Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia.
Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia.
Clin Gastroenterol Hepatol. 2014 Aug;12(8):1349-59.e13. doi: 10.1016/j.cgh.2013.11.032. Epub 2013 Dec 6.
BACKGROUND & AIMS: Interferon-based treatment of chronic hepatitis C virus (HCV) infection can negatively affect patient-reported outcomes (PROs) and work productivity (WP). We assessed these factors in patients with chronic hepatitis C treated with sofosbuvir and ribavirin, with or without pegylated interferon.
The HCV-specific Quality of Life (Chronic Liver Disease Questionnaire-HCV version [CLDQ-HCV]), Functional Assessment of Chronic Illness Therapy-Fatigue, and Work Productivity and Activity Index: Specific Health Problem questionnaires were completed before, during, and after treatment of patients infected with HCV genotypes 2 or 3 who received sofosbuvir and ribavirin for 16 or 12 weeks (the FUSION study, n = 201) or patients infected with HCV genotype 1 who received pegylated interferon, sofosbuvir, and ribavirin for 12 weeks (the NEUTRINO study, n = 327).
Patients in each group of the FUSION study had similar PRO and WP scores at each time point (all comparisons, P > .05). Compared with baseline, patients had modest reductions in fatigue, HCV-specific quality of life, and WP and Activity Index scores during treatment (P = .02 to <.0001). However, by 4 weeks after treatment, all scores returned to baseline levels or higher. Subjects in the NEUTRINO study had greater reductions in these scores during treatment; most remained significant through 4 weeks after treatment (P < .05). Significant improvements in PROs were observed among patients with sustained virologic responses 12 weeks after treatment in the FUSION and NEUTRINO studies (all P < .05). In multivariate analyses after adjustment for confounders, interferon therapy was independently associated with worse PROs after 12 weeks of treatment.
On the basis of an analysis of 2 large clinical trials (FUSION and NEUTRINO), patient outcome and productivity are more negatively affected by the inclusion of pegylated interferon in treatment than by interferon-free regimens. Patients with sustained virologic responses 12 weeks after treatment had significant improvements in PROs in both studies.
基于干扰素的慢性丙型肝炎病毒（HCV）感染治疗可能会对患者报告的结局（PROs）和工作生产力（WP）产生负面影响。我们评估了接受索非布韦和利巴韦林治疗的慢性丙型肝炎患者的这些因素，这些患者的治疗方案包括或不包括聚乙二醇干扰素。
在 HCV 基因型 2 或 3 感染患者中进行了这项研究，这些患者接受了 16 或 12 周的索非布韦和利巴韦林治疗（FUSION 研究，n = 201），或 HCV 基因型 1 感染患者接受了 12 周的聚乙二醇干扰素、索非布韦和利巴韦林治疗（NEUTRINO 研究，n = 327）。在接受治疗前、治疗期间和治疗后，这些患者完成了慢性肝病问卷-HCV 版本（CLDQ-HCV）、慢性疾病治疗疲劳功能评估量表、工作生产力和活动指数：特定健康问题问卷。
FUSION 研究的每个组别的患者在每个时间点的 PRO 和 WP 评分相似（所有比较，P >.05）。与基线相比，患者在治疗期间的疲劳感、HCV 特异性生活质量以及 WP 和活动指数评分均有适度下降（P =.02 至<.0001）。然而，在治疗结束后 4 周时，所有评分均恢复至基线水平或更高。NEUTRINO 研究中的患者在治疗期间这些评分的下降幅度更大；大多数评分在治疗结束后 4 周时仍具有显著差异（P <.05）。在 FUSION 和 NEUTRINO 研究中，治疗结束后 12 周时获得持续病毒学应答的患者的 PRO 有显著改善（所有 P <.05）。在调整混杂因素的多变量分析中，干扰素治疗与治疗 12 周后的 PRO 恶化独立相关。
基于两项大型临床试验（FUSION 和 NEUTRINO）的分析结果，与无干扰素治疗方案相比，聚乙二醇干扰素的加入对患者结局和生产力的负面影响更大。在这两项研究中，治疗结束后 12 周时获得持续病毒学应答的患者的 PRO 均有显著改善。
