Residual risk of hepatocellular carcinoma development for chronic hepatitis C patients treated by all oral direct-acting antivirals with sustained virological response

Sep 29, 2026

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All-oral direct-acting antivirals (DAAs) have transformed chronic hepatitis C treatment by enabling rapid, well-tolerated viral clearance and high sustained virological response (SVR) rates, yet some patients still develop de novo hepatocellular carcinoma (HCC). A real-world cohort study assessed predictors of HCC after SVR in 671 consecutive Taiwanese patients treated between 2017 and 2019. Advanced fibrosis, higher EOT12 AFP, worse EOT12 ALBI grade, and BMI ≥ 25 independently increased risk.

LanguageEnglish

CategoryHealthcare

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Abstract

Background

Methods

Results

Conclusion

Introduction

Disease burden and carcinogenic mechanisms

Impact of interferon-free DAAs

J Chin MedAssoc Original article Residual risk of hepatocellular carcinoma development for chronic hepatitis C patients treated by all oral direct-acting antivirals with sustained virological response Chih-Hsuan Luana, Pin-Shuo Sua, Chi-Jen Chua,b,*, Chung-Chi Linb,c, Chien-Wei Sub,d, Shou-Dong Leeb,e, Yuan-Jen Wangb,c, Fa-Yauh Leea,b, Yi-Hsiang Huanga,b, Ming-Chih Houa,b aDivision of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC; bFaculty of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ROC; cHealthcare and Services Center, Taipei Veterans General Hospital, Taipei, Taiwan, ROC; dDivision of General Medicine, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC; eDivision of Gastroenterology, Department of Medicine, Cheng Hsin General Hospital, Taipei, Taiwan, ROC Abstract Background: The treatment of chronic hepatitis C (CHC) infection underwent a significant transformation with the introduction of all-oral direct-acting anti-virals (DAAs) . These medications offered a high success rate in treatment, shorter duration, good tolerability, and expanded treatment options. However, a residual risk of hepatocellular carcinoma (HCC) development remained for a few patients even after achieving sustained virological response (SVR) . To date, there is a lack of real-world data on evaluating risk factors associated with de novo HCC in CHC patients post-SVR, particularly in Taiwan. Methods: Between January 2017 and December 2019, a total of 671 consecutive CHC patients who achieved SVR after receiving DAAs were included for analysis. Patients with a history of HCC or liver transplantation prior to DAAs, a short follow-up period (<1 year), or treatment failure with DAAs were excluded. The primary outcome was the development of HCC following the initiation of DAAs. Variables associated with the primary outcome were assessed using multivariate Cox proportional hazards models. Results: The mean age of the enrolled patients was 65.1 ± 12.8 years, with 39.6% of them being male. Among the patients, 30.6% had advanced (F3-4) fibrosis, and the median follow-up period was 2.90 years. The cumulative incidence of HCC in CHC patients post-SVR12 was 1.6% at 1 year, 4.4% at 2 years, 4.8% at 3 years, 5.3% at 4 years, and 6. 1% at 4.8 years, respectively. Variables independently associated with de novo HCC were advanced liver fibrosis (hazard ratio [HR] = 6.745; 95% CI = 1.960-23.218; p = 0.002), end-of-treatment 12 weeks (EOT12) alpha-fetoprotein (AFP) >7 ng/mL (HR = 3.059; 95% CI = 1.215-7.669; p = 0.018), EOT12 albumin-bilirubin (ALBI) grade ≥ 2 (HR = 2.664; 95% CI = 1.158-6.128; p = 0.021), and body mass index (BMI) ≥ 25 kg/m2 (HR = 2.214; 95% CI = 1.011-4.852; p = 0.047) . Conclusion: Despite achieving viral clearance with DAAs, CHC patients still face a residual risk of de novo HCC. Establishing a risk stratification model based on independent variables could facilitate the prediction of future HCC development and enhance screening strategies. Keywords: Advanced fibrosis; Chronic hepatitis C; Direct-acting anti-virals; Hepatocellular carcinoma; Risk stratification model; Sustained virological response *Address correspondence. Dr Chi-Jen Chu, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Veterans General Hospital, 201, Section 2, Shi-Pai Road, Taipei 112, Taiwan, ROC. E-mail address: cjchu@ [vghtpe.gov.tw](vghtpe.gov.tw) (C.-J. Chu). Conflicts of interest: Dr. Fa-Yauh Lee, Dr. Yi-Hsiang Huang and Dr. Ming-Chih Hou, editorial board members at Journal of the Chinese Medical Association, have no roles in the peer review process of or decision to publish this article. The other authors declare that they have no conflicts of interest related to the subject matter or materials discussed in this article. Journal of Chinese Medical Association. (2023) 86: 795-805. Received April 17

FAQs

What was the main purpose of this study?

To evaluate real-world risk factors for developing de novo HCC in chronic hepatitis C patients after achieving SVR with all-oral direct-acting antivirals, with particular focus on the Taiwanese population.

How many patients were included and what time window was analyzed?

A total of 671 consecutive chronic hepatitis C patients who achieved SVR after DAA therapy were included, with data covering treatments from January 2017 to December 2019.

Which factors were independently associated with de novo HCC after SVR?

Advanced liver fibrosis, EOT12 alpha-fetoprotein (AFP) > 7 ng/mL, EOT12 ALBI grade ≥ 2, and body mass index (BMI) ≥ 25 kg/m² were independently associated with de novo HCC development.

Sep 29, 2026

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