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- Title
Efficacy of prolonged 5 million units of interferon in combination with ribavirin for relapser patients with chronic hepatitis C.
- Authors
Fattovich, G.; Zagni, I.; Fornaciari, G.; Minola, E.; Fabris, P.; Boccia, S.; Giusti, M.; Abbati, G.; Felder, M.; Rovere, P.; Redaelli, A.; Tonon, A.; Montanari, R.; Paternoster, C.; Distasi, M.; Castagnetti, E.; Tositti, G.; Rizzo, C.; Suppressa, S.; Pantalena, M.
- Abstract
summary. Retreatment of relapser patients with chronic hepatitis C with the standard dose of interferon (IFN) of 3 million units (MU) thrice weekly (tiw) plus ribavirin for 24 weeks achieves a sustained response in 30 and 73% of patients with genotype 1 and 2 or 3, respectively. The aim of this study was to evaluate the efficacy and safety of IFN α -2b induction therapy, followed by prolonged treatment with a high dose of IFN α -2b plus ribavirin in relapser patients. A total of 119 patients were randomized to receive IFN α -2b 5 MU daily (Group A: 59 patients) or IFN α -2b 5 MU tiw (Group B: 60 patients) for 4 weeks followed by IFN (5 MU tiw) and ribavirin (1000–1200 mg/day) for 48 weeks in both groups. The primary end point was hepatitis C virus (HCV)-RNA clearance at week 24 after the end of treatment. A sustained virological response (SVR) was achieved in 68 and 60% of Group A and B patients, respectively (P = 0.37). Logistic regression analysis identified genotype 2 or 3 as the only independent factor associated with response, whereas induction regimen and baseline viraemia levels did not affect the response. The overall SVR was 53 and 72% in patients with genotype 1 or 4 and 2 or 3, respectively. In conclusion, induction IFN therapy does not enhance the SVR to a 48-week combination therapy. Our study suggests that relapsed patients with genotype 1 or 4 may achieve significant response rates of approximately 50%, if retreated with 5 MU tiw IFN plus ribavirin for 48 weeks.
- Subjects
HEPATITIS C; HEPATITIS C virus; INTERFERONS; RIBAVIRIN; DISEASE relapse
- Publication
Journal of Viral Hepatitis, 2003, Vol 10, Issue 2, p111
- ISSN
1352-0504
- Publication type
Article
- DOI
10.1046/j.1365-2893.2003.00409.x