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A prospective, randomized trial comparing lymphoblastoid to recombinant interferon alfa 2a as therapy for chronic hepatitis C
Author(s) -
Rumi M,
Del Ninno E,
Parravicini M L,
Romeo R,
Soffredini R,
Donato M F,
Wilber J,
Russo A,
Colombo M
Publication year - 1996
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.510240609
Subject(s) - bdna test , medicine , gastroenterology , interferon alfa , alpha interferon , interferon , tolerability , immunology , hepatitis c virus , viremia , virology , virus , adverse effect
To compare the long‐term effectiveness and tolerability of lymphoblastoid interferon (IFN‐αN1) and recombinant interferon alfa 2a (IFN‐α2a) in patients with chronic hepatitis caused by hepatitis C virus (HCV), 234 consecutive patients with HCV‐related chronic hepatitis were randomized prospectively to receive titrated doses (starting dose = 6 million units [MU]) of IFN‐α2a (n = 118) or IFN‐αN1 (n = 116) for 12 months. HCV RNA was detected by reverse‐ transcription polymerase chain reaction (RT‐PCR), quantified by branched‐DNA (bDNA) assay, and genotyped by reverse hybridization assay. Thirty‐one patients in the IFN‐α2a group and 28 in the IFN‐ αN1 group (total, 59 [25%]) had normal transaminases and undetectable HCV RNA by RT‐PCR after 12 months of therapy, but only 19 in the first group and 20 in the second group (total, 39 [17%]) had biochemical and virological responses 12 months after treatment was discontinued. The two treatment groups differed in terms of prevalence of major drug‐related adverse reactions (23% vs. 37%, P = .025). The mean total dose per patient was similar for the two groups, i.e., 502 MU IFN‐α2a vs. 496 MU IFN‐αN1, and the cost of each sustained response was $31,800 and $32,440, respectively. By multivariate analysis, pretreatment viremia higher than 0.2 MEq/mL and infection with genotype 1 were independently associated to treatment failure. The outcome of treatment in chronic hepatitis C patients was not improved by the administration of high cumulative doses of lymphoblastoid IFN.