We assessed the characteristics and treatment outcomes of hepatitis C virus (HCV)-infected Canadian immigrants evaluated for antiviral therapy with a specific focus on time from arrival to HCV care engagement and the Dir...We assessed the characteristics and treatment outcomes of hepatitis C virus (HCV)-infected Canadian immigrants evaluated for antiviral therapy with a specific focus on time from arrival to HCV care engagement and the Direct-Acting Antiviral (DAA) era. A retrospective cohort analysis was conducted using medical records from HCV RNA positive patients assessed at The Ottawa Hospital Viral Hepatitis Program between August 1997 and March 2025. Of 2620 patients, 563 (21.5%) were immigrants. Proportions of treatment initiation, completion and SVR were comparable between immigrant and Canadian-born groups. SVR bloodwork completion was higher in the immigrant cohort (93.6% vs. 80.7%, p < 0.001). The overall median time from immigrant arrival in Canada to first HCV clinic assessment was 8 years. This delay in accessing HCV care trended downwards with each 5-year interval from 1990 to 2025 (median years = 23, 18, 12, 7, 3, 2, 1, p < 0.001). More recently immigrated patients demonstrated high proportions of DAA initiation (arrived in Canada 1990-1994: 62.3%; 1995-1999: 80.0%; 2000-2004: 92%; 2005-2009: 80.0%; 2010-2014: 90.7%; 2015-2019: 91.5%; 2020-2025: 89.3%, p < 0.001). Reduced times from immigrant arrival to specialty HCV care engagement and high DAA treatment initiation amongst more recently arrived patients suggest improved success in immigrant progression along the HCV care cascade. This reflects positive developments in Canadian HCV care over the past three decades and reinforces the importance of sustaining efforts towards national HCV elimination.
Biondi MJ, Capraru CI, Harper B
… +15 more, Gill P, Dale CH, Nicolle J, Chung D, Boutrous M, Wilson AD, Lam V, Morkos D, Barber B, Usoro MA, Mendlowitz AB, Shah H, Fontaine G, Hansen B, Feld JJ
J Viral Hepat
· 2026 Jan · PMID 41307439
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This was a nonblinded randomised controlled trial comparing pharmacist-led hepatitis C virus (HCV) treatment in the community, to tertiary care hepatology. Of 34 antibody-positive individuals, 28 completed a rapid HCV RN...This was a nonblinded randomised controlled trial comparing pharmacist-led hepatitis C virus (HCV) treatment in the community, to tertiary care hepatology. Of 34 antibody-positive individuals, 28 completed a rapid HCV RNA test in the pharmacy. The study was terminated after randomising 11 participants over 15 months (recruitment continued until ~27 months), as a result of feasibility concerns of pharmacist-led care, and here we highlight important lessons learned to consider for future efforts.
Mazzilli S, Aslam MK, Ahmed M
… +6 more, Wailly Y, Miazek M, Ashraf S, Ravji A, de Glanville WA, Isaakidis P
J Viral Hepat
· 2026 Jan · PMID 41307434
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Pakistan has the world's highest hepatitis C virus (HCV) prevalence, yet access to HCV care remains limited. In collaboration with the Ministry of Health Sindh, Médecins Sans Frontières implemented a simplified, decentra...Pakistan has the world's highest hepatitis C virus (HCV) prevalence, yet access to HCV care remains limited. In collaboration with the Ministry of Health Sindh, Médecins Sans Frontières implemented a simplified, decentralised model for HCV screening and treatment at a government-run primary health centre (PHC) in Baldia Town, Karachi, Pakistan. This cohort study assessed treatment uptake, effectiveness, and retention among patients screened between August 2022 and July 2023. Individuals aged ≥ 12 years were screened using capillary blood rapid diagnostic tests, with HCV viraemia confirmed via GeneXpert. Viraemic patients were treated with 12- or 24-week regimens of sofosbuvir (400 mg) and daclatasvir (60 mg), depending on the fibrosis degree. Cure was defined as a sustained virological response (viral load < 10 IU/mL) at 12 weeks post-treatment (SVR12). Among 3505 individuals screened, 613 (17.5%) tested HCV-antibody positive. Of these, 610 received confirmatory viral load testing, revealing 225 (37.9%) HCV RNA positive. A total of 161 (71.6%) initiated treatment, with a median time of 5 days (IQR 2-9) from diagnosis, while 23 (10.2%) were deemed ineligible and 41 (18.2%) lost to follow-up. Of the 118 patients assessed for SVR12, 114 (96.6%) achieved cure. Overall, 91.3% of those who started treatment completed it. These findings demonstrate the effectiveness of decentralised, primary care-based HCV management in a high-burden, resource-limited setting. The model appears feasible in terms of patient-level outcomes, though broader operational feasibility-including resources and scalability-was not formally assessed. Remaining barriers to treatment initiation and follow-up need to be addressed to advance national HCV elimination goals.
Lampertico P, Anolli MP, Steppich K
… +1 more, Wedemeyer H
J Viral Hepat
· 2025 Dec · PMID 41287135
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Chronic hepatitis Delta (CHD) represents the most aggressive form of viral hepatitis. In the latest estimates, published in 2024 by the Polaris Observatory, the overall prevalence of the hepatitis Delta virus (HDV) in He...Chronic hepatitis Delta (CHD) represents the most aggressive form of viral hepatitis. In the latest estimates, published in 2024 by the Polaris Observatory, the overall prevalence of the hepatitis Delta virus (HDV) in Hepatitis B surface antigen (HBsAg) + patients was estimated to be 2% worldwide, a lower figure than what was previously estimated to be around 6%-11%. Prevalence figures vary greatly across the globe, with the highest anti-HDV+ prevalence in Mongolia, where it reaches 60% of HBsAg+ individuals. Its clinical manifestations include accelerated progression to cirrhosis, increased risk of hepatic decompensation and heightened incidence of hepatocellular carcinoma (HCC). Notwithstanding the close dependency of HDV on the Hepatitis B virus (HBV), requiring HBsAg for cellular entry and propagation, nucleos(t)ide analogue (NA) therapies do not affect CHD. Ideally, a therapy capable of achieving HBsAg loss would also translate into CHD cure. Monitoring viremia is pivotal in estimating the effectiveness of HDV treatments. Consequently, a "virological response" is defined as a reduction of at least 2 logs in HDV RNA or achieving HDV RNA negativity, compared to baseline. Despite the crucial role of HDV RNA monitoring in managing patients with CHD, significant variability still exists in nucleic acid quantification techniques for HDV RNA. Quantification assays differ in their sensitivity. As previously mentioned, antiviral therapy for CHD had been challenging for decades. Until recently, pegylated interferon-alpha (PegIFNα) stood as the sole available treatment, despite its suboptimal response rates and considerable adverse effects. Furthermore, the high frequency of post-treatment relapse necessitated long-term monitoring of viral load. The landscape of HDV treatment has evolved significantly with the introduction of bulevirtide (BLV), a novel entry inhibitor that targets the sodium taurocholate co-transporting polypeptide (NTCP) receptor, blocking viral entry into hepatocytes. The European Medicines Agency (EMA)'s conditional approval for BLV in July 2020, at a recommended dose of 2 mg daily as subcutaneous injections for adult patients with compensated CHD, marked a central progress in HDV therapeutics. This approval was supported by promising phase II and III trials results, demonstrating both efficacy and tolerability of the compound. Following these promising results, EMA granted full approval for BLV in May 2023. EMA recommends proceeding with BLV therapy until proven clinical benefit, without further details on this topic. This review synthesizes current evidence on BLV's efficacy effectiveness and safety profile, both as monotherapy and in combination with PegIFNα, drawing from clinical trials and real-world studies, with the aim to propose treatment strategies aligned with disease severity and patients' profile.
Drysdale M, Gillespie IA, Christensen D
… +19 more, Davies J, Woods K, Roadknight G, Little S, Salih H, Várnai KA, Noble T, Cooke GS, Glampson B, Papadimitriou D, Mayer E, Khakoo SI, Davis C, Borca F, English L, Nastouli E, Matthews PC, Barnes E, Wang T
J Viral Hepat
· 2025 Dec · PMID 41263109
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Characterisation of people with hepatitis B (PwHB) remains limited, particularly regarding treatment status, disease severity and biomarker profiles. Quantitative hepatitis B surface antigen (qHBsAg) is a key predictor o...Characterisation of people with hepatitis B (PwHB) remains limited, particularly regarding treatment status, disease severity and biomarker profiles. Quantitative hepatitis B surface antigen (qHBsAg) is a key predictor of response to emerging therapies, but its distribution is poorly described. Using a large, ethnically diverse UK cohort, we assessed demographics, clinical features and HBsAg levels to guide treatment strategies. This cross-sectional analysis of PwHB (N = 2000 [prespecified]) used data from four English hospitals, collected via the National Institute for Health and Care Research Health Informatics Collaborative framework. Individual characteristics were assessed overall, and post hoc by qHBsAg levels (≤ 3000/> 3000 IU/mL; < 100/≥ 100-≤ 1000/> 1000 IU/mL) available from one centre (N = 457). The cohort had a slight male predominance (54%) and a mean age of 44.9 years. White and Asian ethnicity each accounted for 25%, and 23% were on nucleos(t)ide analogue therapy. Centres collecting HBsAg data had more individuals with undetectable HBV DNA or on treatment. Among individuals with non-missing qHBsAg data (263/457), 167/263 (63.5%) had qHBsAg ≤ 3000 IU/mL. These were older (49.6 vs. 43.5 years), more likely to be male (53.9% vs. 35.4%), Asian (40.7% vs. 20.8%) or have undetectable HBV DNA (35.9% vs. 17.7%), and less likely to be Black (13.2% vs. 34.4%) versus those with qHBsAg > 3000 IU/mL. Fifty-six (21.3%) people had qHBsAg < 100 IU/mL, 60 (22.8%) between ≥ 100 and ≤ 1000 IU/mL, and 147 (55.9%) > 1000 IU/mL. This cohort of PwHB highlights qHBsAg distribution in clinical settings and could identify people more likely to achieve functional cure with emerging therapies.
Marcellin F, di Beo V, Sogni P
… +10 more, Ramier C, Brouard C, Allier Y, Mourad A, Bureau-Stoltmann M, Deuffic-Burban S, Carrieri P, Rolland B, Bourliere M, Protopopescu C
Campbell C, Wang T, Stockdale AJ
… +28 more, Todd S, Jaworski J, Glampson B, Papadimitriou D, Mayer E, Salih H, Roadknight G, Little S, Noble T, Várnai KA, Davis C, Heinson AI, George M, Borca F, Roberts T, Ribeyre BB, English L, Zhu L, NIHR HIC Viral Hepatitis and Liver Disease Consortium, Woods K, Davies J, Cooke GS, Nastouli E, Khakoo SI, Gelson W, Elsharkawy AM, Barnes E, Matthews PC
J Viral Hepat
· 2025 Nov · PMID 41128166
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Nucleos/tide analogue (NA) drugs are used for long-term treatment of chronic hepatitis B virus (HBV) infection, with treatment eligibility criteria changing rapidly amidst globally evolving clinical guidelines. We aimed...Nucleos/tide analogue (NA) drugs are used for long-term treatment of chronic hepatitis B virus (HBV) infection, with treatment eligibility criteria changing rapidly amidst globally evolving clinical guidelines. We aimed to quantify the prescription of NA drugs to date, and to undertake a preliminary assessment of the impact of relaxing treatment eligibility thresholds, leveraging a unique large real-world secondary care dataset. We assimilated longitudinal clinical data, collected between February 1997 and April 2023 from adults with chronic HBV infection from six centres in England through the UK NIHR Health Informatics Collaborative (HIC) Viral Hepatitis and Liver Disease theme. We describe factors currently associated with the receipt of NA treatment and determine the proportion of the population who would become treatment eligible as thresholds change. Across 7558 adults with a mean follow-up of 4.0 years (SD 3.9), NA treatment was prescribed in 2014/7558 (26.6%), and as expected according to guidelines at the time, was associated with HBV e-antigen (HBeAg) positivity and alanine transferase (ALT) above the upper limit of normal (> ULN). Treatment was more likely in males, older adults, in Asian and Other ethnicities (compared to White), and less likely in socioeconomically deprived individuals. The proportion of treatment-eligible individuals was 32.3% based on 2 records of ALT > ULN over 6-12 months, 41.7% based on ALT > ULN and viral load (VL) > 2000 IU/mL, and 95.1% based on detectable VL and either ALT > ULN or age > 30 years. Evolving clinical guidelines will lead to substantial increases in the proportion of individuals living with HBV who are eligible for treatment, underlining the need for services to adapt rapidly to the changing clinical environment.
Hepatitis B is highly prevalent among migrant communities from endemic regions, with an estimated 70% of Australians living with chronic hepatitis B having been born overseas. Research suggests that there are significant...Hepatitis B is highly prevalent among migrant communities from endemic regions, with an estimated 70% of Australians living with chronic hepatitis B having been born overseas. Research suggests that there are significant gaps in hepatitis B knowledge which may contribute to unsatisfactory preventive and testing practices. There has been little research on hepatitis B knowledge among people of Filipino ethnicity in Australia, despite one in 10 people in the Philippines thought to be living with chronic hepatitis B. The study aims to assess hepatitis B knowledge, attitudes and mistrust in Western medicine among a sample of people of Filipino ethnicity living in Australia, focusing on country of birth to establish whether there are differences between those born in Australia compared with those born in the Philippines on the key variables of interest. Online and hard copy surveys were completed by 576 Filipino adults living in Australia, measuring knowledge of hepatitis B, attitudes, mistrust in Western medicine and demographic characteristics. There were significant gaps in knowledge, with participants born in Australia having significantly less knowledge of hepatitis B than those born in the Philippines. Participants born in Australia also had significantly more negative attitudes towards people living with hepatitis B and significantly more mistrust in Western medicine than those born in the Philippines. These findings highlight the need for improving access to healthcare for migrant populations and improving trust in Western medicine through a multifaceted approach that addresses barriers to care, focuses on the needs of different generations of migrants and builds positive trusting relationships between healthcare providers and migrant communities.
In recent years, an increasing number of acute liver failure (ALF) cases have been attributed to HHV-6, although its pathogenic role remains debated. In the absence of standardised diagnostic criteria, HHV-6 is likely un...In recent years, an increasing number of acute liver failure (ALF) cases have been attributed to HHV-6, although its pathogenic role remains debated. In the absence of standardised diagnostic criteria, HHV-6 is likely underrecognized as a potential etiologic agent. We report three cases of liver injury with confirmed HHV-6 replication; each showing a markedly different degree of viral involvement. A narrative review of all previously reported cases of HHV-6-induced hepatitis in immunocompetent adults was conducted. Based on the available evidence, an algorithm was designed for the management of HHV-6-associated liver injury. Twenty cases were included, showing a predominance of young women (80%), fever as the most consistent symptom (75%), and a notable association (30%) with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome. Overall, 65% of patients met ALF criteria, and mortality reached 30%. Blood RT-PCR was the most frequently used diagnostic tool (70%), while liver biopsy was performed in 35% of cases. Antiviral therapy was administered in 45% of patients and corticosteroids in 40%, mainly due to coexisting DRESS syndrome or initial suspicion of autoimmune hepatitis. Notably, 25% of patients underwent liver transplantation. The proposed algorithm offers a structured approach to managing HHV-6 in patients with ALF and emphasises the importance of considering it in the differential diagnosis. HHV-6 should be considered in cases of ALF, particularly in young febrile women without an identified aetiology and in patients with concomitant DRESS syndrome. Further studies are needed to validate diagnostic criteria and guide treatment strategies.
The long-term prognosis of immune tolerant (IT) phase patients remains unclear. This study aimed to identify true IT-phase patients with favourable outcomes and distinguish grey-zone IT patients. We retrospectively analy...The long-term prognosis of immune tolerant (IT) phase patients remains unclear. This study aimed to identify true IT-phase patients with favourable outcomes and distinguish grey-zone IT patients. We retrospectively analysed 1064 chronic hepatitis B (CHB) patients (516 clinically inclusive IT, 548 antiviral-treated immune active [AVT-IA]). Clinically inclusive IT-phase was defined as HBeAg-positive, no cirrhosis, HBV DNA ≥ 10^6 IU/mL, and ALT < 80 U/L. Favourable prognosis was defined as the absence of HCC development and IA progression during follow-up. IT-phase patients had significantly lower 10-year HCC rates compared to AVT-IA patients (1.7% vs. 2.7%). Among the clinically inclusive IT group, favourable prognosis was associated with younger age (< 35 years), female gender, stringent low ALT (< 35 U/L for males, < 25 U/L for females), high HBV DNA (> 10^8 IU/mL), and no family history of HCC. Patients meeting these criteria showed no HCC cases and had a lower likelihood of progression to IA (~50%) within 10 years. The strict criteria demonstrated 90.3% specificity for identifying true IT-phase patients within the clinically inclusive IT group. Family history of HCC was an independent risk factor for HCC development (HR 6.059, p = 0.019), while stringent low ALT, younger age, and female gender were linked to lower IA progression risk (HR 0.32, p ≤ 0.001). This study highlights the importance of applying strict criteria in distinguishing true IT-phase patients from grey-zone patients. True IT patients are at minimal risk of HCC or progression to IA, while identifying grey-zone patients is crucial, as they may require early antiviral therapy.
Oltmanns C, Witte M, Wranke A
… +6 more, Deterding K, Wedemeyer H, Falk CS, Kraft ARM, Wiegand SB, Cornberg M
J Viral Hepat
· 2025 Nov · PMID 41090388
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Hepatitis B (HBV) and C (HCV) virus coinfection is linked to a higher risk of cirrhosis and hepatocellular carcinoma (HCC) compared to monoinfection. Despite this, data are limited, and further investigation is needed to...Hepatitis B (HBV) and C (HCV) virus coinfection is linked to a higher risk of cirrhosis and hepatocellular carcinoma (HCC) compared to monoinfection. Despite this, data are limited, and further investigation is needed to understand the underlying mechanisms. While patients are classified based on dominance patterns, the impact on the immune system remains largely unknown. It is recognised that HBV reactivation may occur following HCV clearance. This study aims to explore the potential immune interactivity between HCV and HBV by analysing patterns of soluble immune mediators (SIM). A total of 58 soluble immune mediators were measured in serum or plasma samples of 49 patients chronically infected with hepatitis B and hepatitis C virus in a cross-sectional study design. Patients were classified based on dominance patterns: HBV dominance (n = 8), HCV dominance (n = 22), HBV and HCV codominance (n = 11) and no dominance (n = 8). SIM expression was distinct based on different dominance patterns. HBV activity induced higher SIM expression and altered the soluble inflammatory milieu (22 SIM altered, p < 0.05). Altered pathways included JAK-STAT pathway (p = 1.36 × 10), IL-17 signalling (p = 2.47 × 10) and Th17 cell differentiation (p = 1.69 × 10). CCL27/CTACK (r = -0.69, p = 7.02 × 10) and SDF-1alpha (r = -0.55, p = 0.002) correlated inversely with HCV-RNA. Serologically classifying dominance patterns in HBV and HCV coinfection may manifest in a distinct soluble inflammatory milieu. Elevated HBV activity correlates with an increased expression of soluble immune mediators, particularly influencing the alteration of key signalling pathways such as JAK-STAT and the Th17/IL-17 axis. These changes have a potential role in the development of liver fibrosis.
J Viral Hepat
· 2025 Nov · PMID 41090376
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Although previous modelling work indicates treatment of < 10 people who inject drugs (PWID) per 100 person-years (PY) could achieve hepatitis C virus (HCV) elimination targets in many settings, these models frequently ma...Although previous modelling work indicates treatment of < 10 people who inject drugs (PWID) per 100 person-years (PY) could achieve hepatitis C virus (HCV) elimination targets in many settings, these models frequently make simplifying assumptions of heterogeneity in infection risk. Here, we evaluated the impact of incorporating risk heterogeneity in transmission models on the predicted effects of interventions and the feasibility of HCV elimination in high-burden settings. We built an individual-based model of HCV transmission informed by detailed data from a cohort of PWID in Baltimore, MD, including an individual- and time-varying risk multiplier on the force of infection. We contrasted these risk-informed models to risk-agnostic models, ignoring this heterogeneity, and explored various levels of treatment and harm reduction scale-up from 2020 to 2030. Risk-agnostic models routinely estimated greater reductions in incidence (8%-19% higher for treatment rates of 10-90 per 100 PY) and greater numbers of infections averted per treatment course compared to otherwise equivalent populations modelled with risk heterogeneity. Elimination targets were only achieved in risk-informed models when treating 90 PWID per 100 PY. Expanding harm reduction services dramatically improved the impact of elimination programs, particularly in averting new infections soon after treatment scale-up initiation. Achieving HCV elimination targets among PWID in high-burden settings will require substantial improvements in treatment access and harm reduction services. Models that ignore the unequal distribution of HCV risk, including the correlation between reinfection risk and onward transmission, can result in inappropriately optimistic estimates of the feasibility of elimination.
Hardie DR, Korsman SNJ, Valley-Omar Z
… +4 more, Petersen N, Cable R, Spearman CW, Sonderup M
J Viral Hepat
· 2025 Nov · PMID 41078128
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Improved HCV diagnosis and linkage to care is crucial to achieve WHO 2030 elimination targets. Simplification of diagnostics remains key. We evaluated the performance of Elecsys HCV Duo antigen/antibody immunoassay in pa...Improved HCV diagnosis and linkage to care is crucial to achieve WHO 2030 elimination targets. Simplification of diagnostics remains key. We evaluated the performance of Elecsys HCV Duo antigen/antibody immunoassay in patients using public healthcare in Cape Town, South Africa. 253 HCV seropositive and 214 seronegative samples were tested, and results correlated with standard-of-care (SOC) serology, HCV RNA, viral genotype, patient demographics, and disease markers. Thirteen patients on antiviral therapy were also evaluated. Elecsys HCV Duo antibody was equivalent to SOC serology, while antigen had 100% negative percent agreement in non-viraemic samples. One incident infection with viral load (VL) of 54,000 IU/mL was antigen positive/antibody negative. Overall, antigen detection was 63.2% in RNA-positive samples. VL strongly predicted reactivity, with antigen positive rates of 17.5% (< 5 log IU/mL), 75.8% (5-6 log IU/mL), 89.4% (6-7 log IU/mL), and 100% (> 7 log IU/mL). Detection in genotype-1 infections was significantly better, at 69.6% (95% CI 59.5-79.7) than non-genotype-1 at 43.2% (95% CI 28.7-57.7). In treated patients, antigen mirrored RNA clearance but was only reliable if positive at baseline. Elecsys HCV Duo detected active infection in 63% of viraemic patients, 70% with genotype 1. In our cohort, 49% of new patients would require VL testing.
Xie T, Su M, Cai M
… +8 more, Zhao T, Zhang X, Zhang S, Wang M, Xu Q, Cheng Y, Gao S, Cui F
J Viral Hepat
· 2025 Nov · PMID 41078127
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This study aimed to evaluate the status of hepatitis B virus (HBV) mother-to-child transmission (MTCT) among infants born to hepatitis B surface antigen (HBsAg)-positive mothers from 2021 to 2023 and identify key factors...This study aimed to evaluate the status of hepatitis B virus (HBV) mother-to-child transmission (MTCT) among infants born to hepatitis B surface antigen (HBsAg)-positive mothers from 2021 to 2023 and identify key factors influencing HBV MTCT, providing critical insights to inform future HBV prevention strategies. Data were obtained from the case records of HBsAg-positive pregnant women and their newborns in Guangdong Province from January 1, 2021, to December 31, 2023. For HBsAg and anti-HBs positive rates, bivariate analysis was conducted to examine associations between maternal and infant characteristics. Additionally, Firth's bias reduction logistic regression analysis was conducted to identify factors influencing MTCT. Our study analysed data from 131,781 HBsAg-positive pregnant women and their newborns in Guangdong Province from 2021 to 2023. Among 131,781 infants completing PVST, the overall HBV MTCT rate was 0.44%, with an anti-HBs positivity rate of 93.48%. Maternal age, administration of HepB-BD and HBIG and use of antiviral treatment during pregnancy were significantly associated with HBV MTCT. However, birth weight, maternal education level, mode of delivery and number of births were not significantly associated with HBV MTCT risk. This study provides a comprehensive analysis of HBV MTCT among HBsAg-positive pregnant women and their infants in Guangdong Province from 2021 to 2023. Despite significant advancements in HBV MTCT prevention, our findings underscore the need for enhanced strategies, particularly for pregnant women with high HBV viral loads. Strengthening maternal antiviral treatment, ensuring timely and comprehensive infant follow-up, and implementing targeted health education programs will be essential for further reducing MTCT rates and improving long-term outcomes.
Badia L, Ciancio A, Distefano M
… +2 more, Izzi A, Loglio A
J Viral Hepat
· 2025 Nov · PMID 41074608
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Adherence to treatment is a key determinant of clinical outcomes in chronic infectious diseases, including hepatitis D virus (HDV) infection. Even if bulevirtide (BLV) has shown a promising adherence profile in clinical...Adherence to treatment is a key determinant of clinical outcomes in chronic infectious diseases, including hepatitis D virus (HDV) infection. Even if bulevirtide (BLV) has shown a promising adherence profile in clinical trials, adherence is often compromised by various barriers in the context of HDV-especially among migrant populations. The aim of this study was to investigate the factors influencing adherence to BLV treatment in real-life settings in Italy. From May to September 2024, two anonymous surveys-one for HDV patients undergoing bulevirtide (BLV) treatment and one for their hepatologists-were conducted across five tertiary centers in Italy. The study employed the COM-B model (Capability, Opportunity, Motivation-Behaviour) to systematically explore the behavioural drivers influencing treatment adherence in this population and unmet needs. Of the 86 consecutive adult patients receiving bulevirtide (BLV) who were invited to participate, 83 (97%) completed the multilingual survey (35% > 60 years old, 48% Italians; 80% under BLV > 6 months) and were included in the analysis, together with 13 hepatologists. The findings revealed key challenges related to patient education, logistical access to medication, and psychological factors affecting motivation. Specifically, 10% had considered discontinuing treatment and 10% admitted to having missed doses. A deeper understanding of these multifactorial determinants may aid in the development of targeted interventions to enhance adherence and achieve personalized therapeutic outcomes for individuals living with HDV.
Gonzalez CJ, Perez-Mejia CN, Hernandez N
… +9 more, Kapadia SN, Niederdeppe J, Dharia A, Papalamprakopoulou Z, Talal AH, Lloyd AR, Franco R, Shapiro MF, Wethington E
J Viral Hepat
· 2025 Nov · PMID 41042905
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OBJECTIVE: To identify specialty-specific influences in administering HCV treatment among primary care, gastroenterology/hepatology, infectious diseases, and addiction specialties, and strategies to potentially eliminate...OBJECTIVE: To identify specialty-specific influences in administering HCV treatment among primary care, gastroenterology/hepatology, infectious diseases, and addiction specialties, and strategies to potentially eliminate HCV. STUDY SETTING AND DESIGN: Qualitative study using remote interviews with healthcare providers in New York and Alabama who treated or screened patients for HCV, purposefully sampling for specialty, clinical setting, and HCV treatment experience. Data sources and Analytic Sample: Interviews occurred 9/2021-8/2022. Transcripts were analyzed using a hybrid inductive-deductive approach; a content analysis identified codes arising uniquely within specialties. RESULTS: Thirty-six providers were interviewed: primary care (n = 9), addiction medicine (n = 12), infectious diseases (n = 9), and gastroenterology/hepatology (n = 6). Distinct challenges and facilitators emerged across specialties. Primary care and addiction providers similarly emphasized the convenience and usual practice of referring patients to specialists for HCV treatment, while infectious disease and gastroenterology noted challenges with patients not completing the referrals. Primary care providers expressed wanting training and peer support related to treatment provision. Addiction providers described structural barriers, such as lacking on-site phlebotomy services and patients' competing health concern prioritization, but highlighted strategies to improve treatment access, including trust-building. Infectious disease providers highlighted using patient navigators to overcome logistical barriers, while gastroenterologists emphasized collaborative relationships, particularly with addiction specialists. Specialty-specific opportunities emerged regarding training, collaboration, navigation, and infrastructure. CONCLUSIONS: Eliminating HCV requires addressing specialty-specific concerns for providers managing HCV. Potential opportunities include dissemination of specialty-tailored training, facilitating interdisciplinary care and desired cross-specialty collaborations, and overcoming unique infrastructural needs. Future research should evaluate implementation strategies addressing these specialty-specific needs.
J Viral Hepat
· 2025 Nov · PMID 41017776
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People who inject drugs (PWID) are highly affected by hepatitis C (HCV) worldwide, particularly in low- and middle-income countries (LMICs), where access to addiction services is often limited. Reducing the burden of HCV...People who inject drugs (PWID) are highly affected by hepatitis C (HCV) worldwide, particularly in low- and middle-income countries (LMICs), where access to addiction services is often limited. Reducing the burden of HCV, as promoted by WHO, requires effective interventions in this high-risk population. Here, we report the safety and efficacy of a pangenotypic generic HCV treatment among PWID in Vietnam, using a sofosbuvir/daclatasvir regimen. PWID were screened for HCV at two community-based organisations (CBO) premises in Haiphong during both a respondent-driven sampling survey and cohort follow-up visits. PWID with detectable HCV RNA were referred to three public hospitals for a 12-week regimen of generic sofosbuvir/daclatasvir, with ribavirin if cirrhosis, and with CBO support for referral and adherence. Treatment safety was assessed over the course of treatment and success was measured by sustained virologic response 12 weeks after the end of treatment (SVR12). Of the 1201 PWID screened with detectable HCV RNA, 1021 were enrolled: 96% male, median age 42 years, 45% HIV-infected, 16% with advanced liver fibrosis, 55% currently injecting, and 71.5% on methadone maintenance therapy (MMT). In total, 979 participants started HCV treatment, and 901 of the 924 participants tested at SVR12 (98%) were cured. Genotype 3, current drug use, lack of MMT, and HIV infection were independently associated with treatment failure. High HCV cure rates can be achieved among PWID in LMICs such as Vietnam using a simple model of care, including a pangenotypic generic direct-acting antiviral combination and CBO support. Trial Registration: ClinicalTrials.gov identifier: NCT03537196.