Jörg Petersen1, Renate Heyne2, Stefan Mauss3, Jörg Schlaak4, Willibald Schiffelholz5, Christoph Eisenbach6, Heinz Hartmann7, Manfred Wiese8, Klaus Boeker9, Hanns-Friedrich Loehr10, Christine John11, Maria Leuschner12, Christian Trautwein13, Gisela Felten7, Andreas Trein14, Wolfgang Krause15, Susanne Ruppert16, Tobias Warger16, Dietrich Hueppe7. 1. IFI Institut für Interdisziplinäre Medizin an der Asklepios Klinik St. Georg Haus L, University of Hamburg, Lohmühlenstr 5, 20099, Hamburg, Germany. petersen@ifi-medizin.de. 2. Leberzentrum Checkpoint, Berlin, Germany. 3. Zentrum für HIV und Hepatogastroenterologie, Düsseldorf, Germany. 4. Universitätsklinikum, Essen, Germany. 5. Gastroenterologische Schwerpunktpraxis, Augsburg, Germany. 6. Universitätsklinikum, Heidelberg, Germany. 7. Gastroenterologische Gemeinschaftspraxis, Herne, Germany. 8. Gastroenterologische Gemeinschaftspraxis, Leipzig, Germany. 9. Leberpraxis, Hannover, Germany. 10. Facharztpraxis für Innere Medizin, Wiesbaden, Germany. 11. Facharztpraxis für Innere Medizin, Berlin, Germany. 12. Hepatologische Schwerpunktpraxis, Offenbach, Germany. 13. Universitätsklinikum, Aachen, Germany. 14. Gemeinschaftspraxis, Stuttgart, Germany. 15. Praxis Dr. Krause, Bayreuth, Germany. 16. Gilead Sciences, Martinsried, Germany.
Abstract
BACKGROUND AND AIMS: Multiple 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. METHODS: Prospective German field practice study in CHB-mono-infected patients. Patients were TDF-naïve but could have been treated previously with other HBV antivirals. RESULTS: Efficacy 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. CONCLUSIONS: TDF 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.
BACKGROUND AND AIMS: Multiple 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. METHODS: Prospective German field practice study in CHB-mono-infectedpatients. Patients were TDF-naïve but could have been treated previously with other HBV antivirals. RESULTS: Efficacy 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. CONCLUSIONS: TDF 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.
Authors: S J Patterson; J George; S I Strasser; A U Lee; W Sievert; A J Nicoll; P V Desmond; S K Roberts; S Locarnini; S Bowden; P W Angus Journal: Gut Date: 2010-10-29 Impact factor: 23.059
Authors: Jorg Petersen; Vlad Ratziu; Maria Buti; Harry L A Janssen; Ashley Brown; Pietro Lampertico; Jan Schollmeyer; Fabien Zoulim; Heiner Wedemeyer; Martina Sterneck; Thomas Berg; Christoph Sarrazin; Marc Lutgehetmann; Peter Buggisch Journal: J Hepatol Date: 2011-10-26 Impact factor: 25.083
Authors: Patrick Marcellin; Edward Gane; Maria Buti; Nezam Afdhal; William Sievert; Ira M Jacobson; Mary Kay Washington; George Germanidis; John F Flaherty; Raul Aguilar Schall; Jeffrey D Bornstein; Kathryn M Kitrinos; G Mani Subramanian; John G McHutchison; E Jenny Heathcote Journal: Lancet Date: 2012-12-10 Impact factor: 79.321
Authors: Yun-Fan Liaw; I-Shyan Sheen; Chuan-Mo Lee; Ulus Salih Akarca; George V Papatheodoridis; Florence Suet-Hing Wong; Ting-Tsung Chang; Andrzej Horban; Chia Wang; Peter Kwan; Maria Buti; Martin Prieto; Thomas Berg; Kathryn Kitrinos; Ken Peschell; Elsa Mondou; David Frederick; Franck Rousseau; Eugene R Schiff Journal: Hepatology Date: 2010-10-27 Impact factor: 17.425
Authors: Astrid-Jane Greenup; Pok Kern Tan; Vi Nguyen; Anne Glass; Scott Davison; Ushmi Chatterjee; Susan Holdaway; Dev Samarasinghe; Kathy Jackson; Stephen A Locarnini; Miriam T Levy Journal: J Hepatol Date: 2014-05-05 Impact factor: 25.083
Authors: Kathryn M Kitrinos; Amoreena Corsa; Yang Liu; John Flaherty; Andrea Snow-Lampart; Patrick Marcellin; Katyna Borroto-Esoda; Michael D Miller Journal: Hepatology Date: 2014-02 Impact factor: 17.425
Authors: Mar Riveiro-Barciela; David Tabernero; José L Calleja; Sabela Lens; María L Manzano; Francisco Gea Rodríguez; Javier Crespo; Belén Piqueras; Juan M Pascasio; Carmen Comas; Maria L Gutierrez; Alberto Aguirre; Emilio Suárez; Javier García-Samaniego; Miguel Rivero; Doroteo Acero; Miguel Fernandez-Bermejo; Diego Moreno; Pilar Sánchez-Pobre; Beatriz de Cuenca; J J Moreno-Palomares; Rafael Esteban; Maria Buti Journal: Dig Dis Sci Date: 2017-01-11 Impact factor: 3.199
Authors: Kasha P Singh; Megan Crane; Jennifer Audsley; Anchalee Avihingsanon; Joe Sasadeusz; Sharon R Lewin Journal: AIDS Date: 2017-09-24 Impact factor: 4.177
Authors: Young Eun Chon; Dong Joon Kim; Sang Gyune Kim; In Hee Kim; Si Hyun Bae; Seong Gyu Hwang; Jeong Heo; Jeong Won Jang; Byung Seok Lee; Hyung Joon Kim; Dae Won Jun; Kang Mo Kim; Woo Jin Chung; Moon Seok Choi; Jae Young Jang; Hyung Joon Yim; Won Young Tak; Ki Tae Yoon; Jun Yong Park; Kwang-Hyub Han; Ki Tae Suk; Hyun Woong Lee; Byoung Kuk Jang; Sang Hoon Ahn Journal: Medicine (Baltimore) Date: 2016-04 Impact factor: 1.889
Authors: Hyo Jun Ahn; Myeong Jun Song; Jeong Won Jang; Si Hyun Bae; Jong Young Choi; Seung Kew Yoon Journal: PLoS One Date: 2017-01-23 Impact factor: 3.240
Authors: Pierre Gantner; Laurent Cotte; Clotilde Allavena; Firouzé Bani-Sadr; Thomas Huleux; Claudine Duvivier; Marc-Antoine Valantin; Christine Jacomet; Véronique Joly; Antoine Chéret; Pascal Pugliese; Pierre Delobel; André Cabié; David Rey Journal: PLoS One Date: 2019-04-18 Impact factor: 3.240
Authors: Eleanor Barnes; Philippa C Matthews; Tingyan Wang; David A Smith; Cori Campbell; Jolynne Mokaya; Oliver Freeman; Hizni Salih; Anna L McNaughton; Sarah Cripps; Kinga A Várnai; Theresa Noble; Kerrie Woods; Jane Collier; Katie Jeffery; Jim Davies Journal: BMC Infect Dis Date: 2021-06-26 Impact factor: 3.090