Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Si 034/2024 | Other Identifier | Siriraj Institutional Review Board, Faculty of Medicine Siriraj Hospital, Mahidol University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Predictive accuracy of the FIB-4 score for de novo hepatocellular carcinoma | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tawesak Tanwandee, MD | Siriraj Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Bangkok | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35120736 | Background | 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. | |
| 32707225 | 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. |
Not provided
Not provided
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.
Not provided
Beginning after publication of the study results; no fixed end date.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
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 | 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 | 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 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided