Ira M. Jacobson MD: 8-week therapy for patients with HCV infection

Clinical Care Options 

How New Data From AASLD 2017 Inform the Use of 8-Week Regimens for HCV
Ira M. Jacobson MD - 1/9/2018
Several studies presented at the 2017 AASLD meeting in Washington, DC, assessed 8-week therapy for patients with HCV infection. In this commentary, I discuss how key data from these studies may have an impact on management of patients with HCV infection.

Studies discussed:

8-Week GZR/EBR for Treatment-Naive, Noncirrhotic Patients With Genotype 1b HCV Infection
GLE/PIB for Treatment-Naive Genotype 3 HCV
8-Week LDV/SOF for Acute Genotype 1 or 4 HCV and HIV Coinfection

Free registration required
https://www.clinicaloptions.com/Hepatitis.aspx

New At Clinical Care Options 
New Insights on NAFLD/NASH From AASLD 2017
Philip Newsome PhD, FRCPE - 1/8/2018
Here’s my take on how new data from AASLD 2017 on noninvasive imaging modalities and emerging investigational agents may affect the NAFLD/NASH patient management landscape.

How Injection Drug Use Affects HCV Treatment
Norah Terrault MD, MPH - 1/3/2018
Here’s my take on why colocalization of HCV treatment with other medical and social services may be ideal for persons who inject drugs. 

Watch - Breaking News On HCV Regimens

AASLD Symposium 

Released Online December 7, 2017
Great program for savvy patients to learn more about the treatment of hepatitis C.

Breaking News On HCV Regimens: An Interactive Case-based Symposium

Hosted by Fred Poordad, MD; Robert S. Brown, Jr., MD, and MPH; Kris V. Kowdley, MD.

Chapters

1. Breaking News and Introduction
2. CASE 1: GT1a Treatment-Naïve Patient with Early-Stage Disease
3. CASE 2: GT3 Treatment-Experienced Patient with Compensated Cirrhosis
4. CASE 3: GT1b Patient with Renal Disease Who Previously Failed NS5A Therapy 

5. Q&A

Begin here.......

Summary from AASLD 2017 for Hepatitis C HCV: Game over?

Conference Reports from NATAP

Summary from AASLD 2017 for Hepatitis C HCV: Game over?
Jurgen K. Rockstroh M.D., Professor of Medicine
Department of Medicine I, University Hospital Bonn, Bonn, Germany

Introduction
The AASLD Liver Meeting was held in October from 20-24th, 2017 in Washington DC, USA. Many regular AASLD attendees will still remember the completely packed late breaker sessions from recent years, full of phase II and III new direct acting antiviral (DAA) combination trials in varying patient populations. At this year AASLD Liver Meeting, no new DAA combination study results were presented in these sessions but rather were replaced by new drug trials for treatment of NASH or primary sclerosing cholangitis. Indeed, the only two new dual and triple DAA combinations, which were presented at the meeting, were accompanied by press releases from the respective companies Merck and Janssen, which announced the termination of their DAA development programs (1-2). Nevertheless, important new findings from the HCV research space were reported including issues around HCV screening, how to improve linkage to care, and treatment results from many different patient populations and real-life cohorts as well as post HCV cure monitoring. Reassuringly, the high success rates of all oral DAA therapy was further confirmed from a wealth of data particularly from somewhat more challenging HCV patient populations including: PWIDs, patients with concomitant advanced kidney disease, patients before and after kidney or liver transplantation, HCV genotype 3 infection and patients with unfavorable HCV disease characteristics, including compensated and decompensated cirrhosis (3-11). However, there was also data on shorter treatment durations for patients with more favorable HCV disease characteristics such as for non-cirrhotic GT1b patients (12). In addition, there was also new data around retreatment of previous DAA failures (with documented resistance development) with new DAA combinations (13-14). In the area of HIV-coinfection, clearly outcomes of the ACTG trial on treatment of acute hepatitis C in HIV-seropositive individuals for eight weeks with ledipasvir/sofosbuvir (LDV/SOF) were also new and noteworthy (15). Of interest were also reports on the increases in acute HCV infections among HIV-seropositive men who have sex with men (MSM) and the high risk of reinfection in particular patient populations (16-17). Further data was also presented on the question whether there is an increased risk for hepatocellular carcinoma in DAA treated patients from large real-life cohorts and what impact SVR has on clinical endpoints under continued follow-up (18-22).

The following AASLD summary report tries to capture the major new findings and results presented around the topics raised above, as well as to outline some of the status reports of HCV treatment implementation on a global level. Clearly, the successes of modern HCV DAA combination therapy still have not reached all in need for these treatments.

Continue reading... http://www.natap.org/2017/AASLD/AASLD_148.htm

Hepatitis November Newletters & Watch: Comprehensive Expert Review Of AASLD 2017

Newsletters
Welcome to this month's index of newsletters, with follow up links to basic information, research and current news about viral hepatitis.

HepCBC - The Week in Review
Read the latest issue of: Weekly Bull

HCV Advocate
HCV Advocate: November Newsletter
Updated fact sheets: Children and HCV.

In this month's newsletter results from a real-world study is summarized by Alan Franciscus, the study examined retreatment of HCV patients who developed NS5A resistance. Hepatitis C-related liver cancer is featured as well, from symptoms, diagnosis, prevention, to FDA approved medications to treat liver cancer. In addition, the always brilliant Lucinda K. Porter, writes about, "Living with Hepatitis C and Stress." A special thank you to Matthew Zielske, for his eloquent article exploring the sometimes frustrating, yet always amazing, side of advocacy.

Follow Up Link
Healio 
Focus On Children With Viral Hepatitis - 2017 World Hepatitis Summit
Focus on children with viral hepatitis
Recent data revealed that, worldwide, 52 million children are living with viral hepatitis, compared with 2.1 million children with HIV or AIDS, according to data presented at the World Hepatitis Summit 2017 in São Paulo, Brazil.

The 2017 World Hepatitis Summit is a joint initiative between the World Health Organization (WHO) and the World Hepatitis Alliance (WHA) to advance the viral hepatitis agenda.
News & Updates

Patient Support - I Help C
Karen Hoyt shares her own journey living with cirrhosis and liver cancer, to the emotional ups and downs of her lifesaving liver transplant. 
Blog
Videos

Recent articles: Long-Term Success After Hep C Treatment
Emergency Room Diagnosis with Liver Cirrhosis.

The New York City Hepatitis C Task Force

A few topics in the November Newsletter include; NYC Health Department’s 2016 Hepatitis B and C Annual Report, and upcoming activities.

Also mentioned in this months newsletter, is the following documentary highlighting the impact of hepatitis B on the Asian American community, released in October by Gilead.

Follow Up Link
Hepatitis B Foundation
If you have recently been diagnosed with hepatitis B, a new article helping patients cope with various stages of emotions associated with a new HBV diagnosis can be found online at Hep B Blog.
Link: Navigating Our Emotions When We’re First Diagnosed with Hepatitis B

British Liver Trust
All Newsletters
In The News
UK elimination of hepatitis C in jeopardy unless more patients found
Just one in three people with hepatitis C in the UK have been diagnosed according to the latest estimates released at this year’s World Hepatitis Summit in Sao Paulo, Brazil (1-3 November).

GI & Hepatology News

View all newsletters, here.

NIH News in Health

Check out the November NIH News In Health Newsletter, with practical health news and tips based on the latest NIH research.

New Online
ViralEd has started updating: Advances in Chronic Hepatitis C: Management and Treatment, an expert review of the 68th American Association for the Study of the Liver Diseases Annual Meeting (AASLD 2017). This program will feature HCV experts reviewing and discussing the most important studies on chronic hepatitis C presented at the meeting.

View the first presentation: Survival Benefit of Direct-Acting Antiviral Therapy in Patients with Decompensated Cirrhosis,and download the abstract, seven additional presentations coming soon.....

In Case You Missed It
National Viral Hepatitis Progress Report
Report highlighting the nation's progress toward reducing the burden of hepatitis A virus (HAV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infections.

In The Journals 

Clinical Liver Disease - HCV treatment in patients with decompensated liver disease
Elizabeth C. Verna
Published 31 October, in Clinical Liver Disease (CLD)
Full Text (HTML)
Watch a video presentation of this article

Controversies in hepatitis C therapy: Reactivation of hepatitis B virus

Authors Sarah R. Lieber, Michael W. Fried

First Published: 31 October 2017 in Clinical Liver Disease (CLD)

Full Text (HTML)
Watch a video presentation of this article

BMC Infectious Diseases

Testing for chronic hepatitis B and C – a global perspective. 
An open access supplement published during the 2017 World Hepatitis Summit in BMC Infectious Diseases, relating to the WHO 2017 Guidelines on hepatitis B and C testing, provides an array of information to tackle accurate diagnostic testing for viral hepatitis.

Thanks for stopping by, enjoy the rest of your weekend.
Tina

Fatty Liver Common After Direct-Acting Antivirals for Hep C

Medscape Conference Coverage: The Liver Meeting 2017: American Association for the Study of Liver Diseases (AASLD)

Fatty Liver Common After Direct-Acting Antivirals for Hep C
Damian McNamara

October 30, 2017

WASHINGTON, DC — Evidence of steatosis is found in almost half the patients with hepatitis C who achieved a sustained virologic response after treatment with direct-acting antivirals, results from a prospective study show.

"Fatty liver is very common now that hepatitis C is being treated effectively," said Mazen Noureddin, MD, from Cedars-Sinai Medical Center in Los Angeles.

American and European guidelines state that a patient can be discharged from care in the absence of cirrhosis and elevated liver enzymes, but "we wanted to see what happens after direct-acting antiviral treatment," he said.

Steatosis was "very prevalent" in the study population, "although liver enzymes were normal," Dr Noureddin reported here at The Liver Meeting 2017.

Monitoring people for steatosis after a sustained virologic response is not common practice, he told Medscape Medical News, but these findings suggest that long-term monitoring is warranted.

Long-term Monitoring Needed
In their study, Dr Noureddin and his colleagues compared transient elastography findings (FibroScan, Echosens) in 101 patients — 49 men and 52 women — before and after they were treated with direct-acting antivirals. After each participant achieved a sustained virologic response, the researchers used the controlled attenuation parameter (CAP) to assess liver fat.

Mean age of the participants was 60 years and mean body mass index (BMI) was 28 kg/m². In addition, 36% of the patients were white, 25% were Hispanic, and 90% had diabetes. The hepatitis C infection was genotype 1 in 86% of the patients, genotype 2 in 13%, and genotype 4 in 1%. People with genotype 3 infection were excluded from the analysis because the etiology of hepatic steatosis is different in this population.

Decreases were significant in alanine transaminase (ALT) and aspartate transaminase (AST) levels and fibrosis scores from baseline to the achievement of sustained virologic response (P < .05).
In the study cohort, 48% of the patients showed evidence of steatosis after treatment, 6% of whom had advanced fibrosis. None of the 52% of patients without steatosis showed evidence of advanced fibrosis, defined as a score of at least 11 kPa.

For patients with steatosis, weight did not change during the study period. However, there were significant differences between these patients and those without steatosis.

Table. Mean Values After Patients Achieved a Sustained Virologic Response

Parameter	Patients With Steatosis	Patients Without Steatosis	P Value
BMI	29 m/kg²	26 m/kg²	<.05
Glucose level	108 mg/dL	96 mg/dL	<.05
ALT level	20 mg/dL	15 mg/dL	<.05
CAP score	297 dB/m	214 dB/m	<.05
Fibrosis score	7.0 kPa	5.3 kPa	<.05

"We need more follow-up," said Dr Noureddin. "We looked at patients 8 weeks after treatment. Next, we want to follow patients longitudinally to see if more patients with a fatty liver also develop fibrosis."

The study showed that even after achieving a cure for hepatitis C, approximately 50% of those patients demonstrated evidence of NAFLD.

"This is one of the most important studies presented at this meeting," said Naim Alkhouri, MD, from the Texas Liver Institute in San Antonio.

"The treatment of chronic hepatitis C infection has been revolutionized by the introduction of highly effective direct-acting antivirals, with cure rates of 95% or higher," he told Medscape Medical News. "However, the study showed that even after achieving a cure for hepatitis C, approximately 50% of those patients demonstrated evidence of NAFLD, which may increase their risk for liver cirrhosis and liver cancer."

"The use of FibroScan with CAP to assess for the presence of NAFLD and fibrosis progression should be considered in patients who are cured from hepatitis C infection," Dr Alkhouri said.

Dr Noureddin is a speaker and advisor for EchoSense. Dr Alkhouri has disclosed no relevant financial relationships.

The Liver Meeting 2017: American Association for the Study of Liver Diseases (AASLD): Abstract 2155. Presented October 23, 2017.

Follow Medscape Gastroenterology on Twitter @MedscapeGastro and Damian McNamara @MedReporter

https://www.medscape.com/viewarticle/887760#vp_1

Liver Meeting 2017: Diabetes Medications Have Different Effects on the Liver

Conference Coverage from
The Liver Meeting 2017: American Association for the Study of Liver Diseases (AASLD)

Diabetes Medications Have Different Effects on the Liver

Damian McNamara

October 26, 2017

WASHINGTON, DC — For people with advanced liver fibrosis due to nonalcoholic fatty liver disease (NAFLD) who also have type 2 diabetes, outcomes are better with metformin than with sulfonylureas, results from a large international trial show.

"The patients who use metformin can see a long-term benefit," Eduardo Vilar-Gomez, MD, from the Indiana University School of Medicine in Indianapolis, said here at The Liver Meeting 2017.

With metformin, survival improves and the risk for hepatic decompensation and hepatocellular carcinoma decreases.

"The bad news is that taking sulfonylureas can increase mortality and increase hepatic decompensation, in particular, in those taking sulfonylurea monotherapy," he told Medscape Medical News.

Therefore, clinicians should to "try to identify patients with higher rates of decompensation and avoid administration of sulfonylureas," he advised.

Read the article at Medscape......

Liver Meeting 2017: I'm A HCV Patient - Show Me What I Need To Know!

Summary 2018 Meeting
December 1, 2018
After The Liver Meeting 2018 Summary: Viral Hepatitis & Fatty Liver Disease
Follow each post-meeting link provided 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.

Summary - 2017 Meeting
Hi folks, because this blog has always been about you, the patient, I put together a quick overview of the Liver Meeting, using easy to follow video clips, and future learning activities.

Update: Released Online December 7, 2017 - AASLD Symposium
Breaking News On HCV Regimens: An Interactive Case-based Symposium
Watch experts Fred Poordad, MD; Robert S. Brown, Jr., MD, and MPH; Kris V. Kowdley, MD, discuss the following topics:

1. Breaking News and Introduction
2. CASE 1: GT1a Treatment-Naïve Patient with Early-Stage Disease
3. CASE 2: GT3 Treatment-Experienced Patient
4. CASE 3: GT1b Patient with Renal Disease Who Previously Failed NS5A Therapy

5. Q&A

Quick Review 

Jump over to Practice Point, sit back and watch 5 minute video clips reviewing each day of the meeting. The good doctor, Mark Sulkowski, will discuss SVR results, toxicity/adverse events, drug interactions, and HCV management. Although, a free registration is required, its worth the time you'll save looking elsewhere for cure rates that either correlate with your own stage of disease or genotype.

Clinical Clips Each Day Of The Meeting - ‘What you need to know in 5-minutes’
Hosted by Mark Sulkowski, MD

I have summarized each video, followed with a link to a few study results (slides), commentary and media coverage.

Day 1
October 21  - Summary
1 - Treatment: Access in the US, active or recent drug use.
2 - Liver transplant patients HCV genotype 1-4.
3 - Treatment with glecaprevir + pibrentasvir, impact of treatment on renal, cardiovascular and metabolic comorbidities. What happens after a patient is cured. SVR, cohort of persons in clinical trials followed for up to 2.5 years; extreme low rates of liver-related events.
Watch Video Clip (LINK)

Access to treatment in the United States - Medicaid and Medicare
Abstract 561 -  Disparate Access Based on Insurance Status to Highly Effective Direct Acting Antivirals (DAA) for Hepatitis C Virus Treatment in the Post-DAA Era Persists: Alarmingly Impaired Access in Medicaid Recipients

Liver transplant patients HCV genotype 1-4
Abstract  - Sofosbuvir/Velpatasvir for 12 Weeks in Genotype 1-4 HCV-Infected Liver Transplant Recipients

Of Interest - HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C

Patients Who Develop Recurrent HCV Infection Post Liver Transplantation

Treatment with glecaprevir + pibrentasvir  impact of treatment on renal, cardiovascular and metabolic comorbidities
Abstract - Pan-genotypic hepatitis C treatment with glecaprevir + pibrentasvir resulted in improvement in cardiovascular and metabolic extrahepatic manifestations and stable renal function: Results from phase 3 clinical trials

SVR cohort of persons in clinical trials followed for up to 2.5 years; extreme low rates of liver-related events
Abstract - Long-Term Follow Up of Patients with Chronic HCV and No or Minimal Fibrosis Shows Low Risk for Liver-Related Morbidity and Mortality After Achieving SVR with DAA-Based Therapy: Results from the Gilead SVR Registry

Day 2

October 22 - Summary
1 - Mavyret (glecaprevir/pibrentasvir) for genotype 3 patients treated for 8 and 12 weeks with and without cirrhosis; SVR and relapse rates.
2 - Mavyret in patients with genotype 1-6.
3 - Harvoni (Ledipasvir/Sofosbuvir) genotype 1 with kidney disease.
4 - Quality of life in patients achieving SVR in a long-term study.
5 - VA study, does cure matter, reduce in liver cancer, improved survival.
6 - Risk calculator, can you predict which person after SVR will develop liver cancer, calculator will soon be on VA hepatitis website.
Watch Video Clip (LINK)

Commentary 
Maviret cures most people with HCV genotype 3 and those with cirrhosis
Steven Flamm of Northwestern Feinberg School of Medicine in Chicago and colleagues performed an integrated analysis of efficacy and safety data from phase 2 and 3 clinical trials of glecaprevir/pibrentasvir for previously untreated people with HCV genotype 3, either without cirrhosis or with compensated cirrhosis.
http://www.aidsmap.com/iMavireti-cures-most-people-with-HCV-genotype-3-and-those-with-cirrhosis/page/3183352/

(Slides) Mavyret (glecaprevir/pibrentasvir) for genotype 3 patients treated for 8 and 12 weeks
Efficacy and Safety of Glecaprevir/Pibrentasvir for 8 or 12 Weeks in Treatment-naïve Patients with Chronic HCV Genotype 3: An Integrated Phase 2/3 Analysis
Conference Coverage - NATAP

(Slides)Mavyret in patients with genotype 1-6
Efficacy, Safety, and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis
Conference Coverage - NATAP 

(Slides) Harvoni (Ledipasvir/Sofosbuvir) genotype 1 with kidney disease 
Safety and Efficacy of Treatment With Once-Daily Ledipasvir/Sofosbuvir (90/400 mg) for 12 Weeks in Genotype 1 HCV-Infected Patients With Severe Renal Impairment 
Conference Coverage - NATAP  

Abstract 64. Significant and Sustained Improvement of Health-Related Quality of Life (HRQL) Scores in Patients with Hepatitis C (HCV) and Sustained Virologic Response (SVR)

Hepatitis C cure leads to improved quality of life
Commentary - Quality of life in patients achieving SVR in a long-term study.
Liz Highleyman
Cirrhosis, depression, anxiety and fatigue were independent predictors of lower health-related quality of life scores in a multivariate analysis. However, after adjusting for baseline levels, people with cirrhosis, depression, fatigue, insomnia and type 2 diabetes saw larger gains, suggesting that people with co-morbidities may experience the largest improvements after achieving SVR, Younossi said.
Read the article - http://www.infohep.org/Hepatitis-C-cure-leads-to-improved-quality-of-life/page/3182893/

(Slides) VA study, does cure matter, reduce in liver cancer, improved survival
Impact of Sustained Virologic Response with Direct-Acting Antiviral Treatment on Mortality and Hepatocellular Carcinoma - significantly lower mortality, HCC 60% to 84% -

Conference Coverage - NATAP 

AASLD Press Release
The Liver Meeting® - Direct‐Acting Antiviral Therapy Cuts Liver Cancer Risk By 71%

Reuters Health
Direct-acting Antivirals Cut Risk of Liver Cancer
"Our results, I think, are very definitive as far observational studies go, in that we did show that the eradication of hepatitis C with DAAs was associated with a 71% reduction in hepatocellular cancer risk," Dr. Ioannou told Reuters Health. "Eradicating hepatitis C will have a tremendous benefit in reducing liver cancer in individuals and in the entire population," he added in the news release. "Physicians and patients should not be withholding antiviral treatment for fear of inducing liver cancer. On the contrary, physicians should be treating hepatitis C specifically to reduce the risk of liver cancer."

Of Interest

Vets with HCV Might Settle Cancer Controversy
VA experience seems to rule out possible cancer-causing effect of new drugs

In the largest cohort analyzed to date -- some 62,000 patients in the VA system -- there is no evidence that therapy with newer agents that act directly against the virus (DAAs) increases the risk of hepatocellular carcinoma (HCC), according to George Ioannou, BMBCh, of the Veterans Affairs Puget Sound Health Care System in Seattle.
Read the article -  https://www.medpagetoday.com/meetingcoverage/aasld/68717

Day 3

October 23  - Summary
1 - Treatment as prevention in high risk populations, active drug use, risk for HCV infection.
2 - Opioid agonist treatment for acute, first infection or re-infection.  

Watch Video Clip (LINK)

Treatment as prevention in high risk populations - testing.

(Slides) abstract 125 - The Impact of Hepatitis C Diagnosis on Substance-Use Behaviors in Patients Engaged in Opioid Substitution Therapy - HCV screening/diagnosis reduces drug use by 33% (non-prescribed opioids, benzodiazepines and cocaine)

Conference Coverage - NATAP

Low reinfection
(Slides) - HEPATITIS C VIRUS REINFECTION AND INJECTING RISK BEHAVIOR FOLLOWING ELBASVIR/GRAZOPREVIR TREATMENT IN PARTICIPANTS ON OPIATE AGONIST THERAPY: C-EDGE CO-STAR PART B

Conference Coverage - NATAP

Opioid agonist treatment for acute, first infection or re-infection 

(Slides) - A5327 Sofosbuvir-Containing Regimens Without Interferon for Treatment of Acute HCV in HIV-1-infected Individuals (SWIFT-C)

Conference Coverage - NATAP

AASLD Press Release

The Liver Meeting® 2017 - Screening for Hepatitis C Improves Opioid Abuse Treatment Outcomes

Hepatitis C virus, commonly called HCV, is a liver disease that ultimately can cause cirrhosis (scarring of the liver), liver cancer and liver failure. HCV is mainly contracted when a person comes in contact with an infected person’s blood. One of the most common ways to contract HCV is through needle sharing to inject drugs – thus making HCV an additional concern for those working to combat the opioid epidemic.

Commentary
Hepatitis C testing linked to reduced opioid use among people who inject drugs
"Patients diagnosed with HCV reduced their non-prescription drug use, including benzodiazepines and cocaine, in the year following diagnosis," the researchers concluded. "This highlights the importance of screening individuals in OST for HCV, as this alone may have a positive impact on their drug use activity."

Journal Of Hepatology - Shared by Henry E. Chang on twitter
Should we treat acute hepatitis C? A decision and cost-effectiveness analysis

It is not standard practice to treat patients with acute hepatitis C virus (HCV) infection. However, as the incidence of HCV in the United States continues to rise, it may be time to re-evaluate acute HCV management in the era of direct-acting antiviral agents (DAAs).

Day 4

October 24  - Summary
1 - The development of new drugs to treat HCV ends.
2 - Getting difficult people linked to care. 
3 - Treatment adherence, Mavyret
4 - SVR rates in patients who were Non adherent (defined at less than 80%) vs adherent, more than 80%. How many pills can you miss? What were the SVR rates in both groups?
Watch Video Clip (LINK)

Linkage to care
(Slides) - Randomized Controlled Trial of Cash Incentives or Peer Mentors to Improve HCV Linkage and Treatment Among HIV/HCV Coinfected Persons Who Inject Drugs: The CHAMPS Study 
Conference Coverage - NATAP

Treatment adherence Mavyret
(Slides) - Adherence to Pangenotypic Glecaprevir/Pibrentasvir Treatment and SVR12 in HCV-infected Patients: An Integrated Analysis of the Phase 2/3 Clinical Trial Program

(Slides) - C-BREEZE-2: Efficacy and Safety of a Two-Drug Direct-Acting Antiviral Agent Regimen Ruzasvir 180 mg and Uprifosbuvir 450 mg for 12 Weeks in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 3, 4, 5, or 6 

Commentary
New three-drug HCV regimen shows nearly 100% response in 6, 8 weeks
Zeuzem and colleagues presented findings for a three-drug combination called JNJ-4178 that includes the NS5B inhibitor AL-335 (Achillion) at 800 mg, the NS5A inhibitor odalasvir (Achillion) at 25 mg, and Olysio (simeprevir, Janssen) at 75 mg once daily. Researchers followed eligible participants for 24 weeks after the end of treatment.

(Slides) - Evaluation of the efficacy and tolerability of JNJ-4178 (AL-335, odalasvir, and simeprevir) in hepatitis C virus-infected patients without cirrhosis: The Phase IIb OMEGA-1 study 

The presentation was summed up nicely, noting that as the HCV pipeline ends, the task at hand is now testing, access to care and treatment.  

Testing
Implementation of Hepatitis C Elimination
John Ward, MD, CDC

(LINK) - Coverage At NATAP
ID Week San Diego CA October 4-8, 2017

Access To Care 

State of Hepatitis C Medicaid Access

This week, National Viral Hepatitis Roundtable (NVHR) together with The Center for Health Law & Policy Innovation of Harvard Law School (CHLPI) launched Hepatitis C: State of Medicaid, an in-depth evaluation of treatment access in each state’s Medicaid program, while highlighting successes in access expansion as well as ongoing challenges. Over half of Medicaid programs received a “D” or an “F” for imposing discriminatory restrictions on hepatitis C cures.
View an Interactive Map - Click on your state to find out - State of Hepatitis C Medicaid Access - read your states full report, this includes: Liver damage restrictions, Sobriety restrictions, Prescriber restrictions with recommendations, and download the full report: 2017 NATIONAL SUMMARY REPORT.

Some state Medicaid programs continue to restrict access to hepatitis C drugs

By Ed Silverman @Pharmalot
October 23, 2017
Over the past three years, state Medicaid programs have done a much better job of disclosing information about access to expensive hepatitis C medicines and fewer are restricting treatment to patients, according to a new analysis.

Opioid Epidemic

One of the most dramatic medical success stories in recent years has been the introduction of new drugs that eradicate hepatitis C virus (HCV). But it's a different story among HCV patients with substance use disorders. This population typically does not have easy access to conventional health care so it is difficult to screen, diagnose and treat these individuals.
Read the article - Solving the hepatitis C epidemic among people with substance abuse disorders

Surgeon General: We will conquer HCV, opioids ‘one bite at a time’
During a session focused on the connection between the hepatitis and opioid epidemics at The Liver Meeting 2017, Jerome M. Adams, MD, MPH, Surgeon General of the U.S., advised physicians in attendance that hepatitis C elimination will require nontraditional partnerships and innovative strategies for education, prevention and screening.

“I want to ask you all a question that I hope all of you know the answer to,” Adams said to the audience. “How do you eat an elephant? One bite at a time. If you take one bite at a time, if you help all of our partners see which part of that elephant they can take a bite of, we will be able to consume that elephant that is the opioid epidemic.”
Read article available online at Healio

HCV Advocate
UNDER THE UMBRELLA Hepatitis C Statistics and Information: The Elephant in the Room
Matthew Zielske
Statistics are used in the fight to end the hepatitis C epidemic and the opioid crisis; stats show the way certain things have been, most likely are right now and will reasonably end up if nothing is done. Besides laying a foundation for understanding a certain event or situation, statistics and information are neatly packaged inside national ad campaigns and marketing materials. They make their way from the boardrooms of government agencies, private and nonprofit organizations and pharmaceutical companies, to our televisions and smartphones.
Read the article here  (LINK)

HCV In The Older Patient 

(Slides) - Safety and Efficacy of 12 Weeks of Elbasvir (EBR)/Grazoprevir (GZR) in Hepatitis C Virus (HCV) GT1- and GT4-Infected Participants 65 Years and Older: An Integrated Analysis of Twelve Clinical Trials
Conference Coverage - NATAP

ABSTRACT FINAL ID: 1577 - Does age matter? Direct-acting antiviral therapy for hepatitis C in a real-life cohort of elderly patients: pretreatment drug-drug interactions, tolerability and efficacy of current treatment regimens.

Great Article - Published in Infectious Diseases Clinics

HCV in the Older Patient - Natural history, extrahepatic disorders, safety and efficacy of treatment regimens

Read the article - http://hepatitiscnewdrugs.blogspot.com/2017/10/hcv-in-older-patient-natural-history.html

HCV In Our Young People 

Hepatitis C Is Threatening Our Youth
October 23, 2017 • By Lucinda K. Porter, RN

Hepatitis C is the most common bloodborne virus in the U.S. More people die every year from hep C than all 60 reportable infectious diseases combined, including HIV. Historically, hepatitis C virus infection (HCV) was considered a baby boomer disease; a legacy that we hoped would die with us. However, we got that wrong. Today’s opioid crisis is causing a new wave of HCV infections, and is threatening our youth.
Read the article - https://www.hepmag.com/article/hepatitis-c-threatening-youth

Save The Date - Advances in Chronic Hepatitis C: Management and Treatment
Next week, ViralEd will slowly launch a series of video modules with comprehensive coverage of the meeting, hosted by a panel of leading HCV experts. On Nov 3rd: Advances in Chronic Hepatitis C: Management and Treatment, will be available for your viewing pleasure.
Begin here - http://www.viraled.com/modules/info/aasld_2017_comp_review.html

Video - Review Of HCV Treatment Data
VIDEO: Expert reviews promising treatment data from The Liver Meeting 2017
WASHINGTON, D.C. — In this exclusive video from The Liver Meeting 2017, Kris V. Kowdley, MD, FAASLD, of the Swedish Medical Center, Liver Care Network, Seattle, highlights some of the ground-breaking presentations from the meeting.

Fatty Liver
Fatty Liver Common After Direct-Acting Antivirals for Hep C
Medscape Conference Coverage: The Liver Meeting 2017: American Association for the Study of Liver Diseases (AASLD)
Damian McNamara
October 30, 2017
WASHINGTON, DC — Evidence of steatosis is found in almost half the patients with hepatitis C who achieved a sustained virologic response after treatment with direct-acting antivirals, results from a prospective study show.

Helpful Links

December 1, 2017

Summary from AASLD 2017 for Hepatitis C HCV: Game over?

HCV Guidance Updates

New Treatment-Naïve & Treatment-Experienced
The following pages include guidance for management of treatment-naive patients.
Genotype 1
Genotype 2
Genotype 3
Genotype 4
Genotype 5 or 6

The following pages include guidance for management of treatment-experienced patients.

Genotype 1
Genotype 2
Genotype 3
Genotype 4
Genotype 5 or 6

Stay current with all guideline updates, "click here."

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Primary Care Screening for Fatty Liver Disease Debated

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The Liver Meeting 2017: American Association for the Study of Liver Diseases (AASLD)

Primary Care Screening for Fatty Liver Disease Debated
Damian McNamara
October 23, 2017

"We are well aware that more than 50% of patients with fatty livers have normal ATL values," he pointed out. And interoperator variability and "poor predictive ability for diagnosis of fibrosis and steatosis" limit the utility of ultrasonography, which is also commonly used to evaluate patients for liver disease. Liver biopsies are more accurate, but they are invasive, he added.

For their study, Dr Hassanein and his colleagues implemented a 16-week transient elastography screening program at a primary care clinic in Chula Vista, California. They offered screening to 1298 consecutive patients, and ended up with 958 evaluable scans.

Operators used a hand-held FibroScan probe, from Echosens, to assess liver stiffness, an indication of fibrosis, and a controlled attenuation parameter (CAP) score to detect steatosis.

Read the article (LINK)

Surgeon General: We will conquer HCV, opioids ‘one bite at a time’

Surgeon General: We will conquer HCV, opioids ‘one bite at a time’
During a session focused on the connection between the hepatitis and opioid epidemics at The Liver Meeting 2017, Jerome M. Adams, MD, MPH, Surgeon General of the U.S., advised physicians in attendance that hepatitis C elimination will require nontraditional partnerships and innovative strategies for education, prevention and screening.

“I want to ask you all a question that I hope all of you know the answer to,” Adams said to the audience. “How do you eat an elephant? One bite at a time. If you take one bite at a time, if you help all of our partners see which part of that elephant they can take a bite of, we will be able to consume that elephant that is the opioid epidemic.”

Read article available online at Healio

The Liver Meeting® 2017- Conference Coverage

VIDEO: AASLD to speak on Capitol Hill on the public health burden of NAFLD

WASHINGTON — In this exclusive video from The Liver Meeting 2017, Arun Sanyal, MD, FAASLD, from the Virginia Commonwealth University…

Fewer HCC cases from HCV clearance improves quality of life, cost savings

October 23, 2017

WASHINGTON — Through treatment of hepatitis C genotype 1 with direct-acting antivirals, significant direct and indirect cost savings may…

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Liver Meeting 2017 - Nutrition status predicts outcomes in liver transplant

Nutrition status predicts outcomes in liver transplant

Publish date: October 23, 2017

By: Denise Fulton Frontline Medical News

We saw a “high prevalence of malnutrition in patients undergoing liver transplant and the deterioration in nutritional status despite our best efforts while they are on the waiting list,” Ms. Chapman said.

At baseline, two-thirds of patients were malnourished – either mildly to moderately or severely; by transplantation, 77% were malnourished.

Read the article at GI & Hepatology News

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Liver Meeting 2017 - VIDEO: Fibrosis biomarkers show promise to replace liver biopsy

VIDEO: Fibrosis biomarkers show promise to replace liver biopsy

Publish date: October 23, 2017

By: Eli Zimmerman Frontline Medical News

WASHINGTON – The concentrations of three biomarkers successfully identified the severity of fibrosis in patients with nonalcoholic steatohepatitis (NASH), according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.

This noninvasive diagnostic method could replace liver biopsy, the current standard used to diagnose patients with NASH.
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Hepatitis C: State of Medicaid Access - Half of States/Jurisdictions Receive ‘D’ or ‘F’ for imposing discriminatory restrictions

Today, National Viral Hepatitis Roundtable (NVHR) together with The Center for Health Law & Policy Innovation of Harvard Law School (CHLPI) is launching Hepatitis C: State of Medicaid, an in-depth evaluation of treatment access in each state’s Medicaid program, while highlighting successes in access expansion as well as ongoing challenges. Over half of Medicaid programs received a “D” or an “F” for imposing discriminatory restrictions on hepatitis C cures. 

Links
Interactive Map - Click on your state to find out - State of Hepatitis C Medicaid Access - read your states full report, which include: Liver damage restrictions,  Sobriety restrictions, Prescriber restrictions with recommendations.

Download Full Report: 2017 NATIONAL SUMMARY REPORT

CLICK "HERE" FOR THE FULL PRESS RELEASE

Sponsored Segment - Hepatitis C: The State of Medicaid Access

October 25, 2017 | 9:54 AM EDT

A discussion of key finding from the “Hepatitis C: The State of Medicaid Access” report, which details treatment access restrictions in state Medicaid programs, with Ryan Clary, Executive Director of National Viral Hepatitis Roundtable; Robert Greenwald, Clinical Professor of Law and Faculty Director of the Center for Health Law and Policy Innovation at Harvard Law School; and Dr. Robert Zavoski, Medical Director of the Connecticut Department of Social Services.


https://www.washingtonpost.com/video/postlive/sponsored-segment---hepatitis-c-the-state-of-medicaid-access/2017/10/25/22c74b64-b98c-11e7-9b93-b97043e57a22_video.html?utm_term=.e0e7d627cee9

NVHR Press Release: Harvard Law School & NVHR Launch Interactive Project Grading Medicaid Programs for Discriminatory Hepatitis C Treatment Restrictions

‘Hepatitis C: State of Medicaid Access’ Grades Programs & Offers Recommendations to Improve; More than Half of States/Jurisdictions Receive ‘D’ or ‘F’

SAN FRANCISCO, CA & BOSTON, MA (Oct. 23, 2017) – The National Viral Hepatitis Roundtable (NVHR) and the Center for Health Law and Policy Innovation of Harvard Law School (CHLPI) today released “Hepatitis C: State of Medicaid Access” – a report and interactive project grading all 50 state Medicaid programs, as well as the District of Columbia and Puerto Rico, according to access to curative treatments for hepatitis C, the nation’s deadliest infectious disease. More than half of Medicaid programs (52 percent) received a “D” or an “F” for imposing discriminatory restrictions on hepatitis C cures.

Hepatitis C: State of Medicaid Access – which is available online in interactive form at http://stateofhepc.org and being unveiled today at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting in Washington, D.C. – grades each state, as well as the District of Columbia and Puerto Rico, according to its overall “state of access.” Each grade is determined by curative treatment restrictions related to three areas: 1) liver disease progression (fibrosis) restrictions, 2) sobriety/substance use requirements, and 3) prescriber limitations – all of which contradict guidance from the Centers for Medicare & Medicaid Services (CMS), as well as recommendations from AASLD and the Infectious Disease Society of America. The report also offers suggestions for each state to reduce its treatment access requirements.

“At least 3.5 million Americans are infected with hepatitis C in an epidemic that has eclipsed all other infectious diseases in the U.S. and has been exacerbated by the opioid crisis,” said Ryan Clary, executive director of NVHR. “Giving Medicaid recipients broad access to curative treatments is critical if we are really serious about ending this country’s deadliest infectious disease. Our hope with this project is to provide a roadmap for states – and the Centers for Medicare and Medicaid Services – in order to get more people treated, cured and ultimately protected from hepatitis C.”

“While more than half of states still received a D or an F in the report for discriminatory restrictions on hepatitis C treatment, we have seen some progress since 2014, when our analysis indicated that 42 state Medicaid programs could be violating federal Medicaid law,” said Robert Greenwald, Clinical Professor of Law at Harvard Law School and the director of CHLPI. “States with the best grades have taken steps to ensure widespread access to hepatitis C treatments. These states should serve as a model for those still rationing access to a hepatitis C cure based on outdated cost concerns, rules that stigmatize those living with hepatitis C, and non-medically indicated treatment criteria.”

States that received an “A” are: Alaska, Connecticut, Massachusetts, Nevada, and Washington. States that received an “F” are: Arkansas, Louisiana, Montana, Oregon, and South Dakota. Most states – 21 and Puerto Rico – received a “D.”

On its interactive site, Hepatitis C: State of Medicaid Access also includes ways to get involved. Users are invited to share their stories, sign a petition calling for better treatment access, and advocate for the issue on social media using the hashtag #stateofhepc.

About the National Viral Hepatitis Roundtable (NVHR)
The National Viral Hepatitis Roundtable is a broad coalition working to fight, and ultimately end, the hepatitis B and hepatitis C epidemics. We seek an aggressive response from policymakers, public health officials, medical and health care providers, the media, and the general public through our advocacy, education, and technical assistance. NVHR believes an end to the hepatitis B and C epidemics is within our reach and can be achieved through addressing stigma and health disparities, removing barriers to prevention, care and treatment, and ensuring respect and compassion for all affected communities. For more information, visit www.nvhr.org.

About the Center for Health Law and Policy Innovation of Harvard Law School (CHLPI)The Center for Health Law and Policy Innovation of Harvard Law School (CHLPI) advocates for legal, regulatory, and policy reforms to improve the health of underserved populations, with a focus on the needs of low-income people living with chronic illnesses and disabilities. CHLPI works with consumers, advocates, community-based organizations, health and social services professionals, government officials, and others to expand access to high-quality healthcare; to reduce health disparities; to develop community advocacy capacity; and to promote more equitable and effective healthcare systems. CHLPI is a clinical teaching program of Harvard Law School and mentors students to become skilled, innovative, and thoughtful practitioners as well as leaders in health and public health law and policy. For more information, visit http://www.chlpi.org. 

The Liver Meeting® 2017 - Gilead Phase 2 Results for GS-0976 in Nonalcoholic Steatohepatitis (NASH)

Gilead Announces Phase 2 Results for GS-0976 in Nonalcoholic Steatohepatitis (NASH)

- Oral ACC Inhibitor Led to Significant Reductions in Measures of Liver Fat and Fibrosis - - Results from the GS-0976 Phase 2 Study and 18 Other Abstracts from Across Gilead’s Liver Fibrosis Pipeline Presented at The Liver Meeting® 2017 WASHINGTON--(BUSINESS WIRE)--Oct. 24, 2017-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from a Phase 2, randomized, placebo-controlled trial evaluating two doses of GS-0976, an oral, investigational inhibitor of Acetyl-CoA carboxylase (ACC), in patients with nonalcoholic steatohepatitis (NASH). The data demonstrate that the higher dose of GS-0976 (20 mg taken orally once daily) when administered for 12 weeks was associated with statistically significant reductions in hepatic steatosis (buildup of fat in the liver) and a noninvasive marker of fibrosis (TIMP-1) compared to placebo. These results are being presented during a late-breaking abstract session at The Liver Meeting® 2017 in Washington, D.C. (Abstract #LB-9). Eighteen other abstracts on Gilead’s NASH and liver fibrosis pipeline were also presented at the meeting.    “In patients with advanced fibrosis, NASH may lead to severe complications including end-stage liver disease, hepatocellular carcinoma and the requirement for liver transplantation,” said Rohit Loomba, MD, MHSc, lead study author, Director of the NAFLD Research Center, Director of Hepatology, Professor of Medicine, and Vice Chief of the Division of Gastroenterology at University of California San Diego School of Medicine. “Unfortunately, there are no treatments available for these patients. In this first randomized, placebo-controlled, Phase 2 study of an ACC inhibitor in NASH, the data suggest that GS-0976 has the potential to play an important role in treating patients with this disease.”    ACC plays a role in one of several biologically relevant pathways associated with disease progression in NASH. ACC catalyzes the first step in hepatic de novo lipogenesis, the synthesis of fatty acids that contribute to hepatic steatosis and, subsequently, inflammation and liver fibrosis. The study included 126 patients who were randomized to receive GS-0976 20 mg (n=49), GS-0976 5 mg (n=51), or placebo (n=26) once daily for 12 weeks. All patients in the study were diagnosed with NASH and liver fibrosis stages F1 through F3 based on biopsy, or by magnetic resonance elastography (MRE) and MRI proton density fat fraction (MRI-PDFF).    Patients receiving GS-0976 20 mg demonstrated significant decreases in liver fat content (measured by MRI-PDFF) compared to placebo after 12 weeks of treatment. Patients treated with GS-0976 20 mg also experienced a significant decrease in TIMP-1, a serum marker associated with liver fibrosis. Differences between GS-0976 5 mg and placebo were not statistically significant. Data for these efficacy endpoints are summarized in the table below.    Relative (%) Changes in Imaging, ALT and Serum Fibrosis Markers at Week 12* Endpoint (Week 12)   GS-0976 20 mg (n=49)   GS-0976 5 mg (n=51)   Placebo (n=26)   P-values 20 mg vs. Placebo   5 mg vs. Placebo MRI-PDFF -28.9 -13.0 -8.4 0.002 0.142 ≥30% reduction in MRI-PDFF, % (n/N) 48% (22/46) 23% (11/47) 15% (4/26) 0.004 0.433 MRE-stiffness -5.5 -9.6 -12.5 0.100 0.743 Liver stiffness by FibroScan -11.1 -8.4 -3.1 0.212 0.364 ALT -20.5 -9.8 -6.7 0.176 0.765 TIMP-1 -7.9 -2.9 -1.5 0.022 0.301 PIII-NP -13.9 -7.0 -0.5 0.107 0.605   *Unless indicated, all data are median relative (%) changes from baseline. In other measures, including liver stiffness by FibroScan, liver stiffness by MRE, serum ALT and PIII-NP, a serum marker of fibrogenesis, no statistically significant differences were observed between the treatment and placebo arms of the study.    At week 12, a median relative change in triglycerides (TG) from baseline of +11 percent, +13 percent and -4 percent was observed in patients receiving GS-0976 20 mg, GS-0976 5 mg and placebo, respectively. Asymptomatic Grade 3 or 4 TG elevations (>500 mg/dL) were observed in 16 patients receiving GS-0976 20 mg (n=7) or 5 mg (n=9); the primary factor associated with such elevations was a baseline TG level >250 mg/dL (p<0.001). The majority of patients with such elevations either responded to fibrate or fish oil therapy (n=4) or resolved without additional treatment or cessation of GS-0976 (n=7). GS-0976 was well-tolerated. Nausea, abdominal pain and diarrhea were the most common adverse events.    Other Gilead studies being presented at The Liver Meeting include preclinical data examining the combination of inhibitors of ACC and apoptosis signal-regulating kinase 1 (ASK1) in rodent models of NASH. These data suggest that the combination of agents resulted in greater anti-fibrotic and anti-steatotic efficacy than either agent alone (Abstract #425; named a Presidential Poster of Distinction). Gilead is currently conducting clinical studies evaluating combinations of the ASK1 inhibitor selonsertib, ACC inhibitor GS-0976 and the selective, non-steroidal Farnesoid X receptor (FXR) agonist GS-9674 in patients with NASH. Additional abstracts describe the accuracy of noninvasive markers to predict improvements in liver histology in response to treatment in a Phase 2 study of selonsertib, including reductions in fibrosis with MRE (Abstract #2104) and liver fat with MRI-PDFF (Abstract #2169). Phase 3 studies are ongoing with selonsertib in patients with advanced fibrosis due to NASH.    Gilead is also presenting multiple abstracts regarding primary sclerosing cholangitis (PSC), a progressive cholestatic liver disease with no approved therapies. These include presentations on the role of magnetic resonance cholangiopancreatography (MRCP) in PSC including a Presidential Plenary Oral Presentation (Abstract #140) describing a novel MRCP-based risk score for predicting PSC-related complications; an innovative technique for quantifying biliary tree volume in PSC (Abstract #292); prospective data describing the natural history of radiologic progression in PSC (Abstract #279; a Presidential Poster of Distinction); and the development and validation of a PSC-specific patient reported outcome (PRO) measure (Abstract #1351; a Presidential Poster of Distinction). These studies will enhance our understanding of PSC and aid in the development of novel therapies. Gilead is currently conducting a Phase 2 study of the FXR agonist GS-9674 in patients with PSC. http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=2310692 Navigate This Blog The Liver Meeting® 2017 Patient-Friendly Links HCV Sites With Key Data, Expert Review & Summary

The Liver Meeting® 2017 - Is Ribavirin Really Needed for Patients With HCV Genotype 3 on Sofosbuvir/Velpatasvir

Is Ribavirin Really Needed for Patients With HCV Genotype 3 on Sofosbuvir/Velpatasvir

By Andrew D. Bowser

The findings add new perspective to the ongoing discussion among researchers and clinicians as to whether adding ribavirin might prevent a relapse in patients with HCV genotype 3, particularly if they were previously treated.

Results of the current study represent “real world” experience with patients with HCV genotype 3 treated at 9 sites in Germany, according to Stefan Christensen, MD, Department of Infectious Diseases, Center for Interdisciplinary Medicine, Muenster, Germany.

“We could confirm the high SVR12 rates [sustained virologic response at 12 weeks] from the clinical phase 3 studies with sofosbuvir/velpatasvir, [but] in our cohort, it seems like the addition of ribavirin in cirrhotic patients did not have further benefit for those patients,” he said.
Read the article @ FirstWord Pharma

Of Interest - FirstWord Pharma

HCV Genotype 3 Mavyret

Glecaprevir/Pibrentasvir Is Safe, Effective for Treatment-Naive Patients With HCV Genotype 3

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