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The Impact of Hepatitis C Virus Direct-Acting Antivirals on Patient-Reported Outcomes: A Dutch Prospective Cohort Study

机译:丙型肝炎病毒直接作用抗病毒药对患者报告结果的影响:荷兰前瞻性队列研究

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IntroductionPegylated interferon-based therapy for hepatitis C virus (HCV) negatively impacts nutritional state and patient-reported outcomes (PROs) such as health-related quality of life (HRQL). Clinical trials with direct-acting antivirals (DAAs) report significant PRO improvement but real-world data are still scarce. MethodsProspective cohort study recruiting HCV patients treated with DAAs in 2015–2016. Data at baseline, end of treatment (EOT) and 12?weeks thereafter (FU12) included: patient-reported medication adherence; SF-36; Karnofsky Performance Status; paid labour productivity; physical exercise level; nutritional state [by body mass index (BMI) and Jamar hand grip strength (HGS)] and Beliefs about Medicines Questionnaire. Potential factors predicting these PROs were evaluated with multiple regression analysis. ResultsA total of 68 patients were enrolled: 85% male, median age 57?years, 80% genotype 1, 40% cirrhotics, 46% haemophilia. Both cure rate and patient-reported adherence were 97%. SF-36 Physical Component Summary did not change (43.2?±?11.9, 44.9?±?10.3 and 44.7?±?10.9 at baseline, EOT and FU12, p =?0.71). In contrast, SF-36 mental component summary (MCS) decreased transiently during therapy (49.2?±?11.9, 44.6?±?10.3 and 49.9?±?12.6 at baseline, EOT and FU12, p 12, p =?0.56) did not change. ConclusionOur study reveals concomitant ribavirin as the only independent predictor of transient decrease in SF-36 mental HRQL during DAA therapy. In contrast to interferon-based therapy, DAAs do not affect BMI or Jamar HGS.
机译:简介基于聚乙二醇干扰素的丙型肝炎病毒(HCV)治疗会对营养状况和患者报告的结局(PRO)(例如与健康相关的生活质量(HRQL))产生负面影响。使用直接作用抗病毒药(DAA)的临床试验报告PRO有了显着改善,但实际数据仍然很少。方法:前瞻性队列研究招募了2015–2016年接受DAA治疗的HCV患者。基线,治疗结束(EOT)以及此后12周(FU 12 )的数据包括:患者报告的用药依从性; SF-36;卡诺夫斯基绩效状况;有偿劳动生产率;体育锻炼水平;营养状态[通过体重指数(BMI)和Jamar手握力(HGS)]和有关药物问卷的信念。通过多元回归分析评估了预测这些PRO的潜在因素。结果共纳入68例患者:男性85%,中位年龄57岁,基因型1为80%,肝硬化患者为40%,血友病患者为46%。治愈率和患者报告的依从性均为97%。 SF-36物理成分摘要未发生变化(基线时为43.2?±?11.9、44.9?±?10.3和44.7?±?10.9,EOT和FU 12 ,p =?0.71)。相比之下,治疗期间SF-36精神成分摘要(MCS)短暂下降(基线时为49.2±11.9、44.6±10.3和49.9±12.6,EOT和FU 12 ,p 12 ,p =?0.56)没有变化。结论我们的研究表明,伴随病毒唑是DAA治疗期间SF-36精神HRQL短暂降低的唯一独立预测因子。与基于干扰素的治疗相反,DAA不会影响BMI或Jamar HGS。

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