Trials (Jan 2024)

Entecavir versus tenofovir for prevention of hepatitis B virus-associated hepatocellular carcinoma after curative resection: study protocol for a randomized, open-label trial

  • Li-Xin Pan,
  • Yi-Yang Wang,
  • Zhong-Hai Li,
  • Jia-Xi Luo,
  • Kun-Jun Wu,
  • Zhen-Xiu Liu,
  • Pei-Sheng Wu,
  • Kang Chen,
  • Liang Ma,
  • Xiao-Hui Fan,
  • Jian-Hong Zhong

DOI
https://doi.org/10.1186/s13063-023-07742-x
Journal volume & issue
Vol. 25, no. 1
pp. 1 – 9

Abstract

Read online

Abstract Background Entecavir and tenofovir disoproxil fumarate (TDF) are standard first-line treatments to prevent viral reactivation and hepatocellular carcinoma (HCC) in individuals chronically infected with the hepatitis B virus (HBV), but the long-term efficacy of the two drugs remains controversial. Also unclear is whether the drugs are effective at preventing viral reactivation or HCC recurrence after hepatectomy to treat HBV-associated HCC. This trial will compare recurrence-free survival, overall survival, viral indicators and adverse events in the long term between patients with HBV-associated HCC who receive entecavir or TDF after curative resection. Methods This study is a randomized, open-label trial. A total of 240 participants will be randomized 1:1 into groups receiving TDF or entecavir monotherapy. The two groups will be compared in terms of recurrence-free and overall survival at 1, 3, and 5 years after surgery; adverse events; virological response; rate of alanine transaminase normalization; and seroreactivity at 24 and 48 weeks after surgery. Discussion This study will compare long-term survival between patients with HBV-associated HCC who receive TDF or entecavir monotherapy. Numerous outcomes related to prognosis will be analyzed and compared in this study. Trial registration ClinicalTrials.gov NCT02650271. Registered on January 7, 2016.

Keywords