Direct-acting Antiviral Therapy Research Articles

DAA-PASS: A Prospective Evaluation of HCC Recurrence After Direct Acting Antiviral Therapy.

Direct-acting antiviral (DAA) therapy is associated with a significant reduction in hepatocellular carcinoma (HCC) incidence among patients with cirrhosis, but data are conflicting about the risk of recurrence following DAA therapy. DAA-PASS was a prospective, pragmatic, observational study designed to estimate the risk of HCC recurrence associated with DAA therapy exposure during routine clinical care. Eligible patients were DAA treatment naive with Barcelona Clinic Liver Cancer (BCLC) stage A. Patients were followed at regular intervals for up to 24 months. To provide additional data, outcomes were compared to the Italian Liver Cancer Group (ITA.LI.CA) cohort. Of 42 patients enrolled, 24 were treated with DAA therapy. Ten HCC recurrence events were observed during the study, with 5 each in DAA-treated and DAA-untreated patients (cumulative incidences of 23 and 37 per 100 PY, respectively). The overall crude hazard ratio (HR) for HCC recurrence associated with DAA therapy was 0.6 (95% CI, 0.2-2.2). In the ITA.LI.CA cohort, HCC recurrence was observed in 193 patients during 24 months of follow-up, resulting in a cumulative incidence rate of 28 per 100 PY. Although limited by small sample size, this prospective study suggests DAA therapy is not associated with increased HCC recurrence risk among patients with a history of complete response to prior HCC therapy.

Unveiling Hepatitis C: Causes, Impact and advances in treatment

Hepatitis C Virus (HCV) infection continues to pose a major global health issue, with around 58 million chronic cases reported worldwide and about 1.5 million new infections each year. This virus is a primary contributor to chronic liver disease, cirrhosis, and hepatocellular carcinoma (HCC), leading to approximately 290,000 deaths annually (WHO, 2022). The introduction of direct-acting antiviral (DAA) therapies has transformed HCV treatment, with sustained virologic response (SVR) rates surpassing 95% across various genotypes. However, challenges remain in meeting the World Health Organization's target of eliminating HCV as a public health threat by 2030. Key obstacles include low diagnosis rates, as only 21% of those infected with HCV are aware of their condition, and restricted access to treatment, especially in low- and middle-income countries (LMICs). This article reviews the latest epidemiological trends related to HCV, focusing on the disparities in disease burden and access to healthcare. It discusses innovative diagnostic methods, such as point-of-care testing, and emphasizes the importance of universal screening programs in areas with high prevalence. Additionally, we look at new therapeutic strategies, including pan-genotypic DAAs and their effects on marginalized communities. Lastly, we examine public health initiatives aimed at enhancing HCV prevention, such as harm reduction programs and vaccination efforts for co-infections like hepatitis B. By integrating findings from recent studies and reports, this article highlights the necessity for collaborative global efforts to address the challenges of HCV elimination. Strategies that emphasize prevention, early detection, and fair access to treatment are crucial for alleviating the HCV disease burden and reaching elimination goals.

P-456. Reduction in the incidence of chronic hepatitis C, liver cancer, and related healthcare burden following the introduction of interferon-free direct-acting antiviral therapy in Japan: a national claims database study

Abstract Background The World Health Organization aims to eliminate hepatitis C virus (HCV) infections by 2030. Interferon-free direct-acting antiviral (DAA) therapy, available in Japan since 2014, has demonstrated high hepatitis C cure rates and reduced hepatitis C-related hepatocellular carcinoma (HCC). However, DAA therapeutic efficacy on a national scale remains underexplored. In this study, we investigated national trends in HCV prevalence and complications, including liver cancer, during the era of interferon-free DAAs, with particular focus on the impact of coexisting human immunodeficiency virus (HIV) infection. Methods We used the National Database of Health Insurance Claims, covering >98% of the population in Japan, to extract claims data on patients with chronic hepatitis C between 2013 and 2022. We identified patients with chronic hepatitis C annually based on the presence of corresponding diagnostic codes and relevant tests (abdominal ultrasound or HCC tumor markers) within each fiscal year. Next, we analyzed the trends in the prevalence of chronic hepatitis C (stratified by HIV status), DAA therapy, HCC incidence and treatment, and healthcare costs. Results Between 2014 and 2022, 333,020 patients underwent interferon-free DAA therapy in Japan. The number of patients with chronic hepatitis C decreased from 690,336 in 2013 to 414,708 in 2022, representing a 40% prevalence reduction (95% confidence interval: 40%–40%). However, among people living with HIV (PLWH), we observed a 16% decline (10%–20%). Newly diagnosed HCC incidence among patients with chronic hepatitis C declined by 69% (68%–70%) over the 10 years. HCC treatment numbers also declined, with 50%, 80%, and 82% reductions in hepatectomies, radiofrequency ablation, and transarterial chemoembolization therapy, respectively. The total annual healthcare cost of HCV-infected individuals peaked in 2015 (1.1 trillion yen), coinciding with the widespread use of DAAs, and decreased to 65% of the 2013 expenses by 2022. Conclusion The introduction of DAAs significantly reduced the HCV infection-related healthcare burden in Japan. Extensive screening and treatment, particularly in PLWH, are crucial for successful HCV eradication. Disclosures All Authors: No reported disclosures

A randomized clinical study to evaluate the possible antifibrotic effect of zinc sulfate in chronic HCV patient receiving direct-acting anti-viral therapy.

This study aimed to assess the potential antifibrotic impact of zinc sulfate in chronic Hepatitis C Virus (HCV) patients receiving direct-acting antiviral therapy. This randomized controlled study included 50 chronic HCV-infected patients with fibrosis stage (F1 & F2). Participants were randomly assigned to two groups: Group 1 (Control group, n = 25) received standard direct-acting antiviral therapy for 3months, while Group 2 (Zinc group, n = 25) received 50mg/day of zinc sulfate in addition to the standard direct-acting antiviral therapy for the same duration. Baseline and 3-month post-intervention assessments included evaluating serum levels of hyaluronic acid, transforming growth factor beta-1, and fibronectin. Furthermore, indices of liver fibrosis, such as the Fibrosis Index based on the 4 factors (FIB-4) and the Aspartate Transaminase-to-Platelet-Ratio Index (APRI), were calculated during these assessments. At baseline, the two studied groups had no statistical difference in demographic and laboratory data. After treatment, serum zinc levels significantly increased in the zinc-treated group compared to the control group. Additionally, serum fibronectin and hyaluronic acid levels were significantly reduced in group 2 (zinc group) compared to group 1 (control group). Moreover, zinc group showed lower APRI scores than the control group after a 3-month follow-up period, but there was non-significant difference in FIB-4 scores between the two groups after treatment. Furthermore, total bilirubin levels were reduced after zinc therapy for 3months. Administering zinc sulfate could potentially serve as a safe and efficient therapeutic strategy for the management of hepatic fibrosis in individuals with chronic hepatitis C virus. ClinicalTrials.gov identifier: NCT05465434, On 19/7/2022.

Adverse impact of metabolic dysfunction on fibrosis regression following direct-acting antiviral therapy: A multicenter study for chronic hepatitis C.

Direct-acting antivirals (DAAs) effectively eradicate hepatitis C virus (HCV). This study investigated whether metabolic dysfunction influences the likelihood of fibrosis regression after DAA treatment in patients with chronic hepatitis C (CHC). This multicenter, retrospective study included 8,819 patients diagnosed with CHC who were treated with DAAs and achieved a sustained virological response (SVR) between January 2014 and December 2022. Fibrosis regression was defined as a 20% reduction in noninvasive surrogates for liver fibrosis, such as liver stiffness (LS) measured by vibration-controlled transient elastography (VCTE) and the fibrosis-4 (FIB-4) score. Hypercholesterolemia (h-TC) were defined as >200 mg/dL. The median age of the study population was 59.6 years, with a predominance of male patients (n = 4,713, 57.3%). Genotypes 1, 2, and others were confirmed in 3,872 (46.2%), 3,487 (41.6%), and 1,024 (12.2%) patients, respectively. Diabetes mellitus (DM) was present in 1,442 (17.2%) patients and the median LS was 7.50 kPa (interquartile range, 5.30-12.50). Multivariate analysis revealed that the presence of DM and pre-DAA h-TC were independently associated with a decreased probability of fibrosis regression by VCTE Additionally, pre-DAA h-TC was independently associated with a decreased probability of fibrosis regression by the FIB-4. Metabolic dysfunction has an unfavorable influence on fibrosis regression in patients with CHC who achieve SVR after DAA treatment.

Analysis of Repeat Hepatitis C Viremia After Sustained Virologic Response in a Large Cohort of U.S. Veterans.

Chronic hepatitis C virus (HCV) infection affects >1% of the U.S. population, higher among U.S. Veterans. Direct-acting antiviral (DAA) medications are effective for viral cure, termed sustained virologic response (SVR), but repeat viremia after SVR is recognized. Prior work has been limited by use of electronic medical record data. We aim to better understand repeat viremia in the DAA era through detailed chart review. We identified 1,129 individuals from Veteran's Health Administration (VHA) who achieved SVR using DAA therapy but subsequently had detectable serum HCV nucleic acid. A random subset of 110 were chart reviewed and assigned one of four categories using laboratory, diagnosis, and chart review data: definite reinfection (25.5%), probable reinfection (25.5%), false positive (11.8%), and presumed late relapse (37.3%). We conducted between-group analysis of variance to identify demographic, behavioral, and laboratory features specific to each. In our medical record cohort (n=1,129), substance use and unstable housing were common and median time to repeat viremia was 1.9 years. In our chart review cohort (n=110), younger age (18-34) and substance use were more frequent in definite or probable reinfection. Presumed relapse had comparatively more comorbid hepatocellular carcinoma (HCC) (20%, p<0.05) and more than half occurred prior to 1 year. The unique category of false positive has not previously been reported. This study deepens understanding of HCV reinfection and relapse and highlights important features including the HCV and opioid syndemic, contribution of laboratory error, possibility of a viral reservoir in HCC, and clinical engagement implications for those with ongoing risk.

Metabolomic Changes Associated With the Change in HVPG After DAAs Therapy in HCV Cirrhotic Patients.

In response to direct-acting antivirals (DAAs) therapy, patients who experience a decrease in hepatic venous pressure gradient (HVPG) considerably reduce liver complications and have increased survival. This study aimed to assess the metabolomic changes associated with the changes in HVPG from the start of DAA therapy until 48 weeks after effective DAA therapy in patients with advanced HCV-related cirrhosis. We carried out a multicenter longitudinal study in 31 patients with advanced hepatitis C virus (HCV)-related cirrhosis. We performed a non-targeted metabolomic analysis using gas chromatography-mass spectrometry and liquid chromatography-mass spectrometry, as well as analysis of inflammation-related biomarkers using Luminex technology. The statistical analysis was performed by Generalised Linear Mixed-effects Models (GLMM), correcting for multiple testing. We found that increases of 2,3-butanediol (AMR = 1.15; q-value = 0.023) and taurocholic acid (AMR = 1.06; q-value < 0.001) were significantly associated with increases in HVPG and inflammatory biomarker levels from before DAA therapy to one year after completion of successful HCV treatment. These metabolites have a potential role as indicators of portal hypertension evolution.

Evaluation of liver fibrosis in HCV-infected patients using two-dimensional shear-wave elastography (2D-SWE) before and after antiviral treatment.

Chronic hepatitis C virus infections can lead to liver fibrosis. Appropriate treatment of chronic hepatitis C may result in significant fibrosis reversal. The best method to assess liver fibrosis is an invasive hepatic biopsy. Among non-invasive options, one of the most recent methods is two-dimensional shearwave elastography, which allows real-time visualization of liver stiffness. The purpose of this study was to analyze changes in liver fibrosis among patients with hepatitis C virus receiving direct-acting antiviral therapy. Five different elastographic measurements in kilopascals were performed in a group of 50 patients before direct-acting antiviral treatment, at the end of treatment, and 24 weeks after the end of treatment, using an Aixplorer® (Supersonic Imagine, France) ultrasound device. The results were correlated with biochemical serum tests, specifically the Fibrosis-4 and AspAT-to-platelet ratio indices. Time-dependent alterations of all of the parameters were observed, including a significant decrease in liver stiffness in comparison to baseline values (before treatment). A moderate correlation between liver stiffness measurement values and both Fibrosis-4 and AspAT-to-platelet ratio indices was observed. Interestingly, only liver stiffness and blood platelet count changed over time, regardless of the sex and age of the patient. Two-dimensional shear-wave elastography combined with non-invasive serologic tests like Fibrosis-4 and AspAT-to-platelet ratio indices is a sufficient tool for evaluating liver fibrosis regression during and after direct-acting antiviral therapy.

Incidence and Factors of Hepatocellular Carcinoma in Hepatitis C Virus Patients Achieving Sustained Virological Response After Direct-Acting Antiviral Treatment

Background: The incidence and risk factors for Hepatocellular Carcinoma (HCC) in Hepatitis C Virus (HCV) patients who have achieved Sustained Virological Response (SVR) after Direct-Acting Antiviral (DAA) therapy are not well established. Considering there are differences in DAA types, virus genotypes, and patient profiles in Indonesia, this study was conducted to assess the incidence and factors influencing HCC in HCV patients after SVR post DAA therapy. The objective of this study to determine the incidence and factors influencing HCC in HCV patients achieving SVR after DAA treatment.Methods: Retrospective cohort study conducted at Cipto Mangunkusumo National General Hospital, sample of HCV patients had SVR after DAA therapy in 2017 – 2019, followed until 2024. Patients were screened for abdominal ultrasound, alpha-fetoprotein (AFP) and 3-phase abdominal CT scan, if indicated. Descriptive, bivariate analysis with Fisher's exact, and multivariate analysis with logistic regression were conducted.Results: Among 180 subjects, the incidence and incidence ratio of HCC is 4.4% (0.91/100PY). Significant correlation in bivariate analysis from the variables liver cirrhosis (RR 10.5; CI 95% (1. 32 – 83.5); p = 0.0073) and type 2 DM (RR 8.47; CI 95% (2, 3 – 31.1) p = 0.0048). In multivariate analysis, there was significant correlation from type 2 DM variable (aRR 3.1; CI 95% (0.86 – 3.83); p=0.002).Conclusion: The incidence of HCC reaches 4.4% of the total population. Type 2 DM has significant correlation with the incidence of HCC in HCV patients who achieve SVR after DAA treatment.Keywords: Direct-Acting Antiviral, Hepatitis C Virus, Hepatocellular Carcinoma, Incidence, Sustained Virological Response

Hepatitis C Virus Infection in Hemodialysis Patients in the Era of Direct-Acting Antiviral Treatment: Observational Study and Narrative Review.

Background and Objectives: Hepatitis C virus (HCV) infection is a major global public health concern, particularly in hemodialysis (HD) patients. This study aims to evaluate the demographic, clinical, and laboratory characteristics of HCV-positive patients undergoing HD and assess the long-term impact of direct-acting antivirals (DAAs) on patient outcomes. Moreover, a narrative review aims to summarize the current knowledge regarding HCV treatment in HD patients. The search in the PubMed, Google Scholar, and Scopus databases identified 48 studies relevant to our topic, 18 regarding clinical history and 29 related to HCV treatment. Methods: A retrospective analysis was performed on 165 HD patients from Bihor County HD centers, Romania, between 2014 and 2024. The cohort was divided into two groups: 54 patients who tested positive for HCV and 111 controls who were HCV-negative. Data collected from GPs included demographic information, comorbidities, laboratory parameters, and psychological assessments. Outcomes were evaluated at over 5 years after DAA treatment. A literature review was conducted using PubMed and Google Scholar to identify relevant studies on HCV in HD patients from 1989 to 2024. Results: Laboratory results showed similar parameters across groups, except for lower serum cholesterol levels in the HCV-positive DAA-treated group vs. HCV-positive non-treated ones (155.607 mg% vs. 170.174 mg%, p = 0.040) and increased ALT levels when comparing the same groups (29.107 vs. 22.261, p = 0.027), whereas comorbidities did not differ significantly. The incidence of malignancies was significantly higher among HCV-positive compared to HCV-negative patients (20.3% vs. 8.1%, p = 0.023), mainly among those treated with DAAs, highlighted by the multivariate analysis. Cardiovascular disease remains the leading cause of mortality regardless of HCV status or the use of antiviral therapy. Psychological assessments revealed more severe depression in HCV-positive patients compared to their HCV-negative counterparts. Conclusions: HCV infection in the hemodialysis population typically follows a subclinical course. At over five years after DAA therapy, the results indicate a stabilization of the liver function and the absence of major complications. However, the incidence of malignancies remains high in HCV-positive patients.

Health-related Quality of Life in Children and Adolescents After Successful Treatment of Chronic Hepatitis C With Sofosbuvir/Velpatasvir: One-year Outcomes.

The aim of this study was to assess the health-related quality of life (HRQL) of children with chronic hepatitis C (CHC) at 1 year after the effective treatment with sofosbuvir/velpatasvir (SOF/VEL). All 50 patients treated for CHC with a fixed dose SOF/VEL in the noncommercial, nonrandomized, open-label PANDAA-PED study achieved sustained virologic response at 12 weeks after the end of treatment. Evaluation of HRQL at 1-year posttreatment was compared with the baseline (before the treatment) assessment. KIDSCREEN-27 questionnaires, which included 5 dimensions of HRQL, for child self-reporting and parent proxy reporting were used. The normal range for the population was set to T values of 40-60 points. Child-parent agreement was analyzed using the intraclass correlation coefficient (ICC). Mean T values were within the normal range for all HRQL dimensions. A significant improvement in "autonomy & parent relation" in children's self-assessment (from 48.3 to 51.5, P = 0.03) was observed. In parent proxy assessment, a significant decrease occurred in "school" dimension (from 49.5 to 45.8, P = 0.03), which was not revealed at 3-month posttreatment. Older age was associated with worse HRQL scores in all dimensions. Evaluation of the ICC for child self-reports versus parent proxy reports revealed poor-to-moderate agreement for most single measures, lower than at 3-month posttreatment analysis. This is the first study to present the long-term influence of treatment with direct-acting antivirals on patient-reported outcomes in children. At 1 year after effective treatment with SOF/VEL, an improvement in some areas of children's well-being was revealed, which may indicate also some patient-reported outcomes benefits of direct-acting antiviral therapy. Despite the improvement in the child self-report of "autonomy & parent relation," there was a more pronounced discrepancy between children self-reports and parents proxy reports in all dimensions of HRQL. Older patients' age correlated with worse HRQL assessment. If this finding is mediated by the duration of hepatitis C virus infection, it would support recommendation for the treatment of younger children.

Serum levels of interleukin-10 in both responders and non-responders to Direct-acting antivirals therapy for the hepatitis C virus

Serum levels of interleukin-10 in both responders and non-responders to Direct-acting antivirals therapy for the hepatitis C virus

Real-World Experience, Effectiveness, and Safety of Direct-Acting Antivirals for the Treatment of Hepatitis C in Oman: A Cross-Sectional, Multicenter Study.

Background: The advent of direct-acting antiviral (DAA) therapy has revolutionized the treatment landscape of the hepatitis C virus (HCV) infection. This study aimed to provide a comprehensive research study of the real-world effectiveness and safety of DAA treatment, representing the first study conducted in the Omani population. Methods: A cross-sectional study was conducted including 375 HCV patients with different genotypes, treated using different DAA regimens, with or without ribavirin, between January 2012 and December 2020 at the Sultan Qaboos University Hospital and the medical city for military and security services, two tertiary hospitals in Muscat, Oman. The rate of sustained virologic response 12 weeks after completing the regimen (SVR-12) was analyzed as the primary outcome. Secondary outcomes included treatment safety and adverse events related to DAA therapy, as reported by patients and treating physicians. Results: A total of 375 patients were included in the study, with a mean age of 47.3 ± 15.4 years. Most were male (59.2%) and treatment-naïve (71.7%). The prevalence of liver cirrhosis was 19.7%, while 4.0% had hepatocellular carcinoma (HCC). The SVR-12 rate among treatment-naïve and treatment-experienced patients was 95.0% and 93.4%, respectively. Several parameters were associated with DAA treatment failure, including liver cirrhosis (p = 0.004) and active HCC (p = 0.009). Following SVR-12, significant improvements were observed in alanine transaminase, bilirubin, and albumin levels, Fibrosis-4 Index, and liver stiffness measurements compared to baseline (p <0.001 each). No significant adverse effects were reported. Conclusions: Based on our real-world experience, DAAs are highly effective in treating patients with HCV infection in Oman, with an excellent tolerability and safety profile.

Implementation of a novel framework for hepatitis C diagnosis and treatment in an academic health system.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Hepatitis C viral infection is a major public health concern and leading cause of chronic liver disease in the United States. Hepatitis C is primarily transmitted through blood exchange and is highly prevalent among people who inject drugs. Despite the availability of direct-acting antiviral (DAA) treatment, cost and barriers to access remain prohibitive for many patients. In 2018, University of Kentucky HealthCare (UKHC) began a screening program for patients admitted to its emergency department (ED). Despite identifying hepatitis C RNA-positive patients, connection to care proved challenging due to unavailability of follow-up clinic appointments, communication barriers, and lack of insurance coverage. In 2023, UKHC implemented a pharmacist-led hepatitis C screening, assessment, and treatment initiative in the ED following American Association for the Study of Liver Diseases (AASLD) simplified treatment guidelines. Pharmacists order needed laboratory assessments and complete imaging for liver fibrosis in eligible patients. Patients diagnosed with hepatitis C who meet simplified treatment criteria are prescribed DAA therapy by a hepatitis C advanced practice provider employed by the program. The UKHC specialty pharmacy then follows up with dispensing of DAA therapy and proactive refill management for subsequent fills. This holistic, interdisciplinary treatment model has allowed UKHC to increase treatment attachment rates for hepatitis C diagnoses in the ED from approximately 10% to 54%. This program has also reduced the median time to treatment of hepatitis C-infected individuals encountered in the ED from approximately 420 days to 17 days.

Control and Elimination of Hepatitis C Virus Among People With HIV in Australia: Extended Follow-up of the CEASE Cohort (2014-2023).

Approximately 10% of people with HIV in Australia had active hepatitis C virus (HCV) infection prior to availability of government-subsidized direct-acting antiviral (DAA) therapy in 2016. This analysis evaluated progress toward HCV elimination among people with HIV in Australia between 2014 and 2023. The CEASE cohort study enrolled adults with HIV with past or current HCV infection (anti-HCV antibody positive) from 14 primary and tertiary clinics. Biobehavioral, clinical, and virologic data were collected at enrollment (2014-2016), follow-up 1 (2017-2018), and follow-up 2 (2021-2023). HCV treatment uptake, outcome, and HCV RNA prevalence (current infection) were evaluated. Death and HCV reinfection incidence and risk were assessed. Of 402 participants, 341 (85%) had current HCV infection (RNA positive) at enrollment. Among the sample, 83% were gay and bisexual men, 13% had cirrhosis, and 80% had a history of injecting drug use (42%, past 6 months). DAA treatment was scaled up rapidly, with cumulative treatment uptake increasing from 12% in 2014 to 2015 to 92% in 2022 to 2023. HCV RNA prevalence declined from 85% (95% CI, 81%-88%) at enrollment (2014-2016) to 8% (95% CI, 6%-12%) at follow-up 1 (2017-2018) and 0.5% (95% CI, 0%-3%) at follow-up 2 (2020-2023). Sixteen reinfections occurred (incidence, 1.41 per 100 person-years; 95% CI, .81-2.29) as well as 30 deaths (incidence, 1.64 per 100 person-years; 95% CI, 1.11-2.34). HCV reinfection incidence declined over time while mortality remained stable. Universal access and rapid DAA uptake were associated with a dramatic reduction in HCV prevalence and reinfection incidence among people with HIV to levels consistent with microelimination. Registration: NCT02102451 (ClinicalTrials.gov).

Pharmacological interactions in novel oral anticoagulants, statins, and hypertension drugs in patients treated with direct-acting antivirals for hepatitis C: a Delphi Consensus project

To date, no retrospective or real-world studies have comprehensively examined the interactions between direct-acting antivirals (DAAs) and widely used medications such as novel oral anticoagulant, statins, and antihypertensive agents. However, clinical experience from key opinion leaders may guide physicians in managing these interactions in patients undergoing DAA treatment. This study aims to elucidate the interactions between DAAs and commonly prescribed drugs in patients with prevalent comorbidities (e.g., type II diabetes, hypertension, and dyslipidemia), with a particular focus on those receiving polytherapy with cardiovascular drugs while undergoing DAA treatment for hepatitis C. The clinicians’ experience was combined with input from a qualified expert panel using a Consensus Delphi approach. The findings of this study offer essential and practical recommendations that can be readily applied in everyday clinical practice, helping physicians in managing hepatitis C virus patients undergoing DAA therapy.

Elimination of HCV Infection: Recent Epidemiological Findings, Barriers, and Strategies for the Coming Years.

Hepatitis C is a disease for which in approximately 30 years we have gone from the discovery of the causative agent in 1989, to the introduction of direct-acting antiviral (DAAs) therapies starting from 2011, and to a proposal for its elimination in 2016, with some countries being on track for this goal. Elimination efforts, in the absence of a vaccine, rely on prevention measures and antiviral therapies. However, treatment rates have declined in recent years and are not considered adequate to achieve this goal at a global level. This poses a great epidemiological challenge, as HCV in many countries still causes a significant burden and most infected people are not yet diagnosed. Consequently, efforts are needed at different levels with common purposes: to facilitate access to screening and diagnosis and to improve linkage to care pathways. In this review, we discuss the latest epidemiological findings on HCV infection, the obstacles to its elimination, and strategies that are believed to be useful to overcome these obstacles but are applied unevenly across the world.

Clinical factors to predict changes of esophagogastric varices after sustained viral response with direct-acting antiviral therapy.

The clinical course of esophagogastric varices (EGV) after sustained virological response (SVR) with direct-acting antiviral (DAA) therapy has not been clearly elucidated. The predictors for the worsening/improvement of EGV after SVR with DAA therapy were investigated. Of the cirrhosis patients who achieved SVR with DAA therapy, 328 patients who underwent endoscopic examinations both before and after DAA therapy were enrolled. The predictors of EGV worsening or improvement were investigated. Multivariate analysis identified a history of ascites retention, albumin at baseline, and MELD score at baseline as independent factors that contributed to EGV exacerbation. On multivariate analysis, two factors, BMI and platelet count, were related to EGV improvement. An integrated scoring system was created using these risk factors with or without weighting according to each hazard ratio, and the patients were divided into three groups. A scoring system with weighting of each factor appeared to be more useful, with fewer intermediate patients and more cases classified into the low-risk and high-risk groups. Esophagogastric varices after SVR have a varied clinical course. Using this scoring system that can accurately predict EGV outcomes in clinical settings, it may be feasible to establish a risk-based EGV surveillance plan following SVR.

Hepatitis C Infection Confirmation and Fewer Visits Contribute to Improving Treatment Rates in a Predominantly African American Health Center

Background/Objectives: The approval of direct-acting antiviral (DAA) therapy for hepatitis C (HCV) resulted in a highly effective oral treatment for patients. The primary objective of this study was to identify reasons that patients were not treated versus why patients were treated. Identifying potential reasons for the failure to treat can provide a pathway to interventions using evidence-based data. Methods: The electronic medical records in an urban predominately African American (AA) population were searched for all patients with HCV seen at least once in a Gastroenterology or Infectious Disease clinic in 2019. Data collected included demographics, treatment visits, laboratory data, insurance and ZIP codes for median income. Results: Of the 441 patients who were not yet treated at the first 2019 visit, only 43% were treated by July 2020. Insurance and median income were not factors in failure to treat. Patients with an average of four visits were more likely to be treated than those with two or less, suggesting that failure to follow up was a significant factor for patient treatment (42% vs. 8% p &lt; 0.0001). Confirmation of viral infection at first visit was an important factor with respect to treatment (treated 38% vs. not treated 25% p &lt; 0.02). Conclusions: Significant numbers of our patients (57%) failed to be treated after at least one clinic visit. The two critical factors were PCR confirmation prior to the initial visit and the requirement for multiple visits before the initiation of treatment. Since the degree of fibrosis had no impact on treatment, initiating treatment immediately after confirming infection with HCV should improve patient treatment rates and outcomes.

Real-life data of hepatitis C treatment with direct acting antiviral therapy in persons injecting drugs or on opioid substitution therapy.

HCV treatment has been revolutionized by introduction of direct-acting antiviral therapy (DAA). Short treatment duration of eight to twelve weeks combined with significantly improved tolerability opened the opportunity to reach out to difficult-to-treat populations. Here, we retrospectively analyzed real life data on HCV treatment adherence and outcome in people who inject drugs (PWID) or on opioid substitution therapy (OST). All PWID or on OST receiving DAA therapy between 3/2021-11/2022 at an infectious disease clinic in Bonn were retrospectively analyzed. Patients received either 8weeks glecaprevir/pibrentasvir or 12weeks sofosbuvir/velpatasvir (+ ribavirin in genotype 3 cirrhotic patients). Sustained virological response (SVR) was measured 4 and 12weeks after HCV therapy. In our cohort 47 patients (68%) received treatment with glecaprevir/pibrentasvir and 22 patients (32%) sofosbuvir/velpatasvir. All 47 (100%) patients started on glecaprevir/pibrentasvir received prescriptions for the full length of therapy, while patients on sofosbuvir/velpatasvir completed 12weeks therapy in 86% and 8weeks in 14% (p = 0.029). Of 69 patients 74% were found to achieve SVR. In 20% no information is available as they were lost to follow-up. Re-infection was documented in 3 patients and one relapse in a gt3 patient with cirrhosis. High adherence and response rates to HCV treatment were found following DAA based therapy in PWID supporting the call to include difficult-to-treat populations into HCV treatment efforts on the way to HCV elimination. Treatment of OST and HCV at one institution supporting patients by a multidisciplinary team may further facilitate adherence to follow up visits enabling documentation of treatment outcomes more easily.