Sabrina Brasil, Marcelo Ribeiro-Alves, Cristiane Villela-Nogueira, Simone da Costa Cruz Silva, Fabricia Boscate Mafra Coelho Corrêa, Cristiane Siqueira do Valle, Sandra W. Cardoso, Beatriz Grinsztejn, Valdilea G. Veloso, Hugo Perazzo
{"title":"Optimizing the HCV Care Continuum in Primary Care: Opportunistic Screening With Point-Of-Care RNA Testing and Immediate Linkage-To-Care in Rio de Janeiro, Brazil","authors":"Sabrina Brasil, Marcelo Ribeiro-Alves, Cristiane Villela-Nogueira, Simone da Costa Cruz Silva, Fabricia Boscate Mafra Coelho Corrêa, Cristiane Siqueira do Valle, Sandra W. Cardoso, Beatriz Grinsztejn, Valdilea G. Veloso, Hugo Perazzo","doi":"10.1111/jvh.70234","DOIUrl":"10.1111/jvh.70234","url":null,"abstract":"<div>\u0000 \u0000 <p>Optimizing the hepatitis C virus (HCV) care cascade is critical for elimination. We aimed to evaluate a nurse-led opportunistic screening strategy integrated with point-of-care (POC) HCV-RNA testing and immediate linkage-to-care in primary care. A cohort study was conducted across three Basic Health Units located in a low-income region of Rio de Janeiro, Brazil. A simplified health team (nurse and laboratory technician) offered opportunistic HCV screening (HCV rapid-test (RT), SD-Bioline, Abbott) for adults (18–79 years) who were attending or using health services from July/2022 to June/2025. People with positive HCV-RT were linked to care at a reference centre for POC HCV-RNA confirmation (Xpert HCV Viral Load; Cepheid) and pan-genotypic treatment (sofosbuvir/velpatasvir). Among 11,270 screened individuals [74.8% female, median age = 49 (IQR, 35–61), 24% unemployed], 0.78% (<i>n</i> = 88) tested antibody-positive. Independent factors associated with positive HCV rapid test included higher age [aOR = 1.86 (95% CI, 1.52–2.27)], HIV infection [aOR = 13.68 (95% CI, 5.18–36.17)], and history of blood transfusion [aOR = 2.45 (95% CI, 1.60–3.76)]. Among 88 people with positive rapid HCV test, 80 (91%) completed POC-HCV-RNA testing, identifying 49 viraemic cases [prevalence = 0.43% (95% CI, 0.32–0.57)]. Treatment initiation occurred in 42/49 (86%) of viraemic participants and 90% (<i>n</i> = 38/42) returned to assess sustained virological response (SVR12), which was achieved in 38/42 (90% intention-to-treat; 100% per-protocol). The median time from HCV screening to treatment initiation was 20 days (IQR, 14–28; range: 5–54). In conclusion, opportunistic decentralized testing by a nurse-led team, coupled with collaboration with reference centres and POC-RNA confirmation, optimizes the HCV care continuum in resource-limited settings. This model could accelerate cure rates and support the WHO elimination goals.</p>\u0000 </div>","PeriodicalId":17762,"journal":{"name":"Journal of Viral Hepatitis","volume":"33 10","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149030705","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
David Etoori, Annabel Powell, Paul Trembling, Jennifer Plunkett, Ashley Brown, Maud Lemoine, Stephen Ryder, Sarah Montague, Eleanor Pilsworth, Anthony Bains, Laura Harrison, Michael Pavlides, Ahmed Elsharkawy, Caroline Sabin, Monica Desai, Ruth Simmons
{"title":"Estimating the Fraction of Hepatocellular Carcinoma and Decompensated Cirrhosis Attributable to Viral Hepatitis in England Using Electronic Health Records and Case-Notes Review","authors":"David Etoori, Annabel Powell, Paul Trembling, Jennifer Plunkett, Ashley Brown, Maud Lemoine, Stephen Ryder, Sarah Montague, Eleanor Pilsworth, Anthony Bains, Laura Harrison, Michael Pavlides, Ahmed Elsharkawy, Caroline Sabin, Monica Desai, Ruth Simmons","doi":"10.1111/jvh.70228","DOIUrl":"10.1111/jvh.70228","url":null,"abstract":"<p>Viral hepatitis mortality is an impact target required to evidence the elimination of viral hepatitis with a combined mortality rate of less than or equal to six deaths per 100,000 population. Within England, routine healthcare data linked with death registrations are used; however, where these data are not available, the World Health Organization (WHO) recommends overlaying the attributable fraction (AF) over the mortality envelope for decompensated cirrhosis (DC) and hepatocellular carcinoma (HCC). We aimed to estimate viral hepatitis mortality using the attributable fraction and compared it to surveillance methods. Six acute NHS trusts participated across England and reviewed the case records of individuals identified retrospectively up to 31 December 2023 through hospital episode statistics to confirm the diagnosis and complete a proforma on possible exposures and likely cause of DC/HCC. Overall, 563 individuals were identified, 390 for DC review with 127 (32.6%) confirmed and 173 for HCC review with 157 (91.8%) confirmed. The AF for DC was 0.008 for HCV and 0.016 for HBV, equivalent to a crude mortality rate of 0.09 per 100,000 population and 0.17 per 100,000 population, respectively. For HCC 0.1806 for HCV and 0.0645 for HBV, equivalent to 0.85 per 100,000 population and 0.30 per 100,000 population respectively. These results are comparable to applying the attributable fraction methodology to linking healthcare data sets and demonstrate that England continues to meet the WHO impact target.</p>","PeriodicalId":17762,"journal":{"name":"Journal of Viral Hepatitis","volume":"33 10","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13594983/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149017212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Heterogeneity, Prediction Intervals and the Pooled HBsAg Estimate for Cameroon","authors":"Christos Zavos","doi":"10.1111/jvh.70232","DOIUrl":"10.1111/jvh.70232","url":null,"abstract":"","PeriodicalId":17762,"journal":{"name":"Journal of Viral Hepatitis","volume":"33 10","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149012739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Beyond Virological Response: Refining the Assessment of Clinical and Patient-Reported Outcomes in Bulevirtide Therapy for Chronic Hepatitis D","authors":"Noor Fatima, Aqsa Elle","doi":"10.1111/jvh.70233","DOIUrl":"10.1111/jvh.70233","url":null,"abstract":"","PeriodicalId":17762,"journal":{"name":"Journal of Viral Hepatitis","volume":"33 10","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149012651","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Roberto Rossotti, Alessandro Tavelli, Vincenzo Malagnino, Valentina Svicher, Eugenia Quiros-Roldan, Alessandra Bandera, Francesco Maria Fusco, Marco Rivano Capparuccia, Giovanni Battista Gaeta, Valentina Mazzotta, Massimo Puoti, Antonella d’Arminio Monforte, ICONA/HepaICONA Foundation Study Group
{"title":"Persistent ALT Elevation and Liver Outcomes After DAA-Induced HCV Cure in People With HIV: Impact of HBV and HDV Co-Infections","authors":"Roberto Rossotti, Alessandro Tavelli, Vincenzo Malagnino, Valentina Svicher, Eugenia Quiros-Roldan, Alessandra Bandera, Francesco Maria Fusco, Marco Rivano Capparuccia, Giovanni Battista Gaeta, Valentina Mazzotta, Massimo Puoti, Antonella d’Arminio Monforte, ICONA/HepaICONA Foundation Study Group","doi":"10.1111/jvh.70230","DOIUrl":"10.1111/jvh.70230","url":null,"abstract":"<div>\u0000 \u0000 <p>HBV replication is commonly suppressed by HCV, and eradication of HCV with direct-acting antivirals (DAAs) may favour HBV reactivation. Data on long-term hepatic outcomes after HCV clearance in people living with HIV (PLWH) with triple viral infections are limited. We analysed all HIV/HCV co-infected participants in the ICONA and HepaICONA cohorts with complete HBV serology who achieved a sustained virological response (SVR) after DAA therapy. Participants were classified as HIV/HCV, HIV/HCV with isolated anti-HBc positivity (IHBc), or HIV/HCV/HBV, with HDV testing when available. The outcomes included ALT normalisation, hepatitis flares, and two composite clinical endpoints: CO1 (HCC, hepatic decompensation, liver transplantation, or death) and CO2 (the same plus FIB-4 progression > 3.25 in non-cirrhotics). Among 1182 PLWH, 478 had HIV/HCV, 651 had HIV/HCV + IHBc, and 53 had HIV/HCV/HBV co-infection; six were HDV RNA-positive. The prevalence of triple co-infection was 16.6% among HCV-viraemic participants. Triple co-infection reduced the likelihood of ALT normalisation (aHR 0.66, 95% CI: 0.45, 0.97); this effect was related to active HDV replication (aHR 0.39, 95% CI: 0.16, 0.94). Over 5213 person-years, 26 hepatitis flares occurred (IR 0.50/100 PYFU), with only one confirmed HBV reactivation (IR 0.25/100 PYFU). Neither triple nor quadruple infection predicted severe liver events. In PLWH, HCV/HBV co-infection is relatively common but does not appear to increase hepatic morbidity after HCV cure under tenofovir-based ART. Persistent ALT elevation after DAA therapy is mainly driven by replicating HDV, supporting routine HDV testing and timely antiviral management in this population.</p>\u0000 </div>","PeriodicalId":17762,"journal":{"name":"Journal of Viral Hepatitis","volume":"33 10","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149012675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Joanne M. Carson, Sebastiano Barbieri, Andrey Verich, Elise Tu, Andrew Lloyd, Gregory J. Dore, Gail V. Matthews, Marianne Martinello
{"title":"Development of a Machine Learning Model to Predict Short Duration HCV Treatment Response","authors":"Joanne M. Carson, Sebastiano Barbieri, Andrey Verich, Elise Tu, Andrew Lloyd, Gregory J. Dore, Gail V. Matthews, Marianne Martinello","doi":"10.1111/jvh.70229","DOIUrl":"10.1111/jvh.70229","url":null,"abstract":"<p>Standard durations of direct acting antivirals (DAAs; 8–12 weeks) can be a barrier to HCV treatment initiation and completion among marginalized populations. This study developed and internally validated a machine learning model to predict short-duration (4–6 weeks) DAA response using baseline clinical factors with potential to improve treatment uptake, cost-effectiveness and health system efficiency. Baseline data from several short-duration DAA clinical trials and treatment discontinuations from real-world cohort studies were used. Multiple machine learning models were evaluated. Nested cross-validation was employed to optimize model hyperparameters and assess performance. Clinical utility was evaluated using Area Under Receiver Operator Characteristics (AUROC), Area Under Precision Recall Curve (AUPRC) and Matthews Correlation Coefficient (MCC). Threshold optimisation strategies were applied to balance model accuracy and DAA costs. Statistical analyses were conducted to estimate HCV RNA cutoffs predictive of treatment failure. Of 264 participants receiving short-duration DAAs (median 42 days; IQR 28–42), 94 (36%) experienced treatment failure. Predictors of failure included shorter durations, higher HCV RNA, higher AST–ALT ratio, genotype 3 and DAA class. The Elastic Net (regularized logistic regression) model demonstrated strong performance (AUROC: 83%; AUPRC: 73%). The Youden Index threshold balanced sensitivity (81%) and specificity (76%) with MCC of 0.56. A cost-optimized threshold, prioritizing retreatment minimization, achieved high sensitivity (98%) but reduced specificity (51%). HCV RNA cutoffs predictive of treatment failure were higher for protease+NS5A than NS5A + NS5B inhibitor regimens. Predictive models using baseline clinical data can identify individuals likely to respond to short-duration DAAs. Such models, if externally validated in larger and more diverse datasets, could facilitate HCV elimination efforts by improving treatment uptake, particularly for people who inject drugs, people experiencing homelessness or incarceration.</p>","PeriodicalId":17762,"journal":{"name":"Journal of Viral Hepatitis","volume":"33 10","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13579082/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148977155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Robert Whittaker, Linda Couëssurel Wüsthoff, Jørgen Eriksson Midtbø, Håvard Midgard, Olav Dalgard
{"title":"Progress Towards Eliminating Hepatitis C as a Public Health Threat in Norway","authors":"Robert Whittaker, Linda Couëssurel Wüsthoff, Jørgen Eriksson Midtbø, Håvard Midgard, Olav Dalgard","doi":"10.1111/jvh.70202","DOIUrl":"10.1111/jvh.70202","url":null,"abstract":"<p>The World Health Organisation aims to eliminate hepatitis C virus (HCV) infection as a public health threat by 2030. We assessed progress towards HCV elimination in Norway until the end of 2024. We used linked national registry data to describe diagnosed cases of HCV infection by treatment uptake and case characteristics, and the incidence of HCV-related death. We updated a stochastic compartmental model to estimate HCV incidence and prevalence among people who inject drugs and migrants. We summarised all available data to assess progress towards HCV elimination targets. Among 12,620 HCV RNA-positive cases still living in Norway in 2024, 10,824 (86%) had been treated. Among people who inject drugs the estimated incidence was 20 (95% credible interval (CrI): 8–39) new infections, or 0.3 per 100 (95% CrI: 0.1–0.5), and the estimated prevalence was 1498 (95% Crl, 549–3631) chronic infections in 2024. Among migrants, prevalence increased from 598 (95% CrI: 179–1156) in 2021 to 2228 (95% CrI: 1394–3071) in 2024. HCV-related deaths plateaued at 0.6–0.8 per 100,000 from 2017–2024. Norway achieved global targets for HCV incidence, mortality, treatment uptake, harm reduction and (likely) blood safety. There is a lack of data on the target for diagnostic coverage. We conclude that Norway has entered a new phase of the HCV epidemic, with low incidence of new infections, low mortality, and with prevalence becoming more influenced by patterns of migration. Further decentralisation and integration of testing and treatment are necessary to reach new national goals.</p>","PeriodicalId":17762,"journal":{"name":"Journal of Viral Hepatitis","volume":"33 10","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13572965/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148963554","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A Novel Quantitative ELISA Demonstrates Lack of Correlation Between Serum HDV-RNA and Anti-HDV Antibody Levels in Chronic HDV Infection","authors":"Nomin Ariungerel, Khaliunaa Otgonbaatar, Saruul Enkhjargal, Ulziigerel Erdembileg, Sumiya Byambabaatar, Badmaarag Munkhjin, Tuul Tsagaantsooj, Sanjaasuren Enkhtaivan, Byambasuren Ochirsum, Purevjargal Bat-Ulzii, Enkhnomin Ochirbat, Naranjargal Dashdorj, Odgerel Oidovsambuu","doi":"10.1111/jvh.70227","DOIUrl":"https://doi.org/10.1111/jvh.70227","url":null,"abstract":"<div>\u0000 \u0000 <p>Infection with the hepatitis delta virus (HDV) causes the most aggressive type of viral hepatitis and frequently leads to liver cirrhosis and hepatocellular carcinoma. Immunological aspects associated with HDV infection are poorly studied, and quantitative identification of anti-HDV antibodies may be important for understanding the disease. A quantitative, chemiluminescence-based ELISA was developed and validated using 399 serum samples (199 HDV-Ab positive, 200 healthy controls). Serum levels of HDV-RNA, HBV-DNA and hepatic enzymes (ALT, AST) were measured. Statistical analyses included ROC analysis, distribution analysis, Student's <i>t</i>-test and correlation analysis. ELISA demonstrated linear quantification of anti-HDV antibodies with high specificity (Sp = 100%) and sensitivity (Se = 100%), detecting down to 0.5 ng/mL in pure standards. The mean anti-HDV antibody levels were 67,622 ng/mL overall, 70,883 ng/mL in males and 64,043 ng/mL in females. Antibody levels followed a normal distribution, despite population heterogeneity. Student's <i>t</i>-test revealed significant gender differences in antibody levels and ALT (<i>p</i> = 0.0128 and <i>p</i> = 0.0006), whereas HDV-RNA, HBV-DNA and AST did not differ significantly. Comparisons of the high versus low HDV-RNA subgroups showed no significant differences in antibody levels. Correlation analysis indicated no significant associations between anti-HDV antibody levels and HDV-RNA, hepatic enzyme levels. This study presents a robust quantitative ELISA for detecting anti-HDV antibodies. The humoral immune response, as reflected by antibody levels, is independent of the viral load and liver injury markers. Gender-related differences in antibody and ALT levels were observed. These findings provide a foundation for precise evaluation of HDV-specific immunity in chronic infections.</p>\u0000 </div>","PeriodicalId":17762,"journal":{"name":"Journal of Viral Hepatitis","volume":"33 10","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148823407","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kosh Agarwal, Dan Forton, Yoh Zen, Min Wu, Tse-I Lin, Kha Le, Sushmita Chanda, Lawrence Blatt, John Fry, Ed Gane
{"title":"ALG-020572, an Antisense Oligonucleotide for the Treatment of Chronic Hepatitis B Virus Infection Discontinued for Drug-Induced Liver Injury","authors":"Kosh Agarwal, Dan Forton, Yoh Zen, Min Wu, Tse-I Lin, Kha Le, Sushmita Chanda, Lawrence Blatt, John Fry, Ed Gane","doi":"10.1111/jvh.70224","DOIUrl":"10.1111/jvh.70224","url":null,"abstract":"<div>\u0000 \u0000 <p>Current treatment options for chronic HBV infection are suboptimal in that they fail to suppress HBsAg levels. ALG-020572 is an antisense oligonucleotide designed to reduce viral protein synthesis through degradation of HBV mRNA. ALG-020572-401 was a double-blind, randomized, placebo-controlled trial consisting of two parts. Part 1 (single-ascending doses) evaluated the pharmacokinetics, safety and tolerability of single doses of ALG-020572 or placebo in healthy participants. In Part 2 (multiple dosing), participants with non-cirrhotic HBeAg-negative, virologically suppressed chronic HBV infection were administered up to 7 doses of ALG-020572 to evaluate safety, pharmacokinetics and antiviral activity. In Part 1, 32 participants were randomized to ALG 020572 or placebo. Single doses of ALG-020572 up to 480 mg were well tolerated. The most common treatment-emergent adverse event reported was injection site reaction. ALG-020572 was rapidly absorbed and plasma exposures increased with dose. In Part 2, 8 participants with non-cirrhotic HBeAg-negative virologically suppressed chronic hepatitis B infection were enrolled and received up to 7 doses of ALG-020572. The study was prematurely discontinued after 4 participants experienced significant alanine aminotransferase elevations that were subsequently attributed to drug-induced liver injury. Single doses of ALG-020572 demonstrated a favourable pharmacokinetic and safety profile in healthy participants. Unexpectedly, ALG-020572 was poorly tolerated in participants with chronic HBV infection, resulting in the early termination of the study and further development of ALG-020572 due to idiosyncratic drug-induced liver injury, suggesting caution is required in the development of this class of drugs.</p>\u0000 <p><b>Trial Registration:</b> Registered at clinicaltrials.gov: NCT0500102</p>\u0000 </div>","PeriodicalId":17762,"journal":{"name":"Journal of Viral Hepatitis","volume":"33 9","pages":""},"PeriodicalIF":2.3,"publicationDate":"2026-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148813321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}