Long-term response after stopping tenofovir disoproxil fumarate in non-cirrhotic HBeAg-negative patients – FINITE study
| Autor: | Jörg Petersen, Eckart Schott, G Felten, Thomas Berg, T. Warger, Karl-Georg Simon, Markus Cornberg, Julian Schulze-Zur-Wiesch, Christoph Eisenbach, Stefan Mauss, Tania M. Welzel, Hans Reiser, Finite Chb study investigators, Marjoleine L. Op den Brouw, Lothar Gallo, Belinda Jump, Reinhart Zachoval, Dietmar M. Klass, Renate Heyne |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Hepatitis B virus medicine.medical_specialty HBsAg Hepatology business.industry virus diseases Hepatitis B medicine.disease medicine.disease_cause Gastroenterology digestive system diseases Surgery Discontinuation Viral Relapse Clinical trial 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Internal medicine medicine 030211 gastroenterology & hepatology Adverse effect business Viral load |
| Zdroj: | Journal of Hepatology. 67:918-924 |
| ISSN: | 0168-8278 |
| DOI: | 10.1016/j.jhep.2017.07.012 |
| Popis: | Background & Aims There is currently no virological cure for chronic hepatitis B but successful nucleos(t)ide analogue (NA) therapy can suppress hepatitis B virus (HBV) DNA replication and, in some cases, result in HBsAg loss. Stopping NA therapy often leads to viral relapse and therefore life-long therapy is usually required. This study investigated the potential to discontinue tenofovir disoproxil fumarate (TDF) therapy in HBeAg-negative patients. Methods Non-cirrhotic HBeAg-negative patients who had received TDF for ≥4years, with suppressed HBV DNA for ≥3.5years, were randomly assigned to either stop (n=21) or continue (n=21) TDF monotherapy. Standard laboratory tests including HBV DNA viral load, HBsAg and alanine aminotransferase (ALT) measurements, and adverse event reporting were carried out during treatment and post-treatment follow-up for 144weeks. Results Of the patients who stopped TDF therapy, 62% (n=13) remained off-therapy to Week 144. Median HBsAg change in this group was −0.59log 10 IU/ml (range −4.49 to 0.02log 10 IU/ml) vs. 0.21log 10 IU/ml in patients who continued TDF therapy. Four patients (19%) achieved HBsAg loss. Patients stopping therapy had initial fluctuations in viral load and ALT; however, at Week 144, 43% (n=9) had either achieved HBsAg loss or had HBV DNA Conclusions This controlled study demonstrated the potential for HBsAg loss and/or sustained virological response in non-cirrhotic HBeAg-negative patients stopping long-term TDF therapy. Lay summary: Nucleos(t)ide analogue (NA) is usually a life-long therapy for HBV patients. This randomised controlled study investigated the discontinuation of tenofovir disoproxil fumarate (TDF) therapy in HBeAg-negative patients. Of the patients who stopped TDF therapy, 62% remained off-therapy to Week 144, of which 43% of patients had achieved either HBsAg loss or HBV DNA Clinical trial number: NCT01320943. |
| Databáze: | OpenAIRE |
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