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Relevance. In 2016, a resolution was adopted at the 69th World Health Assembly, the goal of which is to eliminate parenteral hepatitis in the world by 2030. In the Republic of Sakha (Yakutia), as in the Russian Federation as a whole, it is necessary to determine the starting positions for the prevalence and incidence of hepatitis B, C, and D, as the leading factors in the development of hepatocellular carcinoma. Aim: to give a clinical and epidemiological characterization of hepatocellular carcinoma in the Republic of Sakha (Yakutia) at the initial stage of the program for the elimination of viral hepatitis for subsequent analysis of its effectiveness. Materials & Methods. A clinical and epidemiological analysis of morbidity, mortality, cumulative survival in hepatocellular carcinoma in the Republic of Sakha (Yakutia) over a 10-year period (2009-2018) was carried out. Predictors for the development of hepatocellular carcinoma were analyzed based on primary medical records and a survey of 125 patients. Results and discussion. The incidence rate of hepatocellular carcinoma in the Republic of Sakha (Yakutia) over the past 10 years is 2.0 3.9 times higher than the corresponding indicator in the Russian Federation. The highest mortality from the studied pathology is noted in the Central and Polar zones of the republic. According to the materials of the cancer registry, the median cumulative survival of patients with carcinoma was 13.7 months from the date of diagnosis, which is significantly higher than ten years ago. The main risk factors have been identified, among which the leading role is played by infection with hepatitis C, B, and D. viruses. Also, alcohol abuse, diabetes mellitus, overweight, and smoking are important. Conclusion. The Republic of Sakha (Yakutia) is a hyperendemic region of the Russian Federation in terms of the incidence of hepatocellular carcinoma with a predominance of the male population in its structure. The rate of decrease in the incidence of liver cancer in the country will depend on the effectiveness of the regional program for the elimination of viral hepatitis and the decrease in the incidence of cirrhosis of the liver of non-infectious etiology.

Background: Hepatitis D virus (HDV) is a defective RNA pathogen that requires the presence of the hepatitis B virus (HBV) for infection. Middle East countries are endemic areas for HDV infection. So, it is important to estimate the prevalence of HDV in these countries. This study aimed to estimate the prevalence of HDV in HBsAg positive patients participated in Azar cohort study, North-west of Iran. Methods: In this cross-sectional study, out of 4949 participants of the Azar cohort study, 51HBsAg positive patients were selected. Five participants did not consent to HDV testing. The presence of anti-HDV IgG was checked in 46 patients (13 chronic hepatitis B and 33 inactive chronic hepatitis B) using enzyme-linked immunosorbent assay (ELISA) kit. The serum level of liver enzymes was measured and a questionnaire about risk factors was completed. Results: In this study, the mean age of HBsAg positive patients was 50.06 (SD 9.14) years and41.3% were female. Only one out of 46 patients was positive for HDV infection. Thus, the prevalence of HDV infection among hepatitis B virus surface antigen (HBsAg) positive patients was 2.17% (95% CI: 0.1-11.5). The positive anti-HDV patient was in the inactive chronic hepatitis B state and she had a history of hospitalization and dental procedures. Conclusion: The results showed that the prevalence of HDV infection in HBsAg positive patients was 2.1% that was lower than the reported prevalence in many other regions of Iran. Health policymakers and healthcare providers should design coherent and orderly epidemiological studies for planning and monitoring HDV infection.

Introduction: Community Advisory Boards (CABs) play an important role in developing and delivering patient-centered care. However, the impact of participation on CAB members has not been well studied, particularly on the global scale. In 2022, the Hepatitis B Foundation (HBF) convened the first global hepatitis B and hepatitis delta CAB with 23 members from 17 countries, representing six out of the seven World Health Organization (WHO) regions, and countries with the largest hepatitis B and hepatitis delta disease burden., Methods: To reflect on the process of assembling an effective and motivated CAB and assess the impact on CAB participants, three virtual focus group sessions were held with 16 participants in July and August 2023. Sessions were recorded and transcribed. Questions focused on motivations for joining the CAB, membership experiences, and lessons learned. Grounded theory analysis was used to generate hypotheses about reasons for CAB members' participation, as well as challenges and suggestions. Qualitative analysis using inductive reasoning identified key themes within responses. Transcripts were independently analyzed by a primary and secondary coder., Results: Motivations for joining the CAB included participants' desire to advocate for people living with hepatitis B and hepatitis delta, and other altruistic factors. Participants reflected that through CAB membership, they gained networking and advocacy opportunities and enhanced their hepatitis B- and hepatitis delta-related knowledge. Challenges participants experienced were related to time, physical limitations, and stigma. Finally, participants discussed their limited direct engagement with drug developers and proposed ways the CAB can increase interactions with stakeholders going forward., Discussion: Based on participants' assessments, establishing a global CAB for stigmatized infectious diseases is worth the effort. Regular internal review of community advisory boards' structure and performance is critical to ensure the CAB is fulfilling its mission., Competing Interests: The Hepatitis B Foundation receives public health program and research grants from BMS, GSK, Gilead Sciences and VBI Vaccines. Chari Cohen serves on a patient/advocacy advisory committee for GSK and Gilead Sciences, with funds being distributed to the Hepatitis B Foundation. Beatrice Zovich has also served on an advisory committee for Gilead for which she was financially compensated. Yasmin Ibrahim serves on a patient/advocacy advisory committee for Roche/Genentech, with funds being distributed to the Hepatitis B Foundation., (Copyright © 2024 Borondy-Jenkins, Ansah, Chen, Goldring, Ibrahim, Issa, Lesidrenska, Machado, Moore, Njouom, Okinedo, Racho, Scott, Zovich and Cohen.)

Objectives: Hepatitis delta virus (HDV) is a defective virus needing the envelope provided by hepatitis B virus (HBV) in order to enter liver cells and propagate. Chronic HDV infection is considered the most severe viral hepatitis, resulting in accelerated fibrosis progression until cirrhosis and its complications (hepatocellular carcinoma, liver decompensation) compared with HBV mono-infected patients. Off-label treatment with interferon has represented the only treatment option in the last 40 years, resulting in suboptimal virological response rates and being limited by safety issues especially in patients with advanced cirrhosis. Recently, the first HBV-HDV entry inhibitor Bulevirtide (BLV) has been approved by the European Medicines Agency (EMA) for treatment of chronic compensated HDV., Methods: This review summarises most recent updates on HDV epidemiology, diagnosis and treatment, with a special focus both on clinical trials and real-life studies about BLV. An overview on new HDV compounds under development is also provided., Results: BLV, the HBV-HDV entry inhibitor, has shown promising safety and efficacy data in clinical trials and in real-life studies, also in patients with advanced cirrhosis and portal hypertension. However, according to EMA label treatment is currently intended long-term until clinical benefit and predictors of responses are still undefined. The potential combination with PegIFNα seems to increase virological and clinical responses. New compounds are under development or in pipeline for treatment of HDV., Conclusion: After more than 40 years since HDV discovery, new treatment options are currently available to provide efficient strategies for chronic hepatitis Delta., Competing Interests: Competing interests: MPA: nothing to disclose. ED: Advisory Board: AbbVie; Speaking and teaching: Gilead, MSD, AbbVie, Roche; Travel Grant: Abbvie, Gilead, Advanz Pharma. PL: advisor and speaker bureau for BMS, Roche, Gilead Sciences, GSK, MSD, Abbvie, Janssen, Arrowhead, Alnylam, Eiger, MYR Pharma, Antios, Aligos, Vir., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Background and Aims: Chronic hepatitis D (CHD) is a severe form of chronic viral hepatitis. The estimated hepatitis delta prevalence in Spain is around 5% of patients with hepatitis B. Reimbursement of new antiviral therapies (Bulevirtide, BLV) was delayed in our country until February 2024. We aimed to characterize the clinical profile of patients with HDV/HBV infection in Spain and current barriers in their management at the time of BLV approval., Method: Multicenter registry including patients with positive anti-HDV serology actively monitored in 30 Spanish centers. Epidemiological, clinical and virological variables were recorded at the start of follow-up and at the last visit., Results: We identified 329 anti-HDV patients, 41% were female with median age 51 years. The most common geographical origin was Spain (53%) and East Europe (24%). Patients from Spain were older and had HCV and HIV coinfection probably associated to past drug injection (p<0.01). HDV-RNA was positive in 138 of 221 assessed (62%). Liver cirrhosis was present at diagnosis in 33% and it was more frequent among viremic patients (58% vs 25%, p<0.01). After a median follow-up of 6 (3-12) years, 44 (16%) resolved infection (18 spontaneously and 26 after Peg-INF). An additional 10% of patients developed cirrhosis (n=137) during follow-up (45% had portal hypertension and 14% liver decompensation). Liver disease progression was associated to persisting viremia., Conclusion: One-third of the patients with CHD already have cirrhosis at diagnosis. Persistence of positive viremia is associated to rapid liver disease progression. Importantly, barriers to locally determine/quantify HDV-RNA were present., (Copyright © 2024. Publicado por Elsevier España, S.L.U.)

[Display omitted] Hepatitis D Virus (HDV) infection is vanishing in Italy. It is therefore believed that hepatitis D is no longer a medical problem in the domestic population of the country but remains of concern only in migrants from HDV-endemic areas. To report the clinical features and the medical impact of the residual domestic HDV infections in Italy. From 2010 to 2019, one hundred ninety-three first-time patients with chronic HDV liver disease attended gastroenterology units in Torino and San Giovanni Rotondo (Apulia); 121 were native Italians and 72 were immigrants born abroad. For this study, we considered the 121 native Italians in order to determine their clinical features and the impact of HDV disease in liver transplant programs. At the last observation the median age of the 121 native Italians was 58 years. At the end of the follow-up, the median liver stiffness was 12.0 kPa (95% CI 11.2–17.4), 86 patients (71.1%) had a diagnosis of cirrhosis; 80 patients (66.1%) remained HDV viremic. The ratio of HDV to total HBsAg transplants varied from 38.5% (139/361) in 2000–2009 to 50.2% (130/259) in 2010–2019, indicating a disproportionate role of hepatitis D in liver transplants compared to the minor prevalence of HDV infections in the current scenario of HBsAg-positive liver disorders in Italy. Though HDV is vanishing in Italy, a legacy of ageing native-Italian patients with advanced HDV liver disease still represents an important medical issue and maintains an impact on liver transplantation. [ABSTRACT FROM AUTHOR]

Hepatitis delta virus (HDV) is a defective single negative chain RNA virus, as its envelope protein synthesis is dependent on hepatitis B virus (HBV). Studies have consistently shown that coinfection of HBV and HDV is the most serious form of viral hepatitis, with accelerated progression to liver cirrhosis and hepatocellular carcinoma. About 74 million of HBV surface antigen (HBsAg) positive patients worldwide are also co-infected with HDV. Besides, patients with intravenous drug use and high-risk sexual behavior are at higher risk of HDV infection. Therapeutic schedules for HDV are limited, and relapse of HDV has been observed after treatment with pegylated interferon alpha. To reduce the transmission of HDV, all people infected with HBV should be screened for HDV. At present, several serological and molecular detection methods are widely used in the diagnosis of HDV. However, due to the lack of international standards diagnostic results from different laboratories are often not comparable. Therefore, the true prevalence of HDV is still unclear. In this manuscript, we have analyzed various factors influencing the estimation of HDV prevalence. We have also discussed about the advantages and disadvantages of currently available HDV laboratory diagnostic methods, in order to provide some ideas for improving the detection of HDV. [ABSTRACT FROM AUTHOR]

Aim: Hepatitis B (HBV) and Hepatitis D (HDV) viruses are among the two important causes of end-stage liver disease today. In this study, we aimed to increase HDV awareness in people infected with HBV by examining the prevalence of HDV in patients with end-stage liver disease due to HBV and who were evaluated for liver transplantation. Materials and Methods: The study was designed as a retrospective single-center and cross-sectional. Patients with HBV decompensated liver cirrhosis were divided into two groups as anti-HDV positive and negative. Child-turcott pugh (CTP), Model for End-Stage Liver Disease (MELD) score, complications of liver cirrhosis, viral hepatitis serology, and platelet count variables were statistically compared between the groups. Results: A total of 147 patients with decompensated liver cirrhosis due to HBV were included in the study. Anti-HDV positivity was detected in 46 (31.3%) patients, and anti-HDV negative in 101 (68.7%) patients. The mean age of HDV positive patients (48.39±9.20) was statistically significantly lower than HDV negative (54.37±7.80) patients (p<0.001). Although MELD and CTP scores were slightly higher in the anti-HDV negative group, there was no statistically significant difference between the groups in terms of both scores (p=0.401; p=0.782, respectively). The platelet count was found to be significantly lower in the anti-HDV positive group than in the anti-HDV negative group (p=0.008). Conclusion: The rate of encountering HDV in end-stage liver disease due to HBV was found to be quite high. HDV is an important factor in the development of end-stage liver disease in HBV-infected individuals, especially at an early age, and taking precautions for this is of great importance. [ABSTRACT FROM AUTHOR]

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Bulevirtide (HEPCLUDEX®), a first-in-class entry inhibitor, is a new option for the treatment of chronic hepatitis D, caused by hepatitis delta virus (HDV) infection, in HDV-RNA positive adults with compensated liver disease. In a pivotal phase IIb trial in patients with chronic hepatitis D, treatment with bulevirtide in combination with tenofovir significantly reduced HDV RNA levels compared with treatment of the underlying HBV infection with tenofovir alone. Alanine aminotransferase (ALT) levels were also normalised by bulevirtide combination therapy. Bulevirtide is generally well tolerated; the most common adverse event in clinical trials was dose-dependent and asymptomatic increase in bile salts (reversible upon treatment discontinuation). Plain Language Summary: Chronic hepatitis D is caused by an infection with the hepatitis delta virus (HDV). It is a fast-progressing and severe form of viral hepatitis that can lead to liver damage, cirrhosis and liver cell cancer. HDV cannot multiply in cells unless the hepatitis B virus is also present. Consequently, all patients with hepatitis D also have hepatitis B. Hepatitis D occurs in ≈ 4.5% of patients with hepatitis B. Treatment options for chronic hepatitis D are limited (no other approved therapy to date) and generally ineffective. Bulevirtide (HEPCLUDEX®), a drug that is self-administered as a daily subcutaneous injection, blocks the entry of HDV into liver cells and limits the ability of HDV to multiply. It is the first drug to be approved for the treatment of chronic hepatitis D in adults with compensated liver disease (the liver is damaged, but can still work). By reducing the amount of HDV in the body, bulevirtide improves liver function in these patients. Bulevirtide is also generally well tolerated. Thus, bulevirtide is a new treatment option for patients with chronic hepatitis D who have compensated liver disease. [ABSTRACT FROM AUTHOR]

Hepatitis D virus may be underestimated because it is a significant problem in HBsAg‐positive patients, especially those who inject drugs, have HIV or HCV co‐infections and/or live in certain endemic regions. In the past few decades, the prevalence of HDV was expected to have decreased as a result of improvements in public healthcare policies and universal HBV vaccination programs. However, HDV has continued to spread in low‐income countries, with local outbreaks and migration to less endemic areas, so that its prevalence has remained stable or even increased in certain regions. As a result, research has been focused on the epidemiology of HDV. Contradicting data from three large recent meta‐analyses have reported that the prevalence of HDV may be between 0.16% and 1.00% in the global general population, and 4.5% and 14.6% in HBsAg‐positive patients, with an estimated 12 to 70 million HDV patients worldwide. The exact prevalence and estimated number of HDV patients is still a subject of debate for several reasons, including the unreliable assessment of the infection and a lack of real‐world screening. HDV infection is associated with an increased risk of progression to cirrhosis and the development of HCC compared to patients with HBV mono‐infection, a risk which is even higher in patients with HIV co‐infection. Morbidity and mortality from HDV‐related cirrhosis should not be overlooked. In conclusion, hepatitis D virus is probably underestimated and certainly underdiagnosed, and screening for HDV should be performed in all HBsAg‐positive patients in clinical practice. [ABSTRACT FROM AUTHOR]

Background: Nepal is a country of low endemicity for chronic hepatitis B, with a prevalence of 0.9%. However, in Dolpo District, a higher prevalence of hepatitis B virus (HBV) was reported in small samples, anecdotal reports and, recently, among pregnant women. We determined data on HBV endemicity and risk factors among people from Dolpo (Dolpopa). Methods: We conducted a cross-sectional HBV prevalence study among two separate convenience samples of overall 524 Dolpopa, assessing HBV serology on a medical supply tour to Upper Dolpo (Group 1, n = 223) and assessing detailed HBV serology, markers for hepatitis D virus (HDV) and human immunodeficiency virus (HIV) coinfection, as well as a questionnaire-based survey of risk behaviour and alcohol consumption patterns in Dolpopa visiting the Dolpali "Winter Clinic" in Kathmandu (Group 2, n = 301). Results: The overall prevalence of hepatitis B surface antigen (HBsAg) was 18.7% [95% confidence interval (CI) 15.6–22.3%]. HBsAg prevalence was independent of age group and gender, but was significantly higher in the settlements lining the trading route between Nepal and China. From the HBsAg-positive participants, 68.8% (95% CI 56.6–78.8%) also tested positive for hepatitis B e antigen (HBeAg). Viral load among HBeAg-positive samples ranged from 3.12 × 107 to 1.42 × 109 IU/mL. HDV and HIV coinfection was not found. Questionnaires confirmed that 92% had never used a condom and 27.6% showed a risky alcohol consumption pattern. Conclusions: HBV prevalence in Dolpo is significantly higher than in the rest of Nepal. Targeted interventions are recommended to address liver and sexual health education, including the introduction of birth dose HBV vaccinations, HBV screening and HBV vaccinations for pregnant women in Dolpo. [ABSTRACT FROM AUTHOR]

This JAMA Patient Page describes hepatitis D infection and its risk factors, outcomes of acute and chronic infection, diagnosis, treatment, and prevention. [ABSTRACT FROM AUTHOR]

Hepatitis D is the most severe viral hepatitis. Hepatitis D virus (HDV) has a very small RNA genome with unique biological properties. It requires for infection the presence of hepatitis B virus (HBV) and is transmitted parenterally, mainly by superinfection of HBsAg carriers who then develop chronic hepatitis D. HDV has been brought under control in high-income countries by the implementation of HBV vaccination, and the clinical pattern has changed to a chronic hepatitis D seen in ageing patients with advanced fibrotic disease; the disease remains a major health concern in developing countries of Africa and Asia. Every HBsAg-positive subject should be tested for HDV serum markers by reflex testing, independently of clinical status. Vaccination against HBV provides the best prophylaxis against hepatitis D. The only therapy available so far has been the poorly performing Interferon alfa; however, several new and promising therapeutic approaches are under study.

The global epidemiology of hepatitis D is changing with the widespread implementation of vaccination against hepatitis B. In high-income countries that achieved optimal control of HBV, the epidemiology of hepatitis D is dual, consisting of an ageing cohort of domestic patients with advanced liver fibrosis who represent the end stage of the natural history of HDV, and of a younger generation of immigrants from endemic countries who account for the majority of new infections. As observed in Europe in the 1980s, the distinctive clinical characteristic of chronic hepatitis D in endemic countries is the accelerated progression to cirrhosis and hepatocellular carcinoma. Despite some recent progress, the therapeutic management of HDV remains unsatisfactory, as most patients are not cured of HDV with currently available medicines. This review article describes the current epidemiology and clinical features of chronic hepatitis D, based on the literature published in the last 10 years. [ABSTRACT FROM AUTHOR]

Introduction: sub-Saharan Africa bears a high prevalence for hepatitis B virus (HBV) infection. This analysis aims at elucidating the exposure to HBV across different age groups in Mbeya Region in Tanzania and determines prevalences of hepatitis C (HCV) and hepatitis delta antigen (HDV) infections. Methods: plasma samples from children and adults with defined HIV status were analysed for HBV, HCV and HDV markers. Results: hepatitis B (HBs)- antigen positivity was 8.3% (3/36) in the 0 to 5 years age group, 13.3% (8/60) in the 6 to 7 years, 17.2% (10/58) in the 8 to 14 years and 13.3% (8/60) in the 15 to 18 years age groups. In adults 5.0% of samples were HBs-antigen positive. Overall, 17.1% were HIV-1 positive. Adults infected with HIV-1 were significantly more often HBs-antigen positive (7.5%) than HIV-1 negative adults (4.5%; p<0.05). A serological sub-study including 174 adults showed that both total anti-HBs and total anti-HBc positivity increased with age in HBs-antigen negative participants. Across all age groups, HCV antibodies were found in 9 individuals, HDV antibodies in 3 individuals. Conclusion: children presented a high prevalence of HBs-antigen carriers, with lower levels in the younger children. Among adults, the overall prevalence of HBsantigen was lower than in children, either corresponding to clearance of HBV over time or due to a die-off effect. HBs-antigen positive adults had higher frequencies of anti-HBc- and anti-HBeantibodies, indicating better immunological control of HBV infection than children. This supports claims that HBV infections in Africa are mostly acquired in childhood and to a large extent cleared again by adulthood. One in 20 adults remains chronically infected, emphasising the importance of HBV vaccination strategies. [ABSTRACT FROM AUTHOR]

A study reported in 2019 showed that hepatitis C virus (HCV) could help disseminate hepatitis D virus (HDV). To test this finding, 2123 plasma samples positive for anti-HCV antibody were screened for anti-HDV antibodies, and HDV-RNA was searched for in samples positive for anti-HDV antibody. Of 41 samples (1.9%) that tested positive for anti-HDV antibody, 27 (65.9%) were positive and 14 (34.1%) negative for antibody to hepatitis B core antigen (anti-HBc). Anti-HDV antibodies were significantly more present in samples positive for anti-HBc (6.21% vs 0.8% in negative samples; P < .001) and in samples negative for HCV RNA (2.9% vs 1.5% for positive samples; P = .03). Serological ratios were significantly higher in samples positive for anti-HBc (P < .01). No anti-HDV-positive sample was HDV RNA positive. In conclusion, this study found no evidence suggesting a role for HCV in HDV dissemination in humans. [ABSTRACT FROM AUTHOR]

Copyright of Viral Hepatitis Journal / Viral Hepatit Dergisi is the property of Galenos Yayinevi Tic. LTD. STI and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Lonafarnib (Zokinvy™) is an orally active farnesyltransferase inhibitor developed by Eiger BioPharmaceuticals under license from Merck & Co. for the treatment of hepatitis D virus (HDV) infections, and progeria and progeroid laminopathies. The drug was originally discovered by Merck & Co as an investigational drug in oncology. In progeria, lonafarnib inhibits farnesyltransferase to prevent farnesylation and subsequent accumulation of progerin and progerin-like proteins in the nucleus and cellular cytoskeleton. In November 2020, lonafarnib received its first approval in the USA to reduce the risk of mortality in Hutchinson-Gilford Progeria Syndrome (HGPS) and for the treatment of processing-deficient progeroid laminopathies (with either heterozygous LMNA mutation with progerin-like protein accumulation, or homozygous or compound heterozygous ZMPSTE24 mutations) in patients ≥ 12 months of age with a body surface area (BSA) of ≥ 0.39 m2. Lonafarnib is under regulatory review in the European Union. Clinical development for the treatment of HDV infections is underway in multiple countries. This article summarizes the milestones in the development of lonafarnib leading to this first approval. [ABSTRACT FROM AUTHOR]

The role of low levels of HDV‐RNA during and after interferon therapy of hepatitis D is unknown. We re‐analysed HDV RNA in 372 samples collected in the HIDIT‐2 trial (Wedemeyer et al, Lancet Infectious Diseases 2019) with the Robogene assay (RA; Jena Analytics). Data were compared with the previously reported in‐house assay (IA). We detected HDV‐RNA in one‐third of samples previously classified as undetectable using the highly sensitive RA. Low HDV viraemia detectable at week 48 or week 96 was associated with a high risk for post‐treatment relapse, defined as HDV RNA positivity in both assays at week 120. HDV RNA relapses occurred in 10/15 (67%) patients with detectable low HDV RNA at week 48 and in 10/13 (77%) patients with low viraemia samples at week 96. In contrast, the post‐treatment relapse rate was lower in patients with undetectable HDV RNA in both assays during treatment. [ABSTRACT FROM AUTHOR]

HBV‐DNA levels are low or even undetectable in the majority HDV‐infected patients. The impact of PEG‐IFNα on HBV‐DNA kinetics in HDV‐infected patients has not been studied in detail. We analysed data of a prospective treatment trial where 120 HDV‐RNA–positive patients were randomized to receive PEG‐IFNα‐2a plus tenofovir‐disoproxil‐fumarate (PEG‐IFNα/TDF, n = 59) or placebo (PEG‐IFNα/PBO; n = 61) for 96 weeks. At week 96, HBV‐DNA was still quantifiable in 71% of PEG‐IFNα/PBO‐treated patients but also in 76% of PEG‐IFNα/TDF‐treated patients, despite low HBV‐DNA baseline values. Surprisingly, a transient HBV‐DNA increase between weeks 12 and 36 was observed in 12 in PEG‐IFNα/TDF‐treated and 12 PEG‐IFNα/PBO‐treated patients. This increase was positively associated with HBsAg loss [(P = 0.049, odds ratio (OR) 5.1] and HDV‐RNA suppression (P = 0.007, OR 4.1) at week 96. Biochemical markers of cell death (M30 and ALT) were higher during the HBV‐DNA peak but no distinct systemic immune pattern could be observed by screening 91 soluble inflammatory markers. In conclusion, an early increase in HBV‐DNA during PEG‐IFNα‐2a therapy occurred in more than 20% of patients, even in TDF‐treated patients. This transient HBV‐DNA rise may indicate PEG‐IFNα–induced cell death and lead to long‐term HDV‐RNA suppression and HBsAg loss. [ABSTRACT FROM AUTHOR]

Several studies have demonstrated that chronic hepatitis delta virus (HDV) infection is associated with a worsening of hepatitis B virus (HBV) infection and increased risk of hepatocellular carcinoma (HCC). However, there is limited data on the role of HDV in the oncogenesis of HCC. This study is aimed at assessing the potential mechanisms of HDV-associated hepatocarcinogenesis, especially to screen and identify key genes and pathways possibly involved in the pathogenesis of HCC. We selected three microarray datasets: GSE55092 contains 39 cancer specimens and 81 paracancer specimens from 11 HBV-associated HCC patients, GSE98383 contains 11 cancer specimens and 24 paracancer specimens from 5 HDV-associated HCC patients, and 371 HCC patients with the RNA-sequencing data combined with their clinical data from the Cancer Genome Atlas (TCGA). Afterwards, 948 differentially expressed genes (DEGs) closely related to HDV-associated HCC were obtained using the R package and filtering with a Venn diagram. We then performed gene ontology (GO) annotation and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis to determine the biological processes (BP), cellular component (CC), molecular function (MF), and KEGG signaling pathways most enriched for DEGs. Additionally, we performed Weighted Gene Coexpression Network Analysis (WGCNA) and protein-to-protein interaction (PPI) network construction with 948 DEGs, from which one module was identified by WGCNA and three modules were identified by the PPI network. Subsequently, we validated the expression of 52 hub genes from the PPI network with an independent set of HCC dataset stored in the Gene Expression Profiling Interactive Analysis (GEPIA) database. Finally, seven potential key genes were identified by intersecting with key modules from WGCNA, including 3 reported genes, namely, CDCA5, CENPH, and MCM7, and 4 novel genes, namely, CDC6, CDC45, CDCA8, and MCM4, which are associated with nucleoplasm, cell cycle, DNA replication, and mitotic cell cycle. The CDCA8 and stage of HCC were the independent factors associated with overall survival of HDV-associated HCC. All the related findings of these genes can help gain a better understanding of the role of HDV in the underlying mechanism of HCC carcinogenesis. [ABSTRACT FROM AUTHOR]

Background: The biochemical response is a crucial indicator of prognosis in chronic hepatitis B (CHB) patients treated with nucleotide/nucleoside analogues (NAs). The impact of hepatitis D virus (HDV) infection on alanine aminotransferase normalization is elusive.Methods: The longitudinal study recruited 1185 CHB patients who received NAs. These patients were tested for anti-HDV antibody and HDV RNA at the initiation of anti-hepatitis B virus (HBV) therapy and annually for patients who were HDV-seropositive. ALT levels were examined at the first and second year of anti-HBV therapy. ALT abnormality was defined as ALT levels above 40 IU/mL in both male and female, and the risk factors associated with ALT abnormality were analysed.Results: Rates of seropositivity for anti-HDV and HDV RNA were 2.0% and 0.8% among 1185 NA-treated CHB patients, respectively. The strongest factor associated with ALT abnormality (>40 IU/mL) after first year treatment with NAs was HDV RNA seropositivity at year 1 (odds ratio [OR]/95% confidence interval [CI]: 31.44/3.49-283.56, P = 0.002), followed by liver cirrhosis (2.18/1.51-3.15, P < 0.001), detectable HBV DNA at year 1 (OR/CI: 1.99/1.36-2.92, P < 0.001), diabetes (OR/CI: 1.75/1.10-2.78, P = 0.02), body mass index (BMI) (OR/CI: 1.13/1.09-1.18, P < 0.001) and age (OR/CI: 0.97/0.96-0.98, P < 0.001). Among patients who were seronegative for HBV DNA at year 1, the strongest factor associated with ALT abnormality was HDV RNA seropositivity at year 1 (OR/CI: 30.00/3.28-274.05, P = 0.003), followed by liver cirrhosis (OR/CI: 1.83/1.21-2.75, P = 0.004), BMI (OR/CI: 1.16/1.11-1.21, P < 0.001) and age (OR/CI: 0.97/0.96-0.99, P < 0.001). Similarly, the impact of HDV RNA seropositivity on ALT abnormality was noted in patients without detectable HBV DNA but not in those with hepatitis B viremia at treatment year 2 (OR/CI: 10.16/1.33-77.74, P = 0.03).Conclusion: HDV infection played an important role in ALT abnormality in CHB patients receiving 1-year and 2-year NAs. The impact was particularly noted in patients who had successfully suppressed HBV DNA. [ABSTRACT FROM AUTHOR]

Introduction: Hepatitis D virus (HDV) is a satellite virus of hepatitis B virus (HBV). An estimated 5% of HBV infected individuals worldwide have HDV infection. There is paucity of studies in Nigeria on the burden of HDV infection. This study aimed at determining the prevalence rate of HDV antibodies among individuals with chronic hepatitis B (CHB) infection and comparing the liver function test (LFT) and disease severity among the anti-HDV positive (anti-HDV+) and anti-HDV negative (anti-HDV-) individuals. Methodology: A cross-sectional study of 180 CHB infected individuals who were clinically evaluated and tested for HDV antibodies using the Enzyme-linked Immunoassay method. Their LFT profile and Child-Turcotte-Pugh (CTP) were also assessed. Data were analyzed using the SPSS version 17. Results: Their mean age was 35.2 ± 10.4 years. There were 150 (83.3%) and 30 (16.7%) individuals with uncomplicated and complicated CHB infection respectively. Thirty-four (18.9%) of the participants were anti-HDV+. The mean serum ALT, AST, albumin and INR of the anti- HDV+ subjects were 16.5 ± 13.8 IU/L, 26.3 ± 32.6 IU/L, 38.9 ± 7.6 g/L, and 1.2 ± 0.2 respectively. The mean values for the same parameters of the anti-HDV- subjects were 10.8 ± 9.5 IU/L, 13.4 ± 11.2 IU/L, 41.4 ± 6.0 g/L and 1.1 ± 0.2 respectively (p < 0.05). The mean CTP scores in the anti-HDV+ and anti-HDV- subjects were 6.1 ± 2.1 and 5.5 ± 1.2 respectively (p= 0.03). Conclusions: Anti-HDV sero-prevalence rate was 18.9% and anti-HDV+ CHB patients had worse LFT results compared to those who were anti-HDV--. [ABSTRACT FROM AUTHOR]

Although hepatitis D is believed to be an important medical problem in Africa and many areas of Asia, the geographical distribution and prevalence rates of infection with the hepatitis D virus (HDV) vary considerably, are often inconsistent and sometimes conflicting. Discrepancies may depend on methodological problems, primarily on different modalities of patients' recruitment; these are analysed in this mini‐review, in order to provide a uniform clinical approach when testing patients with chronic HDV disease. [ABSTRACT FROM AUTHOR]

About 5% of cases with chronic hepatitis B virus (HBV) are co-infected with hepatitis D virus (HDV), and this co-infection possesses a high risk for hepatocellular carcinoma (HCC) and cirrhosis. We aimed to evaluate the epidemiological and histopathological characteristics and response to treatment in patients with HBV and HDV co-infection in a hepatitis clinic in Tehran, Iran. In this study, 80 patients were enrolled and evaluated for age, sex, degree of liver fibrosis, virologic status, and response rate. The incidence of coinfection of hepatitis B and D was 4.9% (80/1,631 HBV-infected cases) in our clinic. Thirty-seven (46.25%) patients had liver cirrhosis, and four (5%) patients had HCC. Besides, HDV Ribonucleic Acid (RNA) polymerase chain reaction (PCR) was positive for 31 (38.75 %) patients. Among 30 patients, 14 (46.6%) completed interferon therapy (for equal to or more than 48 weeks) and had a response with undetectable HDV RNA PCR after treatment. According to our results, for cirrhotic patients in HBV/HDV co-infection that was about 46%, it seems that the early detection of HDV antibody (Ab) plays a significant role in the prevention of progressive liver failure, and treatment with interferon can help these patients by improving the prognosis. [ABSTRACT FROM AUTHOR]