基于替拉瑞韦和博赛泼维的三联疗法在F3 - F4期经治丙型肝炎病毒患者实际治疗中的应用
Telaprevir- and boceprevir-based tritherapies in real practice for F3-F4 pretreated hepatitis C virus patients.
作者信息
Bonnet Delphine, Guivarch Matthieu, Bérard Emilie, Combis Jean-Marc, Remy Andre Jean, Glibert Andre, Payen Jean-Louis, Metivier Sophie, Barange Karl, Desmorat Herve, Palacin Anaïs, Nicot Florence, Abravanel Florence, Alric Laurent
机构信息
Delphine Bonnet, Matthieu Guivarch, Anaïs Palacin, Laurent Alric, Internal Medicine-Digestive Department, Purpan University Hospital, 31059 Toulouse cedex 9, France.
出版信息
World J Hepatol. 2014 Sep 27;6(9):660-9. doi: 10.4254/wjh.v6.i9.660.
AIM
To assess, in a routine practice setting, the sustained virologic response (SVR) to telaprevir (TPV) or boceprevir (BOC) in hepatitis C virus (HCV) null-responders or relapsers with severe liver fibrosis.
METHODS
One hundred twenty-five patients were treated prospectively for 48 wk with TPV or BOC + pegylated-interferon (peg-INF) α2a + ribavirin (PR) according to standard treatment schedules without randomization. These patients were treated in routine practice settings in 10 public or private health care centers, and the data were prospectively collected. Only patients with severe liver fibrosis (Metavir scores of F3 or F4 upon liver biopsy or liver stiffness assessed by elastography), genotype 1 HCV and who were null-responders or relapsers to prior PR combination therapy were included in this study.
RESULTS
The Metavir fibrosis scores were F3 in 35 (28%) and F4 in 90 (72%) of the patients. In total, 62.9% of the patients were null-responders and 37.1% relapsers to the previous PR therapy. The overall SVR rate at 24 wk post-treatment withdrawal was 59.8%. The SVR was 65.9% in the TPV group and 44.1% in the BOC group. Independent predictive factors of an SVR included a response to previous treatment, relapsers vs null-responders [OR = 3.9; (1.4, 10.6), P = 0.0084], a rapid virological response (RVR) [OR 6.9 (2.6, 18.2), P = 0.001] and liver stiffness lower than 21.3 kPa [OR = 8.2 (2.3, 29.5), P = 0.001]. During treatment, 63 patients (50.8%) had at least one severe adverse event (SAE) of grade 3 or 4. A multivariate analysis identified two factors associated with SAEs: female gender [OR = 2.4 (1.1, 5.6), P = 0.037] and a platelet count below 150 × 10(3)/ mm(3) [OR = 5.3 (2.3, 12.4), P ≤ 0.001].
CONCLUSION
More than half of these difficult-to-treat patients achieved an SVR and had SAEs in an actual practice setting. The SVR rate was influenced by the response to previous PR treatment, the RVR and liver stiffness.
目的
在常规临床实践环境中，评估丙型肝炎病毒（HCV）无应答者或复发者且伴有严重肝纤维化患者对特拉匹韦（TPV）或博赛匹韦（BOC）的持续病毒学应答（SVR）情况。
方法
125例患者按照标准治疗方案前瞻性接受TPV或BOC + 聚乙二醇化干扰素（peg - INF）α2a + 利巴韦林（PR）治疗48周，未进行随机分组。这些患者在10家公立或私立医疗中心的常规临床实践环境中接受治疗，数据进行前瞻性收集。本研究仅纳入伴有严重肝纤维化（肝活检Metavir评分F3或F4或通过弹性成像评估的肝脏硬度）、基因型1 HCV且对先前PR联合治疗无应答或复发的患者。
结果
患者的Metavir纤维化评分中，35例（28%）为F3，90例（72%）为F4。总体而言，62.9%的患者对先前PR治疗无应答，37.1%为复发者。治疗停药后24周时的总体SVR率为59.8%。TPV组的SVR为65.9%，BOC组为44.1%。SVR的独立预测因素包括对先前治疗的反应、复发者与无应答者相比[比值比（OR） = 3.9；（1.4，10.6），P = 0.0084]、快速病毒学应答（RVR）[OR 6.9（2.6，18.2），P = 0.001]以及肝脏硬度低于21.3 kPa[OR = 8.2（2.3，29.5），P = 0.001]。治疗期间，63例患者（50.8%）至少发生1次3级或4级严重不良事件（SAE）。多因素分析确定了与SAE相关的两个因素：女性性别[OR = 2.4（1.1，5.6），P = 0.037]和血小板计数低于150×10³/mm³[OR = 5.3（2.3，1)2.4），P≤0.001]。
结论
在实际临床实践环境中，超过一半的这些难治性患者实现了SVR且发生了SAE。SVR率受先前PR治疗反应、RVR和肝脏硬度的影响。
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