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Feasibility of Telaprevir-Based Triple Therapy in Liver Transplant Patients with Hepatitis C Virus: SVR 24 Results

机译:基于特拉法韦的三联疗法在丙型肝炎病毒肝移植患者中的可行性:SVR 24结果

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摘要

Management of recurrent Hepatitis C virus (HCV) infection following liver transplantation remains a major challenge. In non-transplanted HCV genotype 1 patients, the introduction of protease inhibitor-based regimens has significantly increased the rate of sustained virological response. In this follow-up study, on the first published cohort of post-liver transplant patients treated with telaprevir-based triple therapy, we investigated both efficacy and safety data in follow-up to 24 weeks (SVR 24) after end of treatment (EOT). SVR 24 efficacy and safety data from 9 liver transplant HCV patients being treated with telaprevir, pegylated interferon, and ribavirin, showed 5 of the transplanted patients accomplished the full duration of the 48 week triple therapy. Notable were the 4 patients found to be HCV RNA-negative at week 4, and 8 patients at week 12. Upon EOT, at week 48, 6 patients were HCV RNA-negative. Importantly, at follow-up (24 weeks after EOT), a favorable sustained virological response rate was observed in 5 of these patients with HCV RNA remaining negative, including in one patient who discontinued treatment prematurely. Due to side effects, 2 patients discontinued, 2 suffered from virological breakthrough after the telaprevir treatment phase, and 1 patient had a relapse after EOT. Two thirds of patients exhibited hematological side effects requiring ribavirin dose reductions, administration of erythropoetin, or even blood transfusions. This retrospective analysis provides evidence that - with respect to SVR 24 - liver transplant patients suffering from HCV genotype 1 recurrence may benefit from a telaprevir-based triple therapy as this new regimen showed acceptable antiviral efficacy in this small cohort of mostly pre-treated patients. Management of drug-drug interactions is challenging, but feasible. In part severe side effects are frequent during treatment and require therapeutic interventions.
机译:肝移植后复发性丙型肝炎病毒(HCV)感染的管理仍然是一个重大挑战。在非移植的HCV基因型1患者中,基于蛋白酶抑制剂的治疗方案的引入显着提高了持续病毒学应答率。在这项随访研究中,在首次发表基于telaprevir的三联疗法的肝移植后患者队列中,我们调查了治疗结束后(EOT)24周(SVR 24)随访的有效性和安全性数据)。来自9名接受telaprevir,聚乙二醇化干扰素和利巴韦林治疗的肝移植HCV患者的SVR 24疗效和安全性数据显示,其中5例移植患者完成了48周三联疗法的整个疗程。值得注意的是,在第4周发现4例患者的HCV RNA阴性,在第12周发现8例的患者。EOT后第48周,有6例患者的HCV RNA阴性。重要的是,在随访中(EOT后24周),在这些患者中有5例HCV RNA保持阴性,包括一名过早中断治疗的患者,观察到良好的持续病毒学应答率。由于副作用,有2例患者停药,有2例患者在telaprevir治疗阶段后出现病毒学突破,有1例患者在EOT后复发。三分之二的患者表现出血液学方面的副作用,需要降低病毒唑的剂量,施用促红细胞生成素,甚至输血。这项回顾性分析提供了证据,就SVR 24而言,患有HCV基因型1复发的肝移植患者可能会受益于基于telaprevir的三联疗法,因为这种新方案在这一小部分大多数接受过治疗的患者中显示出可接受的抗病毒疗效。药品相互作用的管理具有挑战性,但可行。在治疗过程中,严重的副作用在某种程度上很常见,需要治疗干预。

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