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Purpose: Histologic findings and liver function tests (LFTs) are often nondiagnostic of recurrent hepatitis C virus (HCV) infection. In addition, the relationship between HCV replication and the presence of recurrent HCV after liver transplantation remains unclear. We studied liver transplant recipients to determine if quantitation of HCV RNA in liver tissue by polymerase chain reaction correlates with histopathologic disease and/or LFTs. Methods: Twenty-six patients who received liver transplants for HCV infection were evaluated. Twenty-five had clinically- suspected HCV recurrence. Three sequential biopsies at the time of suspected recurrence were analyzed for each patient (78 biopsies). A biopsy of the transplanted liver taken at the time of transplant was also used in 19 patients as a negative control. HCV RNA was extracted and quantified using the AMPLICOR HCV MONITOR TM test. Histologic examination and RNA quantitation were blinded. All available LFTs on the day of liver biopsy were analyzed. Results: HCV RNA quantity in liver tissue significantly increased over time in all patients with suspected recurrence (pi.0001). HCV RNA levels were highest in biopsies with acute hepatitis, followed by nonspecific inflammation, chronic hepatitis, and rejection. HCV RNA quantity had a significant correlation with increasing portal inflammation (p<.002) and increasing number of acidophil bodies (p<.04). HCV RNA levels also significantly correlated with increasing SGPT and SGOT levels (p<.02, p<.000l respectively). HCV RNA quantity did not correlate with other histologic features or other LFTs. Conclusions: HCV RNA levels are highest at the time of active hepatocellular destruction, confirmed by histologic and LFT abnormalities. HCV RNA quantitation may be a useful diagnostic test for distinguishing HCV recurrence from other inflammatory conditions, particularly in cases with nonspecific inflammation.