Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA.
Hepatology. 2014 Jun;59(6):2161-9. doi: 10.1002/hep.27161. Epub 2014 Apr 30.
Whether the presence of cirrhosis influences patient-reported outcomes (PROs), including health-related quality of life, during treatment with newly available anti-HCV (hepatitis C virus) regimens is unclear. Our aim was to assess the association of cirrhosis with PROs in patients treated with sofosbuvir (SOF)-containing regimens. Four PRO questionnaires (Short Form-36 [SF-36], Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F], Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV), and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem [WPAI-SHP]) were administered to subjects receiving SOF and ribavirin (RBV; FUSION trial, N=201, 34% cirrhosis; VALENCE trial: N=333, 21% cirrhosis) and SOF, RBV, and pegylated interferon (Peg-IFN; NEUTRINO trial: N=327, 17% cirrhosis). HCV patients with cirrhosis showed significant impairment of PROs before initiation of treatment. During treatment, patients with cirrhosis treated with the IFN-free regimen experienced moderate decline in their PRO scores (0.6%-5.2% on a normalized scale of the summary scores; all P>0.02). In contrast, patients with cirrhosis treated with IFN-containing regimen showed decline in PRO scores that ranged from 3.4% to 16.0% (all P<0.005). Nevertheless, by follow-up week 12, no PRO decrement from baseline was observed in patients with cirrhosis regardless of the treatment regimen. Furthermore, in patients with cirrhosis with HCV who achieved sustained virological response at 12 weeks (SVR-12), some improvement in PROs from baseline was observed. During treatment, changes in PRO scores were similar between patients with and without cirrhosis for both treatment regimens (all P>0.05). Independent predictors of lower PROs in patients with cirrhosis included baseline depression, anxiety, fatigue, high HCV viral load, female gender, and receiving IFN-containing treatment.
Treatment with SOF+RBV with or without Peg-IFN is tolerated by HCV patients with and without cirrhosis in terms of their PRO scores. After achieving SVR-12 with the IFN-free regimen, patients with cirrhosis showed improvement in some aspects of their PROs.
评估肝硬化对接受索非布韦（SOF）为基础方案治疗的丙型肝炎病毒（HCV）患者患者报告结局（PRO）的影响，包括健康相关生活质量。
FUSION 试验（N=201，34%为肝硬化）和 VALENCE 试验（N=333，21%为肝硬化）中接受 SOF 和利巴韦林（RBV）以及 SOF、RBV 和聚乙二醇干扰素（Peg-IFN）治疗的受试者，均接受了四种 PRO 问卷（SF-36、慢性肝脏疾病问卷 HCV（CLDQ-HCV）、慢性疾病治疗疲劳评估量表功能性评估[FACIT-F]、工作效率和活动障碍问卷：特定健康问题[WPAI-SHP]）。在开始治疗前，患有肝硬化的 HCV 患者 PRO 明显受损。在治疗期间，接受无干扰素方案治疗的肝硬化患者的 PRO 评分中度下降（标准化总分的 0.6%-5.2%；所有 P 值均>0.02）。相比之下，接受含干扰素方案治疗的肝硬化患者 PRO 评分下降 3.4%-16.0%（所有 P 值均<0.005）。然而，在随访 12 周时，无论治疗方案如何，肝硬化患者的 PRO 均未从基线下降。此外，在接受治疗 12 周时获得持续病毒学应答（SVR-12）的肝硬化合并 HCV 患者中，观察到从基线开始 PRO 改善。在治疗期间，对于两种治疗方案，肝硬化患者与无肝硬化患者的 PRO 评分变化相似（所有 P 值均>0.05）。肝硬化患者 PRO 评分较低的独立预测因素包括基线抑郁、焦虑、疲劳、高 HCV 病毒载量、女性和接受含干扰素治疗。
SOF+RBV 联合或不联合 Peg-IFN 治疗，HCV 患者无论是否有肝硬化，对其 PRO 评分均耐受。无干扰素方案获得 SVR-12 后，肝硬化患者的部分 PRO 得到改善。
