Background: In chronic hepatitis C, relapses of liver disease occur in as many as 50% of patients responding to interferon (IFN) therapy. Although the presence of serum hepatitis C virus (HCV) RNA at the end of therapy predicts a relapse, its absence is not a reliable indicator of cure. In this study we have determined whether responders to IFN (normalization of liver chemistry and clearance of serum HCV-RNA) harbour HCV-RNA in the liver and peripheral blood mononuclear cells (PBMCs), and whether finding the genome at these sites has prognostic significance.
Methods: After the conclusion of therapy, we tested for HCV-RNA in the liver of all the patients (anti-HCV-positive): 16 complete responders with normalization of liver chemistry and clearance of serum HCV-RNA and five non-responders. In 13 of the 16 complete responders we also tested for HCV-RNA in PBMCs. Patients were followed up for 9 months.
Results: Liver HCV-RNA was detected in each of the five non-responders and in four of the 16 complete responders (25%). The viral genome was detected in the PBMCs of six complete responders (46%). During follow-up a relapse of hepatitis C occurred in the 10 complete responders with liver or PBMC HCV-RNA but in only one (16%) of the six complete responders without HCV-RNA in liver or PBMCs.
Conclusion: Reliable information on the prognosis of chronic hepatitis C responders can only be obtained by testing for HCV-RNA in serum, liver and PBMCs at the end of therapy. Patients with HCV-RNA at any of these sites stand a high risk of disease relapse. The risk is low but not abolished in patients without detectable HCV-RNA.