A randomized 4-arm multicenter study of interferon alfa-2b plus ribavirin in the treatment of patients with chronic hepatitis C relapsing after interferon monotherapy
| Autor: | Giovannino Ciccone, Aldo Manca, Alessia Ciancio, G. Tappero, S. Carenzi, Alberto Biglino, Pier Giulio Orsi, G. Croce, Marco Tabone, Antonina Smedile, Massimo Andreoni, A. Olivero, Mario Rizzetto, Giuseppe Cariti, Giorgio Maria Saracco, Luigi Roffi |
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| Rok vydání: | 2002 |
| Předmět: |
medicine.medical_specialty
Chemotherapy Hepatology Combination therapy business.industry medicine.medical_treatment Ribavirin Hepatitis C virus medicine.disease_cause Group A Gastroenterology Group B Surgery law.invention chemistry.chemical_compound Randomized controlled trial chemistry law Internal medicine medicine business Interferon alfa medicine.drug |
| Zdroj: | Hepatology. 36:959-966 |
| ISSN: | 0270-9139 |
| Popis: | To determine whether a higher dosage of interferon (IFN) and/or a prolonged time of administration may improve the efficacy of combination therapy, we conducted a 4-arm randomized trial on patients with chronic hepatitis C relapsing after 1 or more previous treatment courses with IFN monotherapy. Group A (n = 70) received 3 MU IFN alfa-2b 3 times per week plus ribavirin 1,000 mg/d for 12 months; group B (n = 70) received 5 MU 3 times per week plus ribavirin for 12 months; group C (n = 82) received 3 MU 3 times per week plus ribavirin for 6 months, and group D (n = 73) received 5 MU 3 times per week plus ribavirin for 6 months. The primary end point was the clearance of viremia at the end of 6-month follow-up: test results for hepatitis C virus (HCV)-RNA were negative in 54% of group A, 56% of group B, 40% of group C, and 49% of group D patients (P = NS). Among patients with genotype 1 and 4, the sustained response was significantly higher in groups A and B than in group C (45%, 49% vs. 22%, P = .03; group D = 33%, P = NS). In patients with genotype 2 and 3, the sustained virologic response was not affected by the different regimens (group A = 69%, group B = 68%, group C = 62%, group D = 71%, P = NS). In conclusion, duration of therapy rather than IFN dosage is more important in increasing the sustained virologic rate among HCV-positive patients with genotype 1 and 4 relapsing after IFN monotherapy; patients with genotypes 2 and 3 can be effectively retreated with a 6-month course of combination therapy, avoiding unnecessary side effects and waste of resources. |
| Databáze: | OpenAIRE |
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