BACKGROUND: Triple therapy with telaprevir (TVR), pegylated interferon and ribavirin has improved antiviral efficacy in patients with chronic hepatitis C (CH-C). However, the severe adverse effects caused by TVR are important to resolve. In this prospective, randomized, multicenter, open-label study, the antiviral efficacy and safety in the reduced administration of TVR were examined. METHODS: A total of 81 CH-C Japanese patients with HCV genotype 1 were randomized into two regimens of TVR 2250 mg (TVR-2250) or 1500 mg (TVR-1500) and treated with triple therapy for 24 weeks. RESULTS: The mean HCV RNA at start, 2 and 4 weeks of treatment were 6.69 ± 0.70, 1.05 ± 0.74, 0.22 ± 0.48 log10 IU/ml in the TVR-2250 group and 6.70 ± 0.62, 1.02 ± 0.62, 0.13 ± 0.41 log10 IU/ml in the TVR-1500 group. The SVR rates were 85% in both groups (35/41 and 34/40, respectively). There were no patients with viral breakthrough in either group. As for adverse effects, rash more than moderate and severe anemia with <8.5 g/dl of hemoglobin were higher in the TVR-2250 group than in the TVR-1500 group (p = 0.046, p < 0.001, respectively). The increase in serum creatinine levels and decrease in estimated glomerular filtration rates were higher in the TVR-2250 group than in the TVR-1500 group. CONCLUSIONS: The lower dose of TVR (1500 mg/day) can result in similar SVR rates and lower treatment-related adverse effects compared to the higher dose of TVR (2250 mg/day) in triple therapy (UMIN: 000007313, 000007330).
BACKGROUND: Triple therapy with telaprevir (TVR), pegylated interferon and ribavirin has improved antiviral efficacy in patients with chronic hepatitis C (CH-C). However, the severe adverse effects caused by TVR are important to resolve. In this prospective, randomized, multicenter, open-label study, the antiviral efficacy and safety in the reduced administration of TVR were examined. METHODS: A total of 81 CH-C Japanese patients with HCV genotype 1 were randomized into two regimens of TVR 2250 mg (TVR-2250) or 1500 mg (TVR-1500) and treated with triple therapy for 24 weeks. RESULTS: The mean HCV RNA at start, 2 and 4 weeks of treatment were 6.69 ± 0.70, 1.05 ± 0.74, 0.22 ± 0.48 log10 IU/ml in the TVR-2250 group and 6.70 ± 0.62, 1.02 ± 0.62, 0.13 ± 0.41 log10 IU/ml in the TVR-1500 group. The SVR rates were 85% in both groups (35/41 and 34/40, respectively). There were no patients with viral breakthrough in either group. As for adverse effects, rash more than moderate and severe anemia with <8.5 g/dl of hemoglobin were higher in the TVR-2250 group than in the TVR-1500 group (p = 0.046, p < 0.001, respectively). The increase in serum creatinine levels and decrease in estimated glomerular filtration rates were higher in the TVR-2250 group than in the TVR-1500 group. CONCLUSIONS: The lower dose of TVR (1500 mg/day) can result in similar SVR rates and lower treatment-related adverse effects compared to the higher dose of TVR (2250 mg/day) in triple therapy (UMIN: 000007313, 000007330).
Authors: Michael W Fried; Maria Buti; Gregory J Dore; Robert Flisiak; Peter Ferenci; Ira Jacobson; Patrick Marcellin; Michael Manns; Igor Nikitin; Fred Poordad; Morris Sherman; Stefan Zeuzem; Jane Scott; Leen Gilles; Oliver Lenz; Monika Peeters; Vanitha Sekar; Goedele De Smedt; Maria Beumont-Mauviel Journal: Hepatology Date: 2013-10-11 Impact factor: 17.425
Authors: Hendrik W Reesink; Stefan Zeuzem; Christine J Weegink; Nicole Forestier; Andre van Vliet; Jeroen van de Wetering de Rooij; Lindsay McNair; Susan Purdy; Robert Kauffman; John Alam; Peter L M Jansen Journal: Gastroenterology Date: 2006-10 Impact factor: 22.682
Authors: Stefan Zeuzem; Pietro Andreone; Stanislas Pol; Eric Lawitz; Moises Diago; Stuart Roberts; Roberto Focaccia; Zobair Younossi; Graham R Foster; Andrzej Horban; Peter Ferenci; Frederik Nevens; Beat Müllhaupt; Paul Pockros; Ruben Terg; Daniel Shouval; Bart van Hoek; Ola Weiland; Rolf Van Heeswijk; Sandra De Meyer; Don Luo; Griet Boogaerts; Ramon Polo; Gaston Picchio; Maria Beumont Journal: N Engl J Med Date: 2011-06-23 Impact factor: 91.245
Authors: Ira M Jacobson; John G McHutchison; Geoffrey Dusheiko; Adrian M Di Bisceglie; K Rajender Reddy; Natalie H Bzowej; Patrick Marcellin; Andrew J Muir; Peter Ferenci; Robert Flisiak; Jacob George; Mario Rizzetto; Daniel Shouval; Ricard Sola; Ruben A Terg; Eric M Yoshida; Nathalie Adda; Leif Bengtsson; Abdul J Sankoh; Tara L Kieffer; Shelley George; Robert S Kauffman; Stefan Zeuzem Journal: N Engl J Med Date: 2011-06-23 Impact factor: 91.245
Authors: John G McHutchison; Gregory T Everson; Stuart C Gordon; Ira M Jacobson; Mark Sulkowski; Robert Kauffman; Lindsay McNair; John Alam; Andrew J Muir Journal: N Engl J Med Date: 2009-04-30 Impact factor: 91.245