Efficacy and safety of boceprevir plus peginterferon-ribavirin in patients with HCV G1 infection and advanced fibrosis/cirrhosis

Journal of Hepatology

Volumn 58, Issue 3, 2013, Pages 479-487

  Bruno, Savino ^a   Vierling, John M ^b   Esteban, Rafael ^c   Nyberg, Lisa M ^d   Tanno, Hugo ^e   Goodman, Zachary ^f   Poordad, Fred ^g   Bacon, Bruce ^h   Gottesdiener, Keith ⁱ   Pedicone, Lisa D ⁱ   Albrecht, Janice K ⁱ   Brass, Clifford A ⁱ   Thompson, Seth ⁱ   Burroughs, Margaret H ⁱ  

^a AO Fatebenefratelli e Oftalmico ^*  (Italy)

^b BAYLOR COLLEGE OF MEDICINE   (United States)

^c HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^d KAISER PERMANENTE   (United States)

^e Hospital Provincial del Centenario   (Argentina)

^f INOVA FAIRFAX HOSPITAL   (United States)

^g CEDARS SINAI MEDICAL CENTER   (United States)

^h SAINT LOUIS UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Advanced fibrosis; Boceprevir; Cirrhosis; HCV G1 infection; Triple therapy

Indexed keywords

BOCEPREVIR; HEMOGLOBIN; INTERLEUKIN 28B; PEGINTERFERON; PLACEBO; RIBAVIRIN; VIRUS RNA;

ADULT; ANEMIA; ARTICLE; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TREATMENT FAILURE; ESOPHAGUS VARICES; FATIGUE; FEMALE; GASTRITIS; HEMOGLOBIN DETERMINATION; HEPATITIS C; HUMAN; HYPERGLYCEMIA; LIVER CIRRHOSIS; LIVER FIBROSIS; MAJOR CLINICAL STUDY; MALE; NAUSEA; NEUTROPENIA; PANCREATITIS; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RETROSPECTIVE STUDY; SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT DURATION; VIRUS LOAD;

ADULT; ANTIVIRAL AGENTS; DOUBLE-BLIND METHOD; DRUG RESISTANCE, VIRAL; DRUG THERAPY, COMBINATION; FEMALE; HEPACIVIRUS; HEPATITIS C; HUMANS; INTERFERON-ALPHA; LIVER CIRRHOSIS; MALE; MIDDLE AGED; POLYETHYLENE GLYCOLS; PROLINE; RECOMBINANT PROTEINS; RIBAVIRIN; RNA, VIRAL;

EID: 84874117254     PISSN: 01688278     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jhep.2012.11.020     Document Type: Article

References (20)

1. S. Bruno, M.L. Shiffman, S.K. Roberts, E.J. Gane, D. Messinger, and S.J. Hadziyannis Efficacy and safety of peginterferon alfa-2a (40KD) plus ribavirin in hepatitis C patients with advanced fibrosis and cirrhosis Hepatology 51 2010 388 397
2. T. Poynard, M. Colombo, J. Bruix, E. Schiff, R. Terg, and S. Flamm Peginterferon alfa-2b and ribavirin: effective in patients with hepatitis C who failed interferon alfa/ribavirin therapy Gastroenterology 136 2009 1618 1628
3. T. Poynard, J. McHutchison, Z. Goodman, M.H. Ling, and J. Albrecht Is an "a la carte" combination interferon alfa-2b plus ribavirin regimen possible for the first line treatment in patients with chronic hepatitis C? The ALGOVIRC Project Group Hepatology 31 2000 211 218
4. S. Bruno, T. Stroffolini, M. Colombo, S. Bollani, L. Benvegnu, and G. Mazzella Sustained virological response to interferon-alpha is associated with improved outcome in HCV-related cirrhosis: a retrospective study Hepatology 45 2007 579 587
5. S. Bruno, A. Crosignani, C. Facciotto, S. Rossi, L. Roffi, and A. Redaelli Sustained virologic response prevents the development of esophageal varices in compensated, Child-Pugh class A hepatitis C virus-induced cirrhosis. A 12-year prospective follow-up study Hepatology 51 2010 2069 2076
6. F. Poordad, B. Bacon, S. Bruno, M. Mann, M. Sulkowski, and I. Jacobson Boceprevir for untreated chronic HCV genotype 1 infection New Engl J Med 364 2011 1195 1206
7. B. Bacon, S. Gordon, E. Lawitz, P. Marcellin, J. Vierling, and S. Zeuzem Boceprevir for previously treated chronic HCVgenotype 1 infection N Engl J Med 364 2011 1207 1217
8. I.M. Jacobson, J.G. McHutchison, G. Dusheiko, A.M. Di Bisceglie, K.R. Reddy, and N.H. Bzowej Telaprevir for previously untreated chronic hepatitis C virus infection N Engl J Med 364 2011 2405 2416
9. S. Zeuzem, P. Andreone, S. Pol, E. Lawitz, M. Diago, and S. Roberts Telaprevir for retreatment of HCV infection N Engl J Med 364 2011 2417 2428
10. F. Poordad, J.P. Bronowicki, S.C. Gordon, S. Zeuzem, I.M. Jacobson, and M.S. Sulkowski Factors that Predict Response of Patients with HCV Infection to Boceprevir Gastroenterology 2012
11. J.G. McHutchison, E.J. Lawitz, M.L. Shiffman, A.J. Muir, G.W. Galler, and J. McCone Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection N Engl J Med 361 2009 580 593
12. V. Di Marco, P.L. Almasio, D. Ferraro, V. Calvaruso, G. Alaimo, and S. Peralta Peg-interferon alone or combined with ribavirin in HCV cirrhosis with portal hypertension: a randomized controlled trial J Hepatol 47 2007 484 491
13. X. Tong, R. Chase, A. Skelton, T. Chen, J. Wright-Minogue, and B.A. Malcolm Identification and analysis of fitness of resistance mutations against the HCV protease inhibitor SCH 503034 Antiviral Res 70 2006 28 38
14. X. Tong, S. Bogen, R. Chase, V. Girijavallabhan, Z. Guo, and F.G. Njoroge Characterization of resistance mutations against HCV ketoamide protease inhibitors Antiviral Res 77 2008 177 185
15. R. Chase, A. Skelton, E. Xia, S. Curry, S. Liu, and P. McMonagle A novel HCV NS3 protease mutation selected by combination treatment of the protease inhibitor boceprevir and NS5B polymerase inhibitors Antiviral Res 84 2009 178 184
16. S. Susser, C. Welsch, Y. Wang, M. Zettler, F.S. Domingues, and U. Karey Characterization of resistance to the protease inhibitor boceprevir in hepatitis C virus-infected patients Hepatology 50 2009 1709 1718
17. P.Y. Kwo, E.J. Lawitz, J. McCone, E.R. Schiff, J.M. Vierling, and D. Pound Efficacy of boceprevir, an NS3 protease inhibitor, in combination with peginterferon alfa-2b and ribavirin in treatment-naive patients with genotype 1 hepatitis C infection (SPRINT-1): an open-label, randomised, multicentre phase 2 trial Lancet 376 2010 705 716
18. M. Noureddin, and M.G. Ghany Editorial: treatment of patients with HCV-related cirrhosis with peginterferon and ribavirin: swinging the pendulum toward treatment Am J Gastroenterol 105 2010 2174 2176
19. E. Syed, N. Rahbin, O. Weiland, T. Carlsson, A. Oksanen, and M. Birk Pegylated interferon and ribavirin combination therapy for chronic hepatitis C virus infection in patients with Child-Pugh Class A liver cirrhosis Scand J Gastroenterol 43 2008 1378 1386
20. Hezode C, Dorival C, Zoulim F. Safety of telaprevir or boceprevir in combination with peginterferon alfa/ribavirin, in cirrhotic non responders. First results of the French early access program (ANRS CO20-CUPIC); 2012.