Gheorghe Liana, Iacob Speranta, Sporea Ioan, Grigorescu Mircea, Sirli Roxana, Damian Dana, Gheorghe Cristian, Iacob Razvan
Department of Hepatology, Center of Gastroenterology and Hepatology, Fundeni Clinical Institute, Str. Fundeni no. 258, 72437 Bucharest, Romania.
J Gastrointestin Liver Dis. 2007 Mar;16(1):23-9. doi: 10.1007/s11749-007-0047-9.
Increasing evidence to date highlights that individualized treatment regimens with pegylated interferon (PegIFN) and ribavirin represent a better approach for patients nowadays showing negative predictive factors for sustained virological response. The aims of this study were to assess the rate of early (EVR) and sustained virological response (SVR), tolerability and baseline predictive factors associated with EVR and SVR in patients with chronic hepatitis C treated with individualized weight-based dosing regimen for both PegIFN alpha-2b and ribavirin.
The observational analysis included 234 consecutive patients with chronic hepatitis C genotype 1 treated with PegIFN alpha-2b and ribavirin on an out-patient basis between January 2003-March 2006.
The mean age of the study group was 49.5 years, and 35% were male patients; the group was slightly overweight (mean BMI=26.5 kg/sq.m). EVR was achieved in 84.6% (198/234 patients). The end-of-treatment and sustained biochemical responses were 76.3% and 66.1%, respectively. At the end of follow-up, an overall intent-to-treat SVR was achieved by 71 of 127 patients (in 55.9%). Lower baseline (< 1,000 000 IU/mL) HCV viral load was the only predictive factor associated with EVR (p=0.04); absent or mild fibrosis (F0-1) and a low histological activity (HAI < 8) were independently associated with SVR. Side effects resulted in PegIFN and ribavirin dose reductions in 9.4% and, respectively, 18.1%, but definitive discontinuation of therapy was necessary only in 8.7% of patients.
PegIFN alpha-2b and ribavirin can be safe and successful when using a weight-based dosing regimen, leading to high response rates even in overweight patients.
迄今为止，越来越多的证据表明，对于目前显示出持续病毒学应答阴性预测因素的患者，聚乙二醇化干扰素（PegIFN）和利巴韦林的个体化治疗方案是一种更好的方法。本研究的目的是评估采用基于体重的个体化给药方案治疗慢性丙型肝炎患者时，聚乙二醇化干扰素α-2b和利巴韦林的早期病毒学应答（EVR）率、持续病毒学应答（SVR）率、耐受性以及与EVR和SVR相关的基线预测因素。
观察性分析纳入了2003年1月至2006年3月间连续234例门诊接受聚乙二醇化干扰素α-2b和利巴韦林治疗的慢性丙型肝炎1型患者。
研究组的平均年龄为49.5岁，男性患者占35%；该组患者略有超重（平均BMI = 26.5 kg/平方米）。84.6%（198/234例患者）实现了EVR。治疗结束时和持续生化应答率分别为76.3%和66.1%。随访结束时，127例患者中有71例（55.9%）实现了总体意向性治疗SVR。较低的基线（< 1,000,000 IU/mL）HCV病毒载量是与EVR相关的唯一预测因素（p = 0.04）；无或轻度纤维化（F0 - 1）和低组织学活性（HAI < 8）与SVR独立相关。副作用导致聚乙二醇化干扰素和利巴韦林剂量减少的比例分别为9.4%和18.1%，但仅8.7%的患者需要最终停止治疗。
使用基于体重的给药方案时，聚乙二醇化干扰素α-2b和利巴韦林可能是安全且成功的，即使在超重患者中也能带来较高的应答率。
