Rendina Maria, Schena Antonio, Castellaneta Nicola Maurizio, Losito Francesco, Amoruso Anna Cinzia, Stallone Giovanni, Schena Francesco Paolo, Di Leo Alfredo, Francavilla Antonio
Department of Emergency and Organ Transplantation, Section of Gastroenterology, University of Bari, Piazza G. Cesare 11, 70124 Bari, Italy.
J Hepatol. 2007 May;46(5):768-74. doi: 10.1016/j.jhep.2006.12.016. Epub 2007 Feb 5.
BACKGROUND/AIMS: We undertook a pilot study to investigate the efficacy and safety of peginterferon alfa-2a (40 kDa) plus ribavirin in haemodialysed chronic HCV patients awaiting renal transplant.
Patients received peginterferon alfa-2a 135 microg/week plus ribavirin 200 mg/day for 24 or 48 weeks (genotype non-1 and 1, respectively). The dose of ribavirin was tailored according to plasma concentrations and to haemoglobin levels. Outcomes in treated patients were compared with those of a matched untreated control group.
Thirty-five patients received treatment, while 35 served as untreated controls. Thirty patients completed treatment; patients were withdrawn due to transplantation (n=2), severe anaemia (n=1), dermatitis (n=1) and non-response (n=1) resulting in a drop-out rate of 14%. Overall, 34/35 treated patients were HCV RNA negative at week 4 and had undetectable RNA at the end of treatment, compared with none of the untreated controls (ETR 97% vs 0%; p<0.001). Moreover, all achieved sustained virological response after 24 weeks of treatment-free follow-up versus no control patients (SVR 97% vs 0 %; p<0.001).
In this study, we have shown for the first time in a large cohort of patients that HCV-patients on haemodialysis can be treated successfully with peginterferon alfa-2a (40 kDa) plus ribavirin.
背景/目的:我们开展了一项初步研究,以调查聚乙二醇化干扰素α-2a(40 kDa)联合利巴韦林治疗等待肾移植的血液透析慢性丙型肝炎患者的疗效和安全性。
患者分别接受聚乙二醇化干扰素α-2a 135微克/周联合利巴韦林200毫克/天治疗24周或48周(基因型分别为非1型和1型)。利巴韦林的剂量根据血浆浓度和血红蛋白水平进行调整。将治疗患者的结果与匹配的未治疗对照组的结果进行比较。
35例患者接受治疗,35例作为未治疗对照组。30例患者完成治疗;因移植(n = 2)、严重贫血(n = 1)、皮炎(n = 1)和无反应(n = 1)而退出,退出率为14%。总体而言,34/35例治疗患者在第4周时HCV RNA呈阴性,治疗结束时RNA检测不到,而未治疗对照组无一例如此(早期病毒学应答率为97%对0%;p<0.001)。此外,所有患者在无治疗随访24周后均实现了持续病毒学应答,而对照组患者无一例如此(持续病毒学应答率为97%对0%;p<0.001)。
在本研究中,我们首次在大量患者队列中表明,血液透析的丙型肝炎患者可以用聚乙二醇化干扰素α-2a(40 kDa)联合利巴韦林成功治疗。