TY - JOUR
T1 - A prospective, randomized trial comparing lymphoblastoid to recombinant interferon alfa 2a as therapy for chronic hepatitis C
AU - Rumi, Mariagrazia
AU - Del Ninno, Ersilio
AU - Parravicini, Maria Luisa
AU - Romeo, Raffaella
AU - Soffredini, Roberta
AU - Donato, Maria Francesca
AU - Wilber, Judith
AU - Russo, Antonio
AU - Colombo, Massimo
PY - 1996/12
Y1 - 1996/12
N2 - 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.
AB - 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.
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U2 - 10.1053/jhep.1996.v24.pm0008938163
DO - 10.1053/jhep.1996.v24.pm0008938163
M3 - Article
C2 - 8938163
AN - SCOPUS:0029912074
VL - 24
SP - 1366
EP - 1370
JO - Hepatology
JF - Hepatology
SN - 0270-9139
IS - 6
ER -