Economic evaluation of non-invasive liver tests for the diagnosis of liver fibrosis in chronic liver diseases: a systematic review protocol.

OBJECTIVE: The objective of this review is to determine the costs and benefits of non-invasive liver tests vs liver biopsy in patients with chronic liver diseases. INTRODUCTION: Hepatic diseases can lead to liver fibrosis, cirrhosis, and hepatocellular carcinoma. In the past, liver biopsy was the only option for diagnosing fibrosis degree. Liver biopsy is an invasive procedure that depends on the sample size to be able to deliver an accurate diagnosis. In recent years, non-invasive liver tests have been increasingly used to estimate liver fibrosis degree; however, there is a lack of economic assessments of technology implementation outcomes. INCLUSION CRITERIA: This review will include partial (cost studies) and complete economic evaluation studies on hepatitis B, hepatitis C, alcoholic liver disease, and non-alcoholic fatty liver disease that compare non-invasive liver tests with liver biopsies. Studies published in English, French, Spanish, German, Italian, or Portuguese will be included. No date limits will be applied to the search. METHODS: This review will identify published and unpublished studies. Published studies will be identified using MEDLINE (PubMed), Cochrane Library (CENTRAL), Embase, Web of Science, Scopus, and LILACS. Sources of unpublished studies and gray literature will include sources from health technology assessment agencies, clinical practice guidelines, regulatory approvals, advisories and warnings, and clinical trial registries, as well as Google Scholar. Two independent reviewers will screen and assess studies, and extract and critically appraise the data. Data extracted from the included studies will be analyzed and summarized to address the review objective using narrative text, and the JBI dominance ranking matrix. REVIEW REGISTRATION: PROSPERO CRD42023404278.

Metabolomics in chronic hepatitis C: Decoding fibrosis grading and underlying pathways.

BACKGROUND: Chronic Hepatitis C (CHC) affects 71 million people globally and leads to liver issues such as fibrosis, cirrhosis, cancer, and death. A better understanding and prognosis of liver involvement are vital to reduce morbidity and mortality. The accurate identification of the fibrosis stage is crucial for making treatment decisions and predicting outcomes. Tests used to grade fibrosis include histological analysis and imaging but have limitations. Blood markers such as molecular biomarkers can offer valuable insights into fibrosis. AIM: To identify potential biomarkers that might stratify these lesions and add information about the molecular mechanisms involved in the disease. METHODS: Plasma samples were collected from 46 patients with hepatitis C and classified into fibrosis grades F1 (n = 13), F2 (n = 12), F3 (n = 6), and F4 (n = 15). To ensure that the identified biomarkers were exclusive to liver lesions (CHC fibrosis), healthy volunteer participants (n = 50) were also included. An untargeted metabolomic technique was used to analyze the plasma metabolites using mass spectrometry and database verification. Statistical analyses were performed to identify differential biomarkers among groups. RESULTS: Six differential metabolites were identified in each grade of fibrosis. This six-metabolite profile was able to establish a clustering tendency in patients with the same grade of fibrosis; thus, they showed greater efficiency in discriminating grades. CONCLUSION: This study suggests that some of the observed biomarkers, once validated, have the potential to be applied as prognostic biomarkers. Furthermore, it suggests that liquid biopsy analyses of plasma metabolites are a good source of molecular biomarkers capable of stratifying patients with CHC according to fibrosis grade.

Brazilian evidence-based guideline for screening, diagnosis, treatment, and follow-up of metabolic dysfunction-associated steatotic liver disease (MASLD) in adult individuals with overweight or obesity: A joint position statement from the Brazilian Society of Endocrinology and Metabolism (SBEM), Brazilian Society of Hepatology (SBH), and Brazilian Association for the Study of Obesity and Metabolic Syndrome (Abeso).

Introduction: Metabolic dysfunction-associated steatotic liver disease (MASLD), previously known as Nonalcoholic fatty liver disease (NAFLD), is one of the most common hepatic diseases in individuals with overweight or obesity. In this context, a panel of experts from three medical societies was organized to develop an evidence-based guideline on the screening, diagnosis, treatment, and follow-up of MASLD. Material and methods: A MEDLINE search was performed to identify randomized clinical trials, meta-analyses, cohort studies, observational studies, and other relevant studies on NAFLD. In the absence of studies on a certain topic or when the quality of the study was not adequate, the opinion of experts was adopted. Classes of Recommendation and Levels of Evidence were determined using prespecified criteria. Results: Based on the literature review, 48 specific recommendations were elaborated, including 11 on screening and diagnosis, 9 on follow-up,14 on nonpharmacologic treatment, and 14 on pharmacologic and surgical treatment. Conclusion: A literature search allowed the development of evidence-based guidelines on the screening, diagnosis, treatment, and follow-up of MASLD in individuals with overweight or obesity.

Genetic Ancestry, Race, and Severity of Acutely Decompensated Cirrhosis in Latin America.

BACKGROUND & AIMS: Genetic ancestry or racial differences in health outcomes exist in diseases associated with systemic inflammation (eg, COVID-19). This study aimed to investigate the association of genetic ancestry and race with acute-on-chronic liver failure (ACLF), which is characterized by acute systemic inflammation, multi-organ failure, and high risk of short-term death. METHODS: This prospective cohort study analyzed a comprehensive set of data, including genetic ancestry and race among several others, in 1274 patients with acutely decompensated cirrhosis who were nonelectively admitted to 44 hospitals from 7 Latin American countries. RESULTS: Three hundred ninety-five patients (31.0%) had ACLF of any grade at enrollment. Patients with ACLF had a higher median percentage of Native American genetic ancestry and lower median percentage of European ancestry than patients without ACLF (22.6% vs 12.9% and 53.4% vs 59.6%, respectively). The median percentage of African genetic ancestry was low among patients with ACLF and among those without ACLF. In terms of race, a higher percentage of patients with ACLF than patients without ACLF were Native American and a lower percentage of patients with ACLF than patients without ACLF were European American or African American. In multivariable analyses that adjusted for differences in sociodemographic and clinical characteristics, the odds ratio for ACLF at enrollment was 1.08 (95% CI, 1.03-1.13) with Native American genetic ancestry and 2.57 (95% CI, 1.84-3.58) for Native American race vs European American race CONCLUSIONS: In a large cohort of Latin American patients with acutely decompensated cirrhosis, increasing percentages of Native American ancestry and Native American race were factors independently associated with ACLF at enrollment.

Hepatic epithelioid hemangioendothelioma: how fast does it grow and which findings could have prevented diagnostic delay?-a case report.

Background: Hepatic epithelioid hemangioendothelioma (HEHE) is a rare neoplastic disease of varied presentation and unspecific radiological signs in the early stages. The diagnostic delay can lead to metastatic disease, thus increasing the tumor burden and reducing the treatment options. HEHE is usually deemed a slow-growing tumor, but its speed of growth is poorly reported and still unknown. Case Description: In this case report, we documented a HEHE diagnosed in a young woman who had complaints of abdominal pain, weight loss and bloating for a long time. The typical findings observed in histological studies were not promptly recognized in the histological analyzes, even after two laparoscopic-guided liver biopsies, delaying the diagnosis until extrahepatic tumor spreading. Findings observed in computed tomography, magnetic resonance imaging and histological studies are presented. The coalescence of nodules and the rising of giant masses, occupying large parts of the liver in a specific time span, were registered and quantified. As opposed to prior reports, the results show that hepatic HEHE can grow rapidly, reinforcing the need of early diagnosis, thus avoiding the complications presented herein. Conclusions: The findings observed via radiological and histological imaging that could have avoided the diagnosis delay are depicted and discussed, showing that HEHE can rise faster than previously documented.

HLA-DRB1 Polymorphisms and Rheumatologic Manifestations in Chronic Hepatitis C.

BACKGROUND/AIMS: Hepatitis C has been associated with rheumatologic manifestations (HCV-related RM). Clinically, HCV-related RM may be indistinguishable from the symptoms that occur in diffuse connective tissue diseases (DCTD-related RM), making the differential diagnosis difficult. Host genetic factors, such as the Human Leukocyte Antigens (HLA) polymorphisms were associated with HCV infection, however, there are no studies that discriminate between HCVrelated RM and DCTD-related RM. This study focused on verifying associations between HLADRB1 and RM in patients with chronic hepatitis C, aiming to distinguish between DCTD-related RM and HCV-related RM. METHODS: The participants were 152 individuals, of both sexes, aged between 18 and 80 years, and affected by chronic hepatitis C. The patients underwent rheumatologic physical examination and HLA-class II (HLA-DRB1) typing was performed by PCR-SSO (Polymerase Chain Reactionsequence Specific Oligonucleotides). RESULTS: A significant number of patients with rheumatologic complaints (73%) not attributed to other causes was observed. DRB1*08 allele seems to confer protection against RM in chronic hepatitis C. There is no susceptibility association between HLA-DRB1 alleles and RM. CONCLUSION: The absence of association between HLA-DRB1 and the rheumatologic manifestations studied suggests that the pathophysiological pathways of DCTD-related RM and HCV-related RM are distinct.

Brazilian evidence-based guideline for screening, diagnosis, treatment, and follow-up of metabolic dysfunction-associated steatotic liver disease (MASLD) in adult individuals with overweight or obesity: A joint position statement from the Brazilian Society of Endocrinology and Metabolism (SBEM), Brazilian Society of Hepatology (SBH), and Brazilian Association for the Study of Obesity and Metabolic Syndrome (Abeso)

ABSTRACT Introduction: Metabolic dysfunction-associated steatotic liver disease (MASLD), previously known as Nonalcoholic fatty liver disease (NAFLD), is one of the most common hepatic diseases in individuals with overweight or obesity. In this context, a panel of experts from three medical societies was organized to develop an evidence-based guideline on the screening, diagnosis, treatment, and follow-up of MASLD. Material and methods: A MEDLINE search was performed to identify randomized clinical trials, meta-analyses, cohort studies, observational studies, and other relevant studies on NAFLD. In the absence of studies on a certain topic or when the quality of the study was not adequate, the opinion of experts was adopted. Classes of Recommendation and Levels of Evidence were determined using prespecified criteria. Results: Based on the literature review, 48 specific recommendations were elaborated, including 11 on screening and diagnosis, 9 on follow-up, 14 on nonpharmacologic treatment, and 14 on pharmacologic and surgical treatment. Conclusions: A literature search allowed the development of evidence-based guidelines on the screening, diagnosis, treatment, and follow-up of MASLD in individuals with overweight or obesity.

National Brazilian survey on the outcomes of hepatitis c retreatment in patients non-responders to direct antiviral agents.

BACKGROUND AND AIMS: Treatment of hepatitis C with direct antiviral agents (DAA) is associated with almost 95% of sustained virological response. However, some patients need retreatment. In Brazil, it should be done according to the Ministry of Health guidelines, frequently updated to include newly available drugs. This study aimed to conduct a national survey about the characteristics and outcomes of retreatment of hepatitis C in previously non-responders to DAAs. PATIENTS AND METHODS: Institutions from all over the country were invited to participate in a national registry for retreatment, including information about clinical and epidemiological characteristics of the patients, type and outcomes of retreatment regimens. Only patients previously treated with interferon-free regimens were included. RESULTS: As previous treatments the distribution was: SOF/DCV (56%), SOF/SIM (22%), 3D (11%), SOF/LED (6%) and SOF/RBV (5%). For retreatment the most frequently used drugs were SOF/GP (46%), SOF/DCV (23%) and SOF/VEL (11%). From 159 patients retreated, 132/159 (83%) had complete information in the registry and among them only seven patients were non-responders (SVR of 94.6%). All retreatments were well tolerated, without any serious adverse events or interruptions. CONCLUSION: The retreatment of patients previously non-responders to DAAs was associated with high rate of SVR in this sample of Brazilian patients. This finding allows us to conclude that the retreatment options available in the public health system in Brazil are effective and safe and are an important component of the strategy of elimination of hepatitis C in our country.

Factors associated with hepatitis C treatment adherence: an integrative review. / Fatores associados à adesão ao tratamento da hepatite C: revisão integrativa.

This integrative review examined factors associated with hepatitis C treatment adherence. The articles included were published in English, Spanish and Portuguese in the Lilacs, Medline, PsycINFO, Web of Science, Scopus and CINAHL databases, between 2000 and 2019. Initially, 540 publications were found and, after applying the study inclusion criteria, 22 articles were selected. Percentage non-adherence to treatment ranged from 12% to 32%. The variables identified as facilitating adherence were: receiving treatment for psychiatric disorders identified during treatment; knowing about medications and disease; receiving less complex treatment with greater likelihood of cure; fewer adverse events; social support; doctor-patient communication; and/or being in relationships. Barriers to adherence identified were: presence of depressive symptoms and other mental disorders; abuse of alcohol and psychoactive substances; education; age; ethnicity; unemployment; not having a steady partner; stigma; distance from health services; and the complexity and adverse effects of treatment. This review identified gaps in research on adherence.

Esta revisão integrativa propôs-se a analisar na literatura da área estudos sobre fatores associados à adesão ao tratamento da hepatite C. Foram pesquisados artigos, publicados em inglês, espanhol e português, nas bases de dados Lilacs, Medline, PsycINFO, Web of Science, Scopus e CINAHL, entre os anos 2000 a 2019. Foram obtidas, inicialmente, 540 publicações e, posteriormente, aplicando-se os critérios de inclusão estabelecidos, foram selecionados 22 artigos. Constatou-se nos artigos analisados que a porcentagem de não adesão ao tratamento variou de 12% a 32%. Foram identificados como facilitadores da adesão: receber tratamento para transtornos psiquiátricos identificados durante o tratamento, ter conhecimento sobre os medicamentos e doença, receber tratamento menos complexo e com maior possibilidade de cura, apresentar menor número de eventos adversos, ter apoio social e bom vínculo com o médico. Foram identificadas como barreiras à adesão: presença de sintomas depressivos e de outros transtornos mentais, uso abusivo de álcool e substâncias psicoativas, baixa escolaridade, idade (ser mais jovem); etnia (afro-americanos), desemprego, não ter parceiro fixo, relatar estigma, distância do serviço de saúde, complexidade e eventos adversos do tratamento. Foram também identificadas lacunas nas pesquisas sobre adesão.

Fatores associados à adesão ao tratamento da hepatite C: revisão integrativa / Factors associated with hepatitis C treatment adherence: an integrative review

Resumo Esta revisão integrativa propôs-se a analisar na literatura da área estudos sobre fatores associados à adesão ao tratamento da hepatite C. Foram pesquisados artigos, publicados em inglês, espanhol e português, nas bases de dados Lilacs, Medline, PsycINFO, Web of Science, Scopus e CINAHL, entre os anos 2000 a 2019. Foram obtidas, inicialmente, 540 publicações e, posteriormente, aplicando-se os critérios de inclusão estabelecidos, foram selecionados 22 artigos. Constatou-se nos artigos analisados que a porcentagem de não adesão ao tratamento variou de 12% a 32%. Foram identificados como facilitadores da adesão: receber tratamento para transtornos psiquiátricos identificados durante o tratamento, ter conhecimento sobre os medicamentos e doença, receber tratamento menos complexo e com maior possibilidade de cura, apresentar menor número de eventos adversos, ter apoio social e bom vínculo com o médico. Foram identificadas como barreiras à adesão: presença de sintomas depressivos e de outros transtornos mentais, uso abusivo de álcool e substâncias psicoativas, baixa escolaridade, idade (ser mais jovem); etnia (afro-americanos), desemprego, não ter parceiro fixo, relatar estigma, distância do serviço de saúde, complexidade e eventos adversos do tratamento. Foram também identificadas lacunas nas pesquisas sobre adesão.

Abstract This integrative review examined factors associated with hepatitis C treatment adherence. The articles included were published in English, Spanish and Portuguese in the Lilacs, Medline, PsycINFO, Web of Science, Scopus and CINAHL databases, between 2000 and 2019. Initially, 540 publications were found and, after applying the study inclusion criteria, 22 articles were selected. Percentage non-adherence to treatment ranged from 12% to 32%. The variables identified as facilitating adherence were: receiving treatment for psychiatric disorders identified during treatment; knowing about medications and disease; receiving less complex treatment with greater likelihood of cure; fewer adverse events; social support; doctor-patient communication; and/or being in relationships. Barriers to adherence identified were: presence of depressive symptoms and other mental disorders; abuse of alcohol and psychoactive substances; education; age; ethnicity; unemployment; not having a steady partner; stigma; distance from health services; and the complexity and adverse effects of treatment. This review identified gaps in research on adherence.

Cirrhosis regression after SVR with indirect methods of fibrosis analysis: How far is it real?

Hepatitis C virus has infected over 71 million people worldwide, and it is the main cause of cirrhosis in the western world. Currently, the treatment involves direct-acting antiviral agents (DAAs) and its main goal is to achieve sustained virologic response (SVR). The aim of this study was to evaluate the impact of SVR using DAAs in the improvement of liver fibrosis using scores evaluation by indirect method, liver function, and inflammation indirect biomarkers. Patients with cirrhosis with SVR after treatment (n = 104) were evaluated using liver function scores, indirect fibrosis methods, alpha-fetoprotein, and ferritin at t-base and t-SVR. Statistically significant positive results in all parameters were observed: 54 patients were classified as 5 in the CP score in t-base, and 77 in t-SVR; a significant decrease was observed in MELD score, alpha-fetoprotein, ferritin, APRI, FIB-4 and liver stiffness in liver elastography. We did not observe difference in the liver function scores between regressors and non-regressors of liver stiffness, as well as in indirect inflammation biomarkers. The measurements of fibrosis using the indirect methods have significantly decreased in patients with cirrhosis treated who achieved SVR associated with decreased indirect inflammation biomarkers and improved liver function scores.

National Brazilian survey on the outcomes of hepatitis c retreatment in patients non-responders to direct antiviral agents

ABSTRACT Background and aims: Treatment of hepatitis C with direct antiviral agents (DAA) is associated with almost 95% of sustained virological response. However, some patients need retreatment. In Brazil, it should be done according to the Ministry of Health guidelines, frequently updated to include newly available drugs. This study aimed to conduct a national survey about the characteristics and outcomes of retreatment of hepatitis C in previously non-responders to DAAs. Patients and methods: Institutions from all over the country were invited to participate in a national registry for retreatment, including information about clinical and epidemiological characteristics of the patients, type and outcomes of retreatment regimens. Only patients previously treated with interferon-free regimens were included. Results: As previous treatments the distribution was: SOF/DCV (56%), SOF/SIM (22%), 3D (11%), SOF/LED (6%) and SOF/RBV (5%). For retreatment the most frequently used drugs were SOF/GP (46%), SOF/DCV (23%) and SOF/VEL (11%). From 159 patients retreated, 132/159 (83%) had complete information in the registry and among them only seven patients were non-responders (SVR of 94.6%). All retreatments were well tolerated, without any serious adverse events or interruptions. Conclusion: The retreatment of patients previously non-responders to DAAs was associated with high rate of SVR in this sample of Brazilian patients. This finding allows us to conclude that the retreatment options available in the public health system in Brazil are effective and safe and are an important component of the strategy of elimination of hepatitis C in our country.

Segmentation and quantification of COVID-19 infections in CT using pulmonary vessels extraction and deep learning.

At the end of 2019, the World Health Organization (WHO) reported pneumonia that started in Wuhan, China, as a global emergency problem. Researchers quickly advanced in research to try to understand this COVID-19 and sough solutions for the front-line professionals fighting this fatal disease. One of the tools to aid in the detection, diagnosis, treatment, and prevention of this disease is computed tomography (CT). CT images provide valuable information on how this new disease affects the lungs of patients. However, the analysis of these images is not trivial, especially when researchers are searching for quick solutions. Detecting and evaluating this disease can be tiring, time-consuming, and susceptible to errors. Thus, in this study, we aim to automatically segment infections caused by COVID19 and provide quantitative measures of these infections to specialists, thus serving as a support tool. We use a database of real clinical cases from Pedro Ernesto University Hospital of the State of Rio de Janeiro, Brazil. The method involves five steps: lung segmentation, segmentation and extraction of pulmonary vessels, infection segmentation, infection classification, and infection quantification. For the lung segmentation and infection segmentation tasks, we propose modifications to the traditional U-Net, including batch normalization, leaky ReLU, dropout, and residual block techniques, and name it as Residual U-Net. The proposed method yields an average Dice value of 77.1% and an average specificity of 99.76%. For quantification of infectious findings, the proposed method achieves results like that of specialists, and no measure presented a value of ρ < 0.05 in the paired t-test. The results demonstrate the potential of the proposed method as a tool to help medical professionals combat COVID-19. fight the COVID-19.

Automatic method for classifying COVID-19 patients based on chest X-ray images, using deep features and PSO-optimized XGBoost.

The COVID-19 pandemic, which originated in December 2019 in the city of Wuhan, China, continues to have a devastating effect on the health and well-being of the global population. Currently, approximately 8.8 million people have already been infected and more than 465,740 people have died worldwide. An important step in combating COVID-19 is the screening of infected patients using chest X-ray (CXR) images. However, this task is extremely time-consuming and prone to variability among specialists owing to its heterogeneity. Therefore, the present study aims to assist specialists in identifying COVID-19 patients from their chest radiographs, using automated computational techniques. The proposed method has four main steps: (1) the acquisition of the dataset, from two public databases; (2) the standardization of images through preprocessing; (3) the extraction of features using a deep features-based approach implemented through the networks VGG19, Inception-v3, and ResNet50; (4) the classifying of images into COVID-19 groups, using eXtreme Gradient Boosting (XGBoost) optimized by particle swarm optimization (PSO). In the best-case scenario, the proposed method achieved an accuracy of 98.71%, a precision of 98.89%, a recall of 99.63%, and an F1-score of 99.25%. In our study, we demonstrated that the problem of classifying CXR images of patients under COVID-19 and non-COVID-19 conditions can be solved efficiently by combining a deep features-based approach with a robust classifier (XGBoost) optimized by an evolutionary algorithm (PSO). The proposed method offers considerable advantages for clinicians seeking to tackle the current COVID-19 pandemic.

Inflammation response and liver stiffness: predictive model of regression of hepatic stiffness after sustained virological response in cirrhotics patients with chronic hepatitis C.

Cirrhotic patients with chronic hepatitis C should be monitored for the evaluation of liver function and screening of hepatocellular carcinoma even after sustained virological response (SVR). The stage of inflammatory resolution and regression of fibrosis is likely to happen, once treatment and viral clearance are achieved. However, liver examinations by elastography show that 30-40% of patients do not exhibit a reduction of liver stiffness. This work was a cohort study in cirrhotic patients whose purpose was to identify immunological factors involved in the regression of liver stiffness in chronic hepatitis C and characterize possible serum biomarkers with prognostic value. The sample universe consisted of 31 cirrhotic patients who underwent leukocyte immunophenotyping, quantification of cytokines/chemokines and metalloproteinase inhibitors in the pretreatment (M1) and in the evaluation of SVR (M2). After exclusion criteria application, 16 patients included were once more evaluated in M3 (like M1) and classified into regressors (R) or non-regressors (NR), decrease or not ≥ 25% stiffness, respectively. The results from ROC curve, machine learning (ML) and linear discriminant analysis showed that TCD4 + lymphocytes (absolute) are the most important biomarkers for the prediction of the regression (AUC = 0.90). NR patients presented levels less than R of liver stiffness since baseline, whereas NK cells were increased in NR. Therefore, it was concluded that there is a difference in the profile of circulating immune cells in R and NR, thus allowing the development of a predictive model of regression of liver stiffness after SVR. These findings should be validated in greater numbers of patients.

Mixed and disseminated paracoccidioidomycosis after liver transplantation: Case report.

Paracoccidioidomycosis (PCM) is a systemic granulomatous fungal infection rarely associated with solid organ transplantation. We report the second case of PCM in an adult after liver transplantation. A 47-year-old woman who had undergone liver transplantation was hospitalized for flu-like symptoms and multiple erythematous ulcerated skin papules. There was lymphadenopathy, pulmonary compromise, and quickly progression to septic shock. PCM was confirmed by skin biopsy and serologic tests, and a satisfactory response to amphotericin B was achieved.

Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1-6 in Brazil.

INTRODUCTION AND OBJECTIVES: Glecaprevir/pibrentasvir is a highly effective and well tolerated treatment for hepatitis C infection. Brazilian patients were not included in the original development studies for glecaprevir/pibrentasvir. This study aimed to assess safety and efficacy of glecaprevir/pibrentasvir in treatment-naïve Brazilian adults without cirrhosis or with compensated cirrhosis. PATIENTS AND METHODS: EXPEDITION-3 was a Phase 3, open-label, multicenter study in treatment-naïve Brazilian adults with hepatitis C infection genotype 1-6. Patients without cirrhosis (F2 or F3) or with compensated cirrhosis (F4) received 8 or 12 weeks of glecaprevir/pibrentasvir, respectively. The primary efficacy endpoint was the rate of sustained virologic response at post-treatment Week 12. Secondary endpoints were on-treatment virologic failure and relapse rates. Baseline polymorphisms were assessed in NS3 and NS5A. Adverse events and laboratory abnormalities were monitored. RESULTS: 100 patients were enrolled, 75 received 8 weeks of treatment and 25 received 12 weeks; all patients completed treatment. Overall sustained virologic response at post-treatment Week 12 rate was high (98.0%; 98/100; 95% confidence interval: 93.0-99.4) and remained high regardless of baseline viral or host factors, including demographics, hepatitis C virus RNA levels, polymorphisms in NS3 and/or NS5A, genotype, and relevant comorbidities. 55% of patients reported ≥1 adverse event, the most common being headache (18.0%). Four patients reported serious adverse events; none were considered drug related or led to study drug discontinuation. No hepatic decompensations were observed. CONCLUSIONS: Glecaprevir/pibrentasvir was effective and well tolerated in treatment-naïve Brazilian patients with hepatitis C infection without cirrhosis and with compensated cirrhosis. TRIAL REGISTRATION: ClinicalTrials.gov NCT03219216.

P045 Prevalence of non-alcoholic fatty liver disease (NAFLD) in patients with inflammatory bowel disease (IBD) in a Brazilian public healthcare clinic.

BACKGROUND: Inflammatory Bowel Disease (IBD) is an inflammatory and chronic disease, as well as non-alcoholic fatty liver disease (NAFLD). Current literature has shown that IBD patients are at high risk for NAFLD. In those patients, the pathogenesis of NAFLD may be more complex and related to multifactor causes, such as gut dysbiosis, unhealthy nutritional behavior, body composition and systemic inflammation. There is an increase in NAFLD's incidence in the general population, otherwise, there are few studies evaluating NAFLD prevalence in IBD patients. So, this study aimed to evaluate prevalence of NAFLD and identify the clinical factors associated with the presence of NAFLD in patients with IBD. METHODS: This cross-sectional, descriptive, observational study included 71 IBD patients from an IBD public outpatient in São Paulo State, Brazil. Laboratory evaluation and clinical data were collected. The presence of NAFLD was evaluated by ultrasonography. The exclusion criteria were as follows: pre-existing liver disease, history of alcohol intake >20g/day for women and >30g/day for men, and glucocorticoids treatment >20mg/day. Statistical analysis: descriptive statistics and association tests. RESULTS: 71 patients were included, of which 34 (47.89%) were Crohn´s disease (CD) and 37 (52.11%) ulcerative colitis (UC). Median age was 45.32±13.59 years, 63.38% were female, 69.1% Caucasian, 7.04% smokers. The time from diagnosis was 12.55 ± 8.01 years. Regarding the characteristics of the diseases, 42.42% of patients with CD have ileocolonic involvement, 50% penetrating disease and 39.4% perianal involvement. In relation to patients with UC, most patients have pancolitis (72.22%). Mostly, the patients were in clinical (63.89%) and endoscopic (52.86%) remission. Regarding medical treatment, the most used drugs were biological therapy (79.41%) and azathioprine (52.94%) in CD, and mesalazine (45.95%), azathioprine (40.54%) and biological therapy (40.54%) in UC. The NAFLD group consists of 32 (45.07%) patients: 40.63% had mild steatosis; 40.63% moderate and 18.65% intense NAFLD. Development of NAFLD vs no NAFLD was associated with body mass index (29.49 ± 3.93 vs 24.32 ± 3.85, p < 0.0001), and laboratory biomarkers, such as C-reactive protein (1.99 ± 4.39 vs 0.87 ± 0.52, p = 0.0061), AST (29.72 ± 16.64 vs 23.46 ± 5.31, p = 0.0226), ALT (24.92 ± 14.22 vs 17.92 ± 6.57, p = 0.0099), albumin (4.1 ± 0.37 vs 4.36 ± 0.32, p = 0.0415), fasting glucose (95.5 ± 14.01 vs 84.36 ± 13.01, p = 0.0251) and blood insulin (18.41 ± 11.88 vs 6.4 ± 4.26, p = 0.0054). Also, the NAFLD group had higher prevalence of systemic arterial hypertension (31.25% vs 10.26%, p = 0.0369). When comparing patients with the presence or absence of NAFLD, there was no difference between the groups regarding time since diagnosis (p = 0.9684), previous surgery (p = 0.5908), Montreal classification, clinical activity assessed by CDAI (p = 0.2258), clinical activity assessed by the Mayo score (p = 0.4935), endoscopic activity (p = 0.0599), histological activity (p = 1.0), or medical treatment. CONCLUSION: Development of NAFLD is a frequent occurrence in patients with IBD. NAFLD group had higher levels of body mass index, C-reactive protein, AST, ALT, fasting glucose and blood insulin, which are also associated with metabolic syndrome. Early diagnosis and appropriate nutritional orientation are necessary to prevent NAFLD related complications.

P049 Investigation of Liver Diseases by Ultrasound in Patients With Inflammatory Bowel Disease.

BACKGROUND: Inflammatory Bowel Disease (IBD), which can be divided into Crohn's Disease (CD) and Ulcerative Colitis (UC), is an immune mediated disease featured by gastrointestinal tract involvement. Hepatic disease, such as non-alcoholic fatty liver disease (NAFLD), cirrhosis, cholelithiasis, hepatic thromboembolic events and primary sclerosing cholangitis (PSC) are some hepatic complications presented by IBD patients. Since these hepatic disorders have a higher prevalence in IBD patients, ultrasonography is a noninvasive low-cost versatile tool, that allows to identify these manifestations at early stages. Therefore, this study aims to analyze the prevalence of hepatic diseases in patients with IBD. METHODS: A cross-sectional study was performed in a single IBD center, Brazil. This study considered clinical and sociodemographic data of these individuals, besides the evaluation of disease activity, biochemical tests, and liver ultrasound with doppler. Statistical analysis: descriptive, association tests. RESULTS: 71 patients were included, 34 had CD and 37 had UC, mean age 45.32 ± 13.59 years, 63.38% women. Among CD patients, 42.42% have ileocolonic involvement, 50% penetrating behavior and 39.4% perianal involvement. Among patients with UC, most patients have pancolitis (72.22%). Most patients were in clinical (CD: 93.55%, UC: 63.89%) and endoscopic (47.14%) remission. The main medications used were azathioprine (46.48%), infliximab (40.85%), salicylates (28.17%), corticosteroids (16.9%) and adalimumab (11.27%). According to ultrasound, NAFLD was found in 32 (45.07%) patients: 40.63% mild, 40.63% moderate and 18.75% severe. Furthermore, we found a correlation between liver steatosis and blunt liver edge (p < 0.0155). Only 2 patients presented with choledocholithiasis. One patient had features of chronic liver disease such as irregular surface, heterogeneity of a hepatic parenchymal echo and bluntness of the liver edge. No signs of thrombosis were found in portal, splenic or superior mesenteric veins. CONCLUSION: A higher prevalence of NAFLD was found in patients with IBD, and no signs of thrombosis were found in the splanchnic system.