Effectiveness and safety of tenofovir disoproxil fumarate in chronic hepatitis B: a 3-year prospective field practice study in Germany
Background and AimsMultiple clinical trials have demonstrated the efficacy and safety of tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB). However, long-term efficacy and safety data for TDF in real-life clinical practice are limited.MethodsProspective German field practice study in...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2016
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| In: |
Digestive diseases and sciences
Year: 2016, Volume: 61, Issue: 10, Pages: 3061-3071 |
| ISSN: | 1573-2568 |
| DOI: | 10.1007/s10620-015-3960-x |
| Online Access: | Verlag, Volltext: http://dx.doi.org/10.1007/s10620-015-3960-x Verlag, Volltext: https://link.springer.com/article/10.1007/s10620-015-3960-x 
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| Author Notes: | Jörg Petersen, Renate Heyne, Stefan Mauss, Jörg Schlaak, Willibald Schiffelholz, Christoph Eisenbach, Heinz Hartmann, Manfred Wiese, Klaus Boeker, Hanns-Friedrich Loehr, Christine John, Maria Leuschner, Christian Trautwein, Gisela Felten, Andreas Trein, Wolfgang Krause, Susanne Ruppert, Tobias Warger, Dietrich Hueppe |
| Summary: | Background and AimsMultiple clinical trials have demonstrated the efficacy and safety of tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB). However, long-term efficacy and safety data for TDF in real-life clinical practice are limited.MethodsProspective German field practice study in CHB-mono-infected patients. Patients were TDF-naïve but could have been treated previously with other HBV antivirals.ResultsEfficacy analysis included 400 patients; 301 (75 %) completed 36 months of TDF treatment. Both treatment-naïve and treatment-experienced patients showed a rapid decline in HBV DNA within 3 months of TDF initiation. After 36 months, HBV DNA < 69 IU/mL was achieved by 91 % of treatment-naïve patients (90 and 92 % in hepatitis B “e” antigen [HBeAg]-positive and [HBeAg]-negative, respectively) and 96 % of treatment-experienced patients (93 and 97 %, respectively). Three patients experienced virologic breakthrough, all with reported non-compliance. Overall, 5.7 % HBeAg-positive and 2.2 % HBeAg-negative patients lost hepatitis B surface antigen. Safety data were consistent with the known TDF safety profile; the most commonly reported adverse events possibly related to TDF were fatigue (2.0 %) and headache (2.0 %). Few patients (1.3 %) experienced renal-related adverse reactions. Creatinine clearance remained relatively stable over time; patients responded favorably where TDF was dose adjusted per label for decreased creatinine clearance.ConclusionsTDF showed a favorable tolerability profile and induced rapid and sustained suppression of HBV DNA in patients with CHB treated for up to 3 years in routine clinical practice, irrespective of treatment history. Efficacy and safety in this heterogeneous patient population were consistent with data from clinical trials. |
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| Item Description: | First Online: 14 November 2015 Gesehen am 28.11.2017 |
| Physical Description: | Online Resource |
| ISSN: | 1573-2568 |
| DOI: | 10.1007/s10620-015-3960-x |