Effectiveness of Telaprevir or Boceprevir in Treatment-Experienced Patients With HCV Genotype 1 Infection and Cirrhosis

被引：201

作者：

Hezode, Christophe ^{[1
]}

Fontaine, Helene ^{[2
]}

Dorival, Celine ^{[3
]}

Zoulim, Fabien ^{[4
]}

Larrey, Dominique ^{[5
]}

Canva, Valerie ^{[6
,7
]}

De Ledinghen, Victor ^{[8
]}

Poynard, Thierry ^{[9
]}

Samuel, Didier ^{[10
]}

Bourliere, Marc ^{[11
]}

Alric, Laurent ^{[12
]}

Raabe, Jean-Jacques ^{[13
]}

Zarski, Jean-Pierre ^{[14
]}

Marcellin, Patrick ^{[15
]}

Riachi, Ghassan ^{[16
]}

Bernard, Pierre-Henri ^{[17
]}

Loustaud-Ratti, Veronique ^{[18
]}

Chazouilleres, Olivier ^{[19
]}

Abergel, Armand ^{[21
]}

Guyader, Dominique ^{[22
]}

Metivier, Sophie ^{[23
]}

Tran, Albert ^{[24
]}

Di Martino, Vincent ^{[25
]}

Causse, Xavier ^{[26
]}

Dao, Thong ^{[27
]}

Lucidarme, Damien ^{[28
]}

Portal, Isabelle ^{[29
]}

Cacoub, Patrice ^{[30
]}

Gournay, Jerome ^{[31
]}

Grando-Lemaire, Veronique ^{[32
]}

Hillon, Patrick ^{[33
]}

Attali, Pierre ^{[34
]}

Fontanges, Thierry ^{[35
]}

Rosa, Isabelle ^{[36
]}

Petrov-Sanchez, Ventzislava ^{[37
]}

Barthe, Yoann ^{[3
]}

Pawlotsky, Jean-Michel ^{[38
]}

Pol, Stanislas ^{[2
]}

Carrat, Fabrice ^{[3
,20
]}

Bronowicki, Jean-Pierre ^{[39
]}

机构：

[1] Univ Paris Est, Hop Henri Mondor, AP HP, Dept Hepatol & Gastroenterol,INSERM,U955, Creteil, France

[2] Univ Paris 05, Hop Cochin, AP HP, Dept Hepatol,INSERM,U1016, Paris, France

[3] Univ Paris 06, INSERM, UMR S 1136, Paris, France

[4] Univ Lyon, Hosp Civils Lyon, Dept Hepatol, INSERM,U1052, Lyon, France

[5] Hop St Eloi, INSERM1040, Liver Unit, IRB, Montpellier, France

[6] Ctr Hosp Reg, Dept Hepatol & Gastroenterol, Lille, France

[7] Univ Claude Huriez, Lille, France

[8] Univ Bordeaux Segalen, Hop Haut Leveque, Dept Hepatol & Gastroenterol, INSERM,U1053, Bordeaux, France

[9] Univ Paris 06, Grp Hosp Pitie Salpetriere, AP HP, Dept Hepatol & Gastroenterol,INSERM,UMR S938, Paris, France

[10] Univ Paris 11, Hop Paul Brousse, AP HP, Ctr Hepatobiliaire,UMR S785,INSERM,U785, Villejuif, France

[11] Hop St Joseph, Dept Hepatol & Gastroenterol, Marseille, France

[12] Univ Toulouse 3, Dept Internal Med & Digest Dis, UMR 152, F-31062 Toulouse, France

[13] Ctr Hosp Reg, Dept Hepatol & Gastroenterol, Metz, France

[14] Ctr Hosp Univ, INSERM, Dept Hepatol & Gastroenterol,U823, Grenoble, France

[15] Univ Paris Diderot, Hop Beaujon, AP HP, Dept Hepatol,INSERM,CRB3, Clichy, France

[16] CHU Charles Nicolle, Dept Hepatol & Gastroenterol, Rouen, France

[17] Univ Bordeaux Segalen, Hop St Andre Bordeaux, Serv Hepatol & Gastroenterol, Bordeaux, France

[18] Univ Limoges, CHU Dupuytren, Dept Hepatol & Gastroenterol, INSERM,UMR U1092, Limoges, France

[19] Hop St Antoine, AP HP, Dept Hepatol, F-75571 Paris, France

[20] Hop St Antoine, AP HP, Dept Publ Hlth, F-75571 Paris, France

[21] Univ Auvergne, CHU Estaing, Dept Hepatol & Gastroenterol, UMR 6284, Clermont Ferrand, France

[22] Univ Rennes 1, CHU Rennes, INSERM, Serv Malad Foie,U991, Rennes, France

[23] CHU Purpan, Dept Hepatol & Gastroenterol, Toulouse, France

[24] Ctr Hosp Univ Nice, Digest Ctr, INSERM, U1065 8, Nice, France

[25] Univ Franche Comte, CHU Jean Minjoz, Serv Hepatol, F-25030 Besancon, France

[26] CHR La Source, Dept Hepatol & Gastroenterol & Digest Oncon, Orleans, France

[27] CHU, INSERM, Dept Hepatol & Gastroenterol, U1075, Caen, France

[28] Fac Libre Med, Grp Hosp, Inst Cathol, Dept Hepatol & Gastroenterol, Lille, France

[29] Hop Conception, Dept Hepatol & Gastroenterol, Marseille, France

[30] Univ Paris 06, Grp Hosp Pitie Salpetriere, AP HP, CNRS,Dept Internal Med,INSERM,UMR S959,UMR 7211, Paris, France

[31] Hop Hopel Dieu, Dept Hepatol & Gastroenterol, Nantes, France

[32] Univ Paris 13, Hop Jean Verdier, AP HP, Dept Hepatol & Gastroenterol, Bondy, France

[33] Univ Bourgogne, CHU Dijon, Dept Hepatol & Gastroenterol, Dijon, France

[34] Hop Bicetre, AP HP, Dept Hepatol & Gastroenterol, Le Kremlin Bicetre, France

[35] Hop P Oudot, Dept Hepatol & Gastroenterol, Bourgoin Jallieu, France

[36] Ctr Hosp Intercommunal, Dept Hepatol & Gastroenterol, Creteil, France

[37] French Natl Agcy Res AIDS & Viral Hepatitis, Unit Basic & Clin Res Viral Hepatitis, Paris, France

[38] Univ Paris Est, Hop Henri Mondor, AP HP,INSERM,U955, Natl Reference Ctr Viral Hepatitis BC & Delta,Dep, Creteil, France

[39] Univ Lorraine, INSERM, Dept Hepatol & Gastroenterol, Ctr Hosp Univ Nancy,U954, Vandoeuvre Les Nancy, France

来源：

GASTROENTEROLOGY | 2014年 / 147卷 / 01期

关键词：

Chronic Hepatitis C; CUPIC; DAA; Triple Therapy; CHRONIC HEPATITIS-C; SUSTAINED VIROLOGICAL RESPONSE; COMPENSATED CIRRHOSIS; TREATMENT FAILURE; PLUS SOFOSBUVIR; NATURAL-HISTORY; RISK-FACTORS; LONG-TERM; RIBAVIRIN; PEGINTERFERON;

D O I：

10.1053/j.gastro.2014.03.051

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

BACKGROUND & AIMS: We investigated the effectiveness of the protease inhibitors peginterferon and ribavirin in treatment-experienced patients with hepatitis C virus (HCV) genotype 1 infection and cirrhosis. METHODS: In the Compassionate Use of Protease Inhibitors in Viral C Cirrhosis study, 511 patients with HCV genotype 1 infection and compensated cirrhosis who did not respond to a prior course of peginterferon and ribavirin (44.3% relapsers or patients with viral breakthrough, 44.8% partial responders, and 8.0% null responders) were given either telaprevir (n = 299) or boceprevir (n = 212) for 48 weeks. We assessed percentages of patients with sustained viral responses 12 weeks after therapy and safety. This observational study did not allow for direct comparison of the 2 regimens. RESULTS: Among patients given telaprevir, 74.2% of relapsers, 40.0% of partial responders, and 19.4% of null responders achieved SVR12. Among those given boceprevir, 53.9% of relapsers, 38.3% of partial responders, and none of the null responders achieved SVR12. In multivariate analysis, factors associated with SVR12 included prior response to treatment response, no lead-in phase, HCV subtype 1b (vs 1a), and baseline platelet count greater than 100,000/mm(3). Severe adverse events occurred in 49.9% of cases, including liver decompensation, severe infections in 10.4%, and death in 2.2%. In multivariate analysis, baseline serum albumin level less than 35 g/L and baseline platelet counts of 100,000/mm(3) or less predicted severe side effects or death. CONCLUSIONS: Relatively high percentages of real-life, treatment-experienced patients with HCV genotype 1 infection and cirrhosis respond to the combination of peginterferon and ribavirin with telaprevir or boceprevir. However, side effects are frequent and often severe. Baseline levels of albumin and platelet counts can be used to guide treatment decisions. ClinicalTrials.gov number: NCT01514890.

引用

页码：132 / U235

页数：15

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