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Hepatitis C Virus-Related One-Year Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: A Randomized Controlled Trial

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Abstract

Purpose

Available data on hepatocellular carcinoma (HCC) recurrence after direct-acting antivirals (DAAs) treatment for hepatitis C virus (HCV) are conflicting. No randomized trials were done. This study aims to compare the 1-year HCC recurrence rates in patients who received DAAs after tumor ablation versus those who postponed HCV treatment for 1 year.

Methods

Included patients were randomized after complete HCC ablation into two groups: a postponed DAAs group for whom DAAs initiation was postponed for 12 months and a DAAs group who were given sofosbuvir/velpatasvir. Patients were followed for 1 year.

Results

Eighty-four HCV patients with a mean age of 56.35 ± 8.12 years were included; 78.57% of them were males. The number of lesions per patient ranged from 1 to 3 lesions, and the size of the largest lesion ranged from 1.5 to 5 cm. There were no statistically significant differences between both groups regarding baseline characteristics. In the DAAs group (43 patients), 11 patients had HCC recurrence, while 25 patients in the postponed DAAs group (41 patients) had HCC recurrence. Using Kaplan-Meier analysis, the 1-year recurrence-free survival (RFS) was significantly higher in the DAAs group (72.2% vs. 38%, P = 0.001). On multivariate analysis, both higher albumin levels (HR 0.147, 95% CI 0.066–0.329) and receiving DAAs (HR 0.358, 95% CI 0.176–0.730) 1 year after ablation were associated with significantly lower recurrence.

Conclusion

Direct-acting antiviral usage after complete hepatocellular carcinoma ablation significantly decreases the 1-year HCC recurrence rates, but the risk of recurrence is still not eliminated. The study registration number on clinicaltrials.gov: NCT04653818 (initial release on 28/11/2020).

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Data Availability

The data supporting this study’s findings are available from the corresponding author upon request.

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Funding

Self-funded.

Author information

Authors and Affiliations

  1. Hepatology Unit, Internal Medicine Department, Faculty of Medicine, Alexandria University, Alexandria, Egypt

    Ahmed Kamal, Marwa Metawea & Hend Naguib

  2. Pulmonology Clinical Pharmacy, Alexandria University Hospitals, Alexandria University, Alexandria, Egypt

    Heba Omar

  3. Radiodiagnosis and Intervention Department, Faculty of Medicine, Kafrelsheikh University, Kafrelsheikh, Egypt

    Mahmoud Ghallab

  4. Radiology Department, Faculty of Medicine, Port Said University, Port Said, Egypt

    Ahmed Kassem

  5. Fellow of Microbiology, Alexandria University, Alexandria, Egypt

    Heba Omar

Authors
  1. Ahmed Kamal
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Contributions

1- A.K., H.N., and M.M. designed the study with contribution of M.G., A.K., and H.O. 2- A.K., M.M., H.N., A.K, and M.G. enrolled participants while H.O. assigned participants to interventions. 3- A.K., M.M., and H.N. collected the data while A.K. and H.O. assembled it. 4- A.K., M.M. and H.O. analyzed data. 5- All authors interpreted data. 6- H.O. and A.K. wrote the article. 7- Other authors shared in the article writing. 8- All authors revised the article critically for intellectual content. 9- All authors approved the last version of the article.

Corresponding author

Correspondence to Ahmed Kamal.

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Ethics Approval

The study was conducted in accordance with the Declaration of Helsinki, revised in 2013, and Good Clinical Practice guidelines. It was approved by the Ethics Committee of Faculty of Medicine, Alexandria University (IRB No. 00012098).

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All patients signed written informed consent prior to the study.

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All authors gave their consent for publication.

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The authors declare no competing interests.

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Kamal, A., Metawea, M., Omar, H. et al. Hepatitis C Virus-Related One-Year Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: A Randomized Controlled Trial. J Gastrointest Canc (2024). https://doi.org/10.1007/s12029-024-01035-5

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