Faculté de Médecine, Aix Marseille University, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, 27 Bd. Jean Moulin, 13385, Marseille Cedex 5, France.
ORS PACA (Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur), Marseille, France.
Patient. 2017 Oct;10(5):605-614. doi: 10.1007/s40271-017-0232-1.
We aimed to compare health-related quality of life (HRQL) during and after hepatitis C virus (HCV) treatment in patients receiving pegylated-interferon (PEG-IFN)-containing therapy (including boceprevir or telaprevir-ANRS CO20 CUPIC cohort) who subsequently switched to PEG-IFN-free regimens (sofosbuvir + ledipasvir with or without ribavirin [RBV]-SIRIUS trial).
Two analyses were performed. The first compared physical (PCS) and mental (MCS) HRQL (MOS SF-12) scores during treatment between CUPIC and SIRIUS. The second compared PCS and MCS scores after treatment end between CUPIC and SIRIUS. The analyses used linear regression mixed models adjusted for pre-treatment HRQL scores, gender, and age at each visit.
Among patients enrolled successively in both studies, 43 (corresponding to 212 HRQL assessments) and 43 (82 HRQL assessments) were eligible for the 'during' and 'post' treatment analyses, respectively. In the 'during-treatment' analysis, we found significantly higher PCS and MCS values during PEG-IFN-free treatment than for PEG-IFN-containing treatment. In the 'post-treatment' analysis, results showed significantly higher MCS values after PEG-IFN-free treatment than after PEG-IFN-containing treatment. No significant difference was found for PCS in the post-treatment analysis.
These results highlight an improvement in both physical and mental HRQL during HCV treatment, but no major improvement in physical HRQL after treatment end, when comparing PEG-IFN-free regimens with PEG-IFN-containing regimens. This suggests that in the PEG-IFN-free regimens era, screening and comprehensive care of comorbidities and residual somatic symptoms during treatment, and especially after HCV clearance, are still needed to improve patient outcomes.
本研究旨在比较慢性丙型肝炎(HCV)患者接受聚乙二醇干扰素(PEG-IFN)联合治疗(包括 boceprevir 或 telaprevir-ANRS CO20 CUPIC 队列)后转换为 PEG-IFN 无治疗方案(索磷布韦联合利巴韦林[RBV]-SIRIUS 试验)时的健康相关生活质量(HRQL)。
进行了两项分析。第一项分析比较了 CUPIC 和 SIRIUS 中治疗期间的躯体健康(PCS)和心理健康(MCS)评分(MOS SF-12)。第二项分析比较了 CUPIC 和 SIRIUS 治疗结束后 PCS 和 MCS 评分。分析采用线性回归混合模型,根据治疗前 HRQL 评分、性别和每个时间点的年龄进行调整。
在连续纳入两项研究的患者中,43 例(对应 212 次 HRQL 评估)和 43 例(82 次 HRQL 评估)分别符合“治疗期间”和“治疗后”分析的条件。在“治疗期间”分析中,我们发现无干扰素治疗的 PCS 和 MCS 值明显高于干扰素治疗。在“治疗后”分析中,结果显示无干扰素治疗后 MCS 值明显高于干扰素治疗。在治疗后分析中,PCS 无显著差异。
这些结果强调了 HCV 治疗期间 HRQL 的躯体和心理方面均有所改善,但与干扰素联合治疗相比,治疗结束后,在比较无干扰素治疗方案时,患者的躯体 HRQL 并无明显改善。这表明,在无干扰素治疗方案时代,仍需要对合并症和残留躯体症状进行筛查和综合管理,特别是在 HCV 清除后,以改善患者的预后。