Tenofovir Alafenamide(TAF) Reduces the Risk of Hepatocellular Carcinoma(HCC) Recurrence
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
Hepatocellular carcinoma(HCC) is prevalent in the hepatitis B virus(HBV) infection endemic
areas. For early stage of HCC, surgical resection, radiofrequency ablation (RFA) or microwave
ablation (MWA) are the main treatment options. However, the risk of recurrence is as high as
50% in 5 years by surgical resection or 60-70% in 5 years by RFA. In average, the recurrence
rate of HCC at 2 years is 30%. Many factors are associated with the HCC recurrence, including
HBV viral load, cirrhotic stage, tumor size, tumor number, vascular invasion,
alpha-fetoprotein(AFP) level and so on. Of them, high HBV viral load is associated with the
risk of HCC recurrence after surgical resection, especially on late recurrence. In one
previous randomized controlled trial, patients who received lamivudine, adefovir dipivoxil,
or entecavir had significantly decreased early recurrence of HCC, however, whether
nucleos(t)ide analogues(NUCs) can further reduce the risk of recurrence in patients with low
viral loads (<2000 IU/ml) is still unclear.
In EASL 2017 guideline, all patients with compensated or decompensated cirrhosis need
antiviral treatment, with any detectable HBV DNA level and regardless of alanine
aminotransferase(ALT) levels. In Taiwan, even in chronic hepatitis B(CHB) infection patients
with HCC, NUC is not reimbursed if their HBV viral load was less than 2000 IU/ml. It is an
important unmet medical need to understanding the role of TAF in reducing the risk of
recurrence in HBV-HCC patients with low HBV viral load (HBV DNA<2000 IU/ml) and significant
liver fibrosis after curative treatment (The definition of significant liver fibrosis was
based on reference. In our recent retrospective study, the risk of recurrence and survival
are comparable between patients with and without NUCs treatment before HCC development only
if NUCs treatment can be provided after curative treatment of HCC. However, a higher risk of
recurrence was observed in cirrhotic patients with prior NUCs treatment before HCC
occurrence. It would be interesting to investigate the incidence of recurrence by switching
to tenofovir alafenamide(TAF) after curative treatment of HCC in patients already on NUCs
treatment.