Showing posts with label cirrhosis. Show all posts
Showing posts with label cirrhosis. Show all posts

Friday, November 30, 2018

Combination interventions for Hepatitis C and Cirrhosis reduction among people who inject drugs: An agent-based, networked population simulation experiment

Combination interventions for Hepatitis C and Cirrhosis reduction among people who inject drugs: An agent-based, networked population simulation experiment
Bilal Khan, Ian Duncan, Mohamad Saad, Daniel Schaefer, Ashly Jordan, Daniel Smith, Alan eaigus,
Don Des Jarlais, Holly Hagan, Kirk Dombrowski 

Published: November 29, 2018



Fig 1. Finite state diagram of the HCV model used in the experiments.
Once infected, agents face a series of stochastic and enforced progressions through a series of ever worsening liver function. Throughout the simulation, infected agents who have reached a chronic state (non-acute HCV infected agents) face a small but regular chance of moving directly to cirrhosis, decompensated cirrhosis, or hepatocellular carcinoma. In addition, their Metavir fibrosis level is incremented yearly, moving them gradually from early stage fibrosis to cirrhosis. Once in any of the three severe liver stages, agents face an increasing probability of death due to HCV infection, incremented on a five year basis.
https://doi.org/10.1371/journal.pone.0206356.g001

Full-text article:

Abstract
Hepatitis C virus (HCV) infection is endemic in people who inject drugs (PWID), with prevalence estimates above 60% for PWID in the United States. Previous modeling studies suggest that direct acting antiviral (DAA) treatment can lower overall prevalence in this population, but treatment is often delayed until the onset of advanced liver disease (fibrosis stage 3 or later) due to cost. Lower cost interventions featuring syringe access (SA) and medically assisted treatment (MAT) have shown mixed results in lowering HCV rates below current levels. However. little is known about the potential cumulative effects of combining DAA and MAT treatment. While simulation experiments can reveal likely long-term effects, most prior simulations have been performed on closed populations of model agents—a scenario quite different from the open, mobile populations known to most health agencies. This paper uses data from the Centers for Disease Control’s National HIV Behavioral Surveillance project, IDU round 3, collected in New York City in 2012 to parameterize simulations of open populations. To test the effect of combining DAA treatment with SA/MAT participation, multiple, scaled implementations of the two intervention strategies were simulated. Our results show that, in an open population, SA/MAT by itself has only small effects on HCV prevalence, while DAA treatment by itself can lower both HCV and HCV-related advanced liver disease prevalence. More importantly, the simulation experiments suggest that combinations of the two strategies can, when implemented together and at sufficient levels, dramatically reduce HCV incidence. We conclude that adopting SA/MAT implementations alongside DAA interventions can play a critical role in reducing the long-term consequences of ongoing HCV infection.

Perinatal Exposure to HCV Leads to Earlier Cirrhosis

Recommended Reading
Liver Meeting 2018 
Sofosbuvir/ledipasvir cures most young children with hepatitis C
Liz Highleyman / 13 November 2018
Almost all young children ages 3 to 6 years with chronic hepatitis C achieved sustained virological response after 12 weeks of treatment using sofosbuvir/ledipasvir oral granules, according to findings presented at the ..

On Twitter

Full-text article downloaded & shared via twitter by Henry E. Chang:

Perinatal Exposure to HCV Leads to Earlier Cirrhosis
Samantha DiGrande
A recent retrospective review of patients who contracted hepatitis C (HCV) in childhood found that those with perinatal infection developed cirrhosis earlier than other risk groups.

A recent retrospective review of patients who contracted hepatitis C (HCV) in childhood found that those with perinatal infection developed cirrhosis earlier than those in other risk groups.
Read more:
https://www.ajmc.com/newsroom/perinatal-exposure-to-hcv-leads-to-earlier-cirrhosis

Abstract
Modin L, Arshad A, Wilkes B, et al. Epidemiology and natural history of hepatitis C virus infection among children and young people [published online November 26, 2018]. J Hepatol. doi: 10.1016/j.jhep.2018.11.013.

Highlights
• HCV infection in UK children - IV drug use 53%; blood products 24%; perinatal 11%
• Cirrhosis in 32% of patients at median of 33 years irrespective of infection route.
• Treatment impact on disease progression better if started before cirrhosis.
• Anti-HCV therapy should be available in childhood to prevent long-term liver disease.
Read more:
https://www.journal-of-hepatology.eu/article/S0168-8278(18)32545-5/fulltext

Thursday, November 29, 2018

Ribavirin Beneficial For Patients with Hepatitis C Genotype 3

Ribavirin Beneficial For Patients with Hepatitis C Genotype 3
NOVEMBER 29, 2018
Kenneth Bender, PharmD, MA

The addition of ribavirin to a regimen of sofosbuvir and velpatasvir (Epclusa) to treat hepatitis C virus (HCV) genotype 3 appeared to increase efficacy for patients with compensated cirrhosis, particularly in those with resistance-associated substitution (RAS), in a trial that sought to confirm the therapeutic strategy for this considered difficult-to-cure population.

Rafael Esteban, MD, of the Vall d'Hebron Hospital University, Spain, and colleagues conducted the comparison in patients with compensated cirrhosis to elaborate on earlier indications of ribavirin benefit from phase 2 studies, and from the ASTRA-4 study in patients with HCV genotype 3 and decompensated cirrhosis.
Read more:
https://www.mdmag.com/medical-news/ribavirin-beneficial-for-patients-with-hepatitis-c-genotype-3

Recommended Reading
The Liver Meeting
San Francisco
November 2018

On This Blog
Review research articles with a focus on treating HCV according to genotype using FDA approved  medicines. Information is extracted from news articles, peer-reviewed journals, as well as liver meetings/conferences, research manuscripts and interactive learning activities.

Thursday, November 22, 2018

Blogging About Liver Disease: Reasons To Be Grateful


Happy Thanksgiving! This year, and every year, I am grateful for a small group of talented bloggers who continue to keep us informed about all types of viral hepatitis.

In the spirit of the holiday, each blog has featured many reasons to be thankful this year; from curing HCV to improving the treatment of HIV.

Latest Articles 
Some of the following blogs are published by support organizations, healthcare professionals or physicians, while others are written from a patients perspective, offering us healthy tips about each stage of liver disease.

New @ HIV and ID Observations
Paul E. Sax, MD
As noted here before, I’m a big fan of Thanksgiving, a great excuse to get together with family and friends, and to eat a gargantuan amount of food.*

Hepatitis B Foundation
Holidays with Hepatitis B: How to Tell Your Family
hepbtalk
As the holidays approach, families are planning parties and dinners and preparing to spend time with their loved ones. In such a merry atmosphere, the idea of discussing hepatitis B – whether its a recent diagnosis or the first time that you are ready to disclose your status – may be intimidating. However, it doesn’t have to be! In honor of National Family Health History Day – which falls on Thanksgiving – we put together some tips to help you start the conversation.

Joseph Galati, M.D.
Tips for a Healthier Holiday
Ahh, the holidays. A time to celebrate all the good that has come our way during the previous year. First up: Thanksgiving. What better way to begin the year-end wrap-up than to sit down at a hearty meal with family and friends? But the holidays are arguably the toughest time of the year to eat..

Hep Blogs
Finding Gratitude in Sickness, Health and Hepatitis 
By Lucinda K. Porter, RN
Some good news in the hepatitis C realm, plus a look at the practice of gratitude.

Mavyret versus Epclusa
By Greg Jefferys
Both Mavyret and Epclusa give cure rates above 97% for all genotypes of Hepatitis C except for G3 where both give a cure rate of around 95%.

The End Times
By Grace Campbell
Who gave cirrhosis such a catchy generic title? End stage liver disease. There’s a name sure to invoke confidence.

Liver Meeting 2018 Wrap-Up: Vaccines, Diet, and an Increasing Liver Menace 
By Lucinda K. Porter, RN
Ending the week with summaries of research from the 2018 Liver Meeting. I cover hepatitis B vaccination, diet and alcoholic liver disease.

HepatitisC.net
Options for Treatment with Liver Cancer
By Karen Hoyt
After my diagnosis of liver cancer, I had to find out what options for treatment were available.

ADRLF (Al D. Rodriguez Liver Foundation)
Who says a fantastically delicious Thanksgiving spread can’t be healthy? This year, make your Thanksgiving feast even more special with these liver-healthy options that won’t give you or your family that post-holiday guilt; nor will they keep you stuck in the kitchen for hours on end! Check out these appetizing recipes for a healthy, scrumptious, easy-to-prep (or time-saving) Thanksgiving meal!

Finding Hope in Affordable Hepatitis Screening
Screening remains to be the best defense against detecting the hepatitis virus in its earliest stages, and potentially developing life-threatening complications, later down the line. Dubbed as the “silent killer,” hepatitis doesn’t exhibit obvious symptoms in many people, who may live, comfortably, with the virus for years and only discover their condition at its advanced, acute stage. Noting the importance of the timeliness of testing, Texas-based Link2Labs is making affordable hepatitis C tests available to uninsured and underinsured people.

HCV News
Weekly Review
Catch up on what you missed this week, read HepCBC's - Weekly Bull.

FYI - Lettuce Recall 
“I believe it’s all related to a big increase in obesity and type 2 diabetes in this country,” lead study author Zobair M. Younossi, MD, MPH, said in an interview in advance of the annual meeting of the American Association for the Study of Liver Diseases. “Those two risk factors drive NAFLD and its progressive type, nonalcoholic steatohepatitis (NASH). That accounts for at least part of the increase in mortality related to liver disease.”

AGA Journals - Blog
Dr. Kristine Novak
Persistent drinking of very hot coffee can cause exfoliative esophagitis due to thermal injury, researchers report in the November issue of Clinical Gastroenterology and Hepatology. Florian Schertl et al describe the case of a 55-year-old woman with new retrosternal pain upon swallowing. She had been receiving continuous and successful proton pump inhibitor.

Fatty Liver Disease
Canadian Liver Foundation
It Happened To Me | My Fatty Liver Journey
Melanie was all too familiar with fatty liver disease, with her husband being diagnosed 5 years earlier. But, she never thought it would happen to her.

The Flu & You
Canadian Liver Foundation
What’s intended to help shouldn’t hurt
Before you head to the cabinet for medication, there are a few things you should know to ensure that what you take will help, not hurt.

One Medical blog
So you’ve come down with a nasty bug that’s been making the rounds.

This Blog
Flu Activity Updated Nov 10/News Articles Nov 16
Weekend Reading - Baby Boomers and the Flu

Recommended Blogs
Dr Paul Gow talks all things the liver and answers call-in questions on ABC Nightlife 


Source - Hepatitis Victoria

On Twitter
Shared by @HenryEChang 

Just Because
Matthew Kaskavitch
CU Anschutz Medical Campus experts share Thanksgiving health insights
Thanksgiving is almost here, and that means two things: 1) time spent with family and friends around the television watching football, and 2) eating turkey. Lots and lots of turkey. At this time of year, we often overindulge and loosen our belt and wonder how we fit all that stuffing and gravy into our stomach. Don’t worry. We asked leading health experts from the University of Colorado Anschutz Medical Campus a few of the Thanksgiving questions you’ve always wanted to know the answer to.

Happy Thanksgiving!

Tuesday, November 13, 2018

AbbVie's MAVYRET™ (glecaprevir/pibrentasvir) Shows High Virologic Cure* Rates in Treatment-Naïve Hepatitis C Patients with Compensated Cirrhosis

The Liver Meeting® 2018
Meeting Updates 
View all updates on this blog, (LINK), coverage elsewhere, (LINK).
Related Links:
High SVR12 rate for 16 week glecaprevir/pibrentasvir regimen in HCV GT1

Today's Press Release
AbbVie's MAVYRET™ (glecaprevir/pibrentasvir) Shows High Virologic Cure* Rates in Treatment-Naïve Hepatitis C Patients with Compensated Cirrhosis

- EXPEDITION-8 is the first Phase 3b study evaluating 8 weeks of MAVYRET™ in treatment-naïve chronic hepatitis C virus (HCV)-infected patients with compensated cirrhosis across all major genotypes (GT1-6)[1] 

- In cohort one, 100 percent of genotype 1, 2, 4, 5 and 6 treatment-naïve chronic HCV patients with compensated cirrhosis achieved SVR[12] with 8 weeks of MAVYRET per protocol analysis[1]
- Cohort two of the study is ongoing, evaluating treatment-naïve genotype 3 (GT3) patients with compensated cirrhosis 

- MAVYRET is currently approved as an 8-week, pan-genotypic treatment for treatment-naïve patients without cirrhosis

NORTH CHICAGO, Ill., Nov. 13, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new data for its pan-genotypic chronic hepatitis C virus (HCV) treatment, MAVYRET™ (glecaprevir/pibrentasvir), in treatment-naïve patients with compensated cirrhosis. Results from the Phase 3b EXPEDITION-8 study showed that with 8 weeks of MAVYRET, 100 percent (n=273/273) of genotype 1, 2, 4, 5 and 6 patients achieved a sustained virologic response 12 weeks after treatment (SVR12) per protocol analysis.1

These data are being presented today as a late-breaking, oral presentation at The Liver Meeting® 2018 organized by the American Association for the Study of Liver Diseases (AASLD) in San Francisco, California.

"Current guidelines recommend a 12-week pan-genotypic regimen for people who have hepatitis C, are treatment-naïve and have compensated cirrhosis," said Robert S. Brown, Jr., M.D., the Gladys and Roland Harriman professor of medicine, Weill Cornell Medical College. "We are interested in investigating shorter treatment options, which may simplify care for patients with compensated cirrhosis while providing high cure rates."

This analysis is part of the ongoing Phase 3b EXPEDITION-8 study evaluating the safety and efficacy of MAVYRET in treatment-naïve chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6).1 The study includes two cohorts; cohort one with genotype 1, 2, 4, 5, 6 chronic HCV-infected patients, and cohort two with genotype 3 (GT3) chronic HCV-infected patients.1

"MAVYRET is already having a significant impact on people living with HCV. However, there are still groups of patients who may benefit from a shorter treatment option," said Janet Hammond, M.D., Ph.D., vice president, infectious diseases development, AbbVie. "We continue to investigate and understand the value of an 8-week treatment regimen for patients, something we recognize as an important step towards HCV elimination."

To date, no virologic failures have been reported in cohort one of the study and no patients have discontinued treatment due to adverse events.1 Adverse events (>5%) reported of the study populations include pruritus (9.6%), fatigue (8.6%), headache (8.2%) and nausea (6.4%).1 Six serious adverse events (2%) have occurred during the study, none of which were deemed to be related to glecaprevir/pibrentasvir.1 No new safety signals were identified in this study.

Data from the ongoing EXPEDITION-8 Phase 3b study will be presented as a late-breaking, oral presentation during the Late-breaking Abstract Oral Session II on November 13 at 8:30 a.m. PST.

MAVYRET is approved in the U.S. as a 12-week pan-genotypic treatment for treatment-naïve patients with compensated cirrhosis.2

*Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.

About the EXPEDITION-8 Study1
EXPEDITION-8 is an ongoing non-randomized, single arm, open-label, multicenter Phase 3b study evaluating the safety and efficacy of glecaprevir/pibrentasvir in treatment-naïve GT1-6 chronic HCV patients with compensated cirrhosis. The study investigated two cohorts of patients:
Cohort one: treatment-naïve genotype 1, 2, 4, 5, 6 patients with compensated cirrhosis (n=280)
Cohort two: treatment-naïve GT3 patients with compensated cirrhosis (n=60)

The primary endpoint is the percentage of patients achieving SVR12 in a per-protocol analysis and the secondary endpoints are on-treatment virologic failure and relapse rates. For cohort one, 280 patients were enrolled and seven patients were excluded from the SVR12 per-protocol analysis (n=273); five patients were lost to follow up, and two patients received less than 8 weeks of treatment (one of these two patients achieved SVR12).

Additional information on the clinical trials for MAVYRET is available at www.clinicaltrials.gov/.

About MAVYRET™ (glecaprevir/pibrentasvir)
MAVYRET™ is approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6). MAVYRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets, taken with food.

MAVYRET is an 8-week, pan-genotypic option for patients without cirrhosis and who are new to treatment, who comprise the majority of people living with HCV. MAVYRET is also approved as a treatment for patients with specific treatment challenges, including those (GT1) not cured by prior treatment experience to either a protease inhibitor or NS5A inhibitor (but not both), and in patients with limited treatment options, such as those with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV. MAVYRET is a pan-genotypic treatment approved for use in patients across all stages of CKD.

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

Full prescribing information can be found here.

Monday, November 12, 2018

High SVR12 rate for 16 week glecaprevir/pibrentasvir regimen in HCV GT1

Combo HCV Pill Effective in Certain Refractory Patients
High SVR12 rate for 16 week glecaprevir/pibrentasvir regimen in HCV GT1 patients
by Molly Walker, Staff Writer, MedPage Today November 11, 2018 
November 11, 2018
A 16-week treatment course had a SVR 12 of 95%, including 94% in non-cirrhotic patients and 97% in cirrhotic patients who had failed prior treatment containing NS5A inhibitors, with no virologic failure among those with HCV genotype 1b infection, reported Mark S. Sulkowski, MD, of Johns Hopkins Hospital in Baltimore.

He said that glecaprevir/pibrentasvir was approved by the FDA in 2017 for treatment of NS5A inhibitor-experienced patients with genotype 1 infection and no NS3/4A protease inhibitor therapy.

A 16-week course of treatment was approved based on a small group of 17 patients in a trial where 16 of 17 achieved SVR12, Sulkowski explained at a press conference at the annual Liver Meeting, sponsored by the American Association for the Study of Liver Diseases (AASLD).

But that wasn't enough for the AASLD/Infectious Diseases Society of America (IDSA) guidelines panel, which labeled the therapy an "alternative regimen" and did not put it in the recommended category for treatment for this population, with "concerns based on the small number of human beings treated."
Read More: https://www.medpagetoday.com/meetingcoverage/aasld/76266
Website MedPage Today Twitter @medpagetoday

Coverage > Liver Meeting
Mavyret SVR high in patients with Sovaldi, NS5A inhibitor experience
November 11, 2018
SAN FRANCISCO — Mavyret was highly effective and well-tolerated in patients with chronic hepatitis C genotype 1 who had experience with a combination of Sovaldi, NS5A inhibitor and ribavirin, according to data presented at The Liver Meeting 2018.

“The context of this study was that the FDA granted approval in August 2017 for [Mavyret] for 16 weeks in persons who failed an NS5A-containing regimen that did not also contain a protease inhibitor,” Mark S. Sulkowski, MD, from Johns Hopkins Hospital in Maryland, said during a press conference presentation.
Website Healio - Twitter @HealioHep

Combined Glecaprevir/Pibrentasvir Highly Effective in HCV Patients Who Have Failed Other Therapies 
SAN FRANCISCO – Data from a new study presented this week at The Liver Meeting® – held by the American Association for the Study of Liver Diseases – found the combination of glecaprevir and pibrentasvir is highly effective and well tolerated in patients with chronic hepatitis C virus (commonly called HCV) genotype-1 infections who have prior treatment experience with sofosbuvir/NS5A inhibitor.

Meeting Updates 
View all updates on this blog, (LINK), coverage elsewhere, (LINK).

Abstract
American Association for the Study of Liver Diseases
Website AASLD Twitter @AASLDtweets

AASLD Poster Roundup: Factors that Impact Cirrhosis Diagnosis

Meeting Coverage > AASLD
AASLD Poster Roundup: Factors that Impact Cirrhosis Diagnosis
Selections from poster sessions at the annual Liver Meeting
Nov 11
by Elizabeth Hlavinka, Staff Writer, MedPage Today
SAN FRANCISCO -- Over 40,000 people die of cirrhosis and chronic liver disease per year, and determining which factors increase the risk of this illness is important for implementing prevention and treatment methods.

This issue was explored in poster presentations at the annual Liver Meeting, sponsored by the American Association for the Study of Liver Diseases (AASLD).


Meeting Coverage
Website MedPage Today
Twitter @medpagetoday

Sunday, November 11, 2018

Glucose Metabolism Changes in Patients with Chronic Hepatitis C Treated with Direct Acting Antivirals

In Case You Missed It

Can J Gastroenterol Hepatol. 2018 Oct 3;2018:6095097. doi: 10.1155/2018/6095097. eCollection 2018.

Glucose Metabolism Changes in Patients with Chronic Hepatitis C Treated with Direct Acting Antivirals.
Drazilova S1, Janicko M2, Skladany L3, Kristian P4, Oltman M5, Szantova M6, Krkoska D7, Mazuchova E7, Piesecka L8, Vahalova V8, Rac M9, Schreter I4, Virag L4, Koller T10, Liptakova A11, Ondrasova M12, Jarcuska P2.

This retrospective study confirmed that the prevalence of either type 2 diabetes mellitus ( T2DM ) or impaired fasting glucose (IFG) increases in chronic hepatitis C patients with the degree of fibrosis; patients with F4 fibrosis had 27.1% prevalence of IFG and 31.8% of T2DM. The predictive factors for T2DM had besides F4 fibrosis also higher age and BMI. Significant decrease of fasting glycemia at the end of treatment and 12 weeks after that was observed in the whole cohort and in subgroups of patients with type 2 diabetes mellitus, impaired fasting glucose, Child-Pugh A cirrhotic patients, treatment experienced patients, and treatment experienced cirrhotics. Long term follow-up may further show if the achievement of SVR after DAA treatment will reduce the risk of future T2DM development similarly to SVR after interferon treatment and if the improvement of glycemic control in patients with T2DM decreases the risk of chronic complications and improves survival.

Open Access

Abstract
Background and Aims
Chronic hepatitis C is a systemic disease and type 2 diabetes mellitus (T2DM) belongs to more common extrahepatic. The aim of this study was to (i) explore the prevalence of impaired fasting glucose (IFG) and T2DM in patients with chronic hepatitis C, (ii) explore the effect of direct acting antivirals (DAA) treatment on the glycemia, and (iii) explore the factors that modulate the effect of DAA treatment on glycemia in patients with chronic hepatitis C.

Methods 
We performed a longitudinal retrospective observational study focused on the patients undergoing DAA treatment of chronic hepatitis C. Data about glycemia, history of diabetes, hepatitis C virus, treatment, and liver status, including elastography, were obtained at baseline (before treatment start), at the end of treatment and 12 weeks after the end of treatment. Patients were treated with various regimens of direct acting antivirals.

Results
We included 370 patients; 45.9% had F4 fibrosis. At baseline, the prevalence of T2DM increased with the degree of fibrosis (F0-F2 14.4%, F3 21.3%, and F4 31.8%, p=0.004). Fasting glycemia also increased with the degree of fibrosis (F0-F2 5.75±0.18 F3 5.84±0.17, and F4 6.69±0.2 mmol/L, p=0.001). We saw significant decrease of glycemia after treatment in all patients, but patients without T2DM or IFG from 6.21±0.12 to 6.08±0.15 mmol/L (p=0.002). The decrease was also visible in treatment experienced patients and patients with Child-Pugh A cirrhosis.

Conclusion
We confirmed that the prevalence of either T2DM or IFG increases in chronic hepatitis C patients with the degree of fibrosis. The predictive factors for T2DM were, besides F4, fibrosis also higher age and BMI. Significant decrease of fasting glycemia after the DAA treatment was observed in the whole cohort and in subgroups of patients with T2DM, IFG, cirrhotic, and treatment experienced patients.


30402450 PMCID:
PMC6192081 DOI: 10.1155/2018/6095097

Monday, October 29, 2018

Mavyret (glecaprevir/pibrentasvir) 8 Wks Improved Cardiovascular and Metabolic Outcomes and Stable Renal Function

Infect Dis Ther. 2018 Oct 27. doi: 10.1007/s40121-018-0218-x. [Epub ahead of print]

Pan-Genotypic Hepatitis C Treatment with Glecaprevir and Pibrentasvir for 8 Weeks Resulted in Improved Cardiovascular and Metabolic Outcomes and Stable Renal Function: A Post-Hoc Analysis of Phase 3 Clinical Trials. 
Tran TT1, Mehta D2,3, Mensa F3, Park C3, Bao Y3, Sanchez Gonzalez Y4.

First Online: 27 October 2018

Treatment with Glecaprevir and Pibrentasvir G/P for as short as 8 weeks showed improved glucose and triglyceride levels by post-treatment week 4 irrespective of treatment history and cirrhosis status. These benefits were especially pronounced in patients with elevated triglycerides, pre-diabetes and diabetes at baseline. Treatment with G/P also resulted in stable eGFR function in both during and post-treatment periods. Future studies are needed to determine whether these effects are maintained over longer periods of time.

Full-Text

Abstract
Introduction
Chronic hepatitis C (CHC) infection is associated with extrahepatic manifestations (EHMs) which can affect renal, cardiovascular and other comorbidities. The effect of CHC treatment with short-duration regimens on these EHMs is not well defined. Hence, we examined longitudinal estimated glomerular filtration rate (eGFR), triglycerides and glucose values to assess the impact of short-duration CHC therapy on renal, cardiovascular and metabolic diseases, respectively.

Methods
We conducted analyses of all patients without cirrhosis treated with glecaprevir and pibrentasvir (G/P) for 8 weeks in two phase 3 clinical trials. In addition, one phase 3 trial was carried out to explore the effects of treatment on renal EHMs in patients with advanced renal impairment at baseline. As a sensitivity analysis, we included all CHC patients treated with G/P for 8 or 12 weeks enrolled across five phase 3 trials. Adjusting for baseline demographics and clinical properties via mixed regression models enabled evaluation of changes in EHMs through end of treatment.

Results
G/P treatment for 8 weeks resulted in statistically significant declines in triglycerides (− 28.6 mg/dl) and glucose (− 11.2 mg/dl), while there was no statistically significant decline in eGFR. Biomarker improvements were greatest among patients with elevated triglycerides and elevated glucose at baseline. Similar effects were observed across all patients treated with G/P for 8 or 12 weeks.

Conclusion
Short-duration treatment with G/P resulted in stable renal function and improvements in cardiovascular and metabolic EHM markers, especially in patients with severe EHMs at baseline.

Continue reading: https://link.springer.com/article/10.1007%2Fs40121-018-0218-x

Additional Reading
HCV Advocate
Hepatitis C is NOT just a liver disease-it affects the entire body. Check out our fact sheet that lists some of the more common and uncommon extrahepatic manifestations of hepatitis C.

Navigate this blog 
Sift through current research articles on the extrahepatic manifestations of hepatitis C.

Sunday, October 28, 2018

Long term outcome of antiviral therapy in HBV patients with cirrhosis

World J Gastroenterol. Oct 28, 2018; 24(40): 4606-4614
Published online Oct 28, 2018. doi: 10.3748/wjg.v24.i40.4606
Long term outcome of antiviral therapy in patients with hepatitis B associated decompensated cirrhosis 
Young-Cheol Ju, Dae-Won Jun, Jun Choi, Waqar Khalid Saeed, Hyo-Young Lee, Hyun-Woo Oh 

Full-text Article 
https://www.wjgnet.com/1007-9327/full/v24/i40/4606.htm

Core tip: It is well known that antiviral treatment improves clinical outcomes of chronic hepatitis B-associated decompensated cirrhosis. However, long term and large scale clinical data regarding survival rate, and incidence of hepatocellular carcinoma in patients with decompensated cirrhosis in the antiviral era are lacking. We investigated the survival rate and incidence of hepatocellular carcinoma (HCC) in patients with decompensated cirrhosis by using the Health Insurance Review and Assessment database. Long term outcome of treating hepatitis B-associated decompensated cirrhosis using antiviral agents improved much compare to previous reports. Cumulative mortality rate and incidence of HCC was sharply decreased after one year antiviral treatment.

AIM
To investigate survival rate and incidence of hepatocellular carcinoma (HCC) in patients with decompensated cirrhosis in the antiviral era. 

METHODS
We used the Korean Health Insurance Review and Assessment. Korea’s health insurance system is a public single-payer system. The study population consisted of 286871 patients who were prescribed hepatitis B antiviral therapy for the first time between 2007 and 2014 in accordance with the insurance guidelines. Overall, 48365 antiviral treatment-naïve patients treated between 2008 and 2009 were included, and each had a follow-up period ≥ 5 years. Data were analyzed for the 1st decompensated chronic hepatitis B (CHB) and treatment-naïve patients (n = 7166). 

RESULTS
The mean patient age was 43.5 years. The annual mortality rates were 2.4%-19.1%, and 5-year cumulative mortality rate was 32.6% in 1st decompensated CHB treatment-naïve subjects. But the annual mortality rates sharply decreased to 3.4% (2.4%-4.9%, 2-5 year) after one year of antiviral treatment. Incidence of HCC at first year was 14.3%, the annual incidence of HCC decreased to 2.5% (1.8%-3.7%, 2-5 year) after one year. 5-year cumulative incidence of HCC was 24.1%. Recurrence rate of decompensated event was 46.9% at first year, but the annual incidence of second decompensation events in decompensated CHB treatment-naïve patients was 3.4% (2.1%-5.4%, 2-5 year) after one year antiviral treatment. 5-year cumulative recurrence rate of decompensated events was 60.6%. Meanwhile, 5-year cumulative mortality rate was 3.1%, and 5-year cumulative incidence of HCC was 11.5% in compensated CHB treatment-naïve patients. 

CONCLUSION
Long term outcome of decompensated cirrhosis treated with antiviral agent improved much, and incidence of hepatocellular carcinoma and mortality sharply decreased after one year treatment.
Continue reading......

Thursday, October 25, 2018

Curing hepatitis C reduces the risk of cardiovascular events

Liz Highleyman
Published: 25 October 2018
Several studies have found that people with hepatitis C are more prone to developing cardiovascular conditions such as coronary artery disease, peripheral vascular disease, myocardial infarction and stroke; however, other studies have not seen this association.

A growing body of evidence shows that HCV treatment can help reverse this increased risk. A recent study from France, for example, found that curing hepatitis C reduces the risk of cardiovascular events in people with compensated cirrhosis. But again, some large studies from the interferon era did not see a similar benefit. 

On This Blog
A collection of current research articles on ailments related to HCV
Article directory on the extrahepatic manifestations of hepatitis C.

The following study investigated the prevalence of early signs of cardiovascular damage in patients with HCV cirrhosis. Is such damage reversible following treatment with DAAs? 

Full-text article available online @ Medscape, or purchase article, here

A Prospective Study
Aliment Pharmacol Ther. 2018 Oct;48(7):740-749. doi: 10.1111/apt.14934. Epub 2018 Aug 10.

Subclinical cardiovascular damage in patients with HCV cirrhosis before and after treatment with direct antiviral agents: a prospective study.
Novo G1, Macaione F1, Giannitrapani L2, Minissale MG2, Bonomo V1, Indovina F1, Petta S3, Soresi M2, Montalto G2, Novo S1, Craxi A3, Licata A2,3.

Abstract
BACKGROUND:
Cirrhosis is associated with morpho-functional cardiovascular alterations.

AIMS: 
To detect early features of cardiovascular damage in HCV-compensated cirrhotic patients using myocardial deformation indices and carotid arterial stiffness, and, further, to evaluate their short-term behaviour after HCV eradication with direct antiviral agents (DAAs).

METHODS: 
Thirty-nine consecutive patients with HCV cirrhosis, without previous cardiovascular events, were studied and matched for age, gender and cardiovascular risk factors to 39 controls without liver or cardiovascular disease. Patients and controls underwent a baseline echocardiographic evaluation including global longitudinal strain and ultrasound scan of carotid arteries. HCV-cirrhotics were reassessed by echocardiography and carotid ultrasound after obtaining sustained virological response (SVR) on DAAs.

RESULTS: 
HCV-cirrhotics showed at baseline a significantly reduced global longitudinal strain compared to controls -18.1 (16.3-20.5) vs -21.2 (20.4-22.3), P < 0.001. They also had a significantly higher pulse wave velocity 8.6 (7.7-9.1) m/s vs 6.6 (6.0-7.1) m/s, P = 0.0001, and β-stiffness index 12.4 (11.1-13.5) vs 8.6 (8.0-9.2) P = 0.0001. At multiple regression analysis, diabetes and HCV cirrhosis were independent predictors of global longitudinal strain. All HCV-cirrhotic patients had SVR on DAAs. Follow-up available in 32 of 39 (82%) at 9 (8-10) months showed a significant improvement of tricuspid annular plane systolic excursion (P = 0.01) and lateral E' velocity compared to baseline (P = 0.001).

CONCLUSIONS: 
HCV-cirrhotics show a significant rate of subclinical cardiac and vascular abnormalities. At a time when their survival is less linked to progression of liver disease, due to viral eradication on DAAs, cardiovascular morbidity and mortality may take a significant role.
Continue to full-text: https://www.medscape.com/viewarticle/902665
free registration required

Wednesday, October 17, 2018

Effect of cannabis use on chronic liver disease from Hepatitis C Virus infection

In The Media
Marijuana Use May Improve Cirrhosis Risk in Patients With Hepatitis C
Kenneth Bender, PharmD, MA
Publish Date: Wednesday, October 17, 2018
In an observation of a large pool of patients with hepatitis C virus (HCV), cannabis users had a lower prevalence of liver cirrhosis, more favorable health status at hospital discharge, and lower total health care costs than non-users.
Read the article...

In The Journal 
Canadian Journal of Gastroenterology and Hepatology
Volume 2018, Article ID 9430953, 9 pages
https://doi.org/10.1155/2018/9430953

Research Article
Reduced Incidence and Better Liver Disease Outcomes among Chronic HCV Infected Patients Who Consume Cannabis
Received 1 May 2018; Revised 13 August 2018; Accepted 29 August 2018; Published 23 September 2018

Abstract
Background and Aim. The effect of cannabis use on chronic liver disease (CLD) from Hepatitis C Virus (HCV) infection, the most common cause of CLD, has been controversial. Here, we investigated the impact of cannabis use on the prevalence of CLD among HCV infected individuals. Methods. We analyzed hospital discharge records of adults (age ≥ 18 years) with a positive HCV diagnosis. We evaluated records from 2007 to 2014 of the Nationwide Inpatient Sample (NIS). We excluded records with other causes of chronic liver diseases (alcohol, hemochromatosis, NAFLD, PBC, HBV, etc.). Of the 188,333 records, we matched cannabis users to nonusers on 1:1 ratio (4,728:4,728), using a propensity-based matching system, with a stringent algorithm. We then used conditional regression models with generalized estimating equations to measure the adjusted prevalence rate ratio (aPRR) for having liver cirrhosis (and its complications), carcinoma, mortality, discharge disposition, and the adjusted mean ratio (aMR) of total hospital cost and length of stay (LOS) [SAS 9.4]. Results. Our study revealed that cannabis users (CUs) had decreased prevalence of liver cirrhosis (aPRR: 0.81[0.72-0.91]), unfavorable discharge disposition (0.87[0.78-0.96]), and lower total health care cost ($39,642[36,220-43,387] versus $45,566[$42,244-$49,150]), compared to noncannabis users (NCUs). However, there was no difference among CUs and NCUs on the incidence of liver carcinoma (0.79[0.55-1.13]), in-hospital mortality (0.84[0.60-1.17]), and LOS (5.58[5.10-6.09] versus 5.66[5.25-6.01]). Among CUs, dependent cannabis use was associated with lower prevalence of liver cirrhosis, compared to nondependent use (0.62[0.41-0.93]). Conclusions. Our findings suggest that cannabis use is associated with decreased incidence of liver cirrhosis, but no change in mortality nor LOS among HCV patients. These novel observations warrant further molecular mechanistic studies.

Monday, October 15, 2018

Blog & News Updates: Link between viral hepatitis and liver cancer?

Save The Date
October 16th, 3 p.m. EST
In honor of Liver Cancer Awareness Month we have a few news and blog updates to share with you. On Tuesday, October 16th, join Hepatitis B Foundation for a Twitter chat to discuss the link between hepatitis and liver cancer. Representatives from Hepatitis B Foundation, CDC’s Division of Viral Hepatitis, and NASTAD will co-host the chat at 3 p.m. EST.

In addition check out this years Liver Cancer Awareness Campaign aimed at encouraging individuals with an increased risk for liver cancer to receive ongoing screening, launched by the American Liver Foundation (ALF) and Bayer Healthcare. Find out if you're at risk for liver cancer.

October 23, 2018 2:00 p.m. to 3:00 p.m. EST 

Webinar
Timothy M. Block, Ph.D.President and Director, Baruch S. Blumberg Institute and the Hepatitis B Foundation
Read More

November 29, 2018 (1:00-2:30 pm ET)
Strategies to Eliminate HCV in Veterans Webinar November 29
Join NVHR on November 29, 2018 (1:00-2:30 pm ET) for a webinar to discuss how government and community organizations are working to treat Veterans living with hepatitis C.
Read More

Blog & Journal Updates Around The Web
Oct 17, 2018
The Link Between Hepatitis B and Liver Cancer
hepbtalk
October is Liver Cancer Awareness Month! Despite the aggressive nature of this cancer – only one out of every five diagnosed patients survive beyond five years – liver cancer receives little attention from those outside of the health field. To help raise awareness and support those who have been affected, we are using our #justB campaign to share the stories of individuals who have been directly impacted by liver cancer throughout the month of October. The stories are featured throughout the month on the Hepatitis B Foundation, Liver Cancer Connect and Hep B United social media outlets. Check out Alice, Bunmi, Dai, and Kim’s stories.

Oct 15, 2018 
Liver Cancer Awareness Month
• By Lucinda K. Porter, RN
While the incidence of most cancers are declining in the United States, the rate of hepatocellular carcinoma (HCC or liver cancer) is increasing. More than 40,000 people in this country will be diagnosed this year with primary liver cancer, facing a 5-year survival rate of only 18 percent. According to the National Cancer Institute, liver cancer is the fifth leading cause of cancer death. Worldwide, it is the second leading cause of cancer death.
Read More

Oct 14, 2018
VA Continues Hepatocellular Screening, but Study Questions the Value
by Annette Boyle 
SAN FRANCISCO—Although a recent study determined that screening veterans with cirrhosis for hepatocellular carcinoma did not reduce the risk of death associated with liver cancer, the VA has no plans to change its screening practices.

“The VA currently follows the American Association for the Study of Liver Diseases (AASLD) guidelines for HCC screening among patients with cirrhosis,” explained Maggie Chartier, PsyD, MPH, the VA’s deputy director of HIV, Hepatitis and Related Conditions and associate professor at the University of California, San Francisco. The AASLD recommends screening patients with cirrhosis for HCC using ultrasound (USS) with or without serum alpha fetoprotein measurement every six months
Read More

Oct 10, 2018
..positive impact on HRQoL with improvement in mobility, pain/discomfort, anxiety/depression...

Oct 9, 2018
Paul E. Sax, MD
There’s so much going on no one can cover it all, certainly not me. So here’s a sampling of some (emphasis on some) of the interesting research presentations from last week, a “Mini” Really Rapid Review™ of the conference. Use the comments section to chime in with your favorites.

Oct 9, 2018
What support do people with liver cirrhosis and their families need?
People with liver cirrhosis and their families need more information about their condition and prognosis and greater access to palliative care, a systematic review of studies on the needs of people with cirrhosis of the liver has concluded.

Oct 9, 2018
Malnutrition decreases quality of life, social function in cirrhosis
PHILADELPHIA — Malnutrition as measured by subjective global assessment correlated significantly with decreased health-related quality of life in patients with…

Do you know that the liver doesn’t have any nerve cells? Here are some facts about this amazing organ in honor of Liver Awareness Month...

Alcohol and Increased Cirrhosis-related Deaths
Many of us are well aware that excessive (particularly long-term) consumption of alcohol is not good for our body — and is especially not friendly to our liver. But a newly published research study might very well convince us that the effects of alcohol on our liver health are even worse than we may have initially imagined. What’s the sobering research finding? The likelihood that increased cirrhosis-related mortality rates from 1999 to 2016 may be due to alcohol abuse and alcohol-induced liver disease...

Hepatitis C affects more than just the liver- it can affect many parts of the body, and mental wellbeing... 

Stress is not good for any of us, it can lead to serious health issues and depression. Stress is the..

In a pilot study from the October issue of Clinical Gastroenterology and Hepatology, colony stimulating factor 3 (CSF3, also called GCSF) improved liver function and increased survival times in patients with severe alcohol-associated hepatitis (AH), compared with standard therapy. Addition of N-acetyl cysteine (NAC) to GCSF did not improve patient outcomes... 

To all of you with gluten intolerance, first, let me say: I’m sorry. You’re looking for good food for celiac and liver disease. I worked in the kitchen and saved my life with The Liver Loving Diet, I had no idea what celiac was....

In The News
HepCBC - Weekly Review
Here's the latest issue of the Weekly Bull.

Oct 15, 2018
Liver Cancer Treatment Paradigm Undergoing Major Overhaul

Oct 15, 2018
Study Casts Doubt on Connection Between DAAs and Liver Cancer Risk
“There are no significant differences between DAA regimens in HCC risk after antiviral treatment,” concluded the authors, led by Elijah J. Mun, MD, of the University of Washington.

Oct 10, 2018
Hepatitis C - Vosevi safe, effective in ‘triple-infected’ patients with HCV, HBV, HIV
PHILADELPHIA – The direct-acting antiviral Vosevi demonstrated an average sustained virologic response rate of 87% among patients who were “triple-infected” with hepatitis C genotype 3, hepatitis B and HIV, as presented at the American College of Gastroenterology Annual Meeting.

By Nguyen Quy October 8, 2018 
A report by the World Cancer Research Fund International, a leading organization on cancer-prevention research related to diet, nutrition and physical activity, ranks Vietnam fourth among 25 countries with the highest rates of liver cancer this year. The report is based on the latest statistics from Globocan, an interactive web-based platform with cancer statistics from 185 countries....

Mass. General-led study supports ability of regular aspirin use to reduce liver cancer risk
The results of a study led by Massachusetts General Hospital (MGH) investigators support evidence from previous studies suggesting the regular use of aspirin can reduce the risk of developing primary liver cancer – also called hepatocellular carcinoma (HCC). Their report analyzing data from two long-term epidemiologic studies appears in JAMA Oncology and finds that regular aspirin use – taking two or more 325 mg tablets a week for five years or more – led to a significantly reduced risk of developing HCC, which is the second leading cause of cancer death worldwide...

"Compelling" evidence of link between aspirin use, lower hepatoma risk
NEW YORK (Reuters Health) - Regular, long-term use of aspirin is associated with a reduced risk of developing hepatocellular carcinoma (HCC), according to pooled data from more than 133,000 people. "Animal studies have shown that aspirin can block primary liver cancers from developing. Although these studies have been promising, data in humans have been limited," said Dr. Andrew Chan from Massachusetts General Hospital, in Boston.

Scientists use CRISPR to treat genetic liver diseases in neonatal and adult mice
by Arlene Weintraub
The newest issue of the journal Nature Medicine features two animal studies that show progress is being made towards achieving the holy grail of gene editing: the ability to prevent or treat diseases that are caused by gene mutations. In both cases, the researchers used modified versions of CRISPR-Cas9, the most commonly used gene-editing system.

Recommended reading

Evidence does not support statin use for conditions other than heart …
Despite studies suggesting benefits for conditions beyond cardiovascular disease (CVD), the evidence does not support revising current statin …

Early liver disease detection during pregnancy key for improved outcomes
October 7, 2018
PHILADELPHIA — Early detection of liver-related complications and hepatic diseases in patients who are pregnant leads to reduced risks and improved outcomes for…

NAFLD has ‘bidirectional’ course in patients with type 2 diabetes
October 8, 2018
PHILADELPHIA – Nonalcoholic fatty liver disease may have a “bidirectional” nature in patients with type 2 diabetes as NAFLD regressed in 2.2% of patients without any NAFLD-specific interventions despite increase in the prevalence of risk factors, according to a presentation at the American College of Gastroenterology Annual Meeting.

Obesity, Weight Gain Linked to Fibrosis Progression in NAFLD
Medscape Medical News 
October 4, 2018
Obesity and weight gain are independently associated with an increased risk for fibrosis progression in patients with nonalcoholic fatty liver disease (NAFLD), a large cohort study has found. Weight loss was negatively associated with fibrosis progression...

At-Risk Teens and Young Adults Overlooked During Opioid Crisis Too Few Tested for Hepatitis C, Research Suggests 
SAN FRANCISCO – Teens and young adults who have injected drugs are at risk for contracting hepatitis C, but most aren’t tested and therefore don’t receive life-saving treatment, according to a national study being presented at IDWeek 2018. The study of more than 250,000 at-risk youth found only one-third of those with diagnosed opioid use disorder (OUD) were tested for hepatitis C...

NEW YORK (Reuters Health) - The risk of hepatocellular carcinoma (HCC) in patients with chronic hepatitis B (CHB) treated with tenofovir is lower than in those treated with entecavir, according to a nationwide study from South Korea. "Patients with CHB have about 1% risk of developing HCC," Dr. Young-Suk Lim from the University of Ulsan College of Medicine, in Seoul, told Reuters Health by email. "Once diagnosed with HCC, the overall prognosis of the patients is very poor, with 5-year survival rate of less than 30%. Therefore, prevention of HCC is of utmost importance in the management of CHB patients."

Healthy You
October 25. 2018'
The food supplement that ruined my liver'
Trying to identify the cause of Jim's liver injury, those treating him ruled out alcohol. "For the last 30 years I drank maybe a six-pack of beer a year, no wine. So alcohol was not a big part of my life," Jim says. They also ruled out prescription drugs - he wasn't taking any at the time - and smoking, something he had never done. "Then my hepatologist drilled in to, 'What about any over-the-counter supplements?'" says Jim....

October 13, 2018
Dietary Supplements Can Contain Viagra, Steroids, or Worse
October 13, 2018
You know those sexual enhancement dietary supplements for sale at gas stations and markets across the country? Beware, they might actually be viagra. Or steroids. Or an antidepressant. Many supposed dietary supplements for weight loss, erectile dysfunction, and muscle building may contain actual pharmaceuticals—but you likely have no way of knowing what's in them...

October 13, 2018
Weekend Reading - Baby Boomers and the Flu
Did you know that you are more susceptible to flu-related complications if you're over 65, living with chronic liver disease, or viral hepatitis?

Recommended
ACGBLOG
Worldwide Epidemiology of Hepatocellular Carcinoma
In this presentation from the 2017 ACG Annual Scientific Meeting, Dr. El-Serag describes current and evolving global epidemiology, natural history, clinical course and risk factors for HCC.
Watch and listen HERE.

September 2018
Herbal and dietary supplement-induced liver injury is more severe than other types of drug-induced liver injury (DILI), and re-exposure is more likely, researchers report in the September issue of Clinical Gastroenterology and Hepatology. Increasing awareness of the hepatoxic effects of herbal and dietary supplements could help physicians make earlier diagnoses
Read more

Recent Updates
Online learning activity
Screening and Diagnosis of Hepatitis C Infection
Topics; HCV Transmission FAQs, Risk Factors for Acquiring HCV, HCV Disease Burden and more...

Twitter Updates
Open To All
Watch the open access webcasts from #EASL #NAFLDsummit on : https://bit.ly/2NsZkzZ 

Check back for updates!
Tina

Friday, September 28, 2018

Differences in hepatocellular carcinoma risk, predictors and trends over time according to etiology of cirrhosis

Of Interest
Sci Rep. 2018; 8: 13651.
Published online 2018 Sep 12. doi: 10.1038/s41598-018-31839-y

Differences in hepatocellular carcinoma risk, predictors and trends over time according to etiology of cirrhosis 
George N. Ioannou , Pamela Green, Elliott Lowy, Elijah J. Mun, Kristin Berry
Published: September 27, 2018 https://doi.org/10.1371/journal.pone.0204412

Full-text Article 
Download PDF

Abstract
Background and aims
Hepatocellular carcinoma (HCC) risk is high in cirrhosis. We sought to describe differences in HCC risk, predictors and trends over time according to etiology of cirrhosis.

Methods
We identified 116,404 patients with cirrhosis diagnosed between 2001–2014 in the VA healthcare system and determined incident HCC cases occurring from the date of cirrhosis diagnosis until 01/31/2017. Patients were divided by cirrhosis etiology into hepatitis C virus (HCV, n = 52,671), alcoholic liver disease (ALD, n = 35,730), nonalcoholic fatty liver disease (NAFLD, n = 17,354), or OTHER (n = 10,649).

Results
During a mean follow-up of 4.3 years, 10,042 new HCC cases were diagnosed. Patients with HCV had >3 times higher incidence of HCC (3.3 per 100 patient-years) than patients with ALD (0.86/100 patient-years), NAFLD (0.90/100 patient-years) or OTHER (1.0/100 patient-years), an association that persisted after adjusting for baseline characteristics. HCC incidence was 1.6 times higher in patients with cirrhosis diagnosed in 2008–2014 (2.47/100 patient-years) than in 2001–2007 (1.55/100 patient-years). 

Independent predictors of HCC among all cirrhosis etiologies included: age, male sex, Hispanic ethnicity, high serum alpha fetoprotein, alkaline phosphatase and AST/√ALT ratio and low serum albumin and platelet count. Diabetes was associated with HCC in ALD-cirrhosis and NAFLD-cirrhosis, and BMI in ALD-cirrhosis.

Conclusions
HCC risk is 3 times greater in cirrhotic patients with HCV than ALD or NAFLD. HCC risk continues to increase over time in analyses extending to 2017 in cirrhosis of all etiologies. Multiple readily available risk factors for HCC were identified that were influenced by cirrhosis etiology and could be used to develop HCC risk estimation models.

Friday, September 21, 2018

Alcohol abuse kills 3 million a year, most of them men: WHO

Harmful use of alcohol kills more than 3 million people each year, most of them men.
More than 3 million people died as a result of harmful use of alcohol in 2016, according a report released by the World Health Organization (WHO) today. This represents 1 in 20 deaths. More than three quarters of these deaths were among men. Overall, the harmful use of alcohol causes more than 5% of the global disease burden.

WHO’s Global status report on alcohol and health 2018 presents a comprehensive picture of alcohol consumption and the disease burden attributable to alcohol worldwide. It also describes what countries are doing to reduce this burden.

“Far too many people, their families and communities suffer the consequences of the harmful use of alcohol through violence, injuries, mental health problems and diseases like cancer and stroke,” said Dr Tedros Adhanom Ghebreyesus, Director-General of WHO. “It’s time to step up action to prevent this serious threat to the development of healthy societies.”

Of all deaths attributable to alcohol, 28% were due to injuries, such as those from traffic crashes, self-harm and interpersonal violence; 21% due to digestive disorders; 19% due to cardiovascular diseases, and the remainder due to infectious diseases, cancers, mental disorders and other health conditions.

Despite some positive global trends in the prevalence of heavy episodic drinking and number of alcohol-related deaths since 2010, the overall burden of disease and injuries caused by the harmful use of alcohol is unacceptably high, particularly in the European Region and the Region of Americas.

Globally an estimated 237 million men and 46 million women suffer from alcohol-use disorders with the highest prevalence among men and women in the European region (14.8% and 3.5%) and the Region of Americas (11.5% and 5.1%). Alcohol-use disorders are more common in high-income countries.

Global consumption predicted to increase in the next 10 years
An estimated 2.3 billion people are current drinkers. Alcohol is consumed by more than half of the population in three WHO regions – the Americas, Europe and the Western Pacific. Europe has the highest per capita consumption in the world, even though its per capita consumption has decreased by more than 10% since 2010. Current trends and projections point to an expected increase in global alcohol per capita consumption in the next 10 years, particularly in the South-East Asia and Western Pacific Regions and the Region of the Americas.

How much alcohol are people drinking?
The average daily consumption of people who drink alcohol is 33 grams of pure alcohol a day, roughly equivalent to 2 glasses (each of 150 ml) of wine, a large (750 ml) bottle of beer or two shots (each of 40 ml) of spirits.

Worldwide, more than a quarter (27%) of all 15–19-year-olds are current drinkers. Rates of current drinking are highest among 15–19-year-olds in Europe (44%), followed by the Americas (38%) and the Western Pacific (38%). School surveys indicate that, in many countries, alcohol use starts before the age of 15 with very small differences between boys and girls.

Worldwide, 45% of total recorded alcohol is consumed in the form of spirits. Beer is the second alcoholic beverage in terms of pure alcohol consumed (34%) followed by wine (12%). Worldwide there have been only minor changes in preferences of alcoholic beverages since 2010. The largest changes took place in Europe, where consumption of spirits decreased by 3% whereas that of wine and beer increased.

In contrast, more than half (57%, or 3.1 billion people) of the global population aged 15 years and over had abstained from drinking alcohol in the previous 12 months.

More countries need to take action
“All countries can do much more to reduce the health and social costs of the harmful use of alcohol,” said Dr Vladimir Poznyak, Coordinator of WHO’s Management of Substance Abuse unit. “Proven, cost-effective actions include increasing taxes on alcoholic drinks, bans or restrictions on alcohol advertising, and restricting the physical availability of alcohol.”

Higher-income countries are more likely to have introduced these policies, raising issues of global health equity and underscoring the need for greater support to low- and middle-income countries.

Almost all (95%) countries have alcohol excise taxes, but fewer than half of them use other price strategies such as banning below-cost selling or volume discounts. The majority of countries have some type of restriction on beer advertising, with total bans most common for television and radio but less common for the internet and social media.

“We would like to see Member States implement creative solutions that will save lives, such as taxing alcohol and restricting advertising. We must do more to cut demand and reach the target set by governments of a 10% relative reduction in consumption of alcohol globally between 2010 and 2025,” added Dr Tedros.

Reducing the harmful use of alcohol will help achieve a number of health-related targets of the Sustainable Development Goals (SDGs), including those for maternal and child health, infectious diseases, noncommunicable diseases and mental health, injuries and poisonings.

Alcohol abuse kills 3 million a year, most of them men: WHO
Kate Kelland
(Reuters) - More than 3 million people died in 2016 due to drinking too much alcohol, meaning one in 20 deaths worldwide was linked to harmful drinking, the World Health Organization (WHO) said on Friday.

Of Interest
September 2018
Defining ‘Safe’ Alcohol Consumption, published online at HepMag.com.
How much is too much?
This conversation is especially important in light of the BMJ study that uncovered a concerning trend in rising mortality among those aged 25-34 due to excessive alcohol consumption. While obesity and hepatitis C infection may contribute, the rise in liver disease among young Americans due to alcohol is particularly troubling.

Wednesday, September 12, 2018

Epclusa® (Sofosbuvir/Velpatasvir) with or without ribavirin in patients with decompensated cirrhosis

Journal of Gastroenterology - September 10, 2018 

Efficacy and safety of sofosbuvir–velpatasvir with or without ribavirin in HCV-infected Japanese patients with decompensated cirrhosis: an open-label phase 3 trial
Tetsuo Takehara Naoya Sakamoto Shuhei Nishiguchi Fusao IkedaTomohide TatsumiYoshiyuki UenoHiroshi Yatsuhashi Yasuhiro Takikawa Tatsuo Kanda Minoru Sakamoto Akihiro Tamori Eiji MitaKazuaki Chayama Gulan Zhang Shampa De-Oertel Hadas Dvory-SobolTakuma Matsuda Luisa M. Stamm Diana M. Brainard Yasuhito Tanaka Masayuki Kurosaki

Sofosbuvir –velpatasvir for 12 weeks provides a highly effective and well-tolerated therapy for Japanese patients with HCV and decompensated cirrhosis. Ribavirin did not improve efficacy but increased toxicity.

Open Access 
First Online: 10 September 2018
Full text article available online: 

Abstract
Background
In Japan, hepatitis C virus (HCV)-infected patients with decompensated cirrhosis currently have no treatment options. In this Phase 3 study, we evaluated sofosbuvir–velpatasvir with or without ribavirin for 12 weeks in patients with any HCV genotype and decompensated cirrhosis [Child–Pugh–Turcotte (CPT) class B or C] in Japan.

Methods
Patients were randomized 1:1 to receive sofosbuvir–velpatasvir with or without ribavirin for 12 weeks. Randomization was stratified by CPT class and genotype. Sustained virologic response 12 weeks following completion of treatment (SVR12) was the primary efficacy endpoint.

Results
Of the 102 patients enrolled, 57% were treatment naive, 78% and 20% had genotype 1 and 2 HCV infection, respectively, and 77% and 20% had CPT class B and C cirrhosis, respectively, at baseline. Overall, 61% of patients were female and the mean age was 66 years (range 41–83). SVR12 rates were 92% (47/51) in each group. Among patients who achieved SVR12, 26% had improved CPT class from baseline to posttreatment week 12. Most adverse events (AEs) were consistent with clinical sequelae of advanced liver disease or known toxicities of ribavirin. Four patients (8%) who received sofosbuvir–velpatasvir and seven (14%) who received sofosbuvir–velpatasvir plus ribavirin experienced a serious AE. The 3 deaths (bacterial sepsis, gastric varices hemorrhage, hepatocellular carcinoma) were attributed to liver disease progression.

Conclusion
Sofosbuvir–velpatasvir for 12 weeks provides a highly effective and well-tolerated therapy for Japanese patients with HCV and decompensated cirrhosis. Ribavirin did not improve efficacy but increased toxicity.

Monday, September 10, 2018

HCV Newsletters & Updates: Obesity in liver disease, Nasal spray for opioid overdose and Fast-acting flu drug

HCV Newsletters & Updates
Welcome, check out the latest news, review this months collection of newsletters, and finish off by reading a handful of well written blogs focused on living well with hep B or C.

In The News
MSF and groups call for end to Gilead’s hepatitis C drug monopoly in Europe which blocks access 
--Pharmaceutical company Gilead has a patent monopoly on hepatitis C drug sofosbuvir in Europe
--The patent results in exorbitant prices, meaning people are unable to afford treatment
--MSF and other organisations are urging the European Patent Office to overturn the patent in a hearing this week.

With an award-winning newsroom, STAT gives you indispensable insights and exclusive stories on the technologies, personalities, power brokers, and political forces driving massive changes in the life science industry — and a revolution in human health.
Fast-acting flu drug shows strong potential - An experimental, fast-acting flu drug showed strong promise in two newly published trials — but it also led to some surprising and even concerning results. The drug cut the time people were sick with flu symptoms by just over a day, but didn’t make people feel better faster than Tamiflu.

Reuters
California-based Opiant earlier this year was awarded a $7.4 million grant by the U.S. National Institutes of Health’s National Institute on Drug Abuse for the development of a nasally-applied version of overdose treatment nalmefene.

Associated Press 
Doctors explore lifting barriers to living organ donation
WASHINGTON — Surgeons turned down Terra Goudge for the liver transplant that was her only shot at surviving a rare cancer. Her tumor was too advanced, they said — even though Goudge had a friend ready to donate, no matter those odds.

HepCBC 
HepCBC is a Canadian non-profit organization offering awareness with basic information about HCV and a weekly digest of news.
Read the latest issue of the highly successful Weekly Bull.

September Updates
Hepatology - Top Story From Healio 
Healio features the industry’s best news reporting, dynamic multimedia, question-and-answer columns, educational activities in a variety of formats, blogs, and peer-reviewed journals.

HCV NEXT September/October Issue - The following articles appeared in this months issue of HCV NEXT, published online over at Healio

September 7, 2018
Physicians and researchers have noted the increase in liver disease over the last couple decades, especially nonalcoholic fatty liver disease, correlates significantly…

NATAP
NATAP is a New York State non-profit corporation with 501(c)3 Federal tax-exempt status. Our mission is to educate individuals about HIV and Hepatitis treatments and to advocate on the behalf of all people living with HIV/AIDS and HCV. Our efforts in these areas are conducted on local, national, and international levels.
Global Hepatitis Summit A Few Selected Highlights 
Reported by Jules Levin, NATAP
In June the Global Hepatitis Summit took place in Toronto. Here are 3 selected talks highlighted of particular interest to me. The first talk by Andrew Hill he says we have a bleak scenario regarding the possibility of global HCV elimination. He says in many countries new HCV infections outstrip HCV cures and new diagnoses. New diagnoses are much lower in all poorer countries compared to high income countries. Screening is too low, all of which he uses to say the outlook is bleak for global HCV elimination unless we make changes.

The 2nd talk I chose to highlight was by Maria Prims from the Netherlands where she reports high HCV infection & reinfection rates among people taking PrEP to prevent HIV infection. She highlights an increasing HCV incidence among MSM. 376 started PrEP either daily or on demand and there were 12 HCV infections: 6 new infections & 6 reinfections.

The 3rd report below is on the use of a new broader type of model in India for HCV screening & care. A more comprehensive clinic model where IDUs can under 1 roof get a variety of services for IDU and HCV care. Sunil Solomon highlights how big & diverse the HCV epidemic is India, much bigger even only among IDUs compared to the entire HCV epidemic in Western Europe. 
Read it here...…

In Case You Missed It
'A long life with HIV' is now available to read online. The booklet provides information on living well with HIV as you get older, including things you can do to look after your health, health issues and preparing for the future.

Sept 4, 2018
Inovio Pharmaceuticals (NSDQ:INO) and its partner, GeneOne Life Science (KSE:011000), said today that the companies have dosed the first patient in a Phase I study designed to test a preventive vaccine against hepatitis C infection. The companies plan to recruit 24 study participants to evaluate Inovio’s GLS-6150 candidate. Participants will include people who have a sustained virologic response following treatment for Hep. C, as well as healthy controls. They are slated to receive one of two doses of vaccine, administered intra-dermally and followed by electroporation with Inovio’s Cellectra device.

Risk of Liver Cancer in Patients with NAFLD 
(Reuters Health) - People with advanced cases of nonalcoholic fatty liver disease (NAFLD) may need to be monitored for liver cancer, a large U.S. study suggests.

Vosevi Beats Hepatitis C Regardless of Drug Resistance 
In a recent study of people whose previous hep C regimen failed to cure their infection, Vosevi cured almost all of them.

Will an opt-out organ transplant law save lives?
The recent decision in England to change the organ donation law from voluntary consent (opt-in) to presumed consent (opt-out) highlighted the debate around the best approach to organ donation.

Routine oral care to treat gum disease may improve cognitive function in cirrhosis patients
Routine oral care to treat gum disease may play a role in reducing inflammation and toxins in the blood and improving cognitive function in people with liver cirrhosis.

In The Journals 
Hepatitis B Virus and Risk of Non-Hodgkin Lymphoma
Journal of Viral Hepatitis

Chronic Hepatitis C Association with Diabetes Mellitus and Cardiovascular Risk in the Era of DAA Therapy.
Most likely, DAA treatment and subsequently SVR achievement decrease cardiovascular risk. This fact is another reason for early treatment of patients, including those with a lower grade of liver fibrosis. Yet, chronic hepatitis C treatment remains inaccessible not only in developing countries but also in countries with high quality of life..

Newsletters
HCV Advocate
The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education.
In this month’s HCV Advocate newsletter, the following noteworthy articles are available to read and educate:
-SnapShots by Alan Franciscus Risk factors, mortality, and cardiovascular outcomes in patients with type 2 diabetes—A. Rawshani, et. al.
-Incidence of hepatocellular carcinoma after direct antiviral therapy for HCV in patients with cirrhosis included in surveillance programs—P. Nahom, et. al.
-Safety and efficacy of ledipasvir‐sofosbuvir with or without ribavirin for chronic hepatitis C in children ages 6‐11—K. F. Murry, et. al
Briefly……..
-Commentary: A review of the risk of hepatitis B and C transmission through biting or spitting—H. Pintilie, et. al.
-Hepatitis C virus infection in children in the era of direct-acting antivirals—M. Pawlowska, et. al
HealthWise – A Buffet of Health Information – as the title of the article implies, Lucinda discusses the various substances that may or may not be good for your health.
Hepatitis Headlines – Three interesting news stories about hepatitis C that our readers will find interesting including heart transplants, eliminating hepatitis in the U.S. and WHO and HCV treatment guidelines.
Hep C 101 – Overview of Hepatitis C by Alan Franciscus – A new series of article for people who are new to hepatitis C or for those people who want basic information.
What’s Up – We’ve updated several of the HCV Advocate Factsheets. Use the links provided in this section to get current information on several subjects that relate to Hep C, including nutrition, alcohol, co-infection, and motherhood.
Watch our patient video about treating and curing HCV. 

The New York City Hepatitis C Task Force
The New York City Hepatitis C Task Force is a city-wide network of service providers and advocates concerned with hepatitis C and related issues. The groups come together to learn, share information and resources, network, and identify hepatitis C related needs in the community. Committees form to work on projects in order to meet needs identified by the community.
Review all news updates.

HCV Action
HCV Action brings together hepatitis C health professionals from across the patient pathway with the pharmaceutical industry and patient representatives to share expertise and good practice.
HCV Action e-update

World Hepatitis Alliance
We run global campaigns, convene high-level policy events, build capacity and pioneer global movements, ensuring people living with viral hepatitis guide every aspect of our work.
View Recent Newsletters 
World Hepatitis Alliance (WHA) presents hepVoice, a monthly magazine with updates on the latest projects, news from WHA members and key developments in the field of hepatitis.

GI & Hepatology News
Over 17,000 gastroenterologists and hepatologists rely on GI & Hepatology News every month to cover the world of medicine with breaking news, on-site medical meeting coverage, and expert perspectives both in print and online. 
Hot topics
Amy Karon MDedge News 
Modest alcohol consumption was associated with significantly less improvement in steatosis and significantly lower odds of NASH resolution.
View all updates here....

Hep-Your Guide to Hepatitis
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and HepMag.com are the go-to source for educational and social support for people living with hepatitis.
View - all issues
Read the news

Hepatitis Victoria
Hepatitis Victoria is the peak not-for-profit community organisation working across the state for people affected by or at risk of viral hepatitis.
Latest Podcast: Karen Hoyt a HEP Hero and she is unique in being our first international recipient!
Speaking from Oklahoma in the United States, Karen talks about her diagnosis with hepatitis C and how she experienced the full gamut of conditions leading to a liver transplant.



View the Latest Newsletter, or relax and listen to a short podcasts interviewing health experts and practioners on topics related to viral hepatitis - come have a listen!

British Liver Trust
The British Liver Trust is the leading UK liver disease charity for adults – we provide information and support; increase awareness of how liver disease can be prevented and promote early diagnosis; fund and champion research and campaign for better services. 
News: Less Survivable Cancer Taskforce calls for government to double the survival rate of deadliest cancers by 2029
The combined five-year survival rate for people with either liver, brain, lung, oesophageal, pancreatic or stomach cancers stands is currently just 14%. Today, six charities …
View Recent Newsletters, here.

The National Viral Hepatitis Roundtable
The National Viral Hepatitis Roundtable (NVHR) is national coalition working together to eliminate hepatitis B and C in the United States.
View all NVHR newsletters

The Hepatitis C Trust
The Hepatitis C Trust is run by patients with the goal of eliminating HCV in the United Kingdom. The Trust’s mission is to reverse the rapidly increasing death toll caused by hepatitis C in the UK until no-one dies from this preventable and treatable disease and, ultimately, it is all but eradicated in this country.

National Institutes of Health
A monthly newsletter from the National Institutes of Health, part of the U.S. Department of Health and Human Services
September Newsletter
Topics
Body Odor May Be Sign of Disease
Breathe Easier
Dealing with Bad Air Quality

Harvard Health
Lipoprotein(a) is a fatty particle in the blood that invades artery walls, causing atherosclerosis. Also known as Lp(a), the particles are similar to “bad” LDL cholesterol molecules but with an extra protein attached. High blood levels of Lp(a)—which is largely determined by genetics—may explain some unexpected, premature heart attacks. Widespread testing for Lp(a) is not recommended because both the prevalence and the definition of what constitutes a dangerously high level are not yet clear. In addition, there are no FDA-approved treatments proved to lower heart disease risk in people with high Lp(a) levels.

Inspirational Bloggers
Karen Hoyt is devoted to offering support and accurate information to people coping with the effects of hepatitis C.
I hear a lot from people seeking help for autoimmune liver disease. Trying to figure it out is hard, but most symptoms are the same as any type of liver disease. I know, we can’t lump them all into one specific area, but they are in the same region.

Lucinda K. Porter
Lucinda Porter is a nurse, speaker, advocate and patient devoted to increasing awareness about hepatitis C.
Latest blog entry: Happiness: Purging Self-Help Advice

Hep 
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis.
Latest blog entry: By Connie M. Welch
Patient Experience Living With Cirrhosis With John M., Part 2 Part 2 of Connie Welch’s interview with John M, a patient with hepatitis C and cirrhosis, who was successfully treated with Harvoni.

By Greg Jefferys -How Big Pharma Corrupts Health Services 
A look at how bribing bureaucrats and buying doctors brings about bad outcomes for public health.
Check out the talented people who blog at Hep.

We provide information, support, referral and advocacy for people affected by viral hepatitis in NSW. We also provide workforce development and education services both to prevent the transmission of viral hepatitis and to improve services for those affected by it.
Latest blog entry: Pharmacists key in harm reduction

Life Beyond Hepatitis C
Life Beyond Hep C is where faith, medical resources and patient support meet, helping Hep C patients and their families navigate through the entire journey of Hep C.
Latest blog entry: Relief from Itching with Hepatitis C and Cirrhosis

Canadian Liver Foundation 
We strive to improve prevention and the quality of life of those living with liver disease by advocating for better screening, access to treatment, and patient care.
Latest blog entry: Who Gives a Sliver of a Liver to a Stranger?

Hepatitis B Foundation 
The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure and improving the quality of life for those affected by hepatitis B worldwide.
Latest blog entry: - Be Your Own Advocate in the Medical Room
The hepatitis B virus (HBV) can be transmitted two ways: 1) through direct contact with blood and 2) infected body fluids. Some risks for direct blood contact are obvious, such as touching an open wound to another open wound or cleaning up someone’s blood without any protective gear. However, other methods of blood transmission are harder to catch. Common activities like sharing razors, earrings, or toothbrushes are simple, innocent actions, yet they all have the potential for blood exchange.

HepatitisC.net
At HepatitisC.net we empower patients and caregivers to take control of Hepatitis C by providing a platform to learn, educate, and connect with peers and healthcare professionals.
Latest blog entry: Ask the Advocate: What Were Your First Symptoms of Hep C?
There are several common symptoms of chronic HCV, including fatigue, joint pain, muscle aches, low-grade fever, decreased appetite..

HIV and ID Observations 
An ongoing dialogue on HIV/AIDS, infectious diseases, all matters medical, and some not so medical.
Latest blog entry: Doravirine Sets a New Standard for NNRTIs — But What Role in HIV Treatment Today?

KevinMD
Kevin Pho is a practicing physician and most known for his blog KevinMD. Thousands of authors contribute to his blog: primary care doctors, surgeons, specialist physicians, nurses, medical students, policy experts. And of course, patients, who need the medical profession to hear their voices.
One of the aspects of depression that’s particularly difficult is the sleep disturbance which accompanies it and often continues after the traditional symptoms of depression have finally gotten better.

On The Radio
Presented by Dr Norman Swan
Genetic test predicts dementia risk. Warning over new genetic tests on Medicare Benefits Schedule. Colonoscopy standards to reduce unnecessary treatment, risk of complications. Scan your heart to save your life...

Healthy You
This type of observational study is useful for comparing what happens to groups of people in different situations (in this case, people over 75 who have or haven't been prescribed statins), but it can't show cause and effect. So in this case, it can't show whether living longer or having strokes or heart attacks are a direct effect of taking or not taking statins...

Osteoporosis is often called "soft bones." "Osteoporosis is thinning of the bone to the point where the bones can break," says Dr. Bart Clarke, a Mayo Clinic endocrinologist. https://youtu.be/fLS1tDriG3k Watch: The Mayo Clinic Minute Journalists: Broadcast-quality video pkg (1:00) is in the downloads. Read the script. Dr. Clark says common breaks from thinning bones occur in the spine, wrist, shoulder and hip. "Women, in general, past menopause — past the mid-50s — are at high risk for this because of the…

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Tina