Predictors of HCC in Post-HCV Cirrhotic Patients After SVR

Introduction:

Hepatocellular carcinoma (HCC) is a highly fatal cancer with a global 5-year survival rate of less than 20%. In Egypt, HCC is the most common cancer in men and the leading cause of cancer-related death, primarily due to the historically high prevalence of Hepatitis C Virus (HCV). While sustained virologic response (SVR) after direct-acting antiviral (DAA) therapy significantly reduces the risk of HCC, it can still occur, especially in patients with advanced fibrosis or cirrhosis. This necessitates continued HCC surveillance post-HCV cure.

Aim of Work:

To study various clinical and laboratory predictors of hepatocellular carcinoma in Egyptian cirrhotic patients after achieving sustained virologic response.

Methodology:

Study Design: Retrospective, two-center case-control study.

Setting & Period: Two tertiary hepatology centers: Sohag University Hospital and Sohag Oncology Center.

SVR was achieved between January 1, 2016 - December 31, 2019

Participants:

Cases: SVR patients who developed HCC

Inclusion criteria

(1) age ≥ 18 y; (2) HCV related cirrhosis; (3) SVR12 after DAA; (4) radiologic or histologic HCC diagnosis ≤30 Jun 2025

Exclusion criteria

(1) non HCV cirrhosis or combined HCV-HBV cirrhosis; (2) HCC <6 months before SVR; (3) concomitant cholangiocarcinoma

Controls: SVR patients who did not develop HCC Inclusion Criteria: As above plus,

≥36 months post SVR without HCC

Exclusion criteria

Same as cases, plus loss to follow-up before 36 months

Sample Size: Using Fleiss' formula yields 120 cases & 240 controls (360 total). Adding 10 % for incomplete charts ⇒ 132 cases & 264 controls (≈ 400 subjects).

Variables to Study:

Clinical Predictors: Demographics (Age, Sex, Residence), Liver disease status (History of decompensation, Splenomegaly, Time since SVR), Metabolic comorbidities (Diabetes mellitus, Obesity/BMI, Dyslipidemia, HTN), Lifestyle factors (Smoking, Alcohol use), Medications (Statins, Metformin, Aspirin).

Laboratory Predictors: Platelet count, AST, ALT, AST/ALT ratio, Albumin, Total bilirubin, INR, Alpha-fetoprotein (AFP), HbA1c, Creatinine, Urea, GGT, and ALP.

Non-Invasive Scoring Systems: Child-Pugh Score, MELD Score, FIB-4 Score, ALBI Score, APRI, AAR (AST/ALT ratio).

Ethical Considerations: Approved by IRBs of both centers. Waiver of informed consent granted (retrospective chart review, minimal risk).

Duration: 6 months

Inclusion criteria

• for cases:

• age ≥ 18 y;
• HCV related cirrhosis;
• SVR12 after DAA;
• radiologic or histologic HCC diagnosis ≤30 Jun 2025
• for controls: As above plus, ≥36 months post SVR without HCC

Exclusion criteria

• for cases:

• non HCV cirrhosis or combined HCV-HBV cirrhosis;
• HCC <6 months before SVR;
• concomitant cholangiocarcinoma
• for controls: Same as cases, plus, loss to follow up before 36 months