الفهرس 
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Abstract
Chronic Hepatitis C (CHC) affects more than 71 million people worldwide. In Egypt, hepatitis C virus (HCV) infection is a major public health burden with the highest prevalence rate in the world.
Many studies have shown derangements in post therapy levels of total cholesterol, low density lipoprotein cholesterol, and high-density lipoprotein cholesterol levels regardless of the regimen. The role of statins as adjunctive therapy in HCV treatment has so far been limited to the previous standard of care, PEGylated interferon and ribavirin. In vitro studies have showed that statins increase the antiviral activity of different DAAs in an additive manner and delay or even prevent the development of resistance against DAAs.
According to our knowledge no clinical trial has been conducted for the combination of statins and DAAs. So, the current study was conducted to investigate the clinical benefits of using simvastatin in CHC patients receiving Sofosbuvir/Daclatasvir combination in terms of amelioration of lipid profile and glycemic status.
This study was a prospective, interventional, randomized, controlled, double-blinded study included 100 adult (18-75 years old) male Egyptian patients with chronic HCV infection who were diagnosed by anti-HCV antibodies. Patients were recruited from outpatient’s clinic of Kobri El koba Armed Forces Hospital, Cairo, Egypt. Patients included in the study were allocated to either Interventional group or Control group.
Interventional group: 50 patients received low dose statin (simvastatin 10mg) plus sofosbuvir 400mg / daclatasvir 60 mg daily (SOF/DAC) for 12 weeks.
Control group: 50 patients received sofosbuvir 400mg / daclatasvir 60 mg daily for duration of 12 weeks.
Demographic data included: age, gender, body mass index (BMI), hematological tests, liver biochemical profile, serum (ALT) and (AST), lipid profile (fasting T Chol, TG , LDL, HDL in addition to HgbA1C, fasting blood glucose, CK, thyroid functions (T3 and T4) and CRP at baseline.
The primary efficacy endpoint was the percentage of patients achieving a SVR 12 and the secondary efficacy endpoints included End of Treatment (EOT) virological response, virological failure or virological nonresponse. All patients were asked to report any adverse effects (AEs) that may be attributed to the drug during the follow-up period.
The results of the current study showed that:
• SVR12 rates were higher among patients in Interventional group than among those in Control group.
• End of treatment response was (100% vs 98%) in Interventional group and Control group respectively. virological nonresponse occurred slightly more among those who were not treated with statin.
• Regarding lipid profile measurements for patients in interventional group; the average total cholesterol, LDL and TGs levels were initially increased at (1-month); then decreased during serial measurements (especially during 3-month follow up measurement) with high significant difference (p < 0.001). On the other hand, the average HDL level was increased during serial measurements with high significant difference (p < 0.001). However in Control group, the average total cholesterol, LDL, TGs and HDL levels of patients were increased during the whole serial measurements with high significant difference (p < 0.001).
• In Interventional group comparing baseline and follow up fibro-scan measurements revealed a marked increase in stage shift towards class F0 and F1 after therapy; while in Control group comparing baseline and follow up fibro-scan measurements revealed a non-significant difference after therapy.
• Correlation studies between SVR outcome and its relative independent predictors showed that; the increase in baseline CRP; and the decrease in baseline hemoglobin level, and the non-statin usage; had an independent effect on increasing the probability of SVR failure in both groups.