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...
Gespeichert in:
| Hauptverfasser: | , |
|---|---|
| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
2016
|
| In: |
Digestive diseases and sciences
Year: 2016, Jahrgang: 61, Heft: 10, Pages: 3061-3071 |
| ISSN: | 1573-2568 |
| DOI: | 10.1007/s10620-015-3960-x |
| Online-Zugang: | 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 
|
| Verfasserangaben: | 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 |
MARC
| LEADER | 00000caa a2200000 c 4500 | ||
|---|---|---|---|
| 001 | 1565773527 | ||
| 003 | DE-627 | ||
| 005 | 20230427150448.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 171128s2016 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1007/s10620-015-3960-x |2 doi | |
| 035 | |a (DE-627)1565773527 | ||
| 035 | |a (DE-576)495773522 | ||
| 035 | |a (DE-599)BSZ495773522 | ||
| 035 | |a (OCoLC)1340982540 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 084 | |a 33 |2 sdnb | ||
| 100 | 1 | |a Petersen, Jörg |e VerfasserIn |0 (DE-588)133029891 |0 (DE-627)691095485 |0 (DE-576)299575977 |4 aut | |
| 245 | 1 | 0 | |a Effectiveness and safety of tenofovir disoproxil fumarate in chronic hepatitis B |b a 3-year prospective field practice study in Germany |c 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 |
| 264 | 1 | |c 2016 | |
| 300 | |a 11 | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a First Online: 14 November 2015 | ||
| 500 | |a Gesehen am 28.11.2017 | ||
| 520 | |a 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. | ||
| 700 | 1 | |a Eisenbach, Christoph |e VerfasserIn |0 (DE-588)1022807560 |0 (DE-627)71704419X |0 (DE-576)366008579 |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Digestive diseases and sciences |d Dordrecht : Springer Science + Business Media B.V., 1934 |g 61(2016), 10, Seite 3061-3071 |h Online-Ressource |w (DE-627)320525384 |w (DE-600)2015102-0 |w (DE-576)099426617 |x 1573-2568 |7 nnas |a Effectiveness and safety of tenofovir disoproxil fumarate in chronic hepatitis B a 3-year prospective field practice study in Germany |
| 773 | 1 | 8 | |g volume:61 |g year:2016 |g number:10 |g pages:3061-3071 |g extent:11 |a Effectiveness and safety of tenofovir disoproxil fumarate in chronic hepatitis B a 3-year prospective field practice study in Germany |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1007/s10620-015-3960-x |x Verlag |x Resolving-System |3 Volltext |
| 856 | 4 | 0 | |u https://link.springer.com/article/10.1007/s10620-015-3960-x |x Verlag |3 Volltext |
| 951 | |a AR | ||
| 992 | |a 20171128 | ||
| 993 | |a Article | ||
| 994 | |a 2016 | ||
| 998 | |g 1022807560 |a Eisenbach, Christoph |m 1022807560:Eisenbach, Christoph |d 910000 |d 910100 |e 910000PE1022807560 |e 910100PE1022807560 |k 0/910000/ |k 1/910000/910100/ |p 6 | ||
| 999 | |a KXP-PPN1565773527 |e 2988361347 | ||
| BIB | |a Y | ||
| SER | |a journal | ||
| JSO | |a {"type":{"media":"Online-Ressource","bibl":"article-journal"},"note":["First Online: 14 November 2015","Gesehen am 28.11.2017"],"recId":"1565773527","language":["eng"],"title":[{"title":"Effectiveness and safety of tenofovir disoproxil fumarate in chronic hepatitis B","subtitle":"a 3-year prospective field practice study in Germany","title_sort":"Effectiveness and safety of tenofovir disoproxil fumarate in chronic hepatitis B"}],"person":[{"display":"Petersen, Jörg","roleDisplay":"VerfasserIn","role":"aut","family":"Petersen","given":"Jörg"},{"family":"Eisenbach","given":"Christoph","roleDisplay":"VerfasserIn","display":"Eisenbach, Christoph","role":"aut"}],"physDesc":[{"extent":"11 S."}],"relHost":[{"title":[{"title":"Digestive diseases and sciences","title_sort":"Digestive diseases and sciences"}],"note":["Gesehen am 26.05.14"],"disp":"Effectiveness and safety of tenofovir disoproxil fumarate in chronic hepatitis B a 3-year prospective field practice study in GermanyDigestive diseases and sciences","type":{"bibl":"periodical","media":"Online-Ressource"},"language":["eng"],"recId":"320525384","pubHistory":["1.1934/35 - 22.1955; N.S. 1.1956 -"],"titleAlt":[{"title":"The American journal of digestive diseases"}],"part":{"pages":"3061-3071","issue":"10","year":"2016","extent":"11","text":"61(2016), 10, Seite 3061-3071","volume":"61"},"origin":[{"publisher":"Springer Science + Business Media B.V. ; Kluwer","dateIssuedKey":"1934","dateIssuedDisp":"1934-","publisherPlace":"Dordrecht ; Dordrecht [u.a.]"}],"id":{"issn":["1573-2568"],"zdb":["2015102-0"],"eki":["320525384"]},"physDesc":[{"extent":"Online-Ressource"}]}],"origin":[{"dateIssuedDisp":"2016","dateIssuedKey":"2016"}],"id":{"doi":["10.1007/s10620-015-3960-x"],"eki":["1565773527"]},"name":{"displayForm":["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"]}} | ||
| SRT | |a PETERSENJOEFFECTIVEN2016 | ||