An OPTIMIZE Study Retrospective Analysis for Management of Telaprevir-Treated Hepatitis C Virus (HCV)-Infected Patients by Use of the Abbott RealTi m e HCV RNA Assay

Abstract

e Protease inhibitor (PI)-based response-guided triple therapies for hepatitis C virus (HCV) infection are still widely used. Noncirrhotic treatment-naive and prior relapser patients receiving telaprevir-based treatment are eligible for shorter, 24-week total therapy if HCV RNA is undetectable at both weeks 4 and 12. In this study, the concordance in HCV RNA assessments between the Roche High Pure System/Cobas TaqMan and Abbott RealTime HCV RNA assays and the impacts of different HCV RNA cutoffs on treatment outcome were evaluated. A total of 2,629 samples from 663 HCV genotype 1 patients receiving telaprevir/pegylated interferon/ribavirin in OPTIMIZE were analyzed using the High Pure System and reanalyzed using Abbott RealTime (limits of detection, 15.1 IU/ml versus 8.3 IU/ml; limits of quantification, 25 IU/ml versus 12 IU/ml, respectively). Overall, good concordance was observed between the assays. Using undetectable HCV RNA at week 4, 34% of the patients would be eligible for shorter treatment duration with Abbott RealTime versus 72% with the High Pure System. However, using <12 IU/ml for Abbott RealTime, a similar proportion (74%) would be eligible. Of the patients receiving 24-week total therapy, 87% achieved a sustained virologic response with undetectable HCV RNA by the High Pure System or <12 IU/ml by Abbott RealTime; however, 92% of the patients with undetectable HCV RNA by Abbott RealTime achieved a sustained virologic response. Using undetectable HCV RNA as the cutoff, the more sensitive Abbott RealTime assay would identify fewer patients eligible for shorter treatment than the High Pure System. Our data confirm the <12-IU/ml cutoff, as previously established in other studies of the Abbott RealTime assay, to determine eligibility for shortened PI-based HCV treatment. (The study was registered with ClinicalTrials.gov under registration no. NCT01241760.)

Performance characteristics of the VERSANT hepatitis C virus RNA 1.0 (kPCR) assay

“…Since the VERSANT kPCR assay reports HCV RNA concentrations below its limit of detection as ≤LLoQ (i.e., ≤lower limit of quantification) (Siemens Healthcare Diagnostics, 2010), the system is able to provide an information, which is of potential clinical interest. The first observation that a distinction of the result "target not detected" from the finding of HCV RNA observable but below the limit of quantification of the respective assay might be meaningful in the context of response-guided therapeutic regimens containing DAAs had been communicated by Harrington et al (2012) and was meanwhile corroborated by further publications (Peiffer and Sarrazin, 2013;Sarrazin et al, 2015b).…”

Hepatitis C virus: life cycle in cells, infection and host response, and analysis of molecular markers influencing the outcome of infection and response to therapy

“…For instance, patients receiving first generation DAA (Telaprevir) combined with PegIFN and RBV and with HCV RNA undetectable at week 4 were used to identify patients eligible for shortened treatment (24 vs 48 weeks) [63]. Based on this criterion, in the OPTIMIZE study, for instance, 34% or 72% of patients would have been eligible for shorter treatment if HCV RNA was measured with Abbott RealTime or Roche High Pure System/COBAS TaqMan [59]. Thus, current guidelines recommend considering assay performances and performing virological monitoring in the same laboratory for patient management [51, 61].…”

The Role of Oxidative Stress Markers in Î’-Thalassemic Iraqi Patients Infected With Hepatitis C Virus Diagnosed by Rt-PCR

“…The ages of the patients and control groups were distributed between 1 year to 44 years. The more significant majority of the infected persons with HCV was in the middle age groups (15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29) years old, while the lowest rate of infected persons was in the age group (30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42)(43)(44) years of old. Gender did not differ significantly among thalassemia patients with or without HCV infection and healthy subjects (Table2).…”

“…At a global level, between 4.4 % and 85.4 % of the thalassemia patients are positive for anti-HCV antibodies 18 . The distribution of patients according to age were as follow: 73.0% were in the range of (15-29) years; 18.0% in the range (1-14) yearsand 9% inthe range (30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42)(43)(44) years. In our study, the mean age of thalassaemic patients with anti-HCV was20±7.0 years.…”

“…There are apparent differences in the distribution of thalassemia patients infected with hepatitis C according to the age groups. The highest percent of incidence in the age group (15-29 years) as it was estimated at 73% while the lowest percentage is in the age groups (30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42)(43)(44). This may be because early detection of the disease gives more significant opportunity for treatment and cure.…”