Marcellin Fabienne, Mourad Abbas, Lemoine Maud, Kouanfack Charles, Seydi Moussa, Carrieri Patrizia, Attia Alain, Protopopescu Camelia, Lacombe Karine, Boyer Sylvie
Aix Marseille Univ, Inserm, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, ISSPAM, Marseille, France.
Department of Metabolism, Digestion and Reproduction, Division of Digestive Diseases, Section of Hepatology and Gastroenterology, St Mary's Hospital, Imperial College, London, UK.
JHEP Rep. 2022 Dec 28;5(3):100665. doi: 10.1016/j.jhepr.2022.100665. eCollection 2023 Mar.
BACKGROUND & AIMS: Patient-reported outcomes (PROs) are poorly documented for patients with chronic hepatitis C on direct-acting antiviral (DAA) treatment in low-to-middle-income countries. We documented PROs during and after DAA treatment in participants of the TAC ANRS 12311 trial (West and Central Africa).
Trial participants received a 12-week regimen containing either sofosbuvir plus ribavirin (HCV genotype 2, n = 40), or sofosbuvir plus ledipasvir (HCV genotypes 1 and 4, n = 80). Health-related quality of life (SF-12), fatigue (Piper Fatigue scale), and self-reported symptoms (35-symptom list) were assessed at enrolment (Week (W) 0), during treatment (W2, W4, W8 and W12) and after treatment (W24 and W36). These PROs were compared between W0 and W36 (Wilcoxon signed-rank or McNemar tests). Mixed-effects linear regression models helped identify correlates of physical and mental quality of life component summaries (PCS and MCS) in a longitudinal analysis.
Most PROs were significantly improved 24 weeks after treatment end (W36), without significant differences between treatment groups. For the post-treatment period, multivariable analysis showed significant increases in PCS for patients with cirrhosis and in MCS for patients in the sofosbuvir plus ribavirin group. A higher number of self-reported symptoms at W0 was associated with lower PCS and MCS, older age and cirrhosis with lower PCS, and male sex and HCV cure with higher PCS.
Sofosbuvir-based DAA therapy was associated with a significant improvement in PROs 6 months after treatment end in patients with chronic HCV infection from Central and West Africa. These findings may guide HCV treatment providers in low-to-middle-income countries to deliver pre-treatment information concerning the benefits of DAAs beyond viral eradication.
NCT02405013.
Perceptions and experiences ( "patient-reported outcomes") of patients with chronic hepatitis C receiving direct-acting antivirals (DAAs) are poorly documented in the African setting. This study shows significant improvements in health-related quality of life, fatigue, and self-reported symptoms 24 weeks after the end of a 12-week sofosbuvir-based DAA regimen in 120 patients from Central and West Africa. These findings substantially add to the body of knowledge about DAA therapy in the African setting. Treatment providers should be encouraged to inform patients of the benefits of DAAs beyond viral eradication, to increase treatment adherence and retention in care.
在低收入和中等收入国家，接受直接抗病毒药物（DAA）治疗的慢性丙型肝炎患者的患者报告结局（PRO）记录不足。我们记录了TAC ANRS 12311试验（西非和中非）参与者在DAA治疗期间及之后的PRO。
试验参与者接受为期12周的治疗方案，其中一组为索磷布韦联合利巴韦林（丙型肝炎病毒2型，n = 40），另一组为索磷布韦联合来迪派韦（丙型肝炎病毒1型和4型，n = 80）。在入组时（第0周）、治疗期间（第2、4、8和12周）以及治疗后（第24和36周）评估健康相关生活质量（SF-12）、疲劳（Piper疲劳量表）和自我报告症状（35项症状清单）。比较第0周和第36周的这些PRO（Wilcoxon符号秩检验或McNemar检验）。混合效应线性回归模型有助于在纵向分析中确定身体和心理健康相关生活质量成分总结（PCS和MCS）的相关因素。
大多数PRO在治疗结束后24周（第36周）有显著改善，治疗组之间无显著差异。对于治疗后阶段，多变量分析显示，肝硬化患者的PCS显著增加，索磷布韦联合利巴韦林组患者的MCS显著增加。第0周自我报告症状数量较多与较低的PCS和MCS相关，年龄较大和肝硬化与较低的PCS相关，男性和丙型肝炎病毒治愈与较高的PCS相关。
在来自西非和中非的慢性丙型肝炎病毒感染患者中，基于索磷布韦的DAA治疗与治疗结束后6个月的PRO显著改善相关。这些发现可能会指导低收入和中等收入国家的丙型肝炎治疗提供者提供有关DAA除病毒清除之外的益处的治疗前信息。
NCT02405013。
在非洲地区，接受直接抗病毒药物（DAA）治疗的慢性丙型肝炎患者的认知和体验（“患者报告结局”）记录不足。本研究表明，在来自西非和中非的120名患者中，基于索磷布韦的12周DAA治疗方案结束后24周，健康相关生活质量、疲劳和自我报告症状有显著改善。这些发现极大地丰富了非洲地区关于DAA治疗的知识体系。应鼓励治疗提供者告知患者DAA除病毒清除之外的益处，以提高治疗依从性和持续治疗率。
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