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THE IDEAL CUT-OFF OF VIREMIA LEVELS IN TREATING HCV-RELATED CHRONIC HEPATITIS TO IMPROVE THE COST/BENEFIT RATIO OF INTERFERON THERAPY

F Morisco, R Marmo, C Tuccillo, P Iasevoli, G Sessa, N Caporaso Department of Internal Medicine, II University of Naples, Italy

The main objective of managing HCV-related chronic liver disease treated with Interferon (IFN) is to accurately select patients who will experience a sustained beneficial response and to optimize the cost/benefit likelihood of therapeutic strategy. The independent predictive parameters of long-term response (LTR) estimated by logistic regression analysis are non-1b viral genotype and low initial viremia levels. In particular, low initial viremia levels seem to be the best predictive factor. But presently, the "exact" level of viremia which separates the long-term responders from other patients is not know.

Patients and Methods: We assayed the pretreatment levels of HCV-viremia (b-DNA, Chiron) in 76 patients (M/F 48/28, median age 50, range 18-65) with biopsy-proven chronic type C hepatitis. The treatment schedule was 6 MU of r-alpha IFN (3 times weekly) for 16 weeks and then for another 32 weeks (only in those whose alanine aminotransferase levels normalized). The statistical analysis was performed using Median test. Results: In our patients' population, the median level of viremia was 23.64 Eq/ml x 10Ø{5}. The table shows the distribution of patients in relation to viremia levels and type of response to IFN.

   HCV-RNA            LTR      RR     NR    p  Eq/ml x 10Ø{5}
       <=23.64            13      8         17
        >23.64             1        12        25   <0.0018

Long Term Response (LTR), Response with Relapse (RR), No Response (NR)

The 23.64 Eq/ml x 10Ø{5} value of viremia is the best level to distinguish LTR from NR and RR; no patients with >3 x 10Ø{6} Eq/ml levels had an LTR. Conclusions: based on these findings, we suggest not to use IFN (or at least not alone) to treat patients whose viremia levels are high (> 3 x 10Ø{6} Eq/ml). This approach can reduce the number of futile treatments and improve the cost/benefit ratio of IFN therapy.

Source: American Association for the Study of Liver Diseases - 1996 Annual Meeting


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