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

1. juli 2026 opdateret af: Tawesak Tanwandee, Siriraj Hospital

Prediction of Risk of Hepatic Decompensation and Hepatocellular Carcinoma in Advanced Fibrotic or Cirrhotic Patients With Chronic Hepatitis C After Sustained Virologic Response

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This was a single-center retrospective cohort study conducted at Siriraj Hospital, Thailand. Consecutive adult patients with chronic hepatitis C virus infection and compensated advanced chronic liver disease who initiated interferon-free sofosbuvir-based direct-acting antiviral therapy between 2013 and 2023 and achieved sustained virological response at 12 weeks after treatment completion were included. Compensated advanced chronic liver disease was defined according to Baveno VII criteria, including histologic F3/F4 fibrosis, vibration-controlled transient elastography greater than 10 kPa, or clinical evidence of portal hypertension.

Baseline demographic, clinical, laboratory, and transient elastography data were collected from electronic medical records. The FIB-4, APRI, ALBI, and aMAP scores were calculated using laboratory values at SVR12. Patients with known or suspected hepatocellular carcinoma before direct-acting antiviral therapy, failure to achieve SVR12, or incomplete medical records precluding outcome assessment were excluded.

The primary outcome was de novo hepatocellular carcinoma during follow-up. Predictive performance of the non-invasive scores was assessed using time-to-event analysis, Kaplan-Meier methods, Cox proportional hazards regression, and time-dependent receiver operating characteristic curves at 1, 3, 5, and 8 years.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

571

Kontakter og lokationer

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Studiesteder

  • Thailand
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10700
        • Siriraj Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andet: Non-invasive Risk Score Assessment
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Development of de novo hepatocellular carcinoma
Tidsramme: From SVR12 until diagnosis of hepatocellular carcinoma, last follow-up, or up to 8 years after SVR12.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Predictive accuracy of the FIB-4 score for de novo hepatocellular carcinoma
Tidsramme: At 1, 3, 5, and 8 years after SVR12
Time-dependent area under the receiver operating characteristic curve (AUC) of the FIB-4 score for predicting de novo hepatocellular carcinoma.
At 1, 3, 5, and 8 years after SVR12
Predictive accuracy of the APRI score for de novo hepatocellular carcinoma
Tidsramme: At 1, 3, 5, and 8 years after SVR12
Time-dependent area under the receiver operating characteristic curve (AUC) of the APRI score for predicting de novo hepatocellular carcinoma.
At 1, 3, 5, and 8 years after SVR12
Predictive accuracy of the ALBI score for de novo hepatocellular carcinoma
Tidsramme: At 1, 3, 5, and 8 years after SVR12
Time-dependent area under the receiver operating characteristic curve (AUC) of the ALBI score for predicting de novo hepatocellular carcinoma.
At 1, 3, 5, and 8 years after SVR12
Predictive accuracy of the aMAP score for de novo hepatocellular carcinoma
Tidsramme: At 1, 3, 5, and 8 years after SVR12
Time-dependent area under the receiver operating characteristic curve (AUC) of the aMAP score for predicting de novo hepatocellular carcinoma.
At 1, 3, 5, and 8 years after SVR12

Samarbejdspartnere og efterforskere

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Sponsor

Siriraj Hospital

Efterforskere

  • Ledende efterforsker: Tawesak Tanwandee, MD, Siriraj Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2013

Primær færdiggørelse (Faktiske)

31. juli 2023

Studieafslutning (Faktiske)

31. juli 2023

Datoer for studieregistrering

Først indsendt

25. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juli 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 984-2566-IRB1
  • Si 034/2024 (Anden identifikator: Siriraj Institutional Review Board, Faculty of Medicine Siriraj Hospital, Mahidol University)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data underlying the results reported in this study may be made available from the corresponding author upon reasonable request, subject to approval by the investigators and applicable institutional and ethical regulations.

IPD-delingstidsramme

Beginning after publication of the study results; no fixed end date.

IPD-delingsadgangskriterier

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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