博赛泼维用于治疗有严重纤维化或肝硬化的经治慢性丙型肝炎1型感染患者：希腊的真实生活经验。

Boceprevir for chronic HCV genotype 1 infection in treatment-experienced patients with severe fibrosis or cirrhosis: The Greek real-life experience.

作者信息

Manolakopoulos Spilios, Kranidioti Hariklia, Goulis John, Vlachogiannakos John, Elefsiniotis John, Kouroumalis Elias A, Koskinas John, Kontos George, Evangelidou Eftychia, Doumba Polyxeni, Sinakos Emmanuel, Vafiadou Ιrini, Koulentaki Mairi, Papatheodoridis George, Akriviadis Evangelos

机构信息

2 Department of Internal Medicine, General Hospital of Athens "Hippocratio" (Spilios Manolakopoulos, Hariklia Kranidioti, John Koskinas, George Kontos, Polyxeni Doumba).

4 Department of Internal Medicine, General Hospital of Thessaloniki "Hippocratio" (John Goulis, Emmanuel Sinakos, Evangelos Akriviadis).

出版信息

Ann Gastroenterol. 2015 Oct-Dec;28(4):481-6.

PMID:26423714

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4585396/

Abstract

BACKGROUND

The aim of our study was to evaluate the safety and efficacy of triple therapy using boceprevir (BOC) with pegylated interferon (pIFN)/ribavirin (RBV) in chronic hepatitis C (CHC) genotype 1 (G1) treatment-experienced patients with advanced fibrosis or compensated cirrhosis.

METHODS

We report the Greek experience on the first CHC patients who received BOC-based regimen. From September 2011 to June 2012, 26 treatment-experienced CHC patients and G1 with bridging fibrosis or compensated cirrhosis received 48 weeks of BOC+pIFN+RBV antiviral therapy. Data on complete blood counts and HCV RNA levels were obtained prior to therapy, at treatment weeks 4, 8, 12, 24, 36, 48 and 24 weeks after the end of treatment.

RESULTS

A full set analysis was performed in 25 of 26 patients. Nine patients (36%) achieved sustained viral response (SVR). Ten patients (40%) stopped the therapy because of futility rules and 3 (12%) due to adverse events. Four patients (16%) developed a virological breakthrough (3 of those presented futility rules as well) and 2 (8%) relapse. All patients who achieved SVR had G 1b, 6 (67%) were non-cirrhotic and 5 (55%) had >1 log decline in baseline HCV RNA levels at week 4 of the treatment. There were no deaths, while two patients were hospitalized due to side effects.

CONCLUSION

The triple therapy with BOC+pIFN+RBV in this cohort of real-life treatment-experienced CHC G1 patients and advanced liver disease was safe offering cure in the majority of those who could tolerate and complete treatment under a close monitoring.

摘要

背景

我们研究的目的是评估使用博赛匹韦（BOC）联合聚乙二醇干扰素（pIFN）/利巴韦林（RBV）的三联疗法在慢性丙型肝炎（CHC）基因1型（G1）经治且有严重肝纤维化或代偿期肝硬化患者中的安全性和疗效。

方法

我们报告了希腊在首批接受基于BOC方案治疗的CHC患者中的经验。2011年9月至2012年6月，26例经治的CHC G1患者伴有桥接纤维化或代偿期肝硬化，接受了48周的BOC + pIFN + RBV抗病毒治疗。在治疗前、治疗第4、8、12、24、36、48周以及治疗结束后24周获取全血细胞计数和HCV RNA水平的数据。

结果

26例患者中的25例进行了完整分析。9例患者（36%）实现了持续病毒学应答（SVR）。10例患者（40%）因无效规则停止治疗，3例（12%）因不良事件停止治疗。4例患者（16%）发生病毒学突破（其中3例也出现无效规则），2例（8%）复发。所有实现SVR的患者均为G1b型，6例（67%）无肝硬化，5例（55%）在治疗第4周时基线HCV RNA水平下降>1 log。无死亡病例，2例患者因副作用住院。