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Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: A randomised, double-blind, phase 3, multicentre non-inferiority study

The Lancet: Gastroenterology & Hepatology Mar 03, 2020

Lampertico P, Buti M, Fung S, et al. - With this non-inferiority study, researchers tested the safety and effectiveness of tenofovir alafenamide in individuals with hepatitis B virus (HBV) infection switching from tenofovir disoproxil fumarate who are virally suppressed. Participants in the study were patients with chronic HBV infection who had been receiving tenofovir disoproxil fumarate for 48 weeks or more and who had HBV DNA less than the lower limit of quantification for at least 12 weeks. Study participants were randomly assigned in a 1:1 ratio to get tenofovir alafenamide 25 mg once a day or to continue tenofovir disoproxil fumarate 300 mg once a day. Five hundred forty-one patients were screened and 490 individuals were randomly assigned to switch to tenofovir alafenamide or to stay on tenofovir disoproxil fumarate. Upper respiratory tract infection and nasopharyngitis were the most common treatment-emergent adverse events. There was no viral resistance in patients who had qualified for viral sequencing. According to this randomized, multicentre, double-blind, phase 3 non-inferiority study, for patients with HBV infection, tenofovir alafenamide may be substituted for tenofovir disoproxil fumarate for improved safety without loss of efficacy.
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