Document Detail


Telaprevir for previously treated chronic HCV infection.
MedLine Citation:
PMID:  20375406     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Patients with genotype 1 hepatitis C virus (HCV) who do not have a sustained response to therapy with peginterferon alfa and ribavirin have a low likelihood of success with retreatment. METHODS: We randomly assigned patients with HCV genotype 1 who had not had a sustained virologic response after peginterferon alfa-ribavirin therapy to one of four treatment groups: 115 patients to the T12PR24 group, receiving telaprevir (1125-mg loading dose, then 750 mg every 8 hours) for 12 weeks and peginterferon alfa-2a (180 microg per week) and ribavirin (1000 or 1200 mg per day, according to body weight) for 24 weeks; 113 patients to the T24PR48 group, receiving telaprevir for 24 weeks and peginterferon alfa-2a and ribavirin for 48 weeks (at the same doses as in the T12PR24 group); 111 patients to the T24P24 group, receiving telaprevir and peginterferon alfa-2a for 24 weeks (at the same doses as in the T12PR24 group); and 114 patients to the PR48 (or control) group, receiving peginterferon alfa-2a and ribavirin for 48 weeks (at the same doses as in the T12PR24 group). The primary end point was sustained virologic response (undetectable HCV RNA levels 24 weeks after the last dose of study drugs). RESULTS: The rates of sustained virologic response in the three telaprevir groups--51% in the T12PR24 group, 53% in the T24PR48 group, and 24% in the T24P24 group--were significantly higher than the rate in the control group (14%; P<0.001, P<0.001, and P=0.02, respectively). Response rates were higher among patients who had previously had relapses than among nonresponders. One of the most common adverse events in the telaprevir groups was rash (overall, occurring in 51% of patients, with severe rash in 5%). Discontinuation of study drugs because of adverse events was more frequent in the telaprevir groups than in the control group (15% vs. 4%). CONCLUSIONS: In HCV-infected patients in whom initial peginterferon alfa and ribavirin treatment failed, retreatment with telaprevir in combination with peginterferon alfa-2a and ribavirin was more effective than retreatment with peginterferon alfa-2a and ribavirin alone. (ClinicalTrials.gov number, NCT00420784.)
Authors:
John G McHutchison; Michael P Manns; Andrew J Muir; Norah A Terrault; Ira M Jacobson; Nezam H Afdhal; E Jenny Heathcote; Stefan Zeuzem; Hendrik W Reesink; Jyotsna Garg; Mohammad Bsharat; Shelley George; Robert S Kauffman; Nathalie Adda; Adrian M Di Bisceglie;
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  362     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2010 Apr 
Date Detail:
Created Date:  2010-04-08     Completed Date:  2010-04-15     Revised Date:  2010-10-07    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1292-303     Citation Subset:  AIM; IM    
Copyright Information:
2010 Massachusetts Medical Society
Affiliation:
Duke Clinical Research Institute and Duke University Medical Center, Durham, NC, USA.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00420784
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Antiviral Agents / adverse effects,  therapeutic use*
Double-Blind Method
Drug Therapy, Combination
Exanthema / chemically induced
Female
Genotype
Hemoglobins / analysis
Hepacivirus* / genetics,  isolation & purification
Hepatitis C, Chronic / drug therapy*,  virology
Humans
Interferon Alfa-2a / therapeutic use
Male
Middle Aged
Oligopeptides / adverse effects,  therapeutic use*
Polyethylene Glycols / therapeutic use
RNA, Viral / blood
Retreatment
Ribavirin / therapeutic use
Serine Proteinase Inhibitors / adverse effects,  therapeutic use
Treatment Failure
Viral Load / drug effects
Young Adult
Chemical
Reg. No./Substance:
0/Antiviral Agents; 0/Hemoglobins; 0/Oligopeptides; 0/Polyethylene Glycols; 0/RNA, Viral; 0/Serine Proteinase Inhibitors; 0/peginterferon alfa-2a; 0/telaprevir; 36791-04-5/Ribavirin; 76543-88-9/Interferon Alfa-2a
Investigator
Investigator/Affiliation:
E J Heathcote / ; K Kaita / ; M Ma / ; R Myers / ; M Sherman / ; E Yoshida / ; T Berg / ; M P Manns / ; S Zeuzem / ; R de Knegt / ; H W Reesink / ; B van Hoek / ; N H Afdhal / ; S Arora / ; D Bernstein / ; J Cochran / ; A M Di Bisceglie / ; R Dickson / ; D T Dieterich / ; K Etzkorn / ; G T Everson / ; S Faruqui / ; R Ghalib / ; N Gitlin / ; E Godofsky / ; S Gordon / ; T Hassanein / ; I M Jacobson / ; A Kilby / ; M Kugelmas / ; P Y Kwo / ; E S Lawitz / ; K Lindsay / ; M Maillard / ; D R Nelson / ; L Nyberg / ; K Patel / ; A J Muir / ; F F Poordad / ; M Rodriguez-Torres / ; V Rustgi / ; E Schiff / ; O Shaikh / ; K E Sherman / ; M L Shiffman / ; J Smith / ; J Strohecker / ; M S Sulkowski / ; H Te / ; N A Terrault / ; J Vierling / ; L Wruble / ; Z M Younossi / ; N Zein /
Comments/Corrections
Comment In:
Ann Intern Med. 2010 Aug 17;153(4):JC2-7   [PMID:  20713786 ]
Gastroenterology. 2010 Oct;139(4):1412-6; discussion 1416   [PMID:  20732462 ]
Erratum In:
N Engl J Med. 2010 Apr 29;362(17):1647
Note: Dosage error in article text

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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