Center for Hepatitis C, Atlanta Medical Center, Atlanta, GA; Department of Graduate Medical Education, Atlanta Medical Center, Atlanta, GA; Medical College of Georgia, Department of Medicine, Augusta, GA; Emory University School of Medicine, Department of Medicine, Atlanta, GA.
Hepatology. 2014 Jan;59(1):71-7. doi: 10.1002/hep.26624. Epub 2013 Nov 18.
The new standard of care for treatment-naïve patients with hepatitis C virus (HCV) genotype 1 includes triple therapy with peginterferon, ribavirin, and a protease inhibitor. However, patients who achieve a rapid virologic response after 4 weeks of peginterferon and ribavirin therapy are likely to achieve a sustained virologic response (SVR), and we hypothesized that protease inhibitor therapy may be unnecessary in these patients. Treatment-naïve, noncirrhosis patients infected with genotype-1 HCV and a low viral load at baseline were considered for inclusion (n = 233). After 4 weeks of lead-in therapy with peginterferon α-2b and ribavirin, 101 patients (48%) had a rapid virologic response (defined as undetectable levels of hepatitis C virus RNA at 4 weeks) and were eligible to participate. Patients were randomized 1:1 to 20 weeks of additional therapy with peginterferon α-2b and ribavirin (double therapy) or to 24 weeks of peginterferon α-2b, ribavirin, and boceprevir (triple therapy). There was no significant difference in rates of SVR-12 in patients treated with double versus triple therapy. This similarity persisted regardless of viral subtype (genotype 1a or 1b), interleukin (IL)-28b genotype (CC or non-CC), or ethnicity (African American versus non-Hispanic white).
Protease inhibitor therapy could be obviated in genotype 1-infected treatment-naïve patients with low viral load at baseline who achieve undetectable viremia after 4 weeks of peginterferon/ribavirin.
对于初治的慢性丙型肝炎病毒(HCV)基因型 1 感染患者,聚乙二醇干扰素、利巴韦林和蛋白酶抑制剂三联治疗已成为新标准。然而,对于在接受聚乙二醇干扰素和利巴韦林治疗 4 周时快速病毒学应答(RVR)的患者,其持续病毒学应答(SVR)的可能性较高,我们推测这些患者可能无需接受蛋白酶抑制剂治疗。本研究纳入了未经治疗、无肝硬化、基线病毒载量低的基因型 1 HCV 感染患者(n=233)。在接受聚乙二醇干扰素α-2b 和利巴韦林的 4 周导入治疗后,有 101 例患者(48%)达到了 RVR(定义为在第 4 周时 HCV RNA 不可检测),有资格参加研究。这些患者按 1:1 随机分配接受 20 周的聚乙二醇干扰素α-2b 和利巴韦林(双药治疗)或 24 周的聚乙二醇干扰素α-2b、利巴韦林和博赛匹韦(三药治疗)。双药治疗组和三药治疗组的 SVR-12 率无显著差异。无论病毒亚型(基因型 1a 或 1b)、白细胞介素(IL)-28b 基因型(CC 或非 CC)或种族(非裔美国人与非西班牙裔白人)如何,这种相似性都持续存在。
在基线病毒载量低且在接受聚乙二醇干扰素/利巴韦林治疗 4 周后病毒血症不可检测的初治基因型 1 感染患者中,蛋白酶抑制剂治疗可能是不必要的。