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Long-Term Hepatic and Extrahepatic Outcomes of Chronic Hepatitis C Patients After Sofosbuvir-Based Treatment
Chung-Feng Huang1, Jeong Heo2, Rong-Nan Chien3
1Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, 100 Tzyou Road, Kaohsiung, 807, Taiwan.
Insights
Direct-acting antivirals (DAAs) significantly improved long-term health outcomes for hepatitis C patients, reducing liver fibrosis and cardiovascular events. Quality of life was maintained after successful HCV eradication.
Area of Science:
- Hepatology
- Virology
- Clinical Medicine
Background:
- Direct-acting antivirals (DAAs) offer highly effective hepatitis C virus (HCV) treatment.
- Long-term hepatic and extrahepatic outcomes following DAA therapy in chronic hepatitis C (CHC) patients remain incompletely understood.
Purpose of the Study:
- To evaluate the long-term (5-year) hepatic and extrahepatic outcomes in CHC patients treated with DAAs.
- To compare DAA outcomes with a historical interferon-based treatment cohort.
Main Methods:
- Prospective follow-up of 160 CHC patients who achieved sustained virological response after DAA treatment (2013-2014 trials).
- Comparison with a propensity score-matched historical cohort of 480 interferon-treated patients.
- Assessment of quality of life (SF-36), liver fibrosis (electrography), and fibrosis markers (FIB-4, M2BPGi, LOXL2).
Main Results:
- Hepatocellular carcinoma (HCC) incidence was similar between DAA and interferon groups (0.6% annually); FIB-4 was the sole independent predictor of HCC.
- DAA therapy significantly reduced cardio-cerebrovascular events compared to interferon (0.9 vs 13.8 per 1000 person-years).
- Significant regression of liver fibrosis markers (M2BPGi, LOXL2) and liver stiffness observed over 5 years; quality of life generally maintained, with minor decreases in physical/emotional role limitations.
Conclusions:
- HCV eradication with DAAs leads to sustained improvements in liver and non-liver outcomes.
- DAA treatment promotes continuous liver fibrosis regression and maintains quality of life post-cure.
- FIB-4 is a critical predictor for HCC development in treated CHC patients.
Background/Aims:
Direct-acting antivirals (DAAs) are highly effective in treating hepatitis C virus (HCV) infection. The long-term hepatic and extrahepatic outcomes of DAAs in chronic hepatitis C (CHC) patients receiving curative antivirals are elusive.
Methods:
CHC patients were retrieved from two phase III sofosbuvir-based clinical trials conducted from 2013-2014. Patients who achieved a sustained virological response have been followed prospectively for 5 years since 2016. A propensity score-matched interferon-based historical control with a 1:3 ratio was used for comparison. Quality of life (QoL) was measured by the SF-36, liver fibrosis was measured by electrography, and fibrosis-related markers were followed annually in the prospective cohort.
Results:
A total of 160 DAA- and 480 interferon-treated patients were enrolled. Twenty-eight patients developed hepatocellular carcinoma (HCC) over a follow-up period of 4424 person-years (annual incidence: 0.6%). The incidence of HCC did not differ significantly between the DAA cohort and interferon-treated patients (P = 0.07). Cox regression analysis revealed that FIB-4 was the only factor independently associated with HCC development (hazard ratio [HR]: 95% confidence interval [CI] 3.59/1.68-7.66, P = 0.001). The incidence of newly developed cardio-cerebrovascular disease was 13.8 per 1000 person-years and 0.9 per 1000 person-years in interferon-treated patients and the DAA cohort, respectively (P < 0.001). Interferon-based patients had a significantly greater incidence of cardio-cerebrovascular disease (HR/CI 3.39/1.28-8.96, P = 0.014). There was a substantial decrease in liver stiffness (Ptrend = 0.08) and M2BPGi (Ptrend = 0.05) and a significant reduction in LOXL2 (Ptrend = 0.02) over 5 years. A significant decrease in QoL was observed in role limitations due to physical health and emotional problems, whereas the other parameters were maintained consistently throughout the 5 years of follow-up.
Conclusions:
HCV eradication by DAAs improved liver- and non-liver-related outcomes, constantly promoted liver fibrosis regression, and maintained quality of life after HCV cure.
Clinical Trial Number:
NCT03042520.
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