Publications by authors named "Alessia Ciancio"

72 Publications

The effect of cocoa-rich products on depression, anxiety, and mood: A systematic review and meta-analysis.

Crit Rev Food Sci Nutr 2021 May 10:1-13. Epub 2021 May 10.

Department of Clinical and Experimental Medicine, Psychiatry Unit, University of Catania, Catania, Italy.

In the popular imaginary, cocoa-derived products, like chocolate, represent a panacea for mood and affectivity. However, whether this is a myth or a fact has yet to be clarified. A systematic review and meta-analysis were conducted according to the PRISMA guidelines to investigate the effect of cocoa-derived food on depressive and anxiety symptoms, positive and negative affect. We searched Web of Knowledge and PsycINFO up to April 3, 2020. After screening 761 records, we selected nine studies. Two trials evaluated the long-term effects of cocoa consumption (>1 week), two studies the short-term effects (3 days), while five studies were conducted in acute (single administration). Random-effects meta-analyses found an overall significant effect of cocoa-rich products on depressive (Hedge's = -0.42, 95% CI -0.67 to -0.17) and anxiety symptoms (Hedge's = -0.49, 95% CI -0.78 to -0.19). Moreover, both positive (Hedge's  = 0.41, 95% CI 0.06 to 0.77) and negative affect (Hedge's = -0.47, 95% CI -0.91 to -0.03) significantly improved. In all meta-analyses, the effect size was medium, while heterogeneity was low. Our findings suggest that the consumption of cocoa-rich products may improve affect and mood in the short term. However, given the short duration of trials, our results cannot be generalized to long-term intake of cocoa-derived food. Cautious interpretation is also needed due to the low number of participants and studies included in the meta-analyses.
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http://dx.doi.org/10.1080/10408398.2021.1920570DOI Listing
May 2021

Liver function following hepatitis C virus eradication by direct acting antivirals in patients with liver cirrhosis: data from the PITER cohort.

BMC Infect Dis 2021 May 4;21(1):413. Epub 2021 May 4.

Center for Global Health, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161, Rome, Italy.

Background: The development of direct-acting antivirals (DAA) for HCV has revolutionized the treatment of HCV, including its treatment in patients with HIV coinfection. The aim of this study was to compare the changes in liver function between coinfected and monoinfected patients with cirrhosis who achieved HCV eradication by DAA.

Methods: Patients with pre-treatment diagnosis of HCV liver cirrhosis, consecutively enrolled in the multicenter PITER cohort, who achieved a sustained virological response 12 weeks after treatment cessation (SVR12) were analysed. Changes in Child-Pugh (C-P) class and the occurrence of a decompensating event was prospectively evaluated after the end of DAA treatment. Cox regression analysis was used to evaluate factors independently associated with changes in liver function following viral eradication.

Results: We evaluated 1350 patients, of whom 1242 HCV monoinfected (median follow-up 24.7, range 6.8-47.5 months after viral eradication) and 108 (8%) HCV/HIV coinfected (median follow-up 27.1, range 6.0-44.6). After adjusting for age, sex, HCV-genotype, HBsAg positivity and alcohol use, HIV was independently associated with a more advanced liver disease before treatment (C-P class B/C vs A) (OR: 3.73, 95% CI:2.00-6.98). Following HCV eradication, C-P class improved in 17/20 (85%) coinfected patients (from B to A and from C to B) and in 53/82 (64.6%) monoinfected patients (from B to A) (p = 0.08). C-P class worsened in 3/56 coinfected (5.3%) (from A to B) and in 84/1024 (8.2%) monoinfected patients (p = 0.45) (from A to B or C and from B to C). Baseline factors independently associated with C-P class worsening were male sex (HR = 2.00; 95% CI = 1.18-3.36), platelet count < 100,000/μl (HR = 1.75; 95% CI 1.08-2.85) and increased INR (HR = 2.41; 95% CI 1.51-3.84). Following viral eradication, in 7 of 15 coinfected (46.6%) and in 61 of 133 (45.8%) monoinfected patients with previous history of decompensation, a new decompensating event occurred. A first decompensating event was recorded in 4 of 93 (4.3%) coinfected and in 53 of 1109 (4.8%) monoinfected patients (p = 0.83).

Conclusions: Improvement of liver function was observed following HCV eradication in the majority of patients with cirrhosis; however viral eradication did not always mean cure of liver disease in both monoinfected and coinfected patients with advanced liver disease.
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http://dx.doi.org/10.1186/s12879-021-06053-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8094561PMC
May 2021

Clinical features and comorbidity pattern of HCV infected migrants compared to native patients in care in Italy: A real-life evaluation of the PITER cohort.

Dig Liver Dis 2021 Apr 20. Epub 2021 Apr 20.

Center for Global Health, Istituto Superiore di Sanità, Rome, Italy. Electronic address:

Background: Direct-acting antivirals are highly effective for the treatment of hepatitis C virus (HCV) infection, regardless race/ethnicity. We aimed to evaluate demographic, virological and clinical data of HCV-infected migrants vs. natives consecutively enrolled in the PITER cohort.

Methods: Migrants were defined by country of birth and nationality that was different from Italy. Mann-Whitney U test, Chi-squared test and multiple logistic regression were used.

Results: Of 10,669 enrolled patients, 301 (2.8%) were migrants: median age 47 vs. 62 years, (p < 0.001), females 56.5% vs. 45.3%, (p < 0.001), HBsAg positivity 3.8% vs. 1.4%, (p < 0.05). Genotype 1b was prevalent in both groups, whereas genotype 4 was more prevalent in migrants (p < 0.05). Liver disease severity and sustained virologic response (SVR) were similar. A higher prevalence of comorbidities was reported for natives compared to migrants (p < 0.05). Liver disease progression cofactors (HBsAg, HIV coinfection, alcohol abuse, potential metabolic syndrome) were present in 39.1% and 47.1% (p > 0.05) of migrants and natives who eradicated HCV, respectively.

Conclusion: Compared to natives, HCV-infected migrants in care have different demographics, HCV genotypes, viral coinfections and comorbidities and similar disease severity, SVR and cofactors for disease progression after HCV eradication. A periodic clinical assessment after HCV eradication in Italians and migrants with cofactors for disease progression is warranted.
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http://dx.doi.org/10.1016/j.dld.2021.03.020DOI Listing
April 2021

Impact of Direct Antiviral Agents (DAAs) on B-cell Non Hodgkin's Lymphoma in patients with chronic hepatitis C.

Authors:
Alessia Ciancio

Minerva Gastroenterol (Torino) 2021 Apr 15. Epub 2021 Apr 15.

Dipartimento di Scienze Mediche, Scuola di Medicina, Università degli Studi di Torino, Turin, Italy -

The relationship between HCV infection and extrahepatic manifestations has been demonstrated by epidemiological, clinical, immunological and pathological studies. Patients with HCV infection have an increased risk of morbidity and mortality related to these non-liver diseases. For these reasons, HCV chronic infection should be considered a systemic disease in which extrahepatic manifestations increase the severity of the disease. HCV-extrahepatic manifestations may severely affect the overall prognosis, while viral eradication significantly reduces non-liver related deaths. Over the past 5 years, treatment of chronic HCV infection in patients with hematologic malignancies has evolved rapidly and effective and safe direct-acting antivirals (DAAs) have become the standardof-care treatment. The choice of regimens with DAAs should be individualized after thorough assessment for potential hematologic toxic effects and drug-drug interactions. Elimination of HCV from infected cancer patients confers virologic, hepatic, and oncologic benefits.
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http://dx.doi.org/10.23736/S2724-5985.21.02834-8DOI Listing
April 2021

The Clinical Role of Serum Epidermal Growth Factor Receptor 3 in Hepatitis C Virus-Infected Patients with Early Hepatocellular Carcinoma.

Biology (Basel) 2021 Mar 11;10(3). Epub 2021 Mar 11.

Division of Gastroenterology, Città della Salute e della Scienza University-Hospital, 10100 Turin, Italy.

Epidermal growth factor receptor 3 (ERBB3) is a surface tyrosine kinase receptor belonging to the EGFR/ERBB family, involved in tumor development and progression. We evaluated the diagnostic and prognostic value of serum ERBB3 measurement in hepatitis C virus (HCV)-infected patients with early hepatocellular carcinoma (HCC). A total of 164 HCV-infected patients (82 with cirrhosis and 82 with early HCC) were included in the study. HCC was classified according to the Barcelona Clinic Liver Cancer (BCLC) staging system. Among patients with HCC, 23 (28%) had a diagnosis of very early tumor (BCLC = 0), while 59 (62%) had a diagnosis of early HCC (BCLC = A). Median overall survival (OS) in patients with HCC was 79.2 (95% CI 51.6-124.8) months. While ERBB3 serum values were similar between patients with cirrhosis and those with HCC ( = 0.993), in the latter, serum ERBB3 ≥ 2860 RU resulted significantly and independently associated with OS (Hazard Ratio = 2.24, 95% CI 1.16-4.35, = 0.017). Consistently, the 1-, 3-, and 5-year OS rates in patients with serum ERBB3 ≥ 2860 RU were 90% (36/40), 53% (19/36), and 28% (8/29) in comparison to patients with serum ERBB3 < 2860 RU, which were 98% (40/41), 80% (32/40), and 74% (26/35) (Log-rank test; = 0.014). In conclusion, serum ERBB3 values resulted an independent prognostic factor of patients with early HCC and might be useful to tailor more personalized treatment strategies.
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http://dx.doi.org/10.3390/biology10030215DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7999043PMC
March 2021

Low influenza vaccination coverage in subjects with liver cirrhosis. An alert waiting for winter season 2020-2021 during the COVID-19 pandemic.

J Med Virol 2021 04 11;93(4):2446-2452. Epub 2021 Jan 11.

Dipartimento di Salute Mentale e Fisica e Medicina Preventiva, Clinic of Infectious Diseases, University of Naples, Naples, Italy.

We have evaluated flu vaccine coverage and variables associated with the lack of vaccination in cirrhotic subjects with particular attention to the cirrhosis etiology. Cirrhotic subjects consecutively referring to eight Italian centers were prospectively enrolled for a 6-month period in 2019. Subjects were asked if they had received a flu vaccine in the last 12 months. Multiple logistic regression analysis was performed to identify independent predictors of lack of vaccination. A total of 818 cases were recruited. The overall vaccine coverage was 39.6% (26.9% in those younger than 65 years and 51.9% in those older than 64 years; p < 0.001). Age < 65 years (odds ratio [OR] = 2.38; 95% confidence interval [CI] = 1.68-3.36), alcoholic etiology (OR = 2.40; 95% CI = 1.49-3.85), birth abroad (OR = 2.7; 95% CI = 1.10-6.61), and residence in South/Sardinia island (OR = 1.66; 95% CI = 1.14-2.42) all resulted independent predictors of the likelihood of lack of vaccination. The lack of information regarding the vaccine as the reason for no vaccination was reported by 71.4% of foreigners and by 34.7% of natives (p < 0.001). In conclusion, much work still should be done to improve coverage among groups at higher risk of lack of vaccination identified in this survey. The ongoing SARS-CoV-2 pandemic may represent one more alert for improving seasonal flu vaccine coverage to avoid further stress to the National Health System.
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http://dx.doi.org/10.1002/jmv.26763DOI Listing
April 2021

Is positivity for hepatitis C virus antibody predictive of lower risk of death in COVID-19 patients with cirrhosis?

World J Clin Cases 2020 Nov;8(22):5831-5834

Department of Biostatistics, Fondazione IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo 71013, Italy.

Liver injury has been reported in coronavirus disease 2019 (COVID-19) cases but the impact of pre-existing liver damage and related etiology have not been completely elucidated. Our research interests include the potential reciprocal influence of COVID-19 and pre-existing liver damage related to hepatitis C virus (HCV) infection, in particular. To this end, we have evaluated three cohorts of patients admitted at three Italian hospitals during the coronavirus pandemic; these included 332 patients with COVID-19 and 1527 patients with HCV who were from established real-world antiviral treatment study cohorts (sofosbuvir/velpatasvir), with either liver disease (various severities; = 1319) or cirrhosis ( = 208). Among the COVID-19 patients, 10 had cirrhosis (3%), including 7 of metabolic origin and 3 of viral origin. Mortality among the COVID-19 patients was 27.1%, with 70% of those with cirrhosis of metabolic etiology having died. Cirrhosis, older age, low white blood cell count and lymphocyte count being identified as risk predictors of death [odds ratio (OR) = 13.7, 95% confidence interval (CI): 2.59-83.01, = 0.006; OR = 1.05, 95%CI: 1.03-1.08, = 0.0001; OR = 1.09, 95%CI: 1.36-1.16, = 0.001; OR = 0.61, 95%CI: 0.39-0.93, = 0.023, respectively]. In the two cohorts of HCV patients, COVID-19 diagnosis was made in 0.07% of those with liver disease and 1% of those with cirrhosis. Thus, the prevalence of HCV antibodies among COVID-19-infected patients was comparable to that currently reported for the general population in Italy. Amongst the COVID-19 patients, pre-existing metabolic cirrhosis appears to be associated with higher mortality, while HCV antibodies may be suggestive of "protection" against COVID-19.
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http://dx.doi.org/10.12998/wjcc.v8.i22.5831DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7716316PMC
November 2020

Long-term follow-up of diabetic and non-diabetic patients with chronic hepatitis C.

Liver Int 2021 03 2;41(3):640. Epub 2020 Dec 2.

Gastro-hepatoloy Unit, Department of Medical Sciences, University of Turin, Turin, Italy.

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http://dx.doi.org/10.1111/liv.14738DOI Listing
March 2021

Hepatitis B vaccine coverage and risk factors for lack of vaccination in subjects with HBsAg negative liver cirrhosis in Italy: still, much work should be done.

Dig Liver Dis 2020 Nov 5. Epub 2020 Nov 5.

Clinic of Infectious Diseases, University of Naples, Italy.

Background: in Italy, Hepatitis-B-vaccine is advised and provided free-of-charge for subjects with chronic liver disease (CLD), including liver cirrhosis.

Aims: to evaluate HB-vaccine-coverage and variables associated with lack of vaccination in cirrhotic patients with particular attention to cirrhosis' etiology.

Methods: cirrhotic patients of any etiology (excluding HBsAg+) referring to 8 tertiary-centers were prospectively enrolled for a-six-months-period in 2019. Subjects were asked if they received HB-vaccine previously. Multiple-logistic-regression-analysis was performed to identify independent predictors of lack of vaccination.

Results: 731 cases were recruited. Overall-vaccine-coverage was 16.3% (23.7% in those younger than 65y, 10.0% in those older than 64y; p<0.001). Lack of information was the most frequent reason (78.5% of cases) reported by the 608 unvaccinated subjects, without statistical difference by area-of-birth (77.3% in Italians, 80.0% in people-born-abroad). Age>64 y (OR: 4.27; CI 95%: 2.52-7.24), educational level<9 years (OR: 3.52; CI 95%: 2.10-5.90), residence in South/Sardinia (OR 2.52; CI 95%:1.45-4.39), birth-abroad (OR 5.09; CI 95%: 1.07-24-.17), and Child grade B/C(OR 2.68; CI 95%: 1.35-5.33) all resulted independent predictors of likelihood of lack of vaccination.

Conclusions: Vaccination-rate in cirrhotic patients results very low. Vaccine-coverage implementation in these subjects, is warranted. Vaccine should be provided in early CLD, when immunization is most effective.
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http://dx.doi.org/10.1016/j.dld.2020.10.011DOI Listing
November 2020

Alpha-Fetoprotein, Protein Induced by Vitamin K Absence or Antagonist II and Glypican-3 for the Detection and Prediction of Hepatocellular Carcinoma in Patients with Cirrhosis of Viral Etiology.

Cancers (Basel) 2020 Oct 31;12(11). Epub 2020 Oct 31.

Division of Gastroenterology, Città della Salute e della Scienza University-Hospital, 10100 Turin, Italy.

International guidelines recommend the use of ultrasound as a surveillance tool for hepatocellular carcinoma (HCC) in patients with cirrhosis, while the role of serum biomarkers is still debated. We investigated serum alpha-fetoprotein (AFP), protein induced by vitamin K absence or antagonist II (PIVKA-II) and glypican-3 (GPC-3) diagnostic accuracy for HCC detection and prediction in patients with liver cirrhosis of viral etiology under surveillance. A total of 349 patients (200 cirrhosis and 149 HCC) were enrolled. The 200 patients with cirrhosis consisted of 114 patients still HCC-free after 36 months of follow-up and 86 patients that developed HCC after 13.8 (11.0-19.8) months. AFP, PIVKA-II and GPC-3 were measured in serum samples collected at tumor diagnosis in the 149 patients with HCC, and at the beginning of follow-up in the 200 patients with cirrhosis. The higher performance for HCC detection was observed for PIVKA-II (area under the curve (AUC) = 0.790), followed by AFP (AUC = 0.737) and GPC-3 (AUC = 0.637); the combination of AFP + PIVKA-II improved the diagnostic accuracy to AUC = 0.822. Serum PIVKA-II values, but not AFP and GPC-3, were significantly higher in the 86 cirrhotics that developed HCC compared with the 114 cirrhotics still HCC-free after 36 months of follow-up ( = 0.020). PIVKA-II ≥ 55 mAU/mL allowed to identify patients with cirrhosis at higher risk of HCC development (Log-rank test, < 0.001; adjusted Hazard Ratio = 1.99, = 0.001). In conclusion, the measurement of PIVKA-II in patients with cirrhosis may be useful to tailor personalized surveillance strategies.
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http://dx.doi.org/10.3390/cancers12113218DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7692611PMC
October 2020

Chronic hepatitis B virus infection in Italy during the twenty-first century: an updated survey in 2019.

Eur J Clin Microbiol Infect Dis 2021 Mar 8;40(3):607-614. Epub 2020 Oct 8.

Clinic of Infectious Diseases, University of Naples, Naples, Italy.

The aim of this study is to provide updates on the characteristics of chronic HBsAg carriers in Italy before the advent of new drugs eliminating or functionally inactivating the genome HBV reservoirs. HBV endemicity has greatly decreased in Italy over the past decades. A not negligible number of chronic HBsAg carriers are still alive in the country. Chronic HBsAg carriers consecutively referring to 9 units in Italy were prospectively enrolled for a 6-month period in 2019. Multiple logistic regression analysis was performed to identify independent predictors of treatment. A total of 894 cases was recruited (sex ratio 1.6; mean age 53.7 ± 13.5 years). The proportion of subjects born abroad was 19.0%; only 1% of cases reported current heavy alcohol intake (> 4 units/day). Chronic HBV infection, chronic HBV hepatitis, and subjects with liver cirrhosis and/or HCC represented 24.8%, 55%, and 19.3% of cases, respectively. After exclusion of the 222 subjects with chronic HBV infection, the proportion of subjects under therapy was as high as 89.3%. A more severe liver disease (OR 2.52; 95% CI = 1.25-5.14) resulted an independent predictor of the likelihood of treatment; male sex was marginally associated (OR 1.67; 95% CI = 1.02-2.76) to the chance of treatment. People born abroad had same chance than Italians native to be treated (OR 2.12; 95% CI = 0.9-4.97). The high proportion of subjects under treatment and the absence of gender and ethnic barrier against treatment sound good news. These updated figures may represent reference data for evaluating the potential impact of forthcoming new therapy against HBV-related disease.
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http://dx.doi.org/10.1007/s10096-020-04065-6DOI Listing
March 2021

Long-term follow-up of diabetic and non-diabetic patients with chronic hepatitis C successfully treated with direct-acting antiviral agents.

Liver Int 2021 02 23;41(2):276-287. Epub 2020 Nov 23.

Gastro-Hepatology Unit, Department of Medical Sciences, University of Turin, Turin, Italy.

Background And Aims: Clearance of hepatitis C virus (HCV) is associated with improved glycometabolic control in patients with diabetes mellitus (DM) but whether this effect is maintained over the long term with a reduction in liver-related events (LRE) is still debated. To address these issues, we conducted a long-term prospective study on diabetic and non-diabetic patients with chronic hepatitis C cured by direct antiviral agents (DAAs).

Methods: Among 893 recruited patients, 15.7% were diabetic (Group 1) and 84.3% non-diabetic (Group 2); changes in fasting glucose (FG) and glycated haemoglobin (HbA1c) levels were assessed in Group 1 while the incidence of LRE was established in the whole cohort. Differences between groups were evaluated and independent predictors of unfavourable clinical outcome were established.

Results: After a mean follow up of 44.5 months, a significant reduction in FG and HbA1c values was found in Group 1. Death was reported in 5.7% of patients in Group 1 vs 1.6% in Group 2 (P = .003), hepatocellular carcinoma (HCC)-free survival was significantly lower in Group 2 (P = .015) as well as LRE-free survival in Group 1 cirrhotic patients (P = .0006). After adjustment for baseline variables, cirrhosis and albumin levels emerged as independent predictors of LRE; low albumin levels, DM and central obesity were associated with HCC risk in cirrhotic patients while insulin therapy emerged as unfavourable predictor among diabetics.

Conclusions: SVR achieved by DAAs is associated with long-term improvement of glycometabolic control in diabetic patients, but among cirrhotics DM still exerts a detrimental effect on the liver.
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http://dx.doi.org/10.1111/liv.14676DOI Listing
February 2021

Effectiveness and safety of glecaprevir/pibrentasvir in chronic hepatitis C patients: Results of the Italian cohort of a post-marketing observational study.

Dig Liver Dis 2021 May 8;53(5):612-619. Epub 2020 Sep 8.

Medical Department, AbbVie S.r.l., 00144 Roma, Italy.

Background And Aims: The MARS post-marketing, observational study evaluates glecaprevir/pibrentasvir in a large population of Italian patients who are infected with HCV.

Patients And Methods: Achievement of SVR12 was the primary endpoint in the overall population and by subpopulations of interest (treatment-naïve and treatment-experienced patients, subjects infected with different HCV genotype/sub-genotype, cirrhotic and non-cirrhotic patients, patients with different severity of fibrosis, patients with an APRI score ≥1, subjects with comorbidities, HIV-coinfected patients, elderly patients and people who use drugs). Safety and quality of life (assessed by SF-36 and Work Productivity and Activity Impairment) were also evaluated.

Results: The SVR12 rate was 99.4% (319/321; 95% CI: 97.8-99.8%) in the core population with sufficient follow-up (n = 321), 99.7% (289/290) in 8-week treated patients, and high (>96%) across subgroups. Only three patients (0.9%) had treatment-related adverse events that led to treatment discontinuation. In total, 30.1% of patients showed an improvement of ≥2.5 points in the Physical Component Summary of the SF-36 from baseline to the end of treatment, and this figure raised to 37.5% with the achievement of SVR12. Corresponding values for MCS were 42.2% and 42.8%, respectively.

Conclusion: Glecaprevir/pibrentasvir is safe and effective across subpopulations who are underserved in clinical trials.
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http://dx.doi.org/10.1016/j.dld.2020.08.007DOI Listing
May 2021

Self-Reported Autistic Traits Using the AQ: A Comparison between Individuals with ASD, Psychosis, and Non-Clinical Controls.

Brain Sci 2020 May 14;10(5). Epub 2020 May 14.

Department of Clinical and Experimental Medicine, Psychiatry Unit, University of Catania, Via Santa Sofia 78, 95123 Catania, Italy.

The term "autism" was originally coined by Eugen Bleuler to describe one of the core symptoms of schizophrenia. Even if autism spectrum disorder (ASD) and schizophrenia spectrum disorders (SSD) are now considered two distinct conditions, they share some clinical features. The present study aimed to investigate self-reported autistic traits in individuals with ASD, SSD, and non-clinical controls (NCC), using the Autism-Spectrum Quotient (AQ), a 50-item questionnaire. The study was conducted in the Psychiatry Unit of Policlinico "G. Rodolico", Catania, Italy. The AQ was administered to 35 adults with ASD, 64 with SSD, and 198 NCC. Overall, our data showed that the ASD sample scored significantly higher than NCC. However, no significant differences were detected between individuals with ASD and SSD. Notably, the three groups scored similarly in the subscale "attention to detail". AQ showed good accuracy in differentiating ASD from NCC (AUC = 0.84), while discriminant ability was poor in the clinical sample (AUC = 0.63). Finally, AQ did not correlate with clinician-rated ADOS-2 scores in the ASD sample. Our study confirms that symptoms are partially overlapping in adults with ASD and psychosis. Moreover, they raise concerns regarding the usefulness of AQ as a screening tool in clinical populations.
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http://dx.doi.org/10.3390/brainsci10050291DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7288044PMC
May 2020

Migratory flow and hepatitis delta infection in Italy: A new challenge at the beginning of the third millennium.

J Viral Hepat 2020 09 11;27(9):941-947. Epub 2020 May 11.

Clinic of Infectious Diseases, University of Naples, Naples, Italy.

In Italy, HDV infection endemicity has greatly decreased overtime. Migratory flow may change this scenario as migrants often come from high HDV endemicity areas. Here, we studied characteristics of HDV infection in Italy, particularly addressed to the birth area of subjects. Chronic HBsAg carriers consecutively referring to 9 units in Italy prospectively enrolled for a six-month period in 2019 were tested for anti-HDV by ELISA. Multiple logistic regression analysis was performed to identify anti-HDV positivity independent predictors. A total of 894 HBsAg-positive subjects were enrolled. Of them, 786 (87.9%) were tested for anti-HDV. Anti-HDV overall prevalence was 9.9% (6.4% in Italian natives and 26.4% in non-natives; P < .001). HDV-RNA was checked in 63 (80.8%) of the 78 anti-HDV+ subjects, and 49 (77.8%) tested positive. Compared to non-natives, Italians were more likely males (male/female 1.6 vs 0.6; P < .05) and older (median age 57 years vs 46 years; P < .05). Multivariate analysis showed that non-natives (OR = 6.02; CI 95% = 3.06-11.84) and cirrhosis (OR 9.6; CI 95% = 5.39-17.30) were independently associated with anti-HDV positivity. A remarkable changing pattern in some characteristics of anti-HDV-positive subjects was observed over 1987-2019: a decreasing male/female ratio, an increasing mean age and proportion of cirrhotic subjects. Anti-HDV prevalence decreased from 7.4% to 6.4% among Italians, increasing from 12.2% to 26.4% among non-natives during 2001-2019. Hence, HDV infection in Italians is further decreasing and mostly affects old people and subjects with advanced disease reflecting a survival effect. Conversely, non-natives are sixfold more likely anti-HDV-positive with an increasing trend. Migratory flow may be a new challenge for HDV infection at the beginning of the third millennium.
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http://dx.doi.org/10.1111/jvh.13310DOI Listing
September 2020

Analytical and clinical evaluation of a novel assay for anti-HBc IgG measurement in serum of subjects with overt and occult HBV infection.

Diagn Microbiol Infect Dis 2020 Apr 9;96(4):114985. Epub 2020 Jan 9.

Department of Medical Sciences, University of Turin, Gastroenterology Division of Città della Salute e della Scienza of Turin, University Hospital, Turin, Italy.

Objectives: We assessed the analytical and clinical performance of the Lumipulse® G HBcAb-N (Fujirebio, Japan) assay for IgG antibodies to hepatitis B core antigen (anti-HBc IgG) measurement in serum of subjects with overt and occult HBV infection (OBI).

Materials/methods: Serum anti-HBc IgG was assessed in 181 anti-HBc-positive subjects: 119 chronic hepatitis B (CHB) patients in different infection phases and 62 subjects (35 CHB and 27 OBI) with available liver specimens for HBV covalently-close-circular (ccc) DNA analysis.

Results: The anti-HBc IgG assay showed a linear dynamic range (R = 0.9967); lower limit of detection and quantitation were 0.5 IU/mL and 0.8 IU/mL. Reproducibility was 4.9% and accuracy 98.7%. Anti-HBc IgG levels varied according to HBV infection phase, linearly declined during antiviral treatment and resulted correlated to intrahepatic HBV cccDNA (r = 0.752, P < 0.001).

Conclusions: The quantitative anti-HBc IgG assay exhibited appropriate analytical performance and may represent a diagnostic complement in CHB patients and OBI subjects.
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http://dx.doi.org/10.1016/j.diagmicrobio.2020.114985DOI Listing
April 2020

Addition of Bismuth to the Standard Triple Therapy for Helicobacter Pylori Infection.

Clin Gastroenterol Hepatol 2019 12;17(13):2822

Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy.

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http://dx.doi.org/10.1016/j.cgh.2019.05.036DOI Listing
December 2019

Clinical outcomes in chronic hepatitis C long-term responders to pre-direct antiviral agents: a single-center retrospective study.

Minerva Med 2019 Oct 6;110(5):401-409. Epub 2019 May 6.

Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy.

Background: Obesity, type 2 diabetes (T2D), dyslipidemia, arterial hypertension as well as hepatic steatosis (HS) are common conditions that can affect clinical outcomes of patients with chronic hepatitis C (CHC) who achieved sustained virologic response (SVR). The aim of this study was to assess the impact of metabolic cofactors on the occurrence of clinical events during follow-up (FU) in a group of CHC long-term responders (LTRs) to interferon- (IFN) based therapy.

Methods: A total of 5172 medical records of CHC patients enrolled from 1990 to 2011 were examined; 1034 of 5172 (20%) patients were treated with IFN-based therapy and 382 of 1034 (37%) of them achieved SVR. A total of 188 (49%) LTRs underwent liver biopsy before antiviral treatment. Data on liver and cardiometabolic events such as cirrhosis and its complications, hepatocellular carcinoma, coronary artery disease, arterial hypertension, impaired fasting glucose (IFG)/type 2 diabetes (T2D) and dyslipidemia, were collected over time.

Results: The mean age of the whole cohort was 46±12 years and 114/188 (61%) patients were males. HS was found in 82 of 188 (43.6%) patients and most of them were infected by HCV genotype 3a. The prevalence of obesity, IFG/T2D, dyslipidemia and arterial hypertension was 4.3%, 6.9%, 37.2%, and 5.9%, and was similarly distributed among patients with and without HS. Cirrhosis was histologically diagnosed in 18 of 188 (9.6%) patients. After a median follow-up of 11 years (range 3-21 years), the cumulative incidence of cardiovascular events, IFG/T2D and dyslipidemia was higher in CHC-LTRs who had HS at baseline compared to those without HS (1.2%, 2.3%, and 3.0% vs. 0.4%, 0.8%, and 2.5%, respectively). At multivariable Cox regression analysis, HS was significantly associated to the development of cardiovascular events and IFG/T2D (HR=5.2, 95% CI: 1.3-20.7, P=0.019, and HR=2.6, 95% CI: 1.1-6.2, P=0.027, respectively).

Conclusions: In CHC-LTRs, HS at baseline may predispose to the development of cardiovascular events and T2D during follow-up emphasizing the importance of an accurate counseling in order to prevent extra-hepatic complications.
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http://dx.doi.org/10.23736/S0026-4806.19.06108-1DOI Listing
October 2019

SVR12 Higher than 97% in GT3 Cirrhotic Patients with Evidence of Portal Hypertension Treated with SOF/VEL without Ribavirin: A Nation-Wide Cohort Study.

Cells 2019 04 4;8(4). Epub 2019 Apr 4.

Gastroenterology Unit, Università di Torino, 10124Torino, Italy.

In clinical trials, a sofosbuvir/velpatasvir (SOF/VEL) pangenotypic single-tablet regimen was associated with high sustained virological response (SVR) rates at 12 weeks (SVR12) after the end of treatment, regardless of genotype and fibrosis stage. No real-life data on genotype 3 (GT3) cirrhotic patients with portal hypertension are available. The aim of this study was to assess the effectiveness of SOF/VEL in GT3 cirrhotics with portal hypertension. Patients with GT3 and advanced cirrhosis were treated for 12 weeks with SOF/VEL without ribavirin at five different centers in Italy from June 2017 to August 2018 and their SVR12 was assessed. Of the 227 GT3 cirrhotics evaluated, 205 met the inclusion criteria and 111 had transient elastography results ≥20 KPa. SVR12 was 97.6% (95% CI 94.4-98.9), rates were 99.1% (95% CI 95.7-99.8) in patients with ≥20 KPa and 95.8% (95% CI 89.5-98.3) in those with <20 KPa (p = 0.18). Analyzed by presence of esophageal varices, the SVR12 rates were 98.4% (95% CI 91.4-99.7) and 97.1% (95% CI 92.9-98.9) in patients without and with varices, respectively (p = 1.0). In real life, SOF/VEL GT3 cirrhotic patients with evidence of portal hypertension can achieve SVR12 levels comparable to those of patients without portal hypertension. These SVR12 rates are similar to what is reported in compensated cirrhosis treated within clinical trials.
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http://dx.doi.org/10.3390/cells8040313DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6523403PMC
April 2019

A deceiving case of paraplegia.

Intern Emerg Med 2020 04 28;15(3):473-478. Epub 2019 Feb 28.

Department of Medical Sciences, University of Turin, Corso Dogliotti 14, 10126, Turin, Italy.

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http://dx.doi.org/10.1007/s11739-019-02059-7DOI Listing
April 2020

Real life experiences in HCV management in 2018.

Expert Rev Anti Infect Ther 2019 02 15;17(2):117-128. Epub 2019 Jan 15.

y Division of Clinical and Molecular Hepatology, Department of Internal Medicine , University Hospital of Messina , Messina , Italy.

Introduction: Hepatitis C virus (HCV) infection is a major cause of chronic liver disease, with approximately 71 million chronically infected individuals worldwide. Treatment of chronic hepatitis C has considerably improved in the last few years thanks to the introduction of direct-acting antivirals able to achieve sustained virological response in more than 95% of patients. Successful anti-HCV treatment can halt liver disease progression and solve the HCV-related extra-hepatic manifestations, eventually reducing liver-related and overall mortality. Areas covered: With the aim to respond to unmet needs in patient's identification, universal access to antiviral therapy and treatment optimization in specific setting of HCV-infected patients, a group of Italian experts met in Stresa in May 2018. The summary of the considerations arising from this meeting and the final statements are reported in this paper. Expert commentary: All the advances on HCV cure may have a real clinical impact not only in individual patients but also at the social health level if they are applied to all infected patients, independently from the stage of liver disease. Further improvements are needed in order to attain HCV elimination, such as the development of an enhanced screening program working in parallel to the present treatment options.
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http://dx.doi.org/10.1080/14787210.2019.1563755DOI Listing
February 2019

Delta hepatitis in resolved hepatitis B.

Eur J Gastroenterol Hepatol 2018 12;30(12):1528

Unit of Gastroenterology, Department of Medical, Surgical and Neurological Sciences, University of Siena, Siena, Italy.

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http://dx.doi.org/10.1097/MEG.0000000000001253DOI Listing
December 2018

Management of Pt1 tumours removed by endoscopy during colorectal cancer screening: Outcome and treatment quality indicators.

Eur J Surg Oncol 2018 12 16;44(12):1873-1879. Epub 2018 Oct 16.

Division of Gastroenterology, Department of Medical Sciences, Molinette Hospital, University of Turin, Italy.

Introduction: Limited information is available about outcomes of patients with malignant adenomas endoscopically resected at screening. The aim of the study was to evaluate diagnostic and therapeutic quality indicators and to correlate them with clinical and surgical outcomes.

Materials And Methods: We reviewed endoscopic and histology characteristics of all pT1 tumours endoscopically removed at the time of colonoscopy assessment in subjects with a positive screening test result in the context of a population-based program.

Results: 392 pT1 tumours were completely removed by endoscopy (en-bloc = 86.7%, piecemeal = 13.3%) and the histology report was considered complete in 83.2% of cases. Treatment was limited to endoscopic excision for 120 patients (30.7%, Group 1), 272 (69.3%, Group 2) underwent radicalisation surgery. In patients who had at least 1 lymph node examined, the rate of nodal involvement was 5.4% (13/239); no metastatic node was found in the 21 (27.6%) out of 76 patients with low-risk adenomas, who underwent surgery.

Conclusion: Risk of nodal involvement in colorectal pT1 tumours is well predicted by known histologic features also in a screening setting, although it was lower than among patients from clinical series. Surgical overtreatment is still significantly present and there is ample room for improvement regarding diagnostic and therapeutic flow-chart.
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http://dx.doi.org/10.1016/j.ejso.2018.09.009DOI Listing
December 2018

Forecasting Hepatitis C liver disease burden on real-life data. Does the hidden iceberg matter to reach the elimination goals?

Liver Int 2018 12 10;38(12):2190-2198. Epub 2018 Aug 10.

Internal Medicine, Villa Sofia-Cervello Hospital, Palermo, Italy.

Background & Aims: Advances in direct-acting antiviral treatment of HCV have reinvigorated public health initiatives aimed at identifying affected individuals. We evaluated the possible impact of only diagnosed and linked-to-care individuals on overall HCV burden estimates and identified a possible strategy to achieve the WHO targets by 2030.

Methods: Using a modelling approach grounded in Italian real-life data of diagnosed and treated patients, different linkage-to-care scenarios were built to evaluate potential strategies in achieving the HCV elimination goals.

Results: Under the 40% linked-to-care scenario, viraemic burden would decline (60%); however, eligible patients to treat will be depleted by 2025. Increased case finding through a targeted screening strategy in 1948-1978 birth cohorts could supplement the pool of diagnosed patients by finding 75% of F0-F3 cases. Under the 60% linked-to-care scenario, viraemic infections would decline by 70% by 2030 but the patients eligible for treatment will run out by 2028. If treatment is to be maintained, a screening strategy focusing on 1958-1978 birth cohorts could capture 55% of F0-F3 individuals. Under the 80% linked-to-care scenario, screening limited in 1968-1978 birth cohorts could sustain treatment at levels required to achieve the HCV elimination goals.

Conclusion: In Italy, which is an HCV endemic country, the eligible pool of patients to treat will run out between 2025 and 2028. To maintain the treatment rate and achieve the HCV elimination goals, increased case finding in targeted, high prevalence groups is required.
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http://dx.doi.org/10.1111/liv.13901DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6282782PMC
December 2018

Containing the Costs of Recurrent Gastro-Duodenal Ulcer Bleeding.

Dig Dis 2018 23;36(4):269. Epub 2018 May 23.

Department of Medical Sciences, University of Turin, Turin, Italy.

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http://dx.doi.org/10.1159/000488874DOI Listing
August 2018

Performance of protein induced by vitamin K absence or antagonist-II assessed by chemiluminescence enzyme immunoassay for hepatocellular carcinoma detection: a meta-analysis.

Scand J Gastroenterol 2018 06 18;53(6):734-740. Epub 2018 Apr 18.

a Department of Medical Sciences , University of Turin , Turin , Italy.

Objectives: In the setting of surveillance for hepatocellular carcinoma (HCC) detection, the use of serum biomarkers in addition to ultrasonography (US) is still a matter of debate. Hence, we performed a meta-analysis to evaluate the diagnostic accuracy of protein induced by vitamin K absence or antagonist-II (PIVKA-II) and alpha-fetoprotein (AFP) alone or in combination for HCC detection in patients at risk of tumor development.

Materials And Methods: We performed a systematic search in PubMed and Scopus database for original articles published in English from 2011 to 2017, investigating the accuracy of PIVKA-II alone or in combination with AFP (reported as area under the curve [AUC]) for HCC detection among patients at risk of tumor development. Furthermore, we focused on studies in which serum PIVKA-II was assessed by highly sensitive chemiluminescence immunoassay (CLEIA).

Results: A total of 11 studies (873 patients with HCC and 1244 patients with advanced liver disease/cirrhosis) were included in the meta-analysis. The weighted summary AUC (sAUC) of PIVKA-II and AFP for the discrimination between patients with HCC and those without was 0.791 (0.746-0.837) and 0.767 (0.732-0.803), respectively. The combination of PIVKA-II + AFP results in a sAUC of 0.859 (0.837-0.882). The performance for HCC detection of PIVKA-II + AFP was significantly superior to each biomarker used alone (ΔsAUC = 0.068, p = .032 and ΔsAUC = 0.092, p < .001, respectively).

Conclusion: In clinical practice, the use of PIVKA-II + AFP in addition to US examination may improve the effectiveness of surveillance among patients at risk for HCC development.
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http://dx.doi.org/10.1080/00365521.2018.1459824DOI Listing
June 2018

Quantitation of HBV cccDNA in anti-HBc-positive liver donors by droplet digital PCR: A new tool to detect occult infection.

J Hepatol 2018 08 3;69(2):301-307. Epub 2018 Apr 3.

Department of Medical Sciences, University of Turin, Gastroenterology Division of Città della Salute e della Scienza of Turin, University Hospital, Turin, Italy.

Background & Aims: The accurate diagnosis of occult hepatitis B virus (HBV) infection (OBI) requires the demonstration of HBV DNA in liver biopsies of hepatitis B surface antigen-negative individuals. However, in clinical practice a latent OBI is deduced by the finding of the antibody to the hepatitis B core antigen (anti-HBc). We investigated the true prevalence of OBI and the molecular features of intrahepatic HBV in anti-HBc-positive individuals.

Methods: The livers of 100 transplant donors (median age 68.2 years; 64 males, 36 females) positive for anti-HBc at standard serologic testing, were examined for total HBV DNA by nested-PCR and for the HBV covalently closed circular DNA (HBV cccDNA) with an in-house droplet digital PCR assay (ddPCR) (Linearity: R = 0.9998; lower limit of quantitation and detection of 2.4 and 0.8 copies/10 cells, respectively).

Results: A total of 52% (52/100) of the individuals studied were found to have OBI. cccDNA was found in 52% (27/52) of the OBI-positive, with a median 13 copies/10 cells (95% CI 5-25). Using an assay specific for anti-HBc of IgG class, the median antibody level was significantly higher in HBV cccDNA-positive than negative donors (17.0 [7.0-39.2] vs. 5.7 [3.6-9.7] cut-off index [COI], respectively, p = 0.007). By multivariate analysis, an anti-HBc IgG value above 4.4 COI was associated with the finding of intrahepatic HBV cccDNA (odds ratio 8.516, p = 0.009); a lower value ruled out its presence with a negative predictive value of 94.6%.

Conclusions: With a new in-house ddPCR-based method, intrahepatic HBV cccDNA was detectable in quantifiable levels in about half of the OBI cases examined. The titer of anti-HBc IgG may be a useful surrogate to predict the risk of OBI reactivation in immunosuppressed patients.

Lay Summary: The covalently closed circular DNA (cccDNA) form of the hepatitis B virus (HBV) sustains the persistence of the virus even decades after resolution of the symptomatic infection (occult HBV infection). In the present study we developed a highly sensitive method based on droplet digital PCR technology for the detection and quantitation of HBV cccDNA in the liver of individuals with occult HBV infection. We observed that the amount of HBV cccDNA may be inferred from the titer in serum of the IgG class antibody to the hepatitis B core antigen. The quantitation of this antibody may represent a surrogate to determine which patients are at the highest risk of HBV reactivation following immunosuppressive therapies.
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http://dx.doi.org/10.1016/j.jhep.2018.03.021DOI Listing
August 2018

Usefulness of the index of NASH - ION for the diagnosis of steatohepatitis in patients with non-alcoholic fatty liver: An external validation study.

Liver Int 2018 04 3;38(4):715-723. Epub 2017 Nov 3.

Division of Gastroenterology and Hepatology, Department of Medical Sciences, University of Torino, Torino, Italy.

Background & Aims: The non-invasive identification of steatohepatitis (NASH) in patients with Non-Alcoholic Fatty Liver Disease is an unmet need in clinical practice. Index of NASH (ION) is a new tool for the prediction of NASH. We aimed to externally validate ION and to compare it with CK-18. Since necroinflammation precedes fibrosis, we also tested ION in combination with non-invasive tools for fibrosis.

Methods: We analysed data from 292 Italian patients (169 Southern cohort, and 123 Northern cohort) with an histological diagnosis of NAFLD. The ION, FIB-4 and NFS scores were calculated according to published algorithms. Serum cytokeratin18-Aspartate396 levels and liver stiffness (LS) by Fibroscan were assessed within three months from liver biopsy.

Results: The diagnostic accuracy of ION for the identification of NASH was not as satisfactory as reported (area under the ROC curve, AUROC = 0.687 [95% CI = 0.62-0.75]). The proposed cut-off value ≥50 showed a poor sensitivity (Se) (28%) and a good specificity (Sp) (92%), with a positive predictive value (PPV) of 91% and a negative predictive value (NPV) of 30%. A new cut-off value >26 improved Se (73%) but decreased Sp (60%) (PPV of 84% and a NPV of 43%). ION performed slightly better in obese NAFLD (AUROC = 0.700). The combination of ION and markers of fibrosis did not improve the identification of advanced liver disease.

Conclusions: ION is not feasible for the non-invasive diagnosis of NASH across different populations of NAFLD patients, mainly because its limited reproducibility in non-obese subjects.
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http://dx.doi.org/10.1111/liv.13612DOI Listing
April 2018

Significant improvement of glycemic control in diabetic patients with HCV infection responding to direct-acting antiviral agents.

J Med Virol 2018 02 14;90(2):320-327. Epub 2017 Nov 14.

Gastroenterology Unit, Department of Medical Sciences, AOU Città della Salute e della Scienza di Torino, University of Turin, Torino, Italy.

Many studies showed insulin resistance amelioration in HCV-patients achieving Sustained Virologic Response (SVR) but results on glycemic control in diabetic patients are unclear. This study aimed to assess fasting glucose (FG) and glycated hemoglobin (HbA1c) values before and after therapy with direct-acting antivirals (DAAs) in HCV-patients with type 2 diabetes mellitus (T2DM). Of the 122 consecutively recruited patients with chronic hepatitis C and T2DM, 110 patients were treated with DAAs and 12 remained untreated. Clinical, biochemical, virological, and metabolic features were collected both at baseline and at 12 weeks after the end of therapy (EOT) or after a comparable period of time in untreated patients. A total of 101 patients obtained a SVR (Group 1), while nine were relapsers. Group 2 (21 patients) was composed by the nine relapsers and the 12 untreated patients. A significant reduction of mean FG (134.3 ± 41.32 mg/dL vs 152.4 ± 56.40 mg/dL, P = 0.002) and HbA1c values (46.51 ± 16.15 mmoL/moL vs 52.15 ± 15.43 mmoL/moL, P <  0.001) was found in Group 1 but not in Group 2 (140.6 ± 47.87 mg/dL vs. 145.31 ± 30.18 mg/dL, P = 0.707, and 55.31 ± 20.58 mmoL/moL vs. 53.38 ± 9.49 mmoL/moL, P = 0.780). In Group 1, 20.7% of patients could reduce or suspend their antidiabetic therapy compared to none in Group 2 (P = 0.03), despite the significant weight increase observed in Group 1. SVR induced a significant amelioration of glycemic control in diabetic HCV-patients, despite a significant weight increase; larger prospective studies are needed to verify whether these results are maintained over the long-term.
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http://dx.doi.org/10.1002/jmv.24954DOI Listing
February 2018