders showed 57% EoT response and 26% SVR. Positive predictive factors of SVR were non-1 genotype and relapser state. Six percent of the patients interrupted treatment because of adverse events and 45% had dose reduction (mainly associated with leucopenia and anemia). Brazilian patient relapsers and nonresponders to conventional interferon and ribavirin treatment can achieve a sustained virological response when retreated with peginterferon alfa-2a (40KD) and ribavirin. The safety profile is similar to that of naive patients.
聚乙二醇干扰素α联合利巴韦林是目前慢性丙型肝炎的首选治疗方案。聚乙二醇干扰素α-2a（40KD）联合利巴韦林使既往未出现应答的美国F3/F4级患者的总体持续病毒学应答率达到了18%。我们评估了聚乙二醇干扰素α-2a（40KD）联合利巴韦林对巴西复发型或既往基于干扰素治疗无应答患者的有效性。134例经活检证实为慢性丙型肝炎、HCV RNA阳性、ALT升高且为复发型（n = 37）或对至少24周的传统干扰素/利巴韦林治疗无应答型（n = 97）的患者，接受了48周的聚乙二醇干扰素α-2a（40KD）180mg/每周和利巴韦林800mg每日两次的再治疗。疗效评估为治疗结束时（EoT）及随访结束时（SVR - 持续病毒学应答）的病毒学应答（定义为HCV RNA检测不到）。安全性评估包括临床和实验室评估。在患者样本中，72%为1型基因型，34%为肝硬化患者。在意向性分析中，复发型患者的治疗结束时应答率为78%，持续病毒学应答率为51%。无应答型患者的治疗结束时应答率为57%，持续病毒学应答率为26%。持续病毒学应答的阳性预测因素为非1型基因型和复发状态。6%的患者因不良事件中断治疗，45%的患者减少了剂量（主要与白细胞减少和贫血有关）。对传统干扰素和利巴韦林治疗复发及无应答的巴西患者，采用聚乙二醇干扰素α-2a（40KD）和利巴韦林再治疗时可实现持续病毒学应答。安全性与初治患者相似。
