Akiyama Matthew J, Piotrowski Joy I, Roytman Marina M, Chan Siu M A, Hong Leena K, Huddleston Leslie, Trujillo Ruby, Tsai Naoky C S
University of Hawai'i Internal Medicine Residency Program, Honolulu, HI (M.J.A.).
Hawaii J Med Public Health. 2013 Sep;72(9 Suppl 4):6-13.
Recent advances in treatment of chronic hepatitis C virus have improved significantly due to the introduction of two new protease inhibitors-telaprevir and boceprevir. In combination with the previous standard of care, peginterferon and ribavirin, telaprevir and boceprevir have demonstrated improved sustained virologic response rates for HCV genotype 1 patients by approximately 30%. The purpose of this study was to assess the validity of large clinical trial data with respect to efficacy and side effects in a community setting in Honolulu, Hawai'i. This retrospective study was performed by reviewing the charts of 59 chronic HCV patients who were started on triple therapy from July 1, 2011 to July 7, 2012. Sustained virologic response was attained by 73% of patients treated with telaprevir and 46% of patients treated with boceprevir respectively. Our clinical experience with telaprevir demonstrates that SVR rates are compatible with published literature values. Rates of SVR in our cohort were also similar to those reported in cirrhotic patients - about 50%. Due to small number of patients treated with a boceprevir-based regimen, it is difficult to compare our experience with pivotal trial experience. The side effect profiles for the two protease inhibitors were similar to the literature values except for more rectal irritation and a higher incidence and severity of anemia on telaprevir therapy in the clinical setting. While not intended to be conclusive, our study demonstrates that clinical trial data are largely compatible with the outcomes obtained in our community setting.
由于两种新型蛋白酶抑制剂特拉匹韦和博赛匹韦的引入,慢性丙型肝炎病毒的治疗取得了显著进展。与之前的标准治疗方案聚乙二醇干扰素和利巴韦林联合使用时,特拉匹韦和博赛匹韦已证明可使丙型肝炎病毒1型患者的持续病毒学应答率提高约30%。本研究的目的是评估在夏威夷檀香山的社区环境中,大型临床试验数据在疗效和副作用方面的有效性。这项回顾性研究通过查阅2011年7月1日至2012年7月7日开始接受三联疗法的59例慢性丙型肝炎患者的病历进行。接受特拉匹韦治疗的患者中有73%实现了持续病毒学应答,接受博赛匹韦治疗的患者中有46%实现了持续病毒学应答。我们使用特拉匹韦的临床经验表明,持续病毒学应答率与已发表的文献值相符。我们队列中的持续病毒学应答率也与肝硬化患者报告的应答率相似——约为50%。由于接受基于博赛匹韦方案治疗的患者数量较少,很难将我们的经验与关键试验经验进行比较。除了在临床环境中特拉匹韦治疗时直肠刺激更多、贫血的发生率和严重程度更高外,这两种蛋白酶抑制剂的副作用情况与文献值相似。虽然本研究并非旨在得出结论,但我们的研究表明,临床试验数据在很大程度上与我们社区环境中获得的结果相符。