Mangia Alessandra, Cenderello Giovanni, Orlandini Alessandra, Piazzolla Valeria, Picciotto Antonio, Zuin Massimo, Ciancio Alessia, Brancaccio Giuseppina, Forte Paolo, Carretta Vito, Zignego Anna Linda, Minerva Nicola, Brindicci Gaetano, Marignani Massimo, Baroni Gianluca Svegliati, Bertino Gaetano, Cuccorese Giuseppe, Mottola Leonardo, Ripoli Maria, Pirisi Mario
Hospital IRCCS "Casa Sollievo della Sofferenza", Liver Unit, San Giovanni Rotondo, Italy.
Galliera Hospital, Infectious Diseases, Genova, Italy.
PLoS One. 2014 Oct 23;9(10):e110284. doi: 10.1371/journal.pone.0110284. eCollection 2014.
Triple therapy including Telaprevir or Boceprevir still represents in many European countries the standard of care for patients with Hepatitis C Virus genotype 1 infection. The number of patients who received this treatment resulted generally lower than expected. We investigated, among naïve patients, number and characteristics of treatment candidates who were started on triple or dual therapy in comparison to those who were deferred.
621 naïve treatment candidates were prospectively evaluated at each center. Factors associated with decision to defer or treat with dual or triple therapy were investigated by univariate and multivariate analyses. Rates of Sustained Virological Response and safety profile were analysed.
Of candidates to treatment, 33% did not received it. It was mostly due to high risk of Interferon-induced decompensation. Of 397 patients who were started on treatment, 266 (67%) received triple, 131 dual. Among patient receiving treatment, unfavorable IL28B, severe liver damage and higher albumin were independently associated with the physician decision to administer triple therapy. Sustained Virological Response after dual therapy was 66.4%, after triple 73.7% (p = 0.14). 142 patients received Telaprevir. The choice of Telaprevir-based therapy was associated with higher Body Mass Index and advanced liver disease. Sustained Virological Response rates were 71.1% after Telaprevir and 76.6% after Boceprevir.
Individualizing treatment with available regimens allows to maximize Sustained Virological Response and to reduce the number of patients who remain untreated. High proportion of patients with severe liver damage urgently need Interferon free treatment.
在许多欧洲国家，包含特拉匹韦或博赛匹韦的三联疗法仍是丙型肝炎病毒1型感染患者的标准治疗方案。接受该治疗的患者数量总体低于预期。我们调查了初治患者中开始接受三联或双联疗法的候选治疗对象的数量及特征，并与推迟治疗的患者进行比较。
每个中心对621名初治候选患者进行前瞻性评估。通过单因素和多因素分析研究与推迟治疗或采用双联或三联疗法治疗相关的因素。分析持续病毒学应答率和安全性。
在候选治疗对象中，33%未接受治疗。这主要是由于干扰素诱导失代偿的高风险。在397名开始治疗的患者中，266名（67%）接受三联疗法，131名接受双联疗法。在接受治疗的患者中，不良的IL28B、严重肝损伤和较高的白蛋白水平与医生决定给予三联疗法独立相关。双联疗法后的持续病毒学应答率为66.4%，三联疗法后为73.7%（p = 0.14）。142名患者接受了特拉匹韦。基于特拉匹韦的治疗方案选择与较高的体重指数和晚期肝病相关。接受特拉匹韦治疗后的持续病毒学应答率为71.1%，接受博赛匹韦治疗后为76.6%。
采用现有方案进行个体化治疗可使持续病毒学应答最大化，并减少未接受治疗的患者数量。高比例的严重肝损伤患者迫切需要无干扰素治疗。
