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Patient-reported outcomes of the Treatment and Prevention Study: A real-world community-based trial of direct-acting antivirals for hepatitis C among people who inject drugs

机译:患者报告的治疗和预防结果研究:一种注入毒品的人的直接抗诉杀毒剂的真实社区的试验

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The impact of hepatitis C cure with direct-acting antivirals (DAAs) on patient-reported outcomes (PROs) in community settings remains unclear. We aimed to assess changes in PROs over time and whether treatment was associated with sustained improved PROs in a cohort of people who inject drugs. This study is a sub-analysis of the Treatment and Prevention Study, a nurse-led trial where people who inject drugs and their injecting partners were recruited in a community setting, in Melbourne, Australia. Three participant groups were characterized: treatment, untreated and non-viremic (hepatitis C RNA negative at screening). PROs included assessment of health-related quality of life using the Short Form-8 (SF-8) Survey and life satisfaction using Personal Wellbeing Index (PWI). PROs were measured at baseline and every 12 weeks until week 84. Generalized estimating equations were used to measure whether treatment was associated with longitudinal PRO change. A total of 215 participants were included in this analysis. PWI scores were significantly higher at week 12 for both treatment group (p = 0.0309) and non-viremic group (p = 0.0437) compared to baseline. However, treatment was not associated with longitudinal change in PRO scores. In conclusion, we found DAA treatment did not significantly improve PRO scores compared to those not receiving treatment and without hepatitis C. The measures used in this study may not be sensitive enough to capture the hepatitis C specific improvements in quality of life that treatment affords or factors other than treatment may be influencing quality of life scores in this cohort.
机译:在社区环境中,使用直接作用抗病毒药物(DAAs)治疗丙型肝炎对患者报告结果(PROs)的影响尚不清楚。我们的目的是评估PROs随时间的变化,以及在一组注射药物的人群中,治疗是否与持续改善的PROs相关。这项研究是治疗和预防研究的子分析,这是一项由护士领导的试验,在澳大利亚墨尔本的社区环境中招募注射毒品的人及其注射伙伴。三个参与者组的特点是:治疗组、未治疗组和非病毒血症组(筛查时丙型肝炎RNA阴性)。PROs包括使用简表-8(SF-8)调查评估与健康相关的生活质量,以及使用个人幸福指数(PWI)评估生活满意度。在基线检查时,每12周测量一次PROs,直到第84周。广义估计方程用于测量治疗是否与纵向PRO变化相关。共有215名参与者参与了这项分析。与基线检查相比,治疗组(p=0.0309)和非病毒血症组(p=0.0437)在第12周的PWI评分均显著高于基线检查。然而,治疗与PRO评分的纵向变化无关。总之,我们发现,与未接受治疗和未接受丙型肝炎治疗的患者相比,DAA治疗并未显著改善PRO评分。本研究中使用的测量方法可能不够敏感,无法捕捉到治疗带来的丙型肝炎患者生活质量的特异性改善,或者除治疗外的其他因素可能会影响该队列的生活质量评分。

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