Daclatasvir/Sofosbuvir versus Ledipasvir/Sofosbuvir in Patients with Hepatitis C Virus Infection Genotypes 1 and 3

Narjes Shokatpour, S. Sali, Ali Khahanipour, Sara Abolghasemi, M. Shabani
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Abstract

Background: The new direct-acting antiviral agents (DAAs) with high efficacy, low resistance, and low rate of adverse events (AEs) have shown promising outcomes for hepatitis C virus (HCV) treatment. This study assessed the efficacy and safety of Daclatasvir/Sofosbuvir (DCV/SOF) compared to Ledipasvir/Sofosbuvir (LDV/SOF) in patients with HCV infection in the real-world setting in Iran. Materials and Methods: A total of 42 patients with HCV infection were treated with either LDV/SOF (genotype 1) or DCV/SOF (genotypes 1, 3 or unknown) with or without ribavirin (RBV). Assessment of risk factors, laboratory tests, sustained virologic response at post-treatment week 12 (SVR12), and AEs were performed. Results: The highest risk factor for HCV transmission was major surgery (50.0%), followed by tattooing (40.5%), phlebotomy (40.5%), and dental surgery (40.5%). No statistically significant relationships between genotypes and risk factors were observed. In both treatment groups (LDV/SOF and DCV/SOF), all of the patients (100%) with or without cirrhosis and treatment-experience achieved SVR12. One patient with a history of failed LDV/SOF therapy achieved SVR12 following retreatment with DCV/SOF. Both treatment regimens were well-tolerated. No serious AEs or discontinuation due to AEs was observed. The most common AE across both treatment groups were fatigue (42.9%), followed by anxiety (28.6%). Numerically, more adverse events were found with the LDV/SOF regimen than with the DCV/SOF regimen. Conclusion: Our study showed an excellent safety and efficacy of DCV/SOF and LDV/SOF in Iranian patients infected with HCV. The incidence of AEs among patients treated with LDV/SOF was higher than those receiving SOF/DCV.
Daclatasvir/Sofosbuvir与Ledipasvir/Sofosbuvir对基因型1和3型丙型肝炎病毒感染患者的影响
背景:新型直接作用抗病毒药物(DAAs)具有高效、低耐药和低不良事件发生率(ae),在丙型肝炎病毒(HCV)治疗中显示出良好的结果。本研究评估了Daclatasvir/Sofosbuvir (DCV/SOF)与Ledipasvir/Sofosbuvir (LDV/SOF)在伊朗HCV感染患者中的疗效和安全性。材料与方法:42例HCV感染患者分别用利巴韦林(RBV)治疗LDV/SOF(基因型1)或DCV/SOF(基因型1、3或未知)。评估危险因素、实验室检测、治疗后第12周的持续病毒学反应(SVR12)和ae。结果:HCV传播的最高危险因素是大手术(50.0%),其次是纹身(40.5%)、静脉切开(40.5%)和牙科手术(40.5%)。基因型与危险因素之间无统计学意义的关系。在两个治疗组(LDV/SOF和DCV/SOF)中,所有有或没有肝硬化和治疗经验的患者(100%)都达到了SVR12。1例LDV/SOF治疗失败的患者在再次接受DCV/SOF治疗后达到了SVR12。两种治疗方案的耐受性都很好。未观察到严重不良反应或因不良反应而停药。两个治疗组中最常见的AE是疲劳(42.9%),其次是焦虑(28.6%)。数值上,LDV/SOF方案比DCV/SOF方案发现了更多的不良事件。结论:本研究显示,DCV/SOF和LDV/SOF治疗伊朗HCV患者具有良好的安全性和有效性。LDV/SOF组的ae发生率高于SOF/DCV组。
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