关键词: Genotype-3 HCV Health-Related Quality Of Life Ledipasvir Ribavirin Sofosbuvir

来  源:   DOI:10.12669/pjms.40.7.7869   PDF(Pubmed)

Abstract:
UNASSIGNED: This study aimed to assess the overall treatment response of Genotype-3 Chronic HCV Pakistani Patients with or without cirrhosis to Ledipasvir plus Sofosbuvir combination.
UNASSIGNED: In this observational study, HCV Genotype-3 patients were enrolled from Liver Center, DHQ Hospital, Faisalabad and divided into two groups, i.e., non-cirrhotic and compensated cirrhotic patients. The study spanned for a period of 24 months (November 2019 - November 2021) from the first enrollment to the last follow up. Non-cirrhotic patients received Ledipasvir/Sofosbuvir (LDV/SOF) 90/400mg for 12 weeks and cirrhotic patients received LDV/SOF with Ribavirin (RBV) for 12 weeks and without RBV for 24 weeks. The treatment efficacy in terms of sustained virological response (SVR12) was monitored 12 weeks post-treatment. The safety profile, and health-related quality of life (HRQoL) were monitored from baseline to follow-up visits.
UNASSIGNED: Two hundred and ninety out of 309 (93.85%) non-cirrhotic and 31 out of 33 (93.94%) compensated cirrhotic patients achieved SVR-12. The safety profile of the non-cirrhotic and compensated cirrhotic patients was comparable throughout the study duration. Fatigue was the most commonly reported adverse event (AE) in non-cirrhotic and compensated cirrhotic patients, followed by headache, nausea, and fever. The HRQoL improved from baseline to follow-up visits among patients of both groups.
UNASSIGNED: It is concluded that LDV and SOF combination regimen is safe and effective for treating Genotype-3 HCV patients without cirrhosis/compensated cirrhosis, and also improves the patient\'s HRQoL.
摘要:
本研究旨在评估有或没有肝硬化的3型慢性HCV巴基斯坦患者对Ledipasvir加索非布韦组合的总体治疗反应。
在这项观察性研究中,HCV基因型-3患者来自肝脏中心,DHQ医院,费萨拉巴德分为两组,即,非肝硬化和代偿性肝硬化患者。该研究从首次注册到最后一次随访,为期24个月(2019年11月至2021年11月)。非肝硬化患者接受Ledipasvir/Sofosbuvir(LDV/SOF)90/400mg治疗12周,肝硬化患者接受LDV/SOF利巴韦林(RBV)治疗12周,无RBV治疗24周。在治疗后12周监测持续病毒学应答(SVR12)方面的治疗功效。安全简介,和健康相关生活质量(HRQoL)监测从基线到随访.
309例(93.85%)非肝硬化患者中的二百九十例和33例(93.94%)代偿肝硬化患者中的31例获得了SVR-12。非肝硬化和代偿性肝硬化患者的安全性在整个研究期间是相当的。疲劳是非肝硬化和代偿性肝硬化患者中最常见的不良事件(AE)。接着是头痛,恶心,和发烧。两组患者的HRQoL从基线到随访均有所改善。
可以得出结论,LDV和SOF联合方案对于治疗无肝硬化/代偿性肝硬化的基因型3HCV患者是安全有效的,并提高患者的HRQoL。
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