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Primary sclerosing cholangitis (PSC) is an enigmatic disease with scarce therapeutic options, potentially evolving in life-threatening complications, including cholangiocarcinoma (CCA). The clinical management of PSC remains challenging and will benefit from identification of outcome indicators to assess the quality of care and of the outcomes. This study aims at: A) identifying Outcome Indicators (OIs) for PSC, and B) validating OIs in a real-life context, by performing an interim analysis of the VBMH study. METHODS. A) A panel of experts generated a list of OIs using a modified version of the Delphi method. B) OIs with the highest RAND/UCLA score were tested in an ongoing multicentric and prospective study (VBMH). RESULTS. Five OIs were identified on the basis of the highest rating values (close to 9) and the lowest disagreement indexes (next to 0). They include: annual incidence of acute cholangitis episodes (OI#1); mortality rate for patients not yet listed for LTx (OI#2); improvement in patient reported quality of life measured by EQ-VAS (a visual assessment scale ranging from 0 to 100 where the patient points out his present-day health status) and EQ-5D (assessment of 5 domains that measure daily performance: mobility, self care, anxiety/depression, usual activities and pain/discomforts) (OI#3); number of patients died for CCA or colorectal cancer (OI#4); incidence and/or worsening of osteoporosis, expressed as T-score differential over a 2-year interval (OI#5). In the validation study, 63 consecutive patients with PSC enrolled in 3 liver centres in Northern Italy were evaluated for a 24-month follow-up period. For each OI, the following values were reported: OI#1) cumulative incidence of 5.2%, resulting in 0.029 cholangitis/patient; OI#2 and OI#4) no patients died without being listed for transplantation or because of cancer during the study time; OI#3) 38.9 and 19.4% of patients showed an improvement in EQ-VAS and EQ-5D, respectively; OI#5) 3% of patients developed or worsened osteoporosis. In CONCLUSION, five OIs for PSC were identified using the Delphi method and received a highly shared consensus. Albeit the study population is small (consistent with the rarity of PSC) and the follow-up time is short as compared to the long natural history of the disease, these OIs have proven to be easy to collect and to work appropriately. Therefore, they are suitable to be extended to specialized centres involved in PSC management to further validate their clinical usefulness in a larger scale. Patient reported outcomes showed improvements in a significant proportion of patients, indicating the importance to refer these patients to specialized centers

A relevant proportion of patients affected by Chronic Hepatitis C (CHC) is older than 65 years. In the interferon era, comorbidities and a higher susceptibility to interferon/ribavirin adverse events have limited treatment in these patients. Recent approval of interferon-free regimens, with high efficacy and limited toxicity, provide unprecedented chances for these patients to be treated. However, the cost-effectiveness of all-oral Direct-Acting Antivirals (DAAs) has not been addressed in the elderly population. We have performed a cost-effectiveness analysis taking into account the severity of liver disease, the age of the patient and the geriatric (frailty) status. METHODS: A semi-Markov model of CHC natural history was built. The study focuses on CHC Genotype 1 patients older than 65 years, stratified according to liver fibrosis (METAVIR F3 and F4), age (65 to 90 years old) and frailty phenotype defined by Fried’s (not frail, pre-frail and frail) for a total of 30 cohorts simulated. Treatment with sofosbuvir plus ledipasvir (SOF/LDV) versus no treatment was assessed for each cohort. The model estimated costs, Life Years and Quality-Adjusted Life Years (QALY) using a lifetime time horizon and the Health System perspective. Results are presented as incremental cost-effectiveness ratios (ICERs) per QALY gained. Cost-effectiveness was defined as an ICER under the willingness-to-pay threshold of 40,000 € per QALY gained. RESULTS: At each fibrosis score, ICER increased with age and frailty index. Among patients with F3 fibrosis, ICER ranged from €5,530/QALY in not-frail 65 years old and €149,355 in frail 85 years old patients. Among F4 patients ICER ranged from €6,552/QALY in not frail 65 years old and €85,559 in frail 85 years old patients. In F3 and F4 cohorts ICER was below €40,000/QALY up to age 84 and 87 years in non-frail pts, up to age 80 and 83 years in pre-frail patients, and up to age 76 and 80 in frail patients, respectively. Adopting an alternative scenario with a 20% discount of SOF/LDV treatment, cost-effectiveness increases accordingly. CONCLUSION: This analysis shows that, assuming that efficacy and safety of SOF/LDV are not age-dependent, SOF/LDV treatment is cost-effective in most CHC patients older than 65 years, although a careful assessment of the patient status is mandatory. Furthermore, under conditions of restricted budget, it should be considered that ICER varies considerably between two non-frail F4 patients, one at age 65 and the other at 85 years (between 8,000 and 33,000 EUR/QALY, respectively). This cost-effectiveness analysis should promote a prospective study to verify efficacy and side effects in elderly HCV patients

Background and Aims: To allocate treatment resources for CHC G1 patients, we performed a cost-effectiveness analysis of Boceprevir (BOC) and Telaprevir (TVR) based triple therapy according to different patient selection strategies. Methods: A semi-Markov model of CHC natural history and progression toward end stage liver diseases (decompensated cirrhosis, HCC and liver transplantation) was built. Model health states were defined by METAVIR fibrosis stages (F0–F4), and complications of cirrhosis. We considered 3 selection strategies based on fibrosis stage: 1) treat all patients with F1–F4 fibrosis, 2) only F2–F4 and 3) only F3–F4. For each strategy, TVR IL28B-guided and BOC RVR-guided therapy was applied. The model assessed the costs and outcomes, including QALYs, Life Years and the number of End Stage Liver Diseases developed or Death (ESLD-D), using lifetime as time horizon and adopting the NHS perspective. An alternative simulation was performed using 5 year as time horizon. Results: The F3–F4 selection strategy was the least expensive and the least effective. Adopting the lifetime horizon, F1–F4 strategy was cost-effective with an ICER of €5,132.13 for QALY, in TVR IL28Bguided, and €7,042.49 for QALY, in BOC RVR-guided therapy. In the 5 year scenario, the F1–F4 strategy was not cost-effective with an ICER of €1,818,679 (TVR IL-28B-guided) and €1,866.437 (BOC RVR-guided) for each ESLD-D avoided. Conclusions: Our model demonstrated the impact of patient selection strategies, and lifetime versus 5 year time horizons, on cost-effectiveness of HCV therapy, and its implications for the evaluation of cost utility of future interferon-containing and interferon-free regimens.

The impact of liver diseases (LDs) on health-related quality of life (HRQoL) is an important aspect to understand the burden of these conditions and to improve their management. A well characterized impact of the major LDs on HRQoL of the general population is still lacking. The aim of our study was to fill this gap. A dataset with HRQoL data of a representative sample of the general population of most populated Italian region was matched with the dataset from a multicenter study conducted in the same region and time period to generate and validate a set of health care outcomes indicators for the major LDs (hepatitis B (HBV), hepatitis C (HCV), compensated cirrhosis (CC), decompensated cirrhosis (DC), hepatocellular carcinoma (HCC), autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), NAFLD/ NASH and patients listed for liver transplant (LTL)). Within both datasets, HRQoL data were collected using the EQ-5D-3L, a generic instrument that enables HRQoL to be compared within and between clinical conditions and with the general population. It generates a health profile made up of 5 domains (Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/ depression). It also consists of a visual analogue scale (EQ-5D VAS) which measures overall HRQoL. Further, results from the EQ-5D health profile can be converted to utility index, useful to conduct economic evaluations. Multivariate logistic and linear regressions were then performed adjusting for possible confounders (age, sex, education and working status). A total of 6,800 nullhealthy subjectsnull and 3,105 subjects with LDs (625 HCV, 287 HBV, 614 CC, 531 DC, 647 HCC, 59 LTL, 229 NAFLD/NASH, 68 PBC, 55 PSC, and 49 AIH) were included in the analyses. Multivariate logistic analyses showed that DC, HCC, and LTL had significantly (p

INTRODUZIONE: Il virus dell'epatite C (HCV) è la principale indicazione per il trapianto di fegato, con una percentuale che varia dal 10% nei paesi dell'Europa settentrionale a quasi il 50% nei paesi dell’Europa meridionale. La prognosi dei pazienti affetti da HCV sottoposti a trapianto di fegato è gravemente limitata dall’alta probabilità di recidiva dell’HCV post-trapianto. L'unica opzione terapeutica disponibile attualmente per la recidiva da HCV è il trattamento con Peginterferone in combinazione con Ribavirina. Purtroppo, meno del 50% dei pazienti può effettivamente essere trattato con questi farmaci e il tasso di risposta tra i pazienti trattati è inferiore al 30%. Sofosbuvir in combinazione con ribavirina (SOF/RBV) è un nuovo trattamento senza interferone capace di sopprimere la viremia e prevenire la recidiva da HCV quando usato nei pazienti listati per il trapianto. L’obiettivo di questo studio è stato valutare la costo-efficacia del trattamento con SOF/RBV nei pazienti listati per il trapianto con diagnosi di cirrosi da HCV (HCV-cirrosi) o con diagnosi di epatocarcinoma da HCV (HCV-HCC). MATERIALI E METODI: Un modello analitico decisionale di semi-Markov è stato sviluppato per valutare la costo-efficacia del trattamento SOF/RBV nei pazienti listati per trapianto di fegato con HCV-cirrosi e in quelli con HCV-HCC. Il modello simula la progressione dei soggetti HCV-cirrosi o HCV-HCC dal momento del loro inserimento nella lista trapianti fino alla loro morte, considerando il rischio di recidiva da HCV post-trapianto. Con questo modello sono state confrontate due diverse strategie terapeutiche: 1) Trattamento con SOF/RBV fino a un massimo di 24 settimane o fino a trapianto se eseguito prima della 24° settimana dall’inizio del trattamento, 2) Nessun trattamento antivirale. Il modello ha stimato i costi relativi al trattamento con SOF/RBV, i costi associati a ciascun stato di salute, gli anni di vita (LYs), gli anni di vita aggiustati per la qualità (QALYs), ed il rapporto incrementale di costo-efficacia (ICER) espresso in € per QALY guadagnato. L'analisi è stata eseguita usando la prospettiva del Servizio Sanitario Nazionale Italiano, utilizzando i prezzi al 2014 espressi in Euro. L'orizzonte temporale della simulazione è stato la vita dei pazienti, con una durata per ciclo di simulazione di un mese. I costi e benefici clinici futuri sono stati attualizzati con un tasso di sconto del 3% annuo. L’intervento è stato considerato costo-efficace se l’ICER prodotto era inferiore alla soglia di € 60.000 per QALY guadagnato, che rappresenta la soglia della disponibilità a pagare per un nuovo trattamento all’interno del contesto Italiano. RISULTATI: Dalla simulazione fatta col modello, lo scenario che comprendeva il trattamento con SOF/RBV ha riportato una maggiore efficace ma anche un costo maggiore rispetto allo scenario che implicava nessun trattamento antivirale. Nei soggetti trattati con SOF/RBV, il modello ha riportato un incremento medio di LYs e QALYs per paziente di 4,32 e 2,41 nei soggetti HCV-cirrosi e 3,97 e 2,23 nei soggetti HCV-HCC. L’ICER stimato dal modello, confrontando il trattamento SOF/RBV con l’opzione nessun trattamento antivirale, è stato di € 30.518 per QALY guadagnato nei pazienti HCV-cirrosi e € 41.610 nei pazienti HCV-HCC. L'affidabilità dei risultati è stata confermata dall’analisi di sensibilità a una via e dalla curva di accettabilità del rapporto incrementale di costo-efficacia, la quale ha mostrato una probabilità del 97,5% che il trattamento SOF/RBV potesse essere costo-efficacie assumendo una soglia della disponibilità a pagare di € 60.000 per QALY guadagnato nello scenario HCV-cirrosi e dell’88,1% nello scenario HCV-HCC. Gli ICERs stimati sono stati particolarmente sensibili alle variazioni della durata del trattamento SOF/RBV; infatti, assumendo una durata di 12 settimane gli ICERs ottenuti sono stati € 19.317 per QALY guadagnato nello scenario HCV-cirrosi e € 29.540 in quello HCV-HCC. CONCLUSIONI: Lo studio ha dimostrato che un trattamento di 24 settimane con SOF/RBV nei pazienti con HCV-cirrosi o HCV-HCC in lista d'attesa per il trapianto di fegato è costo-efficace con un ICER di € 30.518 per QALY guadagnato nei primi e di € 41.610 nei secondi. Inoltre, questa potenziale costo-efficacia di SOF/RBV potrebbe ulteriormente aumentare se come mostrato dalle prime evidenze disponibili si potesse diminuire la durata del trattamento da 24 a 12 settimane. Questi risultati forniscono un’ulteriore e importante argomentazione a favore del potenziale uso del trattamento senza interferone nei pazienti HCV-positivi listati per il trapianto, tuttavia uno studio prospettico ben disegnato è necessario per confermare il valore dei parametri assunti nel modello e i risultati ottenuti. Infine bisogna considerare che nuove associazioni di antivirali ad azione diretta e senza interferone saranno a disposizione nei prossimi anni creando nuove sfide e opportunità anche nel contesto del trapianto di fegato.

Background and Aims: Hepatocellular carcinoma (HCC) is a worldwide public health problem, accounting for increasing mortality and high costs. Aim of our study was to identify and test outcome indicators (OIs) in HCC, in light of their potential use in policy decision models. Methods: A panel of experts identified a list of OIs using a modified Delphi method; three of these OIs with the highest RAND/UCLA scores were tested in a prospective multicenter observational study (Value Based Medicine in Hepatology, VBMH). During 18 months, 711 HCC patients were enrolled and prospectively followed. Median follow-up time was 14 months. Results: The first OI was survival after 1–3–5 years stratified for BCLC stage or treatment (OI#1). One-year survival for BCLC stage 0/A, B, C, D was 93%, 86%, 50%, 26% respectively. One-year survival of 288 patients who had the first treatment during the study time was 88% for liver transplantation, 97% surgical resection, 100% ablation and 89% for TACE. The remaining two OIs meant to evaluate the appropriateness of treatments. Worsening of BCLC and/or CPT score after loco-regional therapy or surgical resection recorded at three months (OI#2), occurred in 16% of cases (76% after TACE). Very early HCC recurrence (within 6 months) after curative treatments (OI#3) happened in 15% of patients treated (20% after ablation). Conclusions: This set of outcome indicators proved their feasibility in a large cohort of patients and could serve as a benchmark for healthcare providers to move towards a value-based approach in the management of HCC.

Background and Aims: Liver disease (LD) is a major cause of morbidity and mortality worldwide. Development of outcome indicators (OIs) provides health care policy makers with objective criteria that can be used to generate a virtuous competition to improve value of care. Aim of our study was to generate and test a set of health care OIs for the major LDs. Methods: Using a modified Delphi method, 7 expert panels identified a set of OIs according to experience and scientific evidence (as of 2010). Each OI was rated in a two-step process using the RAND 9-point agreement scale. Median scores were computed for each OI. After the second rating, a disagreement index (DI) was calculated to identify and accept (if DI≤1) OIs with median rating ≥7. The final set of selected OIs was tested through an ongoing prospective multicenter observational study involving three tertiary centers in Lombardy, Italy. Results: A total of 51 OIs were identified by the focus groups. We recruited 3213 consecutive liver patients, of whom 91% had at least one follow-up visit after a median follow-up time of 15 months. Among these patients, 1752 were cirrhotic and 711 were affected by HCC. During observation time, 156 patients were transplanted and 210 patients died. All the identified OIs were successfully tested in the clinical setting showing excellent performance and correlation with natural history information. Conclusions: This study provides a set of validated outcomes indicators that can be used to monitor the performance of referral centers and improve the value and sustainability of care.

Background and Aims: Liver Cirrhosis (LC) is responsible for high morbidity, mortality and increasing costs. Aim of our study was to identify outcome indicators (OIs) able to measure quality and value of care in compensated (CC) and decompensated (DC) cirrhosis. Methods: A panel of experts identified a list of OIs using a modified Delphi method; seven of these OIs with the highest RAND/UCLA scores were then tested in a prospective multicenter observational study (Value Based Medicine in Hepatology, VBMH). During 18 months, 1751 patients with LC were enrolled (1004 CC, 747 DC). Results: Annual rate of decompensation (OI#1), annual incidence of first variceal bleeding (OI#2) and annual incidence of HCC (OI#3) in CC were 12%, 2% for low- and 3% for high-risk varices, and 4.3% (81% diagnosed in BCLC-A stage) respectively. One-year survival for CPT score A, B, C was 96%, 81% and 59% (OI#4) respectively, and 94%, 56% when stratified for MELD cut-off of 15 (OI#5). Among DC patients, 4% of them had an episode of variceal bleeding (6 weeks survival 90%, 32% recurrence) (OI#6), 3% had spontaneous bacterial peritonitis (6 weeks survival 86%, 13% recurrence) (OI#7). Conclusions: The seven outcome indicators identified in our study performed well when tested in a large cohort of patients and represent a reference tool to implement a value-based approach to liver diseases.

Development of complications in liver cirrhosis (LC) is associated with increased mortality, hospital admissions and costs. Management of LC complications in clinical practice is well established, but the real value and effectiveness of care provided are still difficult to assess. Measurement of outcome indicators (OIs) together with patients-health related quality of life (p-HRQoL) could assist both clinicians and administrators in the process of care, in order to ensure greater quality in patients with LC. Aim of our study was to validate specific OIs, coupled with p-HRQoL scales, and apply them in the clinical assessment of compensated (CC) and decompensated cirrhosis (DC) management. A panel of hepatologists identified a set of OIs using published evidence, a modified Delphi method and a standard 9-point RAND appropriateness scale. These OIs were part of a larger effort, included in a prospective multicenter observational study (Value Based Medicine in Hepatology Study), involving three European tertiary clinical centers. P-HRQoL collected using the EQ-5D questionnaire, generated an health profile, by means of five utility domains (mobility, self care, anxiety/ depression, usual activities and pain/discomfort), and a visual analogue scale (VAS), which measured overall p-HRQoL in a range from 0 to 100. During 18 months we enrolled 1772 patients with LC: 1015 CC and 757 DC; the median follow-up time was 2 years. Results: the OIs chosen by the panelist were meant to evaluate the efficacy of care of major complications of LC: variceal bleeding occurred with an annual incidence of 3,1%, with 1-year survival of 76% of patients, and hepatocellular carcinoma (HCC) developed in a rate of 3,5% per year, with 83% CC patients diagnosed at early stage HCC. The strongest OIs according to the experts were decompensation rate in CC, which was 6.6% per year in our study, and overall survival in DC patients. The 1-year survival after the first decompensation episode (ascites in 73% of cases) was 96% for CPTA, 82% for CPT-B, 56% CPT-C, whereas it was 94% and 57% for MELD score respectively below or above 15. Furthermore, no significant changes in p-HRQoL between baseline and after 2 years follow-up were found in CC and CPT-A patients, while p-HRQoL progressively decreased in DC and CPT B-C patients. In conclusion, combined measurements of specific OIs and p-HRQoL scales provide the methodological bases to implement a value-based approach to the care of patients with LC. In fact, these outcomes combined with measurements of direct and indirect costs could guide future decision-making process and improve value of care in cirrhosis.

Post-liver transplant recurrent hepatitis C virus (HCV) infection severely limits the prognosis of HCV-infected patients. Sofosbuvir in combination with ribavirin (SOF/RBV) is a novel interferon-free treatment able to suppress HCV viremia when applied to HCV patients listed for transplant, thereby preventing HCV recurrence. Aim of this study was to assess the cost-effectiveness of this regimens in patients listed for transplant for cirrhosis (HCV-cirrhosis) or for hepatocellular carcinoma in cirrhosis (HCV-HCC). A semi-Markov model was developed to assess the cost-effectiveness of pre-transplant SOF/RBV treatment in patients listed for HCV-cirrhosis and HCV-related HCC. The model simulates the progression of HCV-cirrhosis or HCV-HCC patients from the time of listing until death considering the risk of HCV recurrence post-transplant. The model compared 2 different strategies: 1) SOF/RBV up to a maximum of 24 weeks or until OLT if performed before the 24th week from the initiation of treatment, 2) No antiviral treatment. The model estimated the costs related to the treatment with SOF/RBV, the costs associated to each health state, the life-years (LYSs), the quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER) expressed as € per QALY gained. The analysis was performed from the Italian National Health System perspective with a lifetime time horizon and one-month Markov cycles. Future costs and clinical benefits, expressed as QALYs, were discounted at 3% per year. Results: in the base-case analysis the ICER for 24 weeks of SOF/RBVR was €30,518 per QALY gained in HCV-cirrhosis patients and €41,610 in HCV-HCC patients. The reliability of our results was confirmed by the one way sensitivity-analysis and by the cost-effectiveness acceptability curve that reported 97.5% probability of SOF/RBV to be cost-effective at a willingness to pay threshold of €60,000 in the HCV–cirrhosis scenario, and 88.1% in the HCV-HCC scenario. Further, SOF/RBV cost-effectiveness was clearly sensitive to the duration of treatment; assuming 12 weeks SOF/RBV treatment duration, the ICER decreased to €19,317 in HCV-Cirrhosis and €29,540 in HCV-HCC. In conclusion, our study shows that treating patients with HCV-cirrhosis or HCV-HCC in the transplant waiting list with SOF/RBV is cost-effective and may become the new standard of care for these patients. However a well-defined prospective study is needed to confirm the value of the parameters assumed in the model and the results. Furthermore, associations of direct acting antivirals will soon appear into the horizon also in the transplant setting and bring new challenges and opportunities.

Liver Cirrhosis (LC) is responsible for high morbidity, mortality and raising costs. Current guidelines set the standard of care for management of cirrhosis in clinical practice, but explicit outcome indicators (OIs) are lacking. If available, OIs could guide clinical care and decision making, so that efforts and resources can be properly allocated. Aim of our study was to generate and test a set of health care OIs for compensated (CC) and decompensated (DC) LC. This study is part of a larger effort (the V.B.M.H. study) to generate OIs for several liver diseases. An expert panel of hepatologists identified a set of OIs for LC according to experience and scientific evidence (as of 2010), and used a modified Delphi method to rate them through a RAND 9-point agreement scale. A final list of 7 indicators with median rating ≥7 and with disagreement index ≤1 was selected. Three OIs were designed for CC and 4 for DC. In the second phase of the study, the selected OIs were tested in clinical practice through a prospective multicenter observational study, involving three tertiary centers in Lombardy, Italy. A web-based EMR was used to collect data. 1732 LC patients were enrolled in 18 months: 984 CC (57%) and 748 DC (43%). 91% of these LC patients had at least two consultations in a 13 months median follow-up. The annual rate of decompensation in CC (OI#1) was 12%, decompensation being more frequent in HCV-related CC. The annual incidence of 1st variceal bleeding (VB) for low-risk varices was 2% and was null for high risk varices, indicating effective primary profilaxis (OI#2). Annual incidence of HCC was 4%, while the percentage of CC patients diagnosed at early stage HCC (BCLC 0/A) was 74%, reflecting the accuracy of oncologic surveillance (OI#3). In DC patients, survival at 1 year after the first episode of decompensation (ascites in 78% of cases) was 99% for CPT A, 87% for CPT B and 73% for CPT C (OI#4). 3% of DC patients had an episode of VB, with survival of 88% after 6 weeks from the VB episode (OI#5) and with recurrence rate of 27% (OI#6). 19 out of 748 DC patients (3%) had spontaneous bacterial peritonitis, with 79% survival after 6 weeks from the episode (OI#7). In conclusion, the selected OIs performed well in monitoring the rate of decompensation in CC and the accuracy of surveillance for HCC; in DC, OIs were able to capture survival and the efficacy of management of major complications. This study represents the first attempt to identify and test a set of value-based OIs for LC, and provides a reference tool for healthcare policy makers to improve quality of care in patients affected by LC

Liver diseases (LDs) have a high impact on morbidity, mortality and health-related quality of life (HRQoL). Different LDs may have different effects on patients’ HRQoL. The aim of our study was to assess the reliability and benefit of using a generic HRQoL questionnaire to evaluate the health status of patients with the major liver conditions: hepatitis B (HBV), hepatitis C (HCV), cirrhosis, hepatocellular carcinoma (HCC), autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), NAFLD/NASH and patients in the liver transplant list. A naturalistic, prospective, multicenter study has been conducted to generate and validate a set of health care outcomes indicators for the major liver conditions. LDs patients (age>18 years) were enrolled in 3 major Italian medical centers and are still being followed up (median f-up: 13 months). Within this study, socio-demographic, clinical and HRQoL were collected using the EQ-5D-3L, a generic instrument that enables HRQoL to compared within and between clinical conditions and with the general population. It generates a health profile made up of 5 domains (mobility, self care, anxiety/depression, usual activities and pain/discomfort), each one with three levels of severity. It also consists of a visual analogue scale (EQ-5D VAS) which measures overall HRQoL in a range from 0 (worst imaginable health state) to 100 (best imaginable health state). The baseline HRQoL data was analyzed dividing the patients in sub-groups according to the most recently diagnosed and most severe condition. The results reported below focus on the mean VAS. We enrolled 3,217 patients, 64.8% male, aged 19-91 (median=61) years; 95.0% of them filled in the EQ-5D at baseline. Patients in the HCC group were 22.6%, those with compensated cirrhosis were 21.2%, HCV 20.9%, decompensated cirrhosis 10.3%, HBV 9.5%. The HBV group reported the best HRQoL with a mean EQ-5D VAS of 77.8. NAFLD/NASH, HCV and PSC patients had a similar HRQoL with a mean EQ-5D VAS between 76.5 and 75.1. While, compensated cirrhosis and PBC had a slightly worsen values (74.5 and 74.0, respectively). HCC and decompensated cirrhosis showed a mean EQ-5D VAS of about 69.0. At least, AIH and listed for liver transplant patients reported the worst HRQoL levels than the other sub-groups (67.7 and 67.0, respectively). In conclusion, EQ-5D is well accepted by the patients and accurately reflects the changes in HRQoL related to the clinical severity of LDs. Understanding the different impact of LDs on the patients’ HRQoL could help physicians and decision makers to better estimate the burden of these conditions and to improve the quality of care