Showing posts with label AASLD 2018 The Liver Meeting®. Show all posts
Showing posts with label AASLD 2018 The Liver Meeting®. Show all posts

Wednesday, December 5, 2018

December Newsletters: Curing Hep C May Dial Back Liver Damage


Hi folks, over the next few weeks I'll be taking a holiday break to spend time with the family. Can't wait to start my Christmas shopping, trick out my tree, and bake some millennial sugar cookies. Using Pillsbury ready to make slice-and-bake cookies, add sprinkles after baking. Bad Nana!

In any event, here's your list of December newsletters with blog updates from across the web.

News & Review 
Catch up on what you missed this week by reading one of two HCV week in review publications:
The Weekly Bull is published by the Canadian non-profit organization HepCBC, the second publication by Caring Ambassadors Program, is filled with news as well, in addition to a monthly review of relevant HCV research published on PubMed.

December Newsletters
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.
Winter Issue 2018
Highlights
Curing Hep C May Dial Back Liver Damage
Hep C Testing Slowly Rising Among Baby Boomers
People Who Inject Drugs Succeed With Hep C Treatment
and more....

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 newsletter coverage of the Liver Meeting continues; read easy to understand commentary on HCV-related topics that matter most to patients. In next month's issue notable research on liver cancer presented at the meeting will be featured as well.

On This Blog
After The Liver Meeting Summary: Viral Hepatitis & Fatty Liver Disease
For patients - An index of links provide an overview of the meeting with a focus on HCV; read expert analysis of key data, interviews with leading researchers and clinicians, or listen to live presentations, view slidesets and capsule summaries. Sit back and watch daily clips or a live symposium, finally review a webinar with all the notable Liver Meeting updates. 

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.
Read the latest: HCV Action e-update

The World Hepatitis Alliance goal is to achieve a world free from viral hepatitis, World Hepatitis Alliance provides global leadership in awareness-raising, advocacy and in efforts to find the missing millions.
News & Headlines 
Click here to read our latest newsletter.

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.
December Newsletter: Reminder: NYC Hep C Task Force Meeting. December 5 (3-5 PM) @ 132 West 32nd St.
NYC Hep C Task Force
All - Hep Free NYC Newsletters

Hepatitis NSW provides 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.
News Updates

GI & Hepatology News covers the world of liver disease with breaking news, on-site medical meeting coverage, and expert perspectives both in print and online. 
View all updates here....

Hepatitis Victoria is the peak not-for-profit community organisation working across the state for people affected by or at risk of viral hepatitis.
View the Latest Newsletter, or relax and listen to a short podcasts interviewing health experts and practioners on topics related to viral hepatitis - have a listen!

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. 
View Recent Newsletters, here.

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.

The National Viral Hepatitis Roundtable (NVHR) is national coalition working together to eliminate hepatitis B and C in the United States.
NVHR 2018 Year in Review
View all NVHR newsletters

Check out the latest National Institutes of Health Newsletter.
December Newsletter
Plan Your Plate - Shifting to a Healthy Eating Style

Blog Updates
Karen Hoyt is devoted to offering support and accurate information to people coping with the effects of hepatitis C.
Latest blog entry: Holiday and Health Problems
Find Karen on Facebook
YouTube Page

Lucinda K. Porter
Lucinda Porter is a nurse, speaker, advocate and patient devoted to increasing awareness about hepatitis C.
View all new blog updates, here....

Hep 
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis.
Latest blog updates: 
By Lucinda K. Porter, RN
By Connie M. Welch 
Hepatitis C Cure 
By Greg Jefferys
View all blog updates, here...

AGA Blog
Gastroenterology and Clinical Gastroenterology and Hepatology
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: 5 Common Questions and Answers about Hepatitis C Treatment
View all updates, here...

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: Tips for a struggling caregiver
View all updates, here...

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: Ask An Expert: Managing Hepatitis Delta During Pregnancy
View all updates, here....

ADRLF (Al D. Rodriguez Liver Foundation)
Al D. Rodriguez Liver Foundation is a non-profit organization that provides resources, education and information related to screening, the prevention of and treatment for the Hepatitis Virus and Liver Cancer.
View all updates, here....

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.
Part 1: Doctors and Dragons: The Adventure Continues - By Rick Nash
View all updates, here....

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.
View latest blog entry, here... 

Harvard Health Blog
The goal of our publications is to bring people around the world the most current health information that is authoritative, trustworthy, and accessible, drawing on the expertise of the 10,000+ faculty physicians at Harvard Medical School.
Latest blog entry: Safe and effective use of insulin requires proper storage

University of Michigan - Lab Blog
Providing physicians with virtual access to specialists can be lifesaving to liver disease patients.
View all updates: Lab Blog

JAMA Patient Page
This JAMA Patient Page describes recent advancements in hepatitis C treatment.
December 4, 2018
Treating Hepatitis C
From a medical point of view, almost all patients with hepatitis C should be treated.

See you soon!
Tina

Saturday, December 1, 2018

After The Liver Meeting 2018 Summary: Viral Hepatitis & Fatty Liver Disease

The Liver Meeting® 2018
San Francisco, CA.
November 9-13, 2018

Page updated: December 4, 2018

After The Liver Meeting
Hi folks, today we have a nice summary of the Liver Meeting, highlighting significant research on both viral hepatitis and fatty liver disease. Follow each post-meeting link provided below and start reviewing expert analysis of key data presented at the meeting, listen to audio live from the meeting, or view slidesets, and capsule summaries.

HCV Advocate December Newsletter
December 1, 2018
In this month's HCV Advocate Newsletter coverage of the Liver Meeting continues; read easy to understand commentary on HCV-related topics that matter most to patients. In next month's issue notable research on liver cancer presented at the meeting will be featured.
Start here: 
http://hcvadvocate.org/news/NewsUpdates_pdf/Advocate_2018/advocate1218.pdf

Webinar
Dec 4, 2018
Liver Meeting 2018 Updates” presented by Tatyana Kushner, MD, MSCE from Mount Sinai Medical Center, available now over at HepCure.

Webcast Coming Soon
Chronic Liver Disease Foundation
Symposium live from the meeting featuring table discussions with leading physicians discussing viral hepatitis, soon to be launched by Chronic Liver Disease Foundation (CLDF).
Symposium on Hepatitis featuring table discussions with leading physicians!
The primary goal of this CME symposium is to better understand how to effectively identify, manage, and treat patients with viral hepatitis in order to achieve viral eradication by 2030.

Updates
Healio
Website Healio - Twitter @HealioHep
December 4, 2018
This year at The Liver Meeting, data presented on liver transplantation focused on comorbid complications, such as alcohol misuse and obesity, and their correlated…

ID Practitioner
December 4, 2018
Hepatitis C debrief: Therapy has matured, access issues remain
The Liver Meeting 2018: Hepatitis B novel therapies debrief – key abstracts

Modern Medicine 
December 4, 2018
HCV Expert Interview with Jordan Feld, MD, MPH
In this interview, Jordan Feld, MD, MPH, discusses key highlights from studies presented at The Liver Meeting 2018, held recently in San Francisco by the American Association for the Study of Liver Diseases (AASLD).

Hep
Website: Hep 
December 3, 2018
By Benjamin Ryan 
A review of the major findings presented at the Annual Meeting of the American Association for the Study of Liver Diseases in San Francisco

infohep
November 30, 2018
Website infohep Twitter - @infohep
This month’s infohep bulletin focuses on news from The Liver Meeting 2018, organised by the American Association for the Study of Liver Diseases (AASLD), which took place in San Francisco, USA, from 9 to 13 November 2018.
Link: Conference bulletin

Medscape
November 29, 2018
Website Medscape Twitter @Medscape
Viral Hepatitis: Five Highlights From the Liver Meeting
Dr William Balistreri reports on the most important viral hepatitis news from this year's Liver Meeting.

Clinical Care Options
Nov 27, 2018
Website Clinical Care Options - Twitter @CCO_Hepatitis 
Hot Topics in NASH
Nov 28, 2018
Website Healio - Twitter @HealioHep
Healio presents highlights of Fatty Liver and NASH data presented this year at The Liver Meeting.
Fatty liver highlights from The Liver Meeting 2018

Hep B Foundation
Nov 27, 2018
After the Liver Meeting, Dr. Tim Block, the @HepBFoundation's co-founder & President, answered some of the most asked questions about the path to a hepatitis B cure. This is a two-part series. Read the first Q & A here: http://ow.ly/UEAT50jOb61 

Video
Quick Review: Each Day Of The Meeting
Practice Point is once again launching daily clinical clips reviewing hot topics in HCV, presented each day at the meeting. Although the activity is intended for physicians and health care professionals, anyone, especially patients can benefit from each 5-minute review as well:
Independent Conference Coverage from the 2018 Annual Meeting of the American Association for the Study of Liver Disease (AASLD)*

In this video series, Dr. Saab will present ‘what you need to know in 5‐minutes’ regarding today's presentations from AASLD 2018 in San Francisco, CA
Free "registration" is required, once accomplished:
ACCESS ACTIVITY
Answer 3 question pre-test, and click Access Activity.
Twitter - @Practice_Point

Navigate This Blog - Stay Updated

Check back for updates
Enjoy the weekend!
Tina

Friday, November 30, 2018

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

Saturday, November 24, 2018

In half of hepatitis C patients, DAA treatment can shortened to 6 weeks

Recommended 
Media
Hepatitis C treatment can be shortened in 50 percent of patients, study finds
Shorter treatment times could significantly reduce costs of the expensive therapy

Slides available online @ NATAP

AASLD The Liver Meeting 2018
Abstract

In half of hepatitis C patients, DAA treatment can shortened to 6 weeks
Last Updated: 2018-11-23
By Lorraine L. Janeczko

NEW YORK (Reuters Health) - In about half of patients with hepatitis C virus (HCV) infection, response-guided therapy with oral direct-acting antiviral agents (DAAs) can be reduced from the standard 12 weeks to as little as six weeks and still be effective, according to a new pilot study.

DAAs have revolutionized hepatitis C treatment, eliminating the virus and enabling a cure with minimal side effects in over 90% of patients treated. But the high cost, which can exceed $50,000 per patient, limits patient access and burdens the insurance industry, researchers write in a press release.

"Implementing response-guided therapy as standard of care may lead to significant cost savings on the expensive hepatitis C treatment," senior author Dr. Amir Shlomai of Beilinson Hospital in Petah-Tikva, Israel, told Reuters Health by email.

The team enrolled 22 HCV patients with compensated liver disease and genotypes 1 to 6, who were either treatment naive or interferon experienced. Participants were treated with one of four DAA regimens chosen by the investigators.

Viral load was measured at baseline, at day 2, and at weeks 1, 2, and 4 after the start of treatment. The primary endpoint was the proportion of patients with sustained virologic response at 12 weeks (SVR12) post-treatment, with undetectable HCV RNA (<15 IU/mL).

The researchers presented the preliminary proof-of-concept results in a late-breaking abstract poster session on November 12 at The Liver Meeting 2018, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), in San Francisco.

Participants averaged roughly 50 years of age, 11 were female and 9% had METAVIR scores of F3-4. The most common genotypes were G1b (59%) G3 (27%), G1a (9%), and G2 (5%).

The drug combinations sofosbuvir/velpatasvir, elbasvir/grazoprevir, sofosbuvir/ledipasvir and glecaprevir/pibrentasvir were administered to 41%, 31%, 23% and 5% of participants, respectively.

Mathematical modeling of viral kinetics was performed during weeks 2-4 to project time to cure, and model projections were used to individualize each participant's treatment duration.

Modeling predicted that treatment duration could be shortened to 10 weeks in one patient (5%), eight weeks in eight (36%) and six weeks in two (9%).

Of the 19 participants who completed therapy, 100% had undetectable viral load at the end of treatment. Of those, 18 (95%) remained HCV-undetectable four weeks after treatment.

Of the 15 patients who reached post-treatment week 12, 14 (93%) achieved SVR12.

One treatment-naive G3 patient with F1 fibrosis who was treated with sofosbuvir/velpatasvir for six weeks relapsed. Virus sequencing did not detect resistance-associated substitutions at baseline or in response to treatment, and no significant side effects were found among the DAA-treated patients.

"A shorter treatment may lead to improved compliance to treatment, especially in special populations, including hepatitis C patients with limited health insurance benefits," Dr. Harel Dahari of Loyola University Chicago in Maywood, Illinois, who also worked on the study, told Reuters health by email.

Dr. Dahari estimates that the shorter treatment may potentially decrease the cost of HCV drugs by up to 20%.

Now that the proof-of-concept pilot study has shown that response-guided therapy can potentially reduce treatment times, a large multicenter trial to validate the results is underway in Israel, the authors say.

Clalit Health Services in Israel and the United States National Institutes of Health helped support the study. The authors state that they have no conflicts of interest.

http://www.chronicliverdisease.org/reuters/article.cfm?article=20181123Other134843869

SOURCE: LB-34 Response-Guided Therapy with Direct-Acting Antivirals Shortens Treatment Duration in 50% of HCV Treated Patients

AASLD The Liver Meeting 2018.

Wednesday, November 21, 2018

Opioid use more common in chronic liver disease than other chronic diseases

VIDEO: Opioid use more common in chronic liver disease than other chronic diseases
Healio
SAN FRANCISCO — In this exclusive video perspective from The Liver Meeting 2018, Monica Konerman, MD, director of the Michigan Medicine NAFLD Clinic, discusses results of a study that found opioid use to be twice as common among patients with chronic liver disease compared with other common chronic diseases.

See more from The Liver Meeting @ Healio

HCV epidemic continues to rise among young adults

Of Interest 
AASLD 2018 The Liver Meeting®:
“Our data demonstrate that people who inject drugs can achieve SVR at comparable rates to non-drug using populations, even if adherence is imperfect,”

We Cured Hepatitis C - Now The Work Begins: Finding Neglected Patients  
One Health System's Efforts to Eliminate Hepatitis C

Real-World Data Show Rising HCV Epidemic Among Young Adults
Cassandra Pardini, PharmD
Results from the largest real-world study analyzing hepatitis C virus (HCV) screening practices determined that, although HCV antibody (AB) screening and confirmatory RNA testing rates are improving, the HCV epidemic continues to rise among young adults.

The study included 17,149,480 patients obtained from 2 national laboratory datasets who were screened between 2013 and 2016 based on an AB test. The study authors defined an active HCV infection as having an HCV RNA+ result following a positive AB test. The study authors added, "AB screening rates, AB+ rates, RNA follow-up testing rates, and RNA+ rates were assessed descriptively by year and stratified by baby boomers 48-71 years old and young adults 18-39 years old, to reflect the evolving disease epidemiology."

Reference: Abstract
Sulkowski MS, Marx S, Manthena SR, Strezewski J, Chirikov VV. National Estimates for HCV Screening and Diagnosis Rates in the United States (2013-2016) Based on Large Real-World Dataset. Presented at AASLD The Liver Meeting 2018. Study number 1565.

Full-Text Article
First published: 6 November 2018 - In Hepatology

Saturday, November 17, 2018

We Cured Hepatitis C - Now The Work Begins: Finding Neglected Patients

Conference Coverage:
MedPage Today
Twitter @medpagetoday

Video
IDSA Video Conference Reporter: AASLD 2018
Watch exclusive comments from study authors and discussants at AASLD 2018

One Health System's Efforts to Eliminate Hepatitis C

Douglas Dieterich, MD



Topics Of Interest 
Treatment for Non-alcoholic Fatty Liver Disease
Emerging Therapies in Ongoing NASH Studies
What a Clinician is Looking for in New NASH Tx

Thursday, November 15, 2018

In Older Hep B Patients, Carcinoma Surveillance Is Advised

Medscape Medical News > Conference News > AASLD 2018
In Older Hep B Patients, Carcinoma Surveillance Is Advised
Laird Harrison
November 15, 2018 

SAN FRANCISCO — Surveillance for hepatocellular carcinoma (HCC) should continue in patients older than 50 years, even after they have undergone 5 years of therapy for chronic hepatitis B, according to an analysis of the PAGE-B cohort.

But the risk for the cancer is low enough in younger patients — except for those with cirrhosis — that surveillance might not be warranted, said George Papatheodoridis, MD, PhD, from Athens University Medical School in Greece.

"It will save monitoring in some patients," he told Medscape Medical News.

Long-term monotherapy with entecavir (Baraclude, Bristol-Myers Squibb) or tenofovir disoproxil fumarate (Viread, Gilead) suppresses the hepatitis B virus and improves liver lesions, so the survival rate in patients without compensated cirrhosis is comparable to that in the general population, Papatheodoridis explained here at The Liver Meeting 2018...

Free registration may be required

Meeting Coverage
Twitter @Medscape

Recommended Coverage 
Updates on this blog (LINK), recommended coverage elsewhere (LINK). 

Managing DAA Failures When Treating Hepatitis C Virus Infections

Norah Terrault, MPH, MD: 
Managing DAA Failures When Treating Hepatitis C Virus Infections
NOVEMBER 14, 2018
Krista Rossi

Patient nonadherence to treatment is an ongoing issue that physicians from all specialties face. It is particularly prevalent among patients who are infected with hepatitis C virus. Gaps in treatment of any infection or condition can have deleterious effects on patient outcomes; however, new research has revealed that gaps in treatment for hepatitis C virus is no longer a deal-breaker in terms of achieving sustained viral response (SVR), including in patients who abuse drugs.

We sat down with Norah Terrault, MPH, MD, director of the Viral Hepatitis Center at University of California, San Francisco, at the 2018 American Association for the Study of Liver Diseases (AASLD) Liver Meeting, November 9-13, 2018, in San Francisco, California, to discuss gaps in treatment in people who are infected with hepatitis C virus and what steps clinicians should take when treating these patients...

Meeting Coverage 
Twitter - @MDMagazine

Recommended Coverage
View updates on this blog (LINK), recommended coverage (LINK).

Tuesday, November 13, 2018

8-week Maviret HCV genotype 1-6 & compensated cirrhosis:The EXPEDITION-8 Study

Meeting Coverage @ infohep Keith Alcorn / 14 November 2018
An 8-week course of the combination of glecaprevir and pibrentasvir (Maviret) is highly effective in curing hepatitis C in people with compensated cirrhosis, across a wide range of genotypes, Robert S. Brown of Weill Cornell Medical College reported at the AASLD Liver Meeting in San Francisco this week. Maviret is a highly effective combination of an HCV protease inhibitor (glecaprevir) and an NS5A inhibitor (pibrentasvir) that has been shown to cure hepatitis C in 98% of people without cirrhosis after eight weeks of treatment. A previous study showed that a 12-week course of the combination cured hepatitis C in 99% of people with compensated cirrhosis. The EXPEDITION-8 study was designed to test whether an 8-week treatment course was as effective in previously untreated people with compensated cirrhosis as the rate of cure achieved in the previous 12-week study.
High SVR12 rate suggests 8-week treatment could be used for this population
Read more: https://www.medpagetoday.com/meetingcoverage/aasld/76333
Coverage @ MedPage Today Twitter @medpagetoday

Recommended Coverage
View updates on this blog (LINK), recommended coverage (LINK).

Presented at the AASLD: The Liver Meeting®
Preliminary efficacy & safety of 8-week GLE/PIB in patients with #HCV genotype 1-6 infection & compensated cirrhosis: The EXPEDITION-8 Study 

LINK

Shared via @HenryEChang on twitter.





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.

Do Patients with Chronic Liver Disease Face Higher Drug-induced Liver Injury Risk?

Meeting Coverage > AASLD

Do Patients with Chronic Liver Disease Face Higher DILI Risk? 
by Molly Walker, Staff Writer, MedPage Today
November 12, 2018
Research suggests a link of which drug developers should be aware, expert says

SAN FRANCISCO -- Individuals with certain types of chronic liver disease may be particularly susceptible to drug-induced liver injury (DILI), and the pharmaceutical industry should take this population into account during drug development, an expert said here.

Indeed, some research suggested that drug-induced liver injury is linked with a higher risk of poor outcomes in patients with pre-existing liver disease, said Naga Chalasani, MD, of Indiana University School of Medicine in Indianapolis.
Read More:

Links
Meeting Updates @ MedPage Today Twitter @medpagetoday

DAA Treatment and Hepatic Fibrosis Improvement in HCV: What's the Link?

Abstract
Presented at AASLD The Liver Meeting 2018. Study number 0603.
Kommineni VT et al.

Factors Associated with Lack of Improvement in Fibrosis Following HCV Treatment.

Monthly Prescribing Reference
DAA Treatment and Hepatic Fibrosis Improvement in HCV: What's the Link?
According to the results of a prospective cohort study, 57% of patients with hepatitis C virus (HCV) infection who achieved sustained virologic response (SVR) showed no improvement in hepatic fibrosis. The study, which took place at a tertiary liver center, aimed to determine whether direct-acting antiviral (DAA) therapy reduced fibrosis and assessed whether any predictors of treatment failure existed at 1-year follow-up. A total of 193 patients were divided into 2 groups: those who achieved SVR (N=143) and those who failed treatment or did not receive it (N=50). 

Conference Articles
By Cassandra Pardini, PharmD November 13, 2018 

Hepatitis C is detectable in rectal and nasal fluid

Conference Coverage @ infohep
Hepatitis C is detectable in rectal and nasal fluid

Keith Alcorn Published: 12 November 2018

High levels of hepatitis C virus (HCV) can be found in the rectal and nasal fluids of people with high hepatitis C viral loads even when blood is not present, Austrian researchers reported on Sunday at the 2018 AASLD Liver Meeting.

The findings reinforce the plausibility of HCV transmission through sharing up rolled-up bank notes or other equipment for snorting drugs.

The findings were presented by Dr David Chromy of the Medical University of Vienna on behalf of the Vienna HIV & Liver Study Group.


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The incidence of diabetes, stroke and kidney disease falls after hepatitis C cure

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The incidence of diabetes, stroke and kidney disease falls after hepatitis C cure
Keith Alcorn Published: 12 November 2018 

The incidence of some of the most serious extrahepatic health problems caused by hepatitis C declines sharply after the infection is cured by antiviral treatment, a review of people treated for hepatitis C in the Canadian province of British Columbia has found.

The findings were presented by Carmine Rossi of the British Columbia Centre for Disease Control at the 2018 AASLD Liver Meeting in San Francisco on Sunday.

Hepatitis C infection is associated with a higher incidence of chronic kidney disease, diabetes and cardiovascular disease. Although the mechanisms leading to an increased risk of these conditions in people with hepatitis C are not fully understood, liver damage caused by hepatitis C is known to disrupt glucose metabolism. Chronic hepatitis C infection affects the cardiovascular system in numerous ways and also damages the kidneys.


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Sofosbuvir/ledipasvir cures most young children with hepatitis C

Sofosbuvir/ledipasvir cures most young children with hepatitis C
Liz Highleyman 
Published: 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 2018 AASLD Liver Meeting in San Francisco.

The prevalence of hepatitis C virus (HCV) infection is low among children in Europe and the US, though there is concern that the rate may be rising in the US as more young women become infected as a consequence of the burgeoning opioid epidemic. In some resource-limited countries such as Egypt, HCV among children is much more common.

The advent of direct-acting antiviral agents (DAAs) has revolutionised the treatment of hepatitis C for adults. These include Gilead Science's HCV polymerase inhibitor sofosbuvir (marketed alone as Sovaldi) and NS5A inhibitor ledipasvir, which are co-formulated in a 400/90mg once-daily tablet (Harvoni). 

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Full-text article downloaded & shared via twitter by Henry E. Chang:
Safety & efficacy of LDV-SOF with or without RBV for chronic hepatitis C in children ages 6-11.

Monday, November 12, 2018

The Medicines Patent Pool Signs Licence With AbbVie to Expand Access to Key Hepatitis C Treatment, glecaprevir/pibrentasvir

The Medicines Patent Pool Signs Licence With AbbVie to Expand Access to Key Hepatitis C Treatment, glecaprevir/pibrentasvir 

SAN FRANCISCO, November 12, 2018 /PRNewswire/ --
Important collaboration will ensure affordable hepatitis C treatment options in low- and middle-income countries.

The Medicines Patent Pool (MPP) has today announced a new, royalty-free licence agreement with AbbVie for glecaprevir/pibrentasvir (G/P) - a World Health Organization (WHO)-recommended treatment for people living with chronic hepatitis C (HCV). The licence will enable quality-assured manufacturers to develop and sell generic medicines containing G/P in 99 low- and middle-income countries (LMICs) and territories at affordable prices, enabling access to and treatment scale-up with the most effective pan-genotypic regimens. The agreement was launched at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2018 in San Francisco.

"G/P is a priority therapy for licensing for the MPP, so this agreement with AbbVie is very good news for public health," said Dr Marie-Paule Kieny, Chair of the MPP Governance Board. "It is a really important new option for a significant proportion of HCV patients throughout the world. As with previous MPP licences, we look forward to facilitating access to generic versions of this product as quickly as possible in as many territories as possible."

Globally, 71 million people are currently living with chronic HCV, many of them in LMICs. By the end of 2015, only 20 percent had been diagnosed and a mere seven percent of them had received treatment. In February 2017, the MPP issued its annual report on priority medicines for in-licensing. Given its favourable clinical profile and high potential in LMICs, G/P was listed as a key priority treatment.

G/P is an all-oral, once-daily, pan-genotypic combination regimen and was originally approved in 2017. It has achieved high cure (SVR12) rates of 98 per cent in treatment-naïve non-cirrhotic patients across all six genotypes of the virus. It is recommended by the WHO as a first-line treatment for eight weeks in treatment- naïve non-cirrhotic patients. Treatment-naïve patients with compensated liver cirrhosis require a 12-week treatment course.

Further, the regimen is also indicated for use in HCV patients with any degree of renal impairment, including patients on dialysis. Globally between five and ten percent of all people living with chronic HCV infection are estimated to be living with kidney disease and this treatment will be very helpful for them.

There are 95 countries and four territories included in the MPP/AbbVie licence for G/P at this point.

Hepatitis C treatment can be shortened in 50 percent of patients, study finds

Hepatitis C treatment can be shortened in 50 percent of patients, study finds
Shorter treatment times could significantly reduce costs of the expensive therapy

Loyola University Health System

MAYWOOD, IL - Hepatitis C drugs cure more than 90 percent of patients, but can cost more than $50,000 per patient.

Findings from a new study could lead to significant cost savings. Preliminary data from the study, co-led by a theoretical modeling researcher from Loyola University Chicago Stritch School of Medicine and Loyola Medicine, found that in 50 percent of patients, the standard 12-week treatment regimen could be shortened to as little as six weeks without compromising efficacy.

"There's a potential to save up to 20 percent of the costs of hepatitis C drugs," said Loyola researcher Harel Dahari, PhD, co-first author of the study along with Ohad Etzion, MD, of Soroka University Medical Center in Israel. Senior author is Amir Shlomai, MD, PhD, of Beilinson Hospital in Israel.

The study was presented November 12 during the annual meeting of the American Association for the Study of Liver Diseases in San Francisco.

Dr. Dahari is co-director of the Program for Experimental and Theoretical Modeling (PETM) in the division of hepatology of Loyola Medicine and Loyola University Chicago Stritch School of Medicine. Two other Loyola authors are Susan Uprichard, PhD, co-director of PETM and an associate professor in the department of microbiology and immunology and Scott Cotler, MD, head of Loyola Medicine's division of hepatology and a professor in the department of medicine of Loyola University Chicago Stritch School of Medicine.

Hepatitis C is an infection caused by a virus spread through contaminated blood. It can lead to liver damage, liver failure and liver cancer. An estimated 70 million people worldwide, including about three million in the United States, are chronically infected with hepatitis C.

A class of oral medications called direct acting anti-virals (DAA) has revolutionized the treatment of hepatitis C. In more than 90 percent of patients, the medications eliminate the virus and cure the patient, with minimal side effects. But the high cost limits access and is a substantial financial burden on Medicare, Medicaid and private insurers.

"Treatment currently is standardized to be given for a set period of time, usually 12 weeks, rather than being tailored to the individual patient," Dr. Cotler said.

In the new study, researchers used a personalized medicine technique called modeling-based response-guided therapy to reduce treatment times when possible. After patients had undergone treatment for a few weeks, researchers measured how much hepatitis C virus levels had decreased. They used mathematical modeling to estimate how long it would take to completely eliminate the virus.

The study has included 22 patients so far. Mathematical modeling predicted that treatment could be shortened to 10 weeks in one patient (five percent of the total patients), eight weeks in eight patients (36 percent) and six weeks in two patients (nine percent). The other 11 patients (50 percent) needed to be treated for the standard 12 weeks.

Twenty-one patients remained virus-free. The only patient who relapsed had the most difficult-to-treat form of the hepatitis C virus, known as genotype 3.

The proof-of-concept pilot study showed that using response-guided therapy to reduce treatment times is feasible. To validate the results, a large multicenter trial is underway in Israel.

Dr. Dahari said that in addition to cutting costs, shorter treatment regimens would make it easier to treat hepatitis C patients who have limited health insurance benefits.

###
The study was conducted with David Yardeni, MD, Anat Nevo-Shor, MD, Daniela Munteanu, MD, and Naim Abufreha, MD, of the Department of Gastroenterology and Liver Diseases, Soroka University Medical Center, Beesheba, Israel; Assaf Issachar, MD, Michal Cohen-Naftaly, MD, Orly Sneh Arbib, MD, and Marius Braun, MD, of the Liver Institute, Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel; and Orna Mor, PhD, of the Central Virology Laboratory, Ministry of Health, Sheba Medical Center, Israel.

The study is titled, "Response-Guided Therapy with DAA Shortens Treatment Durations in 50 Percent of HCV-Treated Patients."

The study was supported in part by Clalit, a health service organizaton in Israel and the U.S. National Institutes of Health. 

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."
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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.

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