Assessment, by Transcription-Mediated Amplification, of Virologic Response in Patients with Chronic Hepatitis C Virus Treated with Peginterferon {alpha}-2a

doi:10.1128/JCM.39.8.2850-2855.2001

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Journal of Clinical Microbiology, August 2001, p. 2850-2855, Vol. 39, No. 8
0095-1137/01/$04.00+0 DOI: 10.1128/JCM.39.8.2850-2855.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Assessment, by Transcription-Mediated Amplification, of Virologic Response in Patients with Chronic Hepatitis C Virus Treated with Peginterferon $alpha$ -2a

Christoph Sarrazin,¹ David A. Hendricks,² Farhad Sedarati,³ and Stefan Zeuzem¹^,^*

Medizinische Klinik II, Johann Wolfgang Goethe-Universität, 60590 Frankfurt am Main, Germany¹; Bayer Diagnostics, Berkeley, California 94702-0466²; and Hoffmann-LaRoche, Nutley, New Jersey 07110³

Received 12 February 2001/Returned for modification 12 May 2001/Accepted 10 June 2001

Transcription-mediated amplification (TMA) is an isothermal, autocatalytic target amplification method which has the potentialto detect less than 50 hepatitis C virus (HCV) RNA copies/ml (10IU/ml). The TMA assay was used to assess the presence of residualHCV RNA in plasma from patients treated with polyethylene glycol-modifiedinterferon $alpha$ -2a (peginterferon $alpha$ -2a) who showed a virologic relapseafter the end of therapy. Stored end-of-treatment and end-of-follow-upplasma samples from 177 of 267 patients treated with peginterferon $alpha$ -2a (S. Zeuzem et al., N. Engl. J. Med. 343:1666-1672, 2000)were available for retesting by TMA. Plasma samples from patientsin the same study who exhibited virologic relapse after treatmentwith standard interferon $alpha$ -2a served as controls. Virologic responseduring the trial was defined as HCV RNA that was undetectableusing a PCR-based test system with a sensitivity of 50 IU/mL (CobasAmplicor HCV version 2.0) and was compared with TMA-based retestingresults (VERSANT HCV RNA Qualitative Assay). Residual HCV RNAwas detected in 4 of 60 cases (7%) by the TMA technology in end-of-treatmentplasma samples from patients who relapsed after receiving peginterferon $alpha$ -2a and in 6 of 18 patients (33%) following therapy with standardinterferon $alpha$ -2a. For peginterferon $alpha$ -2a-treated patients withsustained virologic response, HCV RNA was detectable by TMA inend-of-treatment samples in 3 of 78 cases but in none of the end-of-follow-upsamples. For all end-of-treatment and end-of-follow-up plasmasamples of virologic nonresponders, a complete concordance betweenthe PCR-based assay and TMA was observed. In conclusion, in patientswith virologic relapse after the end of therapy, according toPCR, who were treated with peginterferon $alpha$ -2a or standard interferon $alpha$ -2a, residual HCV RNA was detectable in end-of-treatment samplesby the TMA-based assay in 7 or 33% of cases, respectively. Thelower rate of residual HCV RNA detection by TMA for patients treatedwith peginterferon $alpha$ -2a than that for patients treated with standardinterferon $alpha$ -2a may be due to the maintained antiviral pressureof the long-acting peginterferon $alpha$ -2a at the end-of-treatmentvisit.

^* Corresponding author. Mailing address: Medizinische Klinik II, Zentrum der Inneren Medizin, Klinikum der Johann Wolfgang Goethe-Universität,Theodor-Stern-Kai 7, D-60590 Frankfurt am Main, Germany. Phone:49-69-6301-5297. Fax: 49-69-6301-4807. E-mail: zeuzem{at}em.uni-frankfurt.de.

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Assessment, by Transcription-Mediated Amplification, of Virologic Response in Patients with Chronic Hepatitis C Virus Treated with Peginterferon -2a

Assessment, by Transcription-Mediated Amplification, of Virologic Response in Patients with Chronic Hepatitis C Virus Treated with Peginterferon $alpha$ -2a