Pawlowska Malgorzata, Dobrowolska Krystyna, Moppert Justyna, Pokorska-Śpiewak Maria, Purzynska Mariola, Marczynska Magdalena, Zarebska-Michaluk Dorota, Flisiak Robert
Department of Infectious Diseases and Hepatology, Faculty of Medicine, Collegium Medicum Bydgoszcz, Nicolaus Copernicus University, 87-100 Torun, Poland.
Department of Paediatrics, Infectious Diseases and Hepatology, Voivodeship Infectious Observation Hospital in Bydgoszcz, 85-030 Bydgoszcz, Poland.
J Clin Med. 2023 Nov 6;12(21):6949. doi: 10.3390/jcm12216949.
The aim of the study was to analyze the effectiveness and safety of anti-HCV treatment based on a pangenotypic direct-acting antiviral (DAA) regimen with glecaprevir/pibrentasvir (GLE/PIB) in children. The multi-center study was conducted in HCV-infected children who were treated in the period from November 2022 to January 2023. The analysis included 23 pediatric patients with a mean (SD) age of 9.61 (3.68) years. The cohort included 13 girls and 10 boys. The most common HCV genotypes were GT1b ( = 9, 39.1%), GT1a ( = 6, 26.1%) and GT3 ( = 5, 21.7%). The SVR was assessed at 12 weeks after the end of treatment and was 100% for both girls and boys. The conducted study showed a very good tolerance of the treatment in the entire analyzed group and confirmed a very high efficacy and safety for 8-week treatment with GLE/PIB in children over three years of age. It seems that our study is the first on the real-world use of an 8-week GLE/PIB pangenotypic therapy in a group of children aged 3-12 years and the first in Europe for adolescents aged 12-17.
本研究的目的是分析基于泛基因型直接抗病毒药物(DAA)glecaprevir/pibrentasvir(GLE/PIB)方案治疗儿童丙型肝炎病毒(HCV)的有效性和安全性。这项多中心研究在2022年11月至2023年1月期间接受治疗的HCV感染儿童中进行。分析纳入了23例儿科患者,平均(标准差)年龄为9.61(3.68)岁。该队列包括13名女孩和10名男孩。最常见的HCV基因型为GT1b(n = 9,39.1%)、GT1a(n = 6,26.1%)和GT3(n = 5,21.7%)。在治疗结束后12周评估持续病毒学应答(SVR),女孩和男孩的SVR均为100%。所进行的研究表明,在整个分析组中该治疗耐受性良好,并证实GLE/PIB对3岁以上儿童进行8周治疗具有很高的疗效和安全性。我们的研究似乎是首次针对3至12岁儿童群体实际应用8周GLE/PIB泛基因型疗法的研究,也是欧洲首次针对12至17岁青少年的此类研究。