治疗儿童HCV的基于索福斯布维尔的疗法的有效性和安全性:从现实世界的环境中观察到的情况
Maria Pokorska-Śpiewak1,2, Anna Dobrzeniecka3,4, Ewa Talarek3,4
1Department of Children's Infectious Diseases, Medical University of Warsaw, Warsaw, Poland. maria.pokorska-spiewak@wum.edu.pl.
概括
基于索福斯布维尔的疗法 (SOF/VEL和SOF/LDV) 在治疗5至17岁儿童的型肝炎方面表现出卓越的疗效和耐受性. 这些治疗方法实现了高持续性病毒学反应率与轻度不良事件,支持其在儿科国家政策中的使用.
科学领域:
- 肝病学 肝病学是一种肝病学.
- 儿科胃肠病学 儿科胃肠病学
- 传染性疾病 传染性疾病
背景情况:
- 在儿童中感染C型肝炎病毒 (HCV) 需要有效和安全的治疗选择.
- 基于索福斯布维尔的疗法 (SOF/velpatasvir和SOF/ledipasvir) 是成熟的成人HCV治疗方案.
研究的目的:
- 评估基于索福斯布维尔的疗法 (SOF/VEL和SOF/LDV) 在儿科患者 (5-17岁) 的安全性和有效性.
- 在现实世界的临床环境中评估治疗结果.
主要方法:
- 对90名接受SOF/VEL或SOF/LDV治疗的儿科患者进行了回顾性分析.
- 治疗持续时间为12周 (基因型1肝硬化患者24周).
- 治疗后12周的持续病毒学反应 (SVR12) 评估了疗效.
主要成果:
- 在99-100%的患者中获得SVR12.
- 在三分之一的参与者中报告了轻度至中度的不良事件 (头痛,疲劳,腹痛).
- SOF/LDV显示出可能比SOF/VEL更好的AE概况.
结论:
- 基于索福斯布维尔的疗法在儿童型肝炎治疗中非常有效和耐受.
- 这些发现支持将儿科患者纳入国家HCV治疗指南.
- 现实世界的数据证实了SOF/VEL和SOF/LDV在儿童中的有用性.
相关概念视频
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
241
Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
241
Pharmacokinetics in Pediatric Patients: Drug Metabolism
191
In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses...
191
Pharmacokinetics in Pediatric Patients: Drug Excretion
209
In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
209
Pharmacokinetics in Pediatric Patients: Drug Distribution
251
Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight,...
251
Retrovirus Life Cycles
49.3K
Retroviruses have a single-stranded RNA genome that undergoes a special form of replication. Once the retrovirus has entered the host cell, an enzyme called reverse transcriptase synthesizes double-stranded DNA from the retroviral RNA genome. This DNA copy of the genome is then integrated into the host’s genome inside the nucleus via an enzyme called integrase. Consequently, the retroviral genome is transcribed into RNA whenever the host’s genome is transcribed, allowing the...
49.3K
Drug Dosing: Infants and Children
250
Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
250


