Aktuelle Empfehlung zur Therapie der chronischen Hepatitis C

C. Sarrazin; T. Berg; P. Buggisch; M. M. Dollinger; H. Hinrichsen; H. Hofer; D. Hüppe; M. P. Manns; S. Mauss; J. Petersen; K.-G. Simon; I. van Thiel; H. Wedemeyer; S. Zeuzem

doi:10.1055/s-0034-1399322

Zeitschrift für Gastroenterologie, Inhaltsverzeichnis

Z Gastroenterol 2015; 53(04): 320-334
DOI: 10.1055/s-0034-1399322

Übersicht

Aktuelle Empfehlung zur Therapie der chronischen Hepatitis C^[1]

S3 guideline hepatitis C addendum

C. Sarrazin

¹Med. Klinik 1, Universitätsklinikum Frankfurt, Frankfurt am Main, Germany

,

T. Berg

²Klinik und Poliklinik für, Universitätsklinikum Leipzig, Leipzig, Germany

,

P. Buggisch

³Leberzentrum Hamburg, Institut für Interdisziplinäre Medizin, IFI, Hamburg, Germany

,

M. M. Dollinger

⁴Innere Medizin I, Universitätsklinik Ulm, Germany

,

H. Hinrichsen

⁵Gastroenterologisch-Hepatologisches Zentrum Kiel, Germany

,

H. Hofer

⁶Division of Gastroenterology and Hepatology Medical University of Vienna, Wien, Austria

,

D. Hüppe

⁷Gastroenterologische Gemeinschaftspraxis Herne, Germany

,

M. P. Manns

⁸Medizinische Hochschule Hannover, Germany

,

S. Mauss

⁹Center for HIV and Hepatogastroenterology, Düsseldorf, Germany

,

J. Petersen

³Leberzentrum Hamburg, Institut für Interdisziplinäre Medizin, IFI, Hamburg, Germany

,

K.-G. Simon

¹⁰MVZ für Gastroenterologie und Hepatologie, Leverkusen, Germany

,

I. van Thiel

¹¹Deutsche Leberhilfe e.V., Köln, Germany

,

H. Wedemeyer

⁸Medizinische Hochschule Hannover, Germany

,

S. Zeuzem

¹Med. Klinik 1, Universitätsklinikum Frankfurt, Frankfurt am Main, Germany

Literatur
1 Afdhal N, Zeuzem S, Kwo P et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med 2014; 370: 1889-1898
2 Bourliere M, Sulkowski MS, Omata M et al. An Integrated Safety and Efficacy Analysis of > 500 Patients with Compensated Cirrhosis Treated with Ledipasvir/Sofosbuvir with or without Ribavirin. Hepatology 2014; 60: 239A
3 Kowdley KV, Gordon SC, Reddy KR et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med 2014; 370: 1879-1888
4 Afdhal N, Reddy KR, Nelson DR et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med 2014; 370: 1483-1493
5 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
6 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: 1594-16031
7 Poordad F, Hezode C, Trinh R et al. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med 2014; 370: 1973-1982
8 Everson GT, Dusheiko G, Coakley E et al. Integrated Efficacy Analysis of Four Phase 3 Studies in HCV Genotype 1a-Infected Patients Treated with ABT450/r/Ombitasvir and Dasabuvir With or Without Ribavirin. Hepatology 2014; 60: 239a-240a
9 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
10 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: 359-365
11 Lawitz E, Sulkowski MS, Ghalib R et al. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Lancet 2014; 384: 1756-1765
12 Dieterich D, Bacon BR, Flamm SL et al. Evaluation of sofosbuvir and simeprevir-based regimens in the TRIO network: academic and community treatment of a real-world, heterogeneous population. Hepatology 2014; 60: 220a-220a
13 Jensen DM, O'Leary JG, Pockros PJ et al. Safety and Efficacy of Sofosbuvir-Containing Regimens for Hepatitis C. Real-World Experience in a Diverse, Longitudinal Observational Cohort. Hepatology 2014; 60: 219a-220a
14 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
15 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
16 Osinusi A, Meissner EG, Lee YJ et al. Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial. JAMA 2013; 310: 804-811
17 Lalezari JP, Nelson DR, Hyland RH et al. Once Daily Sofosbuvir Plus Ribavirin for 12 and 24 Weeks in Treatment-Naive Patients with Hcv Infection: the Quantum Study. Journal of Hepatology 2013; 58: S346-S346
18 Zeuzem S, Hezode C, Bronowicki JP et al. Daclatasvir in combination with simeprevir with or without ribavirin for hepatitis C virus genotype 1 infection. 21st Conferences on Retroviruses and Opportunistic Infections; 2014
19 Lawitz E, Mangia A, Wyles D et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013; 368: 1878-1887
20 Kowdley KV, Lawitz E, Crespo I et al. Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial. Lancet 2013; 381: 2100-2107
21 Pol S, Sulkowski M, Hassanein T et al. Successful retreatment with sofosbuvir of HCV genotype-1 infected patients who failed prior therapy with peginterferon and ribavirin plus 1 or 2 additional direct-acting antiviral agents. Journal of Hepatology 2014; 60: S23-S23
22 Lawitz E, Poordad F, Brainard D et al. Sofosbuvir in combination with PEG-IFN 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: LB-4
23 Forns X, Lawitz E, Zeuzem S et al. Simeprevir With Peginterferon and Ribavirin Leads to High Rates of SVR in Patients With HCV Genotype 1 Who Relapsed After Previous Therapy: A Phase 3 Trial. Gastroenterology 2014; 146: 1669-1679
24 Manns M, Marcellin P, Poordad F et al. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2014; 384: 414-426
25 Jacobson IM, Dore GJ, Foster GR et al. Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet 2014; 384: 403-413
26 Vermehren J, Aghemo A, Falconer K et al. Clinical significance of residual viremia detected by two real-time PCR assays for response-guided therapy of HCV genotype 1 infection. J Hepatol 2014; 60: 913-919
27 Reddy K, Zeuzem S, zoulim F et al. A Phase III randomised, double-blind study to evaluate the efficacy, safety and tolerability of simeprevir vs telaprevir in combination with pegylated interferon and ribavirin in chronic hepatitis C virus genotype 1 treatment-experienced patients: the ATTAIN study. Hepatol Int 2014; 8: S397
28 Hezode C, Hirschfield GM, Ghesquiere W et al. Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study. Gut 2014; epub ahead of print
29 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
30 Poordad F, McCone Jr J, Bacon BR et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011; 364: 1195-1206
31 Sarrazin C, Schwendy S, Möller B et al. Improved responses to pegylated interferon alfa-2b and ribavirin by individualizing treatment for 24-72 weeks. Gastroenterology 2011; 141: 1656-1664
32 Sarrazin C, Berg T, Ross RS et al. Update der S3-Leitlinie Prophylaxe, Diagnose und Therapie der Hepatitis C Virus (HCV) Infektion. Z Gastroenterol 2010; 48: 289-351
33 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
34 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
35 Zeuzem S, Dusheiko GM, Salupere R et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med 2014; 370: 1993-2001
36 Nelson DR, Cooper JN, Lalezari JP et al. All-Oral 12-Week Treatment With Daclatasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 3 Infection: ALLY-3 Phase 3 Study. Hepatology 2015; epub ahead of print
37 Link JO, Taylor JG, Xu LH et al. Discovery of Ledipasvir (GS-5885): A Potent, Once-Daily Oral NS5A Inhibitor for the Treatment of Hepatitis C Virus Infection. Journal of Medicinal Chemistry 2014; 57: 2033-2046
38 Cheng G, Peng B, Corsa A et al. Antiviral Activity and Resistance Profile of the Novel Hcv Ns5a Inhibitor Gs-5885. Journal of Hepatology 2012; 56: S464-S464
39 Gane EJ, Hyland RH, An D et al. High Efficacy of LDV/SOF Regimens for 12 Weeks for Patients with HCV Genotype 3 or 6 Infection. Hepatology 2014; 60: 1274a-1275a
40 Kapoor R, Kohli A, Sidharthan S et al. All Oral Treatment for Genotype 4 Chronic Hepatitis C Infection with Sofosbuvir and Ledipasvir: Interim Results from the NIAID SYNERGY Trial. Hepatology 2014; 60: 321a-321a
41 Pol S, Reddy KR, Baykal T et al. Interferon-Free Regimens of Ombitasvir and ABT-450/r With or Without Ribavirin in Patients With HCV Genotype 4 Infection: PEARL-I Study Results. Hepatology 2014; 60: 1129a-1130a
42 Moreno C, Hezode C, Marcellin P et al. Once-daily simeprevir (TMC435) with peginterferon/ribavirin in treatment-naive or treatment-experienced chronic HCV genotype 4-infected patients: final results of a phase III trial. Journal of Hepatology 2014; 60: S535-S535
43 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
44 Ruane PJ, Ain D, Meshrekey R et al. Sofosbuvir plus ribavirin, an interferon-free regimen, in the treatment of treatment-naive and treatment-experienced patients with chronic genotype 4 HCV infection. Journal of Hepatology 2014; 60: S503-S504
45 Sulkowski MS, Rodriguez-Torres 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). Hepatology 2013; 58: 313A
46 Townsend KS, Osinusi A, Nelson AK et al. High Efficacy of Sofosbuvir/Ledipasvir for the Treatment of HCV Genotype 1 in Patients Coinfected With HIV on or off Antiretroviral therapy: Results from The NIAID ERADICATE Trial. Hepatology 2014; 60: 240a-241a
47 Wyles DL, Sulkowski MS, Eron JJ et al. TURQUOISE-I: 94% SVR12 in HCV/HIV-1 Coinfected Patients Treated with ABT-450/r/Ombitasvir, Dasabuvir and Ribavirin. Hepatology 2014; 60: 1136a-1137a
48 Rodriguez-Torres M, Rodriguez-Orengo J, Gaggar A et al. Sofosbuvir and peginterferon alfa-2a/ribavirin for treatment-naive genotype 1-4 HCV-infected patients who are coinfected with HIV. Infectious Disease Week; 2014 2014A
49 Reddy KR, Everson GT, Flamm SL et al. Ledipasvir/Sofosbuvir with Ribavirin for the Treatment of HCV in Patients with Post Transplant Recurrence: Preliminary Results of a Prospective, Multicenter Study. Hepatology 2014; 60: 200a-201a
50 Flamm SL, Everson GT, Charlton M et al. Ledipasvir/Sofosbuvir with Ribavirin for the Treatment of HCV in Patients with Decompensated Cirrhosis: Preliminary Results of a Prospective, Multicenter Study. Hepatology 2014; 60: 320a-321a
51 Mantry PS, Kwo PY, Coakley E et al. High Sustained Virologic Response Rates in Liver Transplant Recipients With Recurrent HCV Genotype 1 Infection Receiving ABT-450/r/Ombitasvir plus Dasabuvir Plus Ribavirin. Hepatology 2014; 60: 298a-299a
52 Curry MP, Forns X, Chung RT et al. Sofosbuvir and Ribavirin Prevent Recurrence of HCV Infection After Liver Transplantation: An Open-Label Study. Gastroenterology 2015; 148: 100-U519
53 Lawitz E, Ghalib R, Rodriguez-Torres M et al. Simeprevir plus sofosbuvir with/without ribavirin in HCV genotype 1 prior null-responder/treatment-naive patients (Cosmos study): primary endpoint (SVR12) results in patients with metavir F3-4 (Cohort 2). Journal of Hepatology 2014; 60: S524-S524
54 Sulkowski M, Jacobson IM, Ghalib R et al. Once-daily simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in HCV genotype 1 prior null responders with metavir F0-2: Cosmos study subgroup analysis. Journal of Hepatology 2014; 60: S4-S4
55 Charlton M, Gane E, Manns MP et al. Sofosbuvir and ribavirin for the treatment of established recurrent hepatitis C infeciton after liver transplantation: preliminary results of a prospective, multicenter study. Hepatology 2013; 58: LB-2
56 Pellicelli AM, Montalbano M, Lionetti R et al. Sofosbuvir plus daclatasvir for post-transplant recurrent hepatitis C: Potent antiviral activity but no clinical benefit if treatment is given late. Dig Liver Dis 2014; 46: 923-927
57 Donaldson EF, Harrington PR, O'Rear JJ et al. Clinical evidence and bioinformatics characterization of potential hepatitis C virus resistance pathways for sofosbuvir. Hepatology 2015; 61: 56-65
58 Manns M, Pol S, Jacobson IM et al. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet 2014; 384: 1597-1605
59 Krishnan P, Tripathi R, Schnell G et al. Pooled analysis of resistance in patients treated with ombitasvir/ABT-450/r and dasabuvir with or without ribavirin in Phase 2 and Phase 3 clinical trials. Hepatology 2014; 60: 1134a-1135a
60 Sarrazin C, Dvory-Sobol H, Svarovskaia ES et al. Baseline and Post-baseline Resistance Analyses of Phase 2/3 Studies of Ledipasvir/Sofosbuvir ± RBV. Hepatology 2014; 60: 1128a-1128a
61 Lenz O, Verbinnen T, Fevery B et al. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol 2014; epub ahead of print
62 Sullivan JC, De Meyer S, Bartels DJ et al. Evolution of treatment-emergent resistant variants in telaprevir phase 3 clinical trials. Journal of Hepatology 2011; 54 (Suppl. 01) S4-S4
63 Reddy KR, Pol S, Thuluvath PJ et al. Long-term follow-up of patients treated with daclatasvir-based regimens in phase 2 and 3 studies. Hepatology 2014; 60: 1154a-1155a
64 Howe AY, Long JM, Thompson S et al. Analysis of the Durability of Response and Persistance of Resistance Associated Variants during Long Term Follow Up after Boceprevir plus Pegylated Interferon/Ribavirin Therapy-3 Year Analysis. Hepatology 2013; 58: 1095a-1095a
65 Svarovskaia ES, Dvory-Sobol H, Parkin N et al. Infrequent Development of Resistance in Genotype 1-6 Hepatitis C Virus-Infected Subjects Treated With Sofosbuvir in Phase 2 and 3 Clinical Trials. Clinical Infectious Diseases 2014; 59: 1666-1674
66 Bourliere M, Bronowicki JP, de Ledinghen V et al. Ledipasvir/Sofosbuvir Fixed Dose Combination is Safe and Efficacious in Cirrhotic Patients Who Have Previously Failed Protease-Inhibitor Based Triple Therapy. Hepatology 2014; 60: 1270a-1271a

Aktuelle Empfehlung zur Therapie der chronischen Hepatitis C[1]

Aktuelle Empfehlung zur Therapie der chronischen Hepatitis C^[1]