Thursday, October 26, 2017

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

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
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
CommentaryQuality 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.
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 
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


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

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."

On This Blog
Get started by clicking on this (LINK) for patient-friendly coverage of the meeting, or click on the following topics:

Fibrosis
Fatty Liver
Herbal and dietary supplements

I hope this collection of links will help make the rest of your journey a little easier.
Tina

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