Quantitative detection of hepatitis C virus RNA in the serum of patients with chronic hepatitis C treated with interferon: A pilot study

Background: It is not known whether the measurement of serum hepatitis C virus (HCV) RNA by reverse transcription polymerase chain reaction (RT-PCR) could improve the management of patients with chronic hepatitis C being treated with interferon. Objectives: We analysed, in a pilot study, the relations between the variations of HCV-RNA and alanine aminotransferase (ALT) serum levels in 18 anti-HCV positive patients treated with interferon. Study design: Serum HCV-RNA was measured, using a non competitive coamplification assay (Amplicor HCV Monitor(TM)), before (at 3, 2 and 1 months and baseline), during (first, third and sixth month) and after treatment for at least 8 months (range 8-17 months). HCV-RNA levels fluctuations were correlated with those of ALT and treatment outcome. According to the ALT pattern, four patients were non responders, seven partial responders, four relapsers and two long term responders. Results: The median and mean baseline HCV-RNA levels were significantly different in patients infected by HCV type 1, 2 and 3, being 248 449, 235 506; 4170, 17 866 and 22 315, 79 273 molecules per mi, respectively (P < 0.0001). We did not find any significant difference between median and mean baseline viremia of responders and non responders. After 1 month of treatment viremia was below the sensitivity levels of the assay in 77.7% (14/18) of the patients who normalized ALT, at least temporarily. On the contrary, HCV-RNA remained detectable in non responders. Conclusions: Our data suggest that HCV-RNA detection using Amplicor Monitor(TM) at the first month of treatment can be useful to identify non responders, avoiding three additional months of treatment as would be required by ALT monitoring alone. During the post-treatment follow-up, persistence of undetectable I-ICV-RNA and normal ALT levels helps to identify long term responders from patients with the risk of relapse in spite of biochemical remission. (C) 1997 Elsevier Science B.V.