Background: Several studies have resulted in controversial data about the recurrence or new incidence of hepatocellular carcinoma (HCC) in patients with hepatitis C who were treated with direct-acting antivirals (DAAs).  

Aim: This observational study aimed to assess the occurrence rate of HCC in patients who developed a sustained virological response (SVR)..

Methods: A six-month prospective study was done at the National Hepatology and Tropical Medicine Research Institute [NHTMRI] in Cairo, Egypt on 150 chronic hepatitis C (CHC) patients treated with sofosbuvir and daclatasvir with or without ribavirin. Patients were assigned into two groups according to their laboratory values to either receive sofosbuvir/daclatasvir and ribavirin (S/D/R) or receive only sofosbuvir/daclatasvir (S/D). The main outcome measure was the occurrence of HCC.

Results: SVR-12 was 100%. 8.5% of patients developed HCC in the S/D/R group, while 0% in the S/D group.

Conclusion:  New incidence or recurrence of HCC may occur in CHC genotype 4 cirrhotic patients receiving sofosbuvir/daclatasvir and ribavirin (difficult to treat) although achieving SVR. The cause of HCC development in this study is cirrhosis, not the administered DAAs.