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Futility Rules for Telaprevir Combination Treatment for Patients With Hepatitis C Virus Infection |
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Adda N, Bartels DJ, Gritz L, Kieffer TL, Tomaka F, Bengtsson L, Luo D, Jacobson IM, Kauffman RS, Picchio G. Clin Gastroenterol Hepatol. 2012 Nov 14. pii: S1542-3565(12)01386-9. doi: 10.1016/j.cgh.2012.10.045. [Epub ahead of print] |
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Source
Vertex Pharmaceuticals, Inc, Cambridge, Massachusetts.
Abstract
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.
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