Boceprevir for untreated chronic HCV genotype 1 infection

Fred Poordad, Jonathan McCone, Bruce R. Bacon, Savino Bruno, Michael P. Manns, Mark S. Sulkowski, Ira M. Jacobson, K. Rajender Reddy, Zachary D. Goodman, Navdeep Boparai, Mark J. DiNubile, Vilma Sniukiene, Clifford A. Brass, Janice K. Albrecht, Jean Pierre Bronowicki, L. Colombato, J. Curciarello, M. Silva, H. Tanno, R. Terg & 162 others M. Adler, P. Langlet, L. Lasser, F. Nevens, F. Anderson, R. Bailey, M. Bilodeau, C. Cooper, S. V. Feinman, J. Heathcote, M. Levstik, A. Ramji, M. Sherman, S. Shafran, E. Yoshida, A. Achim, S. Ben Ali, M. A. Bigard, C. Bonny, M. Bourliere, N. Boyer-Darrigrand, V. Canva, P. Couzigou, V. De Ledinghen, D. Guyader, C. Hezode, D. Larrey, M. Latournerie, P. Marcellin, P. Mathurin, M. Maynard-Muet, J. Moussalli, R. Poupon, T. Poynard, L. Serfaty, A. Tran, C. Trepo, R. Truchi, J. P. Zarski, T. Berg, N. Dikopoulos, C. Eisenbach, P. R. Galle, G. Gerken, T. Goeser, M. Gregor, D. Klass, M. R. Kraus, C. Niederau, J. F. Schlaak, R. Schmid, P. Thies, K. Schmidt, R. Thimme, H. Weidenbach, S. Zeuzem, M. Angelico, G. Carosi, A. Craxì, A. Mangia, M. Pirisi, M. Rizzetto, G. Taliani, A. L. Zignego, H. W. Reesink, F. Serejo, A. Reymunde, B. Rosado, E. Torres, R. Barcena Marugan, M. De La Mata, J. L. Calleja, G. Castellano, M. Diago, R. Esteban, C. Fernandez-Rodriguez, J. Sanchez Tapias, M. A. Serra Desfilis, N. Afdhal, A. Al-Osaimi, L. Balart, M. Bennett, D. Bernstein, M. Black, C. Bowlus, T. Boyer, D. Dalke, C. Davis, G. Davis, M. Davis, G. Everson, F. Felizarta, S. Flamm, B. Freilich, J. Galati, G. Galler, R. Ghalib, A. Gibas, E. Godofsky, F. Gordon, S. Gordon, J. Gross, S. Harrison, J. Herrera, S. Herrine, K. Q. Hu, J. Imperial, D. Jones, A. Kilby, J. King, A. Koch, K. Kowdley, E. Krawitt, P. Kwo, L. Lambiase, E. Lawitz, W. Lee, J. Levin, R. Levine, X. Li, A. Lok, V. Luketic, M. Mailliard, J. McHutchison, D. Mikolich, T. Morgan, A. Muir, Don Nelson, F. Nunes, A. Nyberg, L. Nyberg, P. Pandya, M. P. Pauly, C. Peine, G. Poleynard, D. Pound, J. Poulos, M. Rabinovitz, N. Ravendhran, J. Ready, R. Reindollar, A. Reuben, T. Riley, L. Rossaro, R. Rubin, M. Ryan, J. Santoro, E. Schiff, T. Sepe, K. Sherman, M. Shiffman, M. Sjogren, R. Sjogren, C. Smith, L. Stein, R. Strauss, R. Szyjkowski, H. Vargas, J. Vierling, D. Witt, R. Yapp, Z. Younes

Research output: Contribution to journalArticle

2139 Citations (Scopus)

Abstract

Background: Peginterferon-ribavirin therapy is the current standard of care for chronic infection with hepatitis C virus (HCV). The rate of sustained virologic response has been below 50% in cases of HCV genotype 1 infection. Boceprevir, a potent oral HCV-protease inhibitor, has been evaluated as an additional treatment in phase 1 and phase 2 studies. Methods: We conducted a double-blind study in which previously untreated adults with HCV genotype 1 infection were randomly assigned to one of three groups. In all three groups, peginterferon alfa-2b and ribavirin were administered for 4 weeks (the leadin period). Subsequently, group 1 (the control group) received placebo plus peginterferon-ribavirin for 44 weeks; group 2 received boceprevir plus peginterferon-ribavirin for 24 weeks, and those with a detectable HCV RNA level between weeks 8 and 24 received placebo plus peginterferon-ribavirin for an additional 20 weeks; and group 3 received boceprevir plus peginterferon- ribavirin for 44 weeks. Nonblack patients and black patients were enrolled and analyzed separately. Results: A total of 938 nonblack and 159 black patients were treated. In the nonblack cohort, a sustained virologic response was achieved in 125 of the 311 patients (40%) in group 1, in 211 of the 316 patients (67%) in group 2 (P

Original languageEnglish
Pages (from-to)1195-1206
Number of pages12
JournalNew England Journal of Medicine
Volume364
Issue number13
DOIs
Publication statusPublished - Mar 31 2011

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Ribavirin
Chronic Hepatitis C
Hepacivirus
Genotype
Infection
Placebos
Standard of Care
Protease Inhibitors
Double-Blind Method
N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide
RNA
Control Groups
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Poordad, F., McCone, J., Bacon, B. R., Bruno, S., Manns, M. P., Sulkowski, M. S., ... Younes, Z. (2011). Boceprevir for untreated chronic HCV genotype 1 infection. New England Journal of Medicine, 364(13), 1195-1206. https://doi.org/10.1056/NEJMoa1010494

Boceprevir for untreated chronic HCV genotype 1 infection. / Poordad, Fred; McCone, Jonathan; Bacon, Bruce R.; Bruno, Savino; Manns, Michael P.; Sulkowski, Mark S.; Jacobson, Ira M.; Reddy, K. Rajender; Goodman, Zachary D.; Boparai, Navdeep; DiNubile, Mark J.; Sniukiene, Vilma; Brass, Clifford A.; Albrecht, Janice K.; Bronowicki, Jean Pierre; Colombato, L.; Curciarello, J.; Silva, M.; Tanno, H.; Terg, R.; Adler, M.; Langlet, P.; Lasser, L.; Nevens, F.; Anderson, F.; Bailey, R.; Bilodeau, M.; Cooper, C.; Feinman, S. V.; Heathcote, J.; Levstik, M.; Ramji, A.; Sherman, M.; Shafran, S.; Yoshida, E.; Achim, A.; Ben Ali, S.; Bigard, M. A.; Bonny, C.; Bourliere, M.; Boyer-Darrigrand, N.; Canva, V.; Couzigou, P.; De Ledinghen, V.; Guyader, D.; Hezode, C.; Larrey, D.; Latournerie, M.; Marcellin, P.; Mathurin, P.; Maynard-Muet, M.; Moussalli, J.; Poupon, R.; Poynard, T.; Serfaty, L.; Tran, A.; Trepo, C.; Truchi, R.; Zarski, J. P.; Berg, T.; Dikopoulos, N.; Eisenbach, C.; Galle, P. R.; Gerken, G.; Goeser, T.; Gregor, M.; Klass, D.; Kraus, M. R.; Niederau, C.; Schlaak, J. F.; Schmid, R.; Thies, P.; Schmidt, K.; Thimme, R.; Weidenbach, H.; Zeuzem, S.; Angelico, M.; Carosi, G.; Craxì, A.; Mangia, A.; Pirisi, M.; Rizzetto, M.; Taliani, G.; Zignego, A. L.; Reesink, H. W.; Serejo, F.; Reymunde, A.; Rosado, B.; Torres, E.; Barcena Marugan, R.; De La Mata, M.; Calleja, J. L.; Castellano, G.; Diago, M.; Esteban, R.; Fernandez-Rodriguez, C.; Sanchez Tapias, J.; Serra Desfilis, M. A.; Afdhal, N.; Al-Osaimi, A.; Balart, L.; Bennett, M.; Bernstein, D.; Black, M.; Bowlus, C.; Boyer, T.; Dalke, D.; Davis, C.; Davis, G.; Davis, M.; Everson, G.; Felizarta, F.; Flamm, S.; Freilich, B.; Galati, J.; Galler, G.; Ghalib, R.; Gibas, A.; Godofsky, E.; Gordon, F.; Gordon, S.; Gross, J.; Harrison, S.; Herrera, J.; Herrine, S.; Hu, K. Q.; Imperial, J.; Jones, D.; Kilby, A.; King, J.; Koch, A.; Kowdley, K.; Krawitt, E.; Kwo, P.; Lambiase, L.; Lawitz, E.; Lee, W.; Levin, J.; Levine, R.; Li, X.; Lok, A.; Luketic, V.; Mailliard, M.; McHutchison, J.; Mikolich, D.; Morgan, T.; Muir, A.; Nelson, Don; Nunes, F.; Nyberg, A.; Nyberg, L.; Pandya, P.; Pauly, M. P.; Peine, C.; Poleynard, G.; Pound, D.; Poulos, J.; Rabinovitz, M.; Ravendhran, N.; Ready, J.; Reindollar, R.; Reuben, A.; Riley, T.; Rossaro, L.; Rubin, R.; Ryan, M.; Santoro, J.; Schiff, E.; Sepe, T.; Sherman, K.; Shiffman, M.; Sjogren, M.; Sjogren, R.; Smith, C.; Stein, L.; Strauss, R.; Szyjkowski, R.; Vargas, H.; Vierling, J.; Witt, D.; Yapp, R.; Younes, Z.

In: New England Journal of Medicine, Vol. 364, No. 13, 31.03.2011, p. 1195-1206.

Research output: Contribution to journalArticle

Poordad, F, McCone, J, Bacon, BR, Bruno, S, Manns, MP, Sulkowski, MS, Jacobson, IM, Reddy, KR, Goodman, ZD, Boparai, N, DiNubile, MJ, Sniukiene, V, Brass, CA, Albrecht, JK, Bronowicki, JP, Colombato, L, Curciarello, J, Silva, M, Tanno, H, Terg, R, Adler, M, Langlet, P, Lasser, L, Nevens, F, Anderson, F, Bailey, R, Bilodeau, M, Cooper, C, Feinman, SV, Heathcote, J, Levstik, M, Ramji, A, Sherman, M, Shafran, S, Yoshida, E, Achim, A, Ben Ali, S, Bigard, MA, Bonny, C, Bourliere, M, Boyer-Darrigrand, N, Canva, V, Couzigou, P, De Ledinghen, V, Guyader, D, Hezode, C, Larrey, D, Latournerie, M, Marcellin, P, Mathurin, P, Maynard-Muet, M, Moussalli, J, Poupon, R, Poynard, T, Serfaty, L, Tran, A, Trepo, C, Truchi, R, Zarski, JP, Berg, T, Dikopoulos, N, Eisenbach, C, Galle, PR, Gerken, G, Goeser, T, Gregor, M, Klass, D, Kraus, MR, Niederau, C, Schlaak, JF, Schmid, R, Thies, P, Schmidt, K, Thimme, R, Weidenbach, H, Zeuzem, S, Angelico, M, Carosi, G, Craxì, A, Mangia, A, Pirisi, M, Rizzetto, M, Taliani, G, Zignego, AL, Reesink, HW, Serejo, F, Reymunde, A, Rosado, B, Torres, E, Barcena Marugan, R, De La Mata, M, Calleja, JL, Castellano, G, Diago, M, Esteban, R, Fernandez-Rodriguez, C, Sanchez Tapias, J, Serra Desfilis, MA, Afdhal, N, Al-Osaimi, A, Balart, L, Bennett, M, Bernstein, D, Black, M, Bowlus, C, Boyer, T, Dalke, D, Davis, C, Davis, G, Davis, M, Everson, G, Felizarta, F, Flamm, S, Freilich, B, Galati, J, Galler, G, Ghalib, R, Gibas, A, Godofsky, E, Gordon, F, Gordon, S, Gross, J, Harrison, S, Herrera, J, Herrine, S, Hu, KQ, Imperial, J, Jones, D, Kilby, A, King, J, Koch, A, Kowdley, K, Krawitt, E, Kwo, P, Lambiase, L, Lawitz, E, Lee, W, Levin, J, Levine, R, Li, X, Lok, A, Luketic, V, Mailliard, M, McHutchison, J, Mikolich, D, Morgan, T, Muir, A, Nelson, D, Nunes, F, Nyberg, A, Nyberg, L, Pandya, P, Pauly, MP, Peine, C, Poleynard, G, Pound, D, Poulos, J, Rabinovitz, M, Ravendhran, N, Ready, J, Reindollar, R, Reuben, A, Riley, T, Rossaro, L, Rubin, R, Ryan, M, Santoro, J, Schiff, E, Sepe, T, Sherman, K, Shiffman, M, Sjogren, M, Sjogren, R, Smith, C, Stein, L, Strauss, R, Szyjkowski, R, Vargas, H, Vierling, J, Witt, D, Yapp, R & Younes, Z 2011, 'Boceprevir for untreated chronic HCV genotype 1 infection', New England Journal of Medicine, vol. 364, no. 13, pp. 1195-1206. https://doi.org/10.1056/NEJMoa1010494
Poordad F, McCone J, Bacon BR, Bruno S, Manns MP, Sulkowski MS et al. Boceprevir for untreated chronic HCV genotype 1 infection. New England Journal of Medicine. 2011 Mar 31;364(13):1195-1206. https://doi.org/10.1056/NEJMoa1010494
Poordad, Fred ; McCone, Jonathan ; Bacon, Bruce R. ; Bruno, Savino ; Manns, Michael P. ; Sulkowski, Mark S. ; Jacobson, Ira M. ; Reddy, K. Rajender ; Goodman, Zachary D. ; Boparai, Navdeep ; DiNubile, Mark J. ; Sniukiene, Vilma ; Brass, Clifford A. ; Albrecht, Janice K. ; Bronowicki, Jean Pierre ; Colombato, L. ; Curciarello, J. ; Silva, M. ; Tanno, H. ; Terg, R. ; Adler, M. ; Langlet, P. ; Lasser, L. ; Nevens, F. ; Anderson, F. ; Bailey, R. ; Bilodeau, M. ; Cooper, C. ; Feinman, S. V. ; Heathcote, J. ; Levstik, M. ; Ramji, A. ; Sherman, M. ; Shafran, S. ; Yoshida, E. ; Achim, A. ; Ben Ali, S. ; Bigard, M. A. ; Bonny, C. ; Bourliere, M. ; Boyer-Darrigrand, N. ; Canva, V. ; Couzigou, P. ; De Ledinghen, V. ; Guyader, D. ; Hezode, C. ; Larrey, D. ; Latournerie, M. ; Marcellin, P. ; Mathurin, P. ; Maynard-Muet, M. ; Moussalli, J. ; Poupon, R. ; Poynard, T. ; Serfaty, L. ; Tran, A. ; Trepo, C. ; Truchi, R. ; Zarski, J. P. ; Berg, T. ; Dikopoulos, N. ; Eisenbach, C. ; Galle, P. R. ; Gerken, G. ; Goeser, T. ; Gregor, M. ; Klass, D. ; Kraus, M. R. ; Niederau, C. ; Schlaak, J. F. ; Schmid, R. ; Thies, P. ; Schmidt, K. ; Thimme, R. ; Weidenbach, H. ; Zeuzem, S. ; Angelico, M. ; Carosi, G. ; Craxì, A. ; Mangia, A. ; Pirisi, M. ; Rizzetto, M. ; Taliani, G. ; Zignego, A. L. ; Reesink, H. W. ; Serejo, F. ; Reymunde, A. ; Rosado, B. ; Torres, E. ; Barcena Marugan, R. ; De La Mata, M. ; Calleja, J. L. ; Castellano, G. ; Diago, M. ; Esteban, R. ; Fernandez-Rodriguez, C. ; Sanchez Tapias, J. ; Serra Desfilis, M. A. ; Afdhal, N. ; Al-Osaimi, A. ; Balart, L. ; Bennett, M. ; Bernstein, D. ; Black, M. ; Bowlus, C. ; Boyer, T. ; Dalke, D. ; Davis, C. ; Davis, G. ; Davis, M. ; Everson, G. ; Felizarta, F. ; Flamm, S. ; Freilich, B. ; Galati, J. ; Galler, G. ; Ghalib, R. ; Gibas, A. ; Godofsky, E. ; Gordon, F. ; Gordon, S. ; Gross, J. ; Harrison, S. ; Herrera, J. ; Herrine, S. ; Hu, K. Q. ; Imperial, J. ; Jones, D. ; Kilby, A. ; King, J. ; Koch, A. ; Kowdley, K. ; Krawitt, E. ; Kwo, P. ; Lambiase, L. ; Lawitz, E. ; Lee, W. ; Levin, J. ; Levine, R. ; Li, X. ; Lok, A. ; Luketic, V. ; Mailliard, M. ; McHutchison, J. ; Mikolich, D. ; Morgan, T. ; Muir, A. ; Nelson, Don ; Nunes, F. ; Nyberg, A. ; Nyberg, L. ; Pandya, P. ; Pauly, M. P. ; Peine, C. ; Poleynard, G. ; Pound, D. ; Poulos, J. ; Rabinovitz, M. ; Ravendhran, N. ; Ready, J. ; Reindollar, R. ; Reuben, A. ; Riley, T. ; Rossaro, L. ; Rubin, R. ; Ryan, M. ; Santoro, J. ; Schiff, E. ; Sepe, T. ; Sherman, K. ; Shiffman, M. ; Sjogren, M. ; Sjogren, R. ; Smith, C. ; Stein, L. ; Strauss, R. ; Szyjkowski, R. ; Vargas, H. ; Vierling, J. ; Witt, D. ; Yapp, R. ; Younes, Z. / Boceprevir for untreated chronic HCV genotype 1 infection. In: New England Journal of Medicine. 2011 ; Vol. 364, No. 13. pp. 1195-1206.
@article{ffcf4b9df31b43a298c824c7fd6f9350,
title = "Boceprevir for untreated chronic HCV genotype 1 infection",
abstract = "Background: Peginterferon-ribavirin therapy is the current standard of care for chronic infection with hepatitis C virus (HCV). The rate of sustained virologic response has been below 50{\%} in cases of HCV genotype 1 infection. Boceprevir, a potent oral HCV-protease inhibitor, has been evaluated as an additional treatment in phase 1 and phase 2 studies. Methods: We conducted a double-blind study in which previously untreated adults with HCV genotype 1 infection were randomly assigned to one of three groups. In all three groups, peginterferon alfa-2b and ribavirin were administered for 4 weeks (the leadin period). Subsequently, group 1 (the control group) received placebo plus peginterferon-ribavirin for 44 weeks; group 2 received boceprevir plus peginterferon-ribavirin for 24 weeks, and those with a detectable HCV RNA level between weeks 8 and 24 received placebo plus peginterferon-ribavirin for an additional 20 weeks; and group 3 received boceprevir plus peginterferon- ribavirin for 44 weeks. Nonblack patients and black patients were enrolled and analyzed separately. Results: A total of 938 nonblack and 159 black patients were treated. In the nonblack cohort, a sustained virologic response was achieved in 125 of the 311 patients (40{\%}) in group 1, in 211 of the 316 patients (67{\%}) in group 2 (P",
author = "Fred Poordad and Jonathan McCone and Bacon, {Bruce R.} and Savino Bruno and Manns, {Michael P.} and Sulkowski, {Mark S.} and Jacobson, {Ira M.} and Reddy, {K. Rajender} and Goodman, {Zachary D.} and Navdeep Boparai and DiNubile, {Mark J.} and Vilma Sniukiene and Brass, {Clifford A.} and Albrecht, {Janice K.} and Bronowicki, {Jean Pierre} and L. Colombato and J. Curciarello and M. Silva and H. Tanno and R. Terg and M. Adler and P. Langlet and L. Lasser and F. Nevens and F. Anderson and R. Bailey and M. Bilodeau and C. Cooper and Feinman, {S. V.} and J. Heathcote and M. Levstik and A. Ramji and M. Sherman and S. Shafran and E. Yoshida and A. Achim and {Ben Ali}, S. and Bigard, {M. A.} and C. Bonny and M. Bourliere and N. Boyer-Darrigrand and V. Canva and P. Couzigou and {De Ledinghen}, V. and D. Guyader and C. Hezode and D. Larrey and M. Latournerie and P. Marcellin and P. Mathurin and M. Maynard-Muet and J. Moussalli and R. Poupon and T. Poynard and L. Serfaty and A. Tran and C. Trepo and R. Truchi and Zarski, {J. P.} and T. Berg and N. Dikopoulos and C. Eisenbach and Galle, {P. R.} and G. Gerken and T. Goeser and M. Gregor and D. Klass and Kraus, {M. R.} and C. Niederau and Schlaak, {J. F.} and R. Schmid and P. Thies and K. Schmidt and R. Thimme and H. Weidenbach and S. Zeuzem and M. Angelico and G. Carosi and A. Crax{\`i} and A. Mangia and M. Pirisi and M. Rizzetto and G. Taliani and Zignego, {A. L.} and Reesink, {H. W.} and F. Serejo and A. Reymunde and B. Rosado and E. Torres and {Barcena Marugan}, R. and {De La Mata}, M. and Calleja, {J. L.} and G. Castellano and M. Diago and R. Esteban and C. Fernandez-Rodriguez and {Sanchez Tapias}, J. and {Serra Desfilis}, {M. A.} and N. Afdhal and A. Al-Osaimi and L. Balart and M. Bennett and D. Bernstein and M. Black and C. Bowlus and T. Boyer and D. Dalke and C. Davis and G. Davis and M. Davis and G. Everson and F. Felizarta and S. Flamm and B. Freilich and J. Galati and G. Galler and R. Ghalib and A. Gibas and E. Godofsky and F. Gordon and S. Gordon and J. Gross and S. Harrison and J. Herrera and S. Herrine and Hu, {K. Q.} and J. Imperial and D. Jones and A. Kilby and J. King and A. Koch and K. Kowdley and E. Krawitt and P. Kwo and L. Lambiase and E. Lawitz and W. Lee and J. Levin and R. Levine and X. Li and A. Lok and V. Luketic and M. Mailliard and J. McHutchison and D. Mikolich and T. Morgan and A. Muir and Don Nelson and F. Nunes and A. Nyberg and L. Nyberg and P. Pandya and Pauly, {M. P.} and C. Peine and G. Poleynard and D. Pound and J. Poulos and M. Rabinovitz and N. Ravendhran and J. Ready and R. Reindollar and A. Reuben and T. Riley and L. Rossaro and R. Rubin and M. Ryan and J. Santoro and E. Schiff and T. Sepe and K. Sherman and M. Shiffman and M. Sjogren and R. Sjogren and C. Smith and L. Stein and R. Strauss and R. Szyjkowski and H. Vargas and J. Vierling and D. Witt and R. Yapp and Z. Younes",
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pages = "1195--1206",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "13",

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TY - JOUR

T1 - Boceprevir for untreated chronic HCV genotype 1 infection

AU - Poordad, Fred

AU - McCone, Jonathan

AU - Bacon, Bruce R.

AU - Bruno, Savino

AU - Manns, Michael P.

AU - Sulkowski, Mark S.

AU - Jacobson, Ira M.

AU - Reddy, K. Rajender

AU - Goodman, Zachary D.

AU - Boparai, Navdeep

AU - DiNubile, Mark J.

AU - Sniukiene, Vilma

AU - Brass, Clifford A.

AU - Albrecht, Janice K.

AU - Bronowicki, Jean Pierre

AU - Colombato, L.

AU - Curciarello, J.

AU - Silva, M.

AU - Tanno, H.

AU - Terg, R.

AU - Adler, M.

AU - Langlet, P.

AU - Lasser, L.

AU - Nevens, F.

AU - Anderson, F.

AU - Bailey, R.

AU - Bilodeau, M.

AU - Cooper, C.

AU - Feinman, S. V.

AU - Heathcote, J.

AU - Levstik, M.

AU - Ramji, A.

AU - Sherman, M.

AU - Shafran, S.

AU - Yoshida, E.

AU - Achim, A.

AU - Ben Ali, S.

AU - Bigard, M. A.

AU - Bonny, C.

AU - Bourliere, M.

AU - Boyer-Darrigrand, N.

AU - Canva, V.

AU - Couzigou, P.

AU - De Ledinghen, V.

AU - Guyader, D.

AU - Hezode, C.

AU - Larrey, D.

AU - Latournerie, M.

AU - Marcellin, P.

AU - Mathurin, P.

AU - Maynard-Muet, M.

AU - Moussalli, J.

AU - Poupon, R.

AU - Poynard, T.

AU - Serfaty, L.

AU - Tran, A.

AU - Trepo, C.

AU - Truchi, R.

AU - Zarski, J. P.

AU - Berg, T.

AU - Dikopoulos, N.

AU - Eisenbach, C.

AU - Galle, P. R.

AU - Gerken, G.

AU - Goeser, T.

AU - Gregor, M.

AU - Klass, D.

AU - Kraus, M. R.

AU - Niederau, C.

AU - Schlaak, J. F.

AU - Schmid, R.

AU - Thies, P.

AU - Schmidt, K.

AU - Thimme, R.

AU - Weidenbach, H.

AU - Zeuzem, S.

AU - Angelico, M.

AU - Carosi, G.

AU - Craxì, A.

AU - Mangia, A.

AU - Pirisi, M.

AU - Rizzetto, M.

AU - Taliani, G.

AU - Zignego, A. L.

AU - Reesink, H. W.

AU - Serejo, F.

AU - Reymunde, A.

AU - Rosado, B.

AU - Torres, E.

AU - Barcena Marugan, R.

AU - De La Mata, M.

AU - Calleja, J. L.

AU - Castellano, G.

AU - Diago, M.

AU - Esteban, R.

AU - Fernandez-Rodriguez, C.

AU - Sanchez Tapias, J.

AU - Serra Desfilis, M. A.

AU - Afdhal, N.

AU - Al-Osaimi, A.

AU - Balart, L.

AU - Bennett, M.

AU - Bernstein, D.

AU - Black, M.

AU - Bowlus, C.

AU - Boyer, T.

AU - Dalke, D.

AU - Davis, C.

AU - Davis, G.

AU - Davis, M.

AU - Everson, G.

AU - Felizarta, F.

AU - Flamm, S.

AU - Freilich, B.

AU - Galati, J.

AU - Galler, G.

AU - Ghalib, R.

AU - Gibas, A.

AU - Godofsky, E.

AU - Gordon, F.

AU - Gordon, S.

AU - Gross, J.

AU - Harrison, S.

AU - Herrera, J.

AU - Herrine, S.

AU - Hu, K. Q.

AU - Imperial, J.

AU - Jones, D.

AU - Kilby, A.

AU - King, J.

AU - Koch, A.

AU - Kowdley, K.

AU - Krawitt, E.

AU - Kwo, P.

AU - Lambiase, L.

AU - Lawitz, E.

AU - Lee, W.

AU - Levin, J.

AU - Levine, R.

AU - Li, X.

AU - Lok, A.

AU - Luketic, V.

AU - Mailliard, M.

AU - McHutchison, J.

AU - Mikolich, D.

AU - Morgan, T.

AU - Muir, A.

AU - Nelson, Don

AU - Nunes, F.

AU - Nyberg, A.

AU - Nyberg, L.

AU - Pandya, P.

AU - Pauly, M. P.

AU - Peine, C.

AU - Poleynard, G.

AU - Pound, D.

AU - Poulos, J.

AU - Rabinovitz, M.

AU - Ravendhran, N.

AU - Ready, J.

AU - Reindollar, R.

AU - Reuben, A.

AU - Riley, T.

AU - Rossaro, L.

AU - Rubin, R.

AU - Ryan, M.

AU - Santoro, J.

AU - Schiff, E.

AU - Sepe, T.

AU - Sherman, K.

AU - Shiffman, M.

AU - Sjogren, M.

AU - Sjogren, R.

AU - Smith, C.

AU - Stein, L.

AU - Strauss, R.

AU - Szyjkowski, R.

AU - Vargas, H.

AU - Vierling, J.

AU - Witt, D.

AU - Yapp, R.

AU - Younes, Z.

PY - 2011/3/31

Y1 - 2011/3/31

N2 - Background: Peginterferon-ribavirin therapy is the current standard of care for chronic infection with hepatitis C virus (HCV). The rate of sustained virologic response has been below 50% in cases of HCV genotype 1 infection. Boceprevir, a potent oral HCV-protease inhibitor, has been evaluated as an additional treatment in phase 1 and phase 2 studies. Methods: We conducted a double-blind study in which previously untreated adults with HCV genotype 1 infection were randomly assigned to one of three groups. In all three groups, peginterferon alfa-2b and ribavirin were administered for 4 weeks (the leadin period). Subsequently, group 1 (the control group) received placebo plus peginterferon-ribavirin for 44 weeks; group 2 received boceprevir plus peginterferon-ribavirin for 24 weeks, and those with a detectable HCV RNA level between weeks 8 and 24 received placebo plus peginterferon-ribavirin for an additional 20 weeks; and group 3 received boceprevir plus peginterferon- ribavirin for 44 weeks. Nonblack patients and black patients were enrolled and analyzed separately. Results: A total of 938 nonblack and 159 black patients were treated. In the nonblack cohort, a sustained virologic response was achieved in 125 of the 311 patients (40%) in group 1, in 211 of the 316 patients (67%) in group 2 (P

AB - Background: Peginterferon-ribavirin therapy is the current standard of care for chronic infection with hepatitis C virus (HCV). The rate of sustained virologic response has been below 50% in cases of HCV genotype 1 infection. Boceprevir, a potent oral HCV-protease inhibitor, has been evaluated as an additional treatment in phase 1 and phase 2 studies. Methods: We conducted a double-blind study in which previously untreated adults with HCV genotype 1 infection were randomly assigned to one of three groups. In all three groups, peginterferon alfa-2b and ribavirin were administered for 4 weeks (the leadin period). Subsequently, group 1 (the control group) received placebo plus peginterferon-ribavirin for 44 weeks; group 2 received boceprevir plus peginterferon-ribavirin for 24 weeks, and those with a detectable HCV RNA level between weeks 8 and 24 received placebo plus peginterferon-ribavirin for an additional 20 weeks; and group 3 received boceprevir plus peginterferon- ribavirin for 44 weeks. Nonblack patients and black patients were enrolled and analyzed separately. Results: A total of 938 nonblack and 159 black patients were treated. In the nonblack cohort, a sustained virologic response was achieved in 125 of the 311 patients (40%) in group 1, in 211 of the 316 patients (67%) in group 2 (P

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U2 - 10.1056/NEJMoa1010494

DO - 10.1056/NEJMoa1010494

M3 - Article

VL - 364

SP - 1195

EP - 1206

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 13

ER -