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Abstract Background The evolution of technology in healthcare has increased the health care’s costs and, the universal healthcare systems, in developed countries, need to ensure proper allocation of resources. Thus, the major issue is assessing the effectiveness of new medical technologies. The evaluation of quality of life in response to new treatments has become a key indicator in chronic conditions for which medical interventions are evaluated not only in terms of increasing the number of expected life years but also in terms of increasing quality of life. The aim of this observational study was to verify whether a simple instrument (EQ-5D-5 L) can capture variations in health-related quality of life (HRQoL) and allow us to evaluate the impact of different drug treatment protocols in patients with hepatitis C virus (HCV) on daily activities. Methods Sixty six patients with HCV were consecutively enrolled in the Hepatology Unit at the University Hospital of Catania “G. Rodolico”. Sixteen patients received new direct-acting-antiviral agents (DAAs) plus pegylated alpha interferon (Peg-α-IFN) protocol (Group A) and 50 DAAs IFN free protocol (Group B). The EQ-5D-5 L® questionnaire and visual analog scale (VAS) were given to both groups to calculate coefficient’s utility. We used the EQ-5D-5 L Crosswalk Index Value Calculator to obtain the utility EQIndex and both parametric and non parametric tests for the statistical analysis. Results The biopsy taken at the beginning of treatment showed comparable cell damage in both groups. The difference in the VAS results was negative for patients who received protocols containing IFN (indicating decreased quality of life),whereas it was positive in patients treated with IFN-free protocols. The baseline EQIndex did not reveal any differences between the two treatment groups. The post-treatment EQIndex was statistically better in the groups that received IFN-free therapy. Conclusions When innovative treatments are introduced into clinical practice, assessing quality of life is mandatory to determine their benefits. The instruments used in the present study are effective in detecting the areas in which improvement has occurred. These instruments can be easily managed by general practitioners for follow up of progression of the disease and referred to the specialist.

Competing Interests: Declarations. Conflict of interest: The authors declare that they have no conflict of interest. Human and animal rights statement: This article does not contain any studies directly involving sperimental procedures on human participants. Informed consent: For this type of study, formal consent is not required.

Background & Aims: Obeticholic acid (OCA) has recently been restricted in patients with primary biliary cholangitis (PBC) with "advanced cirrhosis" because of its narrow therapeutic index. We aimed to better define the predicting factors of hepatic serious adverse events (SAEs) and non-response in cirrhotic patients undergoing OCA therapy., Methods: Safety and efficacy of treatment were evaluated in a cohort of consecutive PBC cirrhotic patients started with OCA. OCA response was evaluated according to the Poise criteria. Risk factors for hepatic SAEs and non-response were reported as risk ratios (RR) with 95% confidence intervals (CIs)., Results: One hundred PBC cirrhotics were included, 97 Child-Pugh class A and 3 class B. Thirty-one had oesophageal varices and 5 had a history of ascites. Thirty-three per cent and 32% of patients achieved a biochemical response at 6 and 12 months respectively. Male sex (adjusted-RR 1.75, 95%CI 1.42-2.12), INR (1.37, 1.00-1.87), Child-Pugh score (1.79, 1.28-2.50), MELD (1.17, 1.04-1.30) and bilirubin (1.83, 1.11-3.01) were independently associated with non-response to OCA. Twenty-two patients discontinued OCA within 12 months: 10 for pruritus, 9 for hepatic SAEs (5 for jaundice and/or ascitic decompensation; 4 for upper digestive bleeding). INR (adjusted-RR 1.91, 95%CI 1.10-3.36), lower albumin levels (0.18, 0.06-0.51), Child-Pugh score (2.43, 1.50-4.04), history of ascites (3.5, 1.85-6.5) and bilirubin (1.30, 1.05-1.56), were associated with hepatic SAEs. A total bilirubin≥1.4 mg/dl at baseline was the most accurate biochemical predictor of hepatic SAEs under OCA., Conclusions: An accurate baseline assessment is crucial to select cirrhotic patients who can benefit from OCA. Although OCA is effective in one third of cirrhotics, bilirubin level ≥1.4 mg/dl should discourage from its use., (© 2022 The Authors. Liver International published by John Wiley & Sons Ltd.)

Background & Aims: Obeticholic acid (OCA) is the second-line treatment approved for patients with primary biliary cholangitis (PBC) and an inadequate response or intolerance to ursodeoxycholic acid. We aimed to evaluate the effectiveness and safety of OCA under real-world conditions., Methods: Patients were recruited into the Italian PBC Registry, a multicentre, observational cohort study that monitors patients with PBC at national level. The primary endpoint was the biochemical response according to Poise criteria ; the secondary endpoint was the biochemical response according to normal range criteria , defined as normal levels of bilirubin, alkaline phosphatase (ALP), and alanine aminotransferase (ALT) at 12 months. Safety and tolerability were also assessed., Results: We analysed 191 patients until at least 12 months of follow-up. Median age was 57 years, 94% female, 61 (32%) had cirrhosis, 28 (15%) had histologically proven overlap with autoimmune hepatitis (PBC-AIH). At 12 months, significant median reductions of ALP (-32.3%), ALT (-31.4%), and bilirubin (-11.2%) were observed. Response rates were 42.9% according to Poise criteria , and 11% by normal range criteria . Patients with cirrhosis had lower response than patients without cirrhosis (29.5% vs. 49.2%, p  = 0.01), owing to a higher rate of OCA discontinuation (30% vs. 12%, p  = 0.004), although with similar ALP reduction (29.4% vs. 34%, p  = 0.53). Overlap PBC-AIH had a similar response to pure PBC (46.4% vs. 42.3%, p  = 0.68), with higher ALT reduction at 6 months (-38% vs. -29%, p  = 0.04). Thirty-three patients (17%) prematurely discontinued OCA because of adverse events, of whom 11 experienced serious adverse events. Treatment-induced pruritus was the leading cause of OCA discontinuation (67%)., Conclusions: Effectiveness and safety of OCA under real-world conditions mirror those in the Poise trial. Patients with cirrhosis had lower tolerability. Overlap PBC-AIH showed higher ALT reduction at 6 months compared with patients with pure PBC., Lay Summary: Obeticholic acid (OCA) was shown to be effective in more than one-third of patients not responding to ursodeoxycholic acid in a real-world context in Italy. Patients with cirrhosis had more side effects with OCA, and this led to suspension of the drug in one-third of patients. OCA was also effective in patients who had overlap between autoimmune hepatitis and primary biliary cholangitis., Competing Interests: The authors have no conflicts of interest to declare related to this work. Please refer to the accompanying ICMJE disclosure forms for further details., (© 2021 The Author(s).)

HCV (Hepatitis C Virus) decreases Health-Related Quality of Life with detriments to physical, mental and social health domains. Interferon and Ribavirin treatment is associated with depression and anxiety that further impairs HRQoL (Health- Related Quality of Life). IFN-free (interferon-free) regimes (Direct Acting Antivirals, DAAs) are safe and highly effective drugs, with improvement also of HRQoL and related Psychological Well-Being. Our aim is to describe how the latest generation IFN-free treatment can change quality of life and related Psychological Well-Being in Italian Chronic Hepatitis C/Cirrhosis affected patients. SF-36v2 (Short Form Health Survey is a 36-item, patient-reported survey of patient health) - HQLQv2 (Hepatitis Quality of Life Questionnaire) was administered at two time points: baseline (n=72) and 12 weeks after the end of therapy [n=72, SVR=72 - Sustained Virologic Response (SVR)]. Patients with chronic HCV undergoing DAAs treatment from two Italian centers were enrolled. The overall average of the answers is configured for most of the domains that make up the questionnaire, with scores above 50. The quality of life of this sample is very close to the average of the US population, with a minimum average score of 45.9 for the Role Emotional scale and an average maximum score of 56.4 for the Vitality scale. Both are significant results from statistical analysis. It seems that DAAs treatment therapy does not affect but improves the general quality and psychological state of adult patients with Chronic HCV infection., Competing Interests: Conflict of interest: The authors declare that they have no conflict of interest., (©Copyright: the Author(s).)

Multiple factors play a pathophysiologic role for the venous thromboembolism (VTE) as a multi-factorial disease. Inflammation might play a peculiar role in shifting towards a pro-thrombotic state. Anticoagulant drugs are the first cure line for VTE. The low-molecular-weight heparins (LMWH) show anti-coagulant capability as well as reducing levels of inflammatory factors, including interleukin (IL)-6. The direct oral anticoagulants (DOACs) have shown efficacy in threating VTE, additionally to the anti-activated factor X these drugs seem able to reduce the abnormal release of pro-inflammatory agents. The present study evaluated the capability of DOACs in reducing plasma level of IL-6 in patients suffered from deep vein thrombosis (DVT) of the lower limbs. Our results showed reduced IL-6 expression levels in the peripheral lymphocytes of DVT compared to controls (fold-change, 2.8; P<0.05). We postulate that lowered IL-6 expression in the lymphocytes of DVT patients may mediate the anti-inflammatory action of DOACs. The present study is the first evidence concerning the anti-inflammatory properties of DOACs in specific setting of VTE patients such as DVT., (Copyright © 2020, Spandidos Publications.)

Objective  The aim of the paper is to review the current information relating to the diagnosis and treatment of hepatitis C virus (HCV) infection in pregnant women and children, particularly those infected by mother-to-child transmission. Study Design  A review of published literature was performed to identify relevant articles published between January 2015 and March 2019 on: HCV infection in pregnant woman, mother-to child-transmission of HCV and HCV infection in pediatrics. The results of the evaluation of the different studies were summarized in two sections describing separately the screening and effective treatments in pregnant women and children. Results  The rate of mother-to-child transmission of HCV is approximately 5%. HCV infection is strongly associated with cholestasis and preterm birth. Prenatal diagnosis of hepatitis C virus has a dual benefit for mother and child. Perinatally infected children develop cirrhosis in earlier age than those who acquire HCV as adolescents. Pregnant women with cirrhosis have a higher risk of poor maternal and neonatal outcomes than those without cirrhosis. Conclusion  To improve public health, universal screening of pregnant women for HCV infection should be performed. Early identification of women and children with HCV infection is important to enable them to be included in assessment and/or treatment programs., Competing Interests: Conflict of Interest The authors declare that they have no conflict of interest.

There are several causes of hepatocellular carcinoma (HCC), but certainly the hepatitis C virus (HCV) is one of the most common. The HCV is able to contribute, both directly and indirectly, to the development of HCC. Determining early HCV clearance before an advanced liver disease develops, is absolutely necessary as this prevents the initiation of the cascade of events induced by HCV that may result in the development of HCC. The early treatment of the infection and the clearance of HCV represents today, in the age of the direct antiviral agents (DAAs), an extraordinary opportunity for true prevention of the development of HCV-related HCC., Competing Interests: Conflict-of-interest statement: The authors declare here that there is no conflict of interest related to this study among them.

Minimization of post-cessation weight gain in quitters is important, but existing approaches (e.g., antismoking medications) shows only limited success. We investigated changes in body weight in smokers who quit or reduced substantially their cigarette consumption by switching to electronic cigarettes (ECs) use. Body weight and smoking/vaping history were extracted from medical records of smokers and ex-smokers to match three study groups: (1) regular EC users on at least two consecutive follow-up visits; (2) regular smokers (and not using ECs); (3) subjects who reported sustained smoking abstinence after completing a cessation program. Review of their medical records was conducted at two follow-up visits at 6- (F/U 6m) and 12-months (F/U 12m). A total of 86 EC users, 93 regular smokers, and 44 quitters were studied. In the EC users study group, cigarettes/day use decreased from 21.1 at baseline to 1.8 at F/U 12m ( p < 0.0001). Dual usage was reported by approximately 50% of EC users. Both within factor (time, p < 0.0001) and between factor (study groups, p < 0.0001) produced significant effect on weight (% change from baseline), with a significant 4.8% weight gain from baseline in the quitters study group at F/U 12m. For the EC users, weight gain at F/U 12m was only 1.5% of baseline. There was no evidence of post-cessation weight increase in those who reduced substantially cigarette consumption by switching to ECs (i.e., dual users) and only modest post-cessation weight increase was reported in exclusive EC users at F/U 12m. By reducing weight gain and tobacco consumption, EC-based interventions may promote an overall improvement in quality of life., Competing Interests: Riccardo Polosa is a full-time employee of the University of Catania, Italy. In relation to his work in the area of tobacco control, Riccardo Polosa has received lecture fees and research funding from Pfizer and GlaxoSmithKline, manufacturers of stop smoking medications. He has also served as a consultant for Pfizer, Global Health Alliance for treatment of tobacco dependence, ECITA (Electronic Cigarette Industry Trade Association, in the UK) and Health Diplomat (consulting company that delivers solutions to global health problems with special emphasis on harm minimization). Lecture fees from a number of European electronic cigarette industry and trade associations (including FIVAPE in France and FIESEL in Italy) were directly donated to vaper advocacy non-profit organizations. He is currently scientific advisor for LIAF, Lega Italiana Anti Fumo (Italian acronym for Italian Anti Smoking League) and Head of the European Technical Committee for standardization on “Requirements and test methods for emissions of electronic cigarettes” (CEN/TC 437; WG4). The other authors have no conflict of interests.

Hepatocellular carcinoma (HCC) is the most common type of liver cancer. The main risk factors for HCC are alcoholism, hepatitis B virus, hepatitis C virus, nonalcoholic steatohepatitis, obesity, type 2 diabetes, cirrhosis, aflatoxin, hemochromatosis, Wilson's disease and hemophilia. Occupational exposure to chemicals is another risk factor for HCC. Often the relationship between occupational risk and HCC is unclear and the reports are fragmented and inconsistent. This review aims to summarize the current knowledge regarding the association of infective and non-infective occupational risk exposure and HCC in order to encourage further research and draw attention to this global occupational public health problem.

Over the last years it has started a real revolution in the treatment of chronic hepatitis C. This occurred for the availability of direct-acting antiviral agents that allow to reach sustained virologic response in approximately 90% of cases. In the near future further progress will be achieved with the use of pan-genotypic drugs with high efficacy but without side effects.

Stop smoking it is often associated to weight gain that is one of the most important causes for relapse. This is the first study to describe long-term changes in body weight in smokers invited to quit or reduce smoking by switching to ECs. Conventional cigarettes consumption and body weight were measured prospectively in a randomized controlled trial of smokers invited to switch to ECs. Post cessation weight changes from baseline at week-12, -24 and -52 were compared among 1) high, medium and zero nicotine strength products and 2) pooled continuous smoking failure, smoking reduction and abstinence phenotypes. Saliva cotinine levels and appetite levels were also measured. No significant changes in body weight were observed among high, medium and zero nicotine strength products. Differences among continuous smoking phenotypes were significant only at week-12 (p = 0.010) and week-24 (p = 0.012) with quitters gaining 2.4{plus minus}4.3 Kg and 2.9{plus minus}4.4 Kg respectively. However, weight gain at week-52 (1.5{plus minus}5.0 Kg) was no longer significant compared to Failures and Reducers. No confounding factors could explain the significant changes in body weight. Smokers who quit smoking by switching to ECs may limit their post-cessation weight gain, with substantial reversal in weight gain being manifest at late time points.

Background: Benign liver tumors are common. They do not spread to other areas of the body, and they usually do not pose a serious health risk. In fact, in most cases, benign liver tumors are not diagnosed because patients are asymptomatic. When they are detected, it's usually because the person has had medical imaging tests, such as an ultrasound (US), computed tomography (CT) scan, or magnetic resonance imaging (MRI), for another condition., Materials and Methods: A search of the literature was made using cancer literature and the PubMed, Scopus, and Web of Science (WOS) database for the following keywords: "hepatic benign tumors", "hepatic cystic tumors", "polycystic liver disease", "liver macroregenerative nodules", "hepatic mesenchymal hamartoma", "hepatic angiomyolipoma", "biliary cystadenoma", and "nodular regenerative hyperplasia"., Discussion and Conclusion: Hepatocellular carcinoma (HCC) is one of the most common malignant tumors in some areas of the world; there is an increasing incidence worldwide. Approximately 750,000 new cases are reported per year. More than 75 % of cases occur in the Asia-Pacific region, largely in association with chronic hepatitis B virus (HBV) infection. The incidence of HCC is increasing in the USA and Europe because of the increased incidence of hepatitis C virus (HCV) infection. Unlike the liver HCC, benign tumors are less frequent. However, they represent a chapter always more interesting of liver disease. In fact, a careful differential diagnosis with the forms of malignant tumor is often required in such a way so as to direct the patient to the correct therapy. In conclusion, many of these tumors present with typical features in various imaging studies. On occasions, biopsies are required, and/or surgical removal is needed. In the majority of cases of benign hepatic tumors, no treatment is indicated. The main indication for treatment is the presence of significant clinical symptoms or suspicion of malignancy or fear of malignant transformation.