Hepatitis C minimal residual viremia (MRV) detected by TMA at the end of Peg-IFN plus ribavirin therapy predicts post-treatment relapse

Gerotto, Martina; Pero, Francesca Dal; Bortoletto, Gladis; Ferrari, Annachiara; Pistis, R.; Sebastiani, Giada; Fagiuoli, Stefano; Realdon, Stefano; Alberti, Alfredo

doi:10.1016/j.jhep.2005.08.016

Cited by 47 publications

(58 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…9,[14][15][16] However, an important caveat from our cohort was that 2 of 19 patients with undetectable HCV RNA by PCR at W48 had a positive TMA result and still achieved SVR. This finding may have been a result of the specialized characteristics of the subjects in our study, all of whom had advanced liver disease and had not been responsive to prior interferon therapy.…”

Section: Discussionmentioning

confidence: 82%

“…[11][12][13] Positive TMA results at the end of treatment (week 48, or W48) have improved the identification of patients who subsequently relapse. 9,[14][15][16] However, the clinical usefulness of the TMA assay over less sensitive PCR-based qualitative assays in monitoring responsiveness to interferon alphabased treatment regimens at other time points is less clear. We sought to determine whether TMA testing during therapy could more accurately predict SVR to peginterferon and ribavirin therapy compared to a standard, less sensitive PCR-based HCV RNA assay.…”

mentioning

confidence: 99%

See 1 more Smart Citation

HCV RNA detection by TMA during the hepatitis C antiviral long-term treatment against cirrhosis (Halt-C) trial

et al. 2006

View full text Add to dashboard Cite

For making treatment decisions related to chronic hepatitis C, the utility of HCV RNA tests with increased sensitivity has not been defined. 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). Nearly all PCR-positive samples (1006/1007, 99.9%) were positive as assessed by TMA. Among 1,294 PCR-negative samples, 22% were TMApositive. 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 ‫؍‬ 0.001). 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 Abbreviations: HCV, hepatitis C virus; SVR, sustained virological response. From the

show abstract

Section: Discussionmentioning

confidence: 82%

mentioning

confidence: 99%

HCV RNA detection by TMA during the hepatitis C antiviral long-term treatment against cirrhosis (Halt-C) trial

et al. 2006

View full text Add to dashboard Cite

show abstract

“…The positive predictive value (PPV) and negative predictive value (NPV) for SVR was evaluated on the basis of undetectable HCV RNA as revealed by each of the three assays at weeks 4,8,12,16,20, and 24 of the start of treatment (Table 1). At week 12, the PPVs by CAM, ART, and CAP/CTM were 74.3%, 88.0%, and 95.2%, respectively.…”

Section: Resultsmentioning

confidence: 99%

“…In general, the HCV RNA levels were measured for each patient in 9 serum specimens obtained at baseline; at weeks 4,8,12,16,20,24, and 48 of treatment; and finally 6 months following the discontinuation of therapy.…”

Section: Patientsmentioning

confidence: 99%

Abbott RealTime Hepatitis C Virus (HCV) and Roche Cobas AmpliPrep/Cobas TaqMan HCV Assays for Prediction of Sustained Virological Response to Pegylated Interferon and Ribavirin in Chronic Hepatitis C Patients

et al. 2009

View full text Add to dashboard Cite

Two commercial real-time PCR assays are currently available for sensitive hepatitis C virus (HCV) RNA quantification: the Abbott RealTime HCV assay (ART) and Roche Cobas AmpliPrep/Cobas TaqMan HCV assay (CAP/CTM). We assessed whether the two real-time PCR assays were more effective than Roche Cobas Amplicor HCV Monitor test, v.2.0 (CAM) for prediction of the sustained virological response (SVR) to pegylated interferon (PEG-IFN) plus ribavirin (RBV) in chronic hepatitis C. Sixty patients chronically infected with HCV genotype 1b (37 males and 23 females, 53 ؎ 12 years of age) were treated with PEG-IFN␣2b plus RBV for 48 weeks. Stored specimens at nine time points for each patient (at baseline, on treatment, and 24 weeks after treatment) were tested by the two real-time PCR assays and CAM. Twenty-six (43.3%) patients reached SVR. The positive predictive values (PPVs) for SVR of undetectable HCV RNA at week 12 by CAM, ART, and CAP/CTM were 74.3%, 88.0%, and 95.2%, respectively. An undetectable HCV RNA level by CAM, ART, and CAP/CTM correctly predicted SVR at week 4 in 100%, 100%, and 100% of patients, at weeks 5 to 8 in 91.7%, 100%, and 100% of patients, at weeks 9 to 12 in 55.6%, 75%, and 87.5% of patients, and at weeks 13 to 24 in 0%, 26.7%, and 40% of patients, respectively. Of 16 patients who relapsed after treatment, HCV RNA was detectable in 2 patients at the end of treatment by CAP/CTM but undetectable by ART and CAM. HCV RNA tests using ART and CAP/CTM are considered to be more effective at predicting SVR than CAM, and the PPV for SVR was slightly higher in CAP/CTM than in ART.The quantification of hepatitis C virus (HCV) RNA is essential for the management of chronic hepatitis C therapy based on the combination of pegylated interferon (PEG-IFN) and ribavirin (RBV). Based on pivotal trials in large multicenter studies, positive and negative predictions of sustained virological response (SVR) using viral load kinetics have been established and are now used for recommendations on antiviral therapy management by the American and European international consensus conferences (6, 9, 17). Initially, the effectiveness of antiviral therapy had been controlled by HCV RNA tests using end-point PCR assays sensitive to a level of 50 to 100 IU/ml, according to the Roche Cobas Amplicor HCV Monitor test, v.2.0 (CAM; Roche Molecular Systems, Inc., Pleasanton, CA). Recently, two novel commercial real-time PCR assays became available for highly sensitive HCV RNA quantification: the Abbott RealTime HCV assay (ART; Abbott Molecular, Inc., Des Plaines, IL) and the Roche Cobas AmpliPrep/Cobas TaqMan HCV assay (CAP/CTM; Roche Molecular Systems, Inc., Pleasanton, CA). The reported sensitivity of these real-time PCR assays is higher than that of CAM, they are reportedly not prone to carryover contamination, and they have a consistently wider dynamic range of quantification, which makes them particularly useful for quantifying the full range of viral genome levels observed in treated and untreated patients. Real-time PCR is rapidly r...

show abstract

“…6,9,26 Cirrhosis is the main independent risk factor for HCC development, 9,27 and residual viremia, i.e., HCV-RNA not detected by the currently available commercial PCR assays, may explain the risk of HCC in these patients. 28 The finding that male subjects aged Ͼ54 years have a higher risk of developing HCC suggests that host-related factors and/or the duration of the disease might enhance the risk of HCC. Therefore, our results support the need of screening/surveillance programs despite viral eradication in patients with cirrhosis as recently stated.…”

Section: Discussionmentioning

confidence: 99%

Sustained virological response to interferon-α is associated with improved outcome in HCV-related cirrhosis: A retrospective study

et al. 2007

Self Cite

View full text Add to dashboard Cite

Hepatitis C minimal residual viremia (MRV) detected by TMA at the end of Peg-IFN plus ribavirin therapy predicts post-treatment relapse

Cited by 47 publications

References 16 publications

HCV RNA detection by TMA during the hepatitis C antiviral long-term treatment against cirrhosis (Halt-C) trial

HCV RNA detection by TMA during the hepatitis C antiviral long-term treatment against cirrhosis (Halt-C) trial

Abbott RealTime Hepatitis C Virus (HCV) and Roche Cobas AmpliPrep/Cobas TaqMan HCV Assays for Prediction of Sustained Virological Response to Pegylated Interferon and Ribavirin in Chronic Hepatitis C Patients

Sustained virological response to interferon-α is associated with improved outcome in HCV-related cirrhosis: A retrospective study

Contact Info

Product

Resources

About