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Risk Factors for Liver Decompensation and HCC in HCV-Cirrhotic Patients after DAAs: A Multicenter Prospective Study
Filomena Morisco1, Alessandro Federico2, Massimo Marignani3
1Gastroenterology and Hepatology Unit, Department of Clinical Medicine and Surgery, University of Naples "Federico II", 80131 Naples, Italy.
Insights
Cirrhotic patients achieving sustained virologic response (SVR) after direct-acting antiviral (DAA) therapy face liver-related events. Baseline liver stiffness (LSM) ≥ 20 kPa predicts higher risk in these Hepatitis C Virus (HCV) patients.
Area of Science:
- Hepatology
- Virology
- Gastroenterology
Background:
- Limited prospective data exists on predicting liver-related events in cirrhotic patients achieving sustained virologic response (SVR) post-direct-acting antiviral (DAA) therapy.
- Hepatitis C Virus (HCV) infection can lead to cirrhosis and significant liver-related complications.
Purpose of the Study:
- To identify predictors of liver-related events in cirrhotic patients with SVR after DAAs.
- To assess the risk of hepatocellular carcinoma (HCC), liver decompensation, and hepatic death.
Main Methods:
- Prospective enrollment of 706 HCV cirrhotic patients across four Italian centers (2015-2017).
- Comparison of SVR (n=687) and no-SVR (n=19) groups regarding liver-related events over 24-month follow-up.
- Cox regression analysis to determine independent predictors of liver-related events.
Main Results:
- SVR was achieved in 97.3% of patients.
- Liver-related events occurred in 8.9% of the SVR group versus 26.3% in the no-SVR group (p < 0.03).
- Baseline liver stiffness (LSM) ≥ 20 kPa and non-genotype 1 were independent predictors of liver decompensation; LSM > 20 kPa predicted HCC. A decrease in LSM did not reduce event risk.
Conclusions:
- Baseline LSM ≥ 20 kPa is a significant predictor of increased risk for liver-related events post-SVR in HCV cirrhotic patients.
- Hepatocellular carcinoma (HCC) and liver decompensation remain risks even after successful SVR.
- Non-genotype 1 and elevated baseline LSM are key factors for monitoring and management.
Background:
Prospective studies on predictors of liver-related events in cirrhotic subjects achieving SVR after DAAs are lacking.
Methods:
We prospectively enrolled HCV cirrhotic patients in four Italian centers between November 2015 and October 2017. SVR and no-SVR cases were compared according to the presence or absence of liver-related events during a 24-month follow-up. Independent predictors of liver-related events were evaluated by Cox regression analysis.
Results:
A total of 706 subjects started DAAs therapy. SVR was confirmed in 687 (97.3%). A total of 61 subjects (8.9%) in the SVR group and 5 (26.3%) in the no-SVR group had liver-related events (p < 0.03). The incidence rate x 100 p/y was 1.6 for HCC, 1.7 for any liver decompensation, and 0.5 for hepatic death. Baseline liver stiffness (LSM) ≥ 20 kPa (HR 4.0; 95% CI 1.1-14.1) and genotype different from 1 (HR 7.5; 95% CI 2.1-27.3) were both independent predictors of liver decompensation. Baseline LSM > 20 KPa (HR 7.2; 95% CI 1.9-26.7) was the sole independent predictor of HCC. A decrease in liver stiffness (Delta LSM) by at least 20% at the end of follow-up was not associated with a decreased risk of liver-related events.
Conclusion:
Baseline LSM ≥ 20 kPa identifies HCV cirrhotic subjects at higher risk of liver-related events after SVR.
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