HCV RNA detected by TMA
Hepatitis C virus RNA can be detected by PCR-based test
Health & Medicine Week - Oct. 02, 2006
A study from the United States has reported that hepatitis C virus (HCV) RNA was detected by TMA during the hepatitis C antiviral long-term treatment against cirrhosis (Halt-C) trial.
"For making treatment decisions related to chronic hepatitis C, the utility of HCV RNA tests with increased sensitivity has not been defined," wrote C. Morishima and colleagues, University of Washington.
"Prior interferon nonresponders with advanced fibrosis (n=1,145) were retreated with peginterferon alpha-2a and ribavirin. Patients who were HCV RNA-negative by a polymerase chain reaction (PCR)-based assay (Roche COBAS Amplicor HCV Test, v. 2.0; lower limit of detection [LOD] 100 IU/mL) at week 20 (W20) received treatment for 48 weeks.
"Stored specimens were tested using the Bayer VERSANT HCV RNA Qualitative (TMA) Assay (LOD 9.6 IU/mL) and compared to PCR results for the ability to predict sustained virological response (SVR, defined as undetectable HCV RNA by PCR at W72)," the investigators explained.
"Nearly all PCR-positive samples (1006/1007, 99.9%) were positive as assessed by TMA. Among 1,294 PCR-negative samples, 22% were TMA-positive. Negative TMA results were more predictive of SVR than were negative PCR results at W12 (82% vs. 64%, p<.001) and at W20 (66% vs. 52%, p=.001). SVR was more likely the earlier TMA had become negative during treatment (82% at W12, 44% at W20, 20% at W24). "Among 45 patients who were TMA-positive but were PCR-negative at W20 and W24, none achieved SVR (95% CI: 0%-8%). Approximately 10% of patients with a single positive TMA result at the end of treatment still achieved SVR," the researchers observed. The authors concluded, "Negative TMA results at or after W12 were superior to negative PCR results for predicting SVR. In patients with negative PCR results during treatment, a single positive TMA test did not exclude SVR, although persistently positive tests did."
Morishima and colleagues published the results of their research in Hepatology (HCV RNA detection by TMA during the hepatitis C antiviral long-term treatment against cirrhosis (Halt-C) trial. Hepatology, 2006;44(2):360-367). For additional information, contact C. Morishima, University of Washington, Department of Laboratory Medicine, Box 359690, Seattle, WA 98104, USA. The publisher of the journal Hepatology can be contacted at: John Wiley & Sons Inc., 111 River St., Hoboken, NJ 07030, USA.
Health & Medicine Week - Oct. 02, 2006
A study from the United States has reported that hepatitis C virus (HCV) RNA was detected by TMA during the hepatitis C antiviral long-term treatment against cirrhosis (Halt-C) trial.
"For making treatment decisions related to chronic hepatitis C, the utility of HCV RNA tests with increased sensitivity has not been defined," wrote C. Morishima and colleagues, University of Washington.
"Prior interferon nonresponders with advanced fibrosis (n=1,145) were retreated with peginterferon alpha-2a and ribavirin. Patients who were HCV RNA-negative by a polymerase chain reaction (PCR)-based assay (Roche COBAS Amplicor HCV Test, v. 2.0; lower limit of detection [LOD] 100 IU/mL) at week 20 (W20) received treatment for 48 weeks.
"Stored specimens were tested using the Bayer VERSANT HCV RNA Qualitative (TMA) Assay (LOD 9.6 IU/mL) and compared to PCR results for the ability to predict sustained virological response (SVR, defined as undetectable HCV RNA by PCR at W72)," the investigators explained.
"Nearly all PCR-positive samples (1006/1007, 99.9%) were positive as assessed by TMA. Among 1,294 PCR-negative samples, 22% were TMA-positive. Negative TMA results were more predictive of SVR than were negative PCR results at W12 (82% vs. 64%, p<.001) and at W20 (66% vs. 52%, p=.001). SVR was more likely the earlier TMA had become negative during treatment (82% at W12, 44% at W20, 20% at W24). "Among 45 patients who were TMA-positive but were PCR-negative at W20 and W24, none achieved SVR (95% CI: 0%-8%). Approximately 10% of patients with a single positive TMA result at the end of treatment still achieved SVR," the researchers observed. The authors concluded, "Negative TMA results at or after W12 were superior to negative PCR results for predicting SVR. In patients with negative PCR results during treatment, a single positive TMA test did not exclude SVR, although persistently positive tests did."
Morishima and colleagues published the results of their research in Hepatology (HCV RNA detection by TMA during the hepatitis C antiviral long-term treatment against cirrhosis (Halt-C) trial. Hepatology, 2006;44(2):360-367). For additional information, contact C. Morishima, University of Washington, Department of Laboratory Medicine, Box 359690, Seattle, WA 98104, USA. The publisher of the journal Hepatology can be contacted at: John Wiley & Sons Inc., 111 River St., Hoboken, NJ 07030, USA.
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