Gemeinsame Stellungnahme der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) und der Deutschen Gesellschaft für Innere Medizin (DGIM) zur Ombitasvir / Paritaprevir / Ritonavir und Dasabuvir -Nutzenbewertung gemäß § 35a SGB V des G-BA

Prof. Dr. Christoph Sarrazin, Frankfurt

Prof. Dr. Stefan Zeuzem, Frankfurt

Prof. Dr. Michael P. Manns, Hannover

• Literaturverzeichnis

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• 2 Wedemeyer H, Duberg AS, Buti M et al. Strategies to manage hepatitis C virus (HCV) disease burden. J Viral Hepat 2014; 21: 60-89
• 3 Sarrazin C, Berg T, Buggisch P et al. Aktuelle Empfehlung zur Therapie der chronischen Hepatitis C. S3 Guideline Hepatitis C Addendum. Z Gastroenterol 2015; 53: 320-334
• 4 Lawitz E, Flamm S, Yang J et al. Retreatment of patients who failed 8 or 12 weeks of ledipasvir / sofosbuvir-based regimens with ledipasvir / sofosbuvir for 24 weeks. Journal of Hepatology 2015; 62: S192
• 5 Feld JJ, Kowdley KV, Coakley E et al. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 2014; 370: 1594-1603
• 6 Ferenci P, Bernstein D, Lalezari J et al. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med 2014; 370: 1983-1992
• 7 Andreone P, Colombo MG, Enejosa JV et al. ABT-450, Ritonavir, Ombitasvir, and Dasabuvir Achieves 97 % and 100 % Sustained Virologic Response With or Without Ribavirin in Treatment-Experienced Patients With HCV Genotype 1b Infection. Gastroenterology 2014; 147: 359-+
• 8 Conway B, Janczewska E, Luo Y et al. Malachite-I: Phase 3b trial of ombitasvir / paritaprevir / r and dasabuvir +/- ribavirin or telaprevir + peginterferon / ribavirin in treatment-naive adults with HCV genotype 1. J Hepatol 2015; 62: S653-S654
• 9 Jezequel C, Bardou-Jacquet E, Desille Y et al. Survival of patients infected by chronic hepatitis C and F0F1 fibrosis at baseline after a 15 years follow-up. J Hepatol 2015; 62: S589
• 10 Zeuzem S, Jacobson IM, Baykal T et al. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 2014; 370: 1604-1614
• 11 Dore GJ, Knysz B, Luo Y et al. Malachite-II: Phase 3b trial of ombitasvir / paritaprevir / r and dasabuvir + ribavirin or telaprevir + peginterferon / ribavirin in peginterferon / ribavirin treatment-experienced adults with HCV genotype 1. J Hepatol 2015; 62: S656-S657
• 12 Zeuzem S, Andreone P, Pol S et al. Telaprevir for retreatment of HCV infection. New England Journal of Medicine 2011; 364: 2417-2428
• 13 Bacon BR, Gordon SC, Lawitz E et al. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med 2011; 364: 1207-1217
• 14 Vierling JM, Zeuzem S, Poordad F et al. Safety and efficacy of boceprevir / peginterferon / ribavirin for HCV G1 compensated cirrhotics: meta-analysis of 5 trials. J Hepatol 2014; 61: 200-209
• 15 Jensen DM, Marcellin P, Freilich B et al. Re-treatment of patients with chronic hepatitis C who do not respond to peginterferon-alpha2b: a randomized trial. Ann Intern Med 2009; 150: 528-540
• 16 Poynard T, Colombo M, Bruix J et al. Peginterferon alfa-2b and ribavirin: effective in patients with hepatitis C who failed interferon alfa / ribavirin therapy. Gastroenterology 2009; 136: 1618-1628
• 17 Flamm SL, Lawitz E, Jacobson I et al. Boceprevir with peginterferon alfa-2a-ribavirin is effective for previously treated chronic hepatitis C genotype 1 infection. Clin Gastroenterol Hepatol 2013; 11: 81-87
• 18 Hezode C, Fontaine H, Dorival C et al. Effectiveness of telaprevir or boceprevir in treatment-experienced patients with HCV genotype 1 infection and cirrhosis. Gastroenterology 2014; 147: 132-142
• 19 Jacobson IM, McHutchison JG, Dusheiko G et al. Telaprevir for previously untreated chronic hepatitis C virus infection. New England Journal of Medicine 2011; 364: 2405-2416
• 20 Bruno S, Vierling JM, Esteban R et al. Efficacy and safety of boceprevir plus peginterferon-ribavirin in patients with HCV G1 infection and advanced fibrosis / cirrhosis. J Hepatol 2013; 58: 479-487
• 21 Van der Meer AJ, Wedemeyer H, Feld J et al. Life expectancy in patients with chronic HCV infection and cirrhosis compared with a general population. JAMA 2014; 312: 1927-1928
• 22 Kwo PY, Mantry PS, Coakley E et al. An interferon-free antiviral regimen for HCV after liver transplantation. N Engl J Med 2014; 371: 2375-2382
• 23 Coilly A, Roche B, Duclos-Vallee JC et al. Management of HCV transplant patients with triple therapy. Liver Int 2014; 34: 46-52
• 24 Hezode C, Asselah T, Reddy KR et al. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet 2015;
• 25 Asselah T, Hassanein T, Qaqish RB et al. A randomized open-label study to evaluate efficacy and safety of ombitasvir / paritaprevir / ritonavir co-administered with ribavirin in adults with genotype 4 chronic hepatitis C infection and cirrhosis. J Hepatol 2015; 62: S861