The term sustained response should be applied to patients with negative serum HCV-RNA and normal values of serum transaminases 6 months after interferon withdrawal. To investigate which factors identify sustained responders early during treatment we analysed 18 reports which used the definition sustained response.
Eight reports, comprising 988 patients, have studied the value of early clearance of viraemia as a predictor of sustained response using multivariate analysis and all of them found that this was the strongest predictor of a sustained response. Determination of HCV-RNA 4 or 12 weeks after initiation of IFN therapy predicts treatment outcome more accurately than baseline viral load (the best pre-treatment predictor). ALT levels during the first 12 weeks of treatment have lower predictive value than early viral clearance. The sensitivity of a negative HCV-RNA test is similar at week 4 and at week 12 of therapy while the specificity and the accuracy is higher at week 4.
The value of persistent viraemia for early prediction of no response is higher than 97%, with similar values at weeks 4 and 12. Persistence of HCV-RNA in serum at week 4 strongly indicates that the patient will not respond to treatment and in these cases interruption of treatment or other therapeutic options could be considered.
CITATION J Hepatol. 1999;31 Suppl 1:237-43
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