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

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...

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Published in:Current controlled trials in cardiovascular medicine 2024-01, Vol.25 (1), p.25-25, Article 25
Main Authors: Pan, Li-Xin, Wang, Yi-Yang, Li, Zhong-Hai, Luo, Jia-Xi, Wu, Kun-Jun, Liu, Zhen-Xiu, Wu, Pei-Sheng, Chen, Kang, Ma, Liang, Fan, Xiao-Hui, Zhong, Jian-Hong
Format: Article
Language:English
Subjects:
Antigens
Antiretroviral drugs
Antiviral agents
Antiviral drugs
Care and treatment
Clinical medicine
Comparative analysis
Complications and side effects
Disease prevention
Dosage and administration
Drug resistance
Drugs
Entecavir
Hepatectomy
Hepatitis B
Hepatitis B virus
Hepatocellular carcinoma
Hepatoma
Liver cancer
Liver cirrhosis
Prevention
Risk factors
Surgery
Tenofovir
Tenofovir disoproxil fumarate
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Summary: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. 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. 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. ClinicalTrials.gov NCT02650271. Registered on January 7, 2016.
ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-023-07742-x