Telaprevir Twice Daily Is Noninferior to Telaprevir Every 8 Hours for Patients With Chronic Hepatitis C

Background & Aims We 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. Methods Patients were randomly assigned to groups t...

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Veröffentlicht in:	Gastroenterology (New York, N.Y. 1943) N.Y. 1943), 2014-03, Vol.146 (3), p.744-753.e3
Hauptverfasser:	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
Format:	Artikel
Sprache:	eng
Schlagworte:	Adult Antiviral Agents - administration & dosage Antiviral Agents - adverse effects Antiviral Agents - therapeutic use Clinical Trial DAA Dose-Response Relationship, Drug Drug Administration Schedule Drug Therapy, Combination Fatigue - epidemiology Female Gastroenterology and Hepatology Genotype Headache - epidemiology Hepacivirus - genetics Hepatitis C, Chronic - blood Hepatitis C, Chronic - drug therapy Humans Incidence Interferon-alpha - adverse effects Interferon-alpha - therapeutic use Male Middle Aged Nausea - epidemiology Oligopeptides - administration & dosage Oligopeptides - adverse effects Oligopeptides - therapeutic use OPTIMIZE Polyethylene Glycols - adverse effects Polyethylene Glycols - therapeutic use Protease Inhibitor Recombinant Proteins - adverse effects Recombinant Proteins - therapeutic use Ribavirin - adverse effects Ribavirin - therapeutic use RNA, Viral - blood Treatment Outcome
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Zusammenfassung:	Background & Aims We 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. Methods Patients 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
ISSN:	0016-5085 1528-0012
DOI:	10.1053/j.gastro.2013.11.047