scholarly journals Clinical Evaluation of the Automated COBAS AMPLICOR HCV MONITOR Test Version 2.0 for Quantifying Serum Hepatitis C Virus RNA and Comparison to the Quantiplex HCV Version 2.0 Test

2000 ◽  
Vol 38 (8) ◽  
pp. 2933-2939 ◽  
Author(s):  
Ming-Lung Yu ◽  
Wan-Long Chuang ◽  
Chia-Yen Dai ◽  
Shinn-Cherng Chen ◽  
Zu-Yau Lin ◽  
...  

A second-generation hepatitis C virus (HCV) quantitative assay (COBAS AMPLICOR HCV MONITOR Test, version 2.0; COBAS HCM-2) has been developed, with the intention of achieving equivalent quantification of all HCV genotypes and improving assay performance. To evaluate the clinical performance of COBAS HCM-2 and its utility in predicting the response to alpha interferon treatment, sera from 215 chronic hepatitis C patients were analyzed and the results were compared with those obtained by the Quantiplex bDNA HCV RNA, version 2.0, assay (bDNA-2). The COBAS HCM-2 had significantly greater sensitivity than bDNA-2 (94.9 versus 88.4%; P < 0.001) when performed with sera from chronic hepatitis C patients who were viremic by a qualitative PCR test. The standard deviations for the within-run and between-run reproducibilities of COBAS HCM-2 were <0.1 and <0.2, respectively, and it showed an improved linear range between genotypes with the threefold serial dilutions tested (r 2 = 0.986 to 0.995). The COBAS HCM-2 results were positively correlated with the bDNA-2 results, but the values for COBAS HCM-2 were on average 0.96 log lower than the values for bDNA-2. The mean difference in quantification values between these two assays did not differ among samples with different genotypes (0.70 to 1.00 log). No genotype-dependent difference in viral load was observed. The pretreatment viral load was significantly lower in complete responders. By using multivariate analysis, the viral load 2 weeks after the initiation of alpha interferon treatment was the strongest predictor of a complete response. In conclusion, COBAS HCM-2 demonstrated good sensitivity, linearity, and reproducibility and efficiency equal to that of bDNA-2 for the quantification of HCV genotypes 1 and 2. Hence, this assay provides a rapid and reliable method for the quantification of HCV RNA in serum and is useful for the planning of interferon treatment.

2012 ◽  
Vol 56 (12) ◽  
pp. 6372-6378 ◽  
Author(s):  
Jacob Lalezari ◽  
David Asmuth ◽  
Arnaldo Casiró ◽  
Hugo Vargas ◽  
Shannon Lawrence ◽  
...  

ABSTRACTIDX184 is a liver-targeted prodrug of 2′-methylguanosine (2′-MeG) monophosphate. This study investigated the safety, tolerability, antiviral activity, and pharmacokinetics of IDX184 as a single agent in treatment-naïve patients with genotype-1 chronic hepatitis C virus (HCV) infection. Forty-one patients with baseline HCV RNA ≥ 5 log10IU/ml, alanine aminotransferase (ALT) ≤ 2.5× the upper limit of normal, and compensated liver disease were dosed. Sequential cohorts of 10 patients, randomized 8:2 (active:placebo), received 25, 50, 75, and 100 mg of IDX184 once daily for 3 days, with a 14-day follow-up. There were no safety-related treatment discontinuations or serious adverse events. The adverse events and laboratory abnormalities observed for IDX184- and placebo-treated patients were similar. At the end of the 3-day treatment period, changes from baseline in HCV RNA levels (means ± standard deviations) were −0.5 ± 0.6, −0.7 ± 0.2, −0.6 ± 0.3, and −0.7 ± 0.5 log10for the 25-, 50-, 75-, and 100-mg doses, respectively, while viral load remained unchanged for the pooled placebo patients (−0.05 ± 0.3 log10). Patients with genotype-1a and patients with genotype-1b responded similarly. Serum ALT levels decreased, especially at daily doses ≥ 75 mg. During the posttreatment period, plasma viremia and serum aminotransferase levels returned to near pretreatment levels. No resistance mutations associated with IDX184 were detected. Plasma exposure of IDX184 and its nucleoside metabolite 2′-MeG was dose related and low. Changes in plasma viral load correlated with plasma exposure of 2′-MeG. In conclusion, the results from this proof-of-concept study show that small doses of the liver-targeted prodrug IDX184 were able to deliver significant antiviral activity and support further clinical evaluation of the drug candidate.


Intervirology ◽  
2006 ◽  
Vol 49 (6) ◽  
pp. 362-369 ◽  
Author(s):  
Hiroshi Kohno ◽  
Shiomi Aimitsu ◽  
Mikiya Kitamoto ◽  
Yasuyuki Aisaka ◽  
Hiroiku Kawakami ◽  
...  

2000 ◽  
Vol 38 (7) ◽  
pp. 2722-2725 ◽  
Author(s):  
Michéle Martinot-Peignoux ◽  
Véronique Le Breton ◽  
Sandrine Fritsch ◽  
Gaëlle Le guludec ◽  
Nathalie Labouret ◽  
...  

The correlation between response to antiviral therapy and pretreatment viral load in patients with chronic hepatitis C has prompted the development of quantitative assays to measure viral load. The aim of our study was to assess the clinical relevance of the newly developed semiautomated PCR system COBAS HCV MONITOR version 2.0 in comparison with (i) the AMPLICOR HCV MONITOR version 1.0 assay, which underestimates RNA concentration of hepatitis C virus (HCV) genotypes 2 to 6, and (ii) the QUANTIPLEX HCV RNA version 2.0 assay, which achieves equivalent quantification for each HCV genotype, with samples from 174 patients diagnosed with chronic hepatitis C before therapy. The level and range of quantification measured with AMPLICOR HCV MONITOR version 1.0 were 1 log lower than when measured with the COBAS HCV MONITOR version 2.0, at 0.261 × 106 RNA copies/ml (range, 0.001 × 106 to 2.50 × 106 RNA copies/ml) and 4.032 × 106 RNA copies/ml (range, 0.026 × 106 to 72.6 × 106 RNA copies/ml), respectively. The two assays showed a poor correlation (r 2 = 0.175). The level and range of quantification were similar when measured with the COBAS HCV MONITOR version 2.0 and QUANTIPLEX HCV RNA version 2.0 assays, at 3.03 × 106 RNA copies/ml (range, 0.023 × 106 to 72.6 × 106 RNA copies/ml) and 4.91 Meq/ml (range, 0.200 to 49.5 Meq/ml), respectively. The two assays showed a strong correlation (r 2 = 0.686) for each HCV genotype. The duration of treatment (6 or 12 months) is modulated according to HCV genotype and viral load. Our results indicate that COBAS HCV MONITOR version 2.0 and QUANTIPLEX HCV RNA version 2.0 assays showing an equal dynamic range for each HCV genotype are suitable tools to assess patients before therapy.


Author(s):  
Nadhya Allia ◽  
Poernomo Boedi Setiawan ◽  
Soebagijo Adi Soelistijo

Background: Insulin resistance (IR) is one of the extrahepatic complications of hepatitis C virus (HCV) infection that needs to be recognized early. HOMA-IR is an effective way to measure insulin resistancy. Core proteins, NS-3, and NS-5 are the main components of HCV RNA proteins which are involved in the incidence of IR. Seeing this, a hypothesis was developed that the level of HCV RNA viral load was related to the HOMA-IR. This study was designed to identify the correlation between HCV RNA viral load with HOMA-IR in chronic hepatitis C patients.Method: We conducted a cross-sectional approach from the medical record of chronic hepatitis C patients at the outpatient clinic dr. Soetomo Hospital, Surabaya. A total of 30 patients aged >19 years old with complete medical records were included. Clinical and laboratory (including HCV RNA viral load level and HOMA-IR) data were obtained from the availability of medical records.Result: A total of 30 chronic hepatitis C patients, 17 (56.7%) were women and 13 (43.3%) were men, with mean age was 50.90 ± 7.17 years. The median of HCV RNA viral load level was 3,14 x106 IU/ml and the median of HOMA-IR was 4.50. The result of the Spearman correlation test showed a moderate positive association between HCV RNA viral load and HOMA-IR (r=0.537 ; p=0.002).Conclusion: A positive moderate correlation was obtained between HCV RNA viral load with HOMA-IR in chronic hepatitis C patients.


2016 ◽  
Vol 29 (2) ◽  
pp. 383 ◽  
Author(s):  
HossamA Galbt ◽  
AmrA Fathy ◽  
KhaledA Khalefa ◽  
MahaM El-Sabawy ◽  
AmalA El Sharnoby

2021 ◽  
pp. 165-167
Author(s):  
Kumkum Sarkar ◽  
Rupak Chatterjee ◽  
Sumanta Sinha ◽  
Netai Pramanik

Background and objectives- Hepatitis C virus (HCV) infection is a major cause of chronic liver disease worldwide, with majority of the patients being asymptomatic and when they present to clinicians, they have already advanced liver disease in form of cirrhosis or hepatocellular carcinoma. Data from developing countries on this evolving global health problem are sparse. Hence this study was planned with the aim to determine the HCV genotypes prevalant in patients attending a tertiary care hospital with their clinical prole. Materials and Methods- Detailed history taking and clinical examination were done of consecutive 30 patients who attended out-patient department or admitted at in- patient department of Tropical Medicine with chronic hepatitis C. Laboratory investigations like LFT, viral serology (HBsAg, AntiHCV, HIV), prothrombin time, ultrasonography of upper abdomen, HCV- RNA Quantative assay with genotyping were done. Data were collected and then analysed using standard statistical methods. Result- Of proposed 30 sample size, complete data could be collected of 28 patients and accordingly, analysis was done. Of the 28 HCV seroreactive individuals, majority (20) were males. The mode of transmission was unknown in 19 patients, blood transfusion in 5 patients who were thalassemic and hemodialysis in remaining 4 patients. Most of the patients (18/28) were asymptomatic even if their viral load was high. Most common presenting symptom was dyspepsia. LFT showed signicant transaminitis in 50% of the patients. Of the 28 seroreactive patients, 15 (53.57%) were HCV RNA positive based on RT-PCR. HCV rNA was below detectable level in 13 patients. HCV genotype 3 was the predominant genotype found in 11 individuals followed by genotype 1 found in 3 and genotype 2 was seen in one individual. Conclusion- Community screening specially among high risk individuals is needed for early diagnosis and prompt treatment of chronic hepatitis C to prevent its several complications and also to prevent community spread.


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