Peter Buggisch1, Johannes Vermehren2, Stefan Mauss3, Rainer Günther4, Eckart Schott5, Anita Pathil6, Klaus Boeker7, Tim Zimmermann8, Gerlinde Teuber9, Heike-Pfeiffer Vornkahl10, Karl-Georg Simon11, Claus Niederau12, Heiner Wedemeyer13, Stefan Zeuzem14. 1. ifi-institute for Interdisciplinary Medicine, Hamburg, Germany. Electronic address: buggisch@ifi-medizin.de. 2. University Hospital Frankfurt, Frankfurt am Main, Germany. 3. Center for HIV and Hepatogastroenterology, Duesseldorf, Germany. 4. Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany. 5. Charité Campus Virchow-Klinikum (CVK), Berlin, Germany. 6. University Hospital Heidelberg, Heidelberg, Germany. 7. Hepatologische Praxis, Hannover, Germany. 8. University Hospital Mainz, Mainz, Germany. 9. Hepatologische Praxis, Frankfurt, Germany. 10. e.factum GmbH, Butzbach, Germany. 11. Hepatologische Praxis, Leverkusen, Germany. 12. St. Josef-Hospital, Katholisches Klinikum Oberhausen, Oberhausen, Germany. 13. Hannover Medical School, Hannover, Germany. 14. University Hospital Frankfurt, Frankfurt am Main, Germany. Electronic address: Zeuzem@em.uni-frankfurt.de.
Abstract
BACKGROUND & AIMS: Ledipasvir/sofosbuvir (LDV/SOF) for 8 to 24 weeks is approved for the treatment of chronic hepatitis C virus infection (HCV). In the ION-3 study, 8 weeks of LDV/SOF was non-inferior to 12 weeks in previously untreated genotype 1 (GT1) patients without cirrhosis. According to the Summary of Product Characteristics (SmPC), 8-week treatment may be considered in naïve non-cirrhotic GT1-patients. However, there are only limited data on the effectiveness of an 8-week regimen of LDV/SOF under real-world conditions. The aim of the present study was to characterise patients receiving 8 weeks of LDV/SOF compared to those receiving 12 weeks of LDV/SOF, and to describe therapeutic outcomes in routine clinical practice. METHODS: The German Hepatitis C-Registry is a large national real-world cohort that analyses effectiveness and safety of antiviral therapies in chronic HCV. This data set is based on 2,404 patients. Treatment with SOF/LDV (without RBV) for 8 or 12 weeks was initiated on or before September 30, 2015. RESULTS: Overall, 84.6% (2,034/2,404) of the safety population (intention-to-treat-1 [ITT1]) and 98.2% (2,029/2,066) of the per protocol (PP) population achieved sustained virological response at week 12 (SVR12). In the 8-week group, 85.1% (824/968) of ITT1 and 98.3% (821/835) of PP patients achieved SVR12, while in the 12-week group, 85.5% (1,210/1,415) of ITT1, and 98.1% (1,208/1,231) of PP patients achieved SVR12. When treated according to the SmPC, 98.7% (739/749) of the patients achieved SVR12 (PP). Relapse was observed in 9.5% (2/21) of cirrhotic patients treated for 8 weeks (PP). CONCLUSIONS: Under real-world conditions a high proportion of eligible patients receiving 8-week LDV/SOF treatment achieved SVR12. Relapse occurred more frequently in patients who did not meet the selection criteria according to the SmPC. LAY SUMMARY: In a large real-world cohort of patients mainly treated by physicians in private practice in Germany, shorter HCV treatment (8-week) resulted in equivalent cure rates to 12-week treatment in genotype 1 HCV-infected patients. Thus, shorter treatment can be recommended in these patients which would substantially reduce costs of therapy. Clinical Trial number: DRKS00009717 (German Clinical Trials Register, DRKS).
BACKGROUND & AIMS:Ledipasvir/sofosbuvir (LDV/SOF) for 8 to 24 weeks is approved for the treatment of chronic hepatitis C virus infection (HCV). In the ION-3 study, 8 weeks of LDV/SOF was non-inferior to 12 weeks in previously untreated genotype 1 (GT1) patients without cirrhosis. According to the Summary of Product Characteristics (SmPC), 8-week treatment may be considered in naïve non-cirrhotic GT1-patients. However, there are only limited data on the effectiveness of an 8-week regimen of LDV/SOF under real-world conditions. The aim of the present study was to characterise patients receiving 8 weeks of LDV/SOF compared to those receiving 12 weeks of LDV/SOF, and to describe therapeutic outcomes in routine clinical practice. METHODS: The German Hepatitis C-Registry is a large national real-world cohort that analyses effectiveness and safety of antiviral therapies in chronic HCV. This data set is based on 2,404 patients. Treatment with SOF/LDV (without RBV) for 8 or 12 weeks was initiated on or before September 30, 2015. RESULTS: Overall, 84.6% (2,034/2,404) of the safety population (intention-to-treat-1 [ITT1]) and 98.2% (2,029/2,066) of the per protocol (PP) population achieved sustained virological response at week 12 (SVR12). In the 8-week group, 85.1% (824/968) of ITT1 and 98.3% (821/835) of PP patients achieved SVR12, while in the 12-week group, 85.5% (1,210/1,415) of ITT1, and 98.1% (1,208/1,231) of PP patients achieved SVR12. When treated according to the SmPC, 98.7% (739/749) of the patients achieved SVR12 (PP). Relapse was observed in 9.5% (2/21) of cirrhoticpatients treated for 8 weeks (PP). CONCLUSIONS: Under real-world conditions a high proportion of eligible patients receiving 8-week LDV/SOF treatment achieved SVR12. Relapse occurred more frequently in patients who did not meet the selection criteria according to the SmPC. LAY SUMMARY: In a large real-world cohort of patients mainly treated by physicians in private practice in Germany, shorter HCV treatment (8-week) resulted in equivalent cure rates to 12-week treatment in genotype 1 HCV-infectedpatients. Thus, shorter treatment can be recommended in these patients which would substantially reduce costs of therapy. Clinical Trial number: DRKS00009717 (German Clinical Trials Register, DRKS).
Authors: Ashley N Tran; Rishabh Sachdev; Zachary P Fricker; Michael Leber; Toni Zahorian; Bhavesh Shah; David P Nunes; Michelle T Long Journal: Dig Dis Sci Date: 2018-08-04 Impact factor: 3.199
Authors: Peter Buggisch; Karsten Wursthorn; Albrecht Stoehr; Petar K Atanasov; Romain Supiot; Janet Lee; Jie Ting; Joerg Petersen Journal: PLoS One Date: 2019-04-04 Impact factor: 3.240
Authors: Massimo Giuseppe Colombo; Erkin Isakovich Musabaev; Umed Yusupovich Ismailov; Igor A Zaytsev; Alexander V Nersesov; Igor Anatoliyevich Anastasiy; Igor Alexandrovich Karpov; Olga A Golubovska; Kulpash S Kaliaskarova; Ravishankar Ac; Sanjay Hadigal Journal: World J Gastroenterol Date: 2019-08-07 Impact factor: 5.742
Authors: Georg Dultz; Tobias Müller; Jörg Petersen; Stefan Mauss; Tim Zimmermann; Marion Muche; Karl-Georg Simon; Thomas Berg; Stefan Zeuzem; Dietrich Hüppe; Klaus Böker; Heiner Wedemeyer; Tania M Welzel Journal: Drugs Aging Date: 2018-09 Impact factor: 4.271
Authors: Luis M Real; Juan Macías; Ana B Pérez; Dolores Merino; Rafael Granados; Luis Morano; Marcial Delgado; María J Ríos; Carlos Galera; Miguel G Deltoro; Nicolás Merchante; Federico García; Juan A Pineda Journal: Sci Rep Date: 2018-10-08 Impact factor: 4.379