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Articles published on Hepatitis C Virus Genotype
- New
- Research Article
- 10.3855/jidc.21228
- Oct 31, 2025
- Journal of infection in developing countries
- Thong D Vo + 1 more
Hepatitis C virus (HCV) genotype 1 is a significant cause of hepatocellular carcinoma (HCC) in Vietnam. Direct-acting antivirals (DAAs) are effective in achieving sustained virologic response (SVR), potentially reducing HCC incidence. This study evaluated how DAA regimens affect HCC incidence in Vietnamese patients with chronic liver disease related to HCV genotype 1. A retrospective cohort study was conducted with 450 HCV-1 patients treated with DAAs at the Liver Clinic, University Medical Center Ho Chi Minh City, Vietnam. Patients were followed for a median duration of 0.5 years. Treatment regimens included combinations of NS5A inhibitors with NS3/4A protease inhibitors or NS5B polymerase inhibitors. Data on demographics, baseline clinical characteristics (e.g., alpha-fetoprotein, albumin levels), and liver function were collected before initiating DAA treatment. Follow-up data, including SVR rates and HCC incidence, were assessed at the end of treatment and during the post-treatment observation period (median follow-up of 0.5 years). This approach allowed us to compare pre-treatment baseline data with post-treatment outcomes to evaluate the impact of DAA therapy on HCC risk factors and incidence. SVR was achieved in 94.8% of patients, with an HCC incidence of 1.1% at 1 year for SVR patients, versus 6.5% for non-SVR patients. Significant risk factors for HCC included hypoalbuminemia, elevated alpha-fetoprotein levels, and non-SVR status. DAAs significantly reduce HCC incidence in Vietnamese patients with HCV-1; however, ongoing surveillance is essential for high-risk patients.
- New
- Research Article
- 10.3390/v17111422
- Oct 26, 2025
- Viruses
- Hoor Alkaabi + 4 more
Direct-acting antivirals (DAAs) have transformed hepatitis C virus (HCV) management, offering high cure rates, favorable safety, and simplified regimens. Management in immunosuppressed patients remains challenging due to drug–drug interactions (DDIs). The objective of this review is to summarize clinical outcomes, safety, and pharmacologic considerations of DAA therapy in immunosuppressed patients, including solid organ transplant recipients and those on biological agents. We reviewed clinical studies, pharmacologic databases, and guidelines to characterize DAA classes, mechanisms, and relevant DDIs in immunosuppressed HCV patients. In transplant recipients, DAAs achieved sustained virological response (SVR) > 90% with minimal graft rejection. Safety profiles were favorable, and immunosuppressant dose adjustments were rarely needed. DDIs, particularly with calcineurin inhibitors (tacrolimus, cyclosporine), require careful monitoring due to variable trough-level effects. Evidence also supports the efficacy and safety of DAAs in patients on biological agents, without compromising SVR. Pharmacokinetic data indicate DAAs maintain antiviral activity across HCV genotypes in the presence of immunosuppressants, though mTOR inhibitors may alter efficacy in certain HCV genotypes. DAAs are highly effective and safe in immunosuppressed patients, achieving high SVR rates and potential graft survival benefits. Prospective studies are needed to assess DAA therapy in patients receiving biological agents and to optimize co-administration strategies with immunosuppressive agents.
- New
- Research Article
- 10.1007/s10096-025-05320-4
- Oct 23, 2025
- European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology
- Maria Pokorska-Śpiewak + 4 more
The aim of this study was to analyze the safety and efficacy of sofosbuvir-based regimens (SOF/velpatasvir and SOF/ledipasvir, SOF/VEL and SOF/LDV) for the treatment of hepatitis C in children aged 5-17 years in a real-life setting. All participants who received SOF-based regimens beginning in August 2019 were included. The treatment duration was 12 weeks for both the SOF/LDV and SOF/VEL regimens; however, in the case of children infected with HCV genotype 1 and presenting with cirrhosis, the duration of the SOF/LDV treatment was extended to 24 weeks. In all cases, fixed doses of SOF/LDV and SOF/VEL were used adjusted to the patients' age and weight. The primary endpoint for these studies included evaluation of treatment efficacy (defined as sustained virologic response, SVR12, with undetectable HCV RNA at 12 weeks posttreatment). We identified 90 patients aged 5 to 17 years eligible for the study: 50 who were treated with SOF/VEL and 40 who received SOF/LDV. The SVR12 assessment was available for 89 patients. In all of them, SVR12 was achieved (100% efficacy in per-protocol analysis; 99% efficacy in intention-to-treat assessment). One-third of the study participants reported adverse events (AEs) related to antiviral treatment, all of which were mild or moderate. Headache, fatigue, and abdominal pain were the most common symptoms. Some differences in the frequency of AEs according to the DAA used were noted (abdominal pain and asthenia were less common in children treated with SOF/LDV than in those treated with SOF/VEL). No case of treatment discontinuation occurred. This study confirms the excellent efficacy and good tolerability of SOF-based regimens for the treatment of hepatitis C in children aged 5 to 17 years in real-life settings, supporting the inclusion of pediatric patients in national treatment policies.
- New
- Research Article
- 10.3390/v17101392
- Oct 19, 2025
- Viruses
- Pietro Torre + 11 more
Background: Hepatitis C Virus (HCV) remains a global health challenge as WHO elimination targets are not achievable in most countries, mainly due to the high number of undiagnosed individuals. In Italy, where national elimination efforts are ongoing, regional disparities further hinder progress. This study aimed to characterize the hidden burden of chronic HCV infection across t he territory of the Province of Salerno, Southern Italy, to suggest a novel municipal-level screening approach, with implications for national strategies. Methods: We analyzed records of residents diagnosed with chronic HCV infection and linked to care between 2015 and 2022. Data included age, sex, municipality of residence, HCV genotype, and fibrosis stage. Observed prevalence was compared with expected prevalence derived from national/regional benchmarks. Municipalities were categorized as urban or rural based on the resident population. Results: A total of 3528 cases were identified across 139 municipalities. Patients had a mean age of 63 years, and 54% were male. Half were diagnosed at an advanced stage (F3–F4), with genotype 1b being predominant. The hidden burden increased with age and showed a higher prevalence in rural areas compared to urban ones, with values of about 7 vs. 3 per 1000 inhabitants respectively. Logistic regression analysis identified age, male sex, urban residence, and genotype 1b as factors associated with advanced fibrosis or cirrhosis. Conclusions: This is the first Italian study to apply a standardized municipal-level classification to quantify the hidden burden of HCV. The model identifies underdiagnosed areas, highlights urban–rural disparities (a higher degree of underdiagnosis in rural areas versus a higher frequency of late diagnosis in urban ones), and provides a replicable tool for precision public health. Its adoption could enhance national HCV elimination efforts by supporting targeted screening, optimized resource allocation, and equitable access to care.
- Research Article
- 10.1111/1348-0421.70013
- Oct 7, 2025
- Microbiology and immunology
- Ryosuke Suzuki + 9 more
We investigated the receptor usage of the hepatitis C virus (HCV) genotype 3a S310 strain using cell culture-derived HCV (HCVcc) and trans-complemented HCV particles (HCVtcp). Infection by HCV strains of genotypes 1, 2, and 3 was inhibited by anti-CD81 antibody. By contrast, anti-claudin (CLDN)1 antibody reduced infection by the genotype 1b TH strain and genotype 2a JFH-1 strain but had no effect on the S310 strain (genotype 3a). Moreover, CLDN1-knockout cells remained permissive to infection with a chimeric HCVcc bearing the S310 envelope in a JFH-1 backbone. In CLDN1-deficient cells, infection by HCVtcp derived from the S310 strain was significantly reduced by treatment with anti-claudin-6 (CLDN6) antibody or knockdown of CLDN6 mRNA, suggesting that the S310 strain utilizes CLDN6 as an alternate entry factor. Further analyses revealed that HCVtcp of genotype 4a (ED43 strain) and genotype 6a (HK6a strain) also infected CLDN1-deficient cells. These findings provide new insights into CLDN usage by diverse HCV genotypes and raise the possibility that CLDN tropism may affect viral entry, infection efficiency, and pathogenesis.
- Research Article
- 10.1016/j.celrep.2025.116418
- Oct 1, 2025
- Cell reports
- Zhiqing Wang + 16 more
Interplay of host and viral genetic variations in modulating antibody responses to genotype 3a hepatitis C virus: Implications for vaccine design.
- Research Article
- 10.1186/s12879-025-11565-3
- Sep 29, 2025
- BMC Infectious Diseases
- Supradip Dutta + 8 more
Background & objectivesGenomic diversity of Hepatitis C Virus (HCV), accessibility and long-term influence of Direct Acting Antiviral (DAA) treatment remain underexplored among HCV-infected chronic liver disease (CLD) patients in the real world. This retrospective study addressed the inadequacy of assessing the effectiveness of DAA and identify genotype-specific variations in treatment response in the context of HCV epidemiology. Additionally, real-world treatment challenges encountered during the COVID-19 pandemic and the transitional phase of implementing the National Viral Hepatitis Control Program (NVHCP) guidelines have also been addressed.MethodsThis retrospective study included 254 CLD patients from November 2017 and February 2020 to assess the effectiveness of DAA and long-term treatment outcomes among CLD patients.ResultsHCV viremia was observed in 58.26% (n = 148) patients. Patients aged 52–59 years with a history of blood transfusions exhibited a higher prevalence of active HCV infection. Two major genotypes (GT) - GT1 and GT3, and seven subtypes with few new subtypes were identified. SVR24 was achieved in 89.6% of patients receiving sofosbuvir (SOF) + daclatasvir (DCV) or SOF/ledipasvir (LDV) drug regimens. For individuals who failed to reach SVR24 (n = 13), a modified regimen (SOF + Velpatasvir (VEL) + ribavirin (Riba) for 6 months) was given and the success rate was 92.31%. GT-1a and GT-1b showed better treatment response, whereas GT-3b had a lower treatment response. Among 77 SVR24 achieved patients, 57.14% were cirrhotic and 42.86% were non-cirrhotic at the start of the therapy.Interpretation & conclusionThis study highlights genotype-specific variations in treatment response, with GT-3b exhibiting lower treatment response which highlights the need to decipher the reasons behind treatment failure for future therapeutic management.Supplementary InformationThe online version contains supplementary material available at 10.1186/s12879-025-11565-3.
- Research Article
- 10.36233/0507-4088-331
- Sep 16, 2025
- Voprosy virusologii
- M D Chanyshev + 7 more
Hepatitis C is a pressing global public health issue. The high variability of the hepatitis C virus (HCV) complicates its whole-genome sequencing; most studies sequence only specific regions of the genome. There is a need for a simple and reliable method for sequencing the whole genome of HCV. Development and validation of NGS panel for whole-genome sequencing of HCV. This study presents NGS amplification panel for sequencing the genomes of HCV genotypes 1, 2, and 3. Depending on the genotype, a set of 79, 67, or 89 primers is used. These primers enable amplification of overlapping regions of the HCV genome. The panel was tested on 153 HCV RNA samples isolated from blood plasma specimens (93/6/54 samples of genotypes 1/2/3, respectively). Shannon entropy analysis showed that genetic heterogeneity within the E2 gene is significantly higher than in other parts of viral genome. The frequency of mutations associated with drug resistance was determined. Specifically, for genotype 1, the following mutation detection rates were observed in NS3: Y56F - 37.6%, V170I - 23.7%; in NS5a: R30Q - 8.6%, P58L/S/T - 6.5%, A92T - 4.3%; in NS5b: L159F - 45.2%, S556G/N - 33.3%. The current study describes a method for whole-genome sequencing of HCV genotypes 1, 2, and 3. The HCV sequencing panel shows great potential for use in scientific research and epidemiological monitoring.
- Research Article
- 10.3389/fpubh.2025.1589562
- Sep 15, 2025
- Frontiers in Public Health
- Katarzyna Schmidt + 9 more
IntroductionIn October 2018, an outbreak of hepatitis C virus (HCV) in southern Germany was communicated to the Robert Koch Institute (RKI). Healthcare-associated transmission during invasive procedures involving a specific anaesthetist at a Bavarian hospital was suspected. The aim was to conduct a retrospective molecular outbreak investigation in order to elucidate the course of the outbreak.MethodsAn exposed patient was defined as a person who underwent a surgical procedure involving the anaesthetist in the Bavarian hospital from May 2016 to April 2018. A probable case was defined as an exposed patient with a positive HCV antibody test result and unknown HCV genotype. A confirmed case represented a probable case with hepatitis C genotype 3 (3a) infection. Descriptive epidemiological and phylogenetic analyses (using four HCV regions: Core, HVR1, NS5A and NS5B) were conducted.ResultsOf the 1,714 exposed patients, to whom HCV testing was recommended, 1,558 (90.9%) responded and were tested, 63 met the definition of a probable case, and 51 of those were confirmed cases. Sequencing data were available for 39 of the 51 confirmed cases. A sample from the anaesthetist was unavailable for further analysis. Phylogenetic analysis revealed close genetic relatedness of all 39 confirmed cases with identified HCV genotype 3a. Phylogenetic results indicated a common source of infection.DiscussionTo prevent healthcare-associated HCV transmission during anaesthetic procedures, protocols must document the amount of medication used and discarded. Regular staff testing and storing of clinical samples are also crucial for timely outbreak analysis and response.
- Research Article
- 10.2196/60207
- Aug 18, 2025
- JMIR Medical Informatics
- Lin Lin + 3 more
BackgroundHepatitis C virus (HCV) remains a significant public health concern in China, particularly in Shandong Province, where detailed molecular epidemiological data are limited. HCV exhibits substantial genetic diversity, and understanding its genotype distribution and transmission dynamics is critical for developing effective control strategies.ObjectiveThis study aimed to investigate the genetic diversity, geographic dissemination, and evolutionary history of HCV genotypes in Shandong Province, China, using molecular techniques and phylogenetic methods.MethodsA total of 320 HCV-positive serum samples were collected from multiple hospitals across Shandong Province between 2013 and 2021. HCV RNA was extracted and amplified targeting the 5′ untranslated region (UTR), Core, and NS5B regions. Sequencing was conducted, and genotypes were determined using the National Center for Biotechnology Information’s Basic Local Alignment Search Tool (NCBI BLAST). Phylogenetic trees were constructed using maximum likelihood methods with the general time reversible with Gamma-distributed rate variation among sites [(GTR)+Gamma model]. The temporal and geographic evolution of the major subtypes (1b and 2a) was analyzed using Bayesian Markov chain Monte Carlo (MCMC) methods implemented in Bayesian Evolutionary Analysis Sampling Trees (BEAST). The Bayesian skyline plot (BSP) was used to infer population dynamics and estimate the time to the most recent common ancestor (tMRCA).ResultsGenotypes 1b (n=165) and 2a (n=131) were identified as the predominant subtypes, with a small number of genotypes 3b, 6a, 6k, and potential recombinant strains also detected. Phylogenetic analysis revealed distinct evolutionary clustering of 1b and 2a strains, suggesting multiple diffusion events within the province. The tMRCA of subtypes 1b and 2a were estimated to be 1957 and 1979, respectively. Bayesian skyline analysis showed that both subtypes experienced long-term population stability, followed by a rapid expansion period between 2014 and 2019 (1b) and 2014 to 2016 (2a), respectively. The analysis also identified key transmission hubs such as Jinan, Liaocheng, Tai’an, and Dezhou, indicating city-level variations in HCV spread.ConclusionsThis study provides data-supported insights into the genotypic landscape and evolutionary patterns of HCV in Shandong Province. The identification of dominant subtypes, potential recombinant strains, and regional transmission pathways enhances our understanding of local HCV epidemiology. These findings have implications for public health policy, resource allocation, and targeted treatment strategies. The integration of molecular epidemiology and phylogenetics offers a valuable model for infectious disease surveillance and control in similar settings.
- Research Article
- 10.1111/jvh.70061
- Aug 6, 2025
- Journal of viral hepatitis
- Mei Wang + 5 more
The objective of this study is to analyse the prevalence and clinical characteristics of HCV/HBV coinfection in Guizhou, and evaluate the rate of HBV reactivation during and after anti-HCV treatment in a real-world study. This retrospective study included 1652 patients with hepatitis C virus (HCV) infection who received direct-acting antiviral (DAA) therapy at the Guiyang Public Health Clinical Center between January 2018 and December 2022 Baseline, on-treatment and posttreatment data were collected, including HCV RNA, HCV genotypes, liver function, hepatitis B virus (HBV) markers (HBsAg, HBcAb) and HBV DNA levels. The HCV/HBV coinfection rate was analysed, and the risk of HBV reactivation and disease progression following DAA therapy was assessed. Among the 1652 HCV-infected patients, the HCV/HBV coinfection rate was 49.88% (824/1652). Of these, 5.08% (84/1652) were HBsAg-positive, while 44.79% (740/1652) were HBsAg-negative/HBcAb-positive with HBV DNA < 20 IU/mL. Compared to patients with HCV monoinfection, HBsAg-positive patients had a higher proportion of males, compensated and decompensated cirrhosis, hepatocellular carcinoma (HCC) and lower platelet (PLT) counts (χ2 = 15.482, 46.101; F = 7.292; all p < 0.05). Differences in HCV genotype distribution were observed among various HBV immune status groups (χ2 = 32.529, p < 0.05). The cumulative incidence of HBV reactivation in HCV/HBV coinfected patients treated with DAAs was 1.2% (10/824). Among these, the reactivation rate was 16.67% (9/54) in HBsAg-positive patients without prophylactic anti-HBV therapy and 0.1% (1/740) in HBsAg-negative/HBcAb-positive patients. Baseline HBsAg levels were significantly higher in patients with HBV reactivation than in those without reactivation (Z = -4.291, p < 0.05). No significant changes were observed in liver function or PLT levels after HBV reactivation compared to baseline (p > 0.05), and no cases of liver failure were reported. In Guizhou, a relatively high prevalence of HBsAg-positivity and a large proportion of past HBV exposure (HBsAg-negative/HBcAb-positive, HBV DNA < 20 IU/mL) were observed among HCV-infected patients. While HBV reactivation can occur in HCV/HBV coinfected patients undergoing DAA therapy, the overall risk is low. A baseline HBsAg level > 185 IU/mL is a significant risk factor for HBV reactivation.
- Research Article
- 10.1093/ofid/ofaf496
- Jul 31, 2025
- Open Forum Infectious Diseases
- Suk-Chan Jang + 16 more
BackgroundAmid the opioid epidemic in the United States, hepatitis C virus (HCV) infections are rising, with one-third of individuals with infection unaware due to the asymptomatic nature. This study aimed to develop and validate a machine learning (ML)-based algorithm to screen individuals at high risk of HCV infection.MethodsWe conducted prognostic modeling using the 2016–2023 OneFlorida+ database of all-payer electronic health records. The study included individuals aged ≥18 years who were tested for HCV antibodies, RNA, or genotype. We identified 275 features of HCV, including sociodemographic and clinical characteristics, during a 6-month period before the test result date. Four ML algorithms—elastic net (EN), random forest (RF), gradient boosting machine (GBM), and deep neural network (DNN)—were developed and validated to predict HCV infection. We stratified patients into deciles based on predicted risk.ResultsAmong 445 624 individuals, 11 823 (2.65%) tested positive for HCV. Training (75%) and validation (25%) samples had similar characteristics (mean, standard deviation age, 45 [16] years; 62.86% female; 54.43% White). The GBM model (C statistic, 0.916 [95% confidence interval = .911–.921]) outperformed the EN (0.885 [.879–.891]), RF (0.854 [.847–.861]), and DNN (0.908 [.903–.913]) models (P < .0001). Using the Youden index, GBM achieved 79.39% sensitivity and 89.08% specificity, identifying 1 positive HCV case per 6 tests. Among patients with HCV, 75.63% and 90.25% were captured in the top first and first to third risk deciles, respectively.ConclusionsML algorithms effectively predicted and stratified HCV infection risk, offering a promising targeted screening tool for clinical settings.
- Research Article
- 10.1093/infdis/jiaf378
- Jul 22, 2025
- The Journal of infectious diseases
- Erwan Vo-Quang + 11 more
We evaluated the ability of the commercial Sentosa SQ Hepatitis C Virus Genotyping Assay to identify the HCV genotype subtype in patients from The Gambia. Subtype was determined from the Sentosa-generated NS5B sequences using 3 bioanalytical methods: the Sentosa SQ HCV Genotyping Assay bioanalytical tool, Geno2pheno, and the National Reference Center in-house method. The Sentosa assay result agreed with the reference method in only 2 of 13 cases. This study highlights the difficulty of correctly identifying HCV subtypes in a region of Africa with a high diversity of HCV genotype 1 and 2 subtypes that may be resistant to antivirals.
- Research Article
- 10.1371/journal.pone.0324088
- Jul 22, 2025
- PLOS One
- Lesley S Miller + 15 more
Improvements in HCV testing, including Point of Care (POC) HCV RNA tests, are necessary to eliminate HCV. With this goal in mind, we established methods to collect capillary whole blood (CWB) via fingerstick, ensured its stability in a microtainer, and determined limit of detection (LoD) for various HCV genotypes. Next, we conducted a prospective study where CWB samples were collected from a cohort of 109 adult subjects at a safety-net hospital and tested for HCV RNA using the Xpert® HCV test on the GeneXpert® Xpress system and the cobas® HCV platform. We consistently obtained 250 μl CWB which was stable for up to 5 hours in the microtainer. Laboratory LoD studies demonstrated that the Xpert® HCV test could detect most HCV genotypes to <100 IU/ml in CWB. In the prospective clinical study, 89 subjects (82%) with valid Xpert® and cobas® HCV comparator results were analyzed. Using Xpert®, 16 out of 89 (18%) subjects had detectable HCV RNA and 73 (82%) had undetectable HCV RNA. Using cobas, 17 out of 89 (19%) participants had detectable HCV RNA, and 72 (81%) were undetectable. One sample was detectable on cobas but not Xpert®, yielding a sensitivity of 94% and specificity of 100%. This study demonstrates the feasibility of HCV RNA testing at POC using CWB obtained by fingerstick and provides preliminary data on the accuracy of the Xpert® HCV test performed by untrained operators in a CLIA-waived setting.
- Research Article
- 10.5009/gnl240581
- Jul 18, 2025
- Gut and liver
- Jae Yoon Jeong + 17 more
Due to the very low incidence of human immunodeficiency virus (HIV) infection in South Korea, epidemiological data on hepatitis C virus (HCV)/HIV coinfection are limited. The aim of this study was to investigate the clinical characteristics and treatment outcomes of patients with HCV/HIV coinfection in South Korea. We retrospectively collected data from patients diagnosed with HCV/HIV coinfection at 12 academic hospitals in South Korea from 2009 to 2020. A total of 124 patients were included in this study; most patients were males (n=112, 90.3%), and the mean age was 46.5±13.5 years. Among the study patients, 11 (8.9%) had cirrhosis, and seven (5.6%) tested positive for the hepatitis B surface antigen. During the follow-up period (mean period: 67.4 months), two patients (1.6%) developed hepatocellular carcinoma, and nine (7.3%) died. Of the 112 patients (90.3%) who underwent HCV genotype testing, most were infected with HCV genotype 2 (n=53, 47.3%) and genotype 1b (n=41, 36.6%). In particular, HCV genotype 1a was identified in 12.5% (n=14) of patients. Ninety-one patients (73.4%) received antiviral therapy, with 104 antiviral treatments administered overall. The sustained virologic response rate was significantly higher in patients treated with direct-acting antiviral agents (DAA) than in those receiving pegylated interferon-based treatment (89.0% vs 58.1%, p<0.001). In South Korea, patients with HCV/HIV coinfection were predominantly male and younger and exhibited a higher prevalence of genotype 1a than those with HCV monoinfection. These patients demonstrated a significantly better treatment response to DAA treatment than to interferon-based therapy.
- Research Article
- 10.1001/jama.2025.10563
- Jul 9, 2025
- JAMA
- Jason Haukoos + 16 more
Identification of individuals with hepatitis C virus (HCV) infection is a public health priority. Emergency departments (EDs) have been a focus of screening efforts, as they serve large numbers of at-risk patients who commonly do not access health care elsewhere. However, the optimal approach to HCV screening in ED settings remains unknown. To evaluate the effectiveness of HCV screening in EDs with the hypothesis that nontargeted screening identifies more new diagnoses than targeted screening. Prospective, multicenter, pragmatic randomized clinical trial performed at 3 urban EDs in Denver, Colorado; Baltimore, Maryland; and Jackson, Mississippi. Patients were 18 years or older, with exclusions for critical illness, inability to provide consent, or previously diagnosed HCV. As part of routine ED care, patients were randomly assigned to undergo either nontargeted screening, in which HCV testing was offered regardless of risk, or targeted screening, in which testing was offered based on risk assessment. The primary outcome was newly diagnosed HCV infection (RNA detected). Secondary outcomes were repeat HCV diagnoses; HCV test offer, acceptance, and completion; HCV genotype and fibrosis staging; components of the HCV care continuum; and all-cause mortality through 18 months of follow-up. Analyses were conducted from January to March 2025 by intention-to-treat analysis, using relative risk (RR) with 95% CIs and Fisher exact tests. A total of 147 498 patient visits were randomized (median [IQR] age, 41 [29-57] years; 51.5% male; and 42.3% Black, 20.9% Hispanic, and 32.2% White). Of these, 73 847 patients underwent nontargeted screening, resulting in 9867 (13.4%) tested for HCV and 154 new HCV diagnoses, whereas 73 651 patients underwent targeted screening and 23 400 (31.8%) were identified to have risk factors for HCV infection, resulting in 4640 (6.3%) patients tested for HCV and 115 new HCV diagnoses. Compared with targeted HCV screening, nontargeted HCV screening identified significantly more new diagnoses of HCV infection (RR, 1.34 [95% CI, 1.05-1.70]; P = .02). Among patients newly diagnosed with HCV infection, small proportions from the nontargeted and targeted screening groups were linked to follow-up care (19.5% vs 24.3%, respectively), initiated direct-acting antiviral (DAA) treatment (15.6% vs 17.4%), completed DAA treatment (12.3% vs 12.2%), and attained sustained virologic response at 12 weeks (SVR12) (9.1% vs 9.6%). In this multicenter randomized clinical trial, a nontargeted screening approach was superior to targeted screening for identifying new HCV infections among patients seen in 3 urban EDs. The substantial decrease in patients who went from diagnosis to SVR12 highlights an urgent need for innovative models of HCV treatment. ClinicalTrials.gov Identifier: NCT04003454.
- Research Article
- 10.3389/fmed.2025.1576654
- Jul 9, 2025
- Frontiers in medicine
- Kaili Wang + 4 more
This investigation assessed the clinical outcomes and adverse effects of combination therapy using sofosbuvir (SOF) and daclatasvir (DCV) among dialysis-dependent patients infected with hepatitis C virus (HCV) genotypes 1b or 2a in real-world settings. We conducted a prospective, single-arm interventional trial comprising 16maintenance hemodialysis patients (14 with HCV-1b, 2 with HCV-2a). Participants received SOF-DCV combination therapy over 24 weeks with monitoring at weeks 4, 12, and 24 during treatment, plus a follow-up assessment 12 weeks post-treatment completion. The primary outcome measure was sustained virologic response at 12 weeks post-treatment (SVR12). Secondary endpoints included therapeutic tolerance and safety profiles. All 16 participants completed the prescribed treatment regimen. Demographic characteristics revealed a mean age of 57.0 years, male predominance (75%), average dialysis duration of 7.0 years, and mean body weight of 63.0 kg. Five patients (31.3%) had compensated cirrhosis. Liver function parameters remained stable throughout the study period. Rapid virologic response (RVR) was documented in 87.5% (14/16) of participants, while end-of-treatment response (ETR) and SVR12 were both achieved in 93.8% (15/16) of cases. All cirrhotic patients (5/5) ultimately attained SVR12. The therapeutic regimen demonstrated favorable tolerability, with no treatment discontinuations due to adverse events. One participant was lost to follow-up. APRI scores significantly decreased from baseline (0.56) to week 24 (0.20, p < 0.001). Reported adverse reactions included headache, fatigue, nausea (each 6.3%), and anemia (18.8%). The 12-week SOF-DCV combination demonstrated robust therapeutic efficacy and acceptable safety profiles in hemodialysis patients infected with HCV genotypes 1b or 2a, including those with compensated cirrhosis.
- Research Article
- 10.1186/s12876-025-04109-1
- Jul 8, 2025
- BMC Gastroenterology
- Zhanyi Li + 4 more
BackgroundChronic hepatitis C (CHC) is associated with an increased risk of type 2 diabetes mellitus (T2DM). However, regional variations in HCV genotypes and clinical characteristics may influence this association. This study aimed to investigate the association between chronic hepatitis C virus (CHC) infection and the development of T2DM in CHC patients in Southern China.MethodsA retrospective case-control cohort study analyzed 442 CHC patients (242 without T2DM, 200 with T2DM) from 2010 to 2018. Biochemical parameters, HCV genotypes, and clinical characteristics were compared. Multivariate logistic regression and ROC analysis were performed to evaluate predictors of T2DM.ResultsThe CHC + T2DM group exhibited significantly higher age (P < 0.001), BMI (P = 0.001), fasting blood glucose (P < 0.001), fasting insulin (P = 0.015), HOMA-IR (Homeostasis Model Assessment-Insulin Resistance) index (P < 0.001), transaminases alanine transaminase (ALT) (P < 0.001) and aspartate transaminase (AST) (P < 0.001), total bilirubin (P < 0.001), γ-Glutamyl Transferase (GGT) (P < 0.001), and cirrhosis prevalence (P < 0.001). Logistic regression analysis showed that age (OR: 1.09), fasting blood glucose (OR: 16.20), fasting insulin (OR: 1.23), HOMA-IR (OR: 0.48), and GGT (OR: 1.01), cirrhosis (OR: 15.32) and hypertension (OR: 31.00) were the risk factors of T2DM in CHC patients. HCV genotype distribution differed significantly between CHC and CHC + DM groups (P = 0.008), with genotype 3a more prevalent in CHC + DM (2.07% vs. 11.36%, P = 0.032). Receiver Operating Characteristic curve analysis highlighted fasting glucose (AUC = 0.904) as the strongest predictor.ConclusionAge, metabolic dysregulation, liver cirrhosis, hypertension, and HCV genotype 3a are key risk factors for T2DM in CHC patients. Early screening for glucose intolerance and genotype-specific interventions are critical in high-risk populations.
- Research Article
- 10.15789/2220-7619-efo-17688
- Jul 8, 2025
- Russian Journal of Infection and Immunity
- Yu A Ermolaeva + 2 more
Introduction. Despite the great advances made in the field of virology and their diagnostics, a number of difficulties affect improvements in the control and elimination of hepatitis C virus (HCV) infection at present. New cases of HCV infection still occur worldwide, including Tomsk Region (TR). The aim of the study was to analyze the epidemiological situation with regard to acute and chronic forms of HCV in adults and children for the period 2022–2023, and the structure of morbidity in TR. Materials and methods. The features of the HCV epidemic process were assessed using official data presented in the State Report “On the state of sanitary and epidemiological well-being of the population in the Russian Federation in 2023”, statistical reporting form No. 2, federal statistical surveillance form No. 65 “Information on chronic viral hepatitis” form 065 for the period of 2023, quarterly reports of regions to the Ministry of Health of the Russian Federation within the framework of the implementation of measures aimed at combating HCV infection in 2021–2030. Results. In TR, stable incidence rates of first-time detected forms of chronic viral hepatitis have been registered over the last years: in 2023 — 18.82 cases of chronic hepatitis C per 100 thousand population, in the population of children — 11.2 cases per 100 thousand population. Indicators of HCV morbidity in the TR indicate a tendency towards the spread of HCV infection in all age groups with an increase in the age limit. Genotypic diversity of HCV infection in the TR in 2023 is represented by subtypes 1a, 1b, 2, 3a/3b. The planned coverage of antiviral therapy in 2024 cannot significantly affect the epidemiologic situation on HCV in TR and achieve the results of elimination by 2030 and requires annual increase of funding. Conclusion. The incidence rate of HCV infection in the TR is 1.7 times lower than the all-Russian one. Low level of HCV prevalence in the pediatric population in the TR made it possible to carry out micro-elimination of HCV among children. Insufficient level of HCV genotypes determination requires increasing the coverage of genotyping for epidemiologic surveillance in each region.
- Research Article
- 10.1177/20499361251351302
- Jul 1, 2025
- Therapeutic Advances in Infectious Disease
- Raina Das + 9 more
Background:Manipur, a north-eastern state of India, has a high incidence of intravenous drug use with an equally high prevalence of Hepatitis C virus (HCV) infection.Objectives:This cross-sectional study aimed to evaluate the impact of certain risk factors enhancing the susceptibility of acquiring HCV.Design:A total of 1008 participants from various risk groups, from nine districts across the state, were enrolled. Blood samples along with demographic data were collected from the study participants.Methods:HCV RNA was isolated and nested RT-PCR was performed followed by Sanger sequencing for genotyping. Phylogenetic and phylogeographic studies were further conducted.Results:Of the total, 493 (48.90%) samples were HCV sero-reactive. Among the sero-reactive samples, 406 (82.35%) were HCV RNA positive. In case of the subgroup PWID + HIV, sero-reactivity (82.22%) and viremia (90.54%) were observed to be exceptionally high. It was noted that HCV sero-reactivity increased four times in people living with HIV (PLHIV) who continued to inject drugs. Three HCV genotypes and eight subtypes were circulating in this study population.Conclusion:In PLHIV who continued to inject drugs, HCV sero-reactivity increased four-fold. About 40% of the population living with HCV belonged to genotype 6, while genotype 1 showed a noticeable decline. Phylogeographic analyses and spatiotemporal reconstructions revealed that most of the subtypes migrated from far south-east Asian countries like Thailand, Malaysia, Myanmar, and Singapore.