Gastroenterologie up2date, Table of Contents Gastroenterologie up2date 2014; 10(02): 95-112DOI: 10.1055/s-0034-1365717 Leber/Galle/Pankreas © Georg Thieme Verlag KG Stuttgart · New YorkTherapien bei Hepatitis C Maximilian David Schneider , Christoph SarrazinRecommend Article Abstract Buy Article All articles of this category Full Text References Literatur 1 Poethko-Muller C, Zimmermann R, Hamouda O et al. [Epidemiology of hepatitis A, B, and C among adults in Germany: results of the German Health Interview and Examination Survey for Adults (DEGS1)]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2013; 56: 707-715 2 Thierfelder W, Hellenbrand W, Meisel H et al. Prevalence of markers for hepatitis A, B and C in the German population. Results of the German National Health Interview and Examination Survey 1998. Eur J Epidemiol 2001; 17: 429-435 3 Wiese M, Fischer J, Lobermann M et al. Evaluation of liver disease progression in the German hepatitis C virus (1b)-contaminated anti-D cohort at 35 years after infection. Hepatology 2014; 59: 49-57 4 Choo QL, Kuo G, Weiner AJ et al. Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome. Science 1989; 244: 359-362 5 Hoofnagle JH, Mullen KD, Jones DB et al. Treatment of chronic non-A,non-B hepatitis with recombinant human alpha interferon. A preliminary report. N Engl J Med 1986; 315: 1575-1578 6 Poynard T, Marcellin P, Lee SS et al. Randomised trial of interferon alpha2b plus ribavirin for 48 weeks or for 24 weeks versus interferon alpha2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus. International Hepatitis Interventional Therapy Group (IHIT). Lancet 1998; 352: 1426-1432 7 Manns MP, McHutchison JG, Gordon SC et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001; 358: 958-965 8 Vermehren J, Sarrazin C. The role of resistance in HCV treatment. Best Pract Res Clin Gastroenterol 2012; 26: 487-503 9 Martinot-Peignoux M, Stern C, Maylin S et al. Twelve weeks posttreatment follow-up is as relevant as 24 weeks to determine the sustained virologic response in patients with hepatitis C virus receiving pegylated interferon and ribavirin. Hepatology 2010; 51: 1122-1126 10 Lam AM, Murakami E, Espiritu C et al. PSI-7851, a pronucleotide of beta-D-2’-Deoxy-2’-Fluoro-2’-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis C virus replication. Antimicrob Agents Chemother 2010; 54: 3187-3196 11 Lawitz E, Mangia A, Wyles D et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013; 368: 1878-1887 12 Lawitz E, Lalezari JP, Hassanein T et al. Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trial. Lancet Infect Dis 2013; 13: 401-408 13 Lawitz E, Poordad F, Brainard D et al. Sofosbuvir in combination with PegIFN and ribavirin for 12 weeks provides high SVR rates in HCV-infected genotype 2 or 3 treatment-experienced patients with and without compensated cirrhosis: results from the LONESTAR-2 study. Hepatology 2013; 58: 1380A 14 Jacobson IM, Gordon SC, Kowdley KV et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med 2013; 368: 1867-1877 15 Zeuzem S, Dusheiko G, Salupere R et al. Sofosbuvir + ribavirin for 12 or 24 weeks for patients with HCV genotype 2 or 3: the VALENCE trial. Hepatology 2013; 58: 733A 16 Lalezari J, Nelson D, Hyland R et al. Once-daily sofosbuvir plus ribavirin given for 12 or 24 weeks in treatment-naïve patients with HCV infection: the QUANTUM Study. J Hepatol 2013; 58: S346 17 Gane EJ, Stedman CA, Hyland RH et al. Once daily sofosbuvir (GS-7977) plus ribavirin in patients with HCV genotypes 1, 2, and 3: The ELECTRON trial. Hepatology 2012; 56: 306A-307A 18 Gilead Sciences International Ltd. Fachinformation Sovaldi (Sofosbuvir). http://www.ema.europa.eu/docs/de_DE/document_library/EPAR_-_Product_Information/human/002798/WC500160597.pdf 19 Lenz O, Vijgen L, Berke JM et al. Virologic response and characterisation of HCV genotype 2-6 in patients receiving TMC435 monotherapy (study TMC435-C202). J Hepatol 2013; 58: 445-451 20 Jacobson I, Dore GJ, Foster GR et al. Simeprevir (TMC435) with peginterferon/ribavirin for chronic HCV genotype 1 infection in treatment-naïve patients: results from QUEST-1, a phase III trial. J Hepatol 2013; 58: 574-S574 21 Manns M, Marcellin P, Poordad FPF et al. Simeprevir (TMC435) with peginterferon-α2a or -α2b and ribavirin in treatment-naïve HCV genotype 1 patients: QUEST-2, a randomised Phase III trial. J Hepatol 2013; 58: 568-568 22 Forns X, Lawitz E, Zeuzem S et al. Simeprevir (TMC435) with peg-interferon alpha-2a/ribavirin for treatment of chronic HCV genotype 1 infection in patients who relapsed after previous interferon-based therapy: efficacy and safety in patient sub-populations in the PROMISE phase III trial. Hepatology 2013; 58: 737A-737A S1 23 Moreno C, Hezode C, Marcellin P et al. Simeprevir with peginterferon/ribavirin in treatment-naïve or experienced patients with chronic HCV genotype 4 infection: Interim results of a phase III trial. 14th European AIDS conference Brussels Belgium Oct 16–19, 2013; Brussels, Belgium 24 Lenz O, Fevery B, Verbinnen T et al. Resistance analyses of HCV isolates from patients treated with simeprevir in phase IIB/III studies. Hepatology 2013; 58: 743A 25 Janssen Therapeutics. OLYSIO (simeprevir) prescribing information. http://www.olysio.com/shared/product/olysio/prescribing-information.pdf 26 White PW, Llinas-Brunet M, Amad M et al. Preclinical characterization of BI 201335, a C-terminal carboxylic acid inhibitor of the hepatitis C virus NS3-NS4A protease. Antimicrob Agents Chemother 2010; 54: 4611-4618 27 Jensen D, Asselah T, Dieterich D et al. A pooled analysis of two randomized, double-blind placebo-controlled phase III trials (STARTVerso1&2) of faldaprevir plus pegylated interferon alfa-2a and ribavirin in treatment-naïve patients with chronic hepatitis C genotype-1 infection. Hepatology 2013; 58: 734A-735A 28 Jacobson I, Asselah T, Ferenci P et al. STARTVerso3: A randomized, double-blind, placebo-controlled phase III trial of faldaprevir in combination with pegylated interferon alfa-2a and ribavirin in treatment-experienced patients with chronic hepatitis C genotype-1 infection. Hepatology 2013; 58: 742A 29 Sane R, Podila L, Mathur A et al. Mechanisms of isolated unconjugated hyperbilirubinaemia induced by the HCV NS3/4A protease inhibitor BI 201335. J Hepatol 2011; 54: 488 30 Berger K, Bethell R, Cartier M et al. Analysis of baseline polymorphisms and persistence of emergent variants from phase Ib and II trials evaluating the HCV NS3 protease inhibitor BI 201335. Hepatology 2012; 56: 574A-574A 31 Sabo JP, Kashuba AD, Ballow CH et al. Cytochrome P450 (CYP) Interactions with the HCV protease inhibitor BI 201335 in healthy volunteers. Abstracts of the Interscience Conference on Antimicrobial Agents and Chemotherapy 2012; 52: A1248 32 Pawlotsky JM. NS5A inhibitors in the treatment of hepatitis C. J Hepatol 2013; 59: 375-382 33 Hezode C, Hirschfield GM, Ghesquiere W et al. Daclatasvir, an NS5A replication complex inhibitor, combined with peginterferon alfa-2a and ribavirin in treatment-naive HCV-genotype 1 or 4 subjects: phase 2b COMMAND-1 SVR12 results. Hepatology 2012; 56: 553A-554A 34 Dore GJ, Lawitz E, Hezode C et al. Daclatasvir combined with peginterferon alfa-2a and ribavirin for 12 or 16 weeks in patients with hepatitis C virus genotype 2 or 3 infection: COMMAND GT2/3 study. J Hepatol 2013; 58: 570-571 35 Lok AS, Gardiner DF, Lawitz E et al. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med 2012; 366: 216-224 36 McPhee F, Toyota J, Chayama K et al. Analysis of HCV resistance variants in a phase 3 trial of daclatasvir combined with asunaprevir for Japanese patients with genotype 1b infection. Hepatology 2013; 58: 749A 37 Karino Y, Toyota J, Ikeda K et al. Characterization of virologic escape in hepatitis C virus genotype 1b patients treated with the direct-acting antivirals daclatasvir and asunaprevir. J Hepatol 2013; 58: 646-654 38 Bifano M, Adamczyk R, Hwang C et al. Daclatasvir pharmacokinetics in healthy subjects: no clinically-relevant drug-drug interactions with either cyclosporine or tacrolimus. Hepatology 2013; 58: 730A-731A 39 Bifano M, Hwang C, Oosterhuis B et al. Assessment of pharmacokinetic interactions of the HCV NS5A replication complex inhibitor daclatasvir with antiretroviral agents: ritonavir-boosted atazanavir, efavirenz and tenofovir. Antivir Ther 2013; 18: 931-940 40 Jacobson I, Ghalib R, Rodriguez-Torres M et al. SVR results of a once-daily regimen of simeprevir (SMV, TMC435) plus sofosbuvir (SOF, GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1 treatment-naïve and prior null responder patients: The COSMOS study. Hepatology 2013; 58: 1379A-1380A 41 Sulkowski MS, Gardiner DF, Rodriguez-Torres M et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med 2014; 370: 211-221 42 Gane EJ, Stedman CA, Hyland RH et al. All-oral sofosbuvir-based 12-week regimens for the treatment of chronic HCV infection: The ELECTRON study. Journal of Hepatology 2013; 58: 6-7 43 Cheng G, Peng B, Corsa A et al. Antiviral activity and resistance profile of the novel HCV NS5A inhibitor GS-5885. J Hepatol 2012; 56: 464-464 44 Lawitz E, Poordad FF, Pang PS et al. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet 2014; 383: 515-523 45 Zeuzem S, Hezode C, Bronowicki JP et al. Daclatasvir in combination with simeprevir with or without ribavirin for hepatitis C virus genotype 1 infection. Conference on Retroviruses and Opportunistic Infections Boston, MA March 3–6, 2014 46 Zeuzem S, Soriano V, Asselah T et al. Faldaprevir and deleobuvir for HCV genotype 1 infection. N Engl J Med 2013; 369: 630-639 47 Kowdley KV, Lawitz E, Poordad F et al. Phase 2b trial of interferon-free therapy for hepatitis C virus genotype 1. N Engl J Med 2014; 370: 222-232 48 Sarrazin C, Berg T, Wedemeyer H et al. Aktuelle Empfehlung der DGVS zur Therapie der chronischen Hepatitis C. Deutsche Gesellschaft für Verdauungs- und Stoffwechselkrankheiten (DGVS) 2014; 49 Gane EJ, Stedman CA, Hyland RH et al. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med 2013; 368: 34-44 50 Curry MP, Forns X, Chung RT et al. Pretransplant Sofosbuvir and Ribavirin to prevent recurrence of HCV infection after liver transplantation. Hepatology 2013; 58: 314A-315A 51 Forns X, Fontana RJ, Moonka D et al. Initial evaluation of the sofosbuvir compassionate use program for patients with severe recurrent HCV following liver transplantation. Hepatology 2013; 58: 732A-733A 52 Kirby B, Mathias A, Rossi S et al. No clinically significant pharmacokinetic drug interactions between sofosbuvir (GS-7977) and HIV antiretrovirals atripla (R), rilpivirine, darunavir/ritonavir, or raltegravir in healthy volunteers. Hepatology 2012; 56: 1067A-1067A 53 Naggie S, Sulkowski M, Lalezari J et al. All-oral therapy with sofosbuvir plus ribavirin for the treatment of HCV genotype 1, 2, and 3 infection in patients co-infected with HIV (PHOTON-1). 21st Conference on Retroviruses and Opportunistic Infections, Boston, MA March 3–6, 2014 54 Ouwerkerk-Mahadevan S, Sekar V, Peeters M et al. The pharmokinetic interactions of HCV protease inhibitor TMC435 with RPV, TDF, EFV, or RAL in healthy volunteers. IDSA Conference (Infectious Disease Society Association), San Diego, CA Oct 17–21, 2012 55 AASLD, American Association for the Study of Liver Dieseases. Recommendations for Testing, Managing, and Treating Hepatitis C. 2014