Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)

Summary

The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic impairment.

Timeline

Start

2017-06-29

Primary completion

2019-03-27

Completion

2020-09-04

Publications

• Results Lim YS, Lin CY, Heo J, Bae H, Chuang WL, Hui AJ, et al. Safety and Efficacy of Switching to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Hepatic Impairment: Week-48 Results From a Phase 2 Open-label Study [Poster SAT442]. The Digital International Liver Congress (ILC); 2020 27-29 August.
• Results Janssen HLA, Lampertico P, Chen CY, Heo J, Fournier C, Ahn SH, et al. Safety and Efficacy of Switching to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Renal Impairment: Week-48 Results From a Phase 2 Open-label Study [Poster SAT429]. The Digital International Liver Congress (ILC); 2020 27-29 August.
• Results Lim YS, Lampertico P, Bae H, Chuang WL, Heo J, Huang YH, et al. Switching From Tenofovir Disoproxil Fumarate or Other Oral Antiviral Therapy to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Hepatic Impairment: Week 24 Efficacy and Safety Results From a Phase 2 Open-label Study [Poster 501]. AASLD: The Liver Meeting; 2019 08-12 November; Boston, MA.
• Results Janssen HLA, Lim YS, Gane EJ, Fournier C, Ahn SH, Tsang O, et al. Efficacy and Safety of Switching to Tenofovir Alafenamide in Virally Suppressed Chronic Hepatitis B Patients With Renal Impairment: Week 24 Results From a Phase 2 Open-label Study [Poster 483]. AASLD: The Liver Meeting; 2019 08-12 November; Boston, MA.
• Liu CJ, Lim YS, Chen CY, Chen CH, Huang YH, Lin CY, Lin CC, Yu ML, Abramov F, Yee LJ, Duan R, Flaherty JF, Su WW, Yang SS, Janssen HLA, Chuang WL. Switching to tenofovir alafenamide in virally-suppressed chronic hepatitis B patients with renal/hepatic impairment: Phase 2 study sub-analysis from Taiwan. J Formos Med Assoc. 2025 Jul 30:S0929-6646(25)00390-0. doi: 10.1016/j.jfma.2025.07.023. Online ahead of print.
• Janssen HLA, Lim YS, Lampertico P, Heo J, Chen CY, Fournier C, Tsang TYO, Bae H, Chen CH, Coffin CS, Ahn SH, Trinh H, Flaherty JF, Abramov F, Zhao Y, Liu Y, Lau A, German P, Chuang WL, Agarwal K, Gane E. Switching to tenofovir alafenamide in patients with virologically suppressed chronic hepatitis B and renal or hepatic impairment: final week 96 results from an open-label, multicentre, phase 2 study. Lancet Gastroenterol Hepatol. 2024 Aug;9(8):718-733. doi: 10.1016/S2468-1253(24)00096-7. Epub 2024 Jun 17.

Drugs

Indications