Borba Helena Hl, Wiens Astrid, Steimbach Laiza M, Tonin Fernanda S, Pedroso Maria LA, Ivantes Cláudia Ap, Fernandez-Llimos Fernando, Pontarolo Roberto
Pharmaceutical Sciences Postgraduate Research Program, Department of Pharmacy.
Gastroenterology Service, Hospital de Clínicas, Federal University of Paraná.
Ther Clin Risk Manag. 2017 Jan 10;13:59-64. doi: 10.2147/TCRM.S124663. eCollection 2017.
Chronic hepatitis C is a major public health issue, but there is a gap in the literature regarding the effectiveness and safety of direct-acting antiviral agents in the Brazilian population. The main aim of this study was to describe the effectiveness of boceprevir and telaprevir in patients treated at public health care institutions in Brazil.
A prospective longitudinal and multicenter study was conducted in five centers in the State of Paraná between September 2014 and June 2016. Data regarding effectiveness and safety were collected from medical records of patients treated with boceprevir or telaprevir. The effectiveness outcome comprised the rapid virological response (RVR). Multivariate analysis was performed to verify the influence of independent variables (ie, age, gender, baseline viral load) on RVR achievement.
Data were collected from 117 patients with chronic hepatitis C virus (HCV) genotype 1 infection. Fifteen patients received treatment with boceprevir and 102 received telaprevir. The mean age was 51.6 years, 64.1% were male, 44.4% were infected with HCV subtype 1a, 62.4% had a high baseline viral load (≥800,000 IU/mL) and 33% were cirrhotic. Furthermore, 79.5% of patients achieved RVR (26.7% in the boceprevir group and 87.3% in the telaprevir group). Multivariate analysis demonstrated that the type of protease inhibitor (boceprevir or telaprevir) and the baseline viral load had an influence on the RVR rate (odds ratio [OR] =0.011; 95% confidence interval [CI]: 0.001-0.119; <0.001/OR =13.004; 95% CI: 1.522-111.115; =0.019, respectively).
In this longitudinal multicenter cohort study conducted from the Brazilian perspective, differences were found in the RVR rates, favoring telaprevir over boceprevir for genotype 1 HCV-infected patients. In addition, the baseline viral load was associated with RVR achievement in both evaluated groups. As RVR is also reported in the literature as a predictor of the sustained virological response (SVR), further analyses of RVR as predictor of SVR outcomes should be further evaluated in Brazil.
慢性丙型肝炎是一个重大的公共卫生问题，但关于直接作用抗病毒药物在巴西人群中的有效性和安全性，文献中存在空白。本研究的主要目的是描述博赛泼维与特拉匹韦在巴西公共医疗机构接受治疗的患者中的有效性。
2014年9月至2016年6月期间，在巴拉那州的五个中心开展了一项前瞻性纵向多中心研究。从接受博赛泼维或特拉匹韦治疗的患者病历中收集有关有效性和安全性的数据。有效性结局包括快速病毒学应答（RVR）。进行多变量分析以验证自变量（即年龄、性别、基线病毒载量）对RVR实现情况的影响。
收集了117例慢性丙型肝炎病毒（HCV）基因1型感染患者的数据。15例患者接受博赛泼维治疗，102例接受特拉匹韦治疗。平均年龄为51.6岁，64.1%为男性，44.4%感染HCV 1a亚型，62.4%基线病毒载量高（≥800,000 IU/mL），33%为肝硬化患者。此外，79.5%的患者实现了RVR（博赛泼维组为26.7%，特拉匹韦组为87.3%）。多变量分析表明，蛋白酶抑制剂类型（博赛泼维或特拉匹韦）和基线病毒载量对RVR率有影响（比值比[OR]=0.011；95%置信区间[CI]：0.001 - 0.119；<0.001/OR = 13.004；95% CI：1.522 - 111.115；=0.019）。
在这项从巴西视角开展的纵向多中心队列研究中，发现RVR率存在差异，对于基因1型HCV感染患者，特拉匹韦优于博赛泼维。此外，在两个评估组中，基线病毒载量均与RVR的实现相关。由于文献中也报道RVR是持续病毒学应答（SVR）的预测指标，在巴西应进一步评估RVR作为SVR结局预测指标的情况。
