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Treatment with Direct-Acting Antivirals in Patients with HCV Infection After Liver Transplantation
Michał Brzdęk1,2, Dorota Zarębska-Michaluk3, Olga Tronina4
1Collegium Medicum, Jan Kochanowski University, 25-317 Kielce, Poland.
Insights
Direct-acting antivirals (DAAs) are highly effective for treating chronic hepatitis C virus (HCV) in liver transplant recipients. This real-world study shows DAAs are safe and achieve high sustained virologic response (SVR) rates in this patient population.
Area of Science:
- Hepatology
- Virology
- Transplantation Medicine
Background:
- Direct-acting antivirals (DAAs) have transformed hepatitis C virus (HCV) management.
- Limited real-world data exist on DAA effectiveness and safety in liver transplant recipients.
- This study addresses the need for data in this specific patient cohort.
Purpose of the Study:
- To evaluate the clinical characteristics of liver transplant recipients with chronic HCV.
- To assess the effectiveness of DAA therapy in this population.
- To determine the safety profile of DAA treatment in liver transplant recipients.
Main Methods:
- Retrospective analysis of adult patients who underwent orthotopic liver transplantation (OLTx) before DAA therapy.
- Data collected from July 2015 to December 2024 within the EpiTer-2 project.
- Included 141 liver transplant recipients with chronic HCV infection.
Main Results:
- High sustained virologic response (SVR) rates: 96.4% (intention-to-treat) and 98.6% (per-protocol).
- DAA therapy was generally well-tolerated with few serious adverse events.
- No significant differences in effectiveness or safety were observed based on time from OLTx to treatment.
Conclusions:
- DAA therapy is highly effective in achieving SVR in liver transplant recipients with chronic HCV.
- DAA treatment demonstrates a favorable safety profile in this complex patient group.
- Real-world evidence supports the use of DAAs for HCV in liver transplant recipients.
Abstract:
Background/Objectives: Direct-acting antivirals (DAAs) have revolutionized the management of chronic hepatitis C virus (HCV) infection. However, real-world data on the effectiveness and safety of DAA therapy in patients with history orthotopic liver transplantation (OLTx) remain limited. This study aimed to evaluate the clinical characteristics, effectiveness, and safety of DAA therapy in liver transplant recipients with chronic hepatitis C in a nationwide, real-world cohort. Methods: A retrospective analysis was performed of all consecutive adult patients who underwent OLTx before starting DAA therapy between July 2015 and December 2024 within the EpiTer-2 project, which included 20,586 patients treated because of chronic hepatitis C. Results: A total of 141 patients participated in the study, with most of them being men (66%) and aged 50 years or older. Most patients (80%) had comorbidities, and nearly a quarter of the population had cirrhosis of the transplanted liver at the start of antiviral therapy. The median time from OLTx to initiation of antiviral therapy was 24 months. Overall, SVR was achieved in 96.4% of patients in the intention-to-treat analysis and in 98.6% after excluding patients lost to follow-up. The treatment was well tolerated. Serious adverse events were reported in five patients. During DAA treatment and 12 weeks of follow-up after treatment, two deaths were reported. Subgroup analysis by time from OLTx to antiviral therapy (≤24 vs. >24 months) revealed no differences in effectiveness and safety despite some baseline clinical variations. Conclusions: DAA therapy in liver transplant recipients with chronic HCV infection is highly effective and well-tolerated.
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