Hepatitis C Update-Treatment Of Genotypes 1,2,3,4,5,and 6

HCV Treatment and Genotypes 

Good day folks, we have a few website updates from Hepatitis C Online, an interactive website from the University of Washington.

The site has comprehensive information on the diagnosis, monitoring, treatment and management of hepatitis C and offers a free online Hepatitis C Course, using AASLD/IDSA/IAS-Recommendations for Testing, Managing, and Treating Hepatitis C.

The hepatitis C patient will have an opportunity to the explore over 7 different modules, slide lectures, and read key data from published studies using new direct-acting antiviral agents.

Updated January 9 2015 
This month, Hepatitis C Online updated Module 5;Treatment of Chronic Hepatitis C Infection.

Click on each lesson to review the course module, or download PDF, I highly suggest the latter for easy viewing.

Genotype 1
PDF - Treatment of HCV Genotype 1
Lesson 1: Treatment of HCV Genotype 1
Contents: Introduction
Genotype 1: Initial Treatment and Retreatment with Prior Relapse
Genotype 1: Retreatment of Patients with prior Treatment Failure
Genotype 1: Future Treatment Options
Summary Points
Reference

Genotype 2

PDF - Treatment of HCV Genotype 2
Lesson 2: Treatment of HCV Genotype 2

Contents: Introduction

Genotype 2: Initial Treatment and Retreatment with Prior Relapse

Genotype 2: Retreatment of Prior Nonresponders

Genotype 2: Future Treatment Options

Summary Points

Genotype 3

PDF - Treatment of HCV Genotype 3
Lesson 3: Treatment of HCV Genotype 3
Contents: Introduction
Genotype 3: Initial Treatment and Retreatment with Prior Relapse
Genotype 3: Retreatment of Prior Nonresponders
Genotype 3: Future Treatment Options
Summary Points

Genotype 4

PDF - Treatment of HCV Genotype 4

Lesson 4: Treatment of HCV Genotype 4

Contents: Introduction

Genotype 4: Initial Treatment and Retreatment with Prior Relapse

Genotype 4: Retreatment of Prior Nonresponders

Genotype 4: Future Treatment Options

Summary Points

Genotype 5 or 6

PDF - Treatment of HCV Genotype 5 or 6.
Lesson 5: Treatment of HCV Genotype 5 or 6
Introduction

Genotype 5 or 6: Initial Treatment and Retreatment with Prior Relapse

Genotype 5 or 6: Retreatment of Prior Nonresponders

Genotype 5 or 6: Future Treatment Options

Summary Points

Index
Genotypes 1-6

Module 5; Treatment of Chronic Hepatitis C Infection

Liver International

Volume 35, Issue Supplement s1, pages 1–3, January 2015

A special supplement of Liver International; Proceedings of the 8th Paris Hepatitis Conference International Conference on the Management of Patients with Viral Hepatitis, is open access this month. This issue will include review articles on both HCV and HBV, with treatment strategies for HCV genotype 2, 4, and HCV-1b. Additional articles include HIV/HCV co-infection, end stage liver disease, liver cancer, and the dire universal need for affordable IFN-free regimens. 

Highlights
Optimal IFN-free therapy in treatment-naïve patients with HCV genotype 1 infection
Optimal therapy in genotype 4 chronic hepatitis C: finally cured?
Optimal therapy of genotype-2 chronic hepatitis C: what's new?
How to optimize current therapy in hepatitis C virus genotype 1 patients. Predictors of response to interferon-based therapy with second wave direct acting antivirals
Pegylated interferon based therapy with second-wave direct-acting antivirals in genotype 1 chronic hepatitis C

In Case You Missed It

November 2014
Hepatitis C Genotype 3

Written by Mr. Alan Franciscus, published in HCV Advocate's November Newsletter.

In the past, HCV genotype 3 was thought to be one of the easiest to cure. As a result there was little incentive to develop newer therapies especially since there were fewer people with genotype 3 in developed countries. Now it has turned out that treatment of genotype 3 is the hardest to cure with HCV inhibitor therapy compared to HCV genotypes 1, 2 and 4. 

Of Interest

AASLD @ HepMag.com

Gilead’s 8-Week Hep C Cure Is Good for Genotype 3, Not 1 or 2

Eight weeks of Gilead Sciences’ Sovaldi and GS-5816, with or without ribavirin, cured high rates of people with genotype 3 of hepatitis C virus (HCV), but yielded unsatisfactory results among those with genotypes 1 and 2.

Genotypes 3 and 6

Harvoni Posts Good Cure Rates for Hepatitis Genotypes 3 and 6
Twelve weeks of Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) plus ribavirin cured 73 percent to 89 percent of people with genotype 3 of hepatitis C virus (HCV), while 96 percent of people with genotype 6 were cured without ribavirin in a recent trial, the National AIDS Treatment Advocacy Project (NATAP) reports.

Insulin resistance and liver steatosis in HCV genotype 3
Three main types of steatosis in the patients with Hepatitis C virus (HCV) infection are known: a metabolic type associated with metabolic syndrome and two viral types: one that seems to be directly triggered by the virus and one that could originate from the interference of the virus in the mechanisms of insulin resistance. The first viral type is particularly widely considered to be predominant and, perhaps, strictly linked to HCV genotype 3 infection and its intra-hepatic viral load. This evidence is supported by the resolution of steatosis in most patients infected with genotype 3 virus after HCV eradication by antiviral therapy.

Enjoy the weekend!

Tina

Interferon-Free Combination Therapy Prevents Recurrence of HCV After Liver Transplantation

Interferon-Free Combination Therapy Prevents Recurrence of HCV After Liver Transplantation

Bethesda, MD (Jan. 9, 2015) — A 24-week course of sofosbuvir and ribavirin can eliminate hepatitis C virus (HCV) infection in two-thirds of patients who undergo liver transplantation, with positive consequences on their short- and long-term prognoses, according to two new studies published in Gastroenterology, the official journal of the American Gastroenterological Association.

The first study1, a Phase 2, open-label study, found that combination therapy with sofosbuvir and ribavirin for up to 48 weeks before liver transplantation can prevent recurrence of HCV infection post-transplantation in 70 percent of patients. This study provides proof of concept that successful interferon-free treatment prior to liver removal can eliminate the disease in most patients.

“Patients with hepatitis C virus at the time of liver transplantation universally experience recurrent HCV infection,” said lead study author Michael P. Curry, MD, from Beth Israel Deaconess Medical Center, Boston, MA. “Recurrent HCV infection follows an aggressive course. Given the burden of disease — the increased morbidity, mortality and costs — and the lack of a safe and broadly effective treatment to prevent recurrence of HCV infection, these results provide hope for patients in need.”

The second study2 was a prospective, multi-center, open-label pilot study, consisting of patients with recurrent HCV infection after a primary or secondary liver transplant. Patients received an all-oral regimen of sofosbuvir and ribavirin for 24 weeks, which resulted in sustained virologic response, with no detectable virus, in 70 percent of patients. This rate is similar to that achieved in clinical trials using the same dose and duration of sofosbuvir and ribavirin in the nontransplant setting.

“A well tolerated and effective treatment protocol for recurrence of HCV infection following liver transplantation is an important unmet clinical need,” said lead study author Michael R. Charlton, MD, Mayo Foundation, Rochester, MN. “Our study demonstrates that patients with characteristics that have historically been difficult to cure with interferon-based regimens, including those with advanced disease, may benefit from this all-oral interferon-free therapy.”

In both studies, the rate of discontinuation due to adverse events was low.

Liver disease secondary to HCV infection is, by far, the most common indication for liver transplantation in the U.S. and is also the most common reason for transplanted livers to fail. Learn more about HCV in the AGA patient brochure.

Both trials were funded by Gilead Sciences, Inc.

1 Curry, M.P., et al. Sofosbuvir and Ribavirin Prevent Recurrence of HCV Infection after Liver Transplantation: An Open-Label Study, Gastroenterology, Volume 148(1): 100-107.e1
2 Charlton, M.R., et al., Sofosbuvir and Ribavirin for Treatment of Recurrent Hepatitis C Virus Infection After Liver Transplantation, Gastroenterology, Volume 148(1): 108-117
About the AGA Institute

The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, the AGA has grown to more than 16,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization. www.gastro.org.
About Gastroenterology

Gastroenterology, the official journal of the AGA Institute, is the most prominent scientific journal in the specialty and is in the top 1 percent of indexed medical journals internationally. The journal publishes clinical and basic science studies of all aspects of the digestive system, including the liver and pancreas, as well as nutrition. The journal is abstracted and indexed in Biological Abstracts, Current Awareness in Biological Sciences, Chemical Abstracts, Current Contents, Excerpta Medica, Index Medicus, Nutrition Abstracts and Science Citation Index. For more information, visit www.gastrojournal.org.

Like AGA and Gastroenterology on Facebook.
Join AGA on LinkedIn.
Follow us on Twitter @AmerGastroAssn.
Check out our videos on YouTube.

At $594 Per Dose Gilead Sciences, Inc. (GILD) Hepatitis Drug Is Too Costly For Veterans Affairs Department

At $594 Per Dose Gilead Sciences, Inc. (GILD) Hepatitis Drug Is Too Costly For Veterans Affairs Department
BY LISA RAY · JANUARY 9, 2015 05:27 AM PST

Gilead Sciences, Inc. (NASDAQ:GILD)‘s hepatitis C drug Sovaldi, which comes at a cost of $1,000 a pill, has proved to be a breakthrough that reduces treatment time to 12 weeks and at reduced risk compared to a year-long treatment option available. However, this heavily-priced therapy has raised concerns and criticisms across the U.S. by payers and consumer support groups.

To consider the impact of Sovaldi’s $84,000 12-week treatment cost, the Veterans Affairs Department provides this therapy only to the sickest patients who need it. The Department is the largest single provider of hepatitis C care in the U.S., which enabled it to negotiate more than 40% discount to the $594 per-dose price with Gilead.

Continue reading...

Anthem selects Gilead as primary supplier of hepatitis C drugs

Anthem selects Gilead as primary supplier of hepatitis C drugs
Jan 8 (Reuters) - Health insurer Anthem Inc on Thursday said it reached a deal under which Gilead Sciences Inc's hepatitis C drug Harvoni will be the primary treatment for patients infected with the most common strain of the liver-destroying virus.

Anthem said the deal effectively lowers its hepatitis C treatment costs. "We were able to achieve a very competitive rate and a freeze on retail pricing for 2015," the insurer said in an emailed statement. "That does favorably impact plan costs for 2015."

Gilead has come under fire for the high cost of Harvoni, as well as predecessor drug Sovaldi, which was launched in late 2013 at a price of $1,000 per pill. Harvoni has a list price of $94,500 for 12 weeks of treatment, or $1,125 per daily pill.

Last month, AbbVie Inc began sales of a competing drug, Viekira Pak, at a similar list price. Express Scripts Holding Co, the largest U.S. pharmacy benefit manager, subsequently chose AbbVie's drug as the exclusive option for patients in its largest commercial plan, covering 25 million people.

CVS Health Corp, the nation's second-largest pharmacy benefit manager announced earlier this week it had selected Gilead's drugs as its exclusive option for patients on commercial plans as well as those covered under its healthcare exchange plans, Medicare and Medicaid.

More than three million people in the United States are believed to be infected with hepatitis C. (Reporting by Deena Beasley; Editing by James Dalgleish)

source

Hep C Drug Deal Raises Patient-Choice Concerns

Hep C Drug Deal Raises Patient-Choice Concerns
By ED SILVERMAN
Jan. 8, 2015 3:51 p.m. ET

At a time when the rising cost of medicines is causing consternation, an exclusive deal between Express Scripts Holding Co. , the nation’s largest pharmacy-benefits manager, and AbbVie Inc., a big drug maker, over a new hepatitis C treatment is generating concern about the implications for patient choice.

The deal came after the benefits manager spent a year railing about the prices charged by Gilead Sciences Inc., which until now has had a lock on the market. Fresh off FDA approval for its drug, AbbVie last month offered Express Scripts an undisclosed discount off its $84,000 list price. The newest Gilead drug, called Harvoni, costs between $63,000 and $94,500, depending upon the regimen.

Continue reading....

Afternoon HCV News Ticker: Hepatitis C drugs offer new options

HCV News Ticker 

Good Day Folks, trying to keep warm here in Michigan, the windchill is below 20, baby its cold outside. Here are a few top headlines making news across the web today.

Hepatitis C drugs offer new options

By Stacey Butterfield

The approval of multiple drugs in 2013 and 2014 that are able to cure hepatitis C without the use of interferon has dramatically changed the screening, treatment, and epidemiologic paradigms of the virus. Soon, internists will be involved in this rapidly changing area of health care.
Continue reading...

Hep C Drug Deal Raises Patient-Choice Concerns
By
ED SILVERMAN
Jan. 8, 2015 3:51 p.m. ET

At a time when the rising cost of medicines is causing consternation, an exclusive deal between Express Scripts Holding Co. , the nation’s largest pharmacy-benefits manager, and AbbVie Inc., a big drug maker, over a new hepatitis C treatment is generating concern about the implications for patient choice.

The deal came after the benefits manager spent a year railing about the prices charged by Gilead Sciences Inc., which until now has had a lock on the market. Fresh off FDA approval for its drug, AbbVie last month offered Express Scripts an undisclosed discount off its $84,000 list price. The newest Gilead drug, called Harvoni, costs between $63,000 and $94,500, depending upon the regimen.
Continue reading....

5 Health Care Megatrends That May Prove Costly In 2015

Robert Pearl, M.D. Contributor
Let’s take a look at five health care megatrends from 2014 and consider their implications for 2015 and beyond.
Megatrend 1: Breakthrough Therapies, Gargantuan Prices
The Food and Drug Administration (FDA) approved several new drugs in 2014 for the treatment of hepatitis C, a chronic liver infection. The biopharmaceutical company Gilead introduced two oral medications that eliminate the hepatitis C infection in around 90 percent of patients. With few major side effects, these drugs signaled a major medical advancement in 2014.
Continue reading @ Forbes

Hepatitis C Drug Discount Deals Still Miss Many Patients

Bruce Japsen
Despite recent deals designed to extract discounts from the makers of expensive Hepatitis C pills, there are still large numbers of Americans, particularly the poor covered by Medicaid insurance, that are missing out on lower costs and in some cases can’t access the treatment.

Continue reading @ Forbes

At The Crossroads, Part 8: Fueled By Opioid Abuse, New Hep C Infections Rise
By KRISTIN GOURLAY
In 2014, hundreds of Rhode Islanders died from accidental drug overdoses. Thousands more remain addicted to prescription painkillers and heroin. For those who inject the drugs, there’s another risk: hepatitis C.  In the final story in our series “At the Crossroads,” we meet a team of outreach workers determined to find new infections before it’s too late.

Continue reading...

Express Scripts' Miller lays out manifesto to fight sky-high drug prices
FiercePharma | January 7, 2015
It's no secret that Express Scripts Chief Medical Officer Steve Miller is hankering for some changes in the pharma business. But what many may not know, he told PharmExec, is that he's got a four-point solution to fix what he sees as the industry's biggest problems.

Continue reading...

Freedom from the Burden of Hepatitis C

Lucinda Porter

Hepatitis C can be a burden. Heck, life with or without hepatitis C isn’t exactly a picnic. Do you ever find yourself having a moment of complete abandon?

Continue reading....

Glass Half-Full or Half-Empty on Flu Vaccine asks Loyola Infectious Disease Specialist

Newswise — In baseball, three strikes and you’re out. The most common annual vaccine targets three strains of flu virus. This year, two vaccine strains are spot on and successfully matched. One strain is partially mismatched, but still believed to offer partial coverage for that strain. The current flu vaccine is still in the game and, more importantly, keeping people well and on the playing field, says a Loyola University Medical Center infectious disease specialist.

Continue reading...

In case you missed it check out; 

2015 HCV Newsletters: The Price Wars, The Good News and Hope

2015 HCV Newsletters: The Price Wars, The Good News and Hope

January Newsletters: Hepatitis C

Hello everyone, what a promising year ahead for treating HCV. Finally we have a medication to cure hepatitis C that doesn’t require interferon or ribavirin. Enter Gilead's Harvoni,  FDA approved in October to treat HCV genotype 1 infection, including individuals with compensated cirrhosis, again, a regimen that does not require interferon or ribavirin. 

In December AbbVie`s Viekira Pak was approved for use with or without ribavirin, also for the treatment of HCV genotype 1, including those with compensated cirrhosis. No interferon needed here as well. 

Tragically, both drugs are not financially accessible to the millions of people who desperately need them.  Many people have been denied coverage by insurance companies, a cure is here, but just out of their reach.  

The Price Wars
The good news is Gilead joined up with CVS Health Corp., the nationwide drugstore chain for exclusive distribution of Sovaldi and Harvoni, according to Bloomberg; both drugs will also be exclusive on the PBM's Affordable Care Act exchange, Medicare Part D and Medicaid formularies.  Gilead`s deal with CVS has not changed the price of Harvoni or Sovaldi. Currently Harvoni is at $94,500 and Sovaldi remains priced at $84,000 for a full course of treatment. Elsewhere, Gilead lowered the price of Sovaldi to $840.00 for 12 weeks of treatment in India, Egypt and Brazil, which figures out to be 1 percent of the American price.

As for Viekira Pak, AbbVie has a distribution deal with Express Scripts.  AbbVie is lowering Viekira Pak to around $51,000-$66,000, the price was $83,319. But the deal will exclude Harvoni and Olysio, and from January 1st Express Script will no longer be offering Gilead`s Sovaldi to its patients. However, Express Spript will provide drugs to those patients who already started treatment with any of the above mentioned drugs.

The Controversy

To get your head around the controversy, start by reading; The Hepatitis C Wall of Shame, written by Lucinda Porter, here is an excerpt.

Express Scripts – You aren’t going to offer Harvoni on your formulary. Seriously? What happens to those with genotype 1a and everyone with cirrhosis who can’t take ribavirin? Do you know how awful ribavirin is? Do you think it is acceptable to force patients to endure anemia, rage, insomnia, anxiety, and so on, so you can save money? Then there is the issue of pregnancy. Is it worth risking fetal death by denying Harvoni? I do appreciate the fact that you are offering treatment to people at all stages of fibrosis (except decompensated cirrhosis), but Viekira Pak isn’t comparable to Harvoni unless you have genotype 1b without cirrhosis

The full article is available, here.

Support
Recently, a new hotline was launched by Patient Advocate Foundation to help hepatitis C patients manage insurance issues.
Hepatitis C CareLine 800-532-5274
Monday through Thursday from 8:30 AM – 8:00 PM ET and Friday from 8:30 AM – 7:00 PM ET.

For more information visit the Patient Advocate Foundation, for patients seeking financial assistance and access to care, click here.

Gilead's Harvoni or AbbVie`s Viekira Pak 

Thus far the consensus is that Gilead's Harvoni is preferred over AbbVie`s Viekira Pak. Harvoni (ledipasvir and sofosbuvir) is a combination pill taken daily, with or without food, as mentioned it never needs ribavirin. Harvoni has no contraindications, treatment duration is most often for 8-12 weeks, the exception is in treatment-experienced patients who have cirrhosis, in this case 24 weeks of treatment is required, still without ribavirin.  

On the other hand Viekira Pak will require the use of ribavirin for many patients, and contains four drugs. The recommended dosage of Viekira Pak is two ombitasvir, paritaprevir, ritonavir tablets once daily (in the morning) and one dasabuvir tablet twice daily (morning and evening), with food, confusing?

Viekira Pak has a list of drug interactions to consider, in addition, liver enzyme tests may be needed four weeks into treatment. See VIEKIRA PAK PRESCRIBING INFORMATION;

During clinical trials with VIEKIRA PAK with or without ribavirin, elevations of ALT to greater than 5 times the upper limit of normal (ULN) occurred in approximately 1% of all. ALT elevations were typically asymptomatic, occurred during the first 4 weeks of treatment, and declined within two to eight weeks of onset with continued dosing of VIEKIRA PAK with or without ribavirin.

The SVR rates for both drugs are highly effective, as mentioned Harvoni is only one pill a day, with a history of use in the real world, very important, and no long list of drug interactions, including oral contraceptives.

In the end many patients will have no voice in their treatment options, at this point some insurance companies have made that treatment decision based solely on need (stage of disease.) Patients will be forced to take what they can get, with nervous anticipation they wonder, they wait, will it be; Harvoni or Viekira Pak. or nothing at all? 

Insurance Coverage Based on Liver Disease Stage
In this article written by Dr. Sulkowski, a female hepatitis C patient is denied coverage for oral HCV therapy based on stage of disease, (no fibrosis). The good doctor makes a strong case for treating HCV early, but in 2015 that may not be possible. Sadly, until an affordable price is established, treating HCV early will apparently be considered a luxury, one that most people will never be able to afford.

He writes; This case represents a clear example of payers looking narrowly at liver disease stage, rather than the whole patient, when making coverage decisions. 

Looking Beyond Liver Disease Stage When Determining Need for HCV Therapy
Mark S. Sulkowski MD - 12/31/2014
Coverage of treatment was recently denied for my 23-year-old patient interested in starting therapy to prevent mother-to-child HCV transmission.

Free registration is required to view links in this article.

As of late 2014, we have access to multiple highly effective, highly tolerable, and safe antivirals for the treatment of hepatitis C virus (HCV) infection. We are able to forego the use of peginterferon and, for many patients, ribavirin is no longer needed. Theoretically, these developments have opened the door for the treatment of a wide array of patients with HCV infection, many of whom had been avoiding therapy because of its previously limited efficacy and notable toxicity. Many of these patients have minimal liver disease and have decided with their healthcare providers to defer treatment after weighing the costs and risks of peginterferon-based treatments against the potential benefits.

Today, I am seeing many of these patients enter my practice wanting access to the newly available all-oral therapies after waiting—in some cases for decades—to start treatment. But many of these individuals are encountering coverage restrictions from third-party payers. One such type of patient with mild liver disease that I see in my practice is women of child-bearing age who plan to have children and are now motivated to clear their hepatitis C infection in order to prevent mother-to-child transmission.

Treatment Motivation in a Young Patient With Mild Disease
I recently saw a 23-year-old black woman who had acquired genotype 1 HCV infection at birth from her mother who was coinfected with HCV and HIV, and had been diagnosed with hepatitis C several years ago. When I first saw her in my office, we performed a noninvasive blood test and determined that she had METAVIR stage 0 liver disease (no fibrosis). She was HIV negative, and her HCV RNA level was relatively low, at approximately 525,000 IU/mL.

She had one child who fortunately had not acquired HCV at birth. Part of her current motivation for treatment was her intention to have additional children. We discussed the small but real risk (estimated at 3% to 10%) of transmitting HCV to future children and the increasing risk as the HCV RNA level increases. (The risk of vertical transmission of HCV is also higher in people with HIV, but fortunately this patient was HIV negative.)

She also noted a psychosocial stigma surrounding her HCV infection in her professional and personal life, and that her HCV infection made her feel generally unhealthy.

Insurance Coverage Based on Liver Disease Stage
Following the patient’s visit, I prescribed a highly effective all-oral therapy, but coverage was denied by her insurance company because she did not have METAVIR stage 3 or 4 liver disease. This outcome is currently under appeal. However, this has become a common scenario for my patients with mild liver disease, regardless of the extenuating circumstances.

This case represents a clear example of payers looking narrowly at liver disease stage, rather than the whole patient, when making coverage decisions.

We have the ability to treat and cure this woman with as little as 8 weeks of all-oral therapy, thereby eliminating the risk of vertical HCV transmission. By denying access to treatment and allowing the woman to remain infected with HCV, we are putting her and her family in a difficult situation. If the HCV infection were to be transmitted vertically, the child would require monitoring and, at some point, treatment. We would need to treat 2 people instead of 1!

Psychosocial Impact of Denied Access to Treatment
Another issue raised by this case is the impact that HCV infection has on a patient’s daily life. Given her early liver disease stage, one could argue that this woman’s HCV infection has limited impact on her overall health. However, I see from my patients that this is not the case. For example, this patient cannot consume alcohol without concern that it may damage her liver. Without treatment, she would also require continual follow up every 6 to 12 months for staging of her liver disease. Additionally, there are extrahepatic manifestations of HCV infection to consider. Finally, she is subject to the psychosocial impact of living with a contagious virus that has the potential to cause her and others great harm—and for her this is particularly true as she is in the medical field.

Fortunately, the AASLD/IDSA HCV guidance panel have recently reiterated their recommendation that all patients with HCV infection are expected to benefit from treatment. To support this recommendation, there remains a great need for patient advocacy from healthcare providers, community-based organizations, and patients and their families. We all need to speak up and demand that persons with HCV infection have greater access to these safe and highly effective HCV treatments.

Your Thoughts?
I’d like to hear about your experiences with access to current all-oral therapies in patients with mild liver disease. I invite readers to post their thoughts in the Comments section below.

Source -  Clinical Care Options.

In The News
Jan 8
Afternoon HCV News Ticker: Hepatitis C drugs offer new options
Hep C Drug Deal Raises Patient-Choice Concerns
Hepatitis C Drug Discount Deals Still Miss Many Patients

Jan 7

Benitec Advances Hepatitis C Clinical Trial

Hepatitis C treatments are 'history in the making' at a high cost
Hepatitis C drug costing VA, DoD millions

At The Crossroads: CVS Inks Exclusive Deal With Gilead For Hep C Drugs

Hepatitis C market competition arrives for 2015

2015 HCV Newsletters
Now for this months newsletters, provided by a small group of hard working people committed to spreading awareness, support and information about viral hepatitis.

This post will be updated later in the month as additional publications become available. 

HCV Advocate Newsletter

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

HCV Advocate Newsletter
January 2015

In This Issue

Top News of 2014
Alan Franciscus, Editor-in-Chief
2014 was by far the most incredible year in hepatitis C (HCV) treatment advances, but there was a lot of bad news about treatment access. However, first let's concentrate on the good news – all oral therapies approved to treat hepatitis C. 

Read more...

AbbVie's VIEKIRA PAK Approval & AASLD 2014
Alan Franciscus, Editor-in-Chief
In this month's HCV Drugs we have news on AbbVie's drug approval of their HCV drugs, and, yes, more coverage from the American Association for the Study of Liver Diseases (AASLD). In Lucinda's Snapshots column this month, information on Janssen's AASLD presentations is included.

Read more...


HCV and Depression
Alan Franciscus, Editor-in-Chief
This article is about the many difficulties that people with hepatitis C face that can lead to depression, how to identify depression and some steps to deal with it. 

Read more...

HealthWise: Denied Hepatitis C Treatment? Here is How to Fight Back
Lucinda K. Porter, RN
People with hepatitis C are facing widespread denials of treatment. This article provides tips for what you can do about it. 

Read more...


Lucinda K. Porter, RN
Read about the association between chronic HCV and low muscle mass, the impact of injecting networks on transmission and treatment in PWID's, the efficacy and safety of Sovaldi plus Olysio in people with advanced cirrhosis and post-transplant. 

Read more...



What's New
Alan Franciscus, Editor-in-Chief
HCV Advocate Drug Pipeline Re-Designed & Updated
Read more...

HCV Advocate Eblast
Stay informed on the latest news...click here to register for email alerts

Connect With HCV Advocate

 

Living Well with Hepatitis B

HBV Advocate: for accurate, timely and cutting-edge information on HBV treatment and vaccines.

HBV Journal Review

January Issue

Connect On Twitter

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

Exclusives
2014 Viral Hepatitis Year-in-Review and Looking to 2015

by Ron Valdiserri
2014 has been a year of both opportunities and challenges in the fight against viral hepatitis.

The Origins of the Hepatitis C Virus

by Alan Franciscus

In 1996, I was diagnosed with hepatitis C and at first I was very frightened. What got triggered was the fear of the unknown. If I don’t know something about something that affects me my head imagines the worst possible scenario.

Hepatitis C Genotype 3
by Alan Franciscus

In the past, HCV genotype 3 was thought to be one of the easiest to cure. As a result there was little incentive to develop newer therapies especially since there were fewer people with genotype 3 in developed countries. Now it has turned out that treatment of genotype 3 is the hardest to cure with HCV inhibitor therapy compared to HCV genotypes 1, 2 and 4.

In The News
January 07, 2015
Estimated U.S. Cirrhosis Rates Are 58% Higher Than Once Believed
New research suggests that the prevalence of cirrhosis among the U.S. population is actually 58 percent higher than the previously thought.

January 05, 2015
People With Hepatitis C Often Get Lost in the Health Care Shuffle
The U.S. health care system is apparently failing to keep people diagnosed with hepatitis C in medical care, and ultimately to treat them for the virus.

More Hep News

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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.

IMPORTANT TREATMENT PRICING UPDATE:

HepCBC wants to clarify that the "speculative price" in Canada for AbbVie's interferon-free HolkiraTM Pak given on page 3 of our January, 2015 Bulletin is not official, and doesn't reflect any real pricing. We can say that on or before January 16th, we will be able to post the actual price on our website blog (www.hepcbc.ca - left column under "HepCBC News").

Newsletter

January 2015

In This Issue

Interferon-Free Combos in USA and Canada: UPDATE as of Dec. 23rd, 2014 

Supported by 66,000+ signatures on Change.org, Jennifer Peever loses battle with hepatitis C, never able to access lifesaving treatment

Treatment in remote, rural, aboriginal communities: new challenges, new solutions? A look at Telehealth

Woman age 61, celebrates success second time doing treatment by winning Bike Road Race medal!

Time for all-new treatment paradigm? "If you have money you'll live. If you don't..." and a Class Action Lawsuit

Low pricing agreements allow patients in low-income countries access to lifesaving drugs Super but don't neglect poor in middle and high income countries

Honour Roll of people cured of hepatitis C - hope your name is on it soon!

Conferences, Medication Assistance, Compensation

View all newsletters, here. 

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Healthy You

A monthly newsletter from the National Institutes of Health, part of the U.S. Department of Health and Human Services

January Issue

Osteoporosis in Aging
Protect Your Bones with Exercise

There’s a lot you can do to reduce your risk for osteoporosis, a condition that affects more than 10 million people nationwide. Getting plenty of calcium, vitamin D, and exercise is a good start.

Read more about osteoporosis.

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HCV - Maintaining A Healthy Liver In 2015

Healthy Lifestyle
Maintaining a healthy weight by eating a suitable diet along with exercise can help reduce inflammation in the liver and slow down the progression to cirrhosis from hepatitis C, in contrast being overweight, having diabetes, high cholesterol or a fatty liver increases disease progression.

To help keep your liver healthy, begin by incorporating the right foods into your diet. Try adding plenty of high-fiber foods such as fresh fruits, vegetables and nuts. Nuts are a great snack, and reduces oxidative stress throughout the body, including the liver. For instance the Mediterranean way of eating is comprised of these liver friendly foods, more importantly a study published in the November 2013 issue of Journal of Hepatology, found the diet to be protective against HCC (liver cancer) with potential benefits for patients chronically infected with viral hepatitis. Read the full article over at NATAP, abstract here.

As a side note, a study out of Sweden examined the consequences of liver damage after successfully completing HCV therapy. They found achieving SVR markedly reduced liver-related complications, including liver cancer, but some long-term risk for liver cancer remained in those who were cured of Hepatitis C. Another reason people living with HCV to continue healthy liver habits long after curing the virus.

Cirrhosis
Because malnutrition is common in people with cirrhosis, a healthy diet is important in all stages of the disease. Health care providers recommend a meal plan that is well balanced. If ascites develops, a sodium-restricted diet is recommended.

As a reminder persons with cirrhosis should not eat raw shellfish, which can contain a bacterium that causes serious infection. Cirrhosis affects the immune system, making people with cirrhosis more likely than healthy people to develop an infection after eating shellfish that contain this bacterium.

Learn more about diet, cirrhosis, hepatitis C, and liver cancer from a patients perspective at; Your Best Friend's Guide to Hepatitis C

HCV and Exercise
Here's an interesting article which was recently published in the African Journal of Health Sciences. The aim of the paper was to investigate the effects of aerobic exercise in 50 male chronic HCV patients. The men were put evenly in two groups, first group (A) received aerobic exercise training in addition to their regular medical treatment; three times a week over a three month period. The second group (B) received no training, only regular medical treatment. Ages ranged from 30 to 50 years, all men had elevated liver enzymes. The study reported significantly improved liver enzymes in the men who received aerobic exercise, group (A), in addition, mental well-being was also improved in the exercise group. Read the full text article, here.

Alcohol and HCV
Alcohol can damage or destroy liver cells. Liver damage can lead to the build up of fat in your liver (fatty liver), inflammation or swelling of your liver (alcoholic hepatitis), and/or scarring of your liver (cirrhosis). For people with liver disease, especially hepatitis C, even a small amount of alcohol can make the disease worse. In a special 2013 issue of Clinical Liver Disease, researchers wrote;

"Long-term alcohol use has synergistic effects with other causes of chronic liver disease to accelerate progression of liver disease. For example, patients with Hepatitis C who regularly consume alcohol experience an accelerated progression to fibrosis, and a higher incidence of cirrhosis and hepatocellular carcinoma (HCC)"

Watch a video presentation of this article - Watch the interview with the author

HCV Guidelines
Again, there is strong evidence that heavy alcohol use (more than 50 grams per day) or 5 drinks, is associated with higher likelihood of advanced fibrosis in people with hepatitis C. However, evidence also exists showing lesser degrees of alcohol intake being associated with higher fibrosis scores and higher HCV RNA levels. Some data have shown a relationship between alcohol use in relation to HCV viral load and response to treatment. The AASLD hepatitis C guidelines from 2015 recommend counseling all patients with hepatitis C to abstain from alcohol use. More information can be found, here.

American Liver Foundation - Manage Your Medications
Prescription drugs can provide important benefits to individuals living with hepatitis C, but taking these medications as prescribed can be difficult. Some individuals struggle with drug side effects and costs while others may forget to take medication on time or order refills. Fortunately there are steps that can help address these challenges and better manage this condition through medication.
Continue reading...

Additional Links
Read more about managing your medications...

May you head into 2015 embracing a healthy lifestyle, maintaining all your good habits and improve those bad habits you may struggle with, good luck.

The information on this page was reproduced, adapted or derived from the following public domain sources: Text from the American Liver Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Reference Collection, and MedlinePlus, a service of the National Library of Medicine and National Institutes of Health (NIH) and U.S. Department of Veterans Affairs website, http://www.hepatitis.va.gov

Until next time.
Tina

Benitec Advances Hepatitis C Clinical Trial

Benitec Advances Hepatitis C Clinical Trial

SYDNEY, Jan. 7, 2015 /PRNewswire/ -- Benitec Biopharma Limited (ASX: BLT, OTC: BTEBY) is pleased to advise that the third patient in its Phase I/IIa clinical trial of TT-034 for hepatitis C was dosed earlier today at the Duke Clinical Research Unit (USA). This is a significant step for this "first in man" study, and follows review of the collective data from the first two patients by the independent Data Safety Monitoring Board (DSMB). The DSMB determined that the patients from the first dosing cohort were clear of any significant treatment-related adverse events.

The newly dosed patient is the first to receive the increased dose of TT-034 (1.25 x 10^11 vg/kg, a concentration that is a half log higher than the doses administered in the first cohort). While TT-034 is designed as a potential "one-shot" cure for hepatitis C, the current dose is still below that expected to inhibit viral replication and data from the second dosing cohort are therefore expected to serve primarily as a further safety assessment.

As with previous patients, the newly dosed patient will be monitored for six weeks and results will be reviewed by the DSMB. Should the results indicate appropriate safety outcomes, the DSMB is expected to recommend that the remaining two patients in the second cohort be dosed. It is aimed to dose both at approximately the same time. The trial sites at Duke Clinical Research Unit and University of California San Diego have identified a number of patients who have passed initial screening who can be prepared in anticipation of this outcome.

About TT-034

TT-034 is a ddRNAi-based therapeutic, designed to treat and potentially cure hepatitis C (HCV) with a single administration. TT-034 targets the hepatitis C viral RNA at three separate, highly conserved sites. As such it acts as a "triple therapy" even though it is a monotherapy, and minimizes the ability of the virus to mutate and escape the therapy. Once it reaches the liver cells, it enters the nucleus and produces three separate short hairpin RNAs continuously for the lifetime of the cell. Thus TT-034 has the potential to not only treat the existing HCV infection, but also to guard against reinfection for months to years without the need to re-treat. TT-034 safety and efficacy has been tested extensively in pre-clinical in vivo studies with no adverse effects observed at therapeutic doses.

worldnow.com.