Sharvadze L G, Gogichaishvili Sh Sh, Sakandelidze Ts G, Zhamutashvili M T, Chkhartishvili N I
Infectious Diseases, AIDS and Clinical Immunology Research Center, Tbilisi, Georgia.
Georgian Med News. 2009 Jan(166):61-4.
The aim of four-year follow up study was evaluation of re-treatment efficacy of antiviral therapy in patients with hepatitis C who failed to respond (non responders) to previous therapy. Study enrolled 29 patients, aged 21-59 with HCV infection (15 had HCV genotype 1, and 14 had HCV non-genotype1), who previously were treated with unmodified interferon alfa (conventional interferon) 2a or 2b 5 MIU TIW plus ribavirin (1000-1200 mg/day) and who failed under this therapy. Study subjects were randomized into two groups: in group I were included 17 patients--relapsers (patient in whom HCV RNA becomes undetectable on treatment and is undetectable at the end of therapy, but is detected again after discontinuation of treatment). Group II was composed of 12 patients: 4 were non responders (patient in whom HCV RNA levels remain stable on treatment), 4--partial responders (HCV RNA levels decline by >2 logs, but never become undetectable during treatment) and 4--breakthrough non responders (HCV RNA become undetectable during treatment, but before-treatment termination again become detectable). The diagnosis of HCV infection was made based on detection of HCV antibodies by ELISA and confirmed by RIBA. Detection of HCV RNA (qualitative) and HCV RNA Viral load--by Real time PCR technique (COBAS TaqMan Test). HCV genotypes were detected by INNO-Lipa method. In group I--rapid virological response (RVR) was observed in 10 (58%) patients, early viral response (EVR) in 12 patients (70%). Among them 9 (52%) patients remained HCV RNA undetectable by the end of treatment. After 6 months sustained viral response (SVR) was received in 7 (41%) patients from group I. In group II--RVR was observed in 5 (41%), EVR in 6 (50%) patients. Among them 5 (41%) patients remained HCV RNA undetectable by the end of treatment. After 6 months Sustained Viral Response was received in 3 (25%) patients. Re-treatment with pegylated interferon and ribavirin in patients with hepatitis C who failed to responds to previous treatment was effective in relapsers. Re-treatment in non responders, partial responders and breakthrough non responders was less effective (especially in non responders). Re-treatment effectiveness was higher in HCV genotype non 1 patients in comparison with HCV genotype 1. Thus re-treatment will be considered for relapsers. For making decision on re-treatment for other nonresponders, severity of disease (advance disease) should be considered.
这项四年随访研究的目的是评估抗病毒治疗对先前治疗无反应（无反应者）的丙型肝炎患者的再治疗效果。该研究纳入了29例年龄在21至59岁之间的丙型肝炎病毒感染患者（15例为丙型肝炎病毒基因1型，14例为非丙型肝炎病毒基因1型），这些患者先前接受过未修饰的干扰素α（常规干扰素）2a或2b 5MIU，每周三次加利巴韦林（1000 - 1200mg/天）治疗，但在此治疗下失败。研究对象被随机分为两组：第一组包括17例复发者（治疗期间丙型肝炎病毒RNA检测不到且治疗结束时检测不到，但停药后再次检测到的患者）。第二组由12例患者组成：4例为无反应者（治疗期间丙型肝炎病毒RNA水平保持稳定的患者），4例为部分反应者（丙型肝炎病毒RNA水平下降超过2个对数，但治疗期间从未检测不到），4例为突破无反应者（治疗期间丙型肝炎病毒RNA检测不到，但在治疗结束前再次变为可检测到）。丙型肝炎病毒感染的诊断基于酶联免疫吸附测定法检测丙型肝炎病毒抗体，并通过重组免疫印迹法确认。通过实时聚合酶链反应技术（COBAS TaqMan检测）检测丙型肝炎病毒RNA（定性）和丙型肝炎病毒RNA病毒载量。通过INNO - Lipa方法检测丙型肝炎病毒基因型。在第一组中，10例（58%）患者观察到快速病毒学反应（RVR），12例（70%）患者观察到早期病毒学反应（EVR）。其中9例（52%）患者在治疗结束时丙型肝炎病毒RNA检测不到。6个月后，第一组中有7例（41%）患者获得持续病毒学反应（SVR）。在第二组中，5例（41%）患者观察到RVR，6例（50%）患者观察到EVR。其中5例（41%）患者在治疗结束时丙型肝炎病毒RNA检测不到。6个月后，3例（25%）患者获得持续病毒学反应。对先前治疗无反应的丙型肝炎患者用聚乙二醇化干扰素和利巴韦林进行再治疗对复发者有效。对无反应者、部分反应者和突破无反应者的再治疗效果较差（尤其是无反应者）。与丙型肝炎病毒基因１型患者相比，丙型肝炎病毒非基因１型患者的再治疗效果更高。因此，将考虑对复发者进行再治疗。对于决定其他无反应者是否进行再治疗，应考虑疾病的严重程度（晚期疾病）。
