Background and aim: Hepatocellular carcinoma (HCC) is commonly attributed to cirrhosis related to chronic HCV infection. We aimed to evaluate the occurrence and the risk factors of HCC as well as assessment of the novel markers for HCC in patients treated with direct-acting antiviral drugs (DAAs).

Patients and methods: We conducted a prospective study on 300 patients with HCV related liver cirrhosis treated with DAAs. Calculation of the incidence rate for HCC was carried out on annual basis. Identification of risk factors correlated with HCC was performed using Cox regression model. The relative expressions of miRNA 122,155 and 200 were measured in patients with HCC and without HCC after DAAs therapy.

Results: 300 patients with HCV related liver cirrhosis were included in the study. The annual rate of incidence of HCC in our cohort was 5 per 100 patients. The predictors for development of HCC in such patients were miRNA-122 and failure to achieve SVR. Patients with HCC had remarkably greater expressions of miRNA-122 , miRNA-155 and miRNA-200. miRNA-122 expression had the best diagnostic accuracy (94.4%) for prediction of HCC in patients who received DAAs at cutoff point > 26.14 fold with 83.3% sensitivity and 95.45% specificity.

Conclusion: DAAs do not appear to be correlated with promotion of HCC following eradication of HCV in cirrhotic patients. We found that DAAs-related SVR is accompanied with lower incidence of HCC. miRNA-122 is taken into consideration as a propitious serum biomarker for the diagnosis of HCC patient after DAAs therapy.