Safety and efficacy of stopping tenofovir disoproxil fumarate in patients with chronic hepatitis B following at least 8 years of therapy: A prespecified follow-up analysis of two randomised trials
The Lancet: Gastroenterology & Hepatology Feb 26, 2019
Buti M, et al. - In this prespecified analysis, researchers assessed if it was safe to stop long-term tenofovir disoproxil fumarate therapy in patients with chronic hepatitis B who achieved persistent viral suppression following at least 8 years of therapy. For participants in two (completed) randomized controlled studies, GS-US-174-0102 and GS-US-174-0103, who were hepatitis B surface antigen (HBsAg)-positive with hepatitis B virus (HBV), a DNA concentration of less than 29 IU/mL was required by the protocol to enter a 24-week treatment-free follow-up (TFFU) phase in patients who completed 8 years or more of nucleotide analogue treatment. According to findings, nearly a third of patients experienced a grade 3 or higher laboratory abnormality within 24 weeks of stopping nucleotide analogue therapy. A subgroup of HBeAg-negative patients are able to attain a low replicative condition within a short follow-up period, although few patients attained a loss of HBsAg.
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