Kevans D, Farrell G, Hopkins S, Mahmud N, White B, Norris S, Bergin C
Department of Hepatology, St James's Hospital, James's Street, Dublin 8, Ireland.
Haemophilia. 2007 Sep;13(5):593-8. doi: 10.1111/j.1365-2516.2007.01489.x.
Hepatitis C virus-infected haemophiliacs are traditionally under represented in international treatment studies thus data assessing response to pegylated-interferon (peg-IFN) and ribavirin (RBV) in HCV mono-infected or HCV/HIV co-infected haemophiliacs are few. Since 2001, 37 haemophiliac patients have received peg-IFN and RBV according to centre-based investigator initiated protocols. Primary end points were: early virological response (EVR); end of treatment response (EOTR) and sustained virological response (SVR). An intention-to-treat analysis was used. Secondary end points were adverse events, haemopoietic stem cell growth factor use, therapy discontinuations and dose reductions. Hepatitis C virus mono-infection group (Mono-I) numbered 20 (60% genotype 1). HCV/HIV co-infected group (Co-I) numbered 17 (59% genotype 1/4). Primary end points were: EVR 76%, EOTR 70% and SVR 43%. Comparison of Mono-I to Co-I demonstrated: EVR rates of 70% and 82%, respectively; EOTR rates of 65% and 76%, respectively, and SVR rates of 35% and 53%, respectively. SVR rates genotype 1/4 group - 17% (Mono-I) vs. 30% (Co-I); SVR rates genotype 2/3 group - 63% (Mono-I) vs. 86% (Co-I). Therapy discontinuations: six of 20 (30%) Mono-I vs. three of 17 (18%) Co-I. Dose reductions: two of 20 (10%) Mono-I vs. zero of 17 Co-I. Haematological support factor use: one of 20 (5%) Mono-I vs. four of 17 (23.5%) Co-I. Virological outcomes to peg-IFN and RBV in HCV-infected haemophiliacs are comparable to published data relating to other HCV-infected cohorts. Good virological outcomes can be achieved in HIV co-infected haemophiliacs particularly when growth factors are used to facilitate full dosing of peg-IFN and RBV.
在国际治疗研究中，丙型肝炎病毒（HCV）感染的血友病患者传统上代表性不足，因此评估HCV单一感染或HCV/HIV合并感染的血友病患者对聚乙二醇化干扰素（peg-IFN）和利巴韦林（RBV）反应的数据很少。自2001年以来，37例血友病患者根据以中心为基础的研究者发起的方案接受了peg-IFN和RBV治疗。主要终点为：早期病毒学应答（EVR）；治疗结束时应答（EOTR）和持续病毒学应答（SVR）。采用意向性分析。次要终点为不良事件、造血干细胞生长因子使用情况、治疗中断和剂量减少。HCV单一感染组（Mono-I）有20例（60%为1型基因型）。HCV/HIV合并感染组（Co-I）有17例（59%为1/4型基因型）。主要终点为：EVR为76%，EOTR为70%，SVR为43%。Mono-I组与Co-I组比较显示：EVR率分别为70%和82%；EOTR率分别为65%和76%，SVR率分别为35%和53%。1/4型基因型组的SVR率——Mono-I组为17%，Co-I组为30%；2/3型基因型组的SVR率——Mono-I组为63%，Co-I组为86%。治疗中断情况：Mono-I组20例中有6例（30%），Co-I组17例中有3例（18%）。剂量减少情况：Mono-I组20例中有2例（10%），Co-I组17例中为0例。造血支持因子使用情况：Mono-I组20例中有1例（5%），Co-I组17例中有4例（23.5%）。HCV感染的血友病患者对peg-IFN和RBV的病毒学转归与其他HCV感染队列的已发表数据相当。在HIV合并感染的血友病患者中可以取得良好的病毒学转归，尤其是当使用生长因子来促进peg-IFN和RBV的全剂量给药时。
