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Published on: September 30, 2021
DIRECT-ACTING ANTIVIRALS FOR HEPATITIS C DO NOT AFFECT THE RISK OF DEVELOPMENT OR THE OUTCOME OF HEPATOCELLULAR
L Gogichaishvili1, G Lobjanidze1, T Tsertsvadze2
11Ivane Javakhishvili Tbilisi State University, Faculty of Medicine, Georgia.
Insights
Direct-acting antiviral (DAA) therapy effectively treats Hepatitis C virus (HCV) infection. This study found DAA regimens do not impact hepatocellular carcinoma (HCC) risk or mortality, making HCC not a contraindication for DAA treatment.
Area of Science:
- Hepatology
- Virology
- Oncology
Background:
- Hepatocellular carcinoma (HCC) is a major complication of Hepatitis C virus (HCV) infection.
- Georgia launched a nationwide HCV elimination program in 2015, including DAA treatment for HCC patients.
- The impact of different DAA regimens on HCC incidence, recurrence, and prognosis requires investigation.
Purpose of the Study:
- To evaluate the effect of various direct-acting antiviral (DAA) therapy regimens on the incidence or recurrence of hepatocellular carcinoma (HCC) in HCV patients.
- To assess the impact of DAA treatment on the prognosis of patients with HCV and HCC.
- To determine if HCC status is a contraindication for DAA treatment.
Main Methods:
- A cohort of 408 HCV patients aged 50-65 with advanced fibrosis (F3-F4) or cirrhosis were recruited between April 2015 and March 2016.
- Patients received DAA treatment according to national protocols, initially with sofosbuvir/ribavirin (±pegylated interferon), and later with ledipasvir/sofosbuvir (±ribavirin).
- Clinical and biological parameters were recorded, with regular monitoring for adverse events.
Main Results:
- No significant difference in HCC incidence or recurrence was observed across different DAA regimens or treatment durations.
- Mortality rates due to HCC did not significantly change between patient groups receiving different DAA therapies.
- DAA treatment was found to be safe and effective, regardless of HCC status, particularly in early-stage, curable cancers.
Conclusions:
- Direct-acting antiviral (DAA) regimens and treatment duration do not influence the risk of hepatocellular carcinoma (HCC) after antiviral therapy for Hepatitis C virus (HCV).
- Hepatocellular carcinoma (HCC) status is not a contraindication for direct-acting antiviral (DAA) treatment, especially for early-stage, curable cancers.
- The national HCV elimination program in Georgia demonstrates the feasibility of treating HCV patients, including those with HCC, using DAAs.
Abstract:
HCV infection and its complications, especially hepatocellular carcinoma, is a substantial public health burden. In 2015 "Nationwide hepatitis C elimination program" was launched in Georgia. According to the protocol, patients with HCC also receive DAA antiviral treatment. We study the effect of the different DAA therapy regiments on the incidence or recurrence of HCC and its prognosis. Overall, 408 patients were recruited in Georgian-French Joint Hepatology Clinic HEPA between April 2015-March 2016. The selection criteria were as follows: 1 - age 50-65 years; 2. Liver fibrosis level F3-F4 or cirrhosis at least 15 years of disease history; 3. HCV positive diagnosed by PCR method, whatever the level of viral load and genotype; 4. absence of previous complications of cirrhosis (ascites, gastrointestinal bleeding or HCC; 5. Child-Pugh class A or B; and 6. absence of severe extrahepatic disease. Essential clinical and biological parameters were recorded. Clinical monitoring and management of adverse events were performed on a regular base. HCV All patients included in the study received anti-HCV treatment with direct-acting antivirals (DAAs) within the national hepatitis C elimination program in accordance with national protocols. During April 2015-March 2016 treatment was provided with sofosbuvir (SOF) in combination with ribavirin (RBV), with or without pegylated interferon (IFN). Since March 2016, ledipasvir/sofosbuvir (LDV/SOF) was prescribed to all patients with or without RBV depending on the HCV genotype, level of fibrosis, and previous treatment experience. In conclusion, we find that neither different DAA regimens nor different treatment duration affects HCC risk after antiviral treatment. Moreover, there are no significant changes in mortality rate due to HCC in these groups. Therefore, it can be concluded, that HCC status is not a contraindication for DAA treatment, especially at the early stages of cancer, when a tumor is curative.
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