Efficacy and Cost-Effectiveness Analyses of Entecavir versus Tenofovir Amibufenamide in Patients with Chronic Hepatitis B

Yuhan Zeng,1 Danna Jiang,2 Lei Guo,1 Yizhang Chen,1,2 Jialu Weng,3 Xiaohan Liu,4 Sunting Qin,1 Mengyu Kong,1 Ziye Zhou,3,5 Xiuhua Zhang6 1Department of Pharmacy, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People’s Republic of China; 2School of Pharmaceutical Sciences, Wenzhou Medical University, Wenzhou, Zhejiang, People’s Republic of China; 3Zhejiang Key Laboratory of Intelligent Cancer Biomarker Discovery and Translation, First Affiliated Hospital, Wenzhou Medical University, Wenzhou, Zhejiang, People’s Republic of China; 4Cheeloo College of Medicine, Shandong University, Jinan, Shandong, People’s Republic of China; 5Clinical Research Office, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People’s Republic of China; 6Clinical Trial Institution Office, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People’s Republic of ChinaCorrespondence: Xiuhua Zhang, Clinical Trial Institution Office, The First Affiliated Hospital of Wenzhou Medical University, Nanbaixiang Street, Ouhai District, Wenzhou City, 325000, People’s Republic of China, Tel +86 577 55579593, Email [email protected] Ziye Zhou, Zhejiang Key Laboratory of Intelligent Cancer Biomarker Discovery and Translation & Clinical Research Office, The First Affiliated Hospital of Wenzhou Medical University, Nanbaixiang Street, Ouhai District, Wenzhou City, 325000, People’s Republic of China, Tel +86 577 55579593, Email [email protected]: To evaluate the efficacy and cost-effectiveness of entecavir (ETV) versus tenofovir amibufenamide (TMF) in patients with chronic hepatitis B.Patients and methods: In this retrospective study, patients diagnosed with chronic hepatitis B between January 2022 and June 2024 were screened. Those receiving ETV as first-line therapy were 1:1 propensity score-matched to TMF recipients. The primary endpoint was HBV-DNA negativity conversion at week 48.Results: Of 50,645 screened patients, 182 met eligibility criteria (TMF, n=91 [48 HBeAg-positive, 43 HBeAg-negative]; ETV, n=91 [36 HBeAg-positive, 55 HBeAg-negative]). HBeAg status was balanced between groups (P = 0.074). At week 48, HBV-DNA negativity was 54.95% for TMF and 76.92% for ETV (P = 0.002; OR 95% CI, 0.193– 0.693). Among HBeAg-negative patients, ETV achieved significantly higher negativity at week 24 (P = 0.028) and week 48 (P = 0.041); subgroup findings are exploratory. Treatment costs over 48 weeks were $14060.62 for TMF and $13334.70 for ETV, largely due to national health insurance coverage of ETV. The ICER of TMF versus ETV was -36.28, indicating ETV is more cost-effective. The substantial cost difference is primarily attributable to ETV being covered by national health insurance. Adverse event rates were comparable between the two drugs, indicating similar safety profiles.Conclusion: ETV showed better virologic response and lower drug-related costs than TMF in this single-center retrospective study, especially in HBeAg-negative patients. Further validation in multicenter prospective studies is needed.Plain Language Summary: Question: Comparative efficacy of entecavir (ETV) versus tenofovir amibufenamide (TMF) and their cost-effectiveness in antiviral therapy for patients with chronic hepatitis B (CHB): which treatment regimen is more advantageous in terms of clinical outcomes and economic value?Findings: In this retrospective cohort study that includes 182 patients with CHB, ETV demonstrated significant advantages in terms of both efficacy and cost-effectiveness compared to TMF, with better clinical outcomes and higher economic value.Meaning: These results suggest that ETV may be considered a potentially preferred antiviral regimen for patients with CHB; however, findings should be interpreted cautiously due to the retrospective design and limited sample size.Ethical approval: This study has been formally approved by the Clinical Research Ethics Committee of the First Affiliated Hospital of Wenzhou Medical University, ensuring that the study design, implementation process, and data handling all comply with medical ethical standards and relevant laws and regulations. In addition, this study has been registered in the platform of China Clinical Trial Registry Center, registration number: ChiCTR2500097387.Keywords: hepatitis B, tenofovir amibufenamide, entecavir, efficacy, cost-effectiveness evaluation