Search Results (116)

The SCANVIR^® project is a regional initiative aimed at accelerating the elimination of hepatitis C virus (HCV) by reaching high-risk populations outside traditional healthcare settings. Launched in 2017 in Limoges and later expanded to Poitiers and Bordeaux, the project organized dedicated screening and treatment days in 43 facilities taking care of intravenous drug users, migrants, and prisoners in Nouvelle-Aquitaine. These events involved multidisciplinary teams and advanced diagnostic tools, including rapid tests for HCV, HBV, and HIV; FibroScan^® for liver assessment; and GeneXpert^® for on-site HCV RNA detection. Patients also received counseling on risk prevention, addiction, psychosocial support, and treatment when needed. Between 2017 and 2024, SCANVIR^® screened 1664 patients, with 98.9% accepting FibroScan^®. Anti-HCV antibodies were detected in 23.4% of participants, among whom 41.5% (N = 162) had a replicative profile. Of these, 83% initiated treatment and 80% were cured or were still undergoing therapy. FibroScan^® assessments showed advanced fibrosis in 17% of patients, severe fibrosis in 7.2%, and severe steatosis in 18%. By promoting a “Test, Treat, Prevent” strategy, SCANVIR^® proved cost-effective in diagnosing and treating individuals distant from care structures, highlighting the value of integrating education and prevention into liver disease screening. SCANVIR^® is an officially registered European trademark. Full article

Introduction: The health care burden of chronic hepatitis B virus (CHB) infection can be reduced by appropriate workup, treatment, and monitoring. Methods: As a primary objective, we determined whether adequate initial hepatitis B virus (HBV) laboratory workup in CHB patients is associated with improved CHB complications risk. Secondary outcomes assessed included: mortality, hospitalization, emergency department, and liver specialist visits. We conducted a retrospective cohort study from 1 January 2012 to 31 December 2018. Participants were followed from 12 months post index event until outcome occurrence, death, loss of eligibility, or 31 March 2023. Health administrative data from Ontario, Canada was utilized. The study cohort included individuals with at least one positive result of either hepatitis B surface antigen, hepatitis B e antigen, or HBV DNA viral load documented during the study window. The exposure of interest was defined as adequate laboratory workup, defined as having subsequent quantitative HBV DNA, and alanine aminotransferase testing completed within 12 months of the index event. CHB-related complications were assessed using previously validated diagnostic codes. Modified Poisson regression modelling was used to estimate relative risks. Results: The study cohort consisted of 30,794 CHB patients, with a mean age 45.7 years. The majority were male (53.5%) and within the lowest two income quintiles (50.2%). In total, 68.0% underwent adequate workup. Individuals with adequate workup were more likely to be older, male, urban based, and of the highest racialized and newcomer populations quintile. The risk for CHB complications was 1.50 (95% CI 1.36–1.65) times greater among those with adequate workup. By multivariable analysis, adequate workup was associated with a lower risk of mortality (RR 0.78; 95% CI 0.69–0.87), all-cause hospitalizations (RR 0.77; 95% CI 0.74–0.80), all-cause (RR 0.77; 95% CI 0.75–0.78), and liver-related (RR 0.67; 95% CI 0.60–0.75) ED visits. Conclusions: Adequate CHB clinical workup is associated with improved patient outcomes. Our findings advocate for the comprehensive evaluation of CHB patients using key laboratory tests to optimize clinical management and improve long-term health outcomes. We identified gaps in the workup of young adults, females, and those residing in rural settings, which should be addressed to ensure equity of HBV care. Full article

Background/Objectives: Conventional serum biomarkers such as ALT and AST exhibit limited sensitivity and specificity in distinguishing the spectrum of HBV-related liver diseases, especially chronic hepatitis (CHB), cirrhosis (LC), and hepatocellular carcinoma (HCC). This study aimed to investigate the diagnostic potential of serum bile acid profiles as novel metabolic discriminators to differentiate among healthy individuals, CHB, LC, HCC, and liver failure, thereby addressing a key unmet need in clinical practice. Methods: A total of 625 participants were recruited and serum concentrations of 15 bile acids were determined by LC-MS/MS using targeted absolute quantification. Machine learning was employed to establish the diagnostic panels for classifying the distinct stages of HBV-related diseases. Results: The combinations of taurolithocholic acid (TLCA) and taurochenodeoxycholic acid (TDCA) effectively differentiated healthy individuals from the patients with liver diseases (AUCs = 0.880–1.000 across subgroups), and the specific panel of four bile acids achieved discriminative AUCs of 0.874 between CHB and LC, and 0.825 between CHB and HCC, which outperformed conventional biomarkers. Bile acid profiles also demonstrated significant responsiveness to antiviral therapy, some bile acid concentrations consistently decreasing during the post-treatment periods. Conclusion: Serum bile acid panels thus offer a sensitive and reliable diagnostic performance that could significantly enhance clinical decision-making and patient management. Full article

Occult hepatitis B virus infection (OBI), characterized by extremely low viral loads and the persistent intrahepatic presence of cccDNA, poses a profound challenge to global public health security. With a prevalence ranging from 0.06% to over 15% in different donor populations, OBI maintains a risk of transmission and can progress to hepatocellular carcinoma. Its prevention and control have long been limited by the sensitivity constraints of conventional detection methods, highlighting the urgent need for more sensitive diagnostic innovations. Emerging technologies offer distinct breakthroughs: ddPCR facilitates absolute quantification; CRISPR-Cas systems coupled with isothermal amplification enable rapid, point-of-care testing; third-generation sequencing resolves viral integration and mutations; and nanomaterials enhance the signal detection. This review synthesises advancements in OBI diagnostic technologies and provides a comparative overview of their strengths, limitations, and transfusion safety implications, as well as their potential applications in blood transfusion. Recommendations are also proposed to inform the advancement of OBI risk control in blood transfusion and to guide the development of novel diagnostic technologies, particularly relevant to regions with high HBV endemicity, such as China. Full article

Background: Hepatitis B virus (HBV) and Plasmodium falciparum infections remain major public health concerns in sub-Saharan Africa, especially among pregnant women, who are particularly vulnerable due to physiological immunomodulation. While mono-infections are well documented, the burden and biological consequences of HBV–P. falciparum co-infection during pregnancy remain under-investigated in Gabon. Aim: To determine the prevalence, clinical relevance, and biochemical impact of HBV–P. falciparum co-infection among pregnant women in Libreville, Gabon, and to explore the interaction between viral and parasitic replication. Methods: A prospective cross-sectional study was conducted between May 2022 and May 2023 at the CHUME-FJE Laboratory in Libreville. Serum samples were tested for HBsAg using rapid diagnostic tests and ELISA confirmation; HBV surface antigen (HBsAg) levels were quantified by electrochemiluminescence (ECLIA). Parasitemia was assessed by rapid diagnostic test, microscopy, and the Lambaréné thick blood film method. Liver function parameters (ALT, AST, ALP, and GGT) were evaluated using an automated biochemistry analyzer. Statistical analysis included Mann–Whitney U tests, chi-square tests and Spearman’s rank correlation coefficient with significance set at p < 0.05. Results: Of the 222 pregnant women enrolled, HBV infection was detected in 9 cases (4.05%). Among these, 6 (2.7% of the study population) were mono-infected with HBV, while 3 (1.35%) were co-infected with Plasmodium falciparum. P. falciparum parasitemia was detected in 58 cases (26.1%). Biochemical profiles revealed elevated transaminases (AST) in HBV mono-infected women, while liver enzymes remained within normal ranges in co-infected individuals. Quantitative analyses demonstrated an inverse relationship between HBV surface antigen levels and P. falciparum parasitemia. This observation could suggest an antagonistic replication dynamic. However, the relationship was not statistically significant (Spearman’s ρ = −0.5, p = 0.67). Conclusions: HBV and P. falciparum co-infection occurs in a small but clinically relevant proportion of pregnant women in Gabon. The observed inverse replication pattern suggests a potential biological antagonism that may modulate disease severity. These findings although preliminary, could highlight the need for integrated screening and management strategies during pregnancy to improve maternal and fetal outcomes. Full article

Background/Objectives: Hepatitis B virus (HBV) remains a significant diagnostic and public health challenge worldwide. Despite widespread vaccination, underdiagnosis persists among adults in Saudi Arabia. This study estimated HBV prevalence and identified sociodemographic, clinical, and behavioral predictors relevant to improving targeted diagnostic screening. Methods: A cross-sectional study of 1196 Saudi adults aged ≥18 years was conducted between September 2024 and February 2025 using a structured questionnaire. Data on demographics, clinical history, and behavioral exposures were analyzed using chi-square tests and multivariate logistic regression to identify independent determinants of HBV infection. Results: The study included 1196 adults (60.0% female, mean age 31 ± 12 years). HBV prevalence was 2.0% (95% CI: 1.3–3.0%). Independent predictors included divorced/widowed marital status (OR = 3.99, p = 0.023), diabetes mellitus (OR = 3.59, p = 0.039), family history of HBV (OR = 2.55, p < 0.001), and massage exposure (OR = 3.99, p = 0.025). No significant associations were found with gender, education, or transfusion history. Conclusions: HBV infection persists among high-risk Saudi adults despite immunization success. Integrating HBV testing into diabetes care, premarital and household screening, and regulation of personal care services may enhance early diagnosis and advance national elimination goals. Full article

Serum Glypican-3 (GPC3) levels in HCC patients are significantly higher than those in healthy individuals or patients with non-malignant liver diseases, making it a diagnostic marker for HCC. However, its diagnostic capability remains controversial due to its low sensitivity. The common marker AFP has limitations in terms of sensitivity and specificity, particularly in early-stage HCC. We sought to combine GPC3 detection with multi-biomarker panels to enhance sensitivity and specificity in early-stage HBV-, HCV-, and ALD-related liver cancer diagnosis. We applied receiver operating characteristic (ROC) analysis, which is used to evaluate the diagnostic performance of different biomarker tests, to develop comprehensive multi-biomarker panels that include GPC3, along with other biomarkers such as gender, age, AFP, AFP-L3%, and DCP, for assessment in the selected patients. We also applied univariate and multivariate logistic regression analysis to generate a specific diagnostic model for early HBV-induced HCC detection. We found that GPC3 levels in serum were significantly higher in HCC patients compared to CLD patients. We performed univariate and multivariate logistic regression analysis on the relevant indicators of early HCC to establish a new GDATA model for diagnosing early HCC. The new model included five indicators of early HCC: GPC3, DCP, AFP-L3%, TBIL and age. The diagnostic efficacy was better than that of GPC3, AFP, DCP and AFP-L3 alone. The diagnostic accuracy of the GDATA model for early HCC was significantly higher than that of the GALAD model or single indicators alone. The GDATA model thus provides a new promising diagnostic strategy for early HCC detection. Full article

Hepatitis B virus (HBV) represents a significant global health challenge, affecting over 254 million individuals and contributing to 1.1 million deaths from liver-related complications in 2022. The World Health Organization has set ambitious targets to reduce HBV infections and mortality by 2030. However, only a small proportion (13%) of infected individuals receives timely diagnosis and treatment. HBV elimination efforts necessitate substantial improvements in HBV diagnosis, particularly in identifying early-stage infections, occult HBV infections (OBI), and breakthrough cases. The hepatitis B surface antigen (HBsAg) is a key biomarker in HBV diagnosis, serving as a reliable indicator of infection status and treatment response. Conventional HBsAg assays, with a lower limit of detection (LoD) between 0.03 and 250 IU/mL, often fail to detect OBI and HBV reactivation. In contrast, ultrasensitive HBsAg assays, with an LoD as low as 0.005 IU/mL, can improve the identification of low concentration levels of HBsAg, facilitating earlier diagnosis, monitoring of therapeutic response, and assessment for functional cure. Research confirms the superiority of ultrasensitive assays in detecting HBV in cases missed by conventional assays, detecting NAT-yield samples, and enabling earlier detection of HBV reactivation. This review examines the challenges in HBV diagnostics and the clinical utility of ultrasensitive HBsAg assays in improving progress toward global HBV elimination. Full article

Background: According to a WHO global hepatitis report, the global prevalence of hepatitis B in 2022 was 254 million and for hepatitis C it was 50 million. The estimated number of people newly infected by viral hepatitis declined from 3 million in 2019 to 2.2 million in 2022. Of these, 1.2 million are hepatitis B infections and nearly 1.0 million are hepatitis C infections. Regarding vertical transmission, it is estimated that 4 to 5 million children are infected worldwide every year from HBV-positive mothers. The United States declared that hepatitis C is the commonest chronic blood-borne infection, with an increase in HCV birth infections from 1.8 to 4.7 per 1000 births. Objectives: This systematic review focuses on highlighting the most suitable screening methods and maternal interventions to prevent HBV/HCV mother-to-child transmission, as well as the appropriate prophylactic strategies for newborns. Materials and methods: We searched a medical database (PubMed) to find papers regarding mother-to-child transmission of hepatitis B and C. Inclusion criteria were human-based studies, studies with large cohorts of subjects, studies conducted in different parts of the globe and position papers from various international associations. Exclusion criteria were non-human-based studies and non-English publications. To present and synthesize results we made use of thematic analysis and narrative synthesis. Results: We included 103 publications. For hepatitis B, the combination of maternal antiviral therapy during pregnancy and timely administration of HBV vaccine alongside HBIG to the newborn has proven to be highly effective in lowering transmission rates. Hepatitis C vertical transmission lacks an effective vaccine or immuno-prophylaxis, turning prevention strategies into a continuous battle. Conclusions: Vertical transmission of hepatitis B and C continues to be a major contributor to the global burden of chronic viral hepatitis. Strengthening prenatal care programs, improving access to diagnostic and therapeutic resources and enhancing public health policies are essential to curb vertical transmission of both hepatitis B and C. Full article

The aim of our study is to determine the changes in the biomarkers CXCL-16, CCL-20, GDF-15, and CD8a, which play an immunological role in CHB patients according to viral load to determine their diagnostic potential and to investigate their relationships with hematological parameters and non-invasive fibrosis indices. Our study included 96 chronic hepatitis B patients and 30 healthy individuals as a control group. The patients were divided into three groups based on their serum HBV DNA levels: mild (0–10² IU/mL), moderate (10³–10⁵ IU/mL), and severe viral load (10⁶–10⁸ IU/mL). HBV DNA levels were determined by the real-time PCR (Anatolia, Istanbul, Turkey) method. CXCL-16, GDF-15, and CD8a levels in patient serum were quantitatively determined by the ELISA method (Elabscience, Wuhan, China), and CCL-20 levels were determined by the ELISA method BT LAB, Shanghai, China). ROC (Receiver Operating Characteristics) and HUM (Hypervolume Under Manifold) analyses were used to determine the diagnostic efficacy of the biomarkers. ROC analyses showed that GDF-15 (AUC = 0.920) and CCL-20 (AUC = 0.751) had “very good” and “good” diagnostic values, respectively, in predicting hepatitis B disease. HUM analyses revealed that all biomarkers have good potential when it comes to distinguishing the severity of the disease. This study has shown that the biomarkers GDF-15 and CCL-20 may be potential diagnostic biomarkers in detecting the presence of chronic hepatitis B, and the biomarkers CXCL-16, CCL-20, GDF-15, and CD8a may be potential diagnostic biomarkers in determining the severity of the disease. These findings suggest that these biomarkers, which can be measured by the simpler and more economical ELISA method, could be a supportive tool for the HBV DNA test. The clinical use of these biomarkers can be expanded with future prospective studies. Full article

Hepatitis B virus (HBV) remains a major global health concern, as it is not only one of the most common hepatotropic viruses but also ranks as the seventh leading cause of mortality worldwide. The most significant routes of infection include vertical transmission (from mother to child before, during, or after birth, including transplacental infection) and horizontal transmission in early childhood through close household contact with infected parents. The aim of our study was to assess the prevalence of chronic and occult hepatitis B virus infection among pregnant women in St. Petersburg (Russia), including molecular characterization. We analyzed plasma samples from 1368 local pregnant women. ELISA screening for HBV markers included qualitative detection of HBsAg, anti-HBs IgG, and anti-HBcore IgG. HBV DNA was identified using highly sensitive nested PCR, followed by whole-genome sequencing for HBV DNA-positive cases. Our study evaluated the prevalence of serological and molecular HBV markers and their association with age, vaccination status, and number of pregnancies. Serological markers HBsAg, anti-HBs IgG, and anti-HBcore IgG were detected in 1.9%, 63.8%, and 12.9% of participants, respectively. HBV DNA was found in 4.7% of pregnant women, including 2.8% with occult HBV infection (OBI). We observed a positive correlation between anti-HBcore IgG and age, but an inverse correlation with anti-HBs IgG; an inverse correlation between anti-HBcore IgG and vaccination status, while anti-HBs IgG showed a positive correlation; and a positive correlation between HBsAg, anti-HBcore IgG, and HBV DNA with the number of pregnancies. We also analyzed the prevalence of clinically significant mutations, including drug resistance mutations, escape mutations (affecting diagnostic detection and vaccine efficacy), and mutations associated with disease progression. The detection of HBsAg-negative HBV infection was linked to circulating viral variants carrying escape mutations, which evade HBsAg detection in diagnostic assays and neutralization by vaccine-induced antibodies. The predominance of HBV isolates in pregnant women harboring dual-threat mutations (those causing diagnostic failure via HBsAg negativity, reduced vaccine/immunoglobulin efficacy, viral reactivation, disease progression) poses a significant public health risk and warrants further investigation. Full article

In Nigeria, hepatitis B virus (HBV) infection remains a significant public health issue. The emergence of immune escape mutants (IEMs), basal core promoters, and precore (BCP/PC) mutants among asymptomatic individuals has enabled the continuous evolution of the virus in the country. In this study, we used Sanger sequencing of the S gene and the BCP/PC region to investigate the genetic diversity, phylogenetic relationships, and mutational profiles of HBV strains detected in two regions in Nigeria. A total of 178 HBsAg-positive samples confirmed by ELISA underwent viral DNA extraction and PCR amplification of the surface and BCP/PC genes, and 76 and 60 sequences were found to be exploitable for S and BCP/PC genes, respectively, which were used for HBV genotyping and mutational analysis. We detected various mutations in the major hydrophilic loop (target of neutralizing antibodies), including vaccine escape mutants (VEMs) (L127P/R, S140T/L, and G145A), HBV immunoglobulin resistance mutants (T131N, S143T, and W156R), and mutations previously reported in patients with reactivated infections (T115N, G159A/R, and F161Y). We also identified a high proportion of C1741T in 34/42 (81%) along with A1762T or G1764A mutation in 14/42 (33%) and 18/42 (43%) as the dominant variants in the BCP region. The predominant classical PC G1896A and G1899A variants were identified in 26/42 (62%) and 17/42 (40%) participants in this study. Two HBV genotypes were identified (A and E). However, HBV genotype E was the most frequently identified genotype, and is still the dominant strain circulating in Nigeria. We report the circulation of HBV IEMs and the preponderance of BCP and classical PC variants among asymptomatic carriers. Our findings suggest that the spread of these HBV mutant variants among asymptomatic carriers may have an impact on the effectiveness of diagnostic immunoassays and the success of HBsAg-based vaccinations. This highlights the need for robust surveillance. Full article

Background/Objective: The hepatitis B virus (HBV) can cause chronic hepatitis B (CHB), which can rapidly progress into fatal liver cirrhosis (CHB-LC) and hepatocellular carcinoma (CHB-HCC). Methods: In this study, we investigated metabolites associated with distinct clinical stages of HBV infection for the identification of stage-specific serum metabolite biomarkers using ¹H-NMR-based metabolomics. Results: A total of 64 serum metabolites were identified, among which six core discriminatory metabolites, namely isoleucine, tryptophan, histamine (for CHB), and pyruvate, TMAO, lactate (for CHB-HCC), were consistently significant across univariate and multivariate statistical analyses, including ANOVA with FDR, OPLS-DA, and VIP scoring. These metabolites were closely linked to key metabolic pathways, such as propanoate metabolism, pyruvate metabolism, and the Warburg effect. Conclusions: The findings suggest that these six core metabolites serve as potential stage-specific biomarkers for CHB, CHB-LC, and CHB-HCC, respectively, and offer a foundation for the future development of metabolomics-based diagnostic and therapeutic strategies. Full article

Hepatitis delta virus (HDV) infection is associated with severe hepatic complications and rapid progression towards liver cirrhosis and hepatocellular carcinoma. Accurate measurement of HDV RNA is critical for monitoring therapeutic responses, especially during treatment with novel therapies such as bulevirtide (BLV). This study compared the analytical performance of two HDV RNA quantification assays, Bosphore (Anatolia) and AltoStar^® (Altona), focusing on their sensitivity, specificity, and potential implications for clinical management. Sixty-one clinical samples from twenty-four patients, including fifteen HDV-infected patients receiving BLV treatment and nine controls, were tested using each assay. Of 30 samples identified as HDV-negative by the Bosphore assay, 17 (56.7%) were HDV-positive with AltoStar^®, demonstrating the superior sensitivity (p < 0.0001) of the latter assay. Quantitative analyses revealed consistently higher viral load measurements with AltoStar^® compared to Bosphore, with a difference of 1.23 Log IU/mL and a moderate correlation (r² = 0.7385) between assays. Each assay demonstrated a high specificity, with no false positives detected among control samples. However, our findings suggest that differences in assay sensitivity could impact the evaluation of virological response, highlighting the risk of false-negative results in chronically HDV-infected patients with low-level viremia. This emphasizes the need for careful assay selection to accurately monitor treatment outcomes. Full article

This study aimed to assess the prevalence of HDV (hepatitis delta virus), HCV (hepatitis C virus), and HIV (human immunodeficiency virus) coinfections among HBsAg-positive patients and to determine the severity of liver fibrosis and biochemical markers. Furthermore, the study sought to evaluate the noninvasive fibrosis scores (APRI and FIB4) in predicting the severity of liver disease in patients with hepatitis B. A retrospective analysis of 1434 patients with chronic HBV admitted between January 2020 and December 2024 was conducted at Sincan Tertiary Hospital. The positivity rates of the following antibodies were the focus of the study: anti-HDV, anti-HCV, and anti-HIV. In addition to these, the levels of HIV-RNA, HCV-RNA and HBV-DNA, as well as several biochemical markers (ALT, AST, INR, albumin, bilirubin and platelet count) were also evaluated. The APRI and FIB-4 scores were calculated. Of the 1434 patients, 49 (3.4%) tested positive for anti-HDV, 784 were screened for anti-HCV, and 749 were screened for anti-HIV. The positivity rates were 3.4% (27/784) and 3.4% (26/749), respectively. According to ROC analysis, the FIB-4 score had a statistically significant effect on predicting anti-HDV negativity (AUC = 0.59, p = 0.031). However, the APRI score was not a significant predictor for anti-HDV positivity (AUC = 0.53, p > 0.05). APRI and FIB-4 scores did not have a statistically significant discriminatory power in predicting anti-HCV and anti-HIV positivity (p > 0.05). The cut-off value for the FIB-4 score in predicting anti-HDV positivity was 1.72, with a sensitivity of 61.4% and a specificity of 42.9% (p = 0.031). Among the HCV/RNA-positive patients (n = 5), all were male, and two also had positive anti-HBe results with undetectable HBV/DNA levels. One HIV/RNA-positive patient, a foreign national, was confirmed to have HIV/HBV/HDV infection. All HBsAg-positive patients should undergo routine anti-HDV testing. Vaccination programmes are vital in preventing the spread of HDV. Dual screening strategies are essential for identifying infected individuals and developing prevention and treatment programmes. Anti-HDV positivity indicates advanced liver fibrosis, emphasising the importance of screening and monitoring. However, the limited accuracy of the APRI and FIB-4 scores for detecting coinfections highlights the need to integrate noninvasive methods with molecular diagnostics for precise management. Full article