Department of Internal Medicine, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.
Clin Mol Hepatol. 2013 Mar;19(1):60-9. doi: 10.3350/cmh.2013.19.1.60. Epub 2013 Mar 25.
BACKGROUND/AIMS: Identifying the impact of a patient's ethnicity on treatment responses in clinical practice may assist in providing individualized treatment regimens for chronic hepatitis C (CHC). The effectiveness of standard peginterferon plus ribavirin therapy and the need for triple combination therapy with protease inhibitors in Koreans remain matters of debate. These issues were investigated in the present study.
The clinical data of 272 treatment-naïve Korean CHC patients who were treated in a community-based clinical trial (Clinical Trial group; n=51) and in clinical practice (Cohort group; n=221), were analyzed and compared. All were treated with standard protocols of peginterferon alfa-2a plus ribavirin therapy.
For patients with hepatitis C virus (HCV) genotype 1, the sustained virological response (SVR) rates in the Clinical Trial and Cohort groups were 81% (21/26) and 55% (58/106), respectively, by intention-to-treat (ITT) analysis (P=0.02), and 100% (13/13) and 80% (32/40), respectively, in treatment-adherent patients (P=0.18). For patients with HCV genotype 2, the SVR rates in these two groups were 96% (24/25) and 88% (101/115), respectively, by ITT analysis (P=0.31). Adherence and treatment duration were independent predictors of SVR for genotypes 1 and 2, respectively (P<0.01 for each). Korean patients with CHC achieved high SVR rates with peginterferon alfa-2a plus ribavirin in both the clinical trial and clinical practice settings.
Measures to raise adherence to standard therapy in clinical practice may improve the SVR rates in these patients as effectively as adding protease inhibitors, thus obviating the need for the latter.
背景/目的:在临床实践中确定患者种族对治疗反应的影响,可能有助于为慢性丙型肝炎(CHC)患者提供个体化的治疗方案。标准聚乙二醇干扰素加利巴韦林治疗的有效性以及在韩国人需要三联蛋白酶抑制剂治疗的问题仍然存在争议。本研究对此进行了调查。
对在社区临床试验(临床试验组;n=51)和临床实践(队列组;n=221)中接受治疗的 272 例初治韩国 CHC 患者的临床数据进行分析和比较。所有患者均采用聚乙二醇干扰素 alfa-2a 加利巴韦林标准方案治疗。
对于 HCV 基因型 1 患者,临床试验组和队列组的持续病毒学应答(SVR)率分别为意向治疗(ITT)分析的 81%(21/26)和 55%(58/106)(P=0.02),治疗依从性患者分别为 100%(13/13)和 80%(32/40)(P=0.18)。对于 HCV 基因型 2 患者,这两组的 SVR 率分别为 ITT 分析的 96%(24/25)和 88%(101/115)(P=0.31)。对于基因型 1 和 2,依从性和治疗持续时间是 SVR 的独立预测因素(P<0.01)。韩国 CHC 患者在临床试验和临床实践环境中均能通过聚乙二醇干扰素 alfa-2a 加利巴韦林获得高 SVR 率。
在临床实践中提高对标准治疗的依从性的措施,可能与添加蛋白酶抑制剂一样有效地提高这些患者的 SVR 率,从而避免后者的使用。