Risk Of Developing Liver Cancer After HCV Treatment

Wednesday, January 7, 2015

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
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. 


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. 


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. 

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

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

HBV Journal Review
January Issue

Connect On Twitter

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http://www.hepmag.com
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.

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

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

Connect With Us On Twitter and Facebook

 

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

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

Stay Connected


Healthy You


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

January Issue

Illustration of 2 people playing tennis.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.


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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

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