Abstract
Whether entecavir (ETV) or tenofovir alafenamide (TAF) is better at preventing hepatocellular carcinoma (HCC) development among patients with chronic hepatitis B (CHB) remains unclear. The present study was conducted to explore the ability of these two antivirals to prevent HCC. From 2012 to 2019, treatment-naïve CHB patients undergoing ETV or TAF therapy were recruited at three academic teaching hospitals. The TAF group comprised patients starting TAF as first-line antiviral and those switching antivirals from tenofovir disoproxil fumarate to TAF. Patients with decompensated cirrhosis or HCC at enrollment were excluded from the analysis. Cumulative probabilities of HCC were assessed using the Kaplan-Meier method. In total, 1810 patients (1525 and 285 in ETV and TAF groups, respectively) were recruited. The annual HCC incidence was statistically not different between the ETV and TAF groups (1.67 vs. 1.19 per 100 person-years, respectively) with an adjusted hazard ratio (HR) of 0.681 (p = 0.255), as determined by multivariate analysis. Male, hypertension, liver cirrhosis, FIB-4 index, and albumin were independent prognostic factors for HCC development. Propensity score-matched and inverse probability of treatment weighting analyses yielded similar results, with non-statistically different HCC incidence between the ETV and TAF groups (1.07 vs. 1.19 per 100 person-years (HR = 0.973; p = 0.953) and 1.67 vs. 1.89 per 100 person-years, respectively (HR = 0.949; p = 0.743). These findings suggest that ETV- and TAF-treated CHB patients have similar risk of developing HCC. Further studies with the larger sample size and longer follow-up are needed to validate these results.
Highlights
Chronic hepatitis B virus (HBV) infection affects approximately 350 million people worldwide, and chronic hepatitis B (CHB) is endemic to East Asia. [1,2,3,4,5] Given the persistent intrahepatic replication status of HBV-DNA, HBV infection itself is significantly associated with increased risk of liver disease progression to cirrhosis and/or hepatocellular carcinoma (HCC). [6, 7] replication-suppressing antiviral therapy with potent nucleos(t)ide analogues (NUCs) and high genetic barrier to resistance is recommended to patients with chronic HBV infection in order to prevent liver disease progression
Along with entecavir (ETV) and tenofovir disoproxil fumarate (TDF), tenofovir alafenamie (TAF) was accepted as first-line NUC for the treatment of older populations or patients with co-morbidities for renal or bone disease. This approval was based on the similar short to intermediate-term antiviral effects of these three agents in treatment-naïve CHB patients. [10, 11] effective rescue regimens may offset the potential hazard by suboptimal virological response or genotypic resistance even in a very small proportion of patients treated with ETV. [12, 13] the long-term clinical efficacy for preventing the risk of liverdisease progression to cirrhosis and/or HCC are expected to be similar among the regimens
This issue remains controversial due to somewhat contradictory results among studies, including similar efficacy between patients receiving two antivirals, overall favorable outcomes among those treated with TDF, or discrepant results according to presence of cirrhosis or follow-up duration. [15,16,17,18,19,20] In addition, a more recent study based on data from two phase III clinical trials [21, 22] showed that patients treated with tenofovir alafenamide (TAF) showed a tendency for lower risk of HCC development, even though not statistically significant (p = 0.14), compared to those treated with TDF. [23]
Summary
Along with entecavir (ETV) and tenofovir disoproxil fumarate (TDF), tenofovir alafenamie (TAF) was accepted as first-line NUC for the treatment of older populations or patients with co-morbidities for renal or bone disease This approval was based on the similar short to intermediate-term antiviral effects of these three agents in treatment-naïve CHB patients. Since Choi et al [14] reported that TDF is associated with a significantly lower risk of HCC (hazard ratio [HR] = 0.61) and all-cause mortality or orthotopic liver transplant (HR = 0.77) than ETV, several studies were conducted to validate such phenomena This issue remains controversial due to somewhat contradictory results among studies, including similar efficacy between patients receiving two antivirals, overall favorable outcomes among those treated with TDF, or discrepant results according to presence of cirrhosis or follow-up duration. The present study was conducted to explore the ability of these two antivirals to prevent HCC
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