索非布韦-维帕他韦治疗慢性丙型肝炎病毒感染儿童和年轻人的疗效和安全性

IF 0.1 Q4 MEDICINE, GENERAL & INTERNAL Annals of King Edward Medical University Lahore Pakistan Pub Date : 2023-08-10 DOI:10.21649/akemu.v29i2.5433
Attique Abou Bakr, Shahid Sarwar, N. Aslam, M. Ghias, Imran Mehfooz
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引用次数: 0

摘要

背景:索非布韦-维帕他韦对慢性丙型肝炎成年患者疗效显著。在本研究中,我们报道了该药物在巴基斯坦儿童和年轻人中的治疗结果。目的:评价索非布韦-维帕他韦治疗hcv感染儿童和青少年的有效性和安全性。方法:本介入(临床试验)于2021年4月10日至2022年1月9日在拉合尔真纳医院肝炎门诊进行。共登记了45例6 ~ 18岁的HCV RNA检测患者。对他们进行临床评估。由于索非布韦-维帕他韦是泛型的,所以没有进行HCV基因分型。所有患者每天口服单剂量索非布韦-维帕他韦。对代偿性肝硬化患者和有治疗经验的患者使用利巴韦林。每月进行临床评估、CBC、LFT、RFT和PT,以确定副作用和安全性。为了评估治疗效果,在12周(治疗结束)和治疗后12周(持续病毒学反应)用PCR检测HCV RNA。代偿性肝硬化患者的治疗持续24周。(儿童Turcotte Pugh得分5分和6分;儿童(A类)或接受过治疗的儿童。采用SPSS 24进行数据分析。结果:非肝硬化患者的平均年龄为13.6±1.45岁,代偿性肝硬化患者的平均年龄为14.1±2.15岁。男性28例,占63.6%,女性17例,占36.4%。治疗12周后,41例(91.11%)患者的HCV RNA检测未检出(持续病毒学应答),表明治疗有效。9例患者合并HBV感染,并在HCV治疗期间同时服用HBV药物。在治疗后12周,所有HBV合并感染的患者均通过PCR检测不到HCV RNA,且HBV滴度较低。有些病人会有轻微的副作用。然而,没有患者因这些副作用而停止治疗,因此,这种治疗是安全有效的。结论:索非布韦/维帕他韦治疗儿童和青少年HCV有效、安全。
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Sofosbuvir-Velpatasvir for Chronic Hepatitis C Virus-Infected Children and Young Adults: Efficacy and Safety
Background: Sofosbuvir-Velpatasvir has a high efficacy in adult patients with chronic hepatitis C infection .In this study, we reported treatment outcome with this drug in children and younger adults in Pakistani population. Objective: To assess the efficacy and safety of Sofosbuvir-velpatasvir in treating HCV-infected children and young adults. Methods: This Interventional(Clinical trial) was done in Hepatitis clinic Jinnah Hospital, Lahore from April 10, 2021 to January 9, 2022.A total of 45 patients aged 6 to 18 years with detectable HCV RNA by PCR were registered. They were evaluated clinically. HCV genotyping was not done as Sofosbuvir – Velpatasvir is pangenotypic. All of the patients were given a single oral dose of Sofosbuvir-velpatasvir per day. Ribavirin was included for patients with compensated cirrhosis and for those who were treatment-experienced .Clinical assessment, CBC, LFT, RFT, and PT were performed monthly to determine side effects and safety. To evaluate treatment efficacy, HCV RNA was measured by PCR at 12 weeks (end of treatment) and 12 weeks post-treatment (sustained virological response). Treatment lasted for 24weeks for those with compensated cirrhosis. (Child Turcotte Pugh score 5 and 6; Child class A) or those who were treatment experienced. SPSS 24 was used for data analysis. Results: Non cirrhotic patients had a mean age of 13.6±1.45 years, while those with compensated cirrhosis had 14.1±2.15 years. There were 63.6% males (28) and 36.4% female (17). 41 patients (91.11%) had undetectable HCV RNA by PCR ,12 weeks after treatment (Sustained virological response), indicating treatment effectiveness. Nine patients had HBV co-infection and took HBV medications as well during HCV treatment. At 12 weeks post-treatment, all HBV-coinfected patients had undetectable HCV RNA by PCR and lower HBV titers. Some of the patients experience minor side effects. However, none of the patients stopped their treatment due to these side effects Thus, this treatment was safe and effective. Conclusion: Sofosbuvir/ velpatasvir has effectiveness and safety in treating HCV in children and young adults.
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