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Background: The relationship between viral infections and host factors holds high hopes for identifying the role of Interferon Lambda 3 (IFNL3) and Interleukin 6 (IL-6) polymorphisms in the development of Chronic Liver Disease (CLD) in patients infected with hepatitis Delta virus (HDV) in the Western Brazilian Amazon. Methods: Cross-sectional study conducted with a cohort of 40 chronic HDV patients, 27 with CLD and 13 without evident liver damage. Biological samples from the participants were analyzed using the polymerase chain reaction (PCR) technique, followed by sequencing by the automated Sanger method. Results: The rs8099917 T allele, from the IFNL3 gene, showed a higher frequency in both groups; however, it was not possible to establish an association with HDV infection [OR = 1.42 (0.42 - 4.75; p = 0.556 (95% CI). For IL-6, the rs1800795 G allele was superior to rs1800795 C. Analyzing both distributions in the studied groups, any association with HDV was absent (p > 0.05). Conclusion: The results suggest that the rs8099917 T/G (IFNL3) and rs1800795 G/C (IL-6) polymorphisms are not associated with the evolution of HDV in the studied population.
Subject(s)
Humans , Hepatitis Delta Virus , Hepatitis D, Chronic , Polymorphism, Single Nucleotide , Brazil/epidemiologyABSTRACT
Objective To investigate the status and molecular epidemiology of hepatitis D virus (HDV) infection in the gathering area of Mongolian population in Inner Mongolia Autonomous Region of China. Methods A total of 230 patients with positive hepatitis B surface antigen (HBsAg) who attended Inner Mongolia International Mongolian Hospital from April 2019 to October 2020 were enrolled, and according to related information, they were divided into hepatitis B+liver cirrhosis group( n =18) and hepatitis B group( n =212). According to HBsAg quantification with a cut-off value of 250 IU/mL, the patients were divided into HBsAg < 250 IU/mL group( n =104) and HBsAg ≥250 IU/mL group( n =126). ELISA was used to detect HDV antibody, and quantitative real-time PCR was used to measure HDV RNA in patients with positive HDV antibody. Genotyping was performed for HDV RNA-positive samples. The chi-square test was used for comparison of categorical data between two groups. Results The positive rate of HDV antibody was 16.09%, and among the patients with positive HDV antibody, the positive rate of HDV RNA was 91.89%. Among the 18 patients with hepatitis B and liver cirrhosis, the positive rate of HDV antibody was 44.44%, and among the patients with positive HDV antibody, the positive rate of HDV RNA was 100%. There were 104 patients with HBsAg < 250 IU/mL, among whom only 3 patients (2.88%) were positive for hepatitis D antibody, and there were 126 patients with HBsAg ≥250 IU/mL, with a positive rate of HDV antibody of 26.98%. Genotype 1 was observed in all the samples that could be genotyped. Conclusion There is a relatively high infection rate of HDV in Inner Mongolia Autonomous Region, especially in patients with HBsAg ≥250 IU/mL or those with liver cirrhosis. It is necessary to strengthen the detection of hepatitis D in HBsAg-positive patients and perform early diagnosis and treatment to prevent the further progression of hepatitis.
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Objective To investigate the prevalence of hepatitis D virus (HDV) infection among patients with chronic hepatitis B virus (HBV) infection in some regions of China. Methods Serum samples were collected from 3 131 patients with chronic HBV infection in 10 provinces, cities, and autonomous regions of China from March 2021 to June 2022, and anti-HDV IgG ELISA was used for the detection of all serum samples. Nested reverse transcription-polymerase chain reaction (nRT-PCR) was used to detect HDV RNA in anti-HDV IgG-positive samples, and the nRT-PCR amplification products of HDV RNA-positive samples were sequenced and analyzed to determine HDV genotype. The clinical features of anti-HDV IgG-positive patients were analyzed. The Mann-Whitney U rank sum test was used for comparison of continuous data between two groups, and the chi-square test or the Fisher's exact test was used for comparison of categorical data between two groups. Results The positive rate of anti-HDV IgG in the 3 131 patients with chronic HBV infection was 0.70% (22/3 131), and that in the patients with chronic HBV infection in Inner Mongolia Autonomous Region, Xinjiang Uygur Autonomous Region, Beijing, and Hunan Province was 1.81% (16/886), 0.88% (2/226), 0.28% (2/708), and 1.00% (2/200), respectively; the patients with chronic HBV infection in Inner Mongolia Autonomous Region had a significantly higher positive rate of anti-HDV IgG than those in Beijing ( P =0.004), and there was no significant difference between the other regions ( P > 0.05). Clinical features of the patients with chronic HBV infection in Inner Mongolia Autonomous Region showed that compared with the anti-HDV IgG-negative group, the anti-HDV IgG-positive group had a significantly higher proportion of patients with Mongol nationality ( P =0.001), abnormal alanine aminotransferase ( P =0.007), or antiviral treatment ( P =0.029), as well as a significantly lower median HBV DNA level ( P =0.030). A total of 19 HDV RNA-positive samples were identified, all of which had HDV genotype 1. Conclusion The prevalence rate of HDV varies greatly across different regions of China, with a higher prevalence rate of HDV in patients with chronic HBV infection from Inner Mongolia Autonomous Region. HDV genotype 1 is the predominant genotype in some provinces and cities of northern China.
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Hepatitis D virus (HDV) is a satellite virus of hepatitis B virus (HBV) and needs the help of HBV envelope protein to complete its own assembly and replication and then establish a new infection cycle. Chronic HDV infection is considered the most severe form of viral hepatitis, which can accelerate disease progression and increase the risk of liver cancer. Effective antiviral therapy is urgently needed to delay disease progression in patients with HDV infection, but Bulevirtide conditionally approved by European Medicines Agency in July 2020 and interferon previously recommended are the only drugs used for the treatment of HDV infection. At present, studies are being conducted for several antiviral drugs targeting viral replication cycle, and early clinical trials have obtained good results. This means that important breakthroughs have been made in the development of antiviral drugs, bringing hope for the treatment of hepatitis D. This article summarizes the current antiviral drugs for hepatitis D and discusses related treatment regimens, so as to provide a reference for the treatment of hepatitis D.
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Hepatitis D virus (HDV) infection requires the participation of hepatitis B virus (HBV), which accelerates disease progression after infection and induces a high risk of progression to end-stage liver diseases such as liver cirrhosis and liver cancer. With the gradual increase in the understanding of hepatitis D in the whole society, some therapeutic drugs for hepatitis D have become a research hotspot in recent years, and with the further improvement in clinical testing methods, researchers have started to pay attention to the epidemiological investigation of hepatitis D. Although many studies have been conducted for the specific situation of HDV infection in China, large data deviation is observed due to small cohorts with strong regional features. This article briefly reviews the population, methods, and indicators in the current epidemiological investigation of hepatitis D and discusses related key issues, in order to obtain more accurate epidemiological data, effectively screen out HDV infection, and provide help for early clinical intervention and treatment.
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Hepatitis D caused by hepatitis D virus (HDV) infection is the most serious type of viral hepatitis. The prevalence rate of HDV has been seriously underestimated due to the lack of accurate HDV RNA detection methods. HDV RNA is the gold standard for the diagnosis of HDV infection and is of great significance in the diagnosis, screening, and treatment guidance of HDV. However, the multiple genotypes and strong secondary structure of HDV have led to great difficulties in HDV RNA detection. This article reviews the advances in HDV RNA detection methods and elaborates on the development from qualitative to quantitative detection methods, in order to provide new ideas for understanding the significance of HDV RNA detection and promoting the research and development of new HDV RNA detection methods.
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Hepatitis D is a severe form of viral hepatitis caused by co-infection with hepatitis D virus (HDV) and hepatitis B virus (HBV) or superinfection of HDV in HBV carriers. There is still a huge gap in the diagnosis of hepatitis D due to insufficient emphasis on this disease for a long time. With the advances in related studies in recent years, the academia and the medical industry have gradually realized the harm of hepatitis D, and meanwhile, breakthroughs in drug development have also brought new opportunities for the treatment or even cure of hepatitis D. These advances greatly increase the demand for the diagnosis of hepatitis D. HDV antibodies are the key markers for the diagnosis of hepatitis D. This article summarizes and compares the detection methods for HDV antibodies including total HDV antibodies, IgG, and IgM and discusses related important issues, so as to understand the current status of the detection of HDV antibodies and provide a reference for developing better diagnostic tools for hepatitis D.
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Since the discovery of hepatitis D virus (HDV) in the 1970s, Chinese scholars have started to conduct extensive studies on HDV and hepatitis D (HD). By searching for related articles published on the platforms of Chinese scientific and technological journals and the journals in PubMed database by Chinese scholars, this article comprehensively analyzes and summarizes the advances and scientific findings in HDV and HD by Chinese scholars from basic to clinical research from the perspective of historical development. Over the past years, Chinese scholars have conducted extensive research on the establishment of detection techniques and methods, the construction of infected animal models, the function and application of ribozymes, and clinical diagnosis and manifestation. The research findings in the past 40 years have laid a foundation for further research on the virological characteristics, infection mechanism, and immune response and injury of HDV, the clinicopathological changes of HD, and related antiviral treatment.
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Due to significant innovations in the diagnosis and treatment of hepatitis D virus （HDV）， the European Society of Hepatology （EASL） published its first international clinical practice guidelines on the management of individuals with HDV infection in July 2023. The guidelines mainly focus on the six aspects of HDV screening， diagnosis， clinical features and influencing factors， patient monitoring and selection for treatment， therapeutic methods and treatment endpoints. The guidelines give recommendations by answering and elaborating on 13 questions covering these six aspects. In addition， the guidelines also provide the prospect of the future treatment of HDV. The author’s team makes an excerpt of the guidelines and systematically introduces various evaluation points in recommendations and clinical management suggestions， in order to promote the development of clinical management and decision-making for individuals with HDV infection in China.
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Abstract Hepatitis B is considered an important public health problem worldwide because it is a chronic infection with a risk factor for cirrhosis and cellular hepatocellular carcinoma. In Brazil, the Rondônia State ranks first in the Northern region regarding the number of deaths due to hepatitis B. In the Amazon basin, genotype F is considered specific to the Americas identified in native populations. But few data on HBV genotyping and phylogenetic analysis are available. The objective of this study was to evaluate the genotypes and subgenotypes of the hepatitis B virus in indigenous people chronic carriers residing in cities of Guajará Mirim and Nova Mamoré in state of Rondônia/Brazil, on the border with Bolivia. A fragment of 417 bp (S gene) was amplified by PCR and submitted to nucleotide sequencing. The genotypes and subgenotypes of the HBV strains were determined through phylogenetic inference using genomic sequences from 197 representatives of the genotypes (A-H). Of the 41 chronic hepatitis B patients enrolled in this study, 27 were HBV-DNA positive. Of the 27 DNA-HBV positives, 39% (17/41) had individual HBV infection and 27% (10/41) were coinfected with HDV. The frequency of genotypes was 40.7% (11/27) for genotype D (HBV-D), 33.3% (9/27) for genotype F (HBV-F) and 25.9% (7/27) for genotype A (HBV-A) with circulating subgenotypes F2, F4, D2, D3, A1, and A2. We characterized the genotypes and subgenotypes of HBV circulating among in indigenous in the State of Rondônia shows for the first time the HBV/D genotype whit greater frequency circulating in nativos of state Rondônia. In conclusion, our findings showed a diversity of HBV genotypes, which is also found in other Brazilian geographical regions.
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Concurrent hepatitis D virus (HDV) infection accelerates the progression of liver disease in patients with chronic hepatitis B and particularly increases the risk of hepatocellular carcinoma (HCC). Further studies are still needed to explore the carcinogenic mechanism of HDV, related treatment methods, and their clinical effects. This article reviews the new epidemiological characteristics of HDV-related HCC, the new understanding of the pathogenic mechanism of HDV, and the advances in diagnosis and treatment, which is of great significance to promote the development of accurate HDV detection methods and effective drugs and reduce HDV-related HCC.
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El virus de la hepatitis delta (VHD) es un virus satélite del virus de la hepatitis B (VHB), dado que requiere el antígeno de superficie del VHB (HBsAg) para la producción de partículas virales infecciosas. Se han caracterizado ocho genotipos del VHD, con una distribución geográfica relacionada con la prevalencia de la infección por VHB. Se estima que aproximadamente el 5% de los pacientes con infección crónica por VHB también están infectados con VHD. Se han descrito dos tipos de infección: la coinfección simultánea por VHB y VHD, y la superinfección con VHD en un paciente previamente infectado por VHB, esta última asociada a una mayor morbilidad y mortalidad por falla hepática aguda. La infección se diagnostica en nuestro medio con la determinación de IgM contra el VHD, acompañada idealmente de la carga viral. Aunque el tratamiento de elección es la terapia con interferón alfa pegilado, en el momento se están evaluando otros medicamentos antivirales en ensayos clínicos, con resultados alentadores, teniendo en cuenta el efecto observado en la carga viral del VHD y/o del VHB en los pacientes. La presente revisión tiene como objetivo incluir temas como la biología del virus, la epidemiología, las características clínicas, el diagnóstico y el tratamiento en la infección por VHD.
Hepatitis delta virus (HDV) is a satellite virus of hepatitis B virus (HBV), as it requires the HBV surface antigen (HBsAg) for the production of infectious viral particles. Eight HDV genotypes have been characterized with a geographic distribution associated with the prevalence of HBV infection. It is estimated that approximately 5% of patients with chronic HBV infection are also infected with HDV. Two types of infection have been described: coinfection, by simultaneously contracting HBV and HDV infection, and superinfection, by contracting HDV when chronically infected with HBV, the latter associated with increased morbidity and mortality from acute liver failure. Anti-HDV IgM is used to diagnose the infection, ideally together with the detection of HDV-RNA. Although the treatment of choice is pegylated interferon alpha, other antiviral drugs are currently being evaluated in clinical trials, with encouraging results, in terms of their effect on HDV and/or HBV viral load in patients. This review aims to include topics such as virus biology, epidemiology, clinical manifestations, diagnosis, and treatment in HDV infection.
Subject(s)
Humans , Hepatitis Delta Virus , Hepatitis B virus , Epidemiology , Diagnosis , Drug TherapyABSTRACT
Hepatitis B virus (HBV)/hepatitis D virus (HDV) co-infection can accelerate the progression of liver diseases, but due to the limitations of the detection methods for HDV RNA, the epidemiology of HDV remains unclear. Further studies are needed to investigate the pathogenesis of HBV/HDV co-infection caused by HDV and related treatment methods. By reviewing the epidemiological features of HDV, HDV-specific immunity, genotype, and pathogenesis in China and other countries and summarizing HDV detection methods and treatment methods, this article shows that current detection methods for HDV infection have low sensitivity and specificity, with a lack of standardized detection methods. Exploration of new HDV detection methods will help to develop new and effective anti-HDV drugs, which has great significance in improving the outcome of HDV infection.
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Hepatitis B virus (HBV)/hepatitis D virus (HDV) co-infection can accelerate the progression of liver diseases, but due to the limitations of the detection methods for HDV RNA, the epidemiology of HDV remains unclear. Further studies are needed to investigate the pathogenesis of HBV/HDV co-infection caused by HDV and related treatment methods. By reviewing the epidemiological features of HDV, HDV-specific immunity, genotype, and pathogenesis in China and other countries and summarizing HDV detection methods and treatment methods, this article shows that current detection methods for HDV infection have low sensitivity and specificity, with a lack of standardized detection methods. Exploration of new HDV detection methods will help to develop new and effective anti-HDV drugs, which has great significance in improving the outcome of HDV infection.
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Abstract Hepatitis delta virus (HDV) has been associated with acute or chronic hepatitis in Latin America, but there is no prevalence study covering South American countries. This meta-analysis aimed to estimate anti-HDV prevalence through a systematic review of published articles in English, Portuguese and Spanish until December 2017. Searches were conducted in Health Virtual Library, Capes, Lilacs, PubMed, and SciELO, according to defined criteria regarding participant selection and geographical setting. Study quality was assessed using the GRADE guidelines. Pooled anti-HDV prevalence was calculated using the DerSimonian-Laird random-effects model with Freeman-Tukey double arcsine transformation. Out of the 405 identified articles, only 31 met the eligibility criteria for inclusion in the meta-analysis. In South America, pooled anti-HDV prevalence among hepatitis B virus carriers was 22.37% (95% confidence interval: 13.72-32.26), though it appeared less frequently in some countries and populations, according to the data collection date. The findings indicated significant successive reductions in anti-HDV prevalence over thirty years. However, there was a scarcity of HDV epidemiological studies outside the Amazon Basin, notably in the Southwest continent and absence of target population standardization. There was a high HDV prevalence in South American countries, despite differences in methodological characteristics and outcomes, highlighting a drastic decline in the last decades. Future studies should identify HDV prevalence estimates in other regions of the continent and identify risk factors.
Subject(s)
Humans , Hepatitis D/epidemiology , Hepatitis Delta Virus/genetics , Hepatitis Delta Virus/immunology , Phylogeny , South America/epidemiology , Prevalence , GenotypeABSTRACT
ABSTRACT BACKGROUND: The Amazon region is one of the main endemic areas of hepatitis delta in the world and the only one related to the presence of genotype 3 of the delta virus. OBJECTIVE: To analyze the profile, mortality and survival of cirrhotic patients submitted to liver transplantation for chronic hepatitis delta virus and compare with those transplanted by hepatitis B virus monoinfection. METHODS: Retrospective, observational and descriptive study. From May 2002 to December 2011, 629 liver transplants were performed at the Walter Cantídio University Hospital, of which 29 patients were transplanted due to cirrhosis caused by chronic delta virus infection and 40 by hepatitis B chronic monoinfection. The variables analyzed were: age, sex, MELD score, Child-Pugh score, upper gastrointestinal bleeding and hepatocellular carcinoma occurrence before the transplantation, perioperative platelet count, mortality and survival. RESULTS: The Delta Group was younger and all came from the Brazilian Amazon Region. Group B presented a higher proportion of male patients (92.5%) compared to Group D (58.6%). The occurrence of upper gastrointestinal bleeding before transplantation, MELD score, and Child-Pugh score did not show statistical differences between groups. The occurrence of hepatocellular carcinoma and mortality were higher in the hepatitis B Group. The survival in 4 years was 95% in the Delta Group and 75% in the B Group, with a statistically significant difference (P=0.034). Patients with hepatitis delta presented more evident thrombocytopenia in the pre-transplantation and in the immediate postoperative period. CONCLUSION: The hepatitis by delta virus patients who underwent liver transplantation were predominantly male, coming from the Brazilian Amazon region and with similar liver function to the hepatitis B virus patients. They had a lower incidence of hepatocellular carcinoma, more marked perioperative thrombocytopenia levels and frequent episodes of upper gastrointestinal bleeding. Patients with hepatitis by delta virus had lower mortality and higher survival than patients with hepatitis B virus.
RESUMO CONTEXTO: A região Amazônica é uma das principais áreas endêmicas da hepatite delta no mundo e a única relacionada com a presença do genótipo 3 do vírus delta. OBJETIVO: Analisar o perfil, mortalidade e sobrevida dos pacientes cirróticos submetidos a transplante hepático por hepatite crônica pelo vírus delta e comparar com os transplantados pela monoinfecção do vírus da hepatite B. MÉTODOS: Estudo retrospectivo, observacional e descritivo. Entre maio de 2002 a dezembro de 2011, foram realizados 629 transplantes de fígado no Hospital Universitário Walter Cantídio, dos quais 29 pacientes foram transplantados por cirrose causada pela infecção crônica do vírus delta e 40 pela monoinfecção crônica da hepatite B. As variáveis analisadas foram: origem, idade, sexo, escore de MELD, classificação de Child-Pugh, ocorrência de hemorragia digestiva alta e carcinoma hepatocelular antes do transplante, número de plaquetas perioperatória, mortalidade e sobrevida. RESULTADOS: O Grupo Delta foi mais jovem e todos oriundos da região Amazônica Brasileira. O Grupo B apresentou maior proporção de pacientes do sexo masculino (92,5%) em relação ao Grupo D (58,6%). A ocorrência de hemorragia digestiva alta antes do transplante, escore de MELD e classificação de Child-Pugh não obtiveram diferenças estatísticas entre os grupos. A ocorrência de carcinoma hepatocelular e a mortalidade foram maiores no grupo com hepatite B. A sobrevida em 4 anos foi de 95% no Grupo delta e 75% no Grupo B com diferença estatisticamente significante (P=0,034). Pacientes com hepatite delta, apresentaram mais acentuada plaquetopenia no pré-transplante e no pós-operatório imediato. CONCLUSÃO: Os pacientes com hepatite por vírus delta submetidos ao transplante hepático eram predominantemente homens, vindos da região da Amazônia brasileira e com função hepática semelhante a dos pacientes com vírus da hepatite B. Apresentavam menor incidência de carcinoma hepatocelular, níveis de trombocitopenia perioperatória mais acentuados e episódios frequentes de hemorragia digestiva alta. Os pacientes com hepatite por vírus delta apresentaram menor mortalidade e maior sobrevida que os pacientes com vírus da hepatite B.
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Humans , Male , Female , Adult , Liver Transplantation/mortality , Hepatitis B, Chronic/mortality , Hepatitis D, Chronic/mortality , Liver Cirrhosis/mortality , Blood Platelets/chemistry , Brazil/epidemiology , Hepatitis Delta Virus/genetics , Retrospective Studies , Liver Transplantation/statistics & numerical data , Sex Distribution , Carcinoma, Hepatocellular/mortality , Hepatitis B, Chronic/complications , Hepatitis D, Chronic/surgery , Hepatitis D, Chronic/complications , Kaplan-Meier Estimate , Liver Cirrhosis/surgery , Liver Cirrhosis/virology , Liver Neoplasms/mortality , Middle AgedABSTRACT
Abstract Acquired hepatocerebral degeneration is a neurological syndrome with typical clinical (extrapyramidal and neuropsychiatric) symptoms and brain magnetic resonance imaging findings (high T1 signal in the globus pallidus). It occurs mainly in patients with advanced liver disease, such as in patients co-infected with hepatitis B virus (HBV) and hepatitis delta virus (HDV). However, there are no reports relating HBV/HDV coinfection and acquired hepatocerebral degeneration. This report presents the case of a 49-year-old woman with characteristics of acquired hepatocerebral degeneration and liver cirrhosis due to HBV/HDV coinfection, and presents the main theories of the physiopathology of this condition.
Subject(s)
Humans , Female , Hepatitis D/complications , Hepatitis B/complications , Hepatolenticular Degeneration/virology , Liver Cirrhosis/virology , Coinfection/virology , Middle AgedABSTRACT
Aims: To determine the seroprevalence of HDV as well as the virological and clinical characteristics of HBV mono-infected and HBV/HDV co-infected patients. Study Design: The few studies on HDV in Cameroon have reported a high prevalence of this viral infection. This is a first step in describing the virological and clinical profile of HBV mono-infected and of HBV/HDV co-infected patients. Place and Duration of Study: Blood collection was carried out in the Gastroenterology Unit of the Yaounde University Hospital Centre, Yaounde General Hospital and “Centre Médical la Cathédrale”, from August 2012 to May 2013. Methodology: We included into this study treatment-naïve HBV-infected patients from Yaounde irrespective of age and gender free of HIV and HCV infection. Blood samples were collected from each patient for laboratory analysis. Detection of HDV antibodies (Diasorin, Germany) was performed by ELISA and viral load for HBV and HDV was determined using real-time PCR (Abbott Molecular Diagnostics). Patients were classified clinically into low replicative hepatitis, immune tolerance and chronic active hepatitis. Moreover, ultrasound and liver histological data were collected. Results: The population comprised 128 chronic HBV-infected patients of which 77 (60.16%) were male and 51 (39.84%) were female. We found 29 HDV-positive patients representing 22.66% of the population. In the HBV/HDV co-infected group, the mean viral load for HBV was significantly low compared to patients with HBV mono-infection (P = .01). These patients also presented with higher liver cytolysis compared to HBV monoinfected patients (P<.001). Chronic active hepatitis was significantly more prevalent in HBV/HDV co-infected patients (68.96%) compared to HBV mono-infected patients (20.20%). Conclusion: We found that HBV/HDV co-infection results in suppression of HBV replication and such patients show broader sequelae of liver disease. The prevalence of HBV and HDV co-infection is high in this population. Routine screening of HBV-positive individuals for HDV should be implemented in the health services nationwide.
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A simple rapid detection of antibody to hepatitis delta virus (anti-HDV) in human serum was developed by using double antigen sandwich ELISA. HDV gene fragment encoding HDAg was isolated from a Chinese patient infected with HDV by RT-PCR, and a high-efficient expression HD-PQE31 strain was constructed with the fragment. We obtained high titer and good quality hepatitis delta virus protein purified by Ni-NTA metal-affinity chromatography, which was identified by Western blot and ELISA, then we set up the double antigen sandwich ELISA for detection of anti-HDV in human serum, and the performance of the sandwich ELISA was evaluated in terms of specificity and sensitivity. Results were: 1) The purified HDAg protein's purity was 90%, and its ELISA titer was 1/100 000. 2) 42 anti-HDV positive sera were detected and showed that the sensitivity of sandwich ELISA was higher than that of competitive ELISA (t=2.44, p<0.01). 3) The inhibitory rates for 2 anti-HDV positive sera by the specific HDAg were 74% and 93% respectively. 4) For the assay of specificity, all 60 samples infected by other hepatitis viruses and 30 normal samples were negative for anti-HDV. These results suggested that the double antigen sandwich ELISA with purified recombinant HDAg showed higher specificity and sensitivity, It can be used in routine laboratories to diagnose the HDV infection.
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BACKGROUND/AIMS: The prevalence of hepatitis delta virus (HDV) infection has been estimated as being approximately 5% among global HBsAg carriers. The anti-delta positive rate in Koreans had been reported as being 0.85% in 1985. While the prevalence of HBV has been decreased from nearly 10% to 5% during the past twenty years, there have been no more studies on the anti-delta prevalence in Koreans. The aim of this study was to estimate the anti-delta prevalence in Koreans and to study the clinical characteristics of anti-delta positive patients in a single center. METHODS: Serum anti-delta was measured in one hundred ninety four HBsAg-positive patients who were admitted to our hospital from February 2003 to August 2003. We checked the genotypes of the HBV in the anti-delta positive patients. The clinical features of the anti-delta positive patients were compared to those clinical features of the anti-delta negative patients from the aspect of age, gender, mode of transmission, the positivity of HBeAg and serum HBV DNA. RESULTS: Serum anti-delta was positive in seven patients among the 194 subjects, giving a 3.6% positive rate. Among these seven patients, six had hepatocellular carcinoma (HCC) and the other one had cholangiocarcinoma. All of the anti-delta positive patients had the C genotype of HBV. The anti-delta positive patients showed significantly suppressed HBV DNA replication compared to the anti-delta negative patients. CONCLUSIONS: In Koreans, anti-delta was positive mainly in HCC patients with an approximate prevalence of 4%, and this rate has not changed much for the past twenty years. HBV DNA replication was suppressed by HDV infection.