COBAS AMPLICOR Hepatitis C Virus Research Articles

Analysis of Hepatitis C Virus NS5A Region in Patients with Cirrhosis Using an Ultra-Deep Pyrosequencing Method.

HCV (Hepatitis C Virus) is genetically more diverse than HBV and HIV (Human Immunodeficiency Virus) and exists as quasispecies within infected individuals. This is due to the lack of efficient proofreading of the viral RNA-dependent RNA polymerase. Consequently, quasispecies emerge depending on the mutation rate of the viral polymerase, which may display a high level of genetic variability in a population. In infected individuals, HCV replicates and circulates as quasispecies composed of a complex mixture of different but closely related genomes that undergoes continuous change due to competitive selection and cooperation between arising mutants. The aim of this study is to investigate mutations in the NS5A region as a whole, including ISDR, PKRBD, IRRDR, and V3 of HCV genotype 1b cirrhosis patients being naive and nonresponders, treated with IFN (interferon) + ribavirin (RBN) by using an ultra-deep pyrosequencing method (UDPS). During the study, five patients (four females, and one male, mean age 59.8 ± 11 years) with HCV related cirrhosis were analyzed. Three patients received IFN + RBN for six months, but two patients did not receive any therapy. HCV-RNA concentrations in patients' sera were determined using a COBAS AMPLICOR HCV MONITOR Test, Version 2.0. Genotyping was performed by using a commercial reverse hybridization method, Line Probe Assay. The quasispecies for the NS5A region were investigated using UDPS. All five patients were HCV genotype 1b (Mean Child-Pugh score 7.2 ± 1.9, 2 pts Child A, 2 pts Child B, and one pt Child C) but only one patient had hepatocellular carcinoma (HCC). A total of 19 different mutations were detected in each of the five patients (ranging from 3 to 6 mutations per patient). In all five patients, several mutations in the ISDR and PKR-BD regions were detected. On the other hand, mutations in the V3 and IRRDR regions were only detected in one patient. UDPS is a new sequencing technology and a very sensitive method in detection of quasispecies with low frequency NS5A region mutations. These mutations may affect the antiviral response and development of HCC. However, further studies in larger number of patients should be conducted to clarify this hypothesis.

Genotype 3 is the predominant hepatitis C genotype in a multi-ethnic Asian population in Malaysia

Genotypes of hepatitis C virus (HCV) are distributed differently across the world. There is a paucity of such data in a multi-ethnic Asian population like Malaysia. The objectives of this study were to determine the distribution of HCV genotypes between major ethnic groups and to ascertain their association with basic demographic variables like age and gender. This was a cross-sectional prospective study conducted from September 2007 to September 2013. Consecutive patients who were detected to have anti-HCV antibodies in the University of Malaya Medical Centre were included and tested for the presence of HCV RNA using Roche Cobas Amplicor Analyzer and HCV genotype using Roche single Linear Array HCV Genotyping strip. Five hundred and ninety-six subjects were found to have positive anti-HCV antibodies during this period of time. However, only 396 (66.4%) were HCV RNA positive and included in the final analysis. Our results showed that HCV genotype 3 was the predominant genotype with overall frequency of 61.9% followed by genotypes 1 (35.9%), 2 (1.8%) and 6 (0.5%). There was a slightly higher prevalence of HCV genotype 3 among the Malays when compared to the Chinese (P=0.043). No other statistical significant differences were observed in the distribution of HCV genotypes among the major ethnic groups. There was also no association between the predominant genotypes and basic demographic variables. In a multi-ethnic Asian society in Malaysia, genotype 3 is the predominant genotype among all the major ethnic groups with genotype 1 as the second commonest genotype. Both genotypes 2 and 6 are uncommon. Neither genotype 4 nor 5 was detected. There is no identification of HCV genotype according to ethnic origin, age and gender.

COBAS ® AmpliPrep/COBAS ® Taqman ® HCV Quantitative Test, version 2.0: an in vitro test for hepatitis C virus RNA quantification.

The COBAS(®) AmpliPrep/COBAS(®) Taqman(®) HCV Quantitative Test, version 2.0, is an in vitro, fully automated, real-time, nucleic acid amplification test indicated for quantifying hepatitis C virus (HCV) RNA levels in the plasma/serum of patients infected with HCV of genotypes 1-6 who are receiving anti-viral therapy. By quantifying levels of HCV RNA in these patients, the test can be used early in the course of treatment to predict the likelihood of a sustained virologic response being achieved and can also be used to assess virologic response during treatment as part of response-guided therapy. The test has excellent sensitivity, high specificity and a broad linear range of quantitation. It correlates well with version 1.0 of the same test, but has the benefit of better sensitivity and genotype inclusivity and a smaller sample input volume. It also correlates well with other available HCV tests, including other quantitative real-time PCR tests (specifically the COBAS(®) Taqman(®) HCV Test, version 2.0, used with the high pure system, and the Abbott Realtime and Artus HCV QS-RGQ tests), the Versant(®) branched DNA quantitative test, the COBAS(®) Amplicor HCV Qualitative PCR Test and the Versant(®) HCV qualitative transcription-mediated amplification assay. The test is not indicated for HCV infection diagnosis or to screen for the presence of HCV in blood/blood products.

Prevalence of Hepatitis C Virus in the Population of Albania for the Period 2007-2010

BACKGROUND: Hepatitis C is a blood-borne, infectious, viral disease that is caused by a hepatotropic virus called Hepatitis C virus (HCV).AIM: The aim of this study is to determine the prevalence of active HCV infection (HCV–RNA) in the cases that were anti-HCV positive.MATERIAL AND METHODS: Plasma of 301 high-risk for HCV infection consecutive from University Hospital Centre “Mother Theresa” Tirana-Albania, during January 2007 to December 2010 was included in this study. To identify the presence of HCV RNA, the samples were examined by Cobas Amplicor HCV test (qualitative method).RESULTS: From 301 samples analyzed in total, 214 of them resulted positive for the presence of HCV-RNA's, corresponding to a prevalence of 71.1%, with 95% CI interval [65.8 - 75.9] for value of χ2 = 52.7 p value <0.0001. Divide by the sex 56% were males and 44% females, with statistically significant difference between them for value χ2 =4306 p value=0.0380. Among the age groups the highest prevalence was observed in the age groups > 25 years with a significant difference with other age groups for p value <0.001.CONCLUSION: Among tested samples, 71.1 % were confirmed to be positive for HCV –RNA infections. The prevalence of male was highest compared to female. For males and females infected the prevalence was highest in the age group of > 25 years.

Prevalência sorológica e intensidade da resposta humoral entre indivíduos infectados com Vírus da Hepatite C

A infecção crônica pelo vírus da Hepatite C (HCV) é considerada grave, podendo progredir para cirrose e descompensação hepática. Objetivos: Verificar a prevalência da infecção pelo HCV entre os indivíduos triados, entre setembro de 2007 e setembro de 2009 determinando a correlação dos níveis séricos de anticorpos com presença do RNA viral. Métodos: Os resultados sorológicos da pesquisa de anticorpos anti HCV pelo método imunoenzimático ELISA (BioMérieux®) de 4536 indivíduos foram analisados retrospectivamente. O resultado da pesquisa molecular (COBAS AMPLICOR HCV Roche Diagnostics®) de 79 pacientes foi obtido através de registros médicos, sendo os genótipos 1 e 3 os mais frequentes. A probabilidade do resultado sorológico estar relacionado com a pesquisa molecular foi verificada através de curva ROC, construída para diferentes valores de Índex (DO amostra/DO ponto de corte do ELISA). Resultados: Das amostras para as quais foi realizado o teste molecular, 82,3% confirmaram presença de RNA HCV. Os Valores preditivos positivos (VPP) e Valores preditivos negativos (VPN) para presença de viremia, considerando valores de Índex 4,0 3,0 e 2,0 foram: para Índex 4,0 sensibilidade (S) de 62%, especificidade (E) 64%, VPP de 89%, VPN de 27%. Para Índex 3,0 S=93,0%; E=36,0%, VPP 87%, VPN 55%. Para Índex 2,0 S=100%, E=21%, VPP 85%; VPN 100%. Conclusão: Pode-se inferir que há grande probabilidade de pacientes com reação sorológica para pesquisa de anti-HCV reagente e Índex menor que 2,0, terem suprimido a infecção pelo HCV, e com Índex superior a 4,0 apresentarem viremia presente.

Performance of Molecular Methods for Hepatitis C Virus Diagnosis: Usefulness among Chronic Cases and during the Course of Infection

Molecular methods are essential to define hepatitis C virus (HCV) infection. This study was conducted to evaluate the performance of molecular qualitative and quantitative methods for HCV RNA among chronic patients and individuals during the course of HCV infection. Single serum samples were obtained from 82 HCV infected individuals where six of them donated serial serum samples (n = 52) during the course of HCV infection. Qualitative (in-house RT-nested PCR and COBAS AMPLICOR HCV Test v2.0 and TMA) and quantitative (COBAS AMPLICOR HCV Monitor Test v2.0 and bDNA) techniques were employed. TMA presented the highest rate (87.8%) of HCV detection among qualitative tests and it was the most sensitive for HCV RNA detection during the early and late phases of HCV infection. HCV RNA was quantified among 56 samples and significant correlation was observed between the two assays (r 0.92; p < 0.0001). It is concluded that both quantitative methods can be used among chronic and acute HCV cases, but TMA was the most efficient for HCV qualitative detection among chronic cases and in the early and late phases of HCV infection.

The Different Distribution of Hepatitis C Virus Genotypes in Eastern Black Sea Region of Turkey

Hepatitis C virus (HCV) has infected about 170-200 million people worldwide and HCV genotypes have been related with a particular geographic distribution. The information of genotypes in chronic hepatitis C is critical for the decision of the pharmaceutical regimen, and for the therapeutic outcome. The aim of the study was determining the dispersion of hepatitis C Virus genotype in our area. The study was conducted on 42 patients who referred from various clinics infected with HCV. Serum HCV RNA levels were quantified by using the COBAS AMPLICOR HCV Monitor 2.0. An 851 bp long fragment spanning codons 63 to 347 of the RNA-dependent RNA polymerase in the NS5b part of the HCV genome was amplified. PCR amplifications were conducted in a BioRad DNA Engine using Quantitect SYBR Green PCR mix. Purified PCR products expressively sequenced with the ABI PRISM 310 Genetic Analyzer appliance utilizing DYEnamic ET Terminator Cycle Sequencing Kit. The most prevalent genotype was type 1b (90.4%) in our study. In the other types, type 3 and 4 were detected. We believe that distribution of HCV genotype in this region should be followed strictly due to difference from reports, which reported other parts of Turkey.

Response to peginterferon-alpha 2b and ribavirin in Japanese patients with chronic hepatitis C genotype 1.

Patient age and gender may be associated with response to peginterferon alpha plus ribavirin, the current standard of care (SOC) for chronic hepatitis C genotype 1. We queried whether there was an association between age, gender, and treatment response to SOC in Japanese patients infected with hepatitis C virus (HCV) genotype 1. Between 2006 and 2009, HCV-infected Japanese patients treated with peginterferon alpha-2b plus ribavirin for 48weeks were enrolled. Patients were allocated into four groups according to age and gender, and epidemiological data and treatment outcomes were retrospectively analyzed. HCV RNA was measured with COBAS AMPLICOR HCV Monitor Test v. 2.0. The overall sustained virological response (SVR) rate was 49.8%: patients aged ≤65 and >65years, 50.9 and 44.0%, respectively; male and female, 56.5 and 39.0%. SVR rates of SOC against HCV genotype-1 females aged >65years (19.0%) were inferior to those in males aged >65years (57.8%) in Japan. Multivariate logistic regression analysis showed that SVR was attained independently of adherence 80/80/80 in all groups. Adherence to medication is also a key factor for the eradication of HCV in patients aged >65years. As the SVR rate of patients aged ≤65years was similar to that of patients aged >65years, SOC could be useful for treating some of the elderly patients.

Pegylated interferon-alfa-2a monotherapy in patients infected with HCV genotype 2 and importance of rapid virological response

BackgroundPegylated (PEG)-interferon (IFN)-alfa-2a plus ribavirin (RBV) therapy for 24 weeks is now a standard treatment protocol for patients with hepatitis C virus (HCV) genotype 2. As RBV cannot be used in certain situations, we examined whether PEG-IFN-alfa-2a monotherapy for 24 weeks or less would be sufficient to obtain a sustained virological response (SVR) in patients infected with HCV genotype 2.MethodsForty-nine consecutive patients with HCV genotype 2 received PEG-IFN-alfa-2a (180 μg/week) subcutaneously without oral RBV for 8-64 weeks. HCV RNA level was determined by COBAS AMPLICOR HCV Test, v2.0.ResultsHCV RNA was equal to or less than 100 KIU/mL (defined as low viral load) in 15 of 49 patients, and the remaining 34 had HCV RNA above 100 KIU/mL (defined as high viral load). All 15 patients with low viral load achieved rapid virological response (RVR; HCV RNA negative at week 4), and also achieved SVR with an average treatment duration of 17.1 weeks. The 34 patients with high viral load were treated for 33.7 weeks on average, and 19 of them (55.9%) achieved RVR. The SVR rates of these patients were significantly higher in those with RVR than without RVR (16/19 vs. 6/15 p = 0.0074).ConclusionPEG-IFN-alfa-2a monotherapy for 24 weeks or less might be sufficient to treat selected patients with HCV genotype 2, especially those with low viral load and becoming negative for HCV RNA by week 4 of treatment.

Response to Peginterferon-alfa 2b and Ribavirin in Japanese Patients with Chronic Hepatitis C Genotype 2

The current standard treatment for patients infected with hepatitis C virus (HCV) of genotype 2 is the combination of peginterferon (PEG-IFN) plus ribavirin (RBV) for 24weeks. We assessed the sustained virological response (SVR) rates in HCV genotype 2-infected Japanese patients in relation to the duration of treatment. Between 2006 and 2009, among 147 patients with HCV genotype 2-infection in Chiba Prefecture, 138 consecutive patients were finally enrolled. Twenty-one, 97 and 20 patients were treated with PEG-IFN-alfa 2b plus RBV for 16, 24 and 48weeks, respectively. Epidemiological data and treatment outcomes were retrospectively evaluated. HCV RNA was measured with COBAS AMPLICOR HCV Monitor Test v. 2.0. The overall SVR rate was 82.6% (114 of 138): treatment-naïve patients, 86.4% (89 of 103); patients with history of previous treatment, 71.4% (25 of 35). Patients treated for 16, 24 and 48weeks obtained SVR rates of 66.6% (14 of 21), 86.5% (84 of 97) and 80.0 (16 of 20), respectively. The SVR rates of PEG-IFN-alfa 2b plus RBV in Japanese patients were similar to those in previous studies. Combination treatment for 24weeks for some patients infected with HCV genotype 2 may be superior to that for 16weeks. More precise patient selection will be needed to shorten the combination treatment.

Definition of rapid virologic response with a highly sensitive real-time PCR-based HCV RNA assay in peginterferon alfa-2a plus ribavirin response-guided therapy

Assessing hepatitis C virus (HCV)-RNA levels is integral to response-guided therapy. Rules for early discontinuation and determination of treatment duration were mainly established with HCV-RNA assays with a detection limit of 50IU/ml (COBAS Amplicor HCV [CA]). The currently used real-time PCR-based COBAS Ampliprep/COBAS-TaqMan HCV (CAP-CTM) test has a detection limit of approximately 10IU/ml. It is unknown whether shortening of treatment duration to 16/24 weeks in patients with rapid virological response at week 4 (RVR) and viral loads between 10 and 50IU/ml is possible. We reanalysed stored serum from two large, multinational, randomized trials in which patients were treated with peginterferon alfa-2a/ribavirin (n=962). Results of CAP-CTM with truly undetectable HCV RNA and those <15IU/ml, which includes patients with residual viraemia (<15), were compared with the originally obtained results using the CA assay. RVR rates were comparable for CA (<50) and CAP-CTM (<15) with 32% and 32% for genotype (gt) 1 and 50% and 49% for gt2/3 patients, respectively. A significantly smaller number of samples really had truly undetectable HCV RNA by the CAP-CTM assay (24% for gt1, 37% for gt2/3). However, sustained virological response rates after shortened treatment (16/24weeks) were not significantly different in patients with a RVR <50, a RVR <15 and RVR undetectable (82%, 83%, 83% for 24weeks gt1 and 95%, 95%, 94% for 16weeks gt2/3). Shortening the treatment duration to 16/24weeks can be performed on the basis of a RVR with HCV-RNA concentrations <15IU/ml by the CAP-CTM assay.

Evaluation of the Real-Q HCV Quantification Kit

Background: Hepatitis C virus (HCV) RNA quantification is necessary for predicting the therapeutic response and assessing treatment results in patients with chronic HCV infection. Recently, real-time PCR technology for HCV RNA quantification displayed good linearity within the dynamic range. Thus, it is gradually replacing branched-DNA (bDNA) and PCRhybridization assays. In this study, we evaluated the performance of the Real-Q HCV quantification kit (biosewoom. Inc., Seoul, Korea) developed in Korea. Methods: We evaluated the HCV quantification kit for detection limit, specificity, linearity, accuracy, and recovery rate of HCV RNA standard material. The results were analyzed for a correlation with those of Cobas Amplicor HCV Monitor 2.0. Results: The HCV quantification kit showed a high recovery rate of HCV RNA standard material of various concentrations and amplication of HCV RNA equally in all genotypes. Hepatitis B virus and human immunodeficiency virus showed no cross-reactivity with HCV. Within-run and between-run coefficients of variation (CV) were 9.52∼15.84% and 9.40∼17.53%, respectively. Between-day coefficients of variation were 11.62∼18.04%, and detection limit was 44 IU/mL. It showed a good correlation with Cobas Amplicor HCV Monitor 2.0 (R=0.8954). Conclusion: The Real-Q HCV quantification kit showed a good specificity, sensitivity, linearity, and accuracy; therefore, we propose that it is fully adequate for monitoring antiviral therapy in patients with chronic HCV infection. (Korean J Clin Microbiol 2009;12:7277)

Insulin Resistance Is Associated With Advanced Liver Fibrosis and High Body Mass Index in HIV/HCV-Coinfected Patients

Insulin Resistance Is Associated With Advanced Liver Fibrosis and High Body Mass Index in HIV/HCV-Coinfected Patients

Abbott RealTime Hepatitis C Virus (HCV) and Roche Cobas AmpliPrep/Cobas TaqMan HCV Assays for Prediction of Sustained Virological Response to Pegylated Interferon and Ribavirin in Chronic Hepatitis C Patients

Two commercial real-time PCR assays are currently available for sensitive hepatitis C virus (HCV) RNA quantification: the Abbott RealTime HCV assay (ART) and Roche Cobas AmpliPrep/Cobas TaqMan HCV assay (CAP/CTM). We assessed whether the two real-time PCR assays were more effective than Roche Cobas Amplicor HCV Monitor test, v.2.0 (CAM) for prediction of the sustained virological response (SVR) to pegylated interferon (PEG-IFN) plus ribavirin (RBV) in chronic hepatitis C. Sixty patients chronically infected with HCV genotype 1b (37 males and 23 females, 53 +/- 12 years of age) were treated with PEG-IFNalpha2b plus RBV for 48 weeks. Stored specimens at nine time points for each patient (at baseline, on treatment, and 24 weeks after treatment) were tested by the two real-time PCR assays and CAM. Twenty-six (43.3%) patients reached SVR. The positive predictive values (PPVs) for SVR of undetectable HCV RNA at week 12 by CAM, ART, and CAP/CTM were 74.3%, 88.0%, and 95.2%, respectively. An undetectable HCV RNA level by CAM, ART, and CAP/CTM correctly predicted SVR at week 4 in 100%, 100%, and 100% of patients, at weeks 5 to 8 in 91.7%, 100%, and 100% of patients, at weeks 9 to 12 in 55.6%, 75%, and 87.5% of patients, and at weeks 13 to 24 in 0%, 26.7%, and 40% of patients, respectively. Of 16 patients who relapsed after treatment, HCV RNA was detectable in 2 patients at the end of treatment by CAP/CTM but undetectable by ART and CAM. HCV RNA tests using ART and CAP/CTM are considered to be more effective at predicting SVR than CAM, and the PPV for SVR was slightly higher in CAP/CTM than in ART.

Development and evaluation of a sensitive enzyme-linked oligonucleotide-sorbent assay for detection of polymerase chain reaction-amplified hepatitis C virus of genotypes 1–6

A high-throughput polymerase chain reaction (PCR)-based enzyme-linked oligonucleotide-sorbent assay (ELOSA) was developed for use in the diagnostic testing of serum from patients who may be infected with different hepatitis C virus (HCV) genotypes. Twelve genotype-specific 5′-aminated DNA-coated probes were designed based on the variable 5′-untranslated region sequences of the HCV genotypes 1–6. Using 100 clinical serum samples, the performance of the PCR-ELOSA method was compared with Roche's COBAS Amplicor HCV Monitor V2.0 assay and the VERSANT HCV genotype assay (LiPA), and the overall agreement was 99% at the level of HCV genotypes with a detection range of 2.0 × 10 2 to 1.0 × 10 7 IU/ml for PCR-ELOSA. The PCR-ELOSA was more comprehensive as demonstrated by the fact that ∼20% of the samples with different subtypes could be discriminated by this method but not by LiPA. In addition, the PCR-ELOSA system showed high accuracy (CV ≤ 6.36%) and even higher reproducibility (CV ≤ 5.55%). Thus, this novel PCR-ELOSA system provides a sensitive and versatile alternative to current HCV detection assays.

The development of a qualitative real-time RT-PCR assay for the detection of hepatitis C virus

Real-time polymerase chain reaction (PCR) represents a favourable option for the detection of hepatitis C virus (HCV). A real-time reverse transcriptase PCR (RT-PCR) assay was developed as a qualitative diagnostic screening method for the detection of HCV using the ABI PRISM 7500 Sequence Detection System. The primers and probe were designed to target the 5'-untranslated region of the hepatitis C viral genome. A second heterologous probe assay was developed for the detection of the haemagglutinin gene of phocine distemper virus (PDV) and was used as an internal control. A semi-automated HCV extraction method was also implemented using the ABI PRISM 6100 Nucleic Acid PrepStation. The HCV assay was optimised as a qualitative singleplex RT-PCR assay with parallel testing of the target and internal control. The assay results (n = 200) were compared to the COBAS AMPLICOR HCV Test v2.0 assay. The assay demonstrated a high rate of sensitivity (99%), specificity (100%) and an acceptable limit of detection (LOD) of 100 IU/ml. The development of a qualitative multiplex assay for the simultaneous detection of HCV and internal control indicates the same high rates of sensitivity and specificity. This sensitive real-time assay may prove to be a valuable method for the detection of HCV.

Evolution of Plasma Hepatitis C Virus Load in Patients Coinfected by HIV and Hepatitis C Virus Started on a Protease Inhibitor-Containing Antiretroviral Regimen, Agence Nationale de Recherches sur le SIDA CO8 APROCO-COPILOTE Cohort

Evolution of Plasma Hepatitis C Virus Load in Patients Coinfected by HIV and Hepatitis C Virus Started on a Protease Inhibitor-Containing Antiretroviral Regimen, Agence Nationale de Recherches sur le SIDA CO8 APROCO-COPILOTE Cohort

Peginterferon Alfa-2a and Ribavirin for 24 Weeks in Hepatitis C Type 1 and 4 Patients With Rapid Virological Response

This analysis reports the rate of sustained virological response (SVR) in patients infected with hepatitis C virus (HCV) genotype 1 or 4 who were assigned to 24 weeks of treatment with pegylated interferon (peginterferon) alfa-2a 180 mug/wk plus ribavirin 1000/1200 mg/day after achieving a rapid virological response (RVR; HCV RNA level <50 IU/mL) at week 4 in a prospective trial investigating response-guided therapy. Non-RVR patients with an early virological response were randomized to 48 or 72 weeks of therapy (this is a still-ongoing trial). A total of 150 of 516 patients (29%) had an RVR, 143 of whom completed 24 weeks of treatment. Younger patients, leaner patients, and those with an HCV RNA level </=400,000 IU/mL and HCV genotype 4 infection were more likely to achieve an RVR; however, among patients with an RVR, no baseline factor predicted SVR. The SVR rate was 80.4% (115/143; 95% confidence interval [CI], 72.9-86.6) in patients who completed 24 weeks of treatment. The SVR rate was 86.7% (26/30; 95% CI, 69.3%-96.2%) in patients infected with genotype 4 and 78.8% in those infected with genotype 1 (89/113; 95% CI, 70.1%-85.9%; intent to treat: 89/120; 74.2%; 65.4-81.7%). Treatment was well tolerated. This prospective study confirms that a 24-week regimen of peginterferon alfa-2a plus ribavirin 1000/1200 mg/day is appropriate in genotype 1 and 4 patients with a low baseline HCV RNA level who achieve an RVR by week 4 of therapy.

Large Intestine Histopathology of Pegylated-Interferon-Alpha Plus Ribavirin Treated Chronic Hepatitis C Patients

Large Intestine Histopathology of Pegylated-Interferon-Alpha Plus Ribavirin Treated Chronic Hepatitis C Patients

Factors influencing a low rate of hepatitis C viral RNA clearance in heroin users from Southern China

To study the virological and host factors influencing hepatitis C infection outcomes in heroin users in southern China. HCV RNA and associated factors were analyzed among 347 heroin users from Guangxi Zhuang Autonomous Region, southern China who were hepatitis C virus (HCV) EIA positive for two or more consecutive visits. Using the COBAS AMPLICOR HCV TEST, a remarkably low HCV RNA negative rate of 8.6% was detected. After multivariate logistic regression analysis, HCV RNA clearance was significantly associated with the presence of HBsAg (OR = 8.436, P < 0.0001), the lack of HIV-1 infection (OR = 0.256, P = 0.038) and age younger than 25 (OR = 0.400, P = 0.029). Our study suggests HCV infection among Chinese heroin users results in high levels of viral persistence even amidst factors previously found to enhance viral clearance. Prospective studies of a possible genetic component within the Chinese population and the pathogenicity of non-genotype 1 HCV infections are needed.