-
1
-
-
0035934568
-
Peginterferon alfa-2b plus ribavirin compared with interferonalfa-2b plus ribavirin for initial treatment of chronic hepatitis C: A randomised trial
-
DOI 10.1016/S0140-6736(01)06102-5
-
Manns MP, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358(9286):958-65. (Pubitemid 32913521)
-
(2001)
Lancet
, vol.358
, Issue.9286
, pp. 958-965
-
-
Manns, M.P.1
McHutchison, J.G.2
Gordon, S.C.3
Rustgi, V.K.4
Shiffman, M.5
Reindollar, R.6
Goodman, Z.D.7
Koury, K.8
Ling, M.-H.9
Albrecht, J.K.10
-
2
-
-
0037179698
-
Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection
-
10.1056/NEJMoa020047 1:CAS:528:DC%2BD38Xnt12rtb0%3D 12324553
-
Fried MW, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347(13):975-82.
-
(2002)
N Engl J Med
, vol.347
, Issue.13
, pp. 975-982
-
-
Fried, M.W.1
-
4
-
-
84872685038
-
-
a.s.o.M.C. Schering Corporation, Inc., Whitehouse Station, NJ 08889, USA
-
PEG-Intron (peginterferon alfa-2b) Package Insert. a.s.o.M.C. Schering Corporation, Inc., Whitehouse Station, NJ 08889, USA.
-
PEG-Intron (Peginterferon alfa-2b) Package Insert
-
-
-
5
-
-
77955853174
-
Thrombocytopenia and the risk of bleeding during treatment with peginterferon alfa and ribavirin for chronic hepatitis C
-
10.1016/j.jhep.2010.04.013 1:CAS:528:DC%2BC3cXhtVelur3I 20561709
-
Roomer R, et al. Thrombocytopenia and the risk of bleeding during treatment with peginterferon alfa and ribavirin for chronic hepatitis C. J Hepatol. 2010;53(3):455-9.
-
(2010)
J Hepatol
, vol.53
, Issue.3
, pp. 455-459
-
-
Roomer, R.1
-
6
-
-
84855924980
-
Dermatological side effects of hepatitis C and its treatment: Patient management in the era of direct-acting antivirals
-
10.1016/j.jhep.2011.08.006 1:CAS:528:DC%2BC38XpsFyhsw%3D%3D 21884670
-
Cacoub P, Bourlière M, Lübbe J, Dupin N, Buggisch P, Dusheiko G, Hézode C, Picard O, Pujol R, Segaert S, Thio B, Roujeau JC. Dermatological side effects of hepatitis C and its treatment: patient management in the era of direct-acting antivirals. J Hepatol. 2012;56(2):455-63.
-
(2012)
J Hepatol
, vol.56
, Issue.2
, pp. 455-463
-
-
Cacoub, P.1
Bourlière, M.2
Lübbe, J.3
Dupin, N.4
Buggisch, P.5
Dusheiko, G.6
Hézode, C.7
Picard, O.8
Pujol, R.9
Segaert, S.10
Thio, B.11
Roujeau, J.C.12
-
7
-
-
77955982189
-
Management of psychiatric disease in hepatitis C treatment candidates
-
10.1007/s11901-010-0035-5 20871787
-
Lotrich F. Management of psychiatric disease in hepatitis C treatment candidates. Curr Hepat Rep. 2010;9:113-8.
-
(2010)
Curr Hepat Rep.
, vol.9
, pp. 113-118
-
-
Lotrich, F.1
-
8
-
-
84865801719
-
Interferon-induced depression in chronic hepatitis C: A systematic review and meta-analysis
-
10.4088/JCP.12r07694 1:CAS:528:DC%2BC38XhslOltL7L 22967776
-
Udina M, Castellví P, Moreno-España J, et al. Interferon-induced depression in chronic hepatitis C: a systematic review and meta-analysis. J Clin Psychiatry. 2012;73(8):1128-38.
-
(2012)
J Clin Psychiatry
, vol.73
, Issue.8
, pp. 1128-1138
-
-
Udina, M.1
Castellví, P.2
Moreno-España, J.3
-
9
-
-
77956268467
-
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
-
SPRINT-,1 Investigators et al. 10.1016/S0140-6736(10)60934-8 1:CAS:528:DC%2BC3cXhtVymt7zP 20692693 The SPRINT-1 trial is the major phase 2 trial evaluating the effectiveness and safety of triple therapy with boceprevir in treatment-naïve patients with chronic hepatitis C. This study proved the large-scale effectiveness and relative safety of triple therapy, as compared with standard PEG-IFN/RBV dual therapy
-
•• Kwo PY, Lawitz EJ, McCone J, Schiff ER, Vierling JM, Pound D, SPRINT-,1 Investigators, et al. 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. 2010;376:705-16. The SPRINT-1 trial is the major phase 2 trial evaluating the effectiveness and safety of triple therapy with boceprevir in treatment-naïve patients with chronic hepatitis C. This study proved the large-scale effectiveness and relative safety of triple therapy, as compared with standard PEG-IFN/RBV dual therapy.
-
(2010)
Lancet
, vol.376
, pp. 705-716
-
-
Kwo, P.Y.1
Lawitz, E.J.2
McCone, J.3
Schiff, E.R.4
Vierling, J.M.5
Pound, D.6
-
10
-
-
79953173221
-
Boceprevir for untreated chronic HCV genotype 1 infection
-
SPRINT-2 Investigators et al. 10.1056/NEJMoa1010494 1:CAS:528: DC%2BC3MXkt1Chtrc%3D 21449783 The SPRINT-2 trial succeeds the SPRINT-1 trial to further evaluate treatment regimens for naïve CHC patients without cirrhosis. The SPRINT-2 data allowed for FDA support of response-guided therapy with the use of boceprevir
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•• Poordad F, McCone JJ, Bacon BR, Bruno S, Manns MP, Sulkowski MS, SPRINT-2 Investigators, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011;364:1195-206. The SPRINT-2 trial succeeds the SPRINT-1 trial to further evaluate treatment regimens for naïve CHC patients without cirrhosis. The SPRINT-2 data allowed for FDA support of response-guided therapy with the use of boceprevir.
-
(2011)
N Engl J Med
, vol.364
, pp. 1195-1206
-
-
Poordad, F.1
McCone, J.J.2
Bacon, B.R.3
Bruno, S.4
Manns, M.P.5
Sulkowski, M.S.6
-
11
-
-
79959438789
-
Telaprevir for previously untreated chronic hepatitis C virus infection
-
ADVANCE Study Team et al. 10.1056/NEJMoa1012912 1:CAS:528: DC%2BC3MXotVCku7Y%3D 21696307 This study identified 12 weeks of triple therapy with telaprevir followed by dual therapy in a response-guided fashion as an optimal regimen over standard dual therapy. In addition, it showed that the development of an extended RVR was the strongest predictor of SVR
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•• Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, ADVANCE Study Team, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011;364:2405-16. This study identified 12 weeks of triple therapy with telaprevir followed by dual therapy in a response-guided fashion as an optimal regimen over standard dual therapy. In addition, it showed that the development of an extended RVR was the strongest predictor of SVR.
-
(2011)
N Engl J Med
, vol.364
, pp. 2405-2416
-
-
Jacobson, I.M.1
McHutchison, J.G.2
Dusheiko, G.3
Di Bisceglie, A.M.4
Reddy, K.R.5
Bzowej, N.H.6
-
12
-
-
84865494240
-
Factors that predict response of patients with hepatitis C virus infection to boceprevir. SPRINT-2 and RESPOND-2 Investigators
-
10.1053/j.gastro.2012.05.011 22626609 Although anemia is recognized as a significant adverse effect of HCV therapy, it is also strongly associated with treatment efficacy. This was first recognized with dual PEG/RBV therapy and continues to hold true for triple therapy, as made evident by this study
-
• Poordad F, Bronowicki JP, Gordon SC, et al. Factors that predict response of patients with hepatitis C virus infection to boceprevir. SPRINT-2 and RESPOND-2 Investigators. Gastroenterology. 2012;143(3):608-18. Although anemia is recognized as a significant adverse effect of HCV therapy, it is also strongly associated with treatment efficacy. This was first recognized with dual PEG/RBV therapy and continues to hold true for triple therapy, as made evident by this study.
-
(2012)
Gastroenterology
, vol.143
, Issue.3
, pp. 608-618
-
-
Poordad, F.1
Bronowicki, J.P.2
Gordon, S.C.3
-
13
-
-
80053477775
-
Anemia during treatment with peginterferon alfa-2b/ribavirin with or without boceprevir is associated with higher SVR rates: Analysis of previously untreated and previous-treatment-failure patients
-
10.1016/S0168-8278(11)60479-0 This study allows for the recommendation to be made to treat anemia with ribavirin dose reduction and was a subanalysis from the SPRINT-2 data
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• Sulkowski MS, Poordad F, Manns MS, Bronowicki JP, Reddy KR, Harrison SA, et al. Anemia during treatment with peginterferon alfa-2b/ribavirin with or without boceprevir is associated with higher SVR rates: analysis of previously untreated and previous-treatment-failure patients. J Hepatol. 2011;54(1):S195-6. This study allows for the recommendation to be made to treat anemia with ribavirin dose reduction and was a subanalysis from the SPRINT-2 data.
-
(2011)
J Hepatol
, vol.54
, Issue.1
-
-
Sulkowski, M.S.1
Poordad, F.2
Manns, M.S.3
Bronowicki, J.P.4
Reddy, K.R.5
Harrison, S.A.6
-
14
-
-
79953176289
-
Boceprevir for previously treated chronic HCV genotype 1 infection
-
10.1056/NEJMoa1009482 1:CAS:528:DC%2BC3MXkt1Cht7k%3D 21449784 Boceprevir-based triple therapy resulted in significantly higher rates of SVR in previously treated patients with chronic HCV genotype 1 infection, as compared with dual therapy
-
•• Bacon BR, et al. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med. 2011;364(13):1207-17. Boceprevir-based triple therapy resulted in significantly higher rates of SVR in previously treated patients with chronic HCV genotype 1 infection, as compared with dual therapy.
-
(2011)
N Engl J Med
, vol.364
, Issue.13
, pp. 1207-1217
-
-
Bacon, B.R.1
-
15
-
-
80053319159
-
Anemia had no effect on efficacy outcomes in treatment-naive patients who received telaprevir-based regimen in the ADVANCE and ILLUMINATE phase 3 studies
-
10.1016/S0168-8278(11)60479-0
-
Sulkowski MS, Reddy R, Afdhal NH, Di Bisceglie AM, Zeuzem S, Poordad F, et al. Anemia had no effect on efficacy outcomes in treatment-naive patients who received telaprevir-based regimen in the ADVANCE and ILLUMINATE phase 3 studies. J Hepatol. 2011;54 suppl 1:S195.
-
(2011)
J Hepatol
, vol.54
, Issue.SUPPL. 1
, pp. 195
-
-
Sulkowski, M.S.1
Reddy, R.2
Afdhal, N.H.3
Di Bisceglie, A.M.4
Zeuzem, S.5
Poordad, F.6
-
16
-
-
84872678655
-
-
FDA April 27 Accessed 8/31/12
-
FDA. Transcript for the meeting of the Antiviral Drugs Advisory Committee. April 27, 2011 Accessed 8/31/12 at: http://www.fda.gov/downloads/ advisorycommittees/committeesmeetingmaterials/drugs/ antiviraldrugsadvisorycommittee/UCM257464.pdf
-
(2011)
Transcript for the Meeting of the Antiviral Drugs Advisory Committee
-
-
-
17
-
-
84872688002
-
-
Program and abstracts of the 47th Annual Meeting of the European Association for the Study of the Liver Barcelona, Spain
-
Hezodé C, Dorival C, Zoulim F, et al. 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). Barcelona, Spain: Program and abstracts of the 47th Annual Meeting of the European Association for the Study of the Liver; 2012.
-
(2012)
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)
-
-
Hezodé, C.1
Dorival, C.2
Zoulim, F.3
-
18
-
-
84872678655
-
-
FDA April 28
-
FDA. Transcript for the meeting of the Antiviral Drugs Advisory Committee. April 28, 2011 Accessed 8/31/12 at: http://www.fda.gov/downloads/ advisorycommittees/committeesmeetingmaterials/drugs/ antiviraldrugsadvisorycommittee/UCM257465.pdf
-
(2011)
Transcript for the Meeting of the Antiviral Drugs Advisory Committee
-
-
-
19
-
-
80051948153
-
Telaprevir user's guide
-
10.1016/j.cld.2011.05.013 21867936
-
Liapakis A, Jacobson I. Telaprevir user's guide. Clin Liver Dis. 2011;15(3):555-71.
-
(2011)
Clin Liver Dis
, vol.15
, Issue.3
, pp. 555-571
-
-
Liapakis, A.1
Jacobson, I.2
-
20
-
-
84866163290
-
-
Cambridge, MA: Vertex Pharmaceuticals Inc
-
Incivek (telaprevir) Package insert. Cambridge, MA: Vertex Pharmaceuticals Inc; 2012.
-
(2012)
Incivek (Telaprevir) Package Insert
-
-
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