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在真实环境中,首例无干扰素治疗丙型肝炎的资格和安全性。

Eligibility and safety of the first interferon-free therapy against hepatitis C in a real-world setting.

机构信息

Department for Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.

出版信息

Liver Int. 2015 Jul;35(7):1845-52. doi: 10.1111/liv.12774. Epub 2015 Feb 2.

Abstract

BACKGROUND & AIMS: Several real world data demonstrated that eligibility for and tolerability of triple therapy against hepatitis C virus (HCV) infection with a first-wave protease inhibitor is limited. With the approval of sofosbuvir (SOF) effective treatment with and without pegylated interferon (PEG-IFN) has become available for most genotypes. However, no data are available regarding the added benefit of an interferon-free treatment concerning eligibility and tolerability in a real-world scenario. We aimed to assess the eligibility and safety of SOF based therapies in patients with primarily advanced cirrhosis, including decompensated cirrhosis, in a real-world setting.

RESULTS

In total, 207 patients were evaluated for a SOF based treatment with and without PEG-IFN. Twenty-six patients did not receive treatment because of safety reasons. Common causes were severe concomitant cardiac disease and advanced renal disease. Autoimmune disease, thrombopaenia, anaemia or hepatic dysfunction did not preclude treatment. Eighty-four patients started treatment, 15 with decompensated cirrhosis. During the first 12 weeks hospitalization occurred in 11 patients most frequently because of typical complications of advanced liver disease. Risk factors for hospitalization were low platelet count and deteriorated liver function. Overall, 982 of 1008 planned treatment weeks (97%) were successfully completed within the first 12 weeks of therapy.

CONCLUSION

With the better safety profile of interferon-free therapies, eligibility for HCV treatment will expand broadly, including patients with decompensated cirrhosis. Current limitations are renal failure and concomitant cardiac disease. Patients with advanced cirrhosis still have a high risk for hospitalization even with interferon-free therapies, but can continue HCV treatment in most cases.

摘要

背景与目的

多项真实世界数据表明,第一代蛋白酶抑制剂三联疗法治疗丙型肝炎病毒(HCV)感染的适用性和耐受性有限。随着索非布韦(SOF)的批准,针对大多数基因型的无聚乙二醇干扰素(PEG-IFN)和含 PEG-IFN 的有效治疗方案已广泛应用。然而,在真实世界环境中,关于无干扰素治疗在适用性和耐受性方面的额外获益,尚无相关数据。我们旨在评估 SOF 为基础的治疗方案在以代偿期肝硬化为主,包括失代偿期肝硬化患者中的适用性和安全性。

结果

共有 207 例患者接受了 SOF 为基础的治疗,包括联合或不联合 PEG-IFN 的治疗。26 例患者因安全性原因未接受治疗。常见原因是严重的合并心脏疾病和晚期肾脏疾病。自身免疫性疾病、血小板减少症、贫血或肝功能障碍并不妨碍治疗。84 例患者开始接受治疗,其中 15 例为失代偿期肝硬化患者。在最初的 12 周治疗期间,有 11 例患者因典型的晚期肝病并发症而住院,住院率较高。住院的危险因素是血小板计数低和肝功能恶化。总体而言,在治疗的前 12 周内,有 1008 个计划治疗周中的 982 个(97%)成功完成。

结论

由于无干扰素治疗的安全性更好,HCV 治疗的适用性将广泛扩大,包括失代偿期肝硬化患者。目前的限制因素是肾衰竭和合并的心脏疾病。即使使用无干扰素治疗,晚期肝硬化患者仍有较高的住院风险,但大多数情况下仍可继续 HCV 治疗。

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