Ahmed Eman I, Abdel Wahed Wafaa Y, Hassan Essam A, Ahmed Tarek I
Department of Pharmacology, Faculty of Medicine, Fayoum University, Fayoum, Egypt.
Department of Public Health and Community Medicine, Faculty of Medicine, Fayoum University, Fayoum, Egypt.
Curr Drug Saf. 2018;13(3):187-195. doi: 10.2174/1574886313666180716111529.
Different combinations of Direct Antiviral Agents (DAAs) have been used against different Hepatitis C Virus (HCV) genotypes and in different types of patients. Despite being effective and characterized by a very low rate of adverse effects in clinical trials, few data are available on adverse events in real life studies.
The aim of this study was to identify the incidence and pattern of Adverse Drug Reactions (ADRs) caused by DAAs; daclatasvir and sofosbuvir and their combination with ribavirin and to assess the causality and the severity of the reported ADRs.
A prospective observational study was conducted over six months at treatment HCV center of Health Insurance Hospital in Fayoum Governorate, Egypt. A pre-tested, interviewed structured questionnaire was used by authors to gather required data from 345 enrolled patients regarding demographics, co-morbidity and ADRs. Causality and severity of ADRs were assessed.
According to our data. we have found that 75.7% (261out of 345) patients reported 36 different ADRs involving different systems, of these 1.2% experienced Serious Adverse Events (SAEs), including three deaths (0.9%). A majority of ADRs were more significantly reported with ribavirin-containing regimen. Out of 345 patients, 23.5% have comorbidities. Among them, 92.6% reported ADRs. Causality assessment of ADRs by WHO-UMC criteria revealed that 38.89% were probable while 61.11% were possible.
New antiviral drugs require careful follow-up of any significant adverse event that may occur and can affect adherence. Special population as the elderly and those with comorbidities should always be managed with caution to avoid development of serious side effects.
不同的直接抗病毒药物（DAA）组合已用于治疗不同丙型肝炎病毒（HCV）基因型的患者以及不同类型的患者。尽管在临床试验中这些药物有效且不良反应发生率极低，但关于现实生活研究中的不良事件的数据却很少。
本研究旨在确定由DAA药物（达卡他韦和索磷布韦）及其与利巴韦林联合使用所引起的药物不良反应（ADR）的发生率和模式，并评估所报告ADR的因果关系和严重程度。
在埃及法尤姆省医疗保险医院的HCV治疗中心进行了为期六个月的前瞻性观察研究。作者使用经过预测试的访谈结构化问卷，从345名登记患者中收集有关人口统计学、合并症和ADR的所需数据。对ADR的因果关系和严重程度进行了评估。
根据我们的数据，我们发现75.7%（345名患者中的261名）报告了涉及不同系统的36种不同ADR，其中1.2%经历了严重不良事件（SAE），包括三例死亡（0.9%）。大多数ADR在含利巴韦林的治疗方案中报告得更为显著。在345名患者中，23.5%患有合并症。其中，92.6%报告了ADR。根据世界卫生组织药物不良反应因果关系评价标准（WHO-UMC）对ADR进行的因果关系评估显示，38.89%可能相关，61.11%可能无关。
新的抗病毒药物需要对可能发生的任何重大不良事件进行仔细随访，这些事件可能会影响依从性。对于老年人和患有合并症的特殊人群，应始终谨慎管理，以避免出现严重的副作用。
