Treatment with recombinant interferon-alpha 2a for patients with chronic hepatitis C: predictive factors for biochemical and virologic response. Osaka Liver Disease Study Group.
BACKGROUND
The heterogeneity of the hepatitis C virus (HCV) genome has been reported to be associated with the effectiveness of interferon therapy. We investigated the correlation of the viral and host factors, including the degree of sequence complexity of the HCV genome for responses to interferon-alpha in patients with chronic hepatitis C.


METHODS
Ninety-seven patients received a 26-week course of recombinant interferon-alpha 2a therapy. The sequence complexity of the envelope 1-2 region was evaluated by polymerase chain reaction-mediated single-strand conformation polymorphism (PCR-SSCP) analysis.


RESULTS
Of the 85 patients who completed the treatment, 31 (36%) achieved a sustained response, and 28 (33%) showed a sustained loss of HCV RNA. A low HCV RNA level, determined by the branched DNA probe assay, and serotype group 2 HCV correlated with a sustained response. In patients with serotype group 1 HCV of more than the threshold of the branched DNA probe assay, a band number on PCR-SSCP analysis of more than 2 could be associated with inefficacy of interferon therapy. Multivariate analysis in the 50 patients whose sera were available for all the virologic tests showed that only the HCV RNA level is independently predictive of a sustained response.


CONCLUSIONS
Determination of the HCV RNA level is most important for predicting the response before interferon therapy. PCR-SSCP analysis may be useful as an additional test for patients with a high HCV RNA level of serotype group 1 HCV.
First Dept. of Medicine, Osaka University, School of Medicine, Suita; Dept. of Gastroenterology, Osaka National Hospital; and Dept. of Pathology, Osaka City University, Medical School, Osaka, Japan.
H
H
Hagiwara
N
N
Hayashi
A
A
Kasahara
M
M
Oshita
K
K
Katayama
M
M
Kato
M
M
Masuzawa
H
H
Fusamoto
M
M
Sakurai
T
T
Kamada
D000328:Adult; D016009:Chi-Square Distribution; D002908:Chronic Disease; D005260:Female; D016174:Hepacivirus / Q000187:drug effects*; D006526:Hepatitis C / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction; D018807:Polymorphism, Single-Stranded Conformational; D011237:Predictive Value of Tests; D012367:RNA, Viral / Q000032:analysis*; D011994:Recombinant Proteins; D016896:Treatment Outcome
D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins