Biography:

André-Jean Remy, is Head of Hepatology and Gastroenterology Unit & of Social Medicine Unit of Perpignan Hospital. He is the Medical coordinator of Mobil Hepatitis Team, General Secretary of ANGH. He is an Administrator of AFEF (French Liver Diseases Association) and a specialist of viral hepatitis in drug users, inmates and precarious populations. He has published more than 150 scientific articles.

Abstract:

Introduction: Although highest European screening rate is in France, 44% of patients are not aware of hepatitis C because they were not diagnosed. Drug injection was main contamination route of hepatitis C virus (HCV) in France and Western Europe since 1990. French guidelines were to treat all inmates and drug users, even fibrosis level. Access of HCV screening, care and treatment in drugs users, prisoners and homeless was low in France, less than 20% and 33% of HCV patients were under diagnosed. They were considered as difficult to treat populations. All these patients need support especially psycho-educative interventions. Hepatitis Mobile Team (HMT) was created in July 2013 to increase screening care and treatment of hepatitis B and C patients. We proposed 15 services: 1. Screening by Dried Blood Spot (DBS) HIV HBV HCV 2. Mobile Fibroscan in different sites 3. Social screening and diagnosis (EPICES score) 4. Outreach center with specific health care workers 5 days/7 5. Free blood tests in primary care if no social insurance 6. Advanced on-site specialist consultation 7. Access to obligatory pre-treatment commissions. 8. Individual psycho-educative sessions 9. Collective educative workshops 10. Staff training 11. Drug users prevention 12. Peer to peer program 13.Low cost specific patients mobile phones 14.Specific one day hospitalizations before and after antiviral treatment 15. Green thread: outside DBS and FIBROSCAN* in specific converted truck.

Objective: Increase screening care treatment access and cure for target population.

Patients & Methods: Target population was drugs users, prisoners, homeless, precarious people, migrants and psychiatric patients. We proposed part or all of our services to our medical and social partners. They choose only services what they need.

Results: From 2013 July to 2015 December, we did 2056 DBS for 1485 people (944 HCV DBS). Our HCV active file was 244 patients, 18% of new patients screened by DBS; 83% realized all blood tests and FibroScan; 59% need treatment according to French recommendations; 50% started treatment and 49% have been cured. Quality of program for patient were free access, closeness (outside hospital), speed (of the results) and availability (of nurse and social workers).

Conclusions: Specific screening, follow up and support of these difficult to treat populations are essential for increase medical management and cure of HCV patients. HMT offered complement services and not substitution of existing services. It was new useful tool to screen, diagnose and treat these patients by outside pathway of care. French Health Ministry announces treatment for all HCV patients in June 2016 and HMT was a cost efficient program to treat every patient.

Biography:

Vince Fragomeli is a Clinical Nurse Consultant at Department of Gastroenterology and Hepatology in Nepean Hospital, Australia.

Abstract:

Introduction: Viekira Pak™ (paritaprevir/ritonavir/ombitasvir, dasabuvir) +/- ribavirin was provided to patients with hepatitis C genotype 1 via a Special Access Scheme (SAS) in Australia prior to Pharmaceutical Benefit Scheme listing. Published data demonstrated good safety and efficacy in clinical trials with SVR (sustained virological response) rates above 90%.

 

Aim: The aim of this nurse-led study is to assess the efficacy and safety of Viekira Pak™ in a “real world” clinical setting and to gain insight into nursing perspectives as Australia progresses towards an interferon free era. To the authors’ best knowledge, this is the first study of its kind examining SVR rates in the “real world” from a nursing perspective.

 

Methods: Data was collected from 140 patients across eight Australian Liver Clinics. Baseline characteristics, pathology results, adherence, compliance, treatment outcomes and adverse events were recorded and analyzed using an approved data collection template.

 

Results: Mean age 56 years, mean weight 84.4 kg, 65.0% male, 95.0% Caucasian, 2.9% Indigenous Australian, 2.1% Asian. 64.3% had genotype 1a, 50.7% treatment naive, 18.6% prior null-response, 77.9% had cirrhosis. Sustained virological response (SVR12) rate 95.0% (n=133). 6 patients did not achieve an SVR12 due to virological failure (n=1), relapse (n=1), lost to follow-up (n=1) premature discontinuation (n=4). 126 (90.0%) patients reported adverse events, mainly mild to moderate fatigue, nausea and headache. Bilirubin elevation was observed in 47.9% of patients; grade 4 in 3 patients (2.1%). Serious adverse events in 19 (13.6%) participants, hyperbilirubinemia (n=8), decompensation (n=2) and anemia (n=1), resulting in hospitalization, no deaths reported. One potential drug-drug interaction was identified resulting in lithium toxicity. Patients were predominantly reviewed by nurses with an average (mean) of 5.1 clinic visits from week 1 to week 12 post treatment. 85.0% of patients attended all scheduled visits. 85.0% of patients reported 100% adherence to medication.

 

Conclusion: This “real world” analysis of Viekira Pak™ demonstrated high SVR rates similar to those achieved in clinical trials. Participants reported excellent treatment adherence, compliance and tolerability of Viekira Pak™. Reported adverse events were mainly mild to moderate intensity and serious adverse events were rare. The potential for drug-drug interactions (DDI’s) highlight the need for adequate monitoring of patients whilst on treatment. This study supports the implementation and utilization of a nursing model of care to treat patients with chronic HCV in the Direct Acting Antiviral (DAA) era. The implementation of a nursing model of care has a far reaching impact in the global ability to reduce the worldwide burden of HCV by facilitating the rapid and safe treatment uptake for HCV patients undergoing HCV therapy.

Biography:

Eman El-Ahwany is a Professor of Immunology, Immunology and Drug Evaluation Department, Theodor Bilharz Research Institute (TBRI), Egypt. She was graduated from Faculty of Science, Cairo University in 1991. She has received her PhD in Immunology in 2001 and worked as a Teaching Assistant and Faculty part-time in the Biology Department, the American University in Cairo (1999-2014). She is a Member in the TBRI technical office and the TBRI Internal Research Projects Committee since 2011. She is a Member in the European Association of Liver Diseases (EASL). Her field of interest is miRNAs and the epigenetic changes as non-invasive diagnostic and therapeutic tools in HCV-induced liver fibrosis and HCC. She has shared and worked as participant, Co-PI and PI in 20 research projects sponsored by international and national agencies, published 35 research articles in peer reviewed international journals, presented several abstracts in 30 international conferences and supervised 15 MSc and PhD theses. She has been awarded the TBRI excellence award in 2014. She is the Coordinator of MOU between TBRI and Basque University in Spain (2016). She has received Post doctorate Fellowships in Germany (2007) and France (2014).

Abstract:

Liver fibrosis is a wound healing scar response following acute and chronic liver diseases including chronic hepatitis B and C, autoimmune hepatitis, non-alcoholic steatohepatitis and alcoholic liver disease. The patho-histological findings of liver cirrhosis, the end-stage of liver fibrosis, show hepatocellular death, a lobular inflammatory cell infiltrate, excessive deposition of ECM proteins, and the appearance of regenerative nodules that may result in liver failure, portal hypertension and hepatocellular carcinoma. The pathophysiology of liver injury has attracted the interest of experimentalists and clinicians over many centuries. With the discovery of liver-HSC, the insight into the cellular and molecular pathobiology of liver fibrosis has evolved and the pivotal role of HSC as a precursor cell-type for ECM-producing myofibroblasts has been established. Although activation and trans-differentiation of HSC to myofibroblasts (MFs) is still regarded as the pathogenetic key mechanism of fibrogenesis, recent studies point to a prominent heterogeneity of the origin of myofibroblasts. The newly discovered pathways supplement the concept of HSC activation to MFs, point to fibrosis as a systemic response involving extrahepatic organs (lung and kidney) and reactions and offer innovative approaches for the development of non-invasive biomarkers and anti-fibrotic agents.

Biography:

Makki Hummadi Fayadh is a senior consultant Physician & Gastroenterologist- Hepatologist & Endoscopist both in Iraq & UAE . He was graduated from the Medical College University of Baghdad and completed his Post graduate studies in Medicine & Gastroenterology in UK-London. Became a member of MRCP UK and worked in Saint Bartholomew’s hospital in London in the Gastroenterology department with Sir A.M.Dawson, during that time trained in endoscopic techniques and did research on malabsorption especially celiac disease, colitis, bile stone dissolution inflammatory bowel diseases & gastrointestinal lymphomas. He joined
in Advanced Center for Day care surgery-ACDS as a consultant physician gastroenterologist & Medical director.

Abstract:

Gastrointestinal and liver diseases are major causes of death and disability in Middle East and North Africa. Diarrheal diseases have been replaced by gastrointestinal cancers and cirrhosis in most countries in the region. In the Gulf GCC countries, Jordan & Iraq, GIT cancers are increasing. Gastrointestinal and liver diseases show variability in the pattern of their prevalence, incidence, mortality and the final burden they impose. Some countries such as Afghanistan and Pakistan are still facing gastrointestinal infectious diseases; other countries with better economy in the region have experienced the obvious transition from communicable to non-communicable diseases. Liver cirrhosis is among the top four causes of death in all countries in our area. The death rate caused by cirrhosis in Egypt is by far the highest in the world, followed by Pakistan, Afghanistan, Yemen and Morocco. Pakistan is specifically experiencing an epidemic of cirrhosis. Liver cancer is among the top four causes of death in 18 countries. In Iraq chronic liver diseases are very prevalent and account for 2/3^rd of the admissions, the important causes is in the following order, hepatitis B, alcohol, hepatitis C, immune hepatitis and metabolic diseases. The prevalence of non-alcoholic fatty liver disease is rapidly increasing and non-alcoholic steatohepatitis has become a leading indication for liver transplantation. Diarrheal diseases have been replaced by gastrointestinal cancers and cirrhosis in most countries in the region. In the Gulf GCC countries, Jordan & Iraq cancers are increasing. Chronic hepatitis B and C are the main causes of liver cirrhosis and progression to hepatocellular carcinoma. Gastrointestinal and liver diseases show variability in the pattern of their prevalence, incidence, mortality and the final burden they impose. There is marked difference in prevalence of liver disease in our area. Diarrheal diseases have been replaced by gastrointestinal cancers and cirrhosis in most countries in the region. Liver cirrhosis is among the top four causes of death in all countries in our area.

Biography:

Osama Hasan Othman has completed his MBChB in Mosul Medical College in 1980, gained DM, CABM Baghdad in 1992, MRCP1in1988 and FRCP London in 2012. He is currently a Chief of Department of Medicine, previously Sub-Dean of Scientific Affairs in Medical College. He shares in most of scientific activities in the college and Azadi Teaching Hospital and has published many papers and editorials.

Abstract:

Hepatitis itself is not a genetic disease. Hepatitis B virus got genetic diversity. HBV is DNA virus which replicates by RNA intermediate as its DNA polymerase has reverse-transcriptase RT. The mutation rate for HBV is high. HVB classified on base of genomic sequencing, antigenic subtypes of glycoprotein surface antigen HBsAg. Genotype-subtype has geographical distribution related to population movement and significant events. Mutation and mutant selection occurred among all HBV variants. They have relevant medical and public health implications. Pre-core (pre-C) defective variant has less susceptibility to Interferon with high failure rate to other antiviral drugs related to selection of resistant variants mutation in genome encoding viral RT activity. As RT overlaps HBsAg molecule code, selection of drug resistant variants indirectly leads to selection of HBsAg variants commonly encountered in chronic HBV carriers. The significance of this emerges under the pressure of neutralizing antibody response leading to resistance to both vaccination and immunotherapy noted often among liver transplant recipients and babies born to HBV-carrier. HBsAg variants also associated with false negative results in diagnosis of new infections, detection of chronic carriers, screening for blood donation and manufacture of therapeutic blood products.

Biography:

Ali received the bachelor of Clinical Laboratory Sciences, College of Applied Medical Sciences from King Saud University in Riyadh, KSA in 2005 and the master degree of Laboratory Medicine from RMIT university in 2010, a master research in the Cytogenetics and Molecular Cytogenetics Laboratories of the Murdoch Children Research Institute in Melbourne.

He worked as medical technologist 1 in biochemistry lab in King Fahad Medical City 2006-2008 and 2011. His work involved the testing of quality control of the automated machines, blood sample for clinical chemistry, liver and lipid profile tests.

He is currently a PhD at rmit university, and A lecturer in the Laboratory Medicine department at Al-Baha University.

Ali current research interest in the evaluation of effectiveness and safety of Chinese medicine in the treatment of non-alcoholic fatty liver disease and liver-related disease. The common research topics include molecular biology, metabolic syndrome, diabetes and biochemistry.

Abstract:

Matrine is a small molecule (MW: 248) isolated from a natural product and used as a prescribed hepatoprotective drug in humans with little adverse effect. Our recent work shows that matrine can reduce glucose intolerance in mice caused by excess lipid intake directly from diet. Here, we investigated whether matrine may also be efficacious for hepatosteatosis and glucose intolerance due to hepatic de novo lipogenesis from high carbohydrate. This study was performed in high fructose-fed mice for 8 weeks with matrine treatment (100 mg/kg/d) administered in the last 2 weeks. We found that matrine markedly reduced hepatosteatosis (100% reduction in triglyceride content, p<0.01 vs. untreated group) and glucose intolerance (ACU: HFru+HuM1 vs. untreated, P<0.05) without affecting caloric intake. Fructose-induced increases in SREBP1c (by 66%) and SCD1 (by 72%) in the hepatic lipogenic pathway were all suppressed by the treatment with matrine (all p<0.05). As our earlier work revealed ER stress as a mechanism of fructose-induced de novo lipogenesis, we examined hepatic ER stress following matrine treatment. Indeed, matrine significantly decreased IRE1 by 2 fold (p<0.01 vs. untreated group) in the ER stress pathway. These results together suggest that matrine eliminates hepatosteatosis and glucose intolerance by suppressing ER stress associated lipogenesis in the liver. To further assess the implications of these findings to the glycaemic control for diabetes, we generated a type-2 diabetes model in mice by high fat feeding (to produce insulin resistance) plus low doses of streptozotocin (to decrease plasma insulin by 50%). Consistent with the effects in high fructose-fed mice, matrine reduced hepatic triglyceride content (by 60%) and SREBP1c level (by 57%, p<0.05) in the liver and significantly lowered the hyperglycaemia. Collectively, our findings indicate that the hepatoprotective drug matrine may be repurposed for the treatment of hepatosteatosis and type-2 diabetes associated de novo lipogenesis in the liver.

Biography:

Salem Awadh is a Consultant Gastroenterologist at Advanced Center for Day Care Surgery LLC, UAE. He has published numerous research papers and articles in reputed journals and has various other achievements in the related studies. He has extended his valuable service towards the scientific community with his extensive research work.

Abstract:

UAE was a country of intermediate prevalence and now it is considered a low prevalence because of the policy of universal vaccination since 1992. The complete, sustained clearance of HBV among chronically infected patients, and the hope of eradicating HBV from our planet should be our dream and mission in the coming years. H BsAg have served as a qualitative serological marker of HBV infection for several decades. Since 2004, due to development of advanced quantitative assays for HBsAg level has led to much interest in its potential use to monitoring the status of chronic HBV infection and antiviral response. Baseline HBsAg level and its dynamic characteristics during therapy with nucleoside/tide analogues or interferon{ INF} have become very important predictors of antiviral response. HBsAg titres are not associated with ALT levels among most patients in the same phase. Genotypes are the most important determinants of HBsAg levels both for treatment-naïve and treated patients. Genotype A seems to have a higher probability of HBsAg loss in both the natural course of HBV infection and antiviral treatment. 10% of patients of affected patients have genotype A in UAE and the predominant genotype is genotype D which is difficult to treat and 25% seroconvert ion fron e antigen positive to e antigen negative after one year Serum HBsAg levels tend to be higher in; HBeAg positive, Genotype A. Special mutations of HBV S gene can lead to HBsAg variants which may be under estimated or undetectable by current assays. Clinicians should therefore pay attention to false loss of HBsAg for some patients with HBV s Ag variants. Achievement of HBsAg seroconversion does not always indicate HBV eradication during PEG-INFa therapy. Coinfection or superinfection of HBV with HCV, HDV, HAV, or HEV may lead to lower levels of HBsAg and HBV DNA than single HBV infection in the same natural phase. Different antiviral treatment protocols have different effects on HBsAg decline and HBsAg is highest in immunotolerant phase. “HBsAg level < 1500 IU/ml at week 12 of PEG-INFa therapy had a PPV of 33% for HBeAg seroconversion 24 weeks after EOT”. at week 24 HBsAg level :  <300 IU/ml is SVR Predictor HBsAg loss is reached in 3-7% of patients. Patients with HBsAg titres > 20 000 IU/ml at weeks 12, 24 of PEG-INF-a were considered not to have achieved a post-treatment response , this could be used as a “stopping rule. PEG-INF-a -Patients with HBsAg  < 1500 IU/ml at week 12 of PEG-INF attained an HBsAg clearance rate of 17.6% at 24 weeks after EOT. PEG-INF-a -In patients with : HBsAg  Decline >1 log 10, and  serum level < 300 IU/ml at 24 weeks during treatment achieved a SVR rate of 75% compared with only 15% those who did not have these criteria. PEG-INF-a -On treatment: HbsAg levels <1,500 IU/ml at 12 week,s could predict SVR 12 months after EOT. After HBeAg loss, serum HBsAg decline seems to somewhat underestimate the decline of cccDNA, and the decline of serum HBV DNA is much greater than the reduction of intrahepatic viral load.

Biography:

Nermeen Nabil Ashoush has completed her PhD in 2015 from Ain Shams University in the field of Clinical Pharmacy and Pharmacy Practice. Also, in 2015 she has completed a Diploma in Health Economics and Outcome Research from the University of Washington. She is working as a Lecturer in Clinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, The British University in Egypt. She is also the Head of the Health Economics Unit, Center for Drug Research and Development, The British University in Egypt.

Abstract:

Hepatitis C is a chronic health problem affecting approximately 180 million people worldwide. Chronic hepatitis C is one of the main causes of end-stage liver disease and hepatocellular carcinoma that have a clinical and economic burden on hepatitis C virus (HCV) patients.

Over the past few years, new medicines for HCV infection have begun to transform the treatment landscape; the development of new regimens involving direct acting antivirals (DAAs) have been so successful that disease experts are heralding an era where all HCV patients of all genotypes can be cured, even debating whether eradication is possible.

These novel agents seem to facilitate the use of shortened courses of combination interferon-free therapy, which are associated with high (>95%) sustained response rates and relatively few toxicities. These regimens have also been successful in patients who were previously difficult to treat, including those with cirrhosis. The main drawback of these new agents is the huge price tag, which will make treatment out of reach for people in the developed and developing world. Understanding the balance between costs and efficacy is critical to making decisions about the optimal use of these new agents, especially for health-care systems constrained by rising costs. Our goal for this workshop is to facilitate an understanding of the importance of health economics and pharmacoeconomics evaluations in guiding policy decisions about the use of newly approved drugs as well as future therapies.