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Biomedical subjects

M L Yu

Publications and source records attributed to M L Yu.

At least 19 recordsLinked to original sources
PubMed2001

GB virus C/hepatitis G virus infection in chronic hepatitis C patients with and without interferon-alpha therapy.

GB virus C/hepatitis G virus (GBV-C/HGV) RNA, detected by polymerase chain reaction, and antibodies to the GBV-C/HGV envelope protein (anti-E2), detected by an enzyme-linked immunosorbent assay, were used to evaluate both the impact of GBV-C/HGV on the coexistent hepatitis C virus (HCV) infection and the course of GBV-C/HGV infection in chronic hepatitis C patients with and without interferon-alpha (IFN-alpha) treatment. Of the 162 chronic hepatitis C patients treated with INF-alpha, 17.9% were GBV-C/HGV RNA-positive and 18.5% anti-E2-positive (total exposure, 35.2%). Neither present nor past GBV-C/HGV infection had impact on the clinical features, HCV virological characteristics and response to IFN-alpha treatment in chronic hepatitis C patients. Among patients with ongoing HCV/GBV-C/HGV coinfection, 20.7% (6/29) in IFN-alpha-treated patients lost GBV-C/HGV RNA concomitant with anti-E2 seropositivity, which was significantly higher than 4.8% (2/42) in patients without INF-alpha treatment (P<0.05). Based on multivariate analyses, the significant factors associated with clearance of GBV-C/HGV viremia combined with anti-E2 seropositivity were baseline anti-E2 seropositivity and IFN-alpha treatment. In summary, GBV-C/HGV did not alter the course of coexistent HCV. IFN-alpha treatment was effective in some patients against GBV-C/HGV and might facilitate anti-E2 seroconversion in chronic hepatitis C patients with GBV-C/HGV viremia.

Adolescent↗
PubMed2001

Hepatitis C virus infection among teenagers in an endemic township in Taiwan: epidemiological and clinical follow-up studies.

The aim of the study was to elucidate the epidemiological features of Hepatitis C virus (HCV) infection among teenagers in an endemic area by conducting a mass screening study. We also investigated the clinical outcome of the anti-HCV-positive subjects by conducting subsequent short-term and long-term follow-up studies. All 2837 students of two junior middle schools in Tzukuan, aged 13-16 years, were invited to be screened for anti-HCV, HBsAg, AST and ALT in October 1995. A total of 2726 (96%) students responded. Anti-HCV, HCV RNA and aminotransferase levels were evaluated among anti-HCV-positive students 1 month and 30 months later, respectively. A total of 38 (1.4%; M/F = 22/16) participants were anti-HCV-positive. The anti-HCV-positive students had higher rates of exposures to transfusion, anti-HCV-positive families and surgery. The prevalence (2.8%) of the 7 maritime villages was markedly higher than that (0.7%) of the other 8 villages (P < 0.001). Subsequent follow-up studies demonstrated that there might be 5 cases of acute or recent HCV infection, and 6 cases who had recovered from chronic HCV infection.

Adolescent↗
PubMed2001

Influence of hepatitis C virus on the profiles of patients with chronic hepatitis B virus infection.

BACKGROUND: Hepatitis B virus (HBV) and hepatitis C virus (HCV) are the most common causes of chronic liver disease, cirrhosis and hepatocellular carcinoma. The influence of HCV infection on the clinicopathological and virological profiles of chronic HBV infection was investigated. METHODS: A total of 100 chronic HBV carriers with histopathological diagnoses by liver biopsy were studied. Hepatitis B e antigen (HBeAg) and anti-HCV antibody were tested. Serum HCV-RNA was detected by using a nested reverse transcription-PCR assay. A branched DNA (bDNA) assay was used to detect HBV-DNA and quantitate the serum levels. RESULTS: Eighteen (18%) of 100 patients were positive for anti-HCV and HCV-RNA. Patients with concurrent HCV and HBV infection were significantly older than those without HCV infection (P < 0.05). The positive rates of HBeAg and HBV-DNA as well as the serum levels of HBV-DNA in patients with concurrent HCV and HBV infection were significantly lower than those without concurrent HCV and HBV infection (P < 0.01, P < 0.05, and P < 0.001, respectively). By using multivariate analysis, the factors of seroconversion of HBeAg and decreasing level of HBV-DNA were significantly correlated to concurrent HCV and HBV infection in chronic HBV carriers. The factors of increasing age and concurrent HCV and HBV infection were significantly correlated to seroconversion of HBeAg. CONCLUSIONS: The concurrent HCV and HBV infection in chronic HBV carriers might result in a suppression of HBV replication that presented with a lower level of serum HBV-DNA and HBeAg seroconversion. Nevertheless, neither more obvious increase in biochemical parameters nor histopathological progression to more advanced liver diseases was observed.

Adult↗
PubMed2001

The serological and molecular epidemiology of GB virus C/hepatitis G virus infection in a hepatitis C and B endemic area.

OBJECTIVES: To investigate the serological and molecular characteristics of GB virus C/hepatitis G virus (GBV-C/HGV) infection in the hepatitis C virus (HCV)/hepatitis B virus (HBV)-endemic areas in Taiwan. METHODS: Sera from 200 residents from Masago, an HCV/HBV-endemic community in Taiwan, and 400 blood donors were tested for GBV-C/HGV RNA by using nested reverse transcription-polymerase chain reaction and for antibodies to GBV-C/HGV E2-protein (anti-E2) by an enzyme-linked immunosorbent assay. Phylogenetic analysis of GBV-C/HGV was performed. RESULTS: The prevalence of GBV-C/HGV viraemia, anti-E2 and GBV-C/HGV exposure among residents of Masago was significantly higher than that among donors (17.0%, 25.5% and 39.5% vs. 3.3%, 7.5% and 10.3%, respectively; all P < 0.0001). In Masago, the prevalence of GBV-C/HGV exposure was significantly higher in residents exposed to HCV than in those without HCV exposure (45.8% vs. 24.1%;P< 0.005). Based on multivariate analyses, HCV viraemia was the only significant factor associated with elevated levels of alanine aminotransferase in Masago. Phylogenetic analysis showed all 34 GBV-C/HGV isolates from Masago clustered within genotype 3. CONCLUSIONS: GBV-C/HGV was highly prevalent in Masago, an HCV/HBV-endemic community in Taiwan. HCV viraemia played the most important clinical hepatopathic role in the area. Infections with other hepatitis viruses did not influence the anti-E2 seroconversion from GBV-C/HGV infections.

Adult↗
PubMed2001

Changing prevalence of hepatitis C virus genotypes: molecular epidemiology and clinical implications in the hepatitis C virus hyperendemic areas and a tertiary referral center in Taiwan.

To determine the hepatitis C virus (HCV) genotype distribution in Taiwan and to clarify the relationship between genotype and the pathogenesis of HCV infection, 1,164 subjects positive for serum HCV antibodies and HCV RNA from three HCV hyperendemic areas (Masago, Tzukuan, and Taoyuan) and a tertiary referral center in Taiwan were studied during 1995-1997. HCV genotypes and viral loads were determined using Okamoto's method and branched DNA assay, respectively. Genotype 1b was the most prevalent in Tzukuan (61.9%), Taoyuan (76.9%), and the referral center (47.0%). By contrast, genotype 2a was the major HCV type in Masago (63.5%). Prevalence of genotype 1b positively and that of genotype 2a negatively correlated to age, regardless of study populations (P < 0.01). Based on multivariate analysis, the significant factors associated with the presence of cirrhosis, with or without hepatocellular carcinoma, in chronic hepatitis C patients were genotype 1b and age. In conclusion, these results underline that independent HCV outbreaks continue in HCV hyperendemic areas in Taiwan, concomitant with a changing relative prevalence of HCV genotypes in relation to age. Both the correlation of genotype 1b with age (cohort effect) and intrinsic properties of HCV genotypes are probably responsible for the association between genotype and the pathogenesis of HCV infection.

Adolescent↗
PubMed2000

Role of serum C-reactive protein as a marker of hepatocellular carcinoma in patients with cirrhosis.

BACKGROUND: The usefulness of C-reactive protein (CRP) as a tumour marker in patients with hepatocellular carcinoma (HCC) is controversial. The purpose of this study was to determine whether CRP estimation could be used to identify patients with HCC among those with cirrhosis. METHODS: Serum levels of CRP and alpha-fetoprotein (AFP) were investigated in 122 previously untreated patients with cirrhosis and HCC. Another 76 patients with cirrhosis alone were also investigated as controls. RESULTS: Of the subjects tested, 47.5% of patients with HCC and 39.5% of controls had elevated CRP values (> 6 microg/mL). Although using elevated CRP and/or AFP (> 20 ng/mL) as a criterion showed a significant difference between controls and patients with multiple nodular, massive, or diffuse type HCC (all P < 0.005), the clinical application of this criterion was limited because of low specificity (58%) and accuracy (all < 73%). By using receiver-operating characteristic curves no valuable threshold value of CRP was found to discriminate various types of HCC, except for distinguishing the diffuse type from controls. The CRP value of 12 microg/mL could be used as the cut-off value to differentiate diffuse-type HCC from controls (sensitivity 82.4%, specificity 82%, accuracy 82.1%, P<0.005). CONCLUSIONS: Serum CRP is not a good marker for HCC. However, very high values of CRP in patients with cirrhosis may suggest the presence of a diffuse-type HCC.

Adult↗
PubMed2000

Serotyping and genotyping of hepatitis C virus in Taiwanese patients with type C chronic liver disease and uraemic patients on maintenance haemodialysis.

BACKGROUND: To evaluate a recombinant immunoblot hepatitis C virus (HCV) serotyping assay, which determines HCV serotypes 1, 2, and 3 by detecting type-specific antibodies to core-and NS-4-derived peptides. METHODS: Immunoreactivity of type-specific antibodies among 173 chronic hepatitis C patients and 43 haemodialysis patients in Taiwan was examined and the serotyping results were compared with genotyping by Okamoto's method. Serial specimens from 29 patients undergoing interferon-alpha therapy were also evaluated. RESULTS: Of the 205 specimens for which genotyping data were available, 51.2% were of serotype 1, 31.7% of serotype 2, 1.0% of serotype 3, 2.4% of either serotype 1 or 3, and the remaining 13.7% were untypable. The serotypable rate was significantly lower in haemodialysis patients than in chronic hepatitis C patients (70.0% vs 94.9%; P < 0.001). Serotyping of genotype 2b specimens was significantly more dependent on core peptide bands than other genotypes. Using genotyping as the reference, the overall sensitivity, specificity and concordance of the recombinant immunoblot HCV serotyping assay were 86.3%, 97.2% and 83.9%, respectively. However, the serotyping assay had significantly lower sensitivity (69.2%), specificity (77.8%) and concordance (53.8%) for genotype 2b specimens. Of nine HCV complete responders, one lost type-specific antibodies 6 months after the cessation of interferon-alpha treatment. CONCLUSIONS: These results suggest that, except for less than optimal performance with immunocompromised or genotype 2b patients, the HCV serotyping assay is a practical and useful method for HCV typing in the clinical setting in Taiwan.

Female↗
PubMed2000

Status and natural course of GB virus C/hepatitis G virus infection among high-risk groups and volunteer blood donors in Taiwan.

BACKGROUND: Hemophilia, thalassemia and uremia patients are at risk of parenterally transmitted infectious agents. The status and nature of the course of GB virus C/hepatitis G virus (GBV-C/HGV) infection among these groups and blood donors in Taiwan was investigated. METHODS: Serum GBV-C HGV-RNA and antibodies to GBV-C/HGV envelope-2-protein (anti-E2) were determined in 500 blood donors and in 44 hemophilia, 37 thalassemia and 85 uremia patients. Phylogenetic analysis was performed. RESULTS: The prevalence of GBV-C/HGV-RNA and anti-E2, respectively, was 38.6 and 27.3% in hemophilia patients, 27.0 and 27.3% in thalassemia patients, 14.1 and 10.6% in uremia patients and 3.4 and 7.2% in blood donors. The prevalence of GBV-C HGV exposure was 59.1 and 51.4% in hemophilia and thalassemia patients, respectively, which was significantly higher than that for uremia patients (22.4%; P < 0.01) and blood donors (10.2%; P < 0.001). The anti-E2 seroconversion rate was 66.7% in blood donors and 47.4, 36.8 and 34.6% in thalassemia, uremia (P < 0.05 compared with blood donors) and hemophilia (P < 0.01 compared with blood donors) patients, respectively. Discrepancies in the prevalence of GBV-C HGV and hepatitis C virus infection were found among the three risk groups. Phylogenetic analysis showed that 51 of 56 GBV-C HGV isolates clustered in group 3; the remaining five were of group 2a. Twelve of 39 viremic patients in the risk groups cleared the virus during the 4 year follow-up period; seven developed concomitant anti-E2 reactivity. CONCLUSIONS: GB virus C hepatitis G virus infection is epidemic among risk groups and GBV-C HGV group 3 is the major strain in Taiwan. In the risk groups, approximately 18% of infections resolve with concomitant anti-E2 seroconversion within 4 years.

5' Untranslated Regions↗
PubMed2000

Incidence and associated factors of neutralizing anti-interferon antibodies among chronic hepatitis C patients treated with interferon in Taiwan.

BACKGROUND: The administration of interferon (IFN) could be complicated by the development of neutralizing anti-interferon antibodies (NA). This study evaluates the frequency and associated factors of NA among chronic hepatitis C patients treated with different IFNs. METHODS: Ninety-five chronic hepatitis C patients were randomized to be treated with recombinant IFN-alpha2a (n = 28), IFN-alpha2b (n = 39) or lymphoblastoid IFN-alpha1 (n = 28) given intramuscularly, 3-6 million units, thrice weekly for 24 weeks. Serum samples collected before, during and after the cessation of treatment were checked for NA. RESULTS: Three patients were withdrawn from treatment. All patients were negative for NA before treatment and 13 (14%) patients developed neutralizing antibodies. Of the 26 patients treated with IFN-alpha2a, 6 (23.1%) developed NA. whereas NA were detected in only 6 (15.4%) of 39 and 1 (3.7%) of 27 patients treated with IFN-alpha2b and IFN-alphanl, respectively. Age, gender, HCV genotype, ALT level, IFN total dose and liver histology were not associated with the development of NA. By using multivariate logistic regression it was shown that pretreatment HCV RNA level and IFN preparation were the two major factors related to the production of NA. The response of treatment was related to pretreatment viremia but not to the presence of NA. CONCLUSIONS: The frequency of development of NA among Taiwanese patients with chronic hepatitis C might be related to different IFN preparations and pretreatment HCV RNA level. The response of treatment was related to pretreatment HCV RNA level but not to the presence of NA.

Adult↗
PubMed2000

Menstruation and reproduction in women with polychlorinated biphenyl (PCB) poisoning: long-term follow-up interviews of the women from the Taiwan Yucheng cohort.

BACKGROUND: In 1979 in Taiwan, about 2000 people were poisoned by cooking oil contaminated with heat-degraded polychlorinated biphenyls (PCBs). Victims developed chloracne and other symptoms; the illness is called Yucheng (oil disease). The chemicals persist in the victims' bodies and some are toxic to the female reproductive system in experimental animals. METHODS: In 1993-1994, we identified the living Yucheng women and neighbourhood controls and interviewed them about their reproductive experience. Of the 596 living Yucheng women aged 30-59 years, we found 368, and interviewed 356. We identified 329 controls, and interviewed 312. RESULTS: Of the Yucheng women, 16% reported abnormal menstrual bleeding compared to 8% (P < 0.05) of control women; 4.2% versus 1.7% reported a stillbirth since 1979 (P = 0.068). Other characteristics of the menses, fertility, frequency of intercourse, and age at menopause appeared unaffected. More of the Yucheng women reported that one of their offspring had died during childhood (10.2% versus 6.1%, P < 0. 05), and that they had decided to limit childbearing because of health problems (7% versus 2%, P = 0.01). CONCLUSIONS: These findings suggest that high level PCB/polychlorinated dibenzofuran (PCDF) exposure has some effect on female endocrine and reproductive function.

Adult↗
PubMed2000

Diagnostic value of immunoglobulin G (IgG) and IgM anti-hepatitis E virus (HEV) tests based on HEV RNA in an area where hepatitis E is not endemic.

Acute hepatitis E (AHE) has rarely been reported in industrialized countries, but the rate of seroprevalence of hepatitis E virus (HEV) antibodies (anti-HEV) is inappropriately high. The sensitivity and specificity of the assay used to test for immunoglobulin G (IgG) and IgM anti-HEV have not been well established in areas where hepatitis E is not endemic (hereafter referred to as "nonendemic areas"). We collected serum samples from 13 AHE patients, 271 healthy subjects, and 160 other liver disease patients in Taiwan to test for HEV RNA by reverse transcription (RT)-PCR and for IgG and IgM anti-HEV by enzyme-linked immunosorbent assays. The sensitivities of IgG and IgM anti-HEV (relative to RT-PCR) were 86.7 and 53.3%, respectively. The specificities of IgG and IgM anti-HEV assays for diagnosing AHE were 92.1 and 98.6%, respectively. The rate of seroprevalence of IgG anti-HEV was 11% among healthy subjects in this nonendemic area, and it increased with age. In summary, IgG anti-HEV is a good diagnostic test for screening for AHE in nonendemic areas. The high rate of prevalence of anti-HEV in healthy subjects indicates that subclinical infection may exist.

Acute Disease↗
PubMed2000

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.

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.

Adolescent↗
PubMed2000

Percutaneous ethanol injection of the supplying artery to hepatocellular carcinoma that is not amenable to conventional treatment.

The purpose of this study was to evaluate the clinical usefulness of ultrasound-guided percutaneous ethanol injection of the supplying artery (PEISA) to the tumour in the palliative management of hepatocellular carcinoma (HCC) that is not amenable to conventional treatments. A total of 23 cases of HCC, measuring from 3.1 cm to larger than 15 cm (median 5.4 cm) in 17 cirrhotic patients, were treated by PEISA. PEISA was used to control rapid growth of the tumour in seven patients and to reduce abdominal discomfort caused by rapid expansion of the tumour in 10 patients. Tumours with arterial Doppler signals persisting after PEISA underwent repeated treatment. The follow-up period ranged from 2-48 months. PEISA was achieved in 69 out of 76 attempts (90.8%). The amount of ethanol injected on each occasion ranged from 2.5-33 ml. Follow-up colour Doppler scanning showed complete elimination of tumour Doppler signals in 22 out of 23 lesions (95.7%). Following treatment, one tumour disappeared, 13 tumours shrank and nine tumours were unchanged in size. All patients with abdominal discomfort had relief after treatment. The common complications of PEISA were local pain and fever. In conclusion, PEISA is effective at treating painful HCC unsuitable for conventional treatment.

Aged↗
PubMed2000

Virologic factors related to interferon-alpha-induced thyroid dysfunction in patients with chronic hepatitis C.

OBJECTIVE: Hepatitis C virus (HCV), being reported to be associated with a high prevalence of serological markers of autoimmunity in HCV-infected patients, and possibly sharing partial sequences in amino acid segments with thyroid tissue antigens, may be associated with interferon-alpha (IFN-alpha)-induced thyroid dysfunction in chronic hepatitis C patients. We conducted this study to clarify the issue. DESIGN AND METHODS: One hundred and fifty chronic hepatitis C patients with normal baseline thyroid function were treated with IFN-alpha 2a, 2b and n1 (3-6 million Units three times weekly for 24 weeks). Pretreatment sera were tested for HCV genotype and HCV RNA levels. Serum thyrotropin, total thyroxine and free thyroxine index were performed every 4 weeks for 24 weeks followed by every 8 weeks for another 24 weeks. RESULTS: Twenty-one (14.0%) patients developed early thyroid dysfunction (abnormal thyroid function during the first 3 months of therapy). Female gender, lower HCV RNA levels, IFN-alpha n1 and a lower IFN-alpha dose were significantly associated with early thyroid dysfunction. On multivariate analysis, gender, IFN-alpha preparation and HCV RNA levels were the significant factors associated with early thyroid dysfunction. Seven (4.7%) patients developed thyroid dysfunction during the second 3 months of IFN-alpha therapy. Taken together, 18.7% patients developed thyroid dysfunction. Female, mixed HCV genotype infection and lower HCV RNA levels were significantly associated with thyroid dysfunction. However, only gender remained significantly associated with IFN-alpha-induced thyroid dysfunction in multivariate analysis. CONCLUSIONS: The virologic features of HCV may be associated with thyroid dysfunction in chronic hepatitis C patients treated with IFN-alpha. Nevertheless, gender still plays the most important role in IFN-alpha-induced thyroid dysfunction.

Adolescent↗
PubMed2000

The epidemiology of TT virus (TTV) infection in a hepatitis C and B virus hyperendemic area of southern Taiwan.

TT virus (TTV) is a newly isolated DNA virus from the serum of a patient with posttransfusion hepatitis of unknown etiology in 1997. To evaluate the clinical and molecular characteristics of TT virus (TTV) in a hepatitis C virus (HCV) and B (HBV) hyperendemic area (Masago), 200 residents were enrolled in the study. The sera were tested for alanine aminotransferase (ALT), HCV RNA and GB virus C/Hepatitis G virus (HGV) RNA, TTV DNA, HBsAg, anti-HCV and antibodies to HGV E2-protein (anti-E2). TTV DNA was positive in 99 of the 200 sera with a prevalence rate of 49.5%. The prevalence of HBsAg, anti-HCV, HCV RNA, HGV RNA, anti-E2 and HGV exposure (defined as positive for serum HGV RNA and/or anti-E2) was 38.9%, 69.5%, 64.5%, 17.0%, 25.5% and 39.5%, respectively. Neither clinical nor virological factors were associated with TTV viremia. The rate of ALT abnormality was significantly elevated in HCV RNA-positive (34.9%) than -negative (7.0%) residents (p < 0.001). HCV viremia was the only factor significantly associated with ALT elevation by multiple logistic regression (odds ratio: 6.96; 95% C.I.: 2.60-18.7). We concluded that in this HCV/HBV hyperendemic area, the prevalence of TTV DNA was high. No significant clinical factor was observed to be associated with TTV infection. TTV infection is not related to abnormal ALT levels and ALT abnormality was mainly attributable to HCV but not TTV, HBV or HGV infection.

Adult↗
PubMed1999

Recent trend of polychlorinated dibenzo-p-dioxins and their related compounds in the blood and sebum of Yusho and Yu Cheng patients.

We investigated the levels of polychlorinated dibenzo-p-dioxins (PCDDs) and their related compounds in blood and sebum from Yusho and Yu-Cheng patients and findings compared with those of normal subjects. Concentrations of these compounds in blood and sebum still were obviously reflected the chemical concentration in the causal rice oil ingested 17 or 26 years since the outbreak. In addition, sebum form the body surface was the most useful sample for monitoring the amount of chemicals contaminating the human body.

Adult↗
PubMed1999

Clinical application of the Quantiplex HCV RNA 2.0 and Amplicor HCV Monitor assays for quantifying serum hepatitis C virus RNA.

AIM: To compare the performance characteristics and clinical application of two different technologies for quantifying serum hepatitis C virus (HCV) RNA levels. METHODS: HCV RNA was quantified by Amplicor HCV Monitor assay (Amplicor) and Quantiplex HCV RNA 2.0 assay (bDNA-2) in 119 sera from 107 HCV infected patients. RESULTS: Both assays had similar sensitivity (79.4% for Amplicor; 86.0% for bDNA-2), acceptable coefficients of variation (5.3% in Amplicor; 2.6% in bDNA-2), and good linearity (r2 > or = 0.98). There was a positive correlation between quantification values of both methods (r = 0.683, p < 0.001). The Amplicor values were on an average 1.76 log lower than bDNA-2 results. Male subjects and HCV genotype 1b were significantly associated with higher viral load determined by Amplicor, but not with viral load measured by bDNA-2. In 70 chronic HCV infected patients treated with interferon alfa, mean (SD) pretreatment viral load in 27 complete responders (3.47 (0.84) logs for Amplicor, 5.63 (0.58) for bDNA-2) was significantly lower than in non-responders (4.43 (1.01) logs for Amplicor, 6.10 (0.67) logs for bDNA-2; p < 0.001). Cut off points of 3.9 logs for Amplicor and 5.8 logs for bDNA-2 were determined to be the best for predicting response to interferon alfa, giving acceptable sensitivity (70.4%, 74.1%), specificity (72.1%, 65.1%), and accuracy (71.4%, 68.6%), respectively. CONCLUSIONS: Both the Amplicor and bDNA-2 assays are clinically useful methods for HCV RNA quantification and are reliable for predicting the outcome of treatment, despite differences in absolute quantification values and in the correlation between HCV genotypes and viral load.

Adult↗