Survival rates rise with new hepatitis C treatments

Survival rates rise with new hepatitis C treatments

Just a few years ago the outlook for treating patients with chronic hepatitis C was grim.

For almost a year, patients would receive a complicated regimen of shots and up to 18 pills a day with drugs that caused major side effects. After that, there was a six-month follow-up period to see if the treatment was successful.

And the cure rate was less than 50 percent.

Thanks to recent research ― some of it conducted in San Antonio ― most patients now can be cured with direct-acting antivirals, a gentler combination of drugs in one or a few pills with only a few months of treatment. Continuing research is promising for new treatments for the groups of patients who don’t respond well to the new standard therapy.

“The good news is patients should know that a paradigm shift has occurred as we now can give all-oral therapy that is simple, safe and highly effective with cure rates of about 95 percent for most patient populations,” said Dr. Eric Lawitz, professor in the School of Medicine at the UT Health Science Center San Antonio.

Lawitz and Dr. Fred Poordad, also a professor of medicine at the UT Health Science Center, see patients at the Texas Liver Institute in San Antonio. They have been researching cures for hepatitis C for years with great success. They have presented oral presentations at international liver meetings and published peer-reviewed articles in major journals that have changed the standard of care for patients.

The FDA-approved drugs they have evaluated include Harvoni (a combination of ledipasvir and sofosbuvir), Olysio (simeprevir), Viekira Pak (ombitasvir, paritaprevir and ritonavir packaged with dasabuvir tablets), Zepatier (elbasvir and grazoprevir) and Daklinza (daclatasvir).

‘Silent epidemic’
The tragedy of hepatitis C is that is that it has no symptoms until the disease progresses, so patients can have the disease for many years and not know it.

“For that reason it is often called a silent epidemic,” Poordad said. “If not identified early, the disease can progress to cirrhosis of the liver, liver cancer and the need for a liver transplant. And even if the patient receives a liver transplant, the disease must be cured or it can infect the new liver 

What causes hepatitis C?
According to the Centers for Disease Control, hepatitis C is the leading blood-borne disease in the U.S. Although some people have only a mild form of the disease, 75 percent to 85 percent of patients who become infected with the hepatitis C virus will develop a chronic infection. This is estimated to be more than 3.5 million people in the nation.

The virus spreads through contact with the blood of an infected person. This often occurs through sharing needles, syringes or other equipment used in drug use. Another common way is through needle-stick injuries in a health-care setting. Mothers with hepatitis C can pass the disease on to their unborn children. Less common ways of spreading the virus are by sharing toothbrushes and razors, or by having sexual contact with a person who has hepatitis C. Some people contracted the disease years ago through blood transfusions before widespread screening of the blood supply began in 1992.

Find out if you have hepatitis C
According to the CDC, baby boomers ― people born between 1945 and 1965 ― are five times more likely to be infected with hepatitis C than other adults. “You can find out if you have hepatitis C through a simple blood test at your doctor’s office. All you have to do is request it,” Poordad said.

More information about hepatitis C, the blood test for the virus, and the newest treatments are available at the CDC website, www.cdc.gov.

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Delaware will treat all Medicaid patients with hepatitis C

Delaware will treat all Medicaid patients with hepatitis C

The state of Delaware said Tuesday that it would phase in a new policy to treat all hepatitis C patients in its Medicaid program.

States have been under pressure from the Obama Administration and lawsuits - in Delaware's case, Harvard Law School's Center for Health Law & Policy Innovation had threatened litigation - to abandon money-saving policies that limited treatment with effective but costly new medications to the sickest patients.

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Regulus Reports Positive Data/Phase II studies of RG-101 for the treatment of Hepatitis C

Regulus Reports Positive Top-line Data

- Results Demonstrate First Successful Shortened 4-week Treatment Regimen to Date -
- Conference Call Today at 8:30 AM EST -

LA JOLLA, Calif., June 7, 2016 /PRNewswire/ -- Regulus Therapeutics Inc. (NASDAQ:RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced  top-line results from the primary endpoint analysis of one of the company's ongoing Phase II studies of RG-101 for the treatment of Hepatitis C Virus infection (HCV). The study was designed to evaluate a shortened, four-week treatment regimen containing a subcutaneous administration of 2 mg/kg of RG-101 at Day 1 and Day 29, in combination with 4 weeks of once/daily approved anti-viral agents Harvoni®, Olysio®, or Daklinza™.  The study enrolled 79 treatment naïve genotype 1 and 4 HCV patients (Harvoni® arm, n=27, Olysio® arm, n=27, Daklinza™ arm, n=25).  The primary endpoint of the study is virologic response 12 weeks following conclusion of treatment.

Time Since Treatment  Completion	RG-101 + Harvoni	RG-101 + Olysio	RG-101 + Daklinza
Week 12	27/27 (100%)	26/27 (96.3%)	22/24 (91.7%)*
Week 16	21/21 (100%)	19/20 (95.0%)	20/22 (90.9%)
Week 20	14/14 (100%)	13/15 (86.7%)	13/13 (100%)
Week 24	10/10 (100%)	8/10 (80.0%)	8/9 (88.9%)

*One patient missed the Week 12 visit. Viral load results for this patient at Week 8 and 16 were collected and indicate that the patient was a responder at both time points.

The results from this interim analysis demonstrate significant virologic response through 24 weeks of follow-up.  RG-101 plus Harvoni continues to demonstrate 100% response rates.  As previously reported, the combination of RG-101 plus either Olysio or Daklinza monotherapies have seen small numbers of viral relapse.  The results reported today include four new relapses: two in the Olysio arm (weeks 20 and 32) and two in the Daklinza arm (weeks 12 and 24).  RG-101 in combination with four weeks of oral DAA therapy has been generally well tolerated with the majority of adverse events considered mild or moderate, and with no study discontinuations.  Commonly reported adverse events (AEs) included fatigue, headache, and injection site reactions. 

"These data strengthen our conviction in the clinical utility of RG-101 to shorten oral HCV treatment regimens to four weeks or less. We are very encouraged by the consistent trend in safety and efficacy, which positions RG-101 to play an important role in advancing the current treatment options for HCV patients worldwide," said Paul Grint, M.D., President and CEO of Regulus.

Conference Call & Webcast Information
Today at 8:30 a.m. EST, Regulus will host a conference call and webcast to discuss the topline results. A live webcast of the call will be available online at www.regulusrx.com. To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 25993262. To access the telephone replay of the call, dial (855) 859-2056 (domestic) or (404) 537-3406 (international), passcode 25993262. The webcast and telephone replay will be archived on the company's website following the call.

About Hepatitis C Virus Infection (HCV)
Hepatitis C is a result of a hepatocyte specific infection induced by the virus known as HCV.  Chronic HCV may lead to significant liver disease, including chronic active hepatitis, cirrhosis, and hepatocellular carcinoma. Up to 185 million people are chronically infected with HCV worldwide, and more than 500,000 people die from HCV annually.  The CDC estimates that there are currently approximately 3.5 million persons infected with HCV in the United States.  HCV shows significant genetic variation in worldwide populations due to its frequent rates of mutation and rapid evolution. There are six genotypes of HCV, with several subtypes within each genotype, which vary in prevalence across the different regions of the world. The response to treatment varies from individual to individual underscoring the inadequacy of existing therapies and highlights the need for combination therapies that not only target the virus but endogenous host factors as well, such as microRNA-122 (miR-122). Regulus believes that its miR-122 antagonist, RG-101, may be a useful agent in emerging combination regimens to address difficult-to-treat genotypes and to potentially expand upon the current therapies available to clinicians treating HCV patients.

About RG-101 for HCV
RG-101 is Regulus' wholly-owned, GalNAc-conjugated anti-miR targeting miR-122, which the HCV virus uses to replicate. Therapies that interfere with miR-122 could inhibit viral replication, acting earlier in the viral life cycle than currently approved oral agents.  In a completed Phase I human proof-of-concept study, Regulus demonstrated that treatment with a single subcutaneous dose of RG-101 as monotherapy resulted in significant and sustained viral load reductions in all treated HCV patients, including patients with difficult to treat genotypes, various liver fibrosis status and those who have experienced viral relapse after a prior IFN-containing regimen. 

Earlier this year, Regulus began enrolling patients in an open-label Phase II clinical trial combining RG-101 and GSK2878175 for the treatment of HCV to evaluate the potential to achieve sustained viral responses post treatment with a single subcutaneous administration of 4 mg/kg of RG-101 in combination with daily oral administrations of 20 mg of GSK2878175 for up to 12 weeks in treatment-naïve patients chronically infected with HCV genotypes 1 and 3.  Regulus and GSK anticipate reporting interim results from this study by year-end.  In an expanded collaboration with GSK, the companies plan to conduct a multi-centered, randomized, dose-ranging Phase II study evaluating the combination of RG-101 and GSK's long-acting parenteral ("LAP") formulation of GSK2878175 as a potential single-visit cure in patients chronically infected with HCV.  This study will be conducted outside the United States and is planned to begin in the fourth quarter of 2016.  Based on predicted enrollment rates, interim results from this expanded collaboration should be available in the second half of 2017, enabling a potential initiation of a pivotal study in late 2017. 

About microRNAs
The discovery of microRNAs in humans during the last decade is one of the most exciting scientific breakthroughs in recent history.  microRNAs are small RNA molecules, typically 20 to 25 nucleotides in length, that do not encode proteins but instead regulate gene expression. More than 800 microRNAs have been identified in the human genome, and over two-thirds of all human genes are believed to be regulated by microRNAs.  A single microRNA can regulate entire networks of genes. As such, these molecules are considered master regulators of the human genome.  microRNA expression, or function, has been shown to be significantly altered or dysregulated in many disease states, including oncology, fibrosis, metabolic diseases, immune-inflammatory diseases and HCV. Targeting microRNAs with anti-miRs, chemically modified, single-stranded oligonucleotides, offers a unique approach to treating disease by modulating entire biological pathways and may become a new and major class of drugs with broad therapeutic application.

About Regulus
Regulus Therapeutics Inc. (NASDAQ:RGLS) is a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs.  Regulus has leveraged its oligonucleotide drug discovery and development expertise to develop a well-balanced microRNA therapeutics pipeline complemented by a maturing microMarkers^SM biomarkers platform and a rich intellectual property estate to retain its leadership in the microRNA field.  Regulus is developing RG-101, a GalNAc-conjugated anti-miR targeting microRNA-122 for the treatment of chronic hepatitis C virus infection, and RG-012, an anti-miR targeting microRNA-21 for the treatment of Alport syndrome, a life-threatening kidney disease driven by genetic mutations with no approved therapy.  In addition, RG-125, a GalNAc-conjugated anti-miR targeting microRNA-103/107 for the treatment of NASH in patients with type 2 diabetes/pre-diabetes, has entered Phase I clinical development through its strategic alliance with AstraZeneca.  Regulus is also advancing several programs toward clinical development in renal, hepatic and central nervous systems diseases, both independently and with our strategic alliance partners, Sanofi and AstraZeneca. Regulus' commitment to innovation has resulted in multiple peer-reviewed publications in notable scientific journals and has resulted in the formation of strategic alliances with AstraZeneca and Sanofi.  Regulus maintains its corporate headquarters in La Jolla, CA.  For more information, please visit http://www.regulusrx.com.

Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Regulus to undertake certain activities and accomplish certain goals (including with respect to development and other activities related to RG-101), the projected timeline of clinical development activities, and expectations regarding future therapeutic and commercial potential of Regulus' business plans, technologies and intellectual property related to microRNA therapeutics and biomarkers being discovered and developed by Regulus.  Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Regulus' current expectations and involve assumptions that may never materialize or may prove to be incorrect.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.  These and other risks concerning Regulus' financial position and programs are described in additional detail in Regulus filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Regulus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Blood-born molecules could predict those who will develop liver cancer

Blood-born molecules could predict those who will develop liver cancer

(PHILADELPHIA) - Hepatocellular carcinoma, the most common type of liver cancer, is increasing in incidence in the United States, and infection with the Hepatitis B virus (HBV) causes about 50 percent of cases. However, it can be difficult to identify who is most likely to develop this cancer. Although earlier research had discovered molecular signatures associated with HBV-driven liver cancer, new research from Thomas Jefferson University has proven that this panel of microRNAs can also predict the patients at high risk for developing the disease before the cancer develops, via a blood test.

The researchers, led by Hushan Yang, Ph.D., an Associate Professor of Medical Oncology and researcher at the Sidney Kimmel Cancer Center at Jefferson studied a large cohort of HBV-infected patients, some of whom eventually developed liver cancer, and analyzed their molecular signature from blood samples. Of the 373 HBV patients who were originally cancer free, 40 developed cancer over a median follow up of 4.5 years. The researchers analyzed a panel of 24 microRNAs -- small molecules that regulate gene activity -- and showed that 15 of these microRNAs had changed their normal gene expression pattern before patients developed cancer, suggesting these molecules could be used to predict patients with a high likelihood of developing cancer. The study was published in the journal Oncotarget,

Earlier studies had identified the 24 microRNAs that Dr. Yang and colleagues studied. However, it was unclear whether those microRNAs caused the cancer, or were a result of already occurring cancerous processes. By following this cohort of patients prospectively, and using blood samples taken at least one year before liver cancer diagnosis, the researchers were able to answer that question for the first time. In addition, prior studies analyzed samples taken from patient biopsies, which require invasive procedures, whereas the current study showed that microRNAs circulating in the blood could predict disease.

"This research confirms previous work on microRNAs and liver cancer and goes further to show that these microRNAs may be able to predict the development of liver cancer through a non-invasive blood test," says first author Chun Wang, a visiting scholar in the Department of Medical Oncology.

The current non-invasive test for determining cancer risk among HBV patients is a diagnostic for the molecule alpha-fetoprotein (AFP). It is also associated with Hepatitis C infections, but it isn't always a good predictor of disease. In fact, the Jefferson researchers identified 15 out of 16 patients, or 94 percent of patients who were misclassified as cancer-free by AFP. Likewise, in the 57 patients who were deemed at high risk of developing liver cancer by AFP, the microRNA testing correctly reclassified 33, or 58 percent, as low risk.

Although the panel of 15 microRNAs was useful, it wasn't perfect. "We need to find more microRNAs that may predict liver cancer in order to sharpen this tool for identifying high risk patients," says Dr. Yang. "Through collaboration with Dr. Hann in the Department of Medicine at Jefferson, we continue to work on improving this diagnostic method."

The work was supported by a Tobacco Grant from the Pennsylvania Department of Health, National Cancer Institute Grant CA159047, American Cancer Society Research Scholar Grant 123741-RSG-13-003-01-CCE, and a V Scholar Grant from the V Foundation for Cancer Research. The authors report no conflicts of interest.

Source: Thomas Jefferson University

June Hep C Newsletters - Medicaid programs should be taking “a long hard look” at their drug policies under state and federal law

June Hepatitis Newsletters and Updates

It's that time of the month for our index of June Newsletters, with noteworthy updates from around the web. 

Web Updates

Ele Hamburger: Medicaid programs should be taking “a long hard look” at their drug policies under state and federal law

Ele Hamburger, one of the plaintiffs’ attorneys in the recent lawsuit against the Washington Health Care Authority, the state Medicaid agency, over its Hepatitis C drug policy, sat down with State of Reform to talk about the case which is already having national implications.

June 6

We cover news in other states where similar policies of cost-based rationing for Hepatitis-C drugs are in place for Medicaid programs. Do you think it likely that other states will begin to model themselves after Washington following this decision?

Ele Hamburger: I think as a result of this case, Medicaid programs should be a taking a long hard look at whether their rationing criteria are justified under the state and federal law. When you have CMS saying it is not proper, and a federal judge saying it is inconsistent with federal Medicaid law, we hope you’re going to start to see other state programs eliminating those restrictions voluntarily.
That’s what just happened in Florida on the same day, Friday May 27. Advocates there went to Florida’s Medicaid Program and asked “do you really want this fight?” And they ended up resolving it.
In New York State, the AG [Attorney General Eric Schneiderman] started going after private insurers over rationing [of HCV medications] and got voluntary agreements from many of them to eliminate it, and then the state Medicaid program followed suit. In Pennsylvania, it has been eliminated through organizing and advocacy without litigation.

Read more...

June

Save The Date - Twitter Chat June 15 @ 2 p.m. EDT

Twitter Chat: Partner Highlights From Hepatitis Awareness Month

Join Hep B United, the National Viral Hepatitis Roundtable, CDC’s Division of Viral Hepatitis, and the Hepatitis B Foundation for a Twitter #HepChat Wednesday, June 15 at 2 p.m. EDT. The chat will highlight Hepatitis Awareness Month outreach events and allow hepatitis B and C partner organizations to share their successes, challenges, and lessons learned from their efforts.

Continue reading

Listen - NPR
For Doctors And Patients, 'Veterans Choice' Often Means Long Waits

Healio

VIDEO: Sofosbuvir/velpatasvir may offer improved patient reported outcomes

June 6

SAN DIEGO — In this exclusive video from DDW 2016, Zobair Younossi, MD, MPH, chairman of the department of medicine, Inova Fairfax Hospital, and vice president for research of Inova Health System, discusses new data showing the pan-genotypic regimen of a fixed-dose combination of Sovaldi (sofosbuvir, Gilead Sciences) and velpatasvir (Gilead Sciences) was associated with improved patient reported outcomes, or PROs.

Watch the video, here

Clinical Care Options
Date posted: 6/1/2016

Genotype 1 HCV in 2016: Clinical Decision Making in a Time of Plenty

In this downloadable slideset, Ira M. Jacobson, MD, reviews the newest regimens and data for genotype 1 HCV infection.

Free registration required

Hepatitis C Spread by Alternative Therapy

Injections given as an alternative medical treatment known as "prolotherapy" or "regenerative injection therapy" spread hepatitis C among at least seven patients of 400 who were potentially exposed. All were treated at a clinic in Santa Barbara, CA, the US Centers for Disease Control and Prevention reported.

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Healio

Top hepatitis stories for Hepatitis Awareness Month
May 30, 2016
As Hepatitis Awareness Month comes to an end, Healio.com/Hepatology and HCV Next have compiled a list of the latest, most relevant research on hepatitis B and C virus infections published on Healio.com in May.

Continue reading...

In Case You Missed It

NATAP

EASL: Summary from EASL 2016 for Hepatitis C Highly efficacious pan-genotypic DAA combinations on their way: the last gaps in difficult-to-treat patient populations are going to be closed soon. - Jurgen K. Rockstroh M.D., Professor of Medicine University of Bonn, Germany

Foretelling toxicity: FDA researchers work to predict risk of liver injury from drugs
In December 2014, the US Food and Drug Administration (FDA) approved a new drug cocktail, from the Chicago-based pharmaceutical company AbbVie, to treat hepatitis C infection. Less than a year later, the agency warned that the cocktail, Viekira Pak, and another, newer AbbVie hepatitis C therapy could cause serious liver injury in individuals with advanced liver disease. The agency noted that it had received reports of at least 26 cases of liver injuries that might have been caused by the drugs...

June Newsletters

HCV Advocate
The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education.

June Newsletter

Dear Advocaters,

Summer is right around the corner and we have you covered for the latest news about hepatitis C with our newsletters, website and our blog.

In the current issue of the HCV Advocate newsletter we feature the following articles:
Snapshots by Alan Franciscus – detailed abstracts about the benefits of curing people with cirrhosis, and the association between head and neck cancers and hepatitis C virus.

“Facing Unique Hurdles in Pursuit of Healthcare” by Matthew Zielske delves into testing, linkage to care and the many barriers that face people with hepatitis C.

HealthWise by Lucinda Porter, RN – “Hepatitis C: Working with a Health Coach”—Lucinda discusses her health coach journey and how to find a health coach that might work for you.

The HCV Advocate Drug Pipeline by Alan Franciscus – I have updated our Drug Pipeline to include more information about the Merck new pan-genotypic drugs being developed to treat hepatitis C.

What’s Up! – We have reviewed and updated the following:
A Guide to Understanding HCV: 2016 – the guide was updated to reflect the newly released epidemiology numbers released by the Centers for Disease Control and Prevention.
Easy C Facts:
HIV and HCV Coinfection Facts
Methadone and HCV
HCV and Hepatitis B Coinfection
HCV and Transgender People

We always welcome any comments or suggestions.

Sincerely,

Alan and the staff of the HCV Advocate

Get tested, Get Treated, Get Cured

Click here to read this issue.

View all newsletters here....

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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 Hep Magazine are the go-to source for educational and social support for people living with hepatitis.

HEP Summer 2016 - Special Issue

In This Issue

Super Friend: Gloria Guzman Inspires Others Hoping for a Hep C Cure
Gloria Guzman, a peer educator at the Special Treatment and Research (STAR) Health Center in Brooklyn, knows a thing or two about survival. At 67, she’s lived through bad relationships, the loss of a child, addiction, HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV). Thankfully, she’s now cured of hep C.

Screening Among 
Baby Boomers Is Inadequate
Despite guidelines calling for universal testing of hepatitis C virus (HCV) among baby boomers, testing rates remain low, with various demographic factors influencing who is screened, as well as who is treated.

Treating Hepatitis C Earlier Is More Cost Effective
Using Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) to treat hepatitis C virus (HCV) when individuals with genotype 1 of the virus have milder cases of liver fibrosis is more cost effective than waiting until their liver disease progresses. Researchers came to this conclusion by devising a mathematical model to help them estimate how earlier versus delayed treatment, specifically among those never before treated for the virus, affected the proportional cost associated with improving their life span as well as individual health.

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

Check Back For June Newsletter....

May 2016 Hep Free NYC Newsletter

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HepCBC Hepatitis C Education and Prevention Society

HepCBC’s MONTHLY NEWSLETTER
The hepc.bull, has been “Canada’s hepatitis C journal” since the late 1990′s and has been published nonstop since 2001. The monthly newsletter contains the latest research results, government policy changes, activities and campaigns you can get involved in, articles by patients and caregivers, and a list of support groups plus other useful links.

Just Released May Newsletter

DOWNLOAD
May, 2016 hepc.bull HERE.

HIGHLIGHTS:
Attend Hearings on Blood Scandal Funds at Vancouver Courthouse: June 20-22 (p 6)
Enjoy HepCBC's Roadshow Outreach trip to Northern Rural and Remote BC!
https://www.youtube.com/watch?v=0Be_ftY8di0 (p 4)

Give your Patient or Caregiver Input to get Sunvepra™ covered by PharmaCare (p 7)

ARTICLES IN THIS ISSUE of the HEPC.BULL include:

· HepCBC Participates in Review of BC Centre for Excellence in HIV/AIDS - HCV-Related Cirrhosis Prevalence Increases over Time - CT Scans: Another HCV Transmission Route - Curing HCV can Reverse Need for Liver Transplant - page 1

· Hepatic Encephalopathy Drug Zaxine™ (rifamaxin) soon to be Covered in All Provinces EXCEPT BC! - page 2

· Upcoming HepCBC EVENTS looking for Visitors and VOLUNTEERS! - page 3

· Photo Essay on HCV Outreach Roadshow to Rural and Remote BC now Online - New Hepatitis C Dietary Supplement Digest by NCCIH - $1500 HCV CURE (Using Generic Drugs) - page 4

· Join "HepCBC Liver Warriors" Team in 2016 Victoria Marathon! - Looking for Potential HepCBC Board Members - Welcome to SVR "Honour Roll" - Upcoming International Conferences - page 5

· ATTEND June 20-22 BLOOD SCANDAL HEARINGS in VANCOUVER (or Montreal or Toronto!) - Patient Input Requested by BC Pharmacare for Sunvepra™ (asunaprevir) - WORLD Hepatitis Day 2016 - Daklinza™ (daclatasvir) Approved by Health Canada for Difficult-to-Treat Patients - page 6

· Medication Co-Pay Subsidy and Care Programs - Compensation Info - page 7

June Newsletter
Please Check Back... 

View All Newsletters, Here

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Blog Updates

When You Don’t Look Sick with Hepatitis C: how to
Karen Hoyt

Some people actually have the words “I told you I was sick” engraved on their tombstone. That SO would be like me. From the age of 30 on I was telling my doctors that my food didn’t metabolize well, my body ached, there was dizziness, fatigue, and a bunch of other symptoms. I honestly felt like a hypochondriac some of the time...

When the Pain won't go away
Kimberly Morgan Bossley
It is a daily struggle to manage pain while trying to manage a active life

Hepatitis C Treatment and a Tincture of Perseverance
Lucinda K. Porter, RN
A discussion about insurance coverage of hepatitis C treatment

Generic Hepatitis C Treament in the UK... Things are improving
Greg Jefferys
Progress regarding hep C generics is happening, albeit slowly

Links:
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Your Guide To Hepatitis

HEP In Print 

These special issues of Hep provide information and education for people living with viral hepatitis, including hepatitis C (HCV), hepatitis B (HBV) and hepatitis A (HAV).

News

Today's Headlines

HEP Exclusives

Original Articles

HEPATITISC.NET

How To Appeal a Social Security Disability Denial
By Mariah Z. Leach - June 6, 2016
Though the statistics vary somewhat from state to state, nationwide about 65% of all disability claims are denied on the first application. Luckily, receiving a denial does not mean that you will...

READ MORE

Expertise and HCV

By Daryl Luster - June 5, 2016
I have always been a little uncomfortable with the term “expert” but do understand that it describes a person having expertise in a given subject or field. The reason I am writing...

READ MORE

Talking to Loved Ones about Hepatitis C

By Jenelle Marie Davis - June 2, 2016
I just got diagnosed, how do I tell my family/friends? As you sit in your doctor’s office or clinic after a positive hepatitis C diagnosis, your first instinct may be to run...

READ MORE

Dr. Kristine Novak is the science editor for Gastroenterology and Clinical Gastroenterology and Hepatology. She has worked as an editor at biomedical research journals and as a science writer for 15 years, covering advances in gastroenterology, hepatology, cancer, immunology, biotechnology, molecular genetics, and clinical trials. She has a PhD in cell biology and an interest in all areas of medical research.

Can Blood Levels of Ammonia Predict Risk and Frequency of Hepatic Encephalopathy in Patients With Cirrhosis?
Fasting levels of ammonia (NH3) in blood identify patients at risk for complications of overt hepatic encephalopathy (HE), researchers report in the June issue of Clinical Gastroenterology and Hepatology. Patients with HE might benefit from NH3-lowering therapy. Humans have no repository for excess dietary nitrogen, so we convert excess dietary

Read more ..

What is HealthNewsReview.org?
The mission of HealthNewsReview.org is to improve the public dialogue about health care by helping consumers critically analyze claims about health care interventions and by promoting the principles of shared decision-making reinforced by accurate, balanced and complete information about the tradeoffs involved in health care decisions. HealthNewsReview.org evaluates health care journalism, advertising, marketing, public relations and other messages that may influence consumers and provides criteria that consumers can use to evaluate these messages themselves. Improving the quality and flow of health care news and information to consumers can be a significant step towards meaningful health care reform.

Readers drowning in flawed “liquid biopsy” stories; other coverage throws a lifeline

The big story out of the American Society of Clinical Oncology meeting over the weekend came from a study about so-called “liquid biopsies.” Major news organizations headlined it as follows:
Washington Post: ‘Liquid biopsy’ study offers hope for a blood test to find cancer
New York Times: ‘Liquid’ Cancer Test Offers Hope for Alternative to Painful Biopsies
TIME magazine: A blood test for cancer gets closer
I think many if not most news consumers are likely to draw the wrong conclusion from these messages.

As these stories later point out with varying levels of urgency, the study involved blood samples from people already known to have cancer. And the researchers compared results from these samples with biopsy tissue samples that were available for about 400 patients. The point was to compare the profile of the tumor as assessed by the blood sample with the existing surgical biopsy sample.
The researchers were not trying to “find cancer” as the Post misleadingly suggests. Nor did the study involve a “blood test for cancer” as TIME states. The cancer had already been found and diagnosed using a surgical biopsy. (Despite the hyped suggestions.....
Read more....

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Of Interest

Behind the Headlines - 'Friendly' virus repairs damaged liver cells (but only in mice)

Researchers were able to improve liver damage in mice, but this does not amount to curing an addiction to alcohol.

The study showed it was possible to create "bespoke friendly" viruses to infect cells known as myofibroblasts, which are cells associated with tissue repair. The virus passed on instructions that transformed the myofibroblasts into healthy liver cells in mice who had fibrosis (scarring) of the liver, known as cirrhosis.

Not all the experiments in the mice worked, but in those that did, the transformed liver cells looked and behaved normally, replaced some of the diseased liver cells, and led to less liver scarring

Read more..

Healthy You

Check out the June issue of NIH News in Health, the monthly newsletter bringing you practical health news and tips based on the latest NIH research. To search for more trusted health information from NIH, bookmark http://health.nih.gov.

Can You Lengthen Your Life?
Researchers Explore How To Stay Healthy Longer
The best way to boost your chance of living a long and active life is through healthy behaviors, including regular physical activity.
Read more about living healthy and longer

Seeking Allergy Relief
When Breathing Becomes Bothersome
When sneezing, runny nose, or itchy eyes suddenly appear, allergies may be to blame.

Read more about airborne allergies

Health Capsules
Experimental Therapy Shows Promise for Type 1 Diabetes

Complementary Approaches for Depression

Featured Website: Prescription Drug Abuse

Wishing you all a wonderful summer.

Tina

Chronic Pain Center Infects Seven Patients With HCV

JUNE 6, 2016
Chronic Pain Center Infects Seven Patients With HCV

By IDSE News Staff

The Centers for Disease Control and Prevention (CDC) has found that a pain clinic in California that delivered prolotherapy for chronic pain infected seven patients with hepatitis C virus (HCV) (MMWR Morb Mortal Wkly Rep 2016;65[21]:547-549).

The index patient was alerted of the infection by a blood bank in 2014. The patient had no symptoms of HCV and no known risk factors, such as injection drug use, incarceration or long-term hemodialysis. A regular blood donor, the patient had been HCV negative 56 days before this donation.

Public health officials investigated possible exposures in this 56-day period and found that the blood donor had received prolotherapy, also known as regenerative injection therapy, from a chronic pain clinic that practices complementary and alternative medicine (CAM). Prolotherapy is a CAM treatment for chronic musculoskeletal pain. Substances commonly injected include hypertonic dextrose, phenol-glycerin-glucose and moorhuate sodium (a mixture of saturated and unsaturated fatty acids from cod liver oil), according to the MMWR report. Some patients also received platelet-rich plasma, which uses autologous blood with a high ratio of platelets to plasma.

According to the CDC, there are no practice guidelines for this procedure, nor are there formal training programs.

Infection control practices in the chronic pain clinic were absent, the CDC said. Breaches included reentering multidose medication vials for use in several patients, poor hand hygiene, inconsistent glove use, and lack of aseptic technique when handling injection equipment and medication.
After the investigation, the Santa Barbara County Public Health Department closed the clinic.

The county health department, the California Department of Public Health and the CDC began investigating other possible exposures, not only for HCV, but also HIV and hepatitis B virus (HBV). The agencies sent warning letters to 400 patients who were potentially infected with a bloodborne pathogen after visiting the clinic in the previous 10 months. They found six other patients who also were infected with HCV. Four of the patients had no known exposures to HCV, nor previous positive tests, but had an injection procedure the same day as the index patient. No one came down with HBV or HIV.

“Identification of a case of acute HCV infection in a frequent blood donor without other risk factors should be considered a sentinel event and should prompt public health investigation,” the CDC said.

In addition, the CDC said ambulatory clinics that practice CAM therapies should consider infection control training and might benefit from inclusion in health care–associated infection surveillance networks, such as the CDC’s National Healthcare Safety Network.

http://www.idse.net/Hepatitis/Article/06-16/Chronic-Pain-Center-Infects-Seven-Patients-With-HCV/36587

Behind the Headlines - 'Friendly' virus repairs damaged liver cells (but only in mice)

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

'Friendly' virus repairs damaged liver cells (but only in mice)

Friday June 3 2016

There are more than 100 different types of liver disease

"Have scientists found a cure for alcoholism?," the Mail Online asks, missing the point of the research entirely.

Researchers were able to improve liver damage in mice, but this does not amount to curing an addiction to alcohol.

The study showed it was possible to create "bespoke friendly" viruses to infect cells known as myofibroblasts, which are cells associated with tissue repair. The virus passed on instructions that transformed the myofibroblasts into healthy liver cells in mice who had fibrosis (scarring) of the liver, known as cirrhosis.

Not all the experiments in the mice worked, but in those that did, the transformed liver cells looked and behaved normally, replaced some of the diseased liver cells, and led to less liver scarring.

Researchers will now attempt to refine this technique before seeing if it works in humans.

Right now, this technique is not available as a new treatment. It represents one of the earliest stages of treatment discovery and development, which can take decades from start to finish.

If you do have a lifestyle that increases your risk of liver disease, such as heavy alcohol consumption, being obese, or injecting drugs, you should ask your GP for a liver function test. The symptoms of liver disease often only occur once it is too late to undo the damage.

Taking action to reduce your risk before this happens could restore your liver back to good health.

Where did the story come from?
The study was carried out by researchers from The University of California and funded by grants from the US National Institutes of Health.

The study was published in the peer-reviewed science journal Cell – Stem Cell.

The Mail Online's reporting was poor, failing on three main points.

Firstly, it asked an inappropriate question in its headline – "Have scientists found a cure for alcoholism?". A cure, or at least a partial repair, of liver damage would not amount to a cure for alcohol addiction. The headline confused alcohol with its main health consequence – alcoholic liver disease. There are many other consequences of chronic alcohol misuse – be it social, financial or mental health-related.

Secondly, nowhere in the article (let alone in the headline) did it mention that the study was on mice, so readers might naturally assume it involved people.

Thirdly, there are other causes of liver disease aside from alcohol, such as obesity (non-alcoholic fatty liver disease) or infection with the hepatitis C virus. The mice studied didn't have alcohol-induced liver disease.

What kind of research was this?
This was a laboratory study investigating a potential new treatment approach for liver fibrosis.

Liver fibrosis is the scarring and demise of your liver, following repeated cell damage and inflammation. Fibrosis can have many causes, including viruses (like hepatitis B and C), alcohol misuse, and fatty liver disease.

Despite the liver's somewhat unique ability to recover and regenerate, when liver cells are repeatedly damaged, such as through sustained heavy alcohol use, they gradually die and the organ stops working. Part of the damage is the build-up of collagen, which causes scarring and restricts blood flow.

The poorly functioning liver and restricted blood flow causes symptoms including jaundice, weight loss, swelling of the abdomen, vomiting blood and, ultimately, death.

The only cure for severe liver scarring, where the liver loses most of its functioning ability (liver failure), is a liver transplant. But there are not enough organs to meet demand, so medical researchers are always looking for alternatives.

What did the research involve?
The researchers reprogrammed types of cells called myofibroblasts into liver cells by injecting reprogramming instructions, via a "designer virus", into mice with liver disease.

Myofibroblasts were chosen as the target, as they produce the excess collagen which causes scarring.

The researchers carefully analysed whether the reprogrammed cells behaved like normal liver cells in the lab and had similar DNA and protein profiles. They also tested whether once injected they were able to grow, repair and replace some or all of the liver damage.

Part of the challenge was devising a safe and effective way to deliver the reprogramming instructions to the mice myofibroblast cells. They used adeno-associated virus 6 (AAV6) vectors to act as delivery vehicles.

This involved taking the packaging of a virus and modifying it, so instead of infecting a mouse and causing disease, it infects the mouse and makes the modifications they wanted – in this case, turning myofibroblasts into liver cells. This involves replacing and modifying the virus DNA – that instructs the virus cell – with DNA encoding instructions you want.

What were the basic results?
The researchers overcame the delivery and reprogramming challenges to influence some cells to change from myofibroblasts into liver cells by injecting the reprogramming instructions into the bloodstreams of the mice using different AAV vectors.

Not all of the vectors worked. But in those that did, not only did some cells change, they appeared to function like normal liver cells, were able to grow and multiply, and reduced the amount of problematic collagen.

This partially alleviated two of the main causes of liver fibrosis – liver cell death and collagen build up – in mice with liver disease.

How did the researchers interpret the results?
The researchers concluded: "Our study establishes the feasibility of in vivo reprogramming of myofibroblasts into fully functional hepatocytes [liver cells] using AAV vectors, a gene delivery tool that proved to be safe and effective in clinical trials of liver-directed gene therapy".

Conclusion
This study showed it was possible to engineer and inject instructions that transform myofibroblasts into liver cells in mice with liver disease, which is quite a feat. Not all delivery mechanisms, called vectors, worked, but in those that did, the new liver cells looked normal, replaced some of the dying cells, and led to less damage due to collagen build up.

Despite the alcoholism-related headline, the mice did not have alcohol-induced liver damage – although this is a major cause of liver damage in people.

This study serves to prove this approach is feasible, and was successful in doing this. Researchers will now need to refine the technique before testing to see if it works in human trials.

The good news is the vector delivery system has been used in human trials before – although not containing the same liver cell transformation message – so has a better chance than normal of working in people.

Right now this technique is not available as a new treatment. It represents one of the earliest types of treatment development, which can take decades from start to finish.

Currently the only cure for severe liver scarring is an organ transplant, but many die while waiting for a transplant as need far outstrips supply. If you are not on the register, you could save lives by joining the NHS Organ Donor Register today.

The liver is tough and can regenerate itself, but it can only take so much damage. Moderating your alcohol consumption, maintaining a healthy weight, and reducing your risk of contracting hepatitis C (mainly spread by injecting drugs), will do much to keep your liver healthy.

Analysis by Bazian. Edited by NHS Choices. Follow NHS Choices on Twitter. Join the Healthy Evidence forum.

Deadly Hep C Going Untreated in Native Communities

Deadly Hep C Going Untreated in Native Communities
Tanya H. Lee
6/6/16

Hepatitis C is raging through American Indian and Alaska Native communities, and the Indian Health Service does not have nearly enough funding to fight the disease, according to a May 26 article in the Journal of the American Medical Association.

Read more at http://indiancountrytodaymedianetwork.com/2016/06/06/deadly-hep-c-going-untreated-native-communities-164670