Journal of Viral Hepatitis最新文献

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.

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.

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.

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

Data on the hepatitis C virus (HCV) care cascade are crucial for determining if the United States (U.S.) is on track to meet 2016 World Health Organization elimination goals. De-identified data were analysed from persons who were screened for HCV antibody and/or tested for HCV RNA by two large U.S. commercial laboratories from 1/1/2014 to 12/31/2021. Validated imputation algorithms were used to identify persons who initiated treatment and who achieved virological cure based on viral load decline and continued negative HCV RNA test results. The 3-digit ZIP code was used to map treatment rates by U.S. state. During 1/1/2014 to 12/31/2021, a total of 46,646,661 persons were tested for HCV antibody of whom 2,253,500 (4.8%) were positive. Among 3,117,372 persons tested for HCV RNA, 1,951,742 (62.6%) were viremic. Cumulatively, a total of 672,745/1,951,742 (34.5%) viremic persons were treated; an estimated 643,043 (96%) were cured. Treatment rates increased with older age, higher fibrosis scores, HIV positivity, residing in an urban area and in the Northeast. Persons diagnosed by reflex testing had higher treatment rates. Comparing COVID-19 pandemic (2021) to pre-pandemic (2019) periods, 24% more HCV antibody tests were performed (10,167,524 vs. 7,727,318), but fewer persons were treated (21,136 vs. 26,124, 23% decline) and cured (19,584 vs. 24,480, 25.0% decline) in 2021, respectively. In 2021, primary care providers diagnosed and treated the greatest proportion of persons. Treatment uptake across the U.S. remains low, underscoring the need for additional measures to expand access to testing and treatment, necessary to reach the U.S. goals for HCV elimination by 2030.

Detection of viral RNA is essential for hepatitis C virus (HCV) diagnosis. Collection and preservation of plasma, the preferred specimen type, is challenging in some areas. The Cobas Plasma Separation Card (PSC) is an alternative specimen type with no cold chain requirements. The PSC is designed to use capillary blood from fingerstick and capillary tube collection, but alternative sample collection options would broaden PSC utility. This study explored qualitative and quantitative HCV RNA detection with PSC prepared using a syringe needle, compared to plasma. Using a 24-gauge syringe, blood was drawn by venipuncture from HCV antibody-positive clinic patients aged > 18 years and used to prepare plasma or spotted directly onto three PSCs using 6, 8 and 10 drops per spot (group 1) or 8, 10 and 12 drops (group 2). HCV RNA was measured using the Cobas HCV assay. Test results for all conditions were available for 143 patients in group 1 and 109 patients in group 2. The proportions with detectable HCV RNA were not significantly different from plasma, and overall agreement was over 88% for any PSC spot number (Fisher exact test p > 0.1). The mean HCV viral load was lower for PSC samples vs. plasma for six or eight spots in group 1 but not statistically different for 10 or 12 spots in either group. Direct spotting of blood using a syringe is a viable alternative to finger prick and capillary tube transfer for PSC preparation. This approach may be beneficial in resource-limited settings and in patient populations for whom capillary blood collection is challenging.

People living with chronic hepatitis B infection (PLWHB) need life-long care to monitor liver health and treatment need. Data on clinical follow-up for PLWHB are essential to monitor the health system response to this infection. We used linked national registry data to calculate the proportion of diagnosed PLWHB in Norway linked to specialist care (LTC), treated and retained in specialist or primary care (RIC) from 2008 to 2022. We described the outcomes by time, age, sex, region of residence, place of birth and residence status. Using log-binomial regression, we explored how these factors were associated with ever being LTC and being RIC during the last 12 months of the study period. Among 10,542 diagnosed PLWHB, 8301 (79%) had ever been LTC and 2454 (23%) had received treatment. In the first 2 years after LTC, 64% were still RIC. At the end of the study period, 4476 (50%) of 8979 PLWHB still resident in Norway had been RIC in the last 12 months. PLWHB born outside Norway had a higher probability of LTC (relative risk [RR]: 1.24; 95% confidence interval [CI] 1.19–1.29) and RIC (RR: 1.67; 95% CI 1.53–1.84). Other significant associations with smaller effect sizes included a higher probability of LTC among PLWHB aged < 25 years and a lower probability of RIC when diagnosed from 2010 to 2013 or aged ≥ 65 years. The management of diagnosed PLWHB in Norway is suboptimal. Our study provides a framework for how key performance indicators can be monitored in ongoing national surveillance.