8 24 Week treatment regimen with peginterferon alpha-2a (40KD) (PEGASYS®) plus ribavirin (COPEGUS®) in HCV genotype 1 or 4 ‘super-responders’

Ferenci, Péter; Bergholz, U.; Laferl, Hermann; Scherzer, Thomas–Matthias; Maieron, A; Gschwantler, Michael; Brünner, H.; Hubmann, Rainer; Datz, C.; Bischof, Martin; Stauber, R; Steindl–Munda, Petra

doi:10.1016/s0168-8278(06)80009-7

Cited by 22 publications

(7 citation statements)

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“…Generally, patients who may have tested HCV RNA negative during or after antiviral therapy by older assays with lower LODs of Ն50 IU/ml may test HCV RNA positive by highly sensitive HCV RNA assays. Highly sensitive HCV RNA assays are now used in clinical practice to define a virologic nonresponse to antiviral therapy and to predict relapses after antiviral therapy (10,18,19,25). In addition, the large dynamic range of the real-time PCR-based assays allows precise HCV RNA quantification without predilution, which was frequently required with previous standard PCR-based assays.…”

Section: Discussionmentioning

confidence: 99%

Differences between Two Real-Time PCR-Based Hepatitis C Virus (HCV) Assays (RealTime HCV and Cobas AmpliPrep/Cobas TaqMan) and One Signal Amplification Assay (Versant HCV RNA 3.0) for RNA Detection and Quantification

et al. 2008

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Hepatitis C virus (HCV) RNA detection and quantification are the key diagnostic tools for the management of hepatitis C. Commercially available HCV RNA assays are calibrated to the HCV genotype 1 (gt1)-based WHO standard. Significant differences between assays have been reported. However, it is unknown which assay matches the WHO standard best, and little is known about the sensitivity and linear quantification of the assays for non-gt1 specimens. Two real-time reverse transcriptase PCR-based assays (RealTime HCV and Cobas Ampliprep/Cobas TaqMan HCV [CAP/CTM]) and one signal amplification-based assay (the Versant HCV RNA, version 3.0, branched DNA [bDNA] assay) were compared for their abilities to quantify HCV RNA in clinical specimens (n ‫؍‬ 65) harboring HCV isolates of gt1 to g5. The mean differences in the amounts detected by RealTime HCV in comparison to those detected by the bDNA assay and CAP/CTM were ؊0.02 and 0.72 log 10 IU/ml HCV RNA, respectively, for gt1; ؊0.22 and 0.03 log 10 IU/ml HCV RNA, respectively, for gt2; ؊0.27 and ؊0.22 log 10 IU/ml HCV RNA, respectively, for gt3; ؊0.19 and ؊1.27 log 10 IU/ml HCV RNA, respectively, for gt4; and ؊0.03 and 0.09 log 10 IU/ml HCV RNA, respectively, for gt5. The lower limits of detection for RealTime HCV and CAP/CTM were 16.8 and 10.3 IU/ml, respectively, for the WHO standard and in the range of 4.7 to 9.0 and 3.4 to 44.4 IU/ml, respectively, for clinical specimens harboring gt1 to gt6. Direct comparison of the two assays with samples of the WHO standard (code 96/798) with high titers yielded slightly smaller amounts by RealTime HCV (؊0.2 log 10 at 1,500 IU/ml and ؊0.3 log 10 at 25,000 IU/ml) and larger amounts by CAP/CTM (0.3 log 10 at 1,500 IU/ml and 0.2 log 10 at 25,000 IU/ml). Finally, all three tests were linear between 4.0 ؋ 10 3 and 1.0 ؋ 10 6 IU/ml (correlation coefficient, >0.99). In conclusion, the real-time PCR based assays sensitively detected all genotypes and showed comparable linearities for the quantification of HCV RNA, with the exception of gt1 and gt4. The previously reported differences in the absolute quantification of samples harboring gt1 were confirmed and may be explained by different calibrations to the WHO standard.Hepatitis C virus (HCV) infection is a common cause of chronic liver disease that can lead to end-stage liver disease, including hepatocellular carcinoma.At present, combination therapy with pegylated interferon and ribavirin is the standard of care. However, this treatment regimen appears to be effective in only 40% to 50% of patients infected with genotype 1 and approximately 80% of patients infected with genotypes 2 and 3 (12, 13, 16).A sustained virologic response, defined as undetectable HCV RNA at least 6 months after the completion of therapy, may be predicted by a number of host and viral factors, including age, race, liver fibrosis, the HCV genotype, and the baseline viral load.Recent reports suggest that decisions on the optimal treatment duration may be made on the basis of the baseline viral load and the virologi...

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Section: Discussionmentioning

confidence: 99%

Differences between Two Real-Time PCR-Based Hepatitis C Virus (HCV) Assays (RealTime HCV and Cobas AmpliPrep/Cobas TaqMan) and One Signal Amplification Assay (Versant HCV RNA 3.0) for RNA Detection and Quantification

et al. 2008

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“…Among patients who had an RVR, there was no difference in the SVR rate according with the ribavirin dose or the treatment duration, whereas in patients who did not have an RVR the highest SVR rate was obtained with the higher ribavirin dose and 48 weeks of treatment [20]. The third, retrospective study suggested that shorter treatment might be suitable for patients infected with HCV genotypes 1 or 4 who have an RVR [18].…”

Section: Future Use Of Viral Kinetics (Virological Response) Monitorimentioning

confidence: 99%

“…Three studies have evaluated a shortened treatment course in patients infected with HCV genotype 1 [18–20]. The first trial, an open‐label study, suggested that 24 weeks was sufficient in a subgroup of patients with a baseline HCV‐RNA level below 600 000 IU/mL and an RVR (HCV‐RNA below 50 IU/mL at week 4) [19].…”

Section: Future Use Of Viral Kinetics (Virological Response) Monitorimentioning

confidence: 99%

Practical use of hepatitis C virus kinetics monitoring in the treatment of chronic hepatitis C

Chevaliez

Pawlotsky

2007

Journal of Viral Hepatitis

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Prevention of hepatitis C virus (HCV) infection complications can be achieved by antiviral therapy based on the use of a combination of pegylated interferon (IFN)-alpha and ribavirin. The steady-state kinetics of HCV infection represents the treatment target. The goal is cure, which is achieved when all infected cells have been cleared from the body. Because of their intrinsic properties, real-time polymerase chain reaction (PCR) methods are rapidly replacing other technologies for routine quantification of HCV-RNA during antiviral therapy. The virological response at week 12 of therapy is currently used to tailor treatment duration in HCV genotype 1 infection only. Recent reports suggest that the virological response at week 4 could be used to tailor treatment duration, whatever the HCV genotype.

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“…Accordingly, treatments for only 12-16 weeks in patients with HCV genotype 3 [38,39] or for only 24 weeks in HCV genotype 1 [42,43] have been proposed for patients with RVR.…”

Section: Optimal Duration Of Hepatitis C Virus Therapymentioning

confidence: 99%

Management and therapy of chronic hepatitis C in HIV

Soriano

Vispo²,

Martín‐Carbonero³

et al. 2007

Current Opinion in HIV and AIDS

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8 24 Week treatment regimen with peginterferon alpha-2a (40KD) (PEGASYS®) plus ribavirin (COPEGUS®) in HCV genotype 1 or 4 ‘super-responders’

Cited by 22 publications

References 0 publications

Differences between Two Real-Time PCR-Based Hepatitis C Virus (HCV) Assays (RealTime HCV and Cobas AmpliPrep/Cobas TaqMan) and One Signal Amplification Assay (Versant HCV RNA 3.0) for RNA Detection and Quantification

Differences between Two Real-Time PCR-Based Hepatitis C Virus (HCV) Assays (RealTime HCV and Cobas AmpliPrep/Cobas TaqMan) and One Signal Amplification Assay (Versant HCV RNA 3.0) for RNA Detection and Quantification

Practical use of hepatitis C virus kinetics monitoring in the treatment of chronic hepatitis C

Management and therapy of chronic hepatitis C in HIV

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