Grazoprevir and elbasvir plus ribavirin for chronic HCV genotype-1 infection after failure of combination therapy containing a direct-acting antiviral agent

Journal of Hepatology

Volumn 63, Issue 3, 2015, Pages 564-572

  Forns, Xavier ^a   Gordon, Stuart C ^b   Zuckerman, Eli ^c   Lawitz, Eric ^d   Calleja, Jose L ^e   Hofer, Harald ^f   Gilbert, Christopher ^g   Palcza, John ^g   Howe, Anita Y M ^g   Dinubile, Mark J ^g   Robertson, Michael N ^g   Wahl, Janice ^g   Barr, Eliav ^g   Buti, Maria ^h  

^a INSTITUT D INVESTIGACIONS BIOMÈDIQUES AUGUST PI I SUNYER IDIBAPS   (Spain)

^b HENRY FORD HEALTH SYSTEM   (United States)

^c CARMEL MEDICAL CENTER   (Israel)

^d UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^e HOSPITAL UNIVERSITARIO PUERTA DE HIERRO   (Spain)

^f MEDICAL UNIVERSITY OF VIENNA   (Austria)

^g MERCK RESEARCH LABORATORIES   (United States)

^h HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

Author keywords

C SALVAGE; Direct acting antiviral agents; Elbasvir; Grazoprevir; HCV genotype 1

Indexed keywords

ANTIVIRUS AGENT; BOCEPREVIR; ELBASVIR; GRAZOPREVIR; HEMOGLOBIN; PEGINTERFERON; RIBAVIRIN; SIMEPREVIR; SOFOSBUVIR; TELAPREVIR; VIRUS RNA; 2-(PYRROLIDIN-2-YL)-5-(2-(4-(5-(PYRROLIDIN-2-YL)-1H-IMIDAZOL-2-YL)PHENYL)BENZOFURAN-5-YL)-1H-IMIDAZOLE; BENZOFURAN DERIVATIVE; IMIDAZOLE DERIVATIVE; MK-5172; QUINOXALINE DERIVATIVE;

ABNORMAL LABORATORY RESULT; ADULT; AGED; ANEMIA; ARTICLE; ASTHENIA; CHRONIC HEPATITIS C; COMBINATION CHEMOTHERAPY; CONSTIPATION; CONTROLLED STUDY; CYTOPENIA; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TREATMENT FAILURE; FATIGUE; FEMALE; GASTROINTESTINAL SYMPTOM; HEADACHE; HEPATITIS C VIRUS GENOTYPE 1; HUMAN; INSOMNIA; LIMIT OF QUANTITATION; LIVER CIRRHOSIS; MAJOR CLINICAL STUDY; MALE; NAUSEA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; TREATMENT OUTCOME; UPPER ABDOMINAL PAIN; VOMITING; CLASSIFICATION; COMBINATION DRUG THERAPY; GENETICS; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; MIDDLE AGED; TREATMENT FAILURE; VIROLOGY;

ADULT; AGED; ANTIVIRAL AGENTS; BENZOFURANS; DRUG THERAPY, COMBINATION; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; IMIDAZOLES; MALE; MIDDLE AGED; QUINOXALINES; RIBAVIRIN; TREATMENT FAILURE;

EID: 84939254831     PISSN: 01688278     EISSN: 16000641     Source Type: Journal    
DOI: 10.1016/j.jhep.2015.04.009     Document Type: Article

References (32)

1. T.J. Liang, and M.G. Ghany Current and future therapies for hepatitis C virus infection N Engl J Med 368 2013 1907 1917
2. American Association for the Study of Liver Diseases, Infectious Disease Society of North America. Recommendations for testing, managing, and treating hepatitis C. Available at: < http://www.hcvguidelines.org > (accessed 1 March 2015).
3. A. Kohli, A. Shaffer, A. Sherman, and S. Kottilil Treatment of hepatitis C: a systematic review JAMA 312 2014 631 640
4. M. Gambarin-Gelwan, and I.M. Jacobson Resistance-associated variants in chronic hepatitis C patients treated with protease inhibitors Curr Gastroenterol Rep 14 2012 47 54
5. R.J. Barnard, J.A. Howe, R.A. Ogert, S. Zeuzem, F. Poordad, S.C. Gordon, and et al. Analysis of boceprevir resistance associated amino acid variants (RAVs) in two phase 3 boceprevir clinical studies Virology 444 2013 329 336
6. J.C. Sullivan, S. De Meyer, D.J. Bartels, I. Dierynck, E.Z. Zhang, J. Spanks, and et al. Evolution of treatment-emergent resistant variants in telaprevir phase 3 clinical trials Clin Infect Dis 57 2013 221 229
7. L. Rong, H. Dahari, R.M. Ribeiro, and A.S. Perelson Rapid emergence of protease inhibitor resistance in hepatitis C virus Sci Transl Med 2 2010 30ra32
8. K.P. Romano, A. Ali, C. Aydin, D. Soumana, A. Ozen, L.M. Deveau, and et al. The molecular basis of drug resistance against hepatitis C virus NS3/4a protease inhibitors PLoS Pathog 2012 2012 1 15
9. R.M. Ribeiro, H. Li, S. Wang, M.B. Stoddard, G.H. Learn, B.T. Korber, and et al. Quantifying the diversification of hepatitis C virus (HCV) during primary infection: estimates of the in vivo mutation rate PLoS Pathog 8 2012 e1002881
10. C. Welsch, and S. Zeuzem Clinical relevance of HCV antiviral drug resistance Curr Opin Virol 2 2012 651 655
11. V. Cento, C. Mirabelli, R. Salpini, S. Dimonte, A. Artese, G. Costa, and et al. HCV genotypes are differently prone to the development of resistance to linear and macrocyclic protease inhibitors PLoS One 7 2012 e39652
12. HCV DrAG Phenotype and Sequence Analysis Working Group. Ann Forum Collab HIV Res. Available at < http://www.idsociety.org/uploadedFiles/IDSA/Hepatitis-C/For-IDSA-Members/ForumforCollaborativeHIV-ClinicallyRelevantHCVDrug.pdf > (accessed 12 December 2014).
13. E. Lawitz, M.S. Sulkowski, R. Ghalib, M. Rodriguez-Torres, Z.M. Younossi, A. Corregidor, and 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 384 2014 1756 1765
14. N. Afdhal, K.R. Reddy, D.R. Nelson, E. Lawitz, S.C. Gordon, E. Schiff, and et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection N Engl J Med 370 2014 1483 1493
15. E. Lawitz, F.F. Poordad, P.S. Pang, R.H. Hyland, X. Ding, H. Mo, and 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 383 2014 515 523
16. F. Poordad, C. Hezode, R. Trinh, K.V. Kowdley, S. Zeuzem, K. Agarwal, and et al. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis N Engl J Med 370 2014 1973 1982
17. M.S. Sulkowski, D.F. Gardiner, M. Rodriguez-Torres, K.R. Reddy, T. Hassanein, I.M. Jacobson, and et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection N Engl J Med 370 2014 211 221
18. S. Zeuzem, I.M. Jacobson, T. Baykal, R.T. Marinho, F. Poordad, M. Bourlière, and et al. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin N Engl J Med 370 2014 1604 1614
19. A.Y. Howe, S. Black, S. Curry, S.W. Ludmerer, R. Liu, R.J. Barnard, and et al. Virologic resistance analysis from a phase 2 study of MK-5172 combined with pegylated interferon/ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection Clin Infect Dis 59 2014 1657 1665
20. T. Leitner, E. Halapi, G. Scarlatti, P. Rossi, J. Albert, E.M. Fenyö, and et al. Analysis of heterogeneous viral populations by direct DNA sequencing Biotechniques 15 1993 120 127
21. D. Koletzki, T. Pattery, B. Fevery, L. Vanhooren, and L.J. Stuyver Amplification and sequencing of the hepatitis C virus NS3/4a protease and the NS5b polymerase regions for genotypic resistance detection of clinical isolates of subtypes 1a and 1b Methods Mol Biol 1030 2013 137 149
22. C.J. Clopper, and E.S. Pearson The use of confidence or fiducial limits illustrated in the case of binomial Biometrika 26 1934 404 413
23. M. Boulière, J.-P. Bronowicki, V. de Ledinghen, C. Hézode, F. Zoulim, P. Mathurin, and et al. Ledipasvir-sofosbuvir with or without ribavirin to treat patients with HCV genotype 1 infection and cirrhosis non-responsive to previous protease-inhibitor therapy: a randomised, double-blind, phase 2 trial (SIRIUS) Lancet Infect Dis 15 2015 397 404
24. G. Dusheiko, and D. MacDonald Hope for non-responders with hepatitis C virus and cirrhosis Lancet Infect Dis 15 2015 363 365
25. N. Akuta, F. Suzuki, T. Fukushima, Y. Kawamura, H. Sezaki, Y. Suzuki, and et al. Utility of detection of telaprevir-resistant variants for prediction of efficacy of treatment of hepatitis C virus genotype 1 infection J Clin Microbiol 52 2014 193 200
26. P.R. Harrington, W. Zeng, and L.K. Naeger Clinical relevance of detectable but not quantifiable hepatitis C virus RNA during boceprevir or telaprevir treatment Hepatology 55 2012 1048 1057
27. H. Wedemeyer, D.M. Jensen, E. Godofsky, N. Mani, J.-M. Pawlotsky, V. Miller, and et al. Recommendations for standardized nomenclature and definitions of viral response in trials of hepatitis C virus investigational agents Hepatology 56 2012 2398 2403
28. J. Chen, J. Florian, W. Carter, R.D. Fleischer, T.S. Hammerstrom, P.R. Jadhav, and et al. Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies Gastroenterology 144 2013 1450 1455
29. E.M. Yoshida, M.S. Sulkowski, E.J. Gane, R.W. Herring Jr, V. Ratziu, X. Ding, and et al. Concordance of sustained virological response 4, 12, and 24 weeks post-treatment with sofosbuvir-containing regimens for hepatitis C virus Hepatology 61 2015 41 45
30. F. Poordad, K. Agarwal, Z. Younes, D. Cohen, W. Xie, and T. Podsadecki Low relapse rate leads to high concordance of sustained virologic response (SVR) at 12 weeks with SVR at 24 weeks after treatment with ABT-450/ritonavir, ombitasvir, and dasabuvir plus ribavirin in subjects with chronic hepatitis C virus genotype 1 infection in the AVIATOR Study Clin Infect Dis 60 2014 608 610
31. E. Lawitz, E. Gane, B. Pearlman, E. Tam, W. Ghesquiere, D. Guyader, and et al. Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): a randomised, open-label phase 2 trial Lancet 2015 [Epub ahead of print]. PubMed ID 25467591
32. M. Sulkowski, C. Hezode, J. Gerstoft, J.M. Vierling, J. Mallolas, S. Pol, and et al. Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a randomised, open-label phase 2 trial Lancet 2015 [Epub ahead of print]. PubMed ID 25467560