ABSTRACT
BACKGROUND: The Roche COBAS TaqMan HIV-1 version 1.0 (v1.0) real-time PCR test detects more low level viral loads (VL) compared to the previous Roche Amplicor version 1.5 assay. Due to under-quantification issues, the Roche TaqMan HIV-1 version 2.0 (v2.0) was introduced in 2009. Controversy remains on differences at the low VL end, where clinical decisions regarding possible viral escape are based. OBJECTIVES: To compare the rate and size of VL blips with v1.0 and v2.0 in virologically suppressed patients and describe the impact of v2.0 on patient management. STUDY DESIGN: A cohort study of HIV-positive patients on antiretroviral therapy with a VL <50 copies/ml at the beginning and end of the study period (July 2008-February 2010). VL blips were compared during two consecutive 9-month periods, initially measured by v1.0, then v2.0. Genotypic resistance testing and treatment switches were described. RESULTS: 1037 of 2584 patients (73.1% male) with median age 43 years were included. 2465 VL samples were measured on v1.0 and 2206 on v2.0. 108 (10.4%) patients had blips on v1.0 (4.4% of samples) compared to 99 (9.5%) patients (4.5% of samples) on v2.0. Median log VL was 1.89 (78 copies/ml) for v1.0 and 2.06 (116 copies/ml) for v2.0 (p=0.002). Further characterisation of 11 samples detected no resistance and no treatment modifications were identified. CONCLUSIONS: TaqMan v1.0 and v2.0 have similar blip rates, while blips are higher with v2.0. This study supports the strategy to increase the threshold of concern for VL blips on v2.0.
Subject(s)
HIV Infections/drug therapy , HIV-1/physiology , RNA, Viral/blood , Real-Time Polymerase Chain Reaction/methods , Viral Load , Adolescent , Adult , Aged , Anti-HIV Agents/pharmacology , Anti-HIV Agents/therapeutic use , Cohort Studies , Female , Genotype , HIV Infections/virology , HIV-1/drug effects , HIV-1/genetics , Humans , Male , Middle Aged , Reagent Kits, Diagnostic , Reproducibility of Results , Young AdultABSTRACT
The need to evaluate antiviral treatment response and the emergence of resistance have made the human immunodeficiency virus (HIV) viral load assay a major feature of the diagnostic monitoring of HIV-infected individuals. The objective of this study was to evaluate the utility of the recently In Vitro Diagnostic Medical Devices Directive-approved Roche COBAS AmpliPrep/TaqMan96 real-time PCR assay by comparison with the existing Roche COBAS AmpliPrep/AMPLICOR MONITOR conventional PCR assay. EDTA-treated plasma samples from 191 HIV-1-infected individuals were tested for HIV-1 RNA by the AMPLICOR assay and the TaqMan assay. This was a prospective study using 191 pairs of samples from the same bleed per patient. The correlation coefficient of the assays was 98.08%. The mean difference between the assays was 0.05 log(10) copy/ml plasma, with a standard deviation (SD) of 0.27 log(10) copy/ml plasma. Thirteen samples gave results with variances greater than 0.5 log(10) copy/ml plasma, which is our clinical cutoff. Two samples were more than 3 SD different (0.81 log(10) copy/ml plasma). The TaqMan assay appeared to be slightly more sensitive at the lower end of the dynamic range. The assays correlated significantly (P > 0.95) with each other, and the regression analysis was also highly significant (R(2) > 0.95).
