Mohamed Hossam Z, Sabri Nagwa A, Zaki Hossam M, Shaheen Sara M
Hepatology Department, Kobri El koba Armed Forces Hospital, Cairo, Egypt.
Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.
Clin Exp Hepatol. 2020 Jun;6(2):99-105. doi: 10.5114/ceh.2020.95566. Epub 2020 May 25.
Chronic hepatitis C (CHC) affects more than 71 million people worldwide. Many therapies containing different direct-acting antivirals (DAAs) are now used. However, lipid profile is considered an important outcome with DAAs. So, this study aimed to assess clinical effects of statins in CHC patients.
One hundred patients were recruited from Kobri El koba Armed Forces Hospital and randomly assigned to: the drug group (D; = 50) receiving simvastatin 10 mg plus sofosbuvir 400 mg/daclatasvir 60 mg (SOF/DAC) daily for 12 weeks; and the placebo group (P; = 50), receiving placebo plus the same (SOF/DAC) regimen. Sustained virological response at 12 weeks after treatment (SVR12), lipid profile, C-reactive protein (CRP) and fibrosis stage were assessed.
One hundred treatment-naïve CHC patients completed 12 weeks of the protocol with no clinically significant side effects. There was an increase in SVR failure rate in P (10%) compared to D (only 2%) but not reaching statistical significant difference; SVR12 ( > 0.05). Logistic regression analysis showed that high baseline CRP, low baseline hemoglobin level and non-statin usage had an independent effect on increasing the probability of SVR failure in both groups; = 0.03, = 0.0028, = 0.02, respectively.
Statins could have an irreplaceable role in successful treatment of CHC patients receiving sofosbuvir/daclatasvir.
慢性丙型肝炎（CHC）在全球影响着超过7100万人。目前使用了许多包含不同直接作用抗病毒药物（DAA）的疗法。然而，血脂水平被认为是DAA治疗的一个重要结果。因此，本研究旨在评估他汀类药物对CHC患者的临床效果。
从科卜里·埃尔·科巴武装部队医院招募了100名患者，并随机分为：药物组（D组；n = 50），每天接受10毫克辛伐他汀加400毫克索磷布韦/60毫克达卡他韦（SOF/DAC），持续12周；安慰剂组（P组；n = 50），接受安慰剂加相同的（SOF/DAC）治疗方案。评估治疗12周后的持续病毒学应答（SVR12）、血脂水平、C反应蛋白（CRP）和纤维化分期。
100名初治CHC患者完成了12周的方案治疗，无临床显著副作用。与D组（仅2%）相比，P组的SVR失败率有所增加（10%），但未达到统计学显著差异；SVR12（P>0.05）。逻辑回归分析表明，高基线CRP、低基线血红蛋白水平和未使用他汀类药物对两组SVR失败概率增加有独立影响；P值分别为0.03、0.0028、0.02。
他汀类药物在接受索磷布韦/达卡他韦治疗的CHC患者的成功治疗中可能具有不可替代的作用。
