Journal Of Viral Hepatitis[JOURNAL]
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200 papers
Outcomes of Assisted Reproductive Technology in Women With Hepatitis B Infection.
Hu X, Wan S, Yan H … +4 more , Tang M, Feng G, Liu A, Zhu Y
J Viral Hepat · 2025 Jul · PMID 40536387 · Publisher ↗
Hepatitis B virus (HBV) infection remains a global public health problem. To investigate whether HBV infection in women with different serostatus affects the outcomes of assisted reproductive technology (ART). This study...
Hepatitis B virus (HBV) infection remains a global public health problem. To investigate whether HBV infection in women with different serostatus affects the outcomes of assisted reproductive technology (ART). This study included a total of 9891 infertile couples, comprising 1670 couples with HBV-infected women and 8221 couples without HBV infection, all undergoing ART treatments during the same period. None of the male partners had chronic HBV infection. Three groups were defined: HBV-positive, HBeAg/preS1-positive and HBV-negative groups. Pregnancy outcomes were evaluated and compared using multivariate logistic regression analysis to control for confounding factors. Decreased rates of implantation, clinical pregnancy and live birth were observed in women with HBeAg/preS1-seropositive status. Following multivariate adjustment for potential confounders, the live birth and clinical pregnancy rates in the HBeAg/preS1-positive group were still significantly lower than those in the HBV-negative group, with adjusted odds ratios of 0.86 (95% CI, 0.75-0.99) and 0.84 (95% CI, 0.73-0.96), respectively. No significant difference was observed between the HBV-positive and HBV-negative groups. Additionally, no differences were found in the miscarriage rate or preterm rate among the three groups. Women who were HBsAg- or HBeAg/preS1-seropositive exhibited a significantly higher incidence of secondary and tubal factor infertility compared to those without HBV infection. Overall HBV infection in women increases the risk of secondary infertility and tubal factor infertility, and female HBeAg/preS1-seropositive status adversely affects live birth and clinical pregnancy outcomes. The effect is likely attributed to the active HBV infection.
Long Term Clinical Outcomes in Chronic Hepatitis C Patients Who Achieved SVR Following DAAs: A Decade Long Prospective Study.
Shiha G, Helmy A, Mikhail N … +6 more , Hassan A, Elkerdawy H, Badawy G, El Maghrabi H, El-Domiaty N, Soliman R
J Viral Hepat · 2025 Jul · PMID 40511633 · Publisher ↗
The long-term impact of direct-acting antivirals (DAAs) in chronic hepatitis C virus (HCV) patients remains debated. This study evaluates all-cause mortality, hepatocellular carcinoma (HCC), and decompensated cirrhosis i...
The long-term impact of direct-acting antivirals (DAAs) in chronic hepatitis C virus (HCV) patients remains debated. This study evaluates all-cause mortality, hepatocellular carcinoma (HCC), and decompensated cirrhosis in DAAs-treated patients enrolled in the 'Educate, Test, and Treat' programme. This prospective observational study included HCV patients treated at the Egyptian Liver Research Institute and Hospital (ELRIAH) from 2015 to 2018. Participants were recruited from 12 villages and followed until the end of 2024. Exclusions included decompensated liver disease, hepatitis B virus (HBV)/human immunodeficiency virus (HIV) co-infection, prior HCC, or severe comorbidities. Follow-up included clinical, biochemical, ultrasound, and liver stiffness measurements (LSM). Primary outcomes were all-cause mortality, HCC, and decompensated cirrhosis. Kaplan-Meier curves and Cox models analyse data. Of 3328 eligible patients, follow-up data were available for 3017 (53% male, mean follow-up: 84.5 ± 28.9 months). Advanced fibrosis (F3-F4) was present in 1125 (37.3%). The study recorded 593 deaths (2.58/100 person-years), 271 HCC cases (1.24/100 person-years), and 281 decompensated cirrhosis cases (1.30/100 person-years). Advanced fibrosis was associated with increased mortality (HR: 1.72, 95% CI: 1.46-2.03, p < 0.001) and decompensation (HR: 2.23, 95% CI: 1.74-2.85, p < 0.001) but not HCC (HR: 1.17, 95% CI: 0.92-1.49, p = 0.192). Fibrosis reversed in 11.9%, improved in 17.8%, remained stable in 50.5%, and progressed in 19.8%. This decade-long study confirms DAAs improve liver function, reduce mortality, and slow disease progression, reinforcing their role in preventing long-term complications.
The Efficacy and Sustainability of an Implementation Intervention (FOCUS Program) on Linkage to Hepatitis C Care Time at a Community Health Center in the Deep South: A Longitudinal Study Based on Electronic Medical Records.
Adebajo A, Qiao S, Esu I … +2 more , Olatosi B, Li X
J Viral Hepat · 2025 Jul · PMID 40511626 · Full text
People with hepatitis C should be identified and promptly linked to care after diagnosis to eliminate hepatitis C virus (HCV) infection by 2030. An implementation intervention, an HCV screening and linkage to care interv...
People with hepatitis C should be identified and promptly linked to care after diagnosis to eliminate hepatitis C virus (HCV) infection by 2030. An implementation intervention, an HCV screening and linkage to care intervention, the FOCUS program, highlighted by four pillars (normalisation of routine testing, promotion of testing based on electronic medical records [EMR], procedure overseen by linkage coordinator, and quality improvement training/feedback among staff), has been conducted in a community health center in South Carolina from 2018 to 2020. We aim to assess the impacts of this intervention on linkage to care time and its sustainability. We analysed a cohort (n = 593) of adults who tested positive for hepatitis C infection, all of whom received hepatitis C care services from the Cooperative Health Center (January 2015 to March 2023) from the EMR data. Descriptive analysis was employed for outcome (linkage to care days [LTC days]) and sociodemographic variables (i.e., race, sex, age, health insurance). We compared the sociodemographic and average LTC days among pre-intervention (2015-2017), during-intervention (2018-2020), and post-intervention (2021-2023) phases. Multivariate linear regressions were conducted on LTC days and intervention phases, controlling for relevant covariates. Most (59.5%) of the participants were 45 to 64 years of age. Sixty percent were males, and 57% were African Americans. Around 45% of the participants did not have health insurance. The mean LTC days at pre-intervention were 66.68 (SD = 72.29). LTC days reduced by 31 days during the intervention compared to pre-intervention (ß = -31.21, p < 0.001). Similarly, in the post-intervention phase, LTC days reduced by 30 days compared to pre-intervention (ß = -29.96, p < 0.001). Age was associated with LTC days, with middle-aged people (45-64 years) having the longest LTC days. Our study suggests that the intervention had a robust immediate effect, which was maintained in the post-intervention period, thus highlighting its lasting impact. Since its implementation, the FOCUS program has significantly shortened the days of linkage to care for people with hepatitis C. We noted the positive impacts across the different demographics studied. More importantly, the impacts were sustainable through the COVID-19 pandemic. We need future efforts to engage middle-aged groups to further reduce the hepatitis C LTC days.
Impact of Universal Screening for HDV in HBV-Infected Patients on Chronic HDV Detection Rate in Israel.
Yardeni D, Cividalli O, Itkowitz B … +7 more , Lipnizkiy I, Juma'a AA, Abufreha N, Keren-Naus A, Eisner N, Shor AN, Etzion O
J Viral Hepat · 2025 Jul · PMID 40497662 · Full text
Hepatitis delta virus (HDV) and hepatitis B virus (HBV) co-infection is considered a progressive chronic viral hepatitis where treatment options are limited and significant morbidity and mortality are prevalent. Studies...
Hepatitis delta virus (HDV) and hepatitis B virus (HBV) co-infection is considered a progressive chronic viral hepatitis where treatment options are limited and significant morbidity and mortality are prevalent. Studies have shown insufficient testing for HDV antibody (anti-HDV) among HBV-infected patients. Unlike European and Asian-Pacific guidelines, the American Association for the Study of Liver Diseases (AASLD) guidelines recommend HDV testing only for high-risk HBV patients. We evaluated the efficacy of universal vs. risk-based screening in identifying HDV infection among HBV patients. We performed a retrospective analysis of patients diagnosed with a positive HBsAg in a tertiary medical center and screened for HDV between 2010 and 2022. 761 patients were found to be HBsAg-positive. 525 (69%) patients met AASLD criteria for HDV screening (high-risk) and 236 (31%) did not (low-risk). Universal screening was performed on 559 (73.4%) patients. In the high-risk group, anti-HDV positivity was found in 33 patients (8.6%). 17 (51.5%) were found to be HDV RNA-positive. In the low-risk group, 4 (2.3%) were found to be anti-HDV-positive. None were found to be HDV RNA-positive. Screening based on AASLD criteria identified only 89% of HDV antibody-positive patients. During the study period, an increased rate of all-cause mortality was observed in the AASLD high-risk group. In this single-center study, universal screening of HBsAg-positive patients identified 11% more anti-HDV-positive patients in comparison to the AASLD-supported high-risk-only screening recommendations. Due to the paramount importance of HDV detection, universal HDV screening in HBsAg-positive patients is encouraged.
Prospective Evaluation of Blood Borne Virus Testing in Custody Suites in North-East England.
Rayner D, McCullough F, McQue K … +5 more , Jones K, Allsop C, Bell J, Miller C, McPherson S
J Viral Hepat · 2025 Jul · PMID 40492648 · Full text
Drug-related crime is a common reason for arrest. Therefore, some arrested individuals are at risk of hepatitis C virus infection (HCV). We present the outcomes of a blood borne virus (BBV) testing programme in custody s...
Drug-related crime is a common reason for arrest. Therefore, some arrested individuals are at risk of hepatitis C virus infection (HCV). We present the outcomes of a blood borne virus (BBV) testing programme in custody suites in North-East England. Individuals reviewed in healthcare departments of three custody suites were offered dry blood spot BBV testing for HCV, hepatitis B (HBV) and human immunodeficiency virus (HIV) between July 2021 and June 2024. Data were collected prospectively on numbers tested, virology results and treatment outcomes. In total, 582 had BBV testing (508 [87%] valid HCV antibody and HCV RNA tests). Overall, 13% (64) had a detectable HCV antibody and 6% (31) had detectable HCV RNA indicating active HCV infection. Of these, 12 (39% of HCV RNA positive; 2.3% of all tested) were newly identified infections. Twenty-four individuals (77%) commenced antiviral treatment. Six individuals did not start antiviral treatment because of non-engagement, and one is in treatment workup. Of the 33 HCV antibody-positive, but RNA-negative individuals, 20 (61%) had previous antiviral treatment and achieved SVR, nine (27%) were thought to have spontaneously cleared the infection and four (12%) were on treatment at the time of testing. There were no cases of HBV or HIV identified. Dry blood spot testing for BBVs in custody suites is feasible and identifies a high proportion with active HCV infection, with the majority commencing antiviral treatment. Viral hepatitis services should consider expanding BBV testing to custody suites to help work towards HCV elimination.
Scoping Review on Strategies for Safe Nucleot(s)ide Analogue Discontinuation and Optimising Functional Cure in Chronic Hepatitis B.
Maung ST, Chaiteerakij R
J Viral Hepat · 2025 Jul · PMID 40478218 · Publisher ↗
Chronic hepatitis B (CHB) remains a global health challenge, contributing to significant morbidity and mortality. While long-term nucleos(t)ide analogue (NA) therapy effectively suppresses viral replication, achieving a...
Chronic hepatitis B (CHB) remains a global health challenge, contributing to significant morbidity and mortality. While long-term nucleos(t)ide analogue (NA) therapy effectively suppresses viral replication, achieving a functional cure remains rare. Current treatment guidelines primarily recommend indefinite therapy. However, long-term NA use poses many challenges, prompting interest in finite therapy. Recent studies suggest that carefully selected patients may safely discontinue NAs, leading to a functional cure in some cases. This review evaluates the latest evidence on NA discontinuation, highlighting key factors influencing outcomes. This review synthesises established and emerging evidence on NA discontinuation in CHB. It explores early studies that identified quantitative HBsAg (qHBsAg) as a predictor of sustained response and HBsAg seroclearance, followed by systematic reviews and meta-analyses reinforcing finite therapy as a feasible approach. Advances in predictive modelling, incorporating biomarkers, have refined patient selection for safe NA withdrawal. Additionally, this review assesses the risks associated with NA discontinuation, highlighting the importance of identifying high-risk patients for hepatic decompensation. Ethnicity-specific qHBsAg cut-offs are also discussed, recognising variations in treatment response between Asian and Caucasian populations. Finite NA therapy is emerging as a viable approach for achieving functional cure. Future strategies should integrate liver fibrosis assessment to enhance patient selection before NA discontinuation. Optimising re-treatment approaches requires balancing timing, immune response, and qHBsAg kinetics to maximise HBsAg seroclearance. Clinical perspectives on NA discontinuation remain a key research priority, necessitating standardised guidelines and improved post-NA monitoring strategies to ensure safe and effective finite therapy in CHB management.
COVID-19 and Liver Injury, Beyond the First Pandemic Waves: Clinical and Immune-Virological Features.
Foroghi Biland L, Di Lorenzo A, De Maria F … +8 more , Muratore G, Compagno M, Campogiani L, Coppola L, Teti E, Malagnino V, Iannetta M, Sarmati L
J Viral Hepat · 2025 Jul · PMID 40470910 · Full text
A liver involvement in Coronavirus disease 19 (COVID-19) has been frequently observed in patients hospitalised for severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) infection during 2020; in such cases, the cl...
A liver involvement in Coronavirus disease 19 (COVID-19) has been frequently observed in patients hospitalised for severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) infection during 2020; in such cases, the clinical and prognostic relevance of hepatocellular damage has been widely acknowledged. On the other hand, there is less extensive evidence of liver injury (LI) in the subsequent waves of the COVID-19 pandemic. The aim of this study was to assess the prevalence of LI and to determine the clinical, biochemical, and immune-virologic characteristics associated with its development in SARS-CoV-2-positive patients hospitalised in 2021-2022. This single-centre retrospective study included 455 patients with confirmed SARS-CoV-2 infection and respiratory failure. LI was defined by the detection of transaminase levels exceeding three times the upper limit of normality (ULN) and was further classified as early or late liver injury based on whether the peak transaminase value occurred within or after 7 days from hospital admission. LI was found in 17.6% (80/455) of the overall cohort, while early liver injury (ELI) and late liver injury (LLI) were detected in 10.4% and 11.5%, respectively. LI was associated with younger age, elevated inflammatory and tissue damage markers, with the presence of chronic liver disease (CLD), and with the use of interleukin-6 (IL-6) inhibitors. Patients with LI had a higher probability of severe COVID-19, transfer to intensive care unit, and in-hospital death than those without. In multivariable analysis, younger age, administration of IL-6 inhibitors, and the presence of higher gammaglutamyl transferase (GGT) levels were independently related to the development of overall LI, whereas in-hospital mortality was independently correlated with the occurrence of LLI. The occurrence of hepatocellular damage therefore has been associated with a pro-inflammatory profile and with worse overall outcomes but not with increased likelihood of liver failure or liver-related mortality.
A Person-Centered Hepatitis B Approach Using the COM-B Model to Understand Barriers and Facilitators of Hepatitis B Testing, Management and Treatment.
Freeland C, Plunkett Q, Sirapu S … +1 more , Cohen C
J Viral Hepat · 2025 Jul · PMID 40470888 · Publisher ↗
Over 250 million individuals live with chronic hepatitis B worldwide. More work is needed to address care gaps associated with chronic hepatitis B. Behavioural theories can assist in understanding gaps and aid in the dev...
Over 250 million individuals live with chronic hepatitis B worldwide. More work is needed to address care gaps associated with chronic hepatitis B. Behavioural theories can assist in understanding gaps and aid in the development of effective interventions to reach elimination goals. Using the COM-B model, a sample of HBV-related direct messages from social media platforms from 2021 to 2023 was collected from individuals directly impacted by hepatitis B. Qualitative analysis was employed for social media messages using a guided codebook and the COM-B model. A sample of 168 unique data points were analysed using thematic analysis. The themes that emerged corresponded to five COM-B subcomponents and represented barriers relating to psychological capability, physical opportunity, social opportunity, reflective motivation and automatic motivation. Within each of the five subcomponents were subthemes, such as limited knowledge; challenges accessing diagnostics, expert care, clinical trials, and treatment; as well as the social and cultural impacts of stigma, discrimination and quality of life. Future hepatitis B interventions should focus on addressing identified gaps and consider behavioural interventions as methods to address identified barriers. While this study further validated previously identified barriers, it also newly identified motivation among those with hepatitis B to seek out information related to care, management and prolonging life.
Unhealthy Behaviours and All-Cause Mortality Among People With Chronic Hepatitis B, With and Without Hepatitis Delta (ANRS CO22 HEPATHER).
Ramier C, Carrat F, Beo VD … +7 more , Parlati L, Lotto M, Marcellin F, Protopopescu C, Carrieri P, Bourliere M, ANRS/AFEF HEPATHER study group
J Viral Hepat · 2025 Jul · PMID 40448453 · Full text
People infected with both hepatitis B virus (HBV) and hepatitis Delta virus (HDV) face a higher mortality risk than those mono-infected with HBV. As unhealthy behaviours can influence liver disease progression, we compar...
People infected with both hepatitis B virus (HBV) and hepatitis Delta virus (HDV) face a higher mortality risk than those mono-infected with HBV. As unhealthy behaviours can influence liver disease progression, we compared the effects of various behavioural factors on all-cause mortality among people with chronic hepatitis B (CHB), with or without chronic hepatitis Delta (CHD). We used 5-year follow-up data from people with CHB participating in the French ANRS CO22 HEPATHER cohort. A Cox proportional hazards model helped determine whether the pattern of risk factors for all-cause mortality differed according to CHD status. Of the 3884 people included, 183 had CHD and 154 died during follow-up. After multivariable adjustment, daily soft drink consumption significantly increased mortality risk in people with CHD and almost reached significance in those without CHD (adjusted hazard ratio (aHR) [95% CI]: 6.09 [2.40-15.48], p < 0.001, and 1.58 [0.97-2.56], p = 0.066 respectively). Moreover, past or current unhealthy alcohol use and tobacco smoking were both associated with a higher risk of mortality in all people with CHB (1.74 [1.09-2.79], p = 0.020, and 1.61 [1.13-2.31], p = 0.009 respectively). Daily soft drink consumption significantly increased all-cause mortality in people with CHD. Unhealthy alcohol use and tobacco smoking were associated with a higher mortality risk in all people with CHB. Education about healthy eating and support for smoking cessation and alcohol reduction could greatly improve health and survival of people with CHB, with and without CHD.
Leading Role of Sofosbuvir/Daclatasvir in Achieving Hepatitis C Elimination in Egypt.
Elbaz T, Al-Naamani K, Abosheaishaa H … +2 more , Alswat K, El-Kassas M
J Viral Hepat · 2025 Jul · PMID 40433912 · Publisher ↗
Chronic hepatitis C virus (HCV) management has historically been challenging, particularly in Egypt, the country with the highest global disease prevalence. The introduction of direct-acting antivirals (DAAs) has revolut...
Chronic hepatitis C virus (HCV) management has historically been challenging, particularly in Egypt, the country with the highest global disease prevalence. The introduction of direct-acting antivirals (DAAs) has revolutionised treatment, providing high rates of sustained virologic response (SVR) with fewer adverse events compared to previous therapies. In Egypt, the locally produced generics of sofosbuvir/daclatasvir (SOF/DAC) have been integral to the national HCV elimination programme, treating millions effectively and affordably, demonstrating similar efficacy and safety to brand-name drugs. Although not currently present in most international guidelines, this cost-effective regimen offers a viable option for large-scale elimination programmes similar to Egypt's successful experience. This review synthesises real-world Egyptian data and highlights the efficacy and safety of the SOF/DAC combination in various population groups. High sustained virological response (SVR) rates were observed across diverse patient populations, including those with advanced liver disease. However, limitations regarding long-term follow-up, especially HCC surveillance, were identified, underscoring the need for further research. Additionally, the review underscores the success of local Egyptian pharmaceutical policies in reducing treatment costs and securing access for all infected individuals. The Egyptian experience offers valuable insights into the potential for replicating its success, particularly in other high-burden regions.
Increasing Treatment Uptake for Chronic Hepatitis B in South America: A Comparative Analysis of Country-Specific and WHO 2024 Guidelines.
Mendizabal M, Sabate CD, González Ballerga E … +29 more , Gruz F, Ridruejo E, Soza A, Poniachik J, Vergara G, Mainardi V, Mezzano G, Bessone F, Anders M, Pessoa MG, Cairo F, Chiodi D, Dirchwolf M, Cheinquer H, Susana M, Rondeau L, Rifrani G, Aguirre H, Hernandez N, Enrique C, Navarro L, Labaronnie E, Zitelli PM, de Araujo A, Olivetti A, Simian D, Giunta D, Silva M, Marciano S
J Viral Hepat · 2025 Jun · PMID 40418118 · Publisher ↗
The 2024 WHO guidelines for chronic hepatitis B (CHB) aim to expand and simplify treatment eligibility. We aimed to estimate treatment eligibility and uptake according to country-specific guidelines and evaluate treatmen...
The 2024 WHO guidelines for chronic hepatitis B (CHB) aim to expand and simplify treatment eligibility. We aimed to estimate treatment eligibility and uptake according to country-specific guidelines and evaluate treatment expansion based on the WHO guidelines. Treatment-naïve CHB patients from Argentina, Brazil, Chile and Uruguay referred to evaluation between January 2010 and June 2024 were retrospectively included. Treatment candidacy was evaluated according to both country-specific and WHO guidelines. A total of 719 patients with CHB, treatment naïve, were included (67.1% male; median age: 50.4 years; HBeAg-positive: 36.3%). The median HBV-DNA level was 43,000 (IQR 633-110,000,000) IU/mL, median ALT was 41 (IQR 23-99) U/L, 47.0% had an APRI > 0.5 and 21.1% had cirrhosis. According to country-specific guidelines, 56.9% (95% CI: 53.2-60.5) met the criteria for treatment. Antiviral treatment was initiated in 84.3% of eligible patients. The proportion of patients meeting treatment criteria under the WHO guidelines increased to 67.3% (95% CI: 63.8-70.6), resulting in a 10.4% (95% CI: 8.1-12.8) increase in treatment candidacy. Treatment expansion was significantly higher in women (15.2%; 95% CI: 10.2-20.1) than in men (8.1%; 95% CI: 5.4-10.7). According to WHO guidelines, a considerable proportion of CHB patients who do not meet country-specific criteria are eligible for antiviral therapy. Implementing WHO criteria can enhance treatment rates and advance efforts toward CHB elimination.
Universal HCV Screening in Hospitalised Patients in France: It Could Be a Good Option! The DEVICHO Study.
Si Nafa SA, Benali S, Penaranda G … +13 more , Deuffic-Burban S, Madau M, Lecomte L, Valle G, Thibault S, Chailloux C, Oules V, Dassetto C, Sellier F, Pietri O, Castellani P, Adhoute X, Bourlière M
J Viral Hepat · 2025 Jun · PMID 40396649 · Full text
In France, chronic hepatitis C whatever fibrosis stage or comorbidities can be freely treated by any physician. However, screening is still currently based on risk factors, and universal screening remains controversial....
In France, chronic hepatitis C whatever fibrosis stage or comorbidities can be freely treated by any physician. However, screening is still currently based on risk factors, and universal screening remains controversial. The aims of this prospective DEVICHO study were to assess the value of universal screening in hospitalised patients, to evaluate the prevalence of HCV infection and to compare the short-term cost and benefit of this strategy with routine screening. From November 2019 to November 2021, all hospitalised patients from 22 departments were asked by their physicians to be tested for HCV. 4986/25,663 (19.4%) in the DEVICHO study (Group 1) and 1803 patients (7%) outside the study (Group 2) were screened. HCV screening rate varied widely (0%-75.1%) between departments. One hundred and ninety-nine patients (2.9%) were HCV-Ab positive. 29/199 HCV-Ab positive patients (14.6%) or 29/6789 patients tested (0.4%) were HCV-RNA positive. Among the 29 viremic patients, 9 (31%) were treated, all achieving sustained virological response, but two patients died rapidly after treatment. Seventeen patients died untreated within a year of diagnosis, and three patients were not treated. Universal screening compared to routine practice would be more expensive and more effective, resulting in an additional cost of €11,060 per HCV RNA infection identified and €36,600 per HCV cure, both below the GDP per capita of France (€38,000, Eurostat 2023). Even if the population screened is older, often with significant comorbidities, hospital-based HCV screening is efficient because its prevalence is higher in hospitalised patients than in the general population. Additionally, this screening strategy appears to be cost effective. However, healthcare professionals and insufficient linkage to care are the main barriers to screening. Trial Registration: ClinicalTrials.gov identifier: NTC 04437277.
Droplet Digital PCR: A Powerful Tool for Accurate Quantification of Hepatitis D Virus RNA Levels and Verification of Detection Limits.
Sandmann L, Windzio L, Bremer B … +7 more , Falak S, Beheim-Schwarzbach J, Kummrow A, Cornberg M, Wedemeyer H, Maasoumy B, Valiente E
J Viral Hepat · 2025 Jun · PMID 40372088 · Full text
Reliable quantification of hepatitis D virus (HDV) RNA levels is necessary for initiating and guiding antiviral treatment. The aim of this work is to develop and validate a digital PCR method for the accurate quantificat...
Reliable quantification of hepatitis D virus (HDV) RNA levels is necessary for initiating and guiding antiviral treatment. The aim of this work is to develop and validate a digital PCR method for the accurate quantification of HDV RNA, including evaluation of its clinical accuracy, especially for low-concentrated clinical samples. The reverse transcription digital PCR (RT-dPCR) development followed the standard procedure, including primer design, determination of linearity, calculation of recovery and the intermediate precision of the RNA extraction kits, determination of the limit of detection (LOD) and quantification (LOQ), droplet size measurements, conversion factor, and uncertainty budget. The World Health Organisation (WHO)-HDV international standard was used for RT-dPCR development. Commutability of the new method was explored, comparing RT-dPCR with quantification assays applied in clinical routine using clinical plasma samples covering a range of HDV RNA concentrations. The conversion factor from copies/mL to IU/mL was 0.77. LOD and LOQ of the RT-dPCR were 0.7 copies/mL (0.56 IU/mL) and 10 copies/mL (8 IU/mL), respectively. When evaluating the qualitative results of the clinical HDV samples at low concentrations, 31% of the HDV clinical samples tested negative by RT-qPCR were tested positive by RT-dPCR. The RT-qPCR and RT-dPCR quantitative data showed a good correlation with a standard deviation of ±1.12 log IU/mL. RT-dPCR is an accurate method for HDV RNA quantification that may serve as a complement to RT-qPCR, especially when accurate detection is essential for decision making in clinical settings.
Chronic Hepatitis B Patients Referred for Liver Transplantation After Nucleos(t)ide Analog Cessation.
Hirode G, Kilany M, Pi S … +8 more , Kim A, Bhat M, Van Uum R, Lilly LB, Hansen BE, Feld JJ, Selzner N, Janssen HLA
J Viral Hepat · 2025 Jun · PMID 40372086 · Full text
Nucleos(t)ide analogs (NAs) provide prolonged viral suppression with favourable clinical outcomes in chronic hepatitis B (CHB) patients. Characterisation of adverse hepatic events after NA cessation leading to liver tran...
Nucleos(t)ide analogs (NAs) provide prolonged viral suppression with favourable clinical outcomes in chronic hepatitis B (CHB) patients. Characterisation of adverse hepatic events after NA cessation leading to liver transplantation (LT) is vital to the improvement of patient management and safety considerations. This is a retrospective case series of CHB patients who developed hepatic decompensation due to NA discontinuation and were referred for LT. Patients with hepatocellular carcinoma or coinfection were excluded. Of 11 CHB patients included (81.8% clinical jaundice, 63.6% ascites, 54.5% hepatic encephalopathy and 18.2% variceal bleeding), 45.5% underwent LT, 36.4% were waitlisted (1 active, 1 died, 2 delisted of whom 1 died), and 18.2% died after referral during the assessment period. Median age was 55.1 years, 81.8% were male, and 72.7% had cirrhosis at NA cessation. Reasons for NA withdrawal included nonadherence (81.8%) and physician discretion (18.2%). Median time from NA cessation to a decompensating event was 3.2 months, and from the decompensating event to referral was 16.0 days. This study shows that most patients experience decompensations soon after NA cessation and reinforces that patients should not discontinue treatment themselves. Physicians should very carefully select non-cirrhotic, adherent patients for NA withdrawal, after which close monitoring and timely retreatment are crucial.
Identifying Risk Factors for Hepatocellular Carcinoma in Patients With Delta Hepatitis: A Prognostic Study.
Iacob S, Chitul M, Stan D … +6 more , Gheorghe D, Grasu M, Iacob R, Gheorghe C, Popescu I, Gheorghe L
J Viral Hepat · 2025 Jun · PMID 40358124 · Full text
Given that delta hepatitis is associated with a 2-6 times higher risk for hepatocellular carcinoma (HCC) compared to HBV monoinfection, we aimed to identify the negative prognostic factors for complications associated wi...
Given that delta hepatitis is associated with a 2-6 times higher risk for hepatocellular carcinoma (HCC) compared to HBV monoinfection, we aimed to identify the negative prognostic factors for complications associated with HDV infection (particularly HCC) and to validate BEA score as a screening tool for HCC in HDV. Our retrospective single centre study included all consecutive admissions of adult patients with chronic HDV infection in the period 01.01.2021-31.12.2022. The negative prognostic factors identified were higher MELD (p < 0.0001) and higher BEA score on admission (p < 0.0001), older age on HBV diagnosis (p < 0.0001) and advanced fibrosis when PegINF was administered (p = 0.01). Good prognostic factors were: Class A-BEA score (p = 0.001), normal platelet count (p = 0.00001), normal albumin level (p = 0.001) and prior treatment with PegInf (p = 0.01). ROC curve showed 78.5% sensitivity for BEA score > 2, validating it as a potential screening tool for HCC. Hence, for patients with BEA score > 2 imaging screening should be intensified in order to early diagnose HCC and prompt access to curative treatment. Additionally, the negative prognostic factors identified (MELD > 15, advanced fibrosis when treated with PegINF or diagnosis with HBV infection at an older age) should encourage more frequent monitoring for HCC compared to local guidelines recommendations.
Host Factor SRSF7 Promotes HBV Replication Through Binding to and Stabilising Viral pgRNA.
Peng Y, Song Y, Liu X … +5 more , Du X, Zhou Z, Yu G, Chen X, Lu F
J Viral Hepat · 2025 Jun · PMID 40343745 · Publisher ↗
Hepatitis B virus (HBV) is the primary etiological agent of chronic hepatitis B (CHB) infection, posing a serious threat to human health. The pregenomic RNA (pgRNA) of HBV is the template for HBV reverse transcription, a...
Hepatitis B virus (HBV) is the primary etiological agent of chronic hepatitis B (CHB) infection, posing a serious threat to human health. The pregenomic RNA (pgRNA) of HBV is the template for HBV reverse transcription, and the epsilon stem-loop (ε) is required for nucleocapsid assembly. The host factor serine/arginine (SR)-rich splicing factor 7 (SRSF7) is a splicing regulator and RNA-binding protein that was involved in regulating viral RNA splicing and export from the nucleus during the viral life cycle, but its biological function and regulatory mechanisms in HBV remain unclear. In this study, SRSF7 was found to promote HBV replication and upregulate HBV RNA levels through knockdown or overexpression of SRSF7 in different cell lines using the HBV replication model. Surprisingly, we found that SRSF7 enhanced HBV RNA stability at the post-transcriptional level, rather than regulating its splicing. We further demonstrated that SRSF7 could bind to pgRNA; deletion of the bulge and loop structures of the ε element significantly reduced its binding capacity. In addition, we confirmed that SRSF7 supports HBV replication in CHB patients. Our study suggests that the host factor SRSF7 promotes HBV replication, which provides new perspectives for further elucidation of HBV-host interactions and the development of host-targeted anti-HBV drugs.
Efficacy of Traditional Chinese Medicine External Therapies in Treating Insomnia in Patients With Chronic Hepatitis B: Systematic Review and Meta-Analysis.
Xu C, Yin DH, Han JH … +3 more , Gao YN, Li XH, Wang XJ
J Viral Hepat · 2025 Jun · PMID 40332371 · Publisher ↗
To systematically evaluate the efficacy of traditional Chinese medicine (TCM) external therapies in treating insomnia in patients with chronic hepatitis B (CHB). PubMed, Embase, Cochrane Library, Web of Science, CNKI, Wa...
To systematically evaluate the efficacy of traditional Chinese medicine (TCM) external therapies in treating insomnia in patients with chronic hepatitis B (CHB). PubMed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang, CQVIP and SinoMed were searched for randomised controlled trials (RCTs) on the treatment of insomnia in patients with CHB using TCM external therapies from the establishment of each database until 31 January 2024. A total of six Chinese articles were included, involving 500 patients. The overall response rate of TCM external therapies for CHB combined with insomnia was superior to that of the control group (odds ratio [OR] = 3.08, 95% confidence interval [CI]: [1.86, 5.12], p < 0.001). Additionally, subgroup analysis showed significant effects of acupuncture (OR = 3.51, 95% CI: [1.80, 6.86], p = 0.001) and other external therapies (OR = 2.58, 95% CI: [1.19, 5.62], p = 0.02). Moreover, TCM external therapies substantially improved the Pittsburgh Sleep Quality Index (mean difference [MD] = -2.08, 95% CI: [-2.86, -1.29], p < 0.001) and the Insomnia Severity Index (MD = -3.17, 95% CI: [-4.07, -2.26], p < 0.001). The group using TCM external therapies showed significantly lower SAS scores than the control group (MD = -6.52, 95% CI: [-12.23, -0.82], p = 0.02). One study reported a higher incidence of adverse reactions in the group treated with TCM external therapies than in the control group (p < 0.05). Another study found that the group treated with TCM external therapies had a significantly lower recurrence rate (15.38%) than the control group (35.90%) (p < 0.05). Traditional Chinese medicine external therapies are clinically effective for CHB combined with insomnia, as they can improve sleep quality and relieve insomnia symptoms.
Epidemiological Burden of Hepatitis Delta Virus in the United States.
Marlowe EM, Swanson BE, Realegeno SE … +3 more , Meyer WA, Gish R, Kagan RM
J Viral Hepat · 2025 Jun · PMID 40298139 · Publisher ↗
Hepatitis D virus (HDV) affects nearly 5% of people globally who are chronically infected with hepatitis B virus, according to the World Health Organisation. The prevalence of HDV in the United States is considered lower...
Hepatitis D virus (HDV) affects nearly 5% of people globally who are chronically infected with hepatitis B virus, according to the World Health Organisation. The prevalence of HDV in the United States is considered lower than in other countries. However, HDV seroprevalence studies of the US population are limited, and reported seroprevalences vary. To improve diagnoses, universal HDV testing of hepatitis B surface antigen (HBsAg)-positive specimens has been proposed. The objective of this study was to estimate the prevalence of HDV infection within the United States in HBsAg-positive specimens. Unique deidentified remnant HBsAg-positive specimens submitted for routine clinical testing to Quest Diagnostics, representing all 10 Health and Human Services (HHS) regions, were included. Reflex testing of HBsAg-positive specimens for HDV antibody testing, and further testing of positive specimens for HDV RNA, was conducted from July 2023 to June 2024 for 5251 HBsAg-positive specimens. The cohort was 45% female, with mean ages of 50.8 (M) and 49.4 (F) years. The seroprevalence of anti-HDV was 2.2% [95% CI: 1.8%-2.6%; range: 2.5%-4.1%]. Of 107 anti-HDV-positive specimens, 28% were positive for HDV RNA (viral load range: 94-7,480,000 IU/mL: n = 23; Detected < 40 IU/mL: n = 7). This is the first nationwide seroprevalence study examining HBsAg-positive samples collected from 10 HHS regions across the United States, which offers an overview of the prevalence of HDV in the United States through the use of HbsAg-positive remnant specimens in proportion to regional population sizes. Expanded screening for HDV would help identify patients who may benefit from HDV-related interventions.
A Government-Led, Patient-Centric Strategy to Re-Engage Diagnosed but Untreated Hepatitis C Patients in Yunnan Province, China.
Li S, Dong W, Yu Y … +8 more , Yang Z, Luo Y, Cai Y, Zhu Y, Wu Q, Li Q, Su S, Yang R
J Viral Hepat · 2025 Jun · PMID 40298138 · Publisher ↗
Diagnosed but untreated (DBU) hepatitis C virus (HCV) infected patients are a key group for HCV elimination efforts. This study aims to pilot a government-led, multi-sectoral approach to universal patient recall and trea...
Diagnosed but untreated (DBU) hepatitis C virus (HCV) infected patients are a key group for HCV elimination efforts. This study aims to pilot a government-led, multi-sectoral approach to universal patient recall and treatment mobilisation in Yunnan Province, China, to determine if this approach can improve treatment uptake among DBU patients and contribute to HCV elimination. In this quasi-experimental before-and-after study, we analysed all hepatitis C cases reported from 2004 to 2021 in the Yuxi City Center for Disease Control (CDC) database. From July to December 2022, the traditional telephone recall model was used, and from July 2023 to January 2024, Yuxi CDC partnered with local stakeholders to implement a patient-centric strategy to re-engage DBU patients in care. We compared the outcomes between these two approaches. The cooperation model significantly improved HCV case management. The contact rate rose from 29.7% (645/2171) to 58.5% (3813/6520) (χ = 25.743, p < 0.001); the HCV-RNA testing rate increased from 18.9% (122/645) to 86.1% (3283/3813) (χ = 2760.164, p < 0.001); and treatment initiation for positive cases improved from 19.6% (9/46) to 57.8% (884/1530) (χ = 26.555, p < 0.001). In total, 936 patients received treatment, and 92 patients (9.8%) were lost to follow-up 12 weeks post-treatment. Of the remaining 844 patients, 841 (99.6%) achieved SVR12 (sustained virological response12 weeks after therapy, defined as HCV quantitative test below 15 IU/mL), with no significant difference in outcomes between tested and untested genotype groups (χ = 0.123, p = 0.725). This study highlights the substantial advantages of the cooperative model over the traditional approach, notably in contact, testing, and treatment rates, and successful SVR12 outcomes, underscoring the potential for such models in advancing HCV elimination.
Cost-Effectiveness of Universal Screen-and-Treat Strategies for Reducing Morbidity and Mortality of Chronic Hepatitis B in a High-Endemicity City.
Wong NS, Chan DP, Wong GL … +1 more , Lee SS
J Viral Hepat · 2025 May · PMID 40168135 · Full text
In the setting of high hepatitis B virus (HBV) endemicity, we studied the cost-effectiveness of universal HBV screen-and-treat strategies for averting HBV-related morbidity and mortality in Hong Kong, where diagnosis and...
In the setting of high hepatitis B virus (HBV) endemicity, we studied the cost-effectiveness of universal HBV screen-and-treat strategies for averting HBV-related morbidity and mortality in Hong Kong, where diagnosis and treatment coverages are low. An age-sex-specific compartmental model for 2000-2040 was developed, with the incorporation of population-based screening strategies targeting different age groups. With a one-time HBV screening programme in 2025-2029, 3.6%-8.9% of HBV-related deaths could be averted. We evaluated the cost-effectiveness of the screening strategies with primary-care-based management in different scenarios with components of annual drug cost levels, screening programme duration, starting year and targeted age groups. Incremental cost-effectiveness ratio (ICER) was calculated, with the willingness-to-pay (WTP) threshold set at USD100,000/quality-adjusted life years (QALY). At the standard drug cost level, only the screening strategy targeting the 40-49 years old is cost-saving. When drug cost decreases to a low level, the strategy targeting the 35-49 years old (ICER USD97,042/QALY gained) is likely to be cost-effective and screening 35-59 years old is marginally cost-effective. In probabilistic sensitivity analysis, screening 40-49 years old (50%) and 35-59 years old (42%) have a half-half probability of being the most cost-effective at USD100,000/QALY WTP threshold, but increased to 93% for screening 35-59 years old at USD150,000/QALY threshold. From scenario analysis, deferred initiation of screening and unlimited programme duration would increase the ICER. Universal HBV screening targeting individuals aged 35-59 years or 40-49 years in the general population, with an earlier start and limited duration of the programme, is likely to be cost-effective.
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