Zarębska-Michaluk Dorota, Piekarska Anna, Jaroszewicz Jerzy, Klapaczyński Jakub, Sitko Marek, Tudrujek-Zdunek Magdalena, Tomasiewicz Krzysztof, Belica-Wdowik Teresa, Pabjan Paweł, Lorenc Beata, Czauż-Andrzejuk Agnieszka, Tronina Olga, Krygier Rafał, Dobracki Witold, Buczyńska Iwona, Simon Krzysztof A, Dybowska Dorota, Halota Waldemar, Pawłowska Małgorzata, Citko Jolanta, Laurans Łukasz, Mazur Włodzimierz, Janczewska Ewa, Socha Łukasz, Deroń Zbigniew, Berak Hanna, Flisiak Robert
Department of Infectious Diseases, Voivodeship Hospital and Jan Kochanowski University, Kielce, Poland.
Department of Infectious Diseases and Hepatology, Medical University of Lodz, Lodz, Poland.
Arch Med Sci. 2019 Jul 11;18(6):1460-1466. doi: 10.5114/aoms.2019.86569. eCollection 2022.
Non-cirrhotic treatment-naive hepatitis C patients infected with genotype 1 can be treated with ledipasvir/sofosbuvir (LDV/SOF) for 8 weeks, but in practice this regimen is frequently extended up to 12 weeks at least in part due to insufficient real-world data supporting shortening of treatment. The aim of our study was to compare 8- and 12-week regimens' efficacy in patients eligible for 8-week therapy in a real-world setting.
Data of HCV genotype 1 infected patients treated with LDV/SOF between 2015 and 2018 included in the EpiTer-2 database were analyzed with respect to patients' characteristics and length of treatment.
Among a total of 1718 patients treated with LDV/SOF, 679 were included in the analysis, 238 (35%) received 8-week regimen, whereas 441 were treated for 12 weeks although they fulfilled the criteria for a shorter course. The majority of patients were infected with genotype 1b (89%) and demonstrated minimal fibrosis (55%). The 12-week regimen was assigned significantly more frequently to patients with comorbidities, concomitant medications and advanced liver fibrosis. The sustained virologic response rate was similar after 8 (98%) and 12 (97%) weeks of therapy according to intent-to-treat analysis and reached 99% in both groups after exclusion of patients lost to follow-up.
We confirmed high effectiveness regardless of treatment duration with LDV/SOF in non-cirrhotics infected with HCV genotype 1 eligible for the 8-week regimen according to the current label. This real-world study also demonstrated no need for addition of ribavirin (RBV) in this population and showed that shortening of treatment significantly improves the safety profile of LDV/SOF medication.
初治的非肝硬化丙型肝炎基因1型感染患者可用来迪派韦/索磷布韦（LDV/SOF）治疗8周，但在实际应用中，该方案常常延长至12周，至少部分原因是缺乏支持缩短疗程的真实世界数据。我们研究的目的是在真实世界环境中比较8周和12周治疗方案对符合8周治疗条件患者的疗效。
分析EpiTer-2数据库中2015年至2018年接受LDV/SOF治疗的丙型肝炎基因1型感染患者的数据，包括患者特征和治疗时长。
在总共1718例接受LDV/SOF治疗的患者中，679例纳入分析，238例（35%）接受8周治疗方案，而441例虽符合更短疗程标准却接受了12周治疗。大多数患者感染基因1b型（89%）且纤维化程度轻微（55%）。12周治疗方案在合并症、同时服用其他药物及肝纤维化晚期患者中分配得更为频繁。根据意向性分析，治疗8周（98%）和12周（97%）后的持续病毒学应答率相似，排除失访患者后两组均达到99%。
我们证实，对于符合现行说明书中8周治疗方案条件的非肝硬化丙型肝炎基因1型感染患者，无论LDV/SOF治疗时长如何，疗效均很高。这项真实世界研究还表明该人群无需加用利巴韦林（RBV），且缩短疗程可显著改善LDV/SOF用药的安全性。
