Telaprevir Twice Daily Is Noninferior to Telaprevir Every 8 Hours for Patients With Chronic Hepatitis C
- Buti, Maria
- Agarwal, Kosh
- Horsmans, Yves
- Sievert, William
- Janczewska, Ewa
- Zeuzem, Stefan
- Nyberg, Lisa
- Brown, Robert S.
- Hézode, Christophe
- Rizzetto, Mario
- Paraná, Raymundo
- De Meyer, Sandra
- De Masi, Ralph
- Luo, Donghan
- Bertelsen, Kirk
- Witek, James
DOIAbstract
Background & AimsWe performed an open-label, multicenter, phase 3 study of the safety and efficacy of twice-daily telaprevir in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with cirrhosis.MethodsPatients were randomly assigned to groups treated with telaprevir 1125 mg twice daily or 750 mg every 8 hours plus peginterferon alfa-2a and ribavirin for 12 weeks; patients were then treated with peginterferon alfa-2a and ribavirin alone for 12 weeks if their level of HCV RNA at week 4 was <25 IU/mL or for 36 weeks if their level was higher. The primary objective was to demonstrate noninferiority of telaprevir twice daily versus every 8 hours in producing a sustained virological response 12 wee...
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