Non-Invasive Risk Stratification for Hepatocellular Carcinoma in HCV-Related Compensated Advanced Chronic Liver Disease Following Sustained Virological Response: Validation of the aMAP Score

NCT07687758 | Completed

• 2 other identifiers: 984-2566-IRB1Si 034/2024
• Study Type: observational
• Target: 571
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective cohort study evaluated the performance of non-invasive risk scores for predicting de novo hepatocellular carcinoma in adults with hepatitis C virus-related compensated advanced chronic liver disease who achieved sustained virological response after sofosbuvir-based direct-acting antiviral therapy. Patients treated at Siriraj Hospital between 2013 and 2023 were included if they had compensated advanced chronic liver disease and documented SVR12. The study compared FIB-4, APRI, ALBI, and aMAP scores calculated at SVR12 for prediction of hepatocellular carcinoma during long-term follow-up. The primary aim was to identify a very-low-risk subgroup in whom hepatocellular carcinoma surveillance might potentially be de-escalated.

Conditions

Hepatitis C Virus Infection; Compensated Advanced Chronic Liver Disease; Hepatocellular Carcinoma (HCC)

Keywords

Sustained Virological Response; Direct-acting Antiviral Therapy; aMAP Score; FIB-4; APRI; ALBI Score; HCC Surveillance; Risk Stratification

Outcome Measures

Primary Outcomes (1)

• Development of de novo hepatocellular carcinoma

  Occurrence of newly diagnosed hepatocellular carcinoma after achievement of sustained virological response (SVR12). Patients with known or suspected hepatocellular carcinoma before direct-acting antiviral therapy were excluded.

  From SVR12 until diagnosis of hepatocellular carcinoma, last follow-up, or up to 8 years after SVR12.

Secondary Outcomes (4)

• Predictive accuracy of the FIB-4 score for de novo hepatocellular carcinoma

  At 1, 3, 5, and 8 years after SVR12

• Predictive accuracy of the APRI score for de novo hepatocellular carcinoma

  At 1, 3, 5, and 8 years after SVR12

• Predictive accuracy of the ALBI score for de novo hepatocellular carcinoma

  At 1, 3, 5, and 8 years after SVR12

• Predictive accuracy of the aMAP score for de novo hepatocellular carcinoma

  At 1, 3, 5, and 8 years after SVR12

Study Arms (1)

HCV-related cACLD After SVR

Adults with hepatitis C virus-related compensated advanced chronic liver disease who achieved sustained virological response at 12 weeks after sofosbuvir-based direct-acting antiviral therapy and were followed for de novo hepatocellular carcinoma.

Other: Non-invasive Risk Score Assessment

Interventions

Non-invasive Risk Score Assessment OTHER

FIB-4, APRI, ALBI, and aMAP scores were calculated using laboratory values at SVR12 to evaluate their performance for predicting de novo hepatocellular carcinoma during follow-up.

HCV-related cACLD After SVR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with chronic hepatitis C virus infection and compensated advanced chronic liver disease who initiated sofosbuvir-based direct-acting antiviral therapy at Siriraj Hospital between 2013 and 2023 and achieved sustained virological response at 12 weeks after treatment completion.

You may qualify if:

• Age 18 years or older
• Chronic hepatitis C virus infection treated with direct-acting antiviral therapy
• Documented sustained virological response at 12 weeks after treatment completion
• Evidence of compensated advanced chronic liver disease before direct-acting antiviral therapy, defined by at least one of the following: histologic F3 or F4 fibrosis, vibration-controlled transient elastography \>10 kPa, radiologic features compatible with advanced fibrosis or cirrhosis, or clinical or endoscopic evidence of portal hypertension
• Minimum follow-up of 12 months after sustained virological response

You may not qualify if:

• Incomplete or missing medical records precluding outcome assessment
• Known or suspected hepatocellular carcinoma before initiating direct-acting antiviral therapy
• Failure to achieve sustained virological response at 12 weeks

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

Location

Related Publications (2)

• de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30.

  PMID: 35120736 BACKGROUND

• Fan R, Papatheodoridis G, Sun J, Innes H, Toyoda H, Xie Q, Mo S, Sypsa V, Guha IN, Kumada T, Niu J, Dalekos G, Yasuda S, Barnes E, Lian J, Suri V, Idilman R, Barclay ST, Dou X, Berg T, Hayes PC, Flaherty JF, Zhou Y, Zhang Z, Buti M, Hutchinson SJ, Guo Y, Calleja JL, Lin L, Zhao L, Chen Y, Janssen HLA, Zhu C, Shi L, Tang X, Gaggar A, Wei L, Jia J, Irving WL, Johnson PJ, Lampertico P, Hou J. aMAP risk score predicts hepatocellular carcinoma development in patients with chronic hepatitis. J Hepatol. 2020 Dec;73(6):1368-1378. doi: 10.1016/j.jhep.2020.07.025. Epub 2020 Jul 21.

  PMID: 32707225 BACKGROUND

MeSH Terms

Conditions

Hepatitis C; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Tawesak Tanwandee, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 7, 2026
• Study Start: January 1, 2013
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning after publication of the study results; no fixed end date.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal for purposes consistent with the approved study protocol and applicable ethical regulations. Requests should be directed to the corresponding author.

Locations

TH (1)