Kogure Takayuki, Ueno Yoshiyuki, Fukushima Koji, Nagasaki Futoshi, Kondo Yasuteru, Inoue Jun, Matsuda Yasunori, Kakazu Eiji, Yamamoto Takeshi, Onodera Hiroyoshi, Miyazaki Yutaka, Okamoto Hiromasa, Akahane Takehiro, Kobayashi Tomoo, Mano Yutaka, Iwasaki Takao, Ishii Motoyasu, Shimosegawa Tooru
Division of Gastroenterology, Tohoku University Hospital, 1-1, Seiryo, Aobaku, Sendai 980-8574, Japan.
World J Gastroenterol. 2008 Dec 21;14(47):7225-4230. doi: 10.3748/wjg.14.7225.
To evaluate the efficacy of pegylated interferon alpha-2b (peg-IFN alpha-2b) plus ribavirin (RBV) therapy in Japanese patients with chronic hepatitis C (CHC) genotype Ib and a high viral load.
One hundred and twenty CHC patients (58.3% male) who received peg-IFN alpha-2b plus RBV therapy for 48 wk were enrolled. Sustained virological response (SVR) and clinical parameters were evaluated.
One hundred (83.3%) of 120 patients completed 48 wk of treatment. 53 patients (44.3%) achieved SVR. Early virological response (EVR) and end of treatment response (ETR) rates were 50% and 73.3%, respectively. The clinical parameters (SVR vs non-SVR) associated with SVR, ALT (108.4 IU/L vs 74.5 IU/L, P = 0.063), EVR (76.4% vs 16.4%, P < 0.0001), adherence to peg-IFN (>or= 80% of planned dose) at week 12 (48.1% vs 13.6%, P = 0.00036), adherence to peg-IFN at week 48 (54.7% vs 16.2%, P < 0.0001) and adherence to RBV at week 48 (56.1% vs 32.1%, P = 0.0102) were determined using univariate analysis, and EVR and adherence to peg-IFN at week 48 were determined using multivariate analysis. In the older patient group (> 56 years), SVR in females was significantly lower than that in males (17% vs 50%, P = 0.0262). EVR and adherence to Peg-IFN were demonstrated to be the main factors associated with SVR.
Peg-IFN alpha-2b plus RBV combination therapy demonstrated good tolerability in Japanese patients with CHC and resulted in a SVR rate of 44.3%. Treatment of elderly female patients is still challenging and maintenance of adherence to peg-IFN alpha-2b is important in improving the SVR rate.
评估聚乙二醇化干扰素α-2b（peg-IFNα-2b）联合利巴韦林（RBV）治疗日本基因Ib型慢性丙型肝炎（CHC）且病毒载量高的患者的疗效。
纳入120例接受peg-IFNα-2b联合RBV治疗48周的CHC患者（男性占58.3%）。评估持续病毒学应答（SVR）和临床参数。
120例患者中有100例（83.3%）完成了48周的治疗。53例患者（44.3%）实现了SVR。早期病毒学应答（EVR）率和治疗结束时应答（ETR）率分别为50%和73.3%。通过单因素分析确定了与SVR相关的临床参数（SVR与非SVR），即谷丙转氨酶（ALT，108.4 IU/L对74.5 IU/L，P = 0.063）、EVR（76.4%对16.4%，P < 0.0001）、第12周时对peg-IFN的依从性（≥计划剂量的80%，48.1%对13.6%，P = 0.00036）、第48周时对peg-IFN的依从性（54.7%对16.2%，P < 0.0001）以及第48周时对RBV的依从性（56.1%对32.1%，P = 0.0102），并通过多因素分析确定了第48周时的EVR和对peg-IFN的依从性。在老年患者组（>56岁）中，女性的SVR显著低于男性（17%对50%，P = 0.0262）。EVR和对peg-IFN的依从性被证明是与SVR相关的主要因素。
peg-IFNα-2b联合RBV的联合治疗在日本CHC患者中显示出良好的耐受性，SVR率为44.3%。老年女性患者的治疗仍然具有挑战性，维持对peg-IFNα-2b的依从性对于提高SVR率很重要。
