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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
Author(s) -
Saracco Giorgio,
Olivero Alda,
Ciancio Alessia,
Carenzi Silvia,
Smedile Antonina,
Cariti Giuseppe,
Andreoni Massimo,
Orsi Pier Giulio,
Biglino Alberto,
Tabone Marco,
Roffi Luigi,
Croce Guido,
Manca Aldo,
Tappero Gianfranco,
Ciccone Giovannino,
Rizzetto Mario
Publication year - 2002
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1053/jhep.2002.35442
Subject(s) - ribavirin , medicine , gastroenterology , alpha interferon , group a , group b , interferon alfa , interferon , randomized controlled trial , hepatitis c virus , immunology , virus
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.