Significance of serum hepatitis C virus RNA levels in chronic hepatitis C

• Published in: The Lancet (British edition) Vol. 341; no. 8859; pp. 1501 - 1504
• Main Authors: Lau, J.Y.N, Davis, G.L, Kniffen, J, Qian, K.-P, Urdea, M.S, Chan, C.S, Neuwald, P.D, Wilber, J.C, Mizokami, M
• Format: Journal Article
• Language: English
• Published: London Elsevier Ltd 12.06.1993; Lancet; Elsevier Limited
• Subjects: Adult; Aged; Amplification; Base Sequence; Biological and medical sciences; Biopsy; Blood transfusion; Chronic infection; Clinical trials; Deoxyribonucleic acid; DNA; Drug abuse; Female; Hepacivirus - genetics; Hepacivirus - isolation & purification; Hepatitis; Hepatitis C; Hepatitis C - blood; Hepatitis C - drug therapy; Hepatitis C - microbiology; Hepatitis, Chronic - blood; Hepatitis, Chronic - drug therapy; Hepatitis, Chronic - microbiology; Human viral diseases; Humans; Infections; Infectious diseases; Interferon; Interferon alpha-2; Interferon-alpha - therapeutic use; Intravenous administration; Lesions; Liver; Male; Medical personnel; Medical research; Medical sciences; Middle Aged; Molecular Sequence Data; Non-A, non-B hepatitis; Patients; Quantitative research; Recombinant Proteins; Ribonucleic acid; RNA; RNA viruses; RNA, Viral - blood; Viral diseases; Viral hepatitis; Viremia; Viremia - microbiology; Viruses; Workers; α-Interferon; Infection; Virus; Human; Chronic; RNA; Viral disease; Digestive diseases; Exploration; Hepatic disease; Serum; Hepatitis C virus; Viral hepatitis C
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/0140-6736(93)90635-T

Hepatitis C virus (HCV) is the main cause of parenteral non-A, non-B hepatitis and serum can be tested for the virus itself by reverse-transcription polymerase chain amplificaton. What of the level of this viraemia? To find out if quantitative study of H CV RNA might be useful clinically we took advantage of participation in trials of interferon-α in patients with chronic HCV infection and applied a new assay, branched DNA (bDNA) signal amplification. Paired serum and liver biopsy specimens from 47 patients with confirmed chronic HCV infection and evidence of HCV RNA in their serum were studied. The quantitative bDNA assay (detection limit 350000 equivalents/mL [eq/mL]) was positive in 34 sera (sensitivity 72%). Patients who acquired HCV infection by blood transfusion had a higher viraemia (median 2701 000 eq/mL, n=29) than health workers and intravenous drug users (635 000 eq/mL, n=13; p<0·01). Patients with a sustained complete response to interferon-α therapy had lower pre-treatment viraemia levels (median at bDNA cut-off, n=11) than complete responders who relapsed after the drug was stopped (1613 000 eq/mL, n=15; p<0·01) and non-responders (3066 000 eq/mL, n=20; p<0·01). High viraemia levels were not related to the histological diagnosis but were associated with lobular inflammation, lymphoid aggregates, and bileduct lesions. These findings indicate that mode of acquisition is an important determinant of HCV viraemia and that patients with low HCV viraemia levels are more likely to respond to interferon in a sustained fashion.