The quantitation of hepatitis C virus (HCV) viremia RNA is measured by molecular techniques such as comcan be helpful in the diagnosis, therapy, and monitoring petitive reverse-transcription polymerase chain reacof patients with chronic hepatitis C. A sensitive and tion and branched DNA (bDNA) signal amplification. 5,6 quantitative fluorescence enzyme immunoassay (FEIA) More recently, a sensitive and quantitative fluoreshas recently been developed for assaying HCV core procence enzyme immunoassay (FEIA) has been developed tein in serum. To assess the utility of measurements of to measure serum HCV core protein, which may also serum HCV core protein during the course of treatment correlate with levels of HCV viremia. 8 We have evaluof chronic hepatitis C, we studied 27 patients who were ated the clinical usefulness of serum HCV core protein treated with a single schedule of interferon alfa (IFN-a) measurements in patients with chronic hepatitis C be-(9 million units per dose for 24 weeks; total dose, 720 fore, during, and after treatment with IFN-a.
million units). Eleven of the 27 patients responded with clearance of HCV RNA and fall of aminotransferase to PATIENTS AND METHODS normal; 16 patients did not respond to treatment. Before therapy, HCV core antigen was detectable in 25 of the
Patients. This study was conducted at Shinshu University 27 patients (93%). The initial serum concentration of Hospital and affiliated hospitals between July 1993 and Sep-HCV core protein was significantly (P Γ΅ .01) higher in tember 1994. Informed consent was obtained from all pathe nonresponders versus the responders. Two weeks tients. Twenty-seven Japanese patients with chronic hepatiafter initiating IFN-a therapy, HCV core protein was not tis type C who were treated with IFN-a therapy (19 men detectable in any of the 11 responders, but was detected and 8 women aged 32 to 65 years; mean, 50.6 years) were in 8 of 16 nonresponders (P Γ΅ .01). All responders, but evaluated. All had antibodies to HCV and HCV RNA in senone of the nonresponders, remained negative for core rum, and were negative for hepatitis B virus surface antigen protein after IFN-a therapy. The measurement of HCV and antibodies to human immunodeficiency virus. Chronic core protein by FEIA may be useful for predicting the hepatitis was diagnosed on the basis of persistence of serum response to IFN-a and for monitoring its therapeutic alanine transaminase (ALT) elevations, determined in serum efficacy. (HEPATOLOGY 1996;23:1330-1333.) tests performed monthly for at least 6 months, and by liver biopsy taken within the previous 6 months. Seven patients had mild, 6 had moderate, and 14 had severe chronic hepati-Infection by hepatitis C virus (HCV) can lead to tis. 9 chronic hepatitis and cirrhosis, and may also be in-Recombinant IFN-a 2a (Roche, Tokyo, Japan, and Takeda, volved in the pathogenesis of hepatocellular carci-Osaka, Japan) was administered in a dose of 9 million units intramuscularly daily for 2 weeks, followed by three times a noma. 1,2 Treatment with interferon alfa (IFN-a) is efweek for 22 weeks. Patients were seen 2 and 4 weeks after fective in some patients with chronic hepatitis C, the initiation of therapy, and then every 4 weeks for at least resulting in a rapid decrease in aminotransferase activ-24 weeks after its completion. Serum samples were collected ities into the normal range and a clearance of HCV at each visit and stored at 070ΠC until assayed. Patients from serum. 3,4 The serum concentration of HCV RNA were regarded as responders if (1) serum ALT concentrations can be used to monitor the efficacy of IFN-a. 5-7 HCV returned to normal during therapy and remained normal for 24 weeks after completing therapy, and (2) serum HCV RNA was undetectable at 4 and 24 weeks after completing therapy. Patients who did not meet at least one of these criteria were Abbreviations: HCV, hepatitis C virus; IFN-a, interferon alfa; bDNA, regarded as nonresponders. branched DNA; FEIA, fluorescence enzyme immunoassay; ALT, alanine trans-Measurement of HCV RNA. RNA extraction and reverse aminase; RFI, relative fluorescence intensity.