Compensated Advanced Chronic Liver Disease, Hepatitis C Virus Infection, Hepatocellular Carcinoma (HCC)
Conditions
Keywords
Sustained Virological Response, Direct-acting Antiviral Therapy, aMAP Score, FIB-4, APRI, ALBI Score, HCC Surveillance, Risk Stratification
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.
Detailed description
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.
Interventions
OTHERNon-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.
Sponsors
Siriraj Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of de novo hepatocellular carcinoma | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predictive accuracy of the FIB-4 score for de novo hepatocellular carcinoma | 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. |
| Predictive accuracy of the APRI score for de novo hepatocellular carcinoma | 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. |
| Predictive accuracy of the ALBI score for de novo hepatocellular carcinoma | 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. |
| Predictive accuracy of the aMAP score for de novo hepatocellular carcinoma | 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. |
Countries
Thailand
Contacts
PRINCIPAL_INVESTIGATORTawesak Tanwandee, MD
Siriraj Hospital
Outcome results
None listed