BACKGROUND & AIMS: Recognition of non-characterized liver nodules (NCLN) prior to direct acting antivirals (DAA) is associated with increased hepatocellular carcinoma (HCC) risk in patients with hepatitis C virus infection (HCV). This risk has not been defined yet in F3/F4 patients in whom NCLN have been ruled-out before starting DAA and at sustained virological response (SVR). This study aimed to estimate HCC incidence in this population.
METHODS: Prospective study including F3/F4 HCV-infected patients, without history of HCC, and who achieved SVR after DAA. Patients should have an ultrasound imaging done within 30 days after SVR excluding the presence of HCC/NCLN. All patients were evaluated every 6-months until developing primary liver-cancer, death or withdrawal of informed consent. HCC incidence was expressed in 100/patient-years (100PY). Adherence to screening program was calculated every 6 months for the first 48-months.
RESULTS: 185 (63/122, F3/F4), were included. Among cirrhotics, 92% were Child-Pugh A and 42.7% had clinically significant portal hypertension (CSPH). Albumin-bilirubin score was 1 and 2 in 84.9% and 15.1% of patients, respectively. The median clinical and radiologic follow-up was 52.4 months and 48 months, respectively. Ten patients developed HCC; HCC incidence was 1.46 100PY (CI95% 0.79-2.71) in the whole cohort and 2.24 100PY (CI95% 1.21-4.17) in F4 only and 3.63 100PY (CI95%1.95-6.74) in patients with CSPH. No HCC was registered in F3 patients. Median time between SVR and HCC occurrence was 28.1 months; 12 non-primary liver cancers were also identified.
CONCLUSIONS: Patients with liver cirrhosis without NCLN at SVR remain at risk of HCC development. The absence of HCC in F3 patients reinforces their marginal cancer risk, but prospective studies are needed to exclude them from screening programs.
LAY SUMMARY: Patients with DAA-cured HCV-related liver cirrhosis without non-characterized liver nodules at SVR remain at risk of HCC development. The absence of HCC in F3 before starting DAA in patients without non-characterized liver nodules at SVR suggests a marginal cancer risk in this population and, if confirmed in larger prospective studies, will imply to revisit the current recommendation for HCC screening in this group of patients.