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Media Release - Friday 25 June

For Immediate Release

Media Release

Treatment advances for Non-Alcoholic Fatty Liver Disease (NAFLD) announced at ILC 2021

New data released on trials involving RNAi therapeutics, antivirals and structurally engineered fatty acids to treat NAFLD

Friday 25 June 2021 (Geneva, Switzerland)– Leading hepatology researchers announced important new developments in the treatment  of  Non-Alcoholic Fatty Liver Disease (NAFLD) at the International Liver Congress 2021 (ILC 2021)  today. This includes new data on trials involving RNAi therapeutics, antivirals and structurally engineered fatty acids to treat NAFLD which is now one of the fastest growing diseases globally.

Linked to growing rates of obesity and diabetes, NAFLD has emerged as the most prominent cause of chronic liver disease worldwide and occurs in about one quarter of the global population. Experts predict that over the next decade, NAFLD will become the leading cause of end stage liver disease and liver transplantation.

Liver disease is on the rise and the fastest growing cause of death in the UK compared to other major killer diseases, such as heart disease and cancer, in which the number of deaths have either remained stable or decreased. In the UK liver disease is the biggest cause of death in those aged between 35-49 years old. NAFLD is already the fastest growing cause of hepatocellular carcinoma (HCC), the commonest form of liver cancer in the USA, France and the UK. Non-alcohol related steatohepatitis (NASH) is the second, more serious stage of NAFLD.

“We are clearly in a race against time to develop new drugs and treatment for NAFLD before the epidemic worsens,” said Philip Newsome, General Secretary of EASL and Professor of Experimental Hepatology and Director of the Centre for Liver Research at the University of Birmingham in the UK.

“News that Resmetiron appears to make inroads against NASH is most welcome – we are hopefully beginning to draw a line in the sand on the treatment of fatty liver disease.”

Today’s official press conference highlighted five studies covering treatment research for NAFLD and NASH selected from over 1500 abstracts being presented at ILC 2021.

Food Insecurity lined to death of Adults with Non-alcoholic Fatty Liver Disease and Advanced Fibrosis

This study followed 34,134 eligible participants followed for a median 7.2 years. 4,816 had NAFLD (mean age 51,58% male, 14% below the poverty line) and 1,654 had advanced fibrosis (mean age 69, 55% male, 15% below the poverty line) with food insecurity present in 28% and 21%, respectively.

All-cause age-adjusted mortality was 12 per 1000 person-years among NAFLD participants (11 if food secure, 15 if food insecure) and 32 per 1000 person-years among advanced fibrosis participants (28 if food secure, 50 if food insecure). In multivariate models adjusted for age, race/ethnicity, poverty-income ratio, education level, insurance status, haemoglobin A1c, body mass index, and smoking, food insecurity was independently associated with higher all-cause mortality among those with NAFLD (HR=1.46, 95%CI:1.08-1.97) and those with advanced fibrosis (HR=1.37; 95%CI:1.01-1.86) (Figure).

Ani Kardashian of the University of Southern California in the U.S. reported that a significant interaction between food insecurity and poverty-income ratio among those with advanced fibrosis (p=0.015. Food insecurity was associated with greater mortality in adults with advanced fibrosis and poverty (HR=2.27, 95%CI:1.41-3.66), but not among those without poverty (HR=1.09, 95%CI:0.66-1.59).

Kardashian concluded that Food insecurity is significantly associated with greater all-cause mortality in adults with NAFLD and advanced fibrosis, independent of other known causes and recommended that interventions that address food insecurity among adults with liver disease should be prioritized to improve health outcomes in this population.

Abstract: Food Insecurity is Associated with All-Cause Mortality in U.S. Adults with Non-alcoholic Fatty Liver Disease and Advanced Fibrosis (GS-1072) 
Session: General Session, Thursday 16:00-17.30

ARO-HSD reduces hepatic HSD17B13 MRNA expression and protein levels in patients with suspected NASH (LBP-2580)

HSD17B13 is a member of the hydroxysteroid dehydrogenase family involved in the metabolism of hormones, fatty acids, and bile acids. Human genetic data indicate that a loss-of-function mutation in HSD17B13 provides strong protection against alcoholic and non-alcoholic steatohepatitis. ARO-HSD
is an investigational GalNAc-conjugated RNAi therapeutic designed to replicate this observed protective loss-of-function effect by knocking down HSD17B13 expression in hepatocytes. This study reports initial results from the ongoing first in human clinical study, AROHSD1001 (NCT04202354), in healthy volunteers (HVs) and patients with NASH or suspected NASH.

ARO-HSD was administered by subcutaneous injection to male and female HVs (19-52 yrs old) in a single-dose escalation design at doses of 25, 50, 100 and 200 mg (4 active, 4 placebo per dose level) and followed to Day 113. Five patients (40-50 yrs old) with suspected NASH (based on MRI-PDFF
liver fat >8% and ALT>ULN) administered 100 mg ARO-HSD have completed the Day 71 biopsy.
Safety was assessed in all subjects including laboratory measures of liver function. A liver biopsy was collected at baseline and Day 71 in patients and change from baseline in hepatic HSD17B13 mRNA expression and protein levels were measured. Additional multi-dose patient cohorts will be analysed following availability of the Day 71 liver biopsies.

Rohit Loomba of the University of California in the U.S noted that ARO-HSD was well-tolerated in both HVs and patients with no ARO-HSD related serious adverse events reported, no AE-related drug discontinuations, and no ARO-HSD associated Grade 3 or 4 laboratory abnormalities (NCI-CTCAE v5.0). In all five patients, hepatic HSD17B13 mRNA decreased by a mean of 84% (range: 62-96%) from baseline. Two patients had a protein decrease of 92% and 97%, while the other 3 patients Day 71 measurements were below the assay’s level of quantitation. Patients had a mean decrease from baseline in ALT of 46% (26-53%) at Day 85. There were no significant changes in weight or lipid parameters.

Gane concluded that ARO-HSD is the first investigational RNAi therapeutic to demonstrate robust inhibition of HSD17B13 mRNA and protein expression with associated reductions in AL and recommended the continued development of ARO-HSD in patients with alcoholic and non-alcoholic steatohepatitis.

Abstract: ARO-HSD reduces hepatic HSD17B13 MRNA expression and protein levels in patients with suspected NASH (LBP-2580)

Icosabutate, an engineered fatty acid, significantly reduces relevant markers of NASH and fibrosis in 4 months

Icosabutate (ICO) is a novel, oral, once-daily, liver-targeted, engineered eicosapentaenoic acid derivative with potent anti-inflammatory and antifibrotic effects acting primarily through the G-coupled protein receptor (GPR120) and the arachidonic acid signalling pathways related signalling pathways. The ICONA trial is an ongoing 52-week, multicentre, placebo-controlled, phase 2b study enrolling 264 subjects with biopsy confirmed NASH.

Rapid, sustained, and significant dose-dependent decreases were seen with both doses in ALT, AST, GGT, and ALP at levels predictive of histologic improvement. The 600 mg dose showed significant reductions in PRO-C3 and ELF score (both total score and individual components) supporting an effect on fibrogenesis. hsCRP significantly decreased by 52% with 600 mg in conjunction with improvements in glycemic control and key atherogenic lipoproteins. There was no change in weight or BMI suggesting a treatment effect independent of weight loss. Both LFC and cT1 were unchanged which is consistent with ICO mechanism of action. Treatment was well tolerated with no evidence of hepatoxicity, cardiovascular events or other safety concerns as confirmed by an independent DSMB.

Arun Sanyal of the Virginia Commonwealth University, Richmond in the U.S. noted that treatment of NASH patients with ICO for 16 weeks had a dose-dependent improvement in multiple relevant biologic pathways, with broad and potent effects on markers of liver injury, inflammation and fibrogenesis along with improvements in glycemic control and atherogenic lipids. Sanyal concluded that these data, combined with a favourable safety profile to date, support a potential for impacting liver histology at 52 weeks as well as improving common comorbid conditions seen in NASH patients.

Abstract: Icosabutate, a novel structurally engineered fatty acid, significantly reduces relevant markers of NASH and fibrosis in 16 weeks: interim analysis results of the ICONA trial (LBP-2907)

Resmetirom reduces fibrosis in Phase III NASH trial

This study reported results from a 52- week Phase III registrational double blind placebo-controlled NASH clinical trials to study the effect of Resmetirom in more than 2000 NASH patients.

169 patients were enrolled in the open label arm, all completed 16 weeks, and 64 had completed 52 weeks. Demographics include mean age 55.7 (11.5 (SD)), female 69%, BMI 35.8 (6.0), diabetes 43%, hypertension 62%, dyslipidaemia >70%, mean ASCVD score 11.5%. Fibroscan (kPa 7.7 (3.6)), and mean MRI-PDFF 18% (7%) are consistent with F2 stage NASH. Statistically significant (p<0.0001) MRI-PDFF reduction of 53% (3.3% (SE)) fat fraction overall, and 62% reduction in a SHBG responder group were observed at Week 52. MRE was statistically significantly reduced at Weeks 16 and 52 (Table). At week 52 Fibroscan CAP and kpa were reduced relative to baseline.  LDL-C (-23% (2.3% (SE))), apolipoprotein-B (-22% (2.3%)), triglycerides (med, -32(7.8) mg/dL), and lipoprotein(a) (-39% (4.6%)) were statistically significantly reduced compared to baseline. Decreases from baseline: ALT -22 IU, AST -12 IU, GGT -25 IU(P<0.0001). Statistically significant reductions in inflammatory and fibrosis biomarkers hsCRP, reverse T3, ELF and M30 were observed. No safety flags were identified.

Stephen Harrison, Visiting Professor of Hepatology at the University of Oxford in the UK reported that noninvasively identified NASH patients treated with 100 mg per day of Resmetirom for up to 52 weeks demonstrated rapid and sustained reduction in 1-hepatic fat; 2-fibrosis stage as assessed by biomarkers, MRE and fibroscan; 3- LDL and atherogenic lipids, 4-liver enzymes and inflammatory biomarkers. Harrison concluded that the results supported the use of non-invasive tests to monitor individual NASH patient response to Resmetirom treatment.

Abstract: Reduction in fibrosis and steatohepatitis imaging and biomarkers in a Phase III 52-week Resmetirom NASH trial (GS-2563)
Session: Friday June 25, 16:00-17:30

Development and validation of Agile 3+: novel Fibroscan based score for the diagnosis of advanced fibrosis in patients with non-alcoholic fatty liver disease (OA-555)

Currently available non-invasive tests, including FIB-4 and liver stiffness measurement (LSM) by Vibration Controlled Transient Elastography (VCTE), are highly effective in excluding advanced fibrosis (F >= 3) yet their ability to rule it in is moderate. This study aimed to develop and validate a new score (Agile 3+), to identify advanced fibrosis in NAFLD patients,
This multi-national, retrospective study included seven cohorts of adults with suspected NAFLD who underwent liver biopsy (LB), LSM by VCTE, and blood sampling in either routine clinical practice or during screening for clinical trials.

Jerome Boursier of Angers University Hospital in France note that in all datasets – platelets, gender, age and presence of diabetes mellitus Agile 3+ outperformed LSM and FIB-4.
Abstract: Development and validation of Agile 3+: novel FibroScan based score for the diagnosis of advanced fibrosis in patients with non-alcoholic fatty liver disease (OA-555)
Session: Saturday June 26, 10:00-11:30

 

Further information

Media Registration: Accredited media can apply for free registration here:

Press Programme: The Official Press Programme can be found here:

All ILC 2021 Official Press Conferences will broadcast  live on Zoom for registered media.

Embargo Policy: Please note that the ILC2021 Embargo Policy has changed this edition -media representatives are asked to familiarise themselves with the new policy.

Contact:

Michael Kessler
Michael Kessler Media
EASL Media Relations
Email: michael.kessler@intoon-media.com
Mob: +34 655 792 699
Twitter: @mickessler

About The International Liver Congress™

This annual congress is EASL’s flagship event, attracting scientific and medical experts from around the world to learn about the latest in liver research and exchange clinical experience. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is being held entirely digitally due to the global health situation.

About The European Association for the Study of the Liver (EASL)

Since its foundation in 1966, this not-for-profit organisation has grown to over 4,500 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European association with international influence, and with an impressive track record in promoting research in liver disease, supporting wider education, and promoting changes in European liver policy.

Media Release - Thursday 24 June

For Immediate Release

Media Release

Advances in new drugs to for curing Hepatitis B and Hepatitis D announced at ILC 2021

Thursday 24 June 2021 (Geneva, Switzerland)– Leading hepatology researchers announced important new developments in hepatitis research at the International Liver Congress 2021 today. This includes new data on antivirals to cure Hepatitis B and Hepatitis D and the application of infusion chemotherapy with P-1 inhibitors to treat liver cancer.Other announcements included a review of  the impact of the COVID-19 pandemic on efforts to eliminate Hepatitis C in the U.S and some encouraging data from a trial of a new liver dialysis  device to treat acute on chronic liver failure (ACLF).

“Scientists and advocates have long argued that if we are realistically going to eliminate Hepatitis B, then we will need a functional cure,” said Philip Newsome, Secretary General of EASL and Professor of Experimental Hepatology and Director of the Centre for Liver Research at the University of Birmingham in the UK. “The results from the trial of RNAi therapeutic drug VIR-2218 are an encouraging example that a cure is possible sooner than later with potential real-world implications for the 300 million people living with the disease.”

Each year 30 million people become newly infected with Hepatitis B and  an estimated 884,000 people die each year from the disease and related complications such as liver cancer.

Today’s official press conference highlighted five studies covering treatment and cure research for hepatitis and acute on chronic liver failure selected from over 1500 abstracts being presented at ILC 2021.

Impact of COVID-19 on eliminating Hepatitis (HCV) in the U.S.

As of 2019, the United States (US) was not on track to achieve the WHO targets for elimination, due to increasing incidence and barriers to treatment. In 2020, the COVID-19 pandemic disrupted HCV services globally, with 25 per cent fewer patients being  initiated on treatment than in 2019.

Researchers updated a previously validated Markov model to estimate HCV-related morbidity and mortality in the US. Three scenarios were developed to bookend possible outcomes for HCV recovery in the wake of the pandemic. These included 1) long-term treatment disruptions; 2) return to pre-COVID-19 treatment forecasts; 3) Achieve WHO targets through increased treatment and harm reduction.

Sarah Blach  of  the CDA Foundation in the U.S. reported that From 2014-2019, ~1.2 million patients were treated for HCV, leading to >50% reduction in hepatocellular carcinoma (HCC) cases and >65% reduction in HCV liver-related deaths (LRDs) in 2019 relative to 2014. In the modeled scenarios, between 780,000 and 2.3 million patients (cumulative) would be initiated on treatment from 2021-2030. WHO Targets (scenario 3) could be achieved in the US by treating at least 240,000 patients per year and increasing access to harm reduction programs. Compared to scenario 1, scenarios 2 and 3 could avert 19,400 LRDs and 9,500 HCC cases and 33,200 LRDs and 24,900 HCC cases, respectively.

Abstract: Modelling HCV elimination recovery following the COVID-19 pandemic in the United States: Pathways to regain progress (LBP-2814)

RNAi therapeutic antiviral drug  VIR-2218 shows promise  in participants with chronic hepatitis B infection

VIR-2218 is an investigational GalNAc-conjugated small interfering ribonucleic acid (siRNA) therapeutic in development for functional cure of chronic hepatitis B virus infection (CHB). VIR-2218 was created using Enhanced Stabilization Chemistry Plus, which retains in vivo potency while reducing off-target effects. VIR-2218 targets a conserved region of the X gene and is designed to silence all major HBV transcripts, from both cccDNA and integrated DNA, across all 10 HBV genotypes as a single siRNA.

Ed Gane of  the University of Auckland in New Zealand reported on the that  two doses of VIR-2218 at 20-200 mg given 4 weeks apart were well tolerated in CHB participants. Substantial reductions in HBsAg were observed in both HBeAg- and HBeAg+ participants across all dose levels, suggesting that VIR-2218 may silence transcripts from both cccDNA and integrated DNA. The antiviral activity of VIR-2218 demonstrated in this study support continued development as part of combination regimens targeting functional cure.

Abstract: Safety and antiviral activity of VIR-2218, an X-targeting RNAi therapeutic, in participants with chronic hepatitis B infection: week 48 follow-up results (OA-44 )
Session: Friday June 25, 14:00-15:30 CET

Encouraging interim data from Phase III trial of  antiviral drug Bulevirtide monotherapy in patients with chronic hepatitis delta

Bulevirtide (BLV) is a first-in-class entry inhibitor for the treatment of chronic hepatitis D virus (HDV) infection. BLV has shown pronounced virological and biochemical responses (HDV RNA and ALT declines) in two phase 2 trials (MYR202/MYR203). This study presented encouraging data  from a predefined 24 weeks interim analysis of the MYR301 phase 3 study in HBV/HDV co-infected patients receiving 2mg/qd or 10mg/qd dose BLV monotherapy in comparison to observation with no antiviral treatment (a total of 150 patients).

Heiner Wedemeyer of  the Hannover Medical Hospital in Germany noted that after 24 weeks of study,
this phase 3 trial confirms that monotherapy with BLV is safe and well tolerated in patients with compensated hepatitis delta. 24 weeks of treatment with BLV was associated with significant HDV RNA declines and improvements in biochemical disease activity. He concluded that these findings further support the conditional approval of BLV.

Abstract: Bulevirtide monotherapy at low and high dose in patients with chronic hepatitis delta: 24 weeks interim data of the phase 3 MYR301 study (LBP-2730)

Infusion chemotherapy combined with sintilimab may help cure liver cancer
This study aimed to explore the efficacy and safety of Hepatic arterial infusion chemotherapy in combination with sintilimab (a PD-1 inhibitor) in locally advanced, potentially resectable HCC. A total of 30 patients were enrolled with median age of 50.5 years (range 34-70), 93.3% male, and 96.7% HBV-infected. The median treatment cycle was 2 years.

Tumour evaluation was performed every 6-8 weeks. Pts with tumour reduction and eligible for R0 resection were referred for hepatectomy, then continued with sintilimab monotherapy to at most 16 courses. Primary endpoint was progression free survival (PFS) per RECIST 1.1 defined as time from the first day of treatment to disease progression or postoperative relapse or death

Li Xu of the Sun Yat-sen University Cancer Center in China explained that as of April 2021, 29 patients had been evaluated regularly with median follow-up time of 17.1 months (range: 6.5-25.6). Median PFS and OS were not reached, and 12 months PFS and OS rates were 57.6% (95%CI 41.9-79.2) and 82.3% (95%CI 69.4-97.1), respectively. ORR and DCR were 44.8% (13/29) and 75.9% (22/29). 19 (65.5%) pts received hepatectomy with 3 pathologic complete response (pCR). Another 2 pts with deep response received radical ablation, and 1 was confirmed pCR by needle biopsy. 14 patients remain tumour free so far. Most treatment related AEs (TRAE) were grade 1-2, the most common AEs were pyrexia (10%), rash (10%) and pruritus (10%). Only 1 patient experienced reversible immune-related liver dysfunction of grade 4. No other grade 3-5 TRAE or SAE was observed.

Hepatic arterial infusion chemotherapy in combination with THE PD-1 inhibitor showed a high conversion rate and good safety profile. The combined strategy may be considered as an optimal treatment choice to provide a chance of cure in locally advanced and potentially resectable HCC.

Abstract: Hepatic arterial infusion chemotherapy in combination with PD-1 inhibitor as a conversion therapy in locally advanced, potentially resectable hepatocellular carcinoma: A Phase II study (OA- 2679) 
Session: Friday June 25, 14:00-15:30

Novel liver dialysis device shows encouraging preliminary results in addressing acute on chronic liver failure (ACLF)

Treatment of acute on chronic liver failure (ACLF) is an unmet need. Currently, standard of care (SOC) involves treating infections with antibiotics and supporting individual organs, dialysis for kidney failure and pressors for low blood pressure. There are very few disease modifying options at present; steroids may have a role in some liver conditions but a large proportion of patients are non-responders to steroids, and steroids come with the inherent risk of new infections. Liver transplant is an option but is not available in the UK for many of these patients.

This randomised study tests the hypothesis that DIALIVE, a novel liver dialysis device ,will significantly improve the prognosis of ACLF patients. The primary end point was safety; device performance; clinical and pathophysiologic effects. DIALIVE principally replaces dysfunctional albumin and removes pathogen and damage associated molecular patterns.

32-ACLF patients with alcoholic cirrhosis were randomised either to DIALIVE or SOC. A minimum of 3 DIALIVE sessions (max 5) were needed for the patient to be evaluable. The trial was conducted in patients who presented in intensive care units with an acute flare of their chronic liver disease, which rapidly progressed to a severe additional worsening of the liver function and failure of a combination of other important organs such as kidneys, brain and lungs.

Banwari Agarwal of the Royal Free Hospital in UK noted that while the number of the patients studied is relatively small, the data so far points to a very strong signal suggesting that the patients treated with Dialive were significantly more likely to recover from this acute flare and return to the pre-illness levels of liver and other organ function. DIALIVE is safe and significantly increases proportion of patients resolving ACLF whilst reducing time to resolution. The data justify start of late phase clinical trials.

Agarwal added that the main advantages of Dialive were two-fold: a) it is relatively simple to assemble and takes advantage of equipment already in use in ICUs, and b) it targets two important pathobiological mechanisms known to trigger acute decline in liver function and associated other organs failure, namely the patient’s own damaged albumin and development of an intense systemic inflammatory response.

Abstract: A multi-centre, randomized controlled study, to evaluate the safety and performance of the DIALIVE Liver Dialysis Device in patients with Acute on Chronic Liver Failure (ACLF) versus standard of care (SOC). (OA-1997)
Session: Thursday June 24, 16:00-17:30 CET.

 

Further information

Media Registration: Accredited media can apply for free registration here:

Press Programme: The Official Press Programme can be found here:

All ILC 2021 Official Press Conferences will broadcast  live on Zoom for registered media.

Embargo Policy: Please note that the ILC2021 Embargo Policy has changed this edition -media representatives are asked to familiarise themselves with the new policy.

Contact:

Michael Kessler
Michael Kessler Media
EASL Media Relations
Email: michael.kessler@intoon-media.com
Mob: +34 655 792 699
Twitter: @mickessler

About The International Liver Congress™

This annual congress is EASL’s flagship event, attracting scientific and medical experts from around the world to learn about the latest in liver research and exchange clinical experience. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is being held entirely digitally due to the global health situation.

About The European Association for the Study of the Liver (EASL)

Since its foundation in 1966, this not-for-profit organisation has grown to over 4,500 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European association with international influence, and with an impressive track record in promoting research in liver disease, supporting wider education, and promoting changes in European liver policy.

Media Release - Wednesday 23 June

For Immediate Release

Media Release

ILC 2021 opens with focus on impact of COVID-19 on global liver disease

New data demonstrates that chronic liver disease increased the odds of COVID-19 death by 80% and Pfizer-BioNTech COVID-19 vaccine confers low immunity on people with advanced liver disease

Wednesday 23 June 2021 (Geneva, Switzerland)–Leading liver disease researchers announced important new developments on the impact of  the COVID-19 pandemic  on people living with  liver  disease at the 2021 International liver Congress (ILC 2021) convened by the European Association for the Study of the Liver (EASL), today. This includes new data indicating that people with advanced liver disease are extremely vulnerable to the novel coronavirus and results of a study that indicates that the PfizerBioNTech  SARS-CoV-2 vaccine confers low immunity on people with advanced liver disease. A third booster shot is being recommended.

Other announcements included new insights into the impact  of the COVID-19 pandemic on the incidence of alcohol related liver disease and mortality rates of people with non-alcoholic fatty liver disease (NAFLD)  and some encouraging data on tenofovir in preventing serious COVID-19 illness amongst people living with chronic Hepatitis B.

“Since 1966 the International Liver Congress  has helped answer the most pressing research questions in hepatology, and this year is no different,” said Philip Newsome, General  Secretary of EASL and Professor of Experimental Hepatology and Director of the Centre for Liver Research at the University of Birmingham in the UK.

“We are beginning to understand  more clearly just how disproportionately COVID-19 is impacting on people living with liver-related diseases and the studies presented at  ILC 2021 advance  our knowledge on multiple fronts, knowledge that can potentially help inform policy responses to the  pandemic going forward.”

Today’s official press conference highlighted six  studies covering the intersection of COVID-19 and liver disease selected from over 1500  thousands of abstracts being presented at ILC 2021.

 

Data measures the contribution of chronic liver disease and of alcohol use disorders to the burden of COVID-19 in France in 2020 and reports that  chronic liver disease increased the odds of Covid-19 death by 80 per cent.

This study used the French National Hospital Discharge database to  select patients (N=187,283; mean [SD] age 66 [22] years; 25% men) aged 18 years and older who were discharged in the year 2020 with a diagnosis code for Covid-19 and captured all, 2011-2020, corresponding, standardized discharge summaries, including demographics (sex, age at entry, and postal code of residency); primary and associated discharge diagnosis codes according to the WHO International Classification of Diseases, tenth revision (ICD-10); medical procedures received; length of stay; and discharge modes (including in-hospital death). Overall, 16,338 (8.7%) patients diagnosed with chronic liver disease were admitted for Covid-19 in France in 2020 and 3943 (24.1%) of them died, including 2518 (63.9%) after a liver-related complication.

Vincent Mallet  of the Cochin University Hospital in France reported that  chronic liver disease increased the odds of Covid-19 death by  80%, that liver-related complications and alcohol use disorders reduced the odds of mechanical ventilation by, and that  therapeutic effort limitation may have contributed to COVID -19 deaths of patients with chronic liver disease

Abstract: Chronic liver disease and the risk of mortality after Covid-19: a national, retrospective, cohort study for 2020 (GS-1587)

Session: Thursday June 24,16:00-17:30 CET

 

Study in Mexico finds that people living with metabolic associated  fatty liver disease (MAFLD) at higher risk of dying from COVID-19

In this study 348   patients admitted in a tertiary referral hospital located in México city with a positive SARS-CoV-2 PCR test from 4 April to 24 June 2020 were analyzed. Three groups were formed: 1.- Control group (n=80), 2.- Isolated hypertransaminasemia (IH) group (n=185) and 3.- MAFLD group (n=83). Additionally, other variables associated with severity in COVID-19 were obtained, including gender, age, and comorbidities (T2D, Hypertension and obesity). A Binary Logistic Regression adjusted to the variables associated with severity in COVID-19 was made to obtain OR of death between the groups.

Martín Uriel Vázquez Medina of  the  Escuela Superior de Medicina reported that  adjusted OR for death with respect to the control group were people living with MAFLD were five times likelier to die during hospitalization by COVID-19 than people without these factors.

Abstract: Association of MAFLD with mortality in patients with COVID-19 in Mexico (PO-445)

 

New research reveals that Tenofovir can reduce the severity of COVID-19 infection in chronic hepatitis B patients (PO-1449)

This study aimed  was to analyse the incidence and severity of COVID-19 in patients with chronic hepatitis B on the antiviral drug  treatment tenofovir  or entecavir. A database search of 4736 CHB patients from 28 Spanish hospitals  was undertaken.

Beatriz Mateos Muñoz  of the Hospital Universitario Ramón y Cajal in Spain reported

that 117 patients with COVID-19 were identified , 67 of whom were taking  tenofovir  and 50 on entecavir. 41 (35%), 5 (4.3%) and 6 (5.1%) out of the 117 patients with COVID-19 were hospitalized, admitted to ICU or died, respectively. Compared with patients on TDF, those on ETV had significantly (p<0.05) greater rates of obesity (22 vs. 9%), diabetes (32 vs. 12 %), ischemic cardiopathy (14 vs. 3%) and arterial hypertension (44 vs. 18%). There was a trend for greater severity of advanced (F3-F4) fibrosis in the ETV groups (35 vs. 18%, p = 0.06). The incidence of COVID-19 in patients on TDF or ETV was similar but compared with those on tenofovir, patients on entecavir  more often had severe COVID-19, required ICU, ventilatory support, had longer hospitalization or died . In multivariate logistic regression adjusted by age, sex, obesity, comorbidities and fibrosis stage, TDF reduced by 6-fold the risk of severe COVID-19. Patients with CHB on TDF have a lower risk of severe COVID-19 infection than those on ETV. TDF seems to exert a protective effect in patients with CHB infected by COVID-19.

Abstract. Tenofovir reduces the severity of COVID-19 infection in chronic hepatitis B patients (PO-1449)

 

New data evaluates the impact of COVID-19 restrictions on patients with alcoholic and non-alcoholic cirrhosis as well as alcoholic hepatitis (AH) who were hospitalized in Alberta, Canada.

This large population-based study  identified 2,916 hospitalizations for non-alcoholic cirrhosis, 2,318 hospitalizations for alcoholic cirrhosis, and 1,408 AH hospitalizations between 2018 and 2020.

Abdel-Aziz Shaheen, of the University of Calgary in Canada, reported that

AH patients had a significant increase in average monthly admission (69.5 vs. 39.6, P<0.001) with April 2020 being the inflection point. Although AH patients admitted post COVID-19 restrictions were younger (median age 43 vs. 47, P=0.02), there were no significant differences in admission outcomes pre- and post-COVID-19 among AH cohort.

Monthly admission rates were stable for non-alcoholic and alcoholic cirrhosis, however, there was a significant 9% increase in AH admissions per month between March and September and the average rate of AH hospitalizations rate compared to overall hospitalizations rate doubled from 11.6/ 10,000 general hospitalizations to 22.1/ 10,000 general hospitalizations for the same period.

Abstract: The alarming impact of COVID-19 pandemic on alcohol-related liver disease: a population-based Canadian study (PO-1099)

 

COVID-19 positive patients with alcohol user disorder had a longer hospital stay and died at a significantly younger age

This  retrospective study identified some that some 18 % of  20 598 people during the pandemic and 27 356 people pre-pandemic ay Nottingham University in the UK were screened positive for alcohol user disorder.

Patients in all the alcohol-risk groups were significantly younger (p<0.05) than low-risk groups. Male sex and white ethnicity were associated with a remarkably higher prevalence of AUD.

Mohsan Subhani from the Nottingham University Hospitals NHS Trust noted that  higher proportions were alcohol-dependent in the Pandemic cohort. In the Pandemic cohort, the alcohol-dependent group had a sixteen-fold increased risk (OR 15.8, P<0.001) of mental and behavioural disorders. The COVID-19 positive patients with concomitant AUD had a longer hospital stay and died at a significantly younger age (mean difference 8 years, p<0.05).

Abstract: Effect of COVID-19 on alcohol use disorder among hospitalised patients: a retrospective cohort control study (OA-1381) 

Session: Saturday June 26, 10:00-11:30 CET

 

Older age and advanced liver disease are risk factors for a lower immune  response to the Pfizer’s-BioNTech COVID-19 vaccine.

Researchers undertook an analysis of 88 patients living with hepatic fibrosis who had received both doses of the Pfizer’s-BioNTech SARS-CoV-2  vaccine to assess their immune response.

Histologic NAS grading and CRN fibrosis scoring showed significant changes. Mean NAS scoring found in the excellent responders as compared with 2.9±1.2 in the good responders (p=0.045), that is mainly derived from significant steatosis changes of 1.6±0.9 vs. 1.2±0.7, repeatedly (p=0.02). Hepatocyte ballooning and lobular inflammation were similar. Importantly, advanced fibrosis corelated with weaker vaccine responses. Mean Fibrosis scoring was 1.7±1.1 vs. 2.2±1.5, percentage of advanced fibrosis (F3-F4) were 23% vs. 48% of each group, respectively (p=0.05). Findings confirmed also by significant changes in blood tests.

Rifaat Safadi of the Hadassah-Hebrew University Hospital in Israel explained that older age, and advanced fibrosis with decreased steatosis are risk factors for lower vaccine response And added that a third dose vaccine booster in those risk factor populations should be evaluated in future trials.

Abstract: Elderly with advanced liver fibrosis had lower response to Pfizer’s SARS-CoV-2 vaccine response (OA-2854)

Session: Saturday June 26, 10:00-11:30 CET

 

Further information

Media Registration: Accredited media can apply for free registration here:

Press Programme: The Official Press Programme can be found here:

All ILC 2021 Official Press Conferences will broadcast  live on Zoom for registered media.

Embargo Policy: Please note that the ILC2021 Embargo Policy has changed this edition -media representatives are asked to familiarise themselves with the new policy.

Contact:

Michael Kessler
Michael Kessler Media
EASL Media Relations
Email: michael.kessler@intoon-media.com
Mob: +34 655 792 699
Twitter: @mickessler

About The International Liver Congress™

This annual congress is EASL’s flagship event, attracting scientific and medical experts from around the world to learn about the latest in liver research and exchange clinical experience. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is being held entirely digitally due to the global health situation.

About The European Association for the Study of the Liver (EASL)

Since its foundation in 1966, this not-for-profit organisation has grown to over 4,500 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European association with international influence, and with an impressive track record in promoting research in liver disease, supporting wider education, and promoting changes in European liver policy.

Media Advisory

For Immediate Release

Elderly with advanced liver fibrosis had lower response to Pfizer-BioNTech´s SARS-CoV-2 vaccine response: breaking study to be presented at the International Liver Congress 2021 (ILC 2021) asks if people with advanced liver disease are protected by COVID-19 vaccine

Monday, 21st June, 2021 (Geneva, Switzerland)The impact of the COVID-19 pandemic on liver disease treatment and research will feature prominently in the press programme of the International Liver Congress 2021 (ILC 2021) being held June 23-26.

The congress is convened annually by the European Association for the Study of the Liver (EASL) and is expected to attract some 10 000 researchers, doctors, policy makers industry leaders and journalists from some 120 countries working in liver disease.

Researchers are beginning to map out the effectiveness of COVID-19 vaccines for people with advanced liver disease.

An Israeli study looking at the Pfizer-BioNtech vaccine will be presented at the Official Opening Press Conference: COVID-19 and Liver Disease  on Wednesday June 23rd 09:00 EDT/15:00 CET:

Thomas Berg,  Incoming Secretary-General, EASL, Germany, (Chair)

 

Vincent Mallett,  Managing Senior Physician and Professor, Hepatology Unit, Cochin University

Chronic liver disease and the risk of mortality after Covid-19: a national, retrospective, cohort study for 2020 (GS-1587)

 

Martin Uriel Vázquez Medina, Researcher,  Laboratory of Biomathematical and Biostatistical Modelling for Health Escuela Superior de Medicina, México

Association of MAFLD with mortality  in patients with COVID-19 in Mexico (PO-445)

 

Beatriz Mateos Muñoz, PhD Specialist in Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, University of Alcalá, Spain

Tenofovir reduces the severity of COVID-19 infection in chronic hepatitis B patients (PO-1449)

 

Abdel-Aziz Shaheen, Assistant Professor, Department of Medicine and Community Health Sciences, Division of Gastroenterology and Hepatology, University of Calgary, Canada

The alarming impact of the COVID- 19 pandemic on alcohol related disease (PO-1099)

 

Mohsan Subhani, Hepatology Ph.D fellow, Nottingham University Hospitals NHS Trust and the University of Nottingham, UK

Effect of COVID-19 on alcohol use disorder among hospitalised patients: a retrospective cohort control study (OA-1381)

 

Rifaat Safadi, Professor of Medicine, Hadassah-Hebrew University Hospital, Israel

Elderly with advanced liver fibrosis had lower response to Pfizer-BioNTech´s SARS-CoV-2 vaccine. (OA- 2854)

Further information

Michael Kessler
Michael Kessler Media
EASL Media Relations
Email: michael.kessler@intoon-media.com
Mob: +34 655 792 699
Twitter: @mickessler

About The International Liver Congress™
This annual congress is EASL’s flagship event, attracting scientific and medical experts from around the world to learn about the latest in liver research and exchange clinical experience. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is being held entirely digitally due to the global health situation.

About The European Association for the Study of the Liver (EASL)
Since its foundation in 1966, this not-for-profit organisation has grown to over 4,500 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European association with international influence, and with an impressive track record in promoting research in liver disease, supporting wider education, and promoting changes in European liver policy.

Media Release

For Immediate Release

The effectiveness of COVID-19 vaccines for people with advanced liver disease and the impact of the pandemic on alcoholic liver disease, to be a focus of the International Liver Congress 2021 (ILC 2021)

Breakthrough studies on the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) and Hepatitis D to be announced at the conference

Wednesday, 9th June, 2021 (Geneva, Switzerland)The impact of the COVID-19 pandemic on liver disease treatment and research will feature prominently in the press programme of the International Liver Congress 2021 (ILC 2021) being held June 23-26.

The congress is convened annually by the European Association for the Study of the Liver (EASL) and is expected to attract some 10 000 researchers, doctors, policy makers industry leaders and journalists from some 120 countries working in liver disease.

A number of key studies to be presented in the Official Opening Press conference on Wednesday June 23 reflect the concerns of researchers around the increased level of alcohol consumption during the pandemic, which has been matched by rises in severe liver illness and death over the past 16 months.

At the same time researchers are beginning to map out the effectiveness of COVID-19 vaccines for people with advanced liver disease. An Israeli study looking at the Pfizer -BioNtech vaccine will also be presented at the Official Opening Press Conference.

“To date we´ve seen little in the way of research around the intersection of COVID-19 and liver disease and it`s our hope ILC2021 will provide much needed insights in the field,” said Philip Newsome, Secretary-General of EASL and Director of the Centre for Liver and Gastrointestinal Research & Professor of Hepatology at the University of Birmingham.

A stand-alone cure for Hepatitis D has so far eluded scientists. Found in 2-3 per cent of people living with Hepatitis B, Chronic Hepatitis Delta, as it also known, is the most acute of the hepatitis family and extremely hard to treat. A new study trialling the drug Bulevirtide to treat the disease will present interim results in the 2nd Official Press Conference on Thursday June 24.

The well-documented disproportionate impact of COVID-19 on people living with noncommunicable diseases such as diabetes, obesity and hypertension also has researchers worried about the vulnerability of people living with Non-Alcoholic Fatty Liver Disease (NAFLD) to the novel coronavirus. The need to find effective tools to measure the disease and new drugs to treat the disease is more urgent than ever.

As a consequence of rising levels of obesity, NAFLD has now become the most common cause of liver disease in Western countries, affecting one in four people. In a proportion of people, NAFLD can cause progressive liver damage, and in some of cases it may even lead to the development of liver cirrhosis and liver cancer. NAFLD currently accounts for one in seven liver transplants in the UK. In the U.S. it is now the most common indication for a liver transplant. More generally, liver disease is now the most common cause of premature mortality in the UK.

The search for new treatments for NAFLD has gained momentum over the past few years and the results of some key drug trials will be presented in the 3rd Official Press Conference on Friday June 25.

“NAFLD is already a public health crisis in the West and we urgently need new therapeutics to reduce its burden,” said Newsome.

“If left unchecked, the annual predicted cost of NAFLD in Europe is estimated to be greater than €35 billion in direct costs to the health system, and a further €200 billion by way of wider costs to society.”

Further information

Michael Kessler
Michael Kessler Media
EASL Media Relations
Email: michael.kessler@intoon-media.com
Mob: +34 655 792 699
Twitter: @mickessler

About The International Liver Congress™
This annual congress is EASL’s flagship event, attracting scientific and medical experts from around the world to learn about the latest in liver research and exchange clinical experience. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is being held entirely digitally due to the global health situation.

About The European Association for the Study of the Liver (EASL)
Since its foundation in 1966, this not-for-profit organisation has grown to over 4,500 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European association with international influence, and with an impressive track record in promoting research in liver disease, supporting wider education, and promoting changes in European liver policy.

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