Younossi Z M, Stepanova M, Schwarz K B, Wirth S, Rosenthal P, Gonzalez-Peralta R, Murray K, Henry L, Hunt S
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.
J Viral Hepat. 2018 Apr;25(4):354-362. doi: 10.1111/jvh.12830. Epub 2017 Dec 26.
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.
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.
