Faculty of Pharmacy, University of Granada, Campus Universitario de Cartuja, Granada, Spain.
Hospital Pharmacy, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
Libyan J Med. 2021 Dec;16(1):1949797. doi: 10.1080/19932820.2021.1949797.
Despite the high efficacy and safety of direct-acting antivirals against hepatitis C virus shown in clinical trials, treatment failures continue to occur. Our aim was to establish the effectiveness of these drugs in routine clinical practice, as well as to determine factors that could influence the response to the treatment. Single-center, observational, retrospective study. Clinical, virological and pharmacotherapeutic variables were registered at baseline. Adverse drug reactions that occurred were recorded until week 24 of follow-up. Achievement of sustained virologic response was also recorded. Univariate and multivariate analysis were done to determine factors of response. A total of 333 treatment regimens corresponding to 330 different patients were evaluated. Sustained virologic response rate was 94.6% [95%CI: 91.6-96.6%]. 67.9% of the patients experienced adverse drugs reactions (92.2% were grade 1). The univariate analysis identified a higher baseline of platelets, albumin and total cholesterol as predictive factors of sustained virologic response (p < 0.05). Presence of diabetes and complications related to liver disease (splenomegaly, portal hypertension, portal hypertensive gastropathy), body mass index ≥30, greater liver fibrosis, receiving simeprevir and higher baseline levels of glucose, aspartate-aminotransferase, alanine-aminotransferase and alkaline-phosphatase, have been identified as predictive factors of non-response (p < 0.05). The multivariate analysis detected the following independent factors of non-response: body mass index ≥30 and presence of complications related to liver disease. The effectiveness and safety of direct-acting antivirals against hepatitis C virus have been maintained in routine clinical practice. Further research on predictive factors of response is required in order to develop more reliable and reproducible predictive models.
尽管临床试验表明直接作用抗病毒药物治疗丙型肝炎病毒具有高疗效和安全性,但治疗失败仍时有发生。我们的目的是评估这些药物在常规临床实践中的疗效,并确定可能影响治疗反应的因素。单中心、观察性、回顾性研究。在基线时记录临床、病毒学和药物治疗变量。记录随访至第 24 周时发生的药物不良反应。同时也记录持续病毒学应答的达成情况。进行单因素和多因素分析以确定反应的影响因素。共评估了 333 种治疗方案,涉及 330 例不同的患者。持续病毒学应答率为 94.6%[95%CI:91.6-96.6%]。67.9%的患者发生药物不良反应(92.2%为 1 级)。单因素分析发现,基线血小板、白蛋白和总胆固醇水平较高是持续病毒学应答的预测因素(p<0.05)。糖尿病和与肝脏疾病相关的并发症(脾肿大、门静脉高压、门静脉高压性胃病)、体重指数≥30、肝纤维化程度更高、接受simeprevir 治疗以及基线血糖、天冬氨酸转氨酶、丙氨酸转氨酶和碱性磷酸酶水平较高,被认为是无应答的预测因素(p<0.05)。多因素分析检测到无应答的独立因素包括:体重指数≥30 和与肝脏疾病相关的并发症。直接作用抗病毒药物治疗丙型肝炎病毒在常规临床实践中的有效性和安全性得到了维持。需要进一步研究反应的预测因素,以开发更可靠和可重复的预测模型。