Efficacy of an interferon- and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection

Gastroenterology

Volumn 146, Issue 2, 2014, Pages 420-429

  Everson, Gregory T ^a   Sims, Karen D ^b   Rodriguez Torres, Maribel ^c   Hézode, Christophe ^d   Lawitz, Eric ^e   Bourlière, Marc ^f   Loustaud Ratti, Veronique ^g   Rustgi, Vinod ^h   Schwartz, Howard ⁱ   Tatum, Harvey ^j   Marcellin, Patrick ^k   Pol, Stanislas ^l   Thuluvath, Paul J ^m   Eley, Timothy ^b   Wang, Xiaodong ^b   Huang, Shu Pang ^b   McPhee, Fiona ^b   Wind Rotolo, Megan ^b   Chung, Ellen ^b   Pasquinelli, Claudio ^b   Grasela, Dennis M ^b   Gardiner, David F ^b   more..

^a UNIVERSITY OF COLORADO   (United States)

^b BRISTOL MYERS SQUIBB   (United States)

^c Department of Hematology and Oncology   (Puerto Rico)

^d HENRI MONDOR HOSPITAL   (France)

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

^f HÔPITAL SAINT JOSEPH   (France)

^g LIMOGES UNIVERSITY HOSPITAL   (France)

^h Metropolitan Research   (United States)

ⁱ MIAMI RESEARCH ASSOCIATES   (United States)

^j Options Health Research   (United States)

^k BEAUJON HOSPITAL   (France)

^l UNIVERSITÉ PARIS DESCARTES   (France)

^m MERCY MEDICAL CENTER   (United States)

more..

Author keywords

DAA; Drug Combination; Liver Disease; Therapy

Indexed keywords

ALANINE AMINOTRANSFERASE; ANTIVIRUS AGENT; ASPARTATE AMINOTRANSFERASE; ASUNAPREVIR; BILIRUBIN; BMS 791325; BOCEPREVIR; DACLATASVIR; PEGINTERFERON ALPHA; RIBAVIRIN; TELAPREVIR; UNCLASSIFIED DRUG; VIRUS RNA;

ABDOMINAL PAIN; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHENIA; BILIRUBIN BLOOD LEVEL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG FATALITY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; GASTROINTESTINAL SYMPTOM; HEPATITIS C; HEPATITIS C VIRUS GENOTYPE 1; HUMAN; INFLUENZA; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; OPEN STUDY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RELAPSE; REVERSIBLE CEREBRAL VASOCONSTRICTION SYNDROME; RISK ASSESSMENT; TREATMENT DURATION; URETER STONE; YOUNG ADULT;

DAA; DRUG COMBINATION; EC(50); GENOTYPE; GT; HCV; HEPATITIS C VIRUS; IL; INTERLEUKIN; LIVER DISEASE; MEDIAN EFFECTIVE CONCENTRATION; SUSTAINED VIROLOGIC RESPONSE; SUSTAINED VIROLOGIC RESPONSE AT 12 WEEKS; SVR; SVR(24); THERAPY;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; ANTIVIRAL AGENTS; BENZAZEPINES; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; IMIDAZOLES; INDOLES; INTENTION TO TREAT ANALYSIS; ISOQUINOLINES; MALE; MIDDLE AGED; PILOT PROJECTS; SULFONAMIDES; TREATMENT OUTCOME; VIRAL LOAD; YOUNG ADULT;

EID: 84892761609     PISSN: 00165085     EISSN: 15280012     Source Type: Journal    
DOI: 10.1053/j.gastro.2013.10.057     Document Type: Article

References (37)

1. M.W. Fried, M.L. Shiffman, and K.R. Reddy et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection N Engl J Med 347 2002 975 982
2. S.J. Hadziyannis, H. Sette Jr., and T.R. Morgan et al. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose Ann Intern Med 140 2004 346 355
3. F. Poordad, J. McCone Jr., and B.R. Bacon et al. Boceprevir for untreated chronic HCV genotype 1 infection N Engl J Med 364 2011 1195 1206
4. I.M. Jacobson, J.G. McHutchison, and G. Dusheiko et al. Telaprevir for previously untreated chronic hepatitis C virus infection N Engl J Med 364 2011 2405 2416
5. F. Poordad, and D. Dieterich Treating hepatitis C: current standard of care and emerging direct-acting antiviral agents J Viral Hepat 19 2012 449 464
6. E. De Clercq The race for interferon-free HCV therapies: a snapshot by the spring of 2012 Rev Med Virol 22 2012 392 411
7. A.S. Lok, D.F. Gardiner, and E. Lawitz et al. Preliminary study of two antiviral agents for hepatitis C genotype 1 N Engl J Med 366 2012 216 224
8. M. Gao, R.E. Nettles, and M. Belema et al. Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect Nature 465 2010 96 100
9. C. Pasquinelli, F. McPhee, and T. Eley et al. Single- and multiple-ascending-dose studies of the NS3 protease inhibitor asunaprevir in subjects with or without chronic hepatitis C Antimicrob Agents Chemother 56 2012 1838 1844
10. F. McPhee, A.K. Sheaffer, and J. Friborg et al. Preclinical profile and characterization of the hepatitis C virus NS3 protease inhibitor asunaprevir (BMS-650032) Antimicrob Agents Chemother 56 2012 5387 5396
11. A. Lok, D. Gardiner, and C. Hezode et al. 79 Sustained virologic response in chronic HCV genotype (GT) 1-infected null responders with combination of daclatasvir (DCV; NS5A inhibitor) and asunaprevir (ASV; NS3 inhibitor) with or without peginterferon alfa-2a/ribavirin (PEG/RBV) Hepatology 56 2012 230A
12. Y. Suzuki, K. Ikeda, and F. Suzuki et al. Dual oral therapy with daclatasvir and asunaprevir for patients with HCV genotype 1b infection and limited treatment options J Hepatol 58 2013 655 662
13. K. Chayama, S. Takahashi, and J. Toyota et al. Dual therapy with the nonstructural protein 5A inhibitor, daclatasvir, and the nonstructural protein 3 protease inhibitor, asunaprevir, in hepatitis C virus genotype 1b-infected null responders Hepatology 55 2012 742 748
14. F. McPhee, J. Friborg, and S. Levine et al. Resistance analysis of the hepatitis C virus NS3 protease inhibitor asunaprevir Antimicrob Agents Chemother 56 2012 3670 3681
15. R.A. Fridell, C. Wang, and J.H. Sun et al. Genotypic and phenotypic analysis of variants resistant to hepatitis C virus nonstructural protein 5A replication complex inhibitor BMS-790052 in humans: in vitro and in vivo correlations Hepatology 54 2011 1924 1935
16. C. Wang, H. Huang, and L. Valera et al. Hepatitis C virus RNA elimination and development of resistance in replicon cells treated with BMS-790052 Antimicrob Agents Chemother 56 2012 1350 1358
17. F. McPhee, P. Falk, and P. Fracasso et al. Characterization of viral escape in HCV genotype 1-infected patients treated with BMS-791325 and pegylated interferon-alfa and ribavirin J Hepatol 56 2012 S473
18. J.R. Kramer, F. Kanwal, and P. Richardson et al. Gaps in the achievement of effectiveness of HCV treatment in national VA practice J Hepatol 56 2012 320 325
19. C. Hezode, C. Dorival, and F. Zoulim Safety and efficacy of telaprevir or boceprevir in combination with peginterferon alfa/ribavirin, in 455 cirrhotic non responders: week 16 analysis of the French early access program (ANRS CO20-CUPIC) in real-life setting Hepatology 56 2012 217A
20. H. Qin, H. Li, and X. Zhou et al. Safety of telaprevir for chronic hepatitis C virus infection: a meta-analysis of randomized controlled trials Clin Drug Investig 32 2012 665 672
21. L. Rong, H. Dahari, and R.M. Ribeiro et al. Rapid emergence of protease inhibitor resistance in hepatitis C virus Sci Transl Med 2 2010 30ra32
22. Sulkowski M, Gardiner D, Rodriguez-Torres M, et al. Daclatasvir plus sofosbuvir for chronic HCV genotype 1, 2, or 3 infection. N Engl J Med In press.
23. Lawitz E, Ghalib R, Rodriguez-Torres M, et al. COSMOS study: SVR4 results of a once daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in HCV genotype 1 null responders. 20th Conference on Retroviruses and Opportunistic Infections, Atlanta, GA, March 3-6, 2013.
24. G.T. Everson, K.D. Sims, and M. Rodriguez-Torres et al. Interim analysis of an interferon (IFN)- and ribavirin (RBV)-free regimen of daclatasvir (DCV), asunaprevir (ASV), and BMS-791325 in treatment-naive, hepatitis C virus genotype 1-infected patients J Hepatol 58 2013 S573
25. F. Poordad, E. Lawitz, and K.V. Kowdley et al. Exploratory study of oral combination antiviral therapy for hepatitis C N Engl J Med 368 2013 45 53
26. E. Lawitz, F. Poordad, and K.V. Kowdley et al. A phase 2a trial of 12-week interferon-free therapy with two direct-acting antivirals (ABT-450/r, ABT-072) and ribavirin in IL28B C/C patients with chronic hepatitis C genotype 1 J Hepatol 59 2013 18 23
27. K.V. Kowdley, E. Lawitz, and F. Poordad et al. Safety and efficacy of interferon-free regimens of ABT-450/r, ABT-267, ABT-333 +/- ribavirin in patients with chronic HCV GT1 infection: results from the aviator study J Hepatol 58 2013 S2
28. C. Hezode, N. Forestier, and G. Dusheiko et al. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection N Engl J Med 360 2009 1839 1850
29. J. Guedj, and A.S. Perelson Second-phase hepatitis C virus RNA decline during telaprevir-based therapy increases with drug effectiveness: implications for treatment duration Hepatology 53 2011 1801 1808
30. M.G. Ghany, D.B. Strader, and D.L. Thomas et al. Diagnosis, management, and treatment of hepatitis C: an update Hepatology 49 2009 1335 1374
31. E.J. Gane, C.A. Stedman, and R.H. Hyland et al. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C N Engl J Med 368 2013 34 44
32. F. Suzuki, H. Sezaki, and N. Akuta et al. Prevalence of hepatitis C virus variants resistant to NS3 protease inhibitors or the NS5A inhibitor (BMS-790052) in hepatitis patients with genotype 1b J Clin Virol 54 2012 352 354
33. Y. Karino, J. Toyota, and K. Ikeda et al. Characterization of virologic escape in hepatitis C virus genotype 1b patients treated with the direct-acting antivirals daclatasvir and asunaprevir J Hepatol 58 2013 646 654
34. X. Wang, W. Li, and S.P. Huang et al. Evaluation of pharmacokinetic drug-drug interaction (DDI) between BMS-791325, an NS5b non-nucleotide polymerase inhibitor, daclatasvir and asunaprevir in triple combination in HCV genotype 1-infected patients J Hepatol 58 2013 S184
35. Vertex Pharmaceuticals. Incivek (telaprevir). Package insert. Revised April 2013.
36. Merck. Victrelis (boceprevir). Package insert. Revised February 2013.
37. Hoffman-LaRoche. Pegasys package insert. In: Genetech, ed. 2013.