Tenofovir alafenamide fumarate therapy in subjects with positive HBV-DNA and normal levels of alanine transaminase: a study protocol for a randomised controlled trial

• Published in: BMJ open Vol. 11; no. 8; p. e048410
• Main Authors: Wang, Lu, Wu, Lina, Li, Xuejun, Zhang, Ying, Lai, Jing, Zhu, Xiang, Xie, Chan, Peng, Liang
• Format: Journal Article
• Language: English
• Published: London British Medical Journal Publishing Group 18.08.2021; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Protocol
• Subjects: Antigens; Antiretroviral drugs; Antiviral drugs; Biopsy; Clinical practice guidelines; clinical trials; Gastroenterology and Hepatology; Hepatitis B; hepatobiliary disease; hepatology; Infections; Laboratories; Liver diseases; Medical prognosis; protocols & guidelines; China
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2020-048410

IntroductionThe current clinical guidelines do not recommend antiviral therapy for subjects with positive hepatitis B virus (HBV)-DNA and normal alanine transaminase (ALT). In this study, we will assess the safety and efficacy of tenofovir alafenamide fumarate (TAF) in the treatment of adults with positive HBV-DNA and normal ALT, including long-term prognosis.Methods and analysisThis study is a non-double-blind randomised controlled trial. Study participants will be randomised into the treatment group and the control group. In the treatment group, subjects will receive TAF monotherapy, while those in the control group will receive no antiviral treatment. Subjects will be followed up at the beginning of the study and every 12 or 24 weeks thereafter for review of laboratory findings and to record adverse events. The primary endpoint is the proportion of patients with serum hepatitis B surface antigen loss.Ethics and disseminationThis study protocol was approved by the Ethics Committee of the Third Affiliated Hospital of Sun Yat-Sen University for Human Study (reference number [2019]02-599-01). The results of this study will be submitted for publication in a peer-reviewed journal.Trial registration numberNCT04231565.