Abbas Zaigham, Tayyab Ghiasun Nabi, Qureshi Mustafa, Memon Mohammad Sadik, Subhan Amna, Shakir Tanzila, Jafri Wasim, Hamid Saeed
Department of Medicine, The Aga Khan University Hospital, Karachi, Pakistan.
Postgraduate Medical Institute, Lahore, Pakistan.
Hepat Mon. 2013 Dec 14;13(12):e14146. doi: 10.5812/hepatmon.14146. eCollection 2013.
Not enough data are available about the effectiveness of consensus interferon (CIFN) among HCV genotype 3 patients who failed to respond to pegylated interferon and ribavirin.
We aimed to assess the efficacy and safety of CIFN and ribavirin in non-responders and relapsers to pegylated interferon with ribavirin therapy.
This open-label investigator-initiated study included 44 patients who received CIFN 15 µg /day plus ribavirin 800-1200 mg daily. In patients with an early virological response (EVR), the dose of CIFN was reduced to 15 µg thrice a week for further 36 weeks. Patients with delayed virological response continued to receive daily CIFN plus ribavirin to complete 48 weeks. The patients were considered "non-responders" if there were less than 2 log reduction in HCV RNA at 12 weeks and detectable HCV RNA at 24 weeks.
Twenty-four patients (55%) were non-responders and 20 patients were relapsers to the previous treatment with pegylated interferon plus ribavirin (mean age 43.6 ± 9.4 years, males 25 (57%)). Nine patients were clinically cirrhotic (Child A). End of treatment virological response was achieved in 19 (43.1%) patients and sustained virological response (SVR) occurred in 12 (27.3%). Out of these 12 patients, eight were non-responders and four were relapsers to the previous treatment. Advanced fibrosis or clinical cirrhosis was associated with low SVR. Adverse events were fever, myalgia, anorexia, depression, and weight loss. Two patients received granulocyte colony stimulating factor for transient neutropenia. Seven patients were given erythropoietin to improve hemoglobin, and six were treated for mild depression. Two patients developed portosystemic encephalopathy.
More than one-quarter of treatment-experienced patients with HCV genotype 3 achieved SVR after re-treatment with consensus interferon plus ribavirin.
对于聚乙二醇干扰素和利巴韦林治疗无效的丙型肝炎病毒3型患者,关于共识干扰素(CIFN)有效性的数据不足。
我们旨在评估CIFN和利巴韦林在聚乙二醇干扰素联合利巴韦林治疗无应答者和复发者中的疗效和安全性。
这项由研究者发起的开放标签研究纳入了44例接受每日15μg CIFN加800 - 1200mg利巴韦林治疗的患者。对于有早期病毒学应答(EVR)的患者,CIFN剂量减至每周三次,每次15μg,持续36周。病毒学应答延迟的患者继续接受每日CIFN加利巴韦林治疗,疗程为48周。如果患者在12周时HCV RNA下降小于2 log且在24周时可检测到HCV RNA,则被视为“无应答者”。
24例患者(55%)为无应答者,20例患者为聚乙二醇干扰素联合利巴韦林既往治疗的复发者(平均年龄43.6±9.4岁,男性25例(57%))。9例患者为临床肝硬化(Child A级)。19例(43.1%)患者实现了治疗结束时病毒学应答,12例(27.3%)患者出现持续病毒学应答(SVR)。在这12例患者中,8例为无应答者,4例为既往治疗的复发者。重度肝纤维化或临床肝硬化与低SVR相关。不良事件包括发热、肌痛、厌食、抑郁和体重减轻。2例患者因短暂性中性粒细胞减少接受了粒细胞集落刺激因子治疗。7例患者接受促红细胞生成素以改善血红蛋白,6例患者接受轻度抑郁治疗。2例患者发生门体性脑病。
超过四分之一既往接受过治疗的丙型肝炎病毒3型患者在接受共识干扰素联合利巴韦林再治疗后实现了SVR。