Kanda Tatsuo, Nakamoto Shingo, Sasaki Reina, Nakamura Masato, Yasui Shin, Haga Yuki, Ogasawara Sadahisa, Tawada Akinobu, Arai Makoto, Mikami Shigeru, Imazeki Fumio, Yokosuka Osamu
1. Department of Gastroenterology and Nephrology, Chiba University Graduate School of Medicine, Chiba, Japan;
2. Department of Molecular Virology, Chiba University Graduate School of Medicine, Chiba, Japan;
Int J Med Sci. 2016 Apr 10;13(4):310-5. doi: 10.7150/ijms.14953. eCollection 2016.
Direct-acting antiviral agents against HCV with or without peginterferon plus ribavirin result in higher eradication rates of HCV and shorter treatment duration. We examined which is better for predicting persistent virologic response, the assessment of serum HCV RNA at 12 or 24 weeks after the end of treatment for predicting sustained virologic response (SVR12 or SVR24, respectively) in patients treated by HCV NS3/4A protease inhibitors with peginterferon plus ribavirin.
In all, 149 Japanese patients infected with HCV genotype 1b treated by peginterferon plus ribavirin with telaprevir or simeprevir were retrospectively analyzed: 59 and 90 patients were treated with telaprevir- and simeprevir-including regimens, respectively. HCV RNA was measured by TaqMan HCV Test, version 2.0, real-time PCR assay. SVR12 or SVR24, respectively, was defined as HCV RNA negativity at 12 or 24 weeks after ending treatment.
Total SVR rates were 78.0% and 66.7% in the telaprevir and simeprevir groups, respectively. In the telaprevir group, all 46 patients with SVR12 finally achieved SVR24. In the simeprevir group, 60 (93.8%) of the total 64 patients with SVR12 achieved SVR24, with the other 4 patients all being previous-treatment relapsers.
SVR12 was suitable for predicting persistent virologic response in almost all cases. In simeprevir-including regimens, SVR12 could not always predict persistent virologic response. Clinicians should use SVR24 for predicting treatment outcome in the use of HCV NS3/4A protease inhibitors with peginterferon plus ribavirin for any group of real-world patients chronically infected with HCV.
使用或不使用聚乙二醇干扰素加利巴韦林的直接抗病毒药物治疗丙型肝炎病毒（HCV），可提高HCV根除率并缩短治疗疗程。我们研究了在接受HCV NS3/4A蛋白酶抑制剂联合聚乙二醇干扰素加利巴韦林治疗的患者中，治疗结束后12周或24周时血清HCV RNA评估哪一个更适合预测持续病毒学应答（分别为SVR12或SVR24）。
对149例接受聚乙二醇干扰素加利巴韦林联合特拉匹韦或simeprevir治疗的日本HCV 1b基因型感染患者进行回顾性分析：分别有59例和90例患者接受了含特拉匹韦和含simeprevir的治疗方案。采用TaqMan HCV检测2.0版实时荧光定量PCR法检测HCV RNA。SVR12或SVR24分别定义为治疗结束后12周或24周时HCV RNA阴性。
特拉匹韦组和simeprevir组的总SVR率分别为78.0%和66.7%。在特拉匹韦组，所有46例获得SVR12的患者最终均获得SVR24。在simeprevir组，64例获得SVR12的患者中有60例（93.8%）获得SVR24，另外4例均为既往治疗复发者。
SVR12在几乎所有情况下都适合预测持续病毒学应答。在含simeprevir的治疗方案中，SVR12不一定能预测持续病毒学应答。对于任何一组慢性感染HCV的真实世界患者，在使用HCV NS3/4A蛋白酶抑制剂联合聚乙二醇干扰素加利巴韦林治疗时，临床医生应使用SVR24来预测治疗结果。
