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在常规临床实践中,很少有医生使用早期病毒动力学来指导丙型肝炎病毒双重疗法的治疗决策。

In routine clinical practice, few physicians use early viral kinetics to guide HCV dual therapy treatment decisions.

作者信息

Mangia Alessandra, Bányai Tivadar, De Bartolomeo Giuseppe, Gervain Judit, Habersetzer François, Mulkay Jean-Pierre, Ouzan Denis, Parruti Giustino, Passariello Nicola, Remy Andre-Jean, Rizzetto Mario, Shiffman Mitchell L, Tice Alan D, Schmitz Manuela, Tatsch Fernando, Rodriguez-Torres Maribel

机构信息

Liver Unit, IRCCS Hospital 'Casa Sollievo della Sofferenza', San Giovanni Rotondo, Italy.

出版信息

Liver Int. 2014 Aug;34(7):e217-28. doi: 10.1111/liv.12352. Epub 2013 Nov 20.

Abstract

BACKGROUND & AIMS: PROPHESYS is a large, multinational, non-interventional prospective cohort study of chronic hepatitis C patients treated with peginterferon alfa/ribavirin. This subanalysis assesses rates of premature treatment discontinuation stratified by on-treatment virological response (VR).

METHODS

This PROPHESYS subanalysis is restricted to treatment-naive, hepatitis C virus (HCV) genotype (G)1/2/3 mono-infected patients who received peginterferon alfa-2a (40KD)/ribavirin with intended treatment duration of 48 (G1) or 24 weeks (G2/3). Early virological responses were classified into four mutually exclusive categories [rapid VR (RVR), complete early VR (cEVR), partial EVR (pEVR), no RVR/EVR], using standard criteria.

RESULTS

The likelihood for shortening treatment owing to good efficacy was highest among patients with an RVR and HCV RNA≤400 000 IU/ml (G1 10.0%; G2/3 5.8%) whereas for poor efficacy, it was highest in G1 non-RVR/EVR patients with HCV RNA>400 000 IU/ml (56.6%). Factors significantly associated with early treatment discontinuation as a result of good efficacy in G1 patients included RVR vs. no RVR/EVR and, at baseline, lower HCV RNA, lower FIB-4 score, HCV infection via injection drug use. For G2/3 patients, factors included lower baseline HCV RNA and G2 vs. G3 infection. Most patients started with the recommended peginterferon alfa-2a dose, but a high proportion received a higher-than-recommended ribavirin dose.

CONCLUSIONS

Despite international guidelines, few physicians used early viral kinetics to abbreviate treatment. Therefore, relatively few patients with an RVR and low baseline HCV RNA abbreviated treatment. In addition, there were deviations in ribavirin starting doses, suggesting that physicians tailor treatment according to local guidelines or previous experience.

摘要

背景与目的

PROPHESYS是一项针对接受聚乙二醇干扰素α/利巴韦林治疗的慢性丙型肝炎患者的大型、跨国、非干预性前瞻性队列研究。该亚组分析评估了根据治疗期间病毒学应答(VR)分层的过早治疗中断率。

方法

这项PROPHESYS亚组分析仅限于初治的丙型肝炎病毒(HCV)基因(G)1/2/3单感染患者,这些患者接受聚乙二醇干扰素α-2a(40KD)/利巴韦林治疗,预期治疗疗程为48周(G1)或24周(G2/3)。使用标准标准将早期病毒学应答分为四个相互排斥的类别[快速VR(RVR)、完全早期VR(cEVR)、部分EVR(pEVR)、无RVR/EVR]。

结果

由于疗效良好而缩短治疗的可能性在RVR且HCV RNA≤400 000 IU/ml的患者中最高(G1为10.0%;G2/3为5.8%),而对于疗效不佳的情况,在HCV RNA>400 000 IU/ml的G1非RVR/EVR患者中最高(56.6%)。在G1患者中,与因疗效良好而早期治疗中断显著相关的因素包括RVR与无RVR/EVR,以及在基线时较低的HCV RNA、较低的FIB-4评分、通过注射吸毒感染HCV。对于G2/3患者,因素包括较低的基线HCV RNA以及G2与G3感染。大多数患者开始时使用推荐的聚乙二醇干扰素α-2a剂量,但很大一部分患者接受了高于推荐剂量的利巴韦林。

结论

尽管有国际指南,但很少有医生使用早期病毒动力学来缩短治疗。因此,相对较少的RVR且基线HCV RNA较低的患者缩短了治疗。此外,利巴韦林起始剂量存在偏差,表明医生根据当地指南或既往经验调整治疗方案。

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