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Chronic viral hepatitis infection affects an estimated 325 million people globally. People who initiate treatment after significant disease progression face increased risk of severe liver complications and death. Data are scarce on the characteristics and risk factors of people who present late to care in Spain and globally. Data were collected from January 2018 to December 2019 to report late presentation (LP) to specialist care at 11 large university hospitals in Spain to assess related risk factors using a multivariable logistic regression model. 2290 (CHB = 505, CHC = 1785) patients were analysed, with 581 (25.2%) presenting late. Hepatitis C patients more frequently reported LP compared to hepatitis B patients (28.1% vs 15.0%; p < 0.001). Older age (p < 0.001), being male (p < 0.001), being Spanish-born (p < 0.001), and having an unknown origin of referral (p = 0.08) were associated with a higher likelihood of LP. Advanced liver disease was identified in 533 (23%) patients and late-stage liver disease in 124 (5.4%). LP, including with irreversible liver damage, to viral hepatitis specialist care is frequent in Spain, despite being a country with unrestricted treatment access. Initiatives to reduce LP should specifically target men, older individuals, foreign-born populations for CHB, and Spanish nationals for CHC.

ObjectiveTo develop a domain-specific large language model (LLM) for LI-RADS v2018 categorization of hepatic observations based on free-text descriptions extracted from MRI reports.Material and methodsThis retrospective study included 291 small liver observations, divided into training (n = 141), validation (n = 30), and test (n = 120) datasets. Of these, 120 were fictitious, and 171 were extracted from 175 MRI reports from a single institution. The algorithm’s performance was compared to two independent radiologists and one hepatologist in a human replacement scenario, and considering two combined strategies (double reading with arbitration and triage). Agreement on LI-RADS category and dichotomic malignancy (LR-4, LR-5, and LR-M) were estimated using linear-weighted κ statistics and Cohen’s κ, respectively. Sensitivity and specificity for LR-5 were calculated. The consensus agreement of three other radiologists served as the ground truth.ResultsThe model showed moderate agreement against the ground truth for both LI-RADS categorization (κ = 0.54 [95% CI: 0.42–0.65]) and the dichotomized approach (κ = 0.58 [95% CI: 0.42–0.73]). Sensitivity and specificity for LR-5 were 0.76 (95% CI: 0.69–0.86) and 0.96 (95% CI: 0.91–1.00), respectively. When the chatbot was used as a triage tool, performance improved for LI-RADS categorization (κ = 0.86/0.87 for the two independent radiologists and κ = 0.76 for the hepatologist), dichotomized malignancy (κ = 0.94/0.91 and κ = 0.87) and LR-5 identification (1.00/0.98 and 0.85 sensitivity, 0.96/0.92 and 0.92 specificity), with no statistical significance compared to the human readers’ individual performance. Through this strategy, the workload decreased by 45%.ConclusionLI-RADS v2018 categorization from unlabelled MRI reports is feasible using our LLM, and it enhances the efficiency of data curation.Critical relevance statementOur proof-of-concept study provides novel insights into the potential applications of LLMs, offering a real-world example of how these tools could be integrated into a local workflow to optimize data curation for research purposes.Key PointsAutomatic LI-RADS categorization from free-text reports would be beneficial to workflow and data mining.LiverAI, a GPT-4-based model, supported various strategies improving data curation efficiency by up to 60%.LLMs can integrate into workflows, significantly reducing radiologists’ workload.

INTRODUCTION:Glecaprevir/pibrentasvir (G/P) is approved for adults infected with hepatitis C virus (HCV) genotypes 1–6. In clinical trials, G/P was associated with high rates of sustained virologic response at post-treatment Week 12 (SVR12) and was well tolerated. Currently, real-world evidence (RWE) regarding G/P use is being collected. A systematic review and meta-analysis of RWE reporting the effectiveness and safety of G/P were undertaken.METHODS:Biosis, Derwent Drug File, Embase®, International Pharmaceutical Abstracts, Medline®, and SciSearch databases were searched using pre-defined terms for “G/P” and “RWE” to identify real-world prospective/retrospective studies (1 January 2017‒15 October 2018) that reported SVR12 and/or safety parameters in HCV-infected adults (N ≥ 20) treated with G/P. Congress presentations up to 12 November 2018 were included. Random effects meta-analysis was used to determine SVR12 and naïve pooling for adverse event (AE) rates. Intention-to-treat (ITT) SVR12 analyses included all patients dosed with G/P; modified ITT (mITT) excluded those who had non-virologic failure.RESULTS:10,048 adults treated with G/P in 16 studies were included; ITT SVR12 rates were reported in 14 studies and mITT SVR12 rates in 11 studies. SVR12 rates overall and by subgroups based on ITT and mITT populations are shown (Table 1). AEs were summarised in 6 studies and reported in 12.7% (724/5685) of patients. Treatment discontinuations due to AEs were summarised in 5 studies and reported in 0.5% (24/4508) of patients. The most frequent AEs were pruritus (4.7%; 126/2698), fatigue (4.4%; 146/3305), and headache (2.7%; 102/3759). SVR12 and safety data will be updated in the final presentation.CONCLUSION:Consistent with results observed in clinical trials, RWE indicates that G/P is a well-tolerated and highly effective pangenotypic treatment option for a broad range of HCV-infected patients.

Virological response to peginterferon + ribavirin (P+R) at week 4 can predict sustained virological response (SVR). While patients with rapid virological response (RVR) do not require triple therapy, patients with a decline <1 log10 IU/ml HCVRNA (D1L) should have treatment discontinued due to low SVR rate. To develop a tool to predict first 4 weeks' viral response in patients with hepatitis C genotype 1&4 treated with P+R. In this prospective and multicenter study, HCV mono-infected (n=538) and HCV/HIV co-infected (n=186) patients were included. To develop and validate a prognostic tool to detect RVR and D1L, we segregated the patients as an estimation cohort (to construct the model) and a validation cohort (to validate the model). D1L was reached in 509 (80.2%) and RVR in 148 (22.5%) patients. Multivariate analyses demonstrated that HIV co-infection, Forns' index, LVL, IL28B-CC and Genotype-1 were independently related to RVR as well as D1L. Diagnostic accuracy (AUROC) for D1L was: 0.81 (95%CI: 0.76 ̶ 0.86) in the estimation cohort and 0.71 (95%CI: 0.62 ̶ 0.79) in the validation cohort; RVR prediction: AUROC 0.83 (95%CI: 0.78 ̶ 0.88) in the estimation cohort and 0.82 (95%CI: 0.76 ̶ 0.88) in the validation cohort. Cost-analysis of standard 48-week treatment indicated a saving of 30.3% if the prognostic tool is implemented. The combination of genetic (IL28B polymorphism) and viral genotype together with viral load, HIV co-infection and fibrosis stage defined a tool able to predict RVR and D1L at week 4. Using this tool would be a cost-saving strategy compared to universal triple therapy for hepatitis C.

BackgroundPrevious studies have evaluated the risk of DDI in HCV patients receiving pDAA, but all based on pairwise interaction. The aim of the study was to describe the prevalence of the risk of potential multiple DDI and its clinical impact in patients treated with pDAAs.MethodsA retrospective observational study from a Spanish database of 1.8 million inhabitants, including patients treated with SOF/VEL or GLE/PIB (2017- 2020). Demographics, comorbidities, comedications, and DDIs were evaluated for the pDAA therapy period. The severity and impact of the DDIs were evaluated using the University of Liverpool tool. Additionally, the ICD-9 coding system was used to identify the presence of SADR during the treatment with pDAAs. An indirect indicator of effectiveness was evaluated (requirement of a new DAA in the 6 months after the end of the pDAA).Results1620 patients were included; 730 with SOF/VEL (median age: 55 y; 37.8% F3/4) and 890 with GLE/PIB (53 y; 28% F3/4). The most prescribed drugs were nervous drugs (35.8%), digestive (24.1%) and cardiovascular (14.2%). The number of patients receiving ≥ 2 comedications at risk of multi-DDI with pDAAs was 123 (9.8%), 52 with SOF/VEL and 71 with GLE/PIB. Patients showing increased risk in comedication as a DDI outcomes were 31% (22) with GLE/PIB and 11% (6) with SOF/VEL (p <0.001). Regarding SADR, there was a higher number in GLE/PIB group (14) vs. SOF/VEL group (4) (p <0.05). 84% (16/18) of patients with SADR had a multi-DDI profile. Most SADR was reported in the statin group, being the percentage higher in GLE/PIB group vs. SOF/VEL group (p <0.05). Both pDAAs showed a similar percentage of patients restarting a new pDAA within the 6 months after the end of treatment (1.0% and 1.1% respectively, p=NS).ConclusionsIn Spain, about 10% of HCV patients taking ≥ 2 comedications are at risk of multiple DDI with pDAAs. The potential risk of increased comedication as a DDI outcome and the presence of suspected adverse reactions were higher in GLE/PIB in comparison with SOF/VEL.

A reduction in hepatic venous pressure gradient (HVPG) of > or =20% of baseline or to < or =12 mmHg (responders) is associated with a reduced risk of first variceal bleeding. The aim of this study was to evaluate whether this protective effect is maintained in the long term and if it extends to other portal hypertension complications. Seventy-one cirrhotic patients with esophageal varices and without previous variceal bleeding who entered into a program of prophylactic pharmacological therapy and were followed for up to 8 yr were evaluated. All had two separate HVPG measurements, at baseline and after pharmacological therapy with propranolol +/- isosorbide mononitrate. Forty-six patients were nonresponders and 25 were responders. Eight-year cumulative probability of being free of first variceal bleeding was higher in responders than in nonresponders (90% vs 45%, p= 0.026). The lack of hemodynamic response and low platelet count were the only independent predictors of first variceal bleeding. Additionally, reduction of HVPG was independently associated with a decreased risk of spontaneous bacterial peritonitis (SBP) or bacteremia. No significant differences in the development of ascites, hepatic encephalopathy, or survival were observed. The hemodynamic response in cirrhotic patients is associated with a sustained reduction in the risk of first variceal bleeding over a long-term follow-up. Reduction of HVPG also correlate with a reduced risk of SBP or bacteremia.

Background and AimsHIV-positive patients on tenofovir hydroxyl fumarate (TDF)/emtricitabine have a lower risk of COVID-19 and hospitalization than those given other treatments. Our aim was to analyze the severity of COVID-19 in patients with chronic hepatitis B (CHB) on TDF or entecavir (ETV).MethodsSpanish hospital databases (n = 28) including information regarding adult CHB patients on TDF or ETV for the period February 1st to November 30th 2020 were searched for COVID-19, defined as a positive SARS-CoV-2 polymerase chain reaction, and for severe COVID-19.ResultsOf 4736 patients, 117 had COVID-19 (2.5%), 67 on TDF and 50 on ETV. Compared to patients on TDF, those on ETV showed (p < 0.05) greater rates of obesity, diabetes, ischemic cardiopathy, and hypertension. COVID-19 incidence was similar in both groups (2.3 vs. 2.6%). Compared to TDF, patients on ETV more often (p < 0.01) had severe COVID-19 (36 vs. 6%), required intensive care unit (ICU) (10% vs. 0) or ventilatory support (20 vs. 3%), were hospitalized for longer (10.8 ± 19 vs. 3.1 ± 7 days) or died (10 vs. 1.5%, p = 0.08). In an IPTW propensity score analysis adjusted for age, sex, obesity, comorbidities, and fibrosis stage, TDF was associated with a sixfold reduction in severe COVID-19 risk (adjusted-IPTW-OR 0.17, 95%CI 0.04–0.67, p = 0.01).ConclusionCompared to ETV, TDF seems to play a protective role in CHB patients with SARS-CoV-2 whereby the risk of severe COVID-19 is lowered.

BackgroundMASLD can manifest as hepatocellular damage, which can result in mild elevation of aminotransferases. However, in some patients, MASLD presents with cholestatic pattern.ObjectiveTo assess the impact of the biochemical pattern on the natural course of MASLD, including liver damage in histology, the accuracy of non-invasive tests(NITs), and prognosis.MethodsMulticenter study enrolling 2156 patients with biopsy-proven MASLD, who were classified based on their[ALT/ULN)]/[(ALP/ULN)] levels at the time of biopsy: (a) hepatocellular pattern(H), > 5; (b) mixed pattern(M),2–5; (c) cholestatic pattern(C), < 2. Outcomes: (a) histological evaluation of the single components of NAS, MASH, and fibrosis; (b) NITs and transient elastography assessing advanced fibrosis; (c) prognosis determined by the appearance of decompensated cirrhosis and death.ResultsOut of the 2156 patients, 22.9% exhibited the H-pattern, whilst 31.7% exhibited the C-pattern. Severe steatosis, ballooning, lobular inflammation, and MASH (56.4% H vs. 41.9% M vs. 31.9% C) were more common in H-pattern (p = 0.0001),whilst C-pattern was linked to cirrhosis (5.8% H vs. 5.6% M vs. 10.9% C; p = 0.0001). FIB-4(0.74(95% CI 0.69–0.79) vs. 0.83 (95% CI 0.80–0.85); p = 0.005) and Hepamet Fibrosis Score(0.77 (95% CI 0.69–0.85) vs. 0.84 (95% CI 0.80–0.87); p = 0.044)exhibited lower AUROCs in the H-pattern. The C-pattern[HR 2.37 (95% CI 1.12–5.02); p = 0.024], along with age, diabetes, and cirrhosis were independently associated with mortality. Most patients maintained their initial biochemical pattern during the second evaluation.ConclusionsThe H-pattern exhibited greater necro-inflammation in the histology than the C-pattern, whereas the latter showed more cirrhosis. The accuracy of NITs in detecting fibrosis was decreased in H-pattern. The occurrence of decompensated events and mortality was predominant in C-pattern. Therefore, identifying MASLD phenotypes based on the biochemical presentation could be relevant for clinical practice.