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接受索磷布韦和利巴韦林治疗的丙型肝炎青少年的生活质量

Quality of life in adolescents with hepatitis C treated with sofosbuvir and ribavirin.

作者信息

Younossi Z M, Stepanova M, Schwarz K B, Wirth S, Rosenthal P, Gonzalez-Peralta R, Murray K, Henry L, Hunt S

机构信息

Department of Medicine, Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, VA, USA.

Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, USA.

出版信息

J Viral Hepat. 2018 Apr;25(4):354-362. doi: 10.1111/jvh.12830. Epub 2017 Dec 26.

Abstract

Chronic HCV infection has been associated with impairment of HRQL in both adults and paediatric patients. Our aim was to assess the HRQL of HCV-positive children treated with SOF + RBV. The data for this post hoc analysis were collected in a phase 2 open-label multinational study that evaluated safety and efficacy of SOF (400 mg/day) plus RBV (weight-based up to 1400 mg/day) for 12 or 24 weeks in adolescents with chronic HCV (GS-US-334-1112). Patients and their parents/guardians completed the PedsQL-4.0-SF-15 questionnaire at baseline, at the end of treatment and in post-treatment follow-up. We included 50 adolescents with HCV genotype 2 and 3 without cirrhosis (14.8 ± 1.9 years; male: 58%; treatment-naïve: 82%; vertically transmitted HCV: 70%). After treatment, 100% of patients with HCV genotype 2 and 95% with genotype 3 achieved SVR-12. During treatment with SOF + RBV, there were no significant decrements in any of patients' self-reported or parent-proxy-reported PRO scores regardless of treatment duration (all P > .05). After treatment cessation, we recorded a statistically significant improvement in patients' self-reported Social Functioning score by post-treatment week 12: on average, +4.8 points on a 0-100 scale (P = .02). By post-treatment week 24, parent-proxy-reported School Functioning score increased by, on average, +13.0 points (P = .0065). In multivariate analysis, history of abdominal pain and psychiatric disorders were predictive of impaired HRQL in adolescents with HCV (P < .05). Adolescents with HCV do not seem to experience any HRQL decrement during treatment with SOF + RBV and experience some improvement of their HRQL scores after achieving SVR.

摘要

慢性丙型肝炎病毒(HCV)感染与成人及儿童患者的健康相关生活质量(HRQL)受损有关。我们的目的是评估接受索磷布韦(SOF)+利巴韦林(RBV)治疗的HCV阳性儿童的HRQL。该事后分析的数据来自一项2期开放标签的多国研究,该研究评估了SOF(400毫克/天)加RBV(根据体重最高1400毫克/天)在慢性HCV青少年(GS-US-334-1112)中治疗12周或24周的安全性和有效性。患者及其父母/监护人在基线、治疗结束时和治疗后随访时完成了儿童生活质量量表4.0简版15项问卷(PedsQL-4.0-SF-15)。我们纳入了50名HCV基因2型和3型且无肝硬化的青少年(14.8±1.9岁;男性:58%;初治患者:82%;垂直传播的HCV:70%)。治疗后,HCV基因2型患者100%和基因3型患者95%实现了治疗结束后12周持续病毒学应答(SVR-12)。在使用SOF+RBV治疗期间,无论治疗持续时间如何,患者自我报告或家长代理报告的患者报告结局(PRO)评分均无显著下降(所有P>.05)。停止治疗后,我们记录到在治疗后第12周患者自我报告的社会功能评分有统计学意义的改善:在0至100分的量表上平均提高4.8分(P=.02)。到治疗后第24周,家长代理报告的学校功能评分平均提高了13.

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