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- Title
A randomized trial of prolonged high dose of interferon plus ribavirin for hepatitis C patients nonresponders to interferon alone.
- Authors
Fattovich, G.; Zagni, I.; Ribero, M. L.; Castagnetti, E.; Minola, E.; Lomonaco, L.; Scattolini, C.; Fabris, P.; Boccia, S.; Giusti, M.; Abbati, G.; Felder, M.; Rovere, P.; Redaelli, A.; Tonon, A.; Tomba, A.; Montanari, R.; Paternoster, C.; Distasi, M.; Fornaciari, G.
- Abstract
Retreatment of chronic hepatitis C patients nonresponders to interferon (IFN) alone with the standard dose of IFN [3 million units (MU) thrice weekly (TIW)] plus ribavirin for 24 weeks has yielded low sustained virological response (SVR), averaging 8%. The aim of the present, open-labelled, randomized study was to evaluate the efficacy of IFN induction therapy followed by prolonged high dose of IFN plus ribavirin in nonresponders. One hundred and fifty-one patients were randomized to receive 5 MU daily of IFN alfa-2b (group 1,n = 73) or 5 MU TIW of IFN alfa 2b (group 2,n = 78) for 4 weeks followed by IFN (5 MU TIW) plus ribavirin (1000/1200 mg/daily) for 48 weeks in both groups. In an intention-to-treat analysis, the sustained virological response (SVR) at 24-week follow-up was 33 and 23% for group 1 and 2, respectively (P = 0.17). The overall SVR was 52 and 18% in patients with genotype 2/3 and 1/4, respectively. Among genotype 1/4 patients the SVR was 29 and 11% for age younger or older than 40 years. Compared with genotype 2/3 patients, the risk (95% confidence interval) of nonresponse to retreatment was 3.0-fold (1.17–8.0) in younger genotype 1/4 patients and 8.4-fold (3.0–23.29) in older genotype 1/4 patients. In conclusion these results suggest that retreatment with a reinforced regimen should be focused in nonresponder genotype 2/3 patients and younger genotype 1/4 patients, who are most likely to benefit. Induction therapy does not improve SVR.
- Subjects
HEPATITIS C treatment; INTERFERONS; RIBAVIRIN; ANTIVIRAL agents; CLINICAL trials; DRUG efficacy
- Publication
Journal of Viral Hepatitis, 2004, Vol 11, Issue 6, p543
- ISSN
1352-0504
- Publication type
Article
- DOI
10.1111/j.1365-2893.2004.00538.x