Bruno Raffaele, Sacchi Paolo, Puoti Massimo, Ciappina Valentina, Zocchetti Cristina, Brunetti Enrico, Maffezzini Elena, Capelli Anna, Patruno Savino F A, Malfitano Antonello, Filice Gaetano
Division of Infectious and Tropical Disease-IRCCS San Matteo Hospital, University of Pavia, Pavia, Italy.
BMC Infect Dis. 2002 Aug 28;2:17. doi: 10.1186/1471-2334-2-17.
The standard of care for HCV Hepatitis is the combination of interferon (IFN) plus Ribavirin. In HIV patients the use of this combination therapy may induce drug interactions, and reduces the adherence to HAART. The aim of this study is to evaluate safety and efficacy of a 48 weeks daily dose IFN schedule.
We evaluated 50 coinfected patients; alpha IFN 2a was administered at a dose of 3 MU daily. The baseline values were the following : CD4+ 515 cells/mmc (mean); HIV-RNA <50 copies/ml in all patients; HCV-RNA 28, 3 x 106 copies/ml.
At 48 weeks, 10 patients (20%) achieved a biochemical and virological response according to an intention to treat analysis.Twenty four patients (48%) underwent a drop-out mainly by side effects related to overlapping toxicity of interferon and antiretroviral therapy. All the patients, who responded to the treatment, showed a fast relapse one month after the end of treatment.
Although our results demonstrated a very poor outcome and a bad tolerance to interferon monotherapy, this approach should not be dropped out, mainly in patients at high risk for side effects and in those with cirrhosis who do not tolerate or are at increased risk for the use of ribavirin.
丙型肝炎的标准治疗方法是干扰素(IFN)联合利巴韦林。在HIV患者中,使用这种联合疗法可能会引发药物相互作用,并降低对高效抗逆转录病毒治疗(HAART)的依从性。本研究的目的是评估每日一次、为期48周的干扰素治疗方案的安全性和疗效。
我们评估了50例合并感染的患者;α干扰素2a的给药剂量为每日3 MU。基线值如下:CD4 +细胞计数平均为515个/mm³;所有患者的HIV-RNA均<50拷贝/ml;HCV-RNA为28.3×10⁶拷贝/ml。
在48周时,根据意向性分析,10例患者(20%)实现了生化和病毒学应答。24例患者(48%)退出研究,主要是由于与干扰素和抗逆转录病毒疗法重叠毒性相关的副作用。所有对治疗有反应的患者在治疗结束后1个月均迅速复发。
尽管我们的结果显示干扰素单药治疗的效果非常差且耐受性不佳,但这种方法不应被摒弃,主要适用于副作用高风险患者以及不耐受利巴韦林或使用利巴韦林风险增加的肝硬化患者。