Friday, April 20, 2018

International Liver Congress 2018 - Webinars covering critical studies on viral hepatitis and NAFLD/NASH

Clinical Care Options 
Program Overview
2018 Annual Meeting of the European Association for the Study of the Liver*
April 11-15, 2018 | Paris, France

Review Capsules Summaries, download slides, and listen to audio commentary from expert-led Webinars covering critical studies on viral hepatitis and NAFLD/NASH from Paris.
Link: https://www.clinicaloptions.com/Hepatitis/Conference%20Coverage/Paris%202018.aspx

Free registration required

Viral Hepatitis
Capsule Summaries (6)
Addition of RBV Associated With Increased Efficacy of 12 Weeks Sofosbuvir/Velpatasvir in Patients With Genotype 3 HCV Infection and Compensated Cirrhosis

Retreatment of Patients Who Failed Glecaprevir/Pibrentasvir Treatment for Hepatitis C Virus Infection

A Phase 3b, Open-Label, Randomized, Pragmatic Study of Glecaprevir/Pibrentasvir +/- Ribavirin (RBV) for HCV Genotype 1 Subjects Who Previously Failed an NS5A Inhibitor + Sofosbuvir (SOF) Therapy

8 Weeks Sofosbuvir/Velpatasvir in Genotype 3 Patients With Significant Fibrosis: Highly Effective Amongst an OST Cohort (Coming soon)

Safety and Efficacy at 1 Year After Switching From Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in Chronic HBV Patients With Risk Factors for TDF Use

High Efficacy and Safety of Grazoprevir and Elbasvir for 8 Weeks in Treatment-Naive, Nonsevere Fibrosis HCV GT1B-Infected Patients: Interim Results of the STREAGER Study


NAFLD/NASH
Capsule Summaries (4) 
Low-Moderate Alcohol Use Is Associated With a Lower Prevalence of Nonalcoholic Fatty Liver Disease in Hispanics/Latinos Living in the US: Results From the Hispanic Community Health Study/Study of Latinos (HCHS/SOL)

Substantial Comorbidities and Rising Economic Burden In Real-World Nonalcoholic Fatty Liver Disease (NAFLD)/Nonalcoholic Steatohepatitis (NASH) Patients With Compensated Cirrhosis (CC): A Large German Claims Database Study (Coming soon)

Nonalcoholic Fatty Liver Disease and Relative Risk of Incident Steatohepatitis, Cirrhosis and Hepatocellular Carcinoma Events in 4 European Primary Care Databases

Prevalence and Stratification of NAFLD/NASH in a UK and US Cohort Using Noninvasive Multiparametric MRI

Begin here.......

Thursday, April 19, 2018

Life of a liver awaiting transplantation - Machine that preserves livers might offer a way forward


NEWS AND VIEWS
18 April 2018

Life of a liver awaiting transplantation
Stefan Schneeberger
People waiting for a liver transplant can die before an organ is found, or, if one is available but of poor quality, there is a risk of transplant failure. A machine that preserves livers might offer a way forward.

The concept of machine perfusion of an organ awaiting transplantation is not new. Indeed, machine-assisted perfusion was in use before cold storage became the method of choice owing to its simplicity and reproducibility2. However, interest in revisiting perfusion as a transplant approach has been gaining momentum.

The main outcome monitored in the latest trial was the post-transplantation level of the enzyme aspartate transaminase in patients’ blood. This measurement is commonly used to assess liver damage and to estimate the risk of transplant failure. The authors found that the use of NMP was associated with less liver damage than that found in livers preserved on ice. Moreover, preservation by NMP reduced the number of organs that were discarded as unsuitable for transplantation compared with livers preserved on ice, and was associated with a better blood-flow profile in the recipient.

Scientific guidelines for using cannabis to treat stress, anxiety and depression

Scientific guidelines for using cannabis to treat stress, anxiety and depression

Washington State University

PULLMAN, Wash.--In a first-of-a-kind study, Washington State University scientists examined how peoples' self-reported levels of stress, anxiety and depression were affected by smoking different strains and quantities of cannabis at home.

Their work, published this month in the Journal of Affective Disorders, suggests smoking cannabis can significantly reduce short-term levels of depression, anxiety, and stress but may contribute to worse overall feelings of depression over time.

It marks one of the first attempts by U.S. scientists to assess how cannabis with varying concentrations of the chemical compounds tetrahydrocannabinol (THC) and cannabidiol (CBD) affect medicinal cannabis users' feelings of wellbeing when smoked outside of a laboratory.

"Existing research on the effects of cannabis on depression, anxiety and stress are very rare and have almost exclusively been done with orally administered THC pills in a laboratory," said Carrie Cuttler, clinical assistant professor of psychology at WSU and lead author of the study. "What is unique about our study is that we looked at actual inhaled cannabis by medical marijuana patients who were using it in the comfort of their own homes as opposed to a laboratory."

For example, the WSU research team found that one puff of cannabis high in CBD and low in THC was optimal for reducing symptoms of depression, two puffs of any type of cannabis was sufficient to reduce symptoms of anxiety, while 10 or more puffs of cannabis high in CBD and high in THC produced the largest reductions in stress.

"A lot of consumers seem to be under the false assumption that more THC is always better," Cuttler said. "Our study shows that CBD is also a very important ingredient in cannabis and may augment some of the positive effects of THC."

The researchers also found that while both sexes reported decreases in all three symptoms after using cannabis, women reported a significantly greater reduction in anxiety following cannabis use.

Data for the study were taken from the trademarked app Strainprint, which provides medical cannabis users a means of tracking how different doses and types of cannabis affect a wide variety of symptoms of wellbeing.

Strainprint users rate the symptoms they are experiencing before using cannabis on a scale of 1-10 and then input information about the type of cannabis they are using. Twenty minutes after smoking, they are prompted to report how many puffs they took and to rerate the severity of their symptoms.

Cuttler and WSU colleagues Alexander Spradlin and Ryan McLaughlin used a form of statistical analysis called multilevel modeling to analyze around 12,000 anonymous Strainprint entries for depression, anxiety and stress. The researchers did not receive any of the Strainprint users personally identifying information for their work.

"This is to my knowledge one of the first scientific studies to provide guidance on the strains and quantities of cannabis people should be seeking out for reducing stress, anxiety and depression," Cuttler said. "Currently, medical and recreational cannabis users rely on the advice of bud tenders whose recommendations are based off of anecdotal not scientific evidence."

The study is among several cannabis-related research projects currently underway at WSU, all of which are consistent with federal law and many of which are funded with Washington state cannabis taxes and liquor license fees.

Photo Credit
WSU

Hepatic Steatosis and its Effects on Fibrosis in Patients With Chronic Hepatitis B Virus Infection

Clinical Gastroenterology and Hepatology (CGH)
April 2018 Volume 16, Issue 4, Pages 491–494

Hepatic Steatosis and its Effects on Fibrosis in Patients With Chronic Hepatitis B Virus Infection
Mauricio Garcia-Saenz-de-Sicilia, MD, Andres Duarte-Rojo, MD, MS, DSC

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Obesity rising prevalence has reawakened interest in the potential interactions between chronic viral hepatitis and hepatic steatosis. The metabolic syndrome and its components are independent risk factors associated with fibrosis progression, development of cirrhosis,1 and potentially with lack of fibrosis reversal following antiviral therapy in chronic viral hepatitis.2 However, the particular role of hepatic steatosis, the hallmark of nonalcoholic fatty liver (NAFLD), has been less of a focus of attention in chronic hepatitis B virus (HBV) infection when compared with chronic hepatitis C, in part because of the lack of proper evaluation tools.3

Liver biopsy is considered to be the gold standard for steatosis grading. However, it is invasive, has potential life-threatening complications, can result in sampling errors particularly when fatty infiltration is unevenly distributed (typical biopsy represents 1/50,000 of liver), and interpretation reaches only moderate interobserver or intraobserver agreement.4 Furthermore, repeated monitoring following a therapeutic intervention is hard to justify because of the invasive nature of the procedure and cost, and the fact that noninvasive options are now available. Imaging techniques provide reliable noninvasive alternatives to assess steatosis. Proton density fat fraction from magnetic resonance is perhaps the most accurate method for steatosis quantification; however, it is not a point-of-care method, and has associated high costs and limited availability, making it impractical for routine clinical care at most institutions. All of these limitations are at least partially overcome by the controlled attenuated parameter (CAP) feature from FibroScan (Echosens, Paris, France). This technique, based on the principle that fat affects ultrasound propagation, quantifies variations in M-mode (unidimensional) ultrasound attenuation during liver stiffness measurement (LSM) with vibration-controlled transient elastography, to yield a steatosis estimate. When testing CAP against steatosis grading by liver biopsy, fair to excellent performance has been reported across studies, and discrepancies are likely explained by variations in liver disease etiology, population body composition, and spectrum bias (Table 1). Although CAP interpretation has been limited by uncertainty as to the optimal cutoff values between grades of steatosis, Karlas et al5 have recently brought some certainty to this issue. In a meta-analysis including 2735 cases with histology and CAP analysis, the authors defined cutoff values and variables influencing the output, such as body mass index (BMI), diabetes, and etiology.

Risk factors for hepatocellular carcinoma by age, sex, and liver disorder status

Cancer. 2018 Apr 18. doi: 10.1002/cncr.31406. [Epub ahead of print]
Risk factors for hepatocellular carcinoma by age, sex, and liver disorder status: A prospective cohort study in Korea.
Yi SW1,2, Choi JS3, Yi JJ4, Lee YH5, Han KJ3.

First published: 18 April 2018

Personal or institutional subscription required to read full text article.

Abstract
BACKGROUND:
To the authors' knowledge, relatively little is known regarding the interaction of risk factors for hepatocellular carcinoma (HCC) with age, sex, and liver disorder status.

METHODS:
The authors followed 504,646 Korean patients aged 40 to 80 years who underwent routine health checkups between 2002 and 2003 until 2013 via linkage to national hospital discharge records.

RESULTS:
HCC occurred in 2744 individuals. In the sex-adjusted and age-adjusted analysis, cirrhosis increased the incidence of HCC by 42-fold, followed by hepatitis B virus (21-fold), hepatitis C virus (HCV; 19-fold), male sex (4.3-fold), and each 5-year age increment (1.24-fold). In the multivariable adjusted analysis, diabetes increased the risk of HCC by 80%, alcohol consumption ≥80 g/day increased the risk by 75%, alcohol consumption of 40 to 79 g/day increased the risk by 37%, and being a current smoker increased the risk by 25%. The multivariable adjusted hazard ratios of male sex and HCV were 6.27 and 5.72, respectively, at age <50 years, but were 2.09 and 22.51, respectively, at age ≥70 years. Each 20 g/day of alcohol consumption increased the risk of HCC by 6% (P = .11), 8% (P = .02), 16% (P<.001), and 30% (P<.001), respectively, in individuals aged <50 years, 50 to 59 years, 60 to 69 years, and 70 to 80 years. In individuals without a liver disorder, body mass index was found to be positively associated with HCC, whereas patients with a liver disorder demonstrated an inverse association. Women had higher adjusted hazard ratios associated with age and cirrhosis compared with men.

CONCLUSIONS:
With advancing age, the effects of alcohol use and HCV on the development of HCC become stronger, whereas the effect of male sex weakens. Lifetime moderate alcohol consumption may cause HCC in the elderly. Smoking increases the risk of HCC irrespective of viral hepatitis, and diabetes increases the risk of HCC independent of cirrhosis. Cancer 2018. © 2018 American Cancer Society.

© 2018 American Cancer Society.

European Food Safety Authority Warns Green Tea Extracts May Be Associated With Liver Damage

According to new research from the European Food Safety Authority (EFSA) consuming more than 800mg of green tea catechins per day may lead to higher health risks, including liver damage.

Scientific opinion on the safety of green tea catechins EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)
Maged Younes Peter Aggett Fernando Aguilar Riccardo Crebelli Birgit Dusemund Metka Filipič Maria Jose Frutos Pierre Galtier David Gott Ursula Gundert‐Remy Claude Lambré Jean‐Charles Leblanc Inger Therese Lillegaard Peter Moldeus Alicja Mortensen Agneta Oskarsson Ivan Stankovic Ine Waalkens‐Berendsen Rudolf Antonius Woutersen Raul J Andrade Cristina Fortes Pasquale Mosesso Patrizia Restani Davide Arcella Fabiola Pizzo Camilla Smeraldi Matthew Wright

First published: 18 April 2018 https://doi.org/10.2903/j.efsa.2018.5239

Full-Text

Abstract
The EFSA ANS Panel was asked to provide a scientific opinion on the safety of green tea catechins from dietary sources including preparations such as food supplements and infusions. Green tea is produced from the leaves of Camellia sinensis (L.) Kuntze, without fermentation, which prevents the oxidation of polyphenolic components. Most of the polyphenols in green tea are catechins. The Panel considered the possible association between the consumption of (‐)‐epigallocatechin‐3‐gallate (EGCG), the most relevant catechin in green tea, and hepatotoxicity. This scientific opinion is based on published scientific literature, including interventional studies, monographs and reports by national and international authorities and data received following a public ‘Call for data’. The mean daily intake of EGCG resulting from the consumption of green tea infusions ranges from 90 to 300 mg/day while exposure by high‐level consumers is estimated to be up to 866 mg EGCG/day, in the adult population in the EU. Food supplements containing green tea catechins provide a daily dose of EGCG in the range of 5–1,000 mg/day, for adult population. The Panel concluded that catechins from green tea infusion, prepared in a traditional way, and reconstituted drinks with an equivalent composition to traditional green tea infusions, are in general considered to be safe according to the presumption of safety approach provided the intake corresponds to reported intakes in European Member States. However, rare cases of liver injury have been reported after consumption of green tea infusions, most probably due to an idiosyncratic reaction. Based on the available data on the potential adverse effects of green tea catechins on the liver, the Panel concluded that there is evidence from interventional clinical trials that intake of doses equal or above 800 mg EGCG/day taken as a food supplement has been shown to induce a statistically significant increase of serum transaminases in treated subjects compared to control.


In The Media
Green tea supplements may cause liver damage, warns EU watchdog
The European Food Safety Authority assessed the safety of the supplements
More than 800mg of green tea catechins each day may pose health concerns
Officials at the EU funded organisation were unable to confirm a safe dose
It today called for further scientific trials into the effect of green tea catechins

Tuesday, April 17, 2018

Every Cloud Has a Silver Lining: Overdose-Death Donors in Organ Transplantation

HIV and ID Observations
Hepatitis C Positive Organ Donors — Coming Soon to a Transplant Center Near You
There’s one immutable fact in solid organ transplantation — the number of patients awaiting transplant exceeds the number of available organs.
Continue reading...

Reuters Health
Organs from overdose-death donors a viable option for transplant
Last Updated: 2018-04-16
By Marilynn Larkin
NEW YORK (Reuters Health) - Transplantation with overdose-death donor (ODD) organs has increased dramatically in the U.S., with equivalent outcomes to non-ODD organs, and therefore these organs should not be routinely discarded, researchers in Maryland say.

"Most Americans know that the U.S. faces an epidemic of deaths due to drug overdose, and many are also aware that there is a critical shortage of organs available for transplant," Dr. Christine Durand of Johns Hopkins University School of Medicine in Baltimore told Reuters Health.

"Perhaps less widely known is that today, more than one in every 10 deceased organ donors died from a drug overdose," she said by email.

"Patients who received transplants from these donors had excellent outcomes; patient survival and organ function were similar to cases when donors died due to trauma, and similar or better than cases when the donor died due to medical causes of death like heart attack or stroke," she added.

Dr. Durand and colleagues examined data from January 2000 to September 2017 on 138,565 deceased donors and 337,934 transplant recipients at 297 transplant centers in the U.S.

Ann Intern Med 2018
Editorial |17 April 2018
Nearly 115 000 candidates currently await organ transplantation in the United States (mostly kidneys [81%] and livers [12%]) (1). Because of the profound organ shortage, many candidates awaiting transplant experience significant morbidity and mortality each year. In this issue, Durand and colleagues (2) review the use of overdose-death donor (ODD) organ transplants involving 138 565 deceased donors and 337 934 solid organ transplant recipients from 2000 to 2017. The study used the Scientific Registry of Transplant Recipients, which includes U.S. national data collected by the Organ Procurement and Transplantation Network (OPTN). The authors found that ODD transplants increased 24-fold, from 149 in 2000 (1.1% of donors) to 3533 in 2016 (12.7% of donors). For the most part, outcomes with ODD organs were noninferior to those with organs from trauma-death donors (TDDs) and medical-death donors (MDDs). Compared with MDDs, ODDs were less likely to have hypertension, diabetes, or prior myocardial infarction but had slightly higher creatinine levels and were more likely to donate after circulatory death. Cold ischemic time of transplanted kidneys was similar across all donor types. In an adjusted analysis, recipients of ODD kidneys and livers had a lower risk for death than recipients of MDD organs and a similar risk for death and graft loss compared with recipients of TDD organs.

Does interferon-free therapy for hepatitis C after curative treatment for hepatocellular carcinoma lead to unexpected recurrences of HCC?

PLOS ONE | https://doi.org/10.1371/journal.pone.0194704
April 16, 2018

Does interferon-free direct-acting antiviral therapy for hepatitis C after curative treatment for hepatocellular carcinoma lead to unexpected recurrences of HCC? A multicenter study by the Japanese Red Cross Hospital Liver Study Group
Toshie Mashiba, Kouji Joko , Masayuki Kurosaki, Hironori Ochi, Yukio Osaki, Yuji Kojima, Ryo Nakata, Tohru Goto, Akahane Takehiro, Hiroyuki Kimura, Akeri Mitsuda, Chiharu Kawanami, Yasushi Uchida, Chikara Ogawa, Atsunori Kusakabe, Ryuichi Narita, Yasushi Ide, Takehiko Abe, Keiji Tsuji, Tadashi Kitamura, Kazuhiko Okada, Tetsuro Sohda, Masaya Shigeno, Takashi Satou, Namiki Izumi

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Since the era in which interferon (IFN) was the standard treatment for hepatitis C, attempts have been made to eliminate hepatitis C virus (HCV) following hepatocellular carcinoma (HCC) treatment, but it could be achieved in only a limited number of patients due to side effects. Recently, dramatic progress has been made in anti-HCV therapies. It is now feasible to achieve a sustained virological response (SVR) rate of ≥95% even in older patients or cirrhosis patients with IFN-free direct-acting antiviral (DAA) therapy that has minimal side effects in older patients and in cirrhosis patients [1], and antiviral therapy can now be performed easily in patients who have undergone HCC treatment. It has been reported that the elimination of HCV with IFN after curative treatment for HCV-associated HCC suppresses HCC recurrences [25]. We have also found that it dramatically extends patients’ survival [6]. However, whether a similar effect can be achieved with DAA therapy is unclear. Furthermore, potential increases in unexpected early recurrence of HCC after HCV elimination have been reported with DAA therapy [7,8]. With this background, the HCC recurrence rate was compared between those who underwent IFN therapy and those who underwent IFN-free therapy after HCC treatment in a large-scale cohort.

Abstract
Background and aim
This study aimed to elucidate whether interferon (IFN)-free direct-acting antiviral (DAA) therapy for hepatitis C after curative treatment of hepatocellular carcinoma (HCC) promotes HCC recurrence in a real-world large-scale cohort.

Methods
This multicenter study was conducted by the Japanese Red Cross Hospital Liver Study Group. This retrospective study analyzed 516 patients who underwent antiviral treatment for hepatitis C with either IFN (n = 148) or IFN-free DAA (n = 368) after curative HCC treatment; 78 IFN-treated patients and 347 IFN-free DAA-treated patients achieved sustained virological response (SVR). The recurrence rate of HCC was compared between the antiviral therapies. Logistic analysis and Cox proportional hazards analysis identified factors associated with early recurrence of HCC within 24 weeks of antiviral therapy and recurrence throughout the observation period, respectively.

Results
AFP at the completion of antiviral therapy, clinical stage of HCC, and non-SVR were independent factors associated with early recurrence of HCC. Among patients who had achieved SVR, the clinical stage of HCC and the level of AFP at completion of antiviral therapy were independent factors associated with early recurrence of HCC. For recurrence throughout the observation period in SVR patients, AFP at completion of antiviral therapy, duration between last HCC treatment to antiviral therapy, and the number of treatments were independent factors. There was no significant difference in the rate of early recurrence of HCC or recurrence throughout the observation period between IFN and IFN-free DAA treated patients.

Conclusions
There were no differences in the early recurrence rate of HCC between patients who underwent IFN and those who underwent IFN-free DAA as antiviral therapies.

Monday, April 16, 2018

DAA therapy effective in patients with HCV and advanced cirrhosis - Real World Experience from the HCV-TARGET Cohort

The International Liver Congress 2018


Healio Coverage
DAA therapy effective in patients with HCV and advanced cirrhosis
April 16, 2018
PARIS — Direct-acting antiviral therapy effectively treated hepatitis C virus in patients with high MELD scores, producing a high rate of sustained viroloic response, according to a presentation at the International Liver Congress 2018.

“Real-life SVR rates with DAAs in patients with advanced liver disease ranged from 85% to 100% and were comparable to clinical trial experience. Ribavirin did not influence SVR in this cohort,” Elizabeth C. Verna, MD, of Columbia University, said in her presentation. “Over the year following treatment, stabilization or marginal improvement is seen in those with low MELDs while greater degree of improvement may occur in patients with MELD greater than 16.”

Verna and colleagues used the HCV-TARGET database of patients to cull patients with cirrhosis and MELD higher than 10. Patients initiated DAA therapy between March 2014 and June 2017. Patients with prior liver transplant were excluded. The researchers enrolled 488 patients in the safety cohort and 412 patients in the efficacy cohort; of those, 373 achieved SVR12 and 39 failed treatment. Patients received a variety of approved regimens.



On This Blog

Nonalcoholic fatty liver disease and liver transplantation - Where do we stand?

World J Gastroenterol. Apr 14, 2018; 24(14): 1491-1506
Published online Apr 14, 2018. doi: 10.3748/wjg.v24.i14.1491

Nonalcoholic fatty liver disease and liver transplantation - Where do we stand?
Ivana Mikolasevic, Tajana Filipec-Kanizaj, Maja Mijic, Ivan Jakopcic, Sandra Milic, Irena Hrstic, Nikola Sobocan, Davor Stimac, Patrizia Burra

Nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH) is a challenging and multisystem disease that has a high socioeconomic impact. NAFLD/NASH is a primary cause of macrovesicular steatosis and has several impacts on liver transplantation (LT), which is transmitted to transplant recipients and organ donors. Current data indicate a new trend in the area of chronic liver disease. Due to the increased incidence of metabolic syndrome (MetS) and its components, NASH cirrhosis and hepatocellular carcinoma caused by NASH will soon become a major indication for LT.

Sunday, April 15, 2018

Long term follow up of HCV pts with F2-F3 fibrosis who had achieved SVR with DAA therapy

Shared on Twitter today by @HenryEChang


Liver-related & HCC events were rare after up to 144 weeks of follow-up in patients with F2-F3 fibrosis who had achieved SVR with DAA therapy: Results from the Gilead Sciences SVR Registry


Sustained & continued improvement in hepatic fibrosis beyond the first-year (& in the subsequent 3 years) following HCV treatment

Shared on Twitter today by @HenryEChang

Sustained & continued improvement in hepatic fibrosis beyond the first-year (& in the subsequent 3 years) following HCV treatment


Download here.... https://jumpshare.com/v/H2I1i5H2NNVi5Xp2vXbM

Michael Kirsch, M.D. - Why I Now Treat Hepatitis C Patients

Michael Kirsch, MD, a full time practicing physician who blogs at “MD Whistleblower ,” in the past has written about the controversies surrounding hepatitis C; from weighing in on the value of HCV screening strategies, treatment risks and benefits, to the price of a cure. After reviewing his previous articles over the years its clear he did not recommend treating HCV patients, today he explains why he has changed his mind, he writes;
Patients come to my office already informed about current HCV treatment. Many are referred to me by physicians expecting me to treat them. The drugs are safe and effective and approved by the F.D.A. Although I still feel we are overtreating, my arguments for holding back have been somewhat dismantled by the new pharmaceutical developments. Am I now at the vanguard of the Medical Industrial Complex?
Check out previous articles, followed by his current take on treating HCV.

2012: 
2018:

April 15, 2018
Why I Now Treat Hepatitis C Patients
Michael Kirsch, M.D.
In a prior post, I shared my heretofore reluctance to prescribe medications to my Hepatitis C (HCV) patients. In summary, after consideration of the risks and benefits of the available options, I could not persuade myself – or my patients – to pull the trigger. These patients were made aware of my conservative philosophy of medical practice. I offered every one of them an opportunity to consult with another specialist who had a different view on the value of HCV treatment.

I do believe that there is a medical industrial complex that is flowing across the country like hot steaming lava. While I have evolved in many ways professionally over the years, I have remained steadfast that less medical care generally results in better outcomes.

Saturday, April 14, 2018

JIAS - Special Issue: Towards global viral hepatitis elimination for all patients in all income settings

Journal of the International AIDS Society
Published on behalf of the International AIDS Society

Special Issue: Towards global viral hepatitis elimination for all patients in all income settings
Guest Editors: Marina B Klein, Karine Lacombe

The complete supplement file is available at

First Published: 10 April 2018
Full text
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Commentary
Open Access
How far are we from viral hepatitis elimination service coverage targets?

Yvan J‐F Hutin Marc Bulterys Gottfried O Hirnschall e25050
First Published: 10 April 2018
Abstract
Full text
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Research Articles
Open Access
Hep‐CORE: a cross‐sectional study of the viral hepatitis policy environment reported by patient groups in 25 European countries in 2016 and 2017

Jeffrey V Lazarus Samya R Stumo Magdalena Harris Greet Hendrickx Kristina L Hetherington
Mojca Maticic Marie Jauffret‐Roustide Joan Tallada Kaarlo Simojoki Tatjana Reic Kelly Safreed‐Harmon the Hep‐CORE Study Group e25052
First Published: 10 April 2018
Abstract
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Reviews
Open Access
Approaches for simplified HCV diagnostic algorithms

Slim Fourati Jordan J Feld Stéphane Chevaliez Niklas Luhmann e25058
First Published: 10 April 2018
Abstract
Full text
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Research
Open Access
Linkage and retention in HCV care for HIV‐infected populations: early data from the DAA era

Rachel Sacks‐Davis Joseph S Doyle Andri Rauch Charles Beguelin Alisa E Pedrana Gail V Matthews Maria Prins Marc van der Valk Marina B Klein Sahar Saeed Karine Lacombe
Nikoloz Chkhartishvili Frederick L Altice Margaret E Hellard e25051
First Published: 10 April 2018
Abstract
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Commentary
Open Access
Treatment advocate tactics to expand access to antiviral therapy for HIV and viral hepatitis C in low‐ to high‐income settings: making sure no one is left behind

Céline Grillon Priti R Krishtel Othoman Mellouk Anton Basenko James Freeman Luís Mendão
Isabelle Andrieux‐Meyer Sébastien Morin e25060
First Published: 10 April 2018
Abstract
Full text
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Research
Open Access
Is hepatitis C virus elimination possible among people living with HIV and what will it take to achieve it?

Natasha K Martin Anne Boerekamps Andrew M Hill Bart J A Rijnders e25062
First Published: 10 April 2018
Abstract
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Commentary
Open Access
Research gaps in viral hepatitis

Anders Boyd Léa Duchesne Karine Lacombe e25054
First Published: 10 April 2018
Abstract
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Watch 3rd Liver Congress Press Conference:NAFLD, Global Access To Hepatitis Treatment, & Upcoming WHO Guidelines

Third official press conference of The ILC 2018 in Paris, France, chaired by EASL Governing Board member, Prof Markus Cornberg on Friday, 13 April 2018. This press conference highlighted studies on late breaking abstracts, food insecurity and NAFLD, and a special guest presentation by Dr Gottfried Hirnschall, Global Hepatitis Programme, World Health Organization (WHO).

Watch - Second Liver Congress™ 2018 Press Conference: Highlighted studies on Hep C, cirrhosis, and PSC

Second official press conference of The ILC 2018 in Paris, France, chaired by EASL Governing Board member, Prof Annalisa Berzigotti on Thursday, 12 April 2018.

This press conference highlighted studies on Hep C, cirrhosis, and PSC.



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Behind the Headlines - People who drink above UK alcohol guidelines 'lose one to two years of life'

What is Behind the Headlines?
Each day the NHS Choices team selects health stories that are making headlines. These, along with the scientific articles behind the stories, are sent to Bazian, a leading provider of evidence-based healthcare information. Bazian's clinicians and scientists analyse the research and produce impartial evidence-based assessments, which are edited and published by NHS Choices.

People who drink above UK alcohol guidelines 'lose one to two years of life'
Friday April 13 2018
"Just one alcoholic drink a day could shorten your life," reports BBC News.

A huge study of almost 600,000 drinkers showed that people who drank more than 12.5 units (100g) of alcohol a week were likely to die sooner than those who drank no more than this amount. The results applied equally to women and men.

The current UK guidelines advise limiting alcohol intake to 14 units a week for women and men. This is equivalent to drinking no more than 6 pints of average-strength beer (4% ABV) or 7 medium-sized glasses of wine (175ml, 12% ABV) a week.

These limits are lower than the levels for many other countries, but this latest study suggests they are about right.

The researchers calculated life would be shortened by an average of 1.3 years for women and 1.6 years for men for people aged 40 who drank above the UK weekly limit in comparison with those drinking below the limit.

The study also looked at the likelihood of having a range of non-fatal, but potentially life-changing, cardiovascular conditions, including heart attacks, heart failure and stroke.

Drinking more alcohol was linked to higher chances of all cardiovascular conditions except heart attacks, where it was linked to a lower chance. However, greater risks from other causes of death outweighed any advantage that might bring.

This high-quality study provides further evidence to support the current UK guidelines advising people to drink no more than 14 units a week. Find out more about calculating units of alcohol.

Where did the story come from?
The study was carried out by a collaboration of 120 researchers worldwide, from regions including Australia, Europe, Japan, the UK and the US. It was funded by the UK Medical Research Council, British Heart Foundation, National Institute for Health Research in the UK, European Union and European Research Council.

It was published in the peer-reviewed medical journal The Lancet on an open-access basis so is free to read online.

The study was covered widely in the UK media, with many outlets reporting variations on the life expectancy that could be lost for every drink or number of drinks consumed.

The Daily Telegraph wrote: "Six glasses of wine a week is too much despite government guidelines suggesting it is a safe limit." While the study did suggest 12.5 units is the threshold above which risks start to rise, the difference in risk between people drinking 12.5 and 14 units was small. There's also no agreed classification for the size of a glass of wine.

As statistics expert Professor David Spiegelhalter explained, the study "estimates that, compared to those who only drink a little, people who drink at the current UK guidelines suffer no overall harm in terms of death rates".

What kind of research was this? 
This was a meta-analysis of individual-level data from 83 prospective cohort studies carried out in 19 countries. This type of research – especially when carried out at this scale and with the care the authors took to ensure their methods were robust – is a good way to summarise the best research we have on a particular subject.

However, the studies analysed were all observational studies, as it wouldn't be ethical to carry out studies where some people were encouraged to drink an unhealthy amount of alcohol. This means we have to be cautious when saying alcohol was the direct cause of the additional deaths, because other confounding factors may have affected the results.

What did the research involve? 
Researchers gathered data from 83 studies, starting between 1964 and 2010, that had information about drinkers who didn't have cardiovascular disease at the start of the study, their level of alcohol consumption and additional health data, and that followed up the participants.

After making adjustments for potential factors that might affect the results – such as age, sex, smoking and physical exercise – they carried out statistical analyses to calculate how different levels of alcohol consumption affected people's risk of:
developing cardiovascular disease
death from any cause

The researchers used a big dataset of life expectancy models to calculate how the relative risks of drinking different amounts of alcohol would affect the life expectancy of people aged 40.

What were the basic results?
Of the 599,912 people in the study, 40,310 died and 39,018 got cardiovascular disease during an average 7.5 years of follow-up. About half of the people in the study reported drinking more than 12.5 units of alcohol a week.

Looking at different levels of alcohol consumption, the researchers found:
people drinking up to 12.5 units of alcohol a week had the lowest risk of death from any cause

above that level, the risk of death rose to a more than 30% increased risk for those drinking more than 37 units a week

each additional 12.5 units of alcohol consumed each week increased the risk of stroke by 14% (hazard ratio [HR] 1.14, 95% confidence interval [CI] 1.10 to 1.17)

each additional 12.5 units of alcohol consumed each week decreased the risk of heart attack by 6% (HR 0.94, 95% CI 0.91 to 0.97)

the risk of all other cardiovascular conditions increased with each additional 12.5 units of alcohol consumed

When they applied their figures to life expectancy at age 40, the researchers calculated that compared with people drinking up to 12.5 units a week:
those who drank 12.5 to 25 units a week were likely to live 6 months less
those who drank 25 to 44 units were likely to live 1 to 2 years less
those who drank more than 44 units were likely to live 4 to 5 years less

Looking at UK limits (14 units a week), the researchers said that compared with those who drank within current limits:
men who drank above the limits would lose an average of 1.6 years (95% CI 1.3 to 1.8)
women who drank above the limit would lose an average of 1.3 years (95% CI 1.1 to 1.5)

How did the researchers interpret the results? 
The researchers said their main finding was that the lowest risk for avoiding harm from alcohol was found in people drinking no more than 100g, or 12.5 units, of alcohol a week.

They said their detailed analysis of cardiovascular conditions helped to explain the complex links between drinking alcohol and cardiovascular disease, which increased risk of conditions mainly caused by high blood pressure but slightly decreased risks of heart attacks – possibly because of links between alcohol and cholesterol.

They concluded: "These data support adoption of lower limits of alcohol consumption than are recommended in most current guidelines."

Conclusion
This was an impressive study that analysed a lot of high-quality data. It offers strong evidence to support recommendations that people drink within relatively low alcohol limits, like those recently introduced in the UK.

The work regarding cardiovascular disease and heart attacks is useful and challenges the widespread belief that alcohol reduces the risk of cardiovascular conditions. While that may be true for heart attacks, it's isn't for stroke or other conditions.

The study did have a couple of limitations that are worth noting.

In many of the individual studies included in the meta-analysis, the participants were asked only once about how much alcohol they drank – and people are notoriously bad at accurately reporting their drinking. However, if people in the studies routinely underestimated their alcohol consumption, that would mean the meta-analysis results tend towards underestimating the harm alcohol causes.

And while the researchers did their best to account for a range of factors that could have affected the results, it's always hard to control for those completely.

Overall, the study adds weight to the recommendations that both women and men drink within the UK limits of 14 units of alcohol a week.

Analysis by Bazian
Edited by NHS Choices

Links to the headlines 

International Liver Congress 2018 - Alcohol, cannabis use have no impact on HCV cure rates

PARIS — Although sustained virologic response maintained a high level no matter the alcohol or cannabis consumption in a German registry, those who reported drinking alcohol in excess were more likely to be lost to follow-up, according to a presentation at the International Liver Congress 2018.

“Alcohol or cannabis consumption did not diminish cure rates,” Stefan Christensen, MD, from Center for Interdisciplinary Medicine, Munster, Germany, said during his presentation. “However, loss to follow-up is more likely in patients with current or former drug use compared to patients without any drug history and in patients with a high alcohol consumption.”


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Hepatitis C Symptoms Can Persist After Cure Cryoglobulins observed 2 years after sustained virologic response

Meeting Coverage > EASL
Hepatitis C Symptoms Can Persist After Cure Cryoglobulins observed 2 years after sustained virologic response
by Ed Susman, Contributing Writer, MedPage Today April 13, 2018

PARIS – Long after hepatitis C virus has been eradicated by direct acting antiviral therapy, manifestations of the disease persist and can relapse with potentially deadly consequences, researchers suggested here.

Despite having achieved a sustained virologic response to therapy, 10% of symptomatic cryoglobulinemic vasculitis still had relapses of symptoms of their disease, said Martin Bonacci, MD, a hepatologist at the Liver and Digestive Diseases Networking Biomedical Research Centre in Barcelona.

"Clinical and particularly immunological response improves significantly over time after hepatitis C virus cure in symptomatic and asymptomatic patients," Bonacci said in his presentation at the International Liver Congress, sponsored by the European Association for the Study of the Liver. "However, 2 years after hepatitis C virus elimination cryoglobulinemia may persist and clinical relapse may occur in a small proportion of patients, suggesting that a longer monitoring of these patients is still warranted."
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Sustained virological response to oral hepatitis C virus treatment associated with reduced mortality

Sustained virological response to oral hepatitis C virus treatment associated with reduced mortality in an Italian cohort

European Association for the Study of the Liver

13 April 2018, Paris, France: Patients with chronic hepatitis C virus (HCV) infection who achieve a sustained virological response (SVR) after direct-acting antiviral agent (DAA) treatment have lower all-cause mortality, according to a real-world study presented today at The International Liver Congress™ 2018 in Paris, France. The study, conducted in Italy, found that patients who achieved SVR were at reduced risk of death from both liver-related and other causes.

Chronic HCV infection affects an estimated 71 million people globally.19 Left untreated, a significant number of those people will develop cirrhosis or liver cancer, which leads to the death of an estimated 700,000 people with HCV infection each year.20 SVR, defined as undetectable HCV RNA 12 or 24 weeks after the end of therapy, equates to cure in >99% of patients.21 Although DAAs have proven highly effective at curing HCV, longer-term morbidity and mortality following DAA-induced SVR has not been well characterized.22

'The long-term health benefits of an HCV cure, in terms of survival, need to be evaluated in long-term, real-world settings', explained Dr Vincenza Calvaruso from the University of Palermo in Italy, and lead author of the study. 'We were able to prospectively follow almost 5,000 patients from when they started DAA treatment and look at the impact of achieving SVR on their survival prospects, particularly in patients with Child-Pugh A compensated cirrhosis'.

The study evaluated data from the prospective RESIST-HCV (Rete Sicilia Selezione Terapia - HCV) cohort which collates data for all HCV cases at Sicilian liver centres.23 Patients who started DAA treatment in 22 centres between March 2015 and December 2016 (4,926 patients, mean age 65.9 ± 11.6 years, 57.6% male) were observed for a median of 65 weeks (range 1-199). The patients were at different stages of disease; 1,158 (23.5%) were non-cirrhotic, 3,326 (67.5%) had compensated cirrhosis, and 442 (9%) had decompensated cirrhosis. Following DAA treatment, more than 90% of patients achieved SVR.

Fifty-three patients (1.1%) died after the antiviral therapy, 23 from liver-related causes and 30 from unrelated causes such as cardiovascular disease and sepsis. Patients who failed to achieve SVR were almost 30 times more likely to die from any cause than those who did achieve SVR (HR 28.9; 95% CI 16.5, 50.8; p<0.001). Both liver-related and non-liver related mortality were predicted by lack of SVR (HR 14.9, 95% CI 6.3, 35.1; p<0.001 and HR 41.77, 95% CI 17.3, 100.9; p<0.001, respectively) and by presence of decompensated cirrhosis (Child-Pugh B; HR 29.4, 95% CI 3.8, 223.9; p<0.001 and HR 3.0, 95% CI 1.4, 6.2; p=0.006, respectively). Body mass index and the presence of diabetes were also found to be predictors of non-liver-related mortality.

'We found that in this real-world setting with patients using a variety of DAA regimens, achieving SVR reduced mortality from both liver-related and unrelated causes at all stages of disease', said Dr Calvaruso. 'An interesting finding that deserves further investigation was a reduced risk of cardiovascular mortality for patients achieving SVR'.

'DAA therapy results in the achievement of SVR, which is a cure of HCV infection in more than 90% of patients', said Prof. Markus Cornberg from the Hannover Medical School, Germany, and EASL Governing Board Member. 'However, a recent Cochrane analysis has challenged whether or not DAA therapy will have an impact on mortality rates. These data are therefore important in documenting that achievement of SVR is beneficial and associated with reduced mortality'.

Session title: Parallel Session: Parallel session: Clinical impact of HCV cure
Time, date and location of session: 14. April 2018, 08:00 AM - 08:15 AM, Main Plenary
Presenter: Dr Vincenza Calvaruso, Italy
Abstract: Disease outcomes after DAA-induced SVR: data from the RESIST-HCV cohort (4253)

References
19. World Health Organization. Global health sector strategy on viral hepatitis 2016-2021. June 2016. Available from: http://www.who.int/hepatitis/strategy2016-2021/ghss-hep/en/. Last accessed: February 2018.

20. GBD 2013 Mortality and Causes of Death Collaborators. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;385(9963):117-71.

21. European Association for the Study of the Liver. EASL recommendations on treatment of hepatitis C 2016. J Hepatol. 2016;2017;66:153-94.

22. Jakobsen JC, et al. Direct-acting antivirals for chronic hepatitis C. Cochrane Database Syst Rev. 2017;18:9.

23. Cartabellotta F, et al. The HCV Sicily Network: a web-based model for the management of HCV chronic liver diseases. Eur Rev Med Pharmacol Sci. 2016;20(1 Suppl):11-16.

International Liver Congress 2018: 8-weeks of Zepatier (elbasvir/grazoprevir) may effectively treat HCV genotype 4

8-weeks of Zepatier may effectively treat HCV genotype 4
April 14, 2018
PARIS — In patients with hepatitis C virus genotype 4, 8 weeks of Zepatier showed effective treatment of the virus, according to a presentation at the International Liver Congress 2018.

“This is an ongoing study investigating a novel 8-week treatment regimen of elbasvir/grazoprevir in participants with genotype 4 infection,” Tarik Asselah, MD, University Paris Diderot, said in his presentation. “We have high rates of SVR among treatment-naive participants with mild to moderate fibrosis who have completed follow up.”


Of Interest
Impact of HCV Viral Load on Elbasvir/Grazoprevir Effectiveness in Chronic Hepatitis C: Updated Retrospective Data Analyses from the TRIO Network - (04/13/18)

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For Patients: The International Liver Congress 2018