BREAKTHROUGH AND INTERFERON DOSE IN THE THERAPY OF CHRONIC HEPATITIS C

G. Bellati, L. Roffi, G. Colloredo!, M. D'Acquino, A. Ricci, A. Bellobuono, F. Bonino{}, G. Ideo and C.H.S.G.$. Internal Medicine, Niguarda Hospital, Milan; Chair Internal Medicine, S. Gerardo Hospital, Monza; !Internal Medicine, Bolognini Hospital, Seriate; Internal Medicine, Mestre Hospital, Venezia; {}Gastroenterology Unit, Molinette Hospital, Torino; $Chronic Hepatitis Study Group; Italy

INTRODUCTION: Breakthrough (BREAK) is a complex phenomenon in which different factors may play a pathogenetic role, such as interferon (IFN) antibodies, down-regulation of IFN receptors and development of escape HCV mutants (1). No data are available on the role of IFN dose and schedule on the BREAK prevalence with different alpha IFNs.

METHODS. We analized the prevalence of BREAK in 790 chronic hepatitis C patients prospectively enrolled for therapeutic trials with different doses and schedules of alpha IFNs. Response was defined as a complete normalization of ALT levels during IFN treatment, and BREAK was defined as a confirmed increase of ALT levels more than two times over the upper normal limit after an initial complete normalization.

RESULTS. The table shows the prevalence of response and BREAK in relation to the different IFN alpha schedules administered.

IFN            PTs  SCHEDULE        RESPONSE       BREAK/     MONTH
MU/w/month              PTs         RESPONSE        mean
r-IFN\alpha2a   92 6x3/2 [->] 3/10  51 (54.4%)  9/51  (17.6%)   4.5
r-IFN\alpha2a  173    3x3/12        95 (54.9%)  15/95( 15.8%)   4.2
r-IFN\alpha2b  207    3x3/12       122 (58.9%)  18/122 (14.7%)  5
l-IFN\alphaNl  141    3x3/12        93 (65.9%)  19/93  (20.4%)  4
l-IFN\alphaNl   18 6x3/2 [->] 3/10  11 (61.1%)  2/11  (18.2%)   5
Leuc-IFN\alpha  83    3x3/12        20 (24.1%)  0/20  (0%)      -
Leuc-IFN\alpha  76    6x3/12        19 (25%)    4/19  (21%)     5
x square  p=NS

CONCLUSION. The response rate was not significant affected by different doses and schedules of recombinant or lymphoblastoid alpha IFNs. No significant difference of BREAK prevalence was found among different schedules of alpha IFNs, although no BREAK occurred with lower dose of leucocyte IFN\alpha. Usually BREAK occurred between the 4th - 5th month of IFN therapy and therefore a carefull monitor is recommended in the first period of treatment.

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