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Discontinuation of hepatitis B (HBV) immune globulin (HBIG) after liver transplantation (LT) for HBV-related cirrhosis with and without hepatocellular carcinoma (HCC) represents a challenging option. The adherence to this option in real-life practice is unknown. In a contemporary cohort of patients transplanted for HBV, with and without HCC, we aimed to; 1) assess the rate of HBV recurrence (HBV-R); 2) evaluate risk factors for HBV-R; 3) evaluate the association between HBV-R and HCC recurrence (HCC-R) and patient survival. This is a multicentric, retrospective study designed by the "Permanent Transplant Commission" of the Italian Association for the Study of the Liver. All recipients who underwent LT for HBV cirrhosis were included. Exclusion criteria were: LT prior to January 1, 2010; age <18 years old; combined transplantation; HIV coinfection; duration of follow-up after LT <12 months. HBV-R was defined by positivity of HBV-DNA and/or HBsAg. Uni and multivariate linear regression analysis were used to identify predictors of HBV/HCC-R. 1115 patients were included. Indications for LT were HCC (51%), decompensated cirrhosis (41.2%), acute on chronic liver failure (ACLF) (3.4%), and acute liver failure (ALF) (4.2%). Life-long HBIG + nuclos(t)ide analogues (NA) was the most common used prophylaxis (94.4%). Overall rate of HBV-R was 2.2% (median time after LT: 7 months). Patients under life-long HBIG + NA had lower rates of HBV-R than those in whom HBIG were withdrawn and those who received NA alone (1.4% vs. 10.7% vs. 13.6%; respectively, p<0.001). HBV-R was associated with a lower survival after LT (p=0.008). In patients transplanted for HCC (n=535), the rate of HBV-R was 2.8% and of HCC-R was 10.3% (median time from LT: 17 months). Rate of HBV-R was higher in patients with vs. without HCC-R (14.6% vs. 1.2%; p<0.001). Multivariate analysis showed that HBV-R was the only parameter independently associated with HCC-R (HR: 20; CI95% 5-86; p<0.001). HCC-R was associated with a significantly reduced survival after LT (5-year survival 36% vs. 94%; p<0.001). Life-long HBIG + NA is the most commonly used scheme for HBV-R prophylaxis after LT in Italy, leading to a low risk of HBV-recurrence. In LT recipients, HBV recurrence is associated with an increased risk of death. In patients transplanted for HCC, HBV-R is independently associated with HCC recurrence. Therefore, discontinuation of HBIG in these patients should be considered only in the setting of clinical trials [ABSTRACT FROM AUTHOR]

Liver transplantation (LT) is the most efficacious curative treatment for hepatocellular carcinoma (HCC) patients. The waiting list (WL) prioritization criteria determine patient outcomes. Since 2015, the Italian Score for Organ Allocation (ISO) has been used in Italy to prioritize patients on the WL, introducing a specific policy for HCC. To assess the impact of ISO-score on WL dropout, HCC recurrence, and patient survival in LT candidates with HCC. We retrospectively analyzed all consecutive LT candidates with HCC at our Hospital from 2013 to 2020, comparing the impact on different outcomes in 2 groups: those patients prioritized before (group A, 2013-2015) and after (group B, 2016-2020) ISO score implementation. During the study period, 378 LT candidates with HCC were included: 261 patients underwent LT, 42 patients (11%) died before LT, and 57 patients (15%) were removed for HCC progression, during a median follow-up of 49 months. The intention-to-treat (ITT)-survival rates at 1- and 3-years were significantly lower in group A compared to group B (85% and 71% vs 89% and 85%, respectively, p=0.009). HCC recurrence rate at 3 years was significantly higher in group A compared to group B (19.5% vs. 8%, respectively, p=0.008) with similar waiting time in the two groups (median: 6 months, IQR 2-14). The dropout rate was not significantly different in the two groups (30% group A vs 25% group B, p=ns). At the same time, the disease-free survival 3 years after LT was significantly lower in group A vs group B (80% vs 92%, respectively, p=0.009). Explant pathology and AFP levels at LT were comparable in the two groups. Implementing ISO score improved ITT-survival of LT candidates with HCC in a single center cohort. This improvement seems mainly related to a lower post-LT HCC recurrence rate than to a significant change in dropout rates. [ABSTRACT FROM AUTHOR]

Hepatitis D virus (HDV) affects approximately 5% of chronically infected hepatitis B (HBV) patients and remains a common indication for liver transplantation (LT), which is the only therapeutic option for patients with end-stage liver disease and unresectable hepatocellular carcinoma (HCC). Our aim was to investigate the different characteristics, indications to LT and long-term patient survival of HDV-coinfected patients compared to HBV-monoinfected patients. All patients waitlisted for LT at our Center between 2006 and 2020 were retrospectively evaluated. Demographic characteristics, indication to LT, liver function, type of antiviral therapy before and after LT were recorded. A total of 1555 patients were included in the waiting list (WL): 18.2% of patients were HBsAg positive of which 32.6% were HDV-coinfected. At the time of admission to WL, HBVD patients differed significantly from HBV-monoinfected patients in terms of gender (females 42.4% vs 14%, p<0.001), and age (54, IQR 45 – 56 vs. 56, IQR 51 – 61, p=0.017). HDV-coinfected patients had significantly lower rate of HCC diagnoses (36/92 – 22% vs 128/192 – 66%, p<0.001) and HCC as indication to LT (21/92 – 17.2% vs 101/192 – 52.6%, p<0.001). Patients with HBVD had similar probability to LT (65.7% vs 64.7%, OR 1.046 CI95% 0.5-2.3, p=0.9) and death (21% vs 19%, OR 1.13 CI95% 0.5-2.8, p=0.8) than monoinfected patients, but they were less often excluded from WL due to stability of disease (1% vs. 5%). HBVD patients had similar patient survival (p=0.981) as HBV-monoinfected patients. Post-transplant prophylaxis was based on combination therapy with NUCs and HBIG. HDV-coinfected patients did not experience viral relapse after LT. Hepatis D infection is still significantly prevalent among HBsAg carriers. LT is the only curative approach for end-stage liver disease. Survival after LT was comparable to that of HBV-monoinfected patients. [ABSTRACT FROM AUTHOR]

Glecaprevir and Pibrentasvir (G/P) determines high rates of sustained virologic response (SVR) with optimal safety profile in patients with chronic hepatitis C virus (HCV) infection. The efficacy and safety of G/P in Caucasian patients aged 75 years and older has not been widely analyzed. This is a retrospective multicenter real-world study enrolling all consecutive patients 75 years and older who received G/P between October 2017 and January 2022 at 5 referral centers in Italy. SVR was analyzed by Intention to Treat (ITT) and Per Protocol analysis (PP). 570 patients met the inclusion criteria and were analyzed: mean age was 80 (75-97) years, 356 were females, 52% (298/570) had HCV-1 and 44% (252/570) had HCV-2. 137 (24%) patients had liver cirrhosis. 463 (81%) patients were taking at least 1 concomitant drug, with 144 (25%) taking ≥5 concomitant drugs. G/P was given for 8 weeks in 488 patients (86%). During treatment 48 patients (8%) reported side effects, with 10 (2%) patients discontinuing treatment prematurely. Two patients developed treatment unrelated serious adverse events. Overall, the SVR rate was 97.9% (558/570) by ITT analysis and 99.6% (558/560) by PP analysis. SVR rates remained consistently high among subgroup analysis stratified by genotype, treatment duration, fibrosis stage and concomitant medications. Treatment with G/P achieved 97.9% SVR rates in HCV patients older than 75 years of age. Safety was optimal with only 2% of patients discontinuing early. [ABSTRACT FROM AUTHOR]