High effectiveness of peginterferon alfa-2a plus ribavirin therapy in Korean patients with chronic hepatitis C in clinical practice

Nae-Yun Heo, Young-Suk Lim, Han Chu Lee, Yung Sang Lee, Kang Mo Kim, Kwan Soo Byun, Kwang-Hyub Han, Kwan Sik Lee, Seung Woon Paik, Seung Kew Yoon, Dong Jin Suh, Nae-Yun Heo, Young-Suk Lim, Han Chu Lee, Yung Sang Lee, Kang Mo Kim, Kwan Soo Byun, Kwang-Hyub Han, Kwan Sik Lee, Seung Woon Paik, Seung Kew Yoon, Dong Jin Suh

Abstract

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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT01596517.

Keywords: Hepatitis C; Medication adherence; Peginterferon alfa-2a; Ribavirin.

Conflict of interest statement

The authors have no conflicts to disclose.

Figures

Figure 1
Figure 1
Schematic depiction of the enrollment of the patients with chronic hepatitis C in the Clinical Trial and the Cohort groups. All study patients were treated with peginterferon alfa-2a (PEG-IFN α-2a) and ribavirin (RBV) combination therapy. The standard durations of treatment were 48 weeks and 24 weeks for hepatitis C virus (HCV) genotypes 1 and 2 or 3, respectively.
Figure 2
Figure 2
Proportion of the patients in the Clinical Trial and Cohort groups who had a sustained virological response (SVR) as a function of early virological response (EVR) and adherence to treatment for patients with HCV genotype 1 (A) or genotype 2 (B). All SVR rates were determined by intention-to-treat analysis. The total number of patient is shown at the base of each bar. Adherence

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