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102. Impact of evidence-based medicine on treatment of patients with unresectable hepatocellular carcinoma

Author

Giannini, EDOARDO GIOVANNI, Bodini, G., Corbo, M., Savarino, Vincenzo, Risso, Domenico, DI NOLFO, M. A., DEL POGGIO, P., Benvegnù, L., Farinati, F., Zoli, M., Borzio, F., Caturelli, E., Chiaramonte, M., Trevisani, F., ITALIAN LIVER CANCER GROUP, E.G. Giannini, G. Bodini, M. Corbo, D. Risso, V. Savarino, M.A. Di Nolfo, P. Del Poggio, L. Benvegnù, F. Farinati, M. Zoli, F. Borzio, E. Caturelli, M. Chiaramonte, F. Trevisani, and for the Italian Liver Cancer (ITALI.CA.) group

Subjects
Male, medicine.medical_specialty, Carcinoma, Hepatocellular, Cirrhosis, EVIDENCE-BASED MEDICINE, Population, Kaplan-Meier Estimate, Gastroenterology, Internal medicine, medicine, Carcinoma, Humans, Pharmacology (medical), HEPATOCELLULAR CARCINOMA, Chemoembolization, Therapeutic, education, Survival rate, Aged, Randomized Controlled Trials as Topic, Retrospective Studies, education.field_of_study, Hepatology, business.industry, Patient Selection, Liver Neoplasms, Cancer, Retrospective cohort study, TREATMENT, Middle Aged, medicine.disease, Survival Rate, Treatment Outcome, Italy, Hepatocellular carcinoma, Female, Liver cancer, business
Abstract

Aliment Pharmacol Ther 31, 493–501 Summary Background A randomized controlled trial performed by the Barcelona Clinic Liver Cancer (BCLC) published in 2002 demonstrated that transcatheter arterial chemoembolisation (TACE) is an effective treatment for well-selected patients with unresectable hepatocellular carcinoma (HCC). Aim To access whether this information has modified the use of TACE in clinical practice. Methods From 2042 HCC patients included in the Italian Liver Cancer database, we selected 336 cases diagnosed over two 4-year periods (1999–2002, n = 161 and 2003–2006, n = 175), fulfilling the inclusion criteria of the BCLC study. These groups were compared for TACE application rate, patient characteristics and survival. Results Patients undergoing TACE increased in the 2003–2006 period (from 62% to 73%, P = 0.035), with an increase in of Child-Pugh class A (from 64% to 77%, P = 0.048) and advanced HCC patients (from 54% to 69%, P = 0.041). In the 1999–2002 period, there was no significant difference in survival between TACE-treated and untreated patients, while in the 2003–2006 period, TACE-treated patients survived longer (P

Published
2010

109. Lack of correlation between serum anti-HBcore detectability and hepatocellular carcinoma in patients with HCV-related cirrhosis

Author

Stroffolini, T, Almasio, Pl, Persico, M, Bollani, S, Benvegnù, L, Di Costanzo, G, Pastore, G, Aghemo, A, Stornaiuolo, G, Mangia, A, Andreone, P, Stanzione, M, Mazzella, G, Saracco, G, Del Poggio, P, Bruno, S, Boccia, S, Di Marco, V, Giannini, EDOARDO GIOVANNI, Morisco, F, Picciotto, Antonino, Fagiuoli, S, Mazzaro, C., Stroffolini T, Almasio PL, Persico M, Bollani S, Benvegnù L, Di Costanzo G, Pastore G, Aghemo A, Stornaiuolo G, Mangia A, Andreone P, Stanzione M, Mazzella G, Saracco G, Del Poggio P, Bruno S, Italian Association of the Study of the Liver Disease (AISF), Stroffolini, T, Almasio, P, Persico, M, Bollani, S, Benvegnù, L, Di Costanzo, G, Pastore, G, Aghemo, A, Stornaiuolo, G, Mangia, A, Andreone, P, Stanzione, M, Mazzella, G, Saracco, G, Del Poggio, P, Bruno, S, Boccia, S, Di Marco, V, Giannini, E, Morisco, F, Picciotto, A, Fagiuoli, S, Mazzaro, C, Almasio, Pl, and Morisco, Filomena

Subjects
Liver Cirrhosis, Male, Pathology, Cirrhosis, Adult, Antibodies, Viral, blood, Carcinoma, Hepatocellular, blood/pathology/virology, Cohort Studies, Female, Hepatitis B Core Antigens, immunology, Hepatitis B virus, immunology, Hepatitis C, blood/complications/pathology, Humans, Liver Cirrhosis, blood/etiology/pathology, Liver Neoplasms, blood/pathology/virology, Male, Middle Aged, Retrospective Studies, Risk Factors, Antibodies, Viral, Gastroenterology, anti HBc, Cohort Studies, immunology, Risk Factors, HBV, HCC, CIRRHOSIS, Liver Neoplasms, virus diseases, HBV HCV COINFECTION, Middle Aged, Hepatitis B Core Antigens, Hepatitis C, Adult, Carcinoma, Hepatocellular, Female, Hepatitis B virus, Humans, Retrospective Studies, Hepatocellular carcinoma, HCV, medicine.medical_specialty, blood/pathology/virology, Antibodies, blood, blood/complications/pathology, Internal medicine, medicine, In patient, HEPATOCELLULAR CARCINOMA, Hepatology, business.industry, Carcinoma, Cancer, medicine.disease, digestive system diseases, blood/etiology/pathology, business
Abstract

BACKGROUND: While the likelihood of developing hepatocellular carcinoma (HCC) in patients coinfected with both HBV and HCV is increased, the role of previous exposure to HBV as a risk factor associated with tumor occurrence in subjects with HCV-related cirrhosis has not been fully investigated. AIM: To assess whether serum anti-HBc positivity, as a marker of previous HBV exposure, is associated with HCC development in HCV-related positive, hepatitis B surface antigen (HBsAg) negative patients with cirrhosis treated with alfa-interferon (IFN) monotherapy. PATIENTS AND: A database including 883 consecutive patients (557 men, mean age 54.7 yr) with histologically METHODS: proven cirrhosis treated with IFN between 1992 and 1997 was analyzed. All subjects have been surveilled every 6 months by ultrasound. Independent predictors of HCC were assessed by Cox multiple regression analysis. RESULTS: Mean follow-up was 96.1 months. Anti-HBc testing was available in 693 cases and, among them, 303 patients (43.7%) were anti-HBc seropositive. Anti-HBc positive patients were more often men (67.0% vs 58.7%, P = 0.03), had lower transaminase levels (3.3 ± 2.0 vs 3.8 ± 2.5 u.l.n., P = 0.004), and had higher rate of alcohol intake (38.3% vs 22.5%, P < 0.001) than anti-HBc negative patients. Overall, the incidence rates of HCC per 100 person-years were 1.84 (95% CI 1.34-2.47) in the anti-HBc positive patients and 1.86 (95% CI 1.41-2.42) in anti-HBc negative ones. By Cox multiple regression, there was no association of serum anti-HBc with HCC development (HR 1.03, 95% CI 0.69-1.52) or liver-related deaths incidence (HR 1.21; 95% CI 0.76-1.95). CONCLUSIONS: In comparison with anti-HBc negative subjects, serum anti-HBc positive patients with HCV-related/HBsAg negative cirrhosis treated with IFN monotherapy did not show a greater risk of HCC.

Published
2008

119. Combined multichannel intraluminal impedance and pH-metry: a novel technique to improve detection of gastro-oesophageal reflux literature review

Author

Zentilin, Patrizia, Dulbecco, Pietro, Savarino, E, Giannini, EDOARDO GIOVANNI, and Savarino, Vincenzo

Subjects
pH monitoring, Electric Impedance, Gastroesophageal Reflux, Humans, Non-Acid Reflux, Hydrogen-Ion Concentration, Gastro-esophageal reflux, Monitoring, Physiologic
Abstract

Ambulatory pH monitoring is currently the best method for detection of gastro-oesophageal reflux. However, pH electrodes are able to measure only acid reflux, and therefore, non-acid reflux episodes, a potentially important cause of symptoms, are ignored by this technique. Multichannel intraluminal electrical impedance has recently been proposed as a novel method to overcome the above limitation of pH testing. Impedance (expressed in ohms) is a measure of the total opposition to current flow between adjacent electrodes. As refluxed contents are characterised by different conductivity, which is the inverse of impedance, for the first time a pH-independent accurate and practical qualitative analysis of refluxate is possible. For instance, the conductivity of air is almost zero and then impedance increases compared with baseline, whereas the conductivity of liquid is much higher and the impedance curve decreases remarkably. The combination of electrical impedance with traditional pH monitoring has the only aim of differentiating acid from non-acid liquid reflux. Moreover, the impedance catheter contains multiple pairs of ring electrodes along the oesophagus, so that an exact assessment of the proximal extent of refluxed material can be achieved. From a clinical point of view, electrical impedance + pH-metry could be useful for identifying the number and percent times of gas, acid and non-acid reflux episodes, to improve the yield of symptom index, to evaluate the reasons for poor response of reflux symptoms to proton pump inhibitors and to know the proximal extent of reflux events in patients with atypical symptoms. Thus, this technique has the potential to become a useful tool for improving our knowledge of gastro-oesophageal reflux disease and optimising the management of these patients.

Published
2004

143. Positive Glucose Breath Testing is More Prevalent in Patients With IBS-like Symptoms Compared With Controls of Similar Age and Gender Distribution

Author

Parodi, Andrea, primary, Dulbecco, Pietro, additional, Savarino, Edoardo, additional, Giannini, Edoardo Giovanni, additional, Bodini, Giorgia, additional, Corbo, Marina, additional, Isola, Luca, additional, De Conca, Stefano, additional, Marabotto, Elisa, additional, and Savarino, Vincenzo, additional

Published
2009
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144. Surveillance for Early Diagnosis of Hepatocellular Carcinoma: Is It Effective in Intermediate/Advanced Cirrhosis?

Author

Trevisani, Franco, Santi, Valentina, Gramenzi, Annagiulia, Di Nolfo, Maria Anna, Del Poggio, Paolo, Benvegnù, Luisa, Rapaccini, Gianludovico, Farinati, Fabio, Zoli, Marco, Borzio, Franco, Giannini, Edoardo Giovanni, Caturelli, Eugenio, and Bernardi, Mauro

Subjects
CLINICAL trials, LIVER cancer, CANCER patients, ULTRASONIC imaging, PREVENTIVE medicine
Abstract

OBJECTIVES: Surveillance of cirrhotic patients for early diagnosis of hepatocellular carcinoma (HCC), based on ultrasonography and alpha-fetoprotein (AFP) measurement, is widely used. Its effectiveness depends on liver function, which affects the feasibility of treatments and cirrhosis-related mortality. We assessed whether patients with intermediate/advanced cirrhosis benefit from surveillance. METHODS: We selected 468 Child-Pugh class B and 140 class C patients from the ITA.LI.CA database, including 1,834 HCC patients diagnosed from January 1987 to December 2004. HCC was detected in 252 patients during surveillance (semiannual 172, annual 80 patients; group 1) and in 356 patients outside surveillance ( group 2). Survival of surveyed patients was corrected for the estimated lead time. RESULTS: Child-Pugh class B: cancer stage ( P < 0.001) and treatment distribution ( P < 0.001) were better in group 1 than in group 2. The median (95% CI) survivals were 17.1 (13.5–20.6) versus 12.0 (9.4–14.6) months and the survival rates at 1, 3, and 5 yr were 60.4% versus 49.2%, 26.1% versus 16.1%, and 10.7% versus 4.3%, respectively ( P= 0.022). AFP, gross pathology, and treatment of HCC were independent prognostic factors. Child-Pugh class C: cancer stage ( P= 0.001) and treatment distribution ( P= 0.021) were better in group 1 than in group 2. Nonetheless, median survival did not differ: 7.1 (2.1–12.1) versus 6.0 (4.1–7.9) months ( P= 0.740). CONCLUSIONS: These results suggest surveillance be offered to class B patients and maintained for class A patients who migrate to the subsequent class. Surveillance becomes pointless in class C patients probably because the poor liver function adversely affects the overall mortality and HCC treatments. [ABSTRACT FROM AUTHOR]

Published
2007
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145. A Nomogram-Based Prognostic Model for Advanced Hepatocellular Carcinoma Patients Treated with Sorafenib: A Multicenter Study.

Author

Marasco, Giovanni, Poggioli, Francesco, Colecchia, Antonio, Cabibbo, Giuseppe, Pelizzaro, Filippo, Giannini, Edoardo Giovanni, Marinelli, Sara, Rapaccini, Gian Ludovico, Caturelli, Eugenio, Di Marco, Mariella, Biasini, Elisabetta, Marra, Fabio, Morisco, Filomena, Foschi, Francesco Giuseppe, Zoli, Marco, Gasbarrini, Antonio, Svegliati Baroni, Gianluca, Masotto, Alberto, Sacco, Rodolfo, and Raimondo, Giovanni

Subjects
RESEARCH, LIVER function tests, ALPHA fetoproteins, PREDICTIVE tests, HEMOGLOBINS, FUNCTIONAL status, MEDICAL cooperation, HEALTH status indicators, TREATMENT duration, REGRESSION analysis, SORAFENIB, SURVIVAL analysis (Biometry), PLATELET count, STATISTICAL models, HEPATOCELLULAR carcinoma, PROPORTIONAL hazards models, BILIRUBIN, ASPARTATE aminotransferase
Abstract

Simple Summary: Accurate prognostic systems capable of predicting the survival of patients with advanced hepatocellular carcinoma undergoing Sorafenib therapy are still lacking. The search for the ideal predictive tool for survival and drug response is justified by the recent availability of several other drugs effective for these patients, licensed as first- and second-line treatment, other than reducing adverse events and costs. In this study, we aimed to identify simple demographic and clinical parameters able to predict survival and Sorafenib response in a large multicenter cohort. In this study, we showed that patient's general status, liver function and damage laboratory parameters and HCC aggressiveness were associated with the outcome of Sorafenib therapy. Two predictive nomograms, helping clinicians in the therapeutic choice, were additionally created. Among scores and staging systems used for HCC, none showed a good prognostic ability in patients with advanced HCC treated with Sorafenib. We aimed to evaluate predictive factors of overall survival (OS) and drug response in HCC patients undergoing Sorafenib included in the Italian Liver Cancer (ITA.LI.CA.) multicenter cohort. Patients in the ITA.LI.CA database treated with Sorafenib and updated on 30 June 2019 were included. Demographic and clinical data before starting Sorafenib treatment were considered. For the evaluation of predictive factors for OS, a time-dependent Cox proportional hazard model was used. A total of 1107 patients were included in our analysis. The mean age was 64.3 years and 81.7% were male. Most patients were staged as BCLC B (205, 18.9%) or C (706, 65.1%). The median time of Sorafenib administration was 4 months (interquartile range (IQR) 2–12), and the median OS was 10 months (IQR: 4–20). A total of 263 patients (33.8%) out of 780 with available evaluation experienced objective tumoral response to Sorafenib. The Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (hazard ratio (HR) 1.284), maximum tumoral diameter (HR 1.100), plasma total bilirubin (HR 1.119), aspartate amino transferase assessed as multiple of the upper normal value (HR 1.032), alpha-fetoprotein ≥200 ng/mL (HR 1.342), hemoglobin (HR 0.903) and platelet count (HR 1.002) were associated with OS at multivariate Cox regression analysis. Drug response was predicted by maximum tumoral diameter and platelet count. A novel prognostic nomogram for patients undergoing Sorafenib is hereby proposed. The novelty introduced is the comprehensive patient's assessment using common markers of patient's general status, liver damage and function and HCC biology. Further studies are required to test its accuracy and provide external validation. [ABSTRACT FROM AUTHOR]

Published
2021
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146. Role of prokinetics in ineffective esophageal motility: A call for broader consideration and future innovations.

Author

Pasta, Andrea, Calabrese, Francesco, Savarino, Edoardo Vincenzo, Giannini, Edoardo Giovanni, and Marabotto, Elisa

Subjects
*ESOPHAGEAL motility disorders, *ESOPHAGEAL motility, *SEROTONIN agonists, *GASTRIC emptying, *MUSCLE contraction
Abstract

The article discusses the role of prokinetics in managing ineffective esophageal motility (IEM) and calls for a broader consideration of these drugs in treatment. While the effectiveness of prokinetics in improving esophageal symptoms is still debated, some studies suggest potential benefits, especially in patients with concomitant delayed gastric emptying. New prokinetic agents are being explored, with ongoing trials like Naronapride offering hope for new therapies. The authors advocate for a more detailed discussion on prokinetics as an alternative or adjunct to conservative care for managing this challenging condition. [Extracted from the article]

Published
2024
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147. Primary biliary cholangitis: perception and expectation of illness

Author

Annarosa Floreani, Michela Scaffidi, Barbara Coco, Edoardo Giovanni Giannini, Sara Labanca, Emanuela Bonaiuto, Sara De Martin, Pietro Invernizzi, Marco Carbone, Domenico Alvaro, Maria Consiglia Bragazzi, Vincenza Calvaruso, Valentina Cossiga, Nora Cazzagon, Floreani, Annarosa, Scaffidi, Michela, Coco, Barbara, Giannini, Edoardo Giovanni, Labanca, Sara, Bonaiuto, Emanuela, De Martin, Sara, Invernizzi, Pietro, Carbone, Marco, Alvaro, Domenico, Bragazzi, Maria Consiglia, Calvaruso, Vincenza, Cossiga, Valentina, and Cazzagon, Nora

Subjects
Quality of life, Motivation, Hepatology, Cholangitis, Liver Cirrhosis, Biliary, Gastroenterology, Illness perception, Humans, Perception, PBC, Questionnaire, Fatigue
Abstract

Unlabelled: An important tool to explore personal experience of symptoms, treatment and clinical outcome is stratification of illness perception in patients affected by PBC. Aim: To assess the perception of illness in a cohort of Italian patients with PBC. Methods: Between June and December 2019, a specific questionnaire was administered to a pool of 210 patients from 7 tertiary Italian centers, in order to identify and assess the patient's past history, symptoms and their impact on the quality of life, follow-up, treatment and perceived satisfaction of patients toward the provided care. Results: Fatigue, pruritus, and abdominal discomfort and sicca syndrome were present in 50.4%, 45%, 30.4% and 28.5% of patients, fatigue having the most impacting the daily-life. After a consultation with a specialist, the diagnosis of PBC was met within 18 months for 143 patients. Patients were mostly concerned about possible health problems that occur and in 25% of cases, symptoms had a negative impact on their life. Eighty percent of patients said they were satisfied with efficacy and tolerability of treatment, while 26% requested an improvement in the relationship with the specialist. Conclusions: The results highlight the importance of both promoting timely referral to the specialist and facilitating communication between healthcare professionals and patients.

Published
2022

148. Review article – esophageal reflux hypersensitivity: Non-GERD or still GERD?

Author

Savarino, V., Marabotto, E., Zentilin, P., Demarzo, M. G., Pellegatta, G., Frazzoni, M., De Bortoli, N., Tolone, S., Giannini, E. G., Savarino, E., Savarino, Vincenzo, Marabotto, Elisa, Zentilin, Patrizia, Demarzo, Maria Giulia, Pellegatta, Gaia, Frazzoni, Marzio, De Bortoli, Nicola, Tolone, Salvatore, Giannini, Edoardo Giovanni, and Savarino, Edoardo

Subjects
Functional heartburn, Gastro-esophageal reflux disease, Non-erosive reflux disease, Reflux hypersensitivity, Rome IV, digestive, oral, and skin physiology, humanities, digestive system diseases
Abstract

The most recent iteration of the classifications for functional esophageal disorders, Rome IV, proposed relevant modifications of the previous definitions for Rome III. They specifically considered increased esophageal acid exposure as the marker of gastroesophageal reflux disease (GERD), including the remaining part of non-erosive reflux disease patients with normal acid in the group with functional alterations, considering both reflux hypersensitivity and functional heartburn. However, recent pathophysiological and therapeutic data suggest the need for a return to including reflux hypersensitivity in the GERD spectrum. Indeed, physiologic alterations in esophageal mucosal integrity and chemical clearance, the presence of microscopic esophagitis, and strict symptom-reflux association support the concept that reflux hypersensitivity pertains to GERD. Surgical anti-reflux therapy has resulted in positive outcomes, even in the long term, in patients with reflux hypersensitivity and not in those with functional heartburn. Moreover, clinical trials using neuromodulators have been scarce and provided conflicting results. As a result, the real progress of the Rome IV classifications is in dispute. This article aims to summarize the most recent knowledge of non-erosive reflux disease and reflux hypersensitivity to discuss the utility of Rome IV criteria in the identification and management of functional esophageal disorders.

Published
2020

149. Incidence of DAA failure and the clinical impact of retreatment in real-life patients treated in the advanced stage of liver disease: Interim evaluations from the PITER network

Author

Maria Grazia Rumi, Teresa Santantonio, Vincenza Calvaruso, D.C. Amoruso, Giovanni Raimondo, Salvatore Petta, Maria Cristina Pasetto, Romina Corsini, Alfredo Di Leo, Anna Linda Zignego, Barbara Coco, Francesco Paolo Russo, Giovanni Battista Gaeta, Maurizia Rossana Brunetto, Giuseppina Brancaccio, Veronica Bernabucci, Alberto Zanetto, Filomena Morisco, Mario Masarone, Pietro Andreone, Pierluigi Blanc, D. Ieluzzi, Salvatore Madonia, Adele Giammario, Marzia Margotti, Edoardo G. Giannini, M. Cannizzaro, Emanuela Zappulo, Gloria Taliani, Monica Monti, Roberto Filomia, Marco Massari, Guglielmo Borgia, Andrea Iannone, Massimo Siciliano, Erica Villa, Marcello Persico, Stefano Vella, Stefano Rosato, Maria Giovanna Quaranta, L. E. Weimer, Carmine Coppola, Liliana Chemello, Loreta A. Kondili, Barbara Del Pin, Loredana Falzano, Luchino Chessa, L. Donnarumma, Luisa Cavalletto, Elisa Biliotti, Antonio Gasbarrini, Kondili, Loreta A., Gaeta, Giovanni Battista, Brunetto, Maurizia Rossana, Di Leo, Alfredo, Iannone, Andrea, Santantonio, Teresa Antonia, Giammario, Adele, Raimondo, Giovanni, Filomia, Roberto, Coppola, Carmine, Amoruso, Daniela Caterina, Blanc, Pierluigi, Del Pin, Barbara, Chemello, Liliana, Cavalletto, Luisa, Morisco, Filomena, Donnarumma, Laura, Rumi, Maria Grazia, Gasbarrini, Antonio, Siciliano, Massimo, Massari, Marco, Corsini, Romina, Coco, Barbara, Madonia, Salvatore, Cannizzaro, Marco, Zignego, Anna Linda, Monti, Monica, Russo, Francesco Paolo, Zanetto, Alberto, Persico, Marcello, Masarone, Mario, Villa, Erica, Bernabucci, Veronica, Taliani, Gloria, Biliotti, Elisa, Chessa, Luchino, Pasetto, Maria Cristina, Andreone, Pietro, Margotti, Marzia, Brancaccio, Giuseppina, Ieluzzi, Donatella, Borgia, Guglielmo, Zappulo, Emanuela, Calvaruso, Vincenza, Petta, Salvatore, Falzano, Loredana, Quaranta, Maria Giovanna, Weimer, Liliana Elena, Rosato, Stefano, Vella, Stefano, Giannini, Edoardo Giovanni, Kondili LA, Gaeta GB, Brunetto MR, Di Leo A, Iannone A, Santantonio TA, Giammario A, Raimondo G, Filomia R, Coppola C, Amoruso DC, Blanc P, Del Pin B, Chemello L, Cavalletto L, Morisco F, Donnarumma L, Rumi MG, Gasbarrini A, Siciliano M, Massari M, Corsini R, Coco B, Madonia S, Cannizzaro M, Zignego AL, Monti M, Russo FP, Zanetto A, Persico M, Masarone M, Villa E, Bernabucci V, Taliani G, Biliotti E, Chessa L, Pasetto MC, Andreone P, Margotti M, Brancaccio G, Ieluzzi D, Borgia G, Zappulo E, Calvaruso V, Petta S, Falzano L, Quaranta MG, Weimer LE, Rosato S, Vella S, Giannini EG., Kondili, L., Gaeta, G., Brunetto, M., Di Leo, A., Iannone, A., Santantonio, T., Giammario, A., Raimondo, G., Filomia, R., Coppola, C., Amoruso, D., Blanc, P., Del Pin, B., Chemello, L., Cavalletto, L., Morisco, F., Donnarumma, L., Rumi, M., Gasbarrini, A., Siciliano, M., Massari, M., Corsini, R., Coco, B., Madonia, S., Cannizzaro, M., Zignego, A., Monti, M., Russo, F., Zanetto, A., Persico, M., Masarone, M., Villa, E., Bernabucci, V., Taliani, G., Biliotti, E., Chessa, L., Pasetto, M., Andreone, P., Margotti, M., Brancaccio, G., Ieluzzi, D., Borgia, G., Zappulo, E., Calvaruso, V., Petta, S., Falzano, L., Quaranta, M., Weimer, L., Rosato, S., Vella, S., and Giannini, E.

Subjects
Simeprevir, Male, Genetics and Molecular Biology (all), Hepacivirus, Pediatrics, Gastroenterology, Biochemistry, 0302 clinical medicine, Animal Cells, 80 and over, Bile, Medicine, Public and Occupational Health, Prospective Studies, lcsh:Science, Aged, 80 and over, Adult, Aged, Antiviral Agents, Drug Therapy, Combination, Female, Hepatitis C, Humans, Incidence, Liver Diseases, Middle Aged, Biochemistry, Genetics and Molecular Biology (all), Agricultural and Biological Sciences (all), Liver Disease, Child Health, Blood, Cirrhosis, Physical Sciences, Regression Analysis, 030211 gastroenterology & hepatology, Cellular Types, Statistics (Mathematics), Human, medicine.medical_specialty, Gastroenterology and Hepatology, Microbiology, 03 medical and health sciences, Drug Therapy, Statistical Methods, Blood Cells, Flaviviruses, lcsh:R, Organisms, Biology and Life Sciences, medicine.disease, Regimen, Prospective Studie, 030104 developmental biology, chemistry, lcsh:Q, Mathematics, Developmental Biology, RNA viruses, 0301 basic medicine, DAA, HCV, resistance, Sofosbuvir, Physiology, lcsh:Medicine, Liver disease, chemistry.chemical_compound, Mathematical and Statistical Techniques, Medicine and Health Sciences, Pathology and laboratory medicine, Multidisciplinary, Hepatitis C virus, Medical microbiology, Body Fluids, Viruses, Combination, Anatomy, Pathogens, Research Article, medicine.drug, Platelets, Ledipasvir, Daclatasvir, Settore MED/12 - GASTROENTEROLOGIA, HCV, liver diseases, Cirrhosis, DAA failure, Research and Analysis Methods, Internal medicine, Antiviral Agent, business.industry, Viral pathogens, Bilirubin, Cell Biology, Fibrosis, Hepatitis viruses, Microbial pathogens, Surgery, Liver function, business
Abstract

Background: Few data are available on the virological and clinical outcomes of advanced liver disease patients retreated after first-line DAA failure. Aim: To evaluate DAA failure incidence and the retreatment clinical impact in patients treated in the advanced liver disease stage. Methods: Data on HCV genotype, liver disease severity, and first and second line DAA regimens were prospectively collected in consecutive patients who reached the 12-week post-treatment and retreatment evaluations from January 2015 to December 2016 in 23 of the PITER network centers. Results: Among 3,830 patients with advanced fibrosis (F3) or cirrhosis, 139 (3.6%) failed to achieve SVR. Genotype 3, bilirubin levels >1.5mg/dl, platelet count

Published
2017

150. Comparison of the Safety and Efficacy of Ustekinumab and Vedolizumab in Patients with Crohn's Disease: A Systematic Review and Meta-Analysis of Propensity Score Matched Cohort Studies.

Author

Pasta A, Calabrese F, Marabotto E, Furnari M, Demarzo MG, Pellegrino R, Gravina AG, Federico A, Giannini EG, and Bodini G

Abstract

Background : Ustekinumab and vedolizumab represent both valid therapeutic options in patients with Crohn's Disease. Data comparing the safety and efficacy of these drugs are indirect, with conflicting results reported. We aim to conduct a systematic review and metanalysis to assess the safety and effectiveness profile of ustekinumab and vedolizumab in patients with Crohn's Disease, including only studies that applied propensity scores to reduce confounding bias. Methods : We identified 59 reports that compared ustekinumab and vedolizumab after a propensity score match analysis, of which 16 were assessed for eligibility, and finally, ten retrospective studies were included. The main outcomes considered were clinical steroid-free remission at 14 ± 4, 24 ± 4, and 52 ± 4 weeks, drug discontinuation rate, adverse events, serious infections, and hospitalization during the first year of treatment. Results : A total of 4398 patients were treated with ustekinumab (n = 2774, 63.1%) or vedolizumab (1624, 36.9%). Steroid-free clinical remission was not significantly different between ustekinumab and vedolizumab at 12 ± 4 weeks (OR 1.31, 95%CI 0.88-1.94, p = 0.180), at 24 ± 4 weeks (OR 1.18, 95%CI 0.79-1.75, p = 0.420), and at 52 ± 4 weeks (1.35, 95%CI 0.91-2.01, p = 0.140). In patients receiving ustekinumab, the rate of adverse events (OR 0.54, 95%CI 0.35-0.83, p = 0.005), infection (OR 0.61, 95%CI 0.47-0.80, p < 0.001) and the need of hospitalization at 1-year (OR 0.68, 95%CI 0.58-0.80, p < 0.001) appeared to be lower. Conclusion : Ustekinumab and vedolizumab do not significantly differ in inducing and maintaining clinical steroid-free remission, while ustekinumab was associated with a lower risk of serious infections and hospitalization during the first year of treatment.

Published
2024
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