Dutch guidance for the treatment of chronic hepatitis C virus infection in a new therapeutic era

Netherlands Journal of Medicine

Volumn 72, Issue 8, 2014, Pages 388-400

  Berden, F A C ^a   Kievit, W ^b   Baak, L C ^c   Bakker, C M ^d   Beuers, U ^e   Boucher, C A B ^f   Brouwer, J T ^g   Burger, D M ^b   Van Erpecum, K J L ^h   Van Hoek, B ⁱ   Hoepelman, A I M ^h   Honkoop, P ^j   Kerbert Dreteler, M J ^k   De Knegt, R J ^f   Koek, G H ^l   Van Nieuwkerk, C M J ^m   Van Soest, H ⁿ   Tan, A C I T L ^o   Vrolijk, J M ^p   Drenth, J P H ^a  

^a Departments of Gastroenterology and Hepatology   (Netherlands)

^b RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^c ONZE LIEVE VROUWE GASTHUIS   (Netherlands)

^d Sittard Geleen Heerlen   (Netherlands)

^e ACADEMIC MEDICAL CENTER   (Netherlands)

^f ERASMUS MEDICAL CENTER   (Netherlands)

^g REINIER DE GRAAF HOSPITAL   (Netherlands)

^h UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

ⁱ LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^j Albert Schweizer Hospital   (Netherlands)

^k MEDISCH SPECTRUM TWENTE   (Netherlands)

^l MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^m VU UNIVERSITY MEDICAL CENTER   (Netherlands)

ⁿ MEDICAL CENTER HAAGLANDEN   (Netherlands)

^o CANISIUS WILHELMINA HOSPITAL   (Netherlands)

^p RIJNSTATE HOSPITAL   (Netherlands)

more..

Author keywords

Direct acting antivirals; Guidance; Hepatitis C; Sofosbuvir

Indexed keywords

DACLATASVIR; PEGINTERFERON; PEGINTERFERON ALPHA2B PLUS RIBAVIRIN; PLACEBO; SIMEPREVIR; SOFOSBUVIR; ANTIVIRUS AGENT; FUSED HETEROCYCLIC RINGS; PROTEINASE INHIBITOR; SULFONAMIDE; URIDINE PHOSPHATE;

ARTICLE; GENOTYPE; HEPATITIS C; HUMAN; LIVER CIRRHOSIS; LIVER FIBROSIS; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; WATCHFUL WAITING; ANALOGS AND DERIVATIVES; CLINICAL TRIAL (TOPIC); COMPLICATION; GENETICS; HEPATITIS C, CHRONIC;

ANTIVIRAL AGENTS; CLINICAL TRIALS AS TOPIC; GENOTYPE; HEPATITIS C, CHRONIC; HETEROCYCLIC COMPOUNDS, 3-RING; HUMANS; LIVER CIRRHOSIS; PRACTICE GUIDELINES AS TOPIC; PROTEASE INHIBITORS; SULFONAMIDES; URIDINE MONOPHOSPHATE;

EID: 84908108421     PISSN: 03002977     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (61)

1. Marino Z, van Bommel F, Forns X, Berg T. New concepts of sofosbuvirbased treatment regimens in patients with hepatitis C. Gut. 2014;63:207-15.
2. Gevers TJ, Slavenburg S, van Oijen MG, Drenth JP. Treatment extension benefits HCV genotype 1 patients without rapid virological response: a systematic review. Neth J Med 2011;69:216-21.
3. Lamers MH, Broekman MM, Boucher CA, et al. Treatment of hepatitis C monoinfection in adults--Dutch national guidances. Neth J Med. 2013;71:377-85.
4. Hezode C, Fontaine H, Dorival C, et al. Triple therapy in treatmentexperienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC) – NCT 01514890. J Hepatol. 2013;59:434-41.
5. Bichoupan K, Schwartz JM, Martel-Laferriere V, et al. Effect of fibrosis on adverse events in patients with hepatitis C treated with telaprevir. Aliment Pharmacol Ther. 2014;39:209-16.
6. Virlogeux V, Pradat P, Bailly F, et al. Boceprevir and telaprevir-based triple therapy for chronic hepatitis C: virological efficacy and impact on kidney function and model for end-stage liver disease score. J Viral Hepat. 2014;21:e98-e107.
7. Vriend HJ, Op de Coul EL, van de Laar TJ, Urbanus AT, van der Klis FR, Boot HJ. Hepatitis C virus seroprevalence in the Netherlands. Eur J Public Health. 2012;22:819-21.
8. Vriend HJ, Van Veen MG, Prins M, Urbanus AT, Boot HJ, Op De Coul EL. Hepatitis C virus prevalence in The Netherlands: migrants account for most infections. Epidemiol Infect. 2013;141:1310-7.
9. Slavenburg S, Verduyn-Lunel FM, Hermsen JT, Melchers WJ, te Morsche RH, Drenth JP. Prevalence of hepatitis C in the general population in the Netherlands. Neth J Med. 2008;66:13-7
10. de Vries MJ, te Rijdt B, van Nieuwkerk CM. Genotype distribution amongst hepatitis C patients in the Netherlands. Neth J Med. 2006;64:109-13.
11. 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;368:1867-77.
12. www.mdl.nl and www.internisten.nl.
13. Guyatt G, Oxman AD, Akl EA, et al. GRADE guidances: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011;64:383-94.
14. Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013;368:1878-87.
15. 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;381:2100-7.
16. 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;13:401-8.
17. 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.
18. Summary of Product Characteristics Sovaldi EMA. 2014.
19. 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;310:804-11.
20. Sulkowski M, Jacobson I, Ghalib RH, 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. J Hepatol. 2014;60:S4.
21. Lawitz E, Ghalib RH, 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). J Hepatol. 2014;60:S524.
22. Jacobson IM, Ghalib RH, Rodriguez-Torres M, et al. SVR results of a once-daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1 treatment-naive and prior null responder patients: The COSMOS study. Hepatology. 2013;58:1379a-80a.
23. Zeuzem S, Berg T, Gane E, et al. Simeprevir increases rate of sustained virologic response among treatment-experienced patients with HCV genotype-1 infection: a phase IIb trial. Gastroenterology. 2014;146:430-41.
24. Fried MW, Buti M, Dore GJ, et al. Once-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-naive genotype 1 hepatitis C: the randomized PILLAR study. Hepatology. 2013;58:1918-29.
25. Forns X, Lawitz E, Zeuzem S, et al. Simeprevir (tmc435) with peginterferon/ribavirin for treatment of chronic hcv genotype 1 infection in European patients who relapsed after previous interferon-based therapy: the promise trial. J Hepatol. 2014;60:S6.
26. Schneider MD, Sarrazin C. Antiviral therapy of hepatitis C in 2014: do we need resistance testing? Antiviral Res. 2014;105:64-71.
27. 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;370:211-21.
28. 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;383:515-23.
29. Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection. N Engl J Med. 2014;370:1889-98.
30. Afdhal N, Reddy KR, Nelson DR, et al. Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection. N Engl J Med. 2014;370:1483-93.
31. 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;370:1879-88.
32. Everson GT, Sims KD, Rodriguez-Torres M, et al. Efficacy of an interferon- and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection. Gastroenterology. 2014;146:420-9.
33. Lok AS, Gardiner DF, Lawitz E, et al. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med. 2012;366:216-24.
34. Lok AS, Gardiner DF, Hezode C, et al. Randomized trial of daclatasvir and asunaprevir with or without PegIFN/RBV for hepatitis C virus genotype 1 null responders. J Hepatol. 2014;60:490-9.
35. 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;370:222-32.
36. 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;370:1604-14.
37. 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;370:1594-603.
38. 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;370:1973-82.
39. Andriulli A, Mangia A, Iacobellis A, Ippolito A, Leandro G, Zeuzem S. Meta-analysis: the outcome of anti-viral therapy in HCV genotype 2 and genotype 3 infected patients with chronic hepatitis. Aliment Pharmacol Ther. 2008;28:397-404.
40. Slavenburg S, Weggelaar I, van Oijen MG, Drenth JP. Optimal length of antiviral therapy in patients with hepatitis C virus genotypes 2 and 3: a meta-analysis. Antiviral Ther. 2009;14:1139-48.
41. Zeuzem S, Dusheiko GM, Salupere R, et al. Sofosbuvir plus Ribavirin for 12 or 24 Weeks for Patients with HCV Genotype 2 or 3: the VALENCE trial. Hepatology. 2013;58:733a-4a.
42. 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.
43. Lawitz E, Poordad F, Brainard DM, 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(6): 1380a-a.
44. Zeuzem S, Dusheiko GMD, Colombo M, et al. Early viral kinetics do not predict treatment outcome with sofosbuvir + ribavirin for 12 or 24 weeks in HCV genotype 2/3 patients in the VALENCE trial. J Hepatol. 2014;60:S452.
45. Dore GJ, Lawitz E, Hezode C, et al. Twelve- or 16-Week Treatment With Daclatasvir Combined With Peginterferon Alfa and Ribavirin for Hepatitis C Virus Genotype 2 or 3 Infection: Command GT2/3 Study. Hepatology. 2012;56:558a-9a.
46. Gane E, Hyland RH, An D,et al. Sofosbuvir/ledipasvir fixed dose combination is safe and effective in difficult-to-treat populations including genotype-3 patients, decompensated genotype-1 patients, and genotype-1 patients with prior sofosbuvir treatment experience. J Hepatol. 2014;60:S3.
47. 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. J Hepatol. 2014;60:S503.
48. Ruane PJ, Ain D, Riad J, et al. Sofosbuvir plus Ribavirin in the Treatment of Chronic HCV Genotype 4 Infection in Patients of Egyptian Ancestry. Hepatology. 2013;58:736a-a.
49. 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. J Hepatol. 2014;60:S535.
50. Bronowicki JP, Ratziu V, Gadano A, et al. Asunaprevir with Peginterferon-Alfa and Ribavirin in Treatment-Naive Patients with Genotype-1 or-4 Chronic Hepatitis C: Svr24 Results from a Randomized Phase 2b Study (Ai447016). J Hepatol. 2013;58:S571-S2.
51. 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-4a.
52. Hassanein T, Sims K, Bennett M, et al. All-oral therapy with daclatasvir in combination with asunaprevir and bms-791325 for treatment-naive patients with chronic hcv genotype 4 infection J Hepatol. 2014;60:S472.
53. Hezode C, Marcellin P, Pol S, et al. Results from the phase 2 pearl-i study: interferon-free regimens of abt-450/r + abt-267 with or without ribavirin in patients with hcv genotype 4 infection. J Hepatol. 2014;60:S24.
54. Burger D, Back D, Buggisch P, et al. Clinical management of drug-drug interactions in HCV therapy: challenges and solutions. J Hepatol. 2013;58:792-800.
55. http://www.hep-druginteractions.org University of Liverpool.
56. Recommendations for Testing, Managing, and Treating Hepatitis C. 2014; Available from: www.hcvguidances.org.
57. Sarrazin C, Buggisch P, Hinrichsen H, et al. Praxisempfehlung zur Therapie der chronischen Hepatitis C nach Zulassung des Polymerase-Inhibitors Sofosbuvir. Berufsverband Niedergelassener Gastroenterologen Deutschlands e.V.; 2014; Available from: http:// www.gastromed-bng.de/tl_files/Aerzte%20News/140128-EmpfehlungTherapieHCVnachZulassungSofosbuvir.pdf.
58. Sarrazin C, Berg T, Wedemeyer H, et al. Aktuelle Empfehlung der DGVS zur Therapie der chronischen Hepatitis C. 2014.
59. Pawlotsky JM, Aghemo A, Dusheiko G, Forns X, Puoti M, Sarrazin C. EASL Recommendations on Treatment of Hepatitis C 2014.
60. Drenth JP. HCV treatment--no more room for interferonologists? N Engl J Med. 2013;368:1931-2.
61. Helsper CW, Hellinga HL, van Essen GA, et al. Real-life costs of hepatitis C treatment. N Engl J Med. 2012;70:145-53.