Occurrence of hepatocellular carcinoma following direct antiviral agents (DAA) therapy

Document Type : Original Clinical

Authors

1 Asian institute of medical sciences, Hyderabad, Pakistan.

2 The University of Modern Sciences, Hyderabad, Pakistan.

Abstract

Background and Aim: The study aimed to identify the risk factors associated with hepatocellular 
carcinoma (HCC) development in patients with chronic hepatitis C virus (HCV) infection treated with 
direct-acting antivirals (DAAs) in Pakistan. 
Methods: A retrospective cohort study included 246 patients with chronic HCV infection who 
received DAA therapy between March 2020 and March 2024. Patients were followed for a median 
duration of 33 months to monitor the development of HCC. Baseline characteristics and potential 
risk factors were analyzed using univariate and multivariate analyses to determine their association 
with HCC occurrence. 
Results: Of the 246 patients, 34 (13.5%) developed HCC during the follow-up period. Univariate 
analysis revealed that older age (p<0.001), male gender (p=0.004), lower baseline platelet count 
(p<0.001), higher baseline alpha-fetoprotein (AFP) level (p<0.001), and the presence of liver cirrhosis 
(p<0.001) were significantly associated with the development of HCC. Multivariate analysis 
confirmed that advanced age (HR 1.06, 95% CI 1.03-1.08, p<0.001), male sex (HR 1.86, 95% CI 1.13
3.08, p=0.014), elevated baseline AFP (HR 1.28, 95% CI 1.18-1.39, p<0.001), and liver cirrhosis (HR 
4.84, 95% CI 2.78-8.42, p<0.001) were independent predictors of HCC development. Additionally, 
patients who achieved sustained virological response (SVR) had a significantly lower incidence of HCC 
compared to those who did not achieve SVR (1.1% vs. 6.9%, p<0.001). 
Conclusion: This study identifies key risk factors for HCC development in chronic HCV patients 
treated with DAAs, emphasizing the need for vigilant monitoring, especially in older males with 
cirrhosis and elevated AFP levels. Achieving SVR significantly reduces the risk of HCC, underscoring 
the importance of effective antiviral treatment in this population. 

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Footnotes. Sara Salem (lecturer in internal medicine, gastroenterology, and hepatology unit), Mohamed Emara (professor of gastroenterology, hepatology, and infectious diseases), and Amany Mohamed (Assistant professor of family medicine) were the peer reviewers. E- Editor: Salem Youssef Mohamed, Osama Ahmed Khalil, Amany Mohammed. Copyright ©. This open-access article is distributed under the Creative Commons Attribution License (CC BY). It may be used, distributed, or reproduced in other forums, provided the original author(s) and the copyright owner(s) are credited. The original publication in this journal must be cited according to accepted academic practice. Disclaimer: The authors' claims in this article are solely their own and do not necessarily represent their affiliated organizations or those of the publisher, the editors, and the reviewers. Any product evaluated in this article or its manufacturer's claim is not guaranteed or endorsed by the publisher. Ethical approval: All procedures involving human participants followed the institutional and national research committee's moral standards, the 1964 Helsinki Declaration, and its later amendments or comparable ethical standards. All authors declare that consent was obtained from the patients (or other approved parties) to publish this study. Study protocol: In adherence to the principles outlined in the Helsinki Declaration, the study protocol was implemented with approval from the institutional review board (#AIMS/IRB/298) at the Asian Institute of Medical Sciences. Before commencing the research, written consent was obtained from all patients to utilize their clinical information. Data and materials availability: The datasets used or analyzed during the current study are available from the corresponding author upon reasonable request. Competing interests: The authors declare that they have no competing interests. Funding: This study had no funding from any resource. This work was done according to the STROBE guidelines. Authors’ contributions Sadik Memon and Madiha Zaki conceived the research concept. At the same time, Bushra Qadir and Saddat Ali Jiskani conducted the clinical examinations and monitored the patients. Madiha Zaki and Bushra Qadir collaborated to gather laboratory data. All authors actively participated in analyzing and interpreting the patient information and composing the manuscript. All authors thoroughly reviewed and approved the final version of the manuscript.

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