HCV复发和它与肝移植术后纤维化进展的关系被很好的记录下来。到目前为止，包含干扰素的抗病毒治疗是肝移植后HCV患者治疗的标志性方案。包含干扰素的治疗方案的持续病毒学应答(SVR)和安全性都不能满足肝移植后患者的需求。2014年1月，直接抗病毒药物sofosbuvir (SBV)被引入德国，紧接着，2014年5月，simeprevir药物也被引入，2014年8月daclatasvir药物也被引入。这些新引进的药物的有效性和安全性令人期待，其相互作用信息很有限。
这一进行中的分析旨在评估应用不含干扰素的、包含sofosbuvir的抗HCV治疗方案逆转肝移植后患者的肝纤维化的疗效，从而避免肝移植患者纤维化的进展。
研究方法
病理证实为丙型肝炎的肝移植后的患者应用SBV (n=18)治疗24个周。在第0, 12, 24, 36周应用实验室参数和肝弹性成像系统进行评估。回顾应用聚乙二醇干扰素和/或利巴韦林和/或特拉匹韦抗病毒治疗的肝移植后患者，以此作为对照组并进行评估。
研究结果
到目前为止，我们获得了应用SBV治疗的13个受试者的数据。对照组有17个受试者。9/13的应用SBV治疗的受试者达到快速病毒学应答，另外还有3位患者达到早期病毒学应答。比较两组患者的快速病毒性应答的比例发现，应用SBV方案治疗的患者快速病毒性应答的比例较高(p= 0.025，F检验，双侧)。4位干扰素抗病毒治疗失败的患者对SBV治疗敏感。已经应用SBV治疗24周的患者的肝弹性成像系统分析的原始数据显示，4位患者肝纤维化得以逆转。未观察到不良反应，这导致了SBV治疗的提前终止。
结论
SBV貌似是治疗肝移植后感染HCV的患者的一种安全有效的治疗方案。初步结果显示，经过24个周的治疗，肝移植后肝纤维化的逆转是可行的，至少在这一亚组中如此。
英文原文
Regression of fibrosis in interferon-free sofosbuvir-based anti-HCV therapy after liver transplantation（摘要号：LB-15）
Background: Recurrence of HCV and its related progression of fibrosis after liver transplantation (OLT) are well documented. So far, interferon (IFN) based antiviral therapy represents the hallmark in treating HCV patients also after OLT. Neither sustained virologic response (SVR) nor safety profiles of the INF-based therapies are satisfactory for transplant recipients. In January 2014 the direct-acting antiviral drug sofosbuvir (SBV) was introduced in Germany followed by simeprevir in May 2014 and daclatasvir in August 2014. Efficacy and safety of these newly introduced drugs are promising, experience in interactions are limited. The purpose of this ongoing analysis is to circumvent the progression of fibrosis in HCV liver transplant recipients.
Methods: Patients post OLT presenting with biopsy proven HCV inflammation were/are treated with SBV (n=18) for 24 weeks. Laboratory parameters and Fibroscan were/are assessed at week 0, 12, 24, 36. As control group HCV liver transplant recipients who received originally antiviral therapy with pegylated INF and/or ribavirin (RBV) and/or telaprevir (TLV) were retrospectively evaluated.
Results: So far we obtained data on 13 subjects being treated with SBV (figure). The control cohort exists of 17 subjects. Nine out of 13 subjects with SBV had a rapid virologic reponse (RVR) and additional 3 patients developed an early virologic response (EVR). Comparing the two studied groups the rate of RVRs is significantly higher in the SBV-based therapies (p= 0.025, Fisher’s exact test, 2-sided). Four patients who experienced a failure of an INF-based antiviral response responded to SBV. Preliminary data on fibroscan analysis in patients who achieved already 24 weeks of SBV therapy revealed 4 patients with regression of fibrosis. There were no side effects observed, which resulted in premature termination of SBV.
Conclusions: SBV seems to be a safe and effective therapeutic option in OLT patients infected with HCV. Preliminary results show that regression of fibrosis after OLT is feasible within 24 weeks of therapy at least in a subgroup of patients.
