Lee Hyuk, Choi Moon Seok, Paik Seung Woon, Kim Jeong Hwan, Kim Do Young, Lee Joon Hyoek, Koh Kwang Cheol, Yoo Byung Chul, Rhee Jong Chul, Song Soon Mi
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Korean J Hepatol. 2006 Mar;12(1):31-40.
BACKGROUND/AIMS: Combination therapy with peginterferon and ribavirin is a standard therapy for western patients with chronic hepatitis C; however, its efficacy remains unclear in East Asian patients. We evaluated the efficacy and safety of administering peginterferon alfa-2a plus ribavirin in native Korean patients with chronic hepatitis C.
Seventy-five patients with detectable HCV RNA (52.0% male, median age: 50.8 years) were eligible for the study. The patients were treated with peginterferon alfa-2a 180 mcg/week plus ribavirin 800 mg/day for 24 weeks (for genotype non-1, n=46) or 1000-1200 mg/day for 48 weeks (for genotype 1, n=29). The early virologic response (EVR), the end of treatment virologic response (ETVR), the sustained virologic response (SVR), the biochemical response and the adverse event were analyzed.
EVR was seen in 86.2% of the patients with genotype 1. The ETVR was 58.6% in the genotype 1 group and 84.8% in the genotype non-1 group (P=0.02). The overall SVR was 70.7%: 55.2% in the genotype 1 group and 80.4% in the non-1 group (P=0.04). The sustained biochemical response was 64.0%. Multivariate analysis showed that the baseline HCV RNA level (Odds ratio: 0.045, 95% CI: 0.011-0.183, P<0.001) and genotype (Odds ratio: 0.247, 95% CI: 0.063-0.969, P=0.045) had an independent effect on the SVR. Neutropenia, anemia, flu-like symptoms and itching were the common adverse events. Aggravated liver function led to discontinuation of therapy for six patients. Dose modification in twenty-nine patients was effective without producing a significant reduction of the SVR.
Our data suggest that the efficacy of peginterferon plus ribavirin therapy in Koreans is comparable to those from studies on Western patients as an initial treatment for chronic hepatitis C patients. The baseline HCV RNA level and the genotype can be significant factors influencing the SVR.
背景/目的：聚乙二醇干扰素与利巴韦林联合治疗是西方慢性丙型肝炎患者的标准疗法；然而，其在东亚患者中的疗效仍不明确。我们评估了聚乙二醇干扰素α-2a联合利巴韦林治疗韩国慢性丙型肝炎患者的疗效和安全性。
75例可检测到丙型肝炎病毒核糖核酸（HCV RNA）的患者（男性占52.0%，中位年龄：50.8岁）符合研究条件。患者接受聚乙二醇干扰素α-2a 180微克/周联合利巴韦林800毫克/天治疗24周（基因非1型，n = 46）或1000 - 1200毫克/天治疗48周（基因1型，n = 29）。分析早期病毒学应答（EVR）、治疗结束时病毒学应答（ETVR）、持续病毒学应答（SVR）、生化应答及不良事件。
基因1型患者中86.2%出现EVR。基因1型组ETVR为58.6%，基因非1型组为84.8%（P = 0.02）。总体SVR为70.7%：基因1型组为55.2%，非1型组为80.4%（P = 0.04）。持续生化应答率为64.0%。多因素分析显示，基线HCV RNA水平（比值比：0.045，95%可信区间：0.011 - 0.183，P < 0.001）和基因型（比值比：0.247，95%可信区间：0.063 - 0.969，P = 0.045）对SVR有独立影响。中性粒细胞减少、贫血、流感样症状和瘙痒是常见不良事件。肝功能恶化导致6例患者停药。29例患者调整剂量有效，且未导致SVR显著降低。
我们的数据表明，聚乙二醇干扰素联合利巴韦林治疗韩国慢性丙型肝炎患者的疗效与西方患者研究结果相当，可作为慢性丙型肝炎患者的初始治疗。基线HCV RNA水平和基因型可能是影响SVR的重要因素。
