Neukam Karin, Munteanu Daniela I, Rivero-Juárez Antonio, Lutz Thomas, Fehr Jan, Mandorfer Mattias, Bhagani Sanjay, López-Cortés Luis F, Haberl Annette, Stoeckle Marcel, Márquez Manuel, Scholten Stefan, de Los Santos-Gil Ignacio, Mauss Stefan, Rivero Antonio, Collado Antonio, Delgado Marcial, Rockstroh Juergen K, Pineda Juan A
Unit of Infectious Diseases and Microbiology, Valme University Hospital and Seville Institute of Biomedicine (IBiS), Seville, Spain; RIS-HEP07 Study Group of the Spanish AIDS Research Network.
Department of Medicine I, Bonn University Hospital, Bonn-Venusberg, Germany; Matei Bals National Institute of Infectious Diseases, Bucharest, Romania.
PLoS One. 2015 Apr 29;10(4):e0125080. doi: 10.1371/journal.pone.0125080. eCollection 2015.
Clinical trials of therapy against chronic hepatitis C virus (HCV) infection including boceprevir (BOC) or telaprevir (TVR) plus pegylated interferon and ribavirin (PR) have reported considerably higher response rates than those achieved with PR alone. This study sought to evaluate the efficacy and safety of triple therapy including BOC or TVR in combination with PR in HIV/HCV-coinfected patients under real-life conditions.
In a multicentre study conducted in 24 sites throughout five European countries, all HIV/HCV-coinfected patients who initiated a combination of BOC or TVR plus PR and who had at least 60 weeks of follow-up, were analyzed. Sustained virologic response 12 weeks after the scheduled end of therapy date (SVR12) and the rate of discontinuations due to adverse events (AE) were evaluated.
Of the 159 subjects included, 127 (79.9%) were male, 45 (34.4%) were treatment-naïve for PR and 60 (45.4%) showed cirrhosis. SVR12 was observed in 31/46 (67.4%) patients treated with BOC and 69/113 (61.1%) patients treated with TVR. Overall discontinuations due to AE rates were 8.7% for BOC and 8% for TVR. Grade 3 or 4 hematological abnormalities were frequently observed; anemia 7%, thrombocytopenia 17.2% and neutropenia 16.4%.
The efficacy and safety of triple therapy including BOC or TVR plus PR under real-life conditions of use in the HIV/HCV-coinfected population was similar to what is observed in clinical trials. Hematological side effects are frequent but manageable.
针对慢性丙型肝炎病毒（HCV）感染的治疗进行的临床试验，包括博赛匹韦（BOC）或特拉匹韦（TVR）联合聚乙二醇化干扰素及利巴韦林（PR），报告的应答率显著高于单独使用PR所取得的应答率。本研究旨在评估在实际应用条件下，BOC或TVR联合PR的三联疗法在HIV/HCV合并感染患者中的疗效和安全性。
在欧洲五个国家的24个地点开展的一项多中心研究中，对所有开始使用BOC或TVR联合PR治疗且随访至少60周的HIV/HCV合并感染患者进行了分析。评估了预定治疗结束日期后12周的持续病毒学应答（SVR12）以及因不良事件（AE）导致的停药率。
纳入的159名受试者中，127名（79.9%）为男性，45名（34.4%）既往未接受过PR治疗，60名（45.4%）有肝硬化。接受BOC治疗的46名患者中有31名（67.4%）观察到SVR12，接受TVR治疗的113名患者中有69名（61.1%）观察到SVR12。因AE导致的总体停药率，BOC为8.7%，TVR为8%。经常观察到3级或以上血液学异常；贫血7%，血小板减少17.2%，中性粒细胞减少16.4%。
在HIV/HCV合并感染人群的实际应用条件下，BOC或TVR联合PR的三联疗法的疗效和安全性与临床试验中观察到的情况相似。血液学副作用常见但可控。
