Wahsh Engy A, Hussein Amal K, Gomaa Ahmed A, Baraka Mohamed A, Al-Deen Abead Mohie
Department of Clinical Pharmacy, Faculty of Pharmacy, Nahda University, Beni Suef, Egypt.
Department of Pharmaceutical Technology, Faculty of Pharmacy, Minia University, Minia, Egypt.
Infect Disord Drug Targets. 2020;20(1):43-48. doi: 10.2174/1871526518666180716141806.
Chronic infection with Hepatitis C virus (HCV) is considered as a major cause for developing liver cirrhosis and hepatocellular carcinoma. A new era in HCV treatment is ongoing using Direct Acting Antiviral activity (DAA). The first approved DAA drug was Sofosbuvir which has a high tolerability and preferable pharmacokinetic profile. Another recently developed drug is Daclatasvir a first-in-class HCV NS5A replication complex inhibitor. Both drugs are administered orally once daily and have potent antiviral activity with wide genotypic coverage.
In the outpatient clinic, one hundred and fifty naïve difficult to treat chronic HCV patients were recruited from Tropical Medicine Department at Fayoum public hospital. A combination of Daclatasvir (60 mg) and Sofosbuvir (400 mg) (DCV/SOF) has been administered for those patients once daily with Ribavirin (1200 mg or 1000 mg based on patients' weight on two divided doses) over a period of 12 weeks. All patients have been followed up for clinical, laboratory assessment and HCV PCR to detect the efficacy and safety of the therapy.
Sustained Virologic Response rate (SVR12) was achieved in the vast majority of patients (90.67%). Cirrhotic patients showed lower SVR compared to non-cirrhotic patients (88.89% vs 90.91%, respectively). Around half of the patients (49.33%) developed adverse events (AEs) during treatment. The most common AEs were headache, fatigue and abdominal pain.
The available evidence seems to suggest that combination therapy of (DCV/SOF with RBV) in the treatment of chronic HCV genotype IV naïve difficult to treat patients either cirrhotic or non-cirrhotic is safe and effective. Monitoring for clinical and laboratory hepatic parameters was the basis for these findings.
丙型肝炎病毒（HCV）慢性感染被认为是发展为肝硬化和肝细胞癌的主要原因。使用直接抗病毒活性（DAA）药物正在开启HCV治疗的新时代。首个获批的DAA药物是索磷布韦，它具有高耐受性和良好的药代动力学特征。另一种最近研发的药物是达卡他韦，它是一流的HCV NS5A复制复合物抑制剂。这两种药物均每日口服一次，具有强大的抗病毒活性，对多种基因型有效。
在门诊，从法尤姆公立医院热带医学科招募了150例初治的难治性慢性HCV患者。给予这些患者每日一次达卡他韦（60毫克）和索磷布韦（400毫克）（DCV/SOF）联合利巴韦林（根据患者体重为1200毫克或1000毫克，分两次给药），疗程为12周。对所有患者进行临床、实验室评估及HCV PCR检测，以评估治疗的疗效和安全性。
绝大多数患者（90.67%）实现了持续病毒学应答率（SVR12）。肝硬化患者的SVR低于非肝硬化患者（分别为88.89%和90.91%）。约一半患者（49.33%）在治疗期间出现不良事件（AE）。最常见的AE是头痛、疲劳和腹痛。
现有证据似乎表明，（DCV/SOF联合RBV）的联合疗法用于治疗初治的难治性慢性HCV基因IV型患者（无论是否为肝硬化患者）是安全有效的。对临床和实验室肝脏参数的监测是这些发现的基础。
