Futility Rules for Telaprevir Combination Treatment for Patients With Hepatitis C Virus Infection

被引：7

作者：

Adda, Nathalie ^{[1
]}

Bartels, Doug J. ^{[1
]}

Gritz, Linda ^{[1
]}

Kieffer, Tara L. ^{[1
]}

Tomaka, Frank ^{[2
]}

Bengtsson, Leif ^{[1
]}

Luo, Don ^{[2
]}

Jacobson, Ira M. ^{[3
]}

Kauffman, Robert S. ^{[1
]}

Picchio, Gaston ^{[2
]}

机构：

[1] Vertex Pharmaceut Inc, Cambridge, MA USA

[2] Janssen Res & Dev, Titusville, NJ 08560 USA

[3] Weill Cornell Med Coll, New York, NY USA

来源：

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY | 2013年 / 11卷 / 02期

关键词：

Chronic Hepatitis; Protease Inhibitor; SVR; PEGINTERFERON; RIBAVIRIN;

D O I：

10.1016/j.cgh.2012.10.045

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

For patients treated with telaprevir, peginterferon, and ribavirin, futility rules have been developed to prevent needless drug exposure and minimize development of drug-resistant variants for patients who have little or no chance of achieving a sustained virologic response. We performed retrospective analyses of data from phase 3 trials and validated the current futility rule. All therapy should be stopped for treatment-naive and treatment-experienced patients if hepatitis C virus RNA levels are greater than 1000 IU/mL at weeks 4 or 12, or if hepatitis C virus RNA is detectable at week 24.

引用

页码：193 / 195

页数：3

共 8 条

[1]

[Anonymous], 2011, PEG

[2]

Cambridge MA, 2012, INC

[3] Telaprevir and Peginterferon with or without Ribavirin for Chronic HCV Infection [J].

Hezode, Christophe ;

Forestier, Nicole ;

Dusheiko, Geoffrey ;

Ferenci, Peter ;

Pol, Stanislas ;

Goeser, Tobias ;

Bronowicki, Jean-Pierre ;

Bourliere, Marc ;

Gharakhanian, Shahin ;

Bengtsson, Leif ;

McNair, Lindsay ;

George, Shelley ;

Kieffer, Tara ;

Kwong, Ann ;

Kauffman, Robert S. ;

Alam, John ;

Pawlotsky, Jean-Michel ;

Zeuzem, Stefan .

NEW ENGLAND JOURNAL OF MEDICINE, 2009, 360 (18) :1839-1850

[4] Telaprevir for Previously Untreated Chronic Hepatitis C Virus Infection [J].

Jacobson, Ira M. ;

McHutchison, John G. ;

Dusheiko, Geoffrey ;

Di Bisceglie, Adrian M. ;

Reddy, K. Rajender ;

Bzowej, Natalie H. ;

Marcellin, Patrick ;

Muir, Andrew J. ;

Ferenci, Peter ;

Flisiak, Robert ;

George, Jacob ;

Rizzetto, Mario ;

Shouval, Daniel ;

Sola, Ricard ;

Terg, Ruben A. ;

Yoshida, Eric M. ;

Adda, Nathalie ;

Bengtsson, Leif ;

Sankoh, Abdul J. ;

Kieffer, Tara L. ;

George, Shelley ;

Kauffman, Robert S. ;

Zeuzem, Stefan .

NEW ENGLAND JOURNAL OF MEDICINE, 2011, 364 (25) :2405-2416

[5] Telaprevir for Previously Treated Chronic HCV Infection. [J].

McHutchison, John G. ;

Manns, Michael P. ;

Muir, Andrew J. ;

Terrault, Norah A. ;

Jacobson, Ira M. ;

Afdhal, Nezam H. ;

Heathcote, E. Jenny ;

Zeuzem, Stefan ;

Reesink, Hendrik W. ;

Garg, Jyotsna ;

Bsharat, Mohammad ;

George, Shelley ;

Kauffman, Robert S. ;

Adda, Nathalie ;

Di Bisceglie, Adrian M. .

NEW ENGLAND JOURNAL OF MEDICINE, 2010, 362 (14) :1292-1303

[6] Telaprevir with Peginterferon and Ribavirin for Chronic HCV Genotype 1 Infection [J].

McHutchison, John G. ;

Everson, Gregory T. ;

Gordon, Stuart C. ;

Jacobson, Ira M. ;

Sulkowski, Mark ;

Kauffman, Robert ;

McNair, Lindsay ;

Alam, John ;

Muir, Andrew J. .

NEW ENGLAND JOURNAL OF MEDICINE, 2009, 360 (18) :1827-1838

[7] Response-Guided Telaprevir Combination Treatment for Hepatitis C Virus Infection [J].

Sherman, Kenneth E. ;

Flamm, Steven L. ;

Afdhal, Nezam H. ;

Nelson, David R. ;

Sulkowski, Mark S. ;

Everson, Gregory T. ;

Fried, Michael W. ;

Adler, Michael ;

Reesink, Hendrik W. ;

Martin, Marie ;

Sankoh, Abdul J. ;

Adda, Nathalie ;

Kauffman, Robert S. ;

George, Shelley ;

Wright, Christopher I. ;

Poordad, Fred .

NEW ENGLAND JOURNAL OF MEDICINE, 2011, 365 (11) :1014-1024

[8] Telaprevir for Retreatment of HCV Infection [J].

Zeuzem, Stefan ;

Andreone, Pietro ;

Pol, Stanislas ;

Lawitz, Eric ;

Diago, Moises ;

Roberts, Stuart ;

Focaccia, Roberto ;

Younossi, Zobair ;

Foster, Graham R. ;

Horban, Andrzej ;

Ferenci, Peter ;

Nevens, Frederik ;

Muellhaupt, Beat ;

Pockros, Paul ;

Terg, Ruben ;

Shouval, Daniel ;

van Hoek, Bart ;

Weiland, Ola ;

Van Heeswijk, Rolf ;

De Meyer, Sandra ;

Luo, Don ;

Boogaerts, Griet ;

Polo, Ramon ;

Picchio, Gaston ;

Beumont, Maria .

NEW ENGLAND JOURNAL OF MEDICINE, 2011, 364 (25) :2417-2428

← 1 →