Unità operativa di Gastroenterologia e Medicina, Ospedali Riuniti Villa Sofia e Cervello, Palermo, Italy.
Pharmacoepidemiol Drug Saf. 2010 Nov;19(11):1113-23. doi: 10.1002/pds.2025.
Treatment of patients with chronic hepatitis C with alpha-interferon and ribavirin usually produces adverse events within the first 3 months. We aimed to assess safety and predictors of discontinuation or dose modification of these drugs.
Observational study of 312 patients with predominantly genotype 1 chronic hepatitis C treated openly along 5 years in a clinical practice setting.
Eighty-four percent of patients experienced at least one adverse event (853 events in total, 3.3 per patient on average). Incidence rate was higher during the first 90 days and decreased thereafter (<5%). Discontinuation rates at 30 and 90 days and at end of treatment were 2, 4 and 8%, respectively. Seventy percent of discontinuation cases were due to adverse events rather than to laboratory abnormalities. Serious adverse events were rare (<1%). Dose modifications were made in 158 patients (51%) on 237 occasions. After adjusting for covariates, older age was a predictor of early discontinuation, whereas HCV genotypes 1-4 and daily ribavirin dose of 1000 mg or more were predictors of dose modification.
The majority of real-world patients with chronic hepatitis C tolerate acceptably dual therapy and very few discontinue it. Subjective decisions on dose reduction of either compound appears to have a major impact on adherence of patients. There is a need to better define, collect and analyse clinical features which may predict adverse events and safety-related decisions during therapy of chronic hepatitis C.
用α干扰素和利巴韦林治疗慢性丙型肝炎患者通常会在头 3 个月内出现不良反应。我们旨在评估这些药物的安全性和停药或剂量调整的预测因素。
在临床实践环境中对 312 名主要基因型 1 慢性丙型肝炎患者进行了 5 年的开放性观察性研究。
84%的患者至少出现了一次不良反应（总共发生了 853 次事件，平均每位患者 3.3 次）。发病率在头 90 天较高，此后降低（<5%）。30 天、90 天和治疗结束时的停药率分别为 2%、4%和 8%。70%的停药病例是由于不良反应而不是实验室异常。严重不良反应罕见（<1%）。158 名患者（51%）共 237 次进行了剂量调整。调整了协变量后，年龄较大是早期停药的预测因素，而 HCV 基因型 1-4 和每日利巴韦林剂量 1000mg 或以上是剂量调整的预测因素。
大多数慢性丙型肝炎的真实世界患者能够耐受双重治疗，很少有人停药。对任一药物剂量的主观减少决定似乎对患者的依从性有重大影响。有必要更好地定义、收集和分析可能预测慢性丙型肝炎治疗期间不良反应和与安全性相关的决策的临床特征。
