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Hepatocellular carcinoma risk in patients with chronic hepatitis B receiving tenofovir-vs. entecavir-based regimens: individual patient data meta-analysis. Journal of hepatology Choi, W., Cheuk-Fung Yip, T., Lai-Hung Wong, G., Kim, W. R., Yee, L. J., Brooks-Rooney, C., Curteis, T., Cant, H., Chen, C., Chen, C., Huang, Y., Jin, Y., Jun, D. W., Kim, J., Park, N. H., Peng, C., Shin, H. P., Shin, J. W., Yang, Y., Lim, Y. 2022

Abstract

BACKGROUND AND AIMS: Comparative risk of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B (CHB) receiving tenofovir disoproxil fumarate (TDF) versus entecavir (ETV) remains controversial. This individual patient data (IPD) meta-analysis aimed to compare HCC risk between the two drugs and identify any subgroup of patients who may benefit more from one treatment than the other.METHODS: Published meta-analyses, electronic databases and congress proceedings were searched to identify eligible studies through January 2021. We compared HCC risk between the two drugs using a multivariable Cox proportional hazards model with anonymised IPD from treatment-naive CHB patients receiving TDF or ETV for =1 year. Treatment effect consistency was explored in propensity score matching (PSM), weighting (PSW) and subgroup analyses for age, sex, hepatitis B e-antigen (HBeAg) positivity, cirrhosis, and diabetes status.RESULTS: We included 11 studies from Korea, Taiwan, and Hong Kong involving 42,939 patients receiving TDF (n=6,979) or ETV (n=35,960) monotherapy. Patients receiving TDF had significantly lower HCC risk: adjusted HR 0.77 (95% CI 0.61-0.98; p=0.03). Lower HCC risk with TDF was consistently observed in PSM (HR 0.73, 95% CI 0.59-0.88; p<0.01) and PSW (HR 0.83, 95% CI 0.67-1.03; p=0.10) analyses and in all subgroups, with statistical significance in the =50 years of age (HR 0.76, 95% CI 0.58-1.00; p<0.05), male (HR 0.74, 95% CI 0.58-0.96; p=0.02), HBeAg-positive (HR 0.69, 95% CI 0.49-0.97; p=0.03), and non-diabetic (HR 0.79, 95% CI 0.63-1.00; p<0.05) subgroups.CONCLUSION: TDF was associated with significantly lower HCC risk than ETV in CHB patients, particularly those with HBeAg positivity. Longer follow-up may be needed to better define incidence differences between the treatments in various subgroups.IMPACT AND IMPLICATIONS: Previous aggregate data meta-analyses have reported inconsistent conclusions on the relative effectiveness of tenofovir disoproxil fumarate (TDF) and entecavir (ETV) in reducing hepatocellular carcinoma (HCC) risk in patients with chronic hepatitis B (CHB). This individual patient data meta-analysis on 11 studies involving 42,939 patients from Korea, Taiwan, and Hong Kong suggested that TDF-treated patients have a significantly lower HCC risk than ETV-treated patients, which was observed in all subgroups of clinical interest and by different analytical methodologies. These findings may have to be taken into account by healthcare providers when determining the optimal course of treatment for patients with CHB and may be considered in ensuring that treatment guidelines for CHB remain pertinent.

View details for DOI 10.1016/j.jhep.2022.12.007

View details for PubMedID 36572349