The Risk of Long-term Morbidity and Mortality in Patients With Chronic Hepatitis C Results From an Analysis of Data From a Department of Veterans Affairs Clinical Registry
The Risk of Long-term Morbidity and Mortality in Patients With Chronic Hepatitis C Results From an Analysis of Data From a Department of Veterans Affairs Clinical Registry
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DOI：
10.1001/jamainternmed.2013.12505
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发表时间：
2014-02-01
影响因子：
39
通讯作者：
Yuan, Yong
中科院分区：
文献类型：
--
作者：
McCombs, Jeffrey;Matsuda, Tara;Yuan, Yong
重要性病毒载量抑制、基因型、种族和其他因素对丙型肝炎（HCV）患者晚期肝脏相关事件风险的影响以前已使用小型观察性队列或临床试验的数据进行了评估。需要从大的真实世界的实践样本的数据，以提高晚期肝脏事件和死亡的危险因素估计在HCV. ObjectiveTo描述在现实世界的临床practice.Design，设置和参与者HCV的自然历史观察性队列研究。可检测到病毒载量的患者（>25 IU/mL）和记录的基线基因型选自退伍军人事务部（VA）HCV临床登记处（CCR），该登记处汇编了1999年至今的电子病历数据。主要结果和测量主要结果是死亡时间和肝-肝复合物的时间。相关临床事件。次要结局包括复合临床结局的组成部分。结果采用时间到事件的格式进行测量，并进行了分析，使用考克斯比例风险models.Results的360 857个独特的HCV CCR患者共28 769符合所有研究标准。只有24.3%的患者接受了治疗，16.4%的治疗患者（占所有患者的4.0%）达到了不可检测的病毒载量。达到病毒载量抑制的患者的未校正死亡率为6.8（95% CI，6.0-7.7）/1000人-年，未达到此目标的患者为21.8（95% CI，21.5-22.2）/1000人-年。考克斯模型结果发现，实现病毒抑制可使复合临床终点的风险降低27%（风险比[HR]，0.73 [95%CI，0.66-0.82]），死亡风险降低45%（HR，0.55 [95%CI，0.47-0.64]）。相对于基因型1，基因型2患者的风险显著降低，基因型3患者的所有研究结果风险较高。黑人患者的所有肝脏事件的风险低于白色patients.CONCLUSION和RELEVANCE实现不可检测的病毒载量与降低肝脏发病率和死亡率。新的治疗方案是否能在现实环境中提供更高的反应率和更少的副作用，还有待确定。
IMPORTANCE The impact of viral load suppression, genotype, race, and other factors on the risk of late-stage liver-related events in patients with hepatitis C (HCV) has been assessed previously using data from small observational cohorts or clinical trials. Data from large real-world practice samples are needed to improve risk factor estimates for late-stage liver events and death in HCV.OBJECTIVE To describe the natural history of HCV in real-world clinical practice.DESIGN, SETTING, AND PARTICIPANTS Observational cohort study. Patients with a detectable viral load (>25 IU/mL) and a recorded baseline genotype were selected from the Veterans Affairs (VA) HCV clinical registry (CCR), which compiles electronic medical records data from 1999 to present.EXPOSURES Risk factors included genotype, race, age, sex, and time to achieving an observed undetected viral load.MAIN OUTCOMES AND MEASURES The primary outcomes were time to death and time to a composite of liver-related clinical events. Secondary outcomes included the components of the composite clinical outcome. Outcomes were measured using a time-to-event format and were analyzed using Cox proportional hazards models.RESULTS A total of 28 769 of 360 857 unique HCV CCR patients met all study criteria. Only 24.3% of patients received treatment, and 16.4% of treated patients (4.0% of all patients) achieved an undetectable viral load. The unadjusted death rates were 6.8 (95% CI, 6.0-7.7) per 1000 person-years for patients who achieved viral load suppression vs 21.8 (95% CI, 21.5-22.2) deaths per 1000 person-years in patients who did not achieve this goal. Cox model results found that achieving viral suppression reduced risk of the composite clinical end point by 27% (hazard ratio [HR], 0.73 [95% CI, 0.66-0.82]) and the risk of death by 45% (HR, 0.55 [95% CI, 0.47-0.64]). Genotype 2 patients were at significantly lower risk, and genotype 3 patients were at higher risk for all study outcomes relative to genotype 1. Black patients were at lower risk for all liver events than white patients.CONCLUSION AND RELEVANCE Achieving an undetectable viral load was associated with decreased hepatic morbidity and mortality. It remains to be determined whether newer treatment regimens can offer higher response rates with fewer adverse effects in real-world settings.