Saturday, March 5, 2016

March Hepatitis Newsletters With News and Updates - Discounted drugs end the buyers' club era for Hepatitis C sufferers

March Hepatitis Newsletters and Updates: 

Greetings everyone, here is your digest of March Newsletters, with today's news and updates from around the web.

Today's News
March 5
Treatment for Hepatitis C became drastically more affordable this week when four new-generation medicines were added to the Pharmaceutical Benefits Scheme.
By Laignee Barron | Friday, 04 March 2016

Beware of fake hepatitis medication ​The World Health Organization has warned hepatitis C patients that counterfeit medications are being sold in Myanmar.

Drugs branded as “Ledso” and “Dakavir” are fakes, according to an alert put out by the WHO.

The WHO said it was notified of the drugs by a local NGO. The medications were listed as being manufactured by pharmaceutical company PHARCO based in Alexandria, Egypt. The company denied manufacturing drugs under either name.

“If you are in possession of these products, please do not use them, contact a healthcare professional as soon as possible for advice and report the incident as indicated above,” the WHO alert said.

The drugs claim to be versions of Daclatasvir and a combination of Ledipasvir and Sofosbuvir, all relatively new medications used to treat chronic hepatitis C.

Dr Jorge Luna, country director for the WHO, said it remains unclear what the fake pills actually contain.

“Laboratory analysis is pending so as to better assess the threat posed to public health,” he said.

He added that the WHO is not aware who is manufacturing or supplying the drugs, but that the Ministry of Health has been informed.

The alert comes just after results of a nationwide survey released in January revealed that nearly 10 percent of the country suffers from either hepatitis B or C, with over 1.3 million people living with hepatitis C. Both viruses affect the liver, can cause cancer and are usually transmitted through bodily fluids.

The Food and Drug Administration yesterday confirmed it was aware of the counterfeit medications, and will send out a public alert soon.

Watch: This Week in Managed Care: March 5, 2016
Seniors must pay more out of pocket for prescriptions, but because inflation has remained flat, their Social Security payments have not kept pace—in fact, there was no increase in 2016. AARP found the average annual cost of the 622 drugs commonly used in Medicare was $11,341 in 2013, more than twice the average cost from 2006. Most of that increase is due to skyrocketing costs in specialty pharmacy—which includes drugs for cancer and hepatitis C.

Foreign patients turn to India for cut-price cures - Taipei Times
Taipei Times39 mins ago - When doctors told Australian Greg Jefferys he had hepatitis C and the disease was destroying his liver, the devastating diagnosis was compounded by the cost

'Black Death' Offers Clues to Battling HIV and Hepatitis C Centuries Later
CINCINNATI—The Black Death swept Europe in the 14th century eliminating up to half of the population but it left genetic clues that now may aid a University of Cincinnati (UC) researcher in treating HIV patients co-infected with hepatitis C using an anti-retroviral drug therapy.

Kenneth Sherman, MD, PhD, Gould Professor of Medicine, says he will look at the blood samples of nearly 3,000 patients, primarily individuals with hemophilia, who were exposed to HIV during the early 1980s and late 1990s, to see if an inherited genetic variant that protects against HIV might also help prevent injury from Hepatitis C and other liver diseases. 

New York attorney general probes insurers over hepatitis C drug coverage

EMA panel recommends approval of DAA regimen for HCV with cirrhosis
Healio
“This positive CHMP opinion brings us one step closer to delivering a ribavirin-free treatment option for GT1b patients with compensated cirrhosis that has demonstrated high cure rates with no treatment discontinuations in our clinical trial,” Michael ...

Senator Al Franken has introduced a bill to eliminate tax breaks given to drug makers for advertising medicines to consumers.
Called the Protecting Americans from Drug Marketing Act, the bill is designed to encourage companies to focus on developing new medicines, instead of “marketing schemes,” according to US Senator Al Franken (D-Minn.) who introduced the legislation on Thursday.

10 hours ago
Express Scripts' Hepatitis Cure Value Program® solved the unprecedented challenge of providing hepatitis C treatment to all who need it and saving clients tens ...

Mar 3
Medical Xpress
"Our findings demonstrate that the damaging effects of liver cirrhosis in laboratory rats can be effectively treated, and perhaps even reversed, using a protein therapeutic that has been modified to enhance its activity through site-specific ...

SVR rates remain unchanged despite resistance-associated variants
BOSTON — The presence or absence of resistance-associated variants in patients with hepatitis C virus infection did not hinder sustained virologic response rates after treatment with Viekira Pak, according to a Late Breaker presented at CROI 2016.

Mar 1

Physicians Greet New HCV Drug Zepatier Cautiously
The debut of a new drug called elbasvir/grazoprevir (Zepatier, Merck) for adults infected with chronic hepatitis C virus (HCV) genotypes 1 and 4 has not generated much excitement among physicians, at least not yet, according to a Medscape Medical News survey.

Treatment options of patients with chronic hepatitis C who have failed prior therapy
The development of direct-acting antivirals (DAAs) has provided physicians with a toolbox to achieve near-universal cure of hepatitis C. Combinations of nucleoside polymerase inhibitors (sofosbuvir), nonnucleoside polymerase inhibitors (dasabuvir), protease inhibitors (PIs; simeprevir, paritaprevir, grazoprevir), and NS5A inhibitors (ledipasvir, ombitasvir, daclatasvir, elbasvir, velpatasvir) have proved highly effective for eradicating HCV.

Biomarkers for the diagnosis of fibrosis in chronic Hepatitis C and B
​The latest publication of the Alimentary Pharmacology & Therapeutics compares biomarkers for the diagnosis of fibrosis in chronic Hepatitis C and B.

AARP: Price hikes doubled average drug price over 7 years

Publication Updates

 Insights into the diagnosis of hepatocellular carcinomas with hepatobiliary MRI
The incidence of hepatocellular carcinomas (HCCs) has increased worldwide in line with an improved screening by high-resolution imaging of cirrhotic livers. Besides abdominal ultrasonography and computerised tomography, magnetic resonance imaging (MRI) is an important tool to detect HCCs. With commercialisation of MR hepatobiliary contrast agents that cross membrane transporters in hepatocytes or tumour cells, MRI adds new information to detect and characterise HCCs. When tumour cells lose organic anion transporting polypeptides (OATP1B1/B3) in cell membranes facing sinusoidal blood, tumours appear hypointense (decreased contrast agent concentrations) in comparison to surrounding normal or cirrhotic liver that retains OATP1B1/B3 expression. However, expression, regulation, and prognostic significance of transporter evolution along carcinogenesis are not completely known. Moreover, understanding signal intensities in focal lesions also relies on transport functions of cellular efflux transporters. This manuscript reviews all the publications that associate liver imaging with hepatobiliary contrast agents and expression of transporters. The regulation of transporters along carcinogenesis to anticipate the prognosis of focal lesions is also included.

Concordance of sustained virologic response at weeks 4, 12 and 24 post-treatment of hepatitis C in the era of new oral direct-acting antivirals: A concise review
The goal of treatment for chronic hepatitis C viral (HCV) infection is to cure the infection rather than suppress the virus. Historically, a sustained virological response (SVR) defined as undetectable HCV RNA at 24 weeks following the completion of treatment was considered the gold standard to define successful eradication of the virus as a primary endpoint in clinical trials. SVR measured at 12 weeks post-treatment has been shown to be highly concordant with SVR24 in trials of pegylated interferon and ribavirin. The appropriateness and durability of SVR12 as the efficacy endpoint with new oral direct-acting antivirals is less established.

This version of the Guidance has been updated to reflect several important developments, including the recent approval of elbasvir/grazoprevir, together with new information regarding the use of testing for HCV resistance associated variants.

The Real Cost of Hepatitis C Treatment: Part 2
Posted by Jack Bilson on Feb 26, 2016
It is critical that we understand that the new crop of Hep C treatments represent a medical breakthrough that dramatically improves and sustains life for a large swath of the population. Even at a high per patient cost for treatment, these drugs pay for themselves in the long haul. These politicians fail to understand the economic and moral value in eliminating Hep C.

Timely Access: The Waiting Game
Innovation in pharma is in itself a complex and drawn-out process – where inspiration and perspiration merge over years to produce a novel compound or molecule that will benefit human health. Yet while this process has been increasingly streamlined as science and technology progresses, drug approval processes remain a painstaking process that can significantly delay access to groundbreaking and effective therapies. Despite the central role of industry in healthcare delivery, outcomes and development, innovation in the form of lifesaving or life-prolonging medicines is now being scuppered by lengthy gaps between marketing...

March 2016 Newsletters

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.

March Newsletter
hepc.bull -- 03 2016

In This Issue
A Word from Robin / Patients & RBV
It was back in the ‘90s that a few victims of Hep C got together to help all people with Hep C, through education and support. These brave few started what we now know as HepCBC and bonded a bunch of men and women from all over BC and from all walks of life
 
William’s Story
The pain was constant. Day after day, week after week, it seemed to go on endlessly. I started to deal with the pain by sleeping a lot. I had been infected for many years, and at first my body managed to cope. I slowly broke down bit by bit. It’s a slow and almost unnoticeable process. The virus began to win. My body had done as much as it could do. It sneaks up on you very slowly. 

Undetectable –Book Hep C 
Award-winning poet and journalist Kim Goldberg of Nanaimo, author of Where to See Wildlife on Vancouver Island and Red Zone (about urban homelessness) and winner of several top poetry and alternative journalism prizes, lived for over 40 years with chronic hepatitis C. She never told anyone, and thought she would never live to see a cure for hepatitis C. 

HEP C TREATMENT: STILL A ROLE FOR IFN?
Unfortunately, there are some patients for whom the new DAAs don’t have such good success rates. Cure rates sometimes fall well short of the high figures we are getting used to seeing of 95%+. Often it is cirrhotic patients and/or patients with GT3 who don’t do so well, particularly those who are treatment experienced. The new DAAs do work on these patients, but there are treatment failures, and that, we don’t want to see.... 


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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.

March Issue

This month’s HCV Advocate newsletter is full of valuable information about hepatitis C.

HCV Drugs by Alan Franciscus
Harvoni: The Food and Drug Administration has granted Gilead new indications to treat people with HCV genotype 1 and 4 pre- and post-liver transplant. Read about the new indications along with the very high cure rates for people who have the highest need for treatment.

RG-101 is an injectable drug that has mid-study results. RG-101 is given at Day 1 and Day 29 along with currently approved HCV direct-acting antivirals. Check out the results – very impressive. These drugs have the potential to produce high cure rates and shorter treatment durations. A very intriguing new study is listed at the end of HCV Drugs.

HealthWise –by Lucinda K. Porter, RN
Hepatitis C Treatment and Cirrhosis – Lucinda discusses the importance of treating people with cirrhosis in this timely article to coincide with the FDA approval of the new indications for Harvoni.

SnapShots by Alan Franciscus
In this month’s Snapshots, I discuss treatment of decompensated cirrhosis with direct-acting antivirals, the use of statins in people with compensated cirrhosis, and an analysis of Harvoni (ledipasvir/sofosbuvir) phase 3 studies that compare the cure rates of blacks vs. non-black patients.

What’s Up! 
We have the following topics to tell you about:

Basics: 
 We have updated this valuable module that includes the latest basic information about hepatitis C.

Acetaminophen: This is one of our most popular fact sheets – it has been reviewed and re-posted to our website. The fact sheet is available in English and Espanol.

Click here to read this issue.

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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.

March 2016 Hep Free NYC Newsletter

Join us March 9 for the Brooklyn Hep C Task Force Meeting!
Get the latest data on Hep B and C in NYC for your reports, proposals and advocacy efforts!
Tell Congress by March 4 that viral hepatitis services need more funding!
Spread the word about an exciting new internship with Hep Free NYC!

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GI & Hepatology News
GI & Hepatology News is the official newspaper of the AGA Institute and provides the gastroenterologist with timely and relevant news and commentary about clinical developments and about the impact of health-care policy. The newspaper is led by an internationally renowned board of editors.

GI & Hepatology Newsletter

March 2016 PDF ( 7.9MB)
March 2016 Interactive Version

Highlights 
New HCV drug approved FDA approved Zepatier for hepatitis C genotypes
Hep C infection incidence rising in dialysis patientsThe CDC confirmed patient-to-patient transmission
MRI topped transient elastography for staging NAFLD

Click here to read this issue

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Read breaking news stories now: visit the GI & Hepatology News website.

Stay connected

 

HCV Action brings together hepatitis C health professionals from across the patient pathway with the pharmaceutical industry and patient representatives to share expertise and good practice.

March HCV Action e-update
Gilead Viral Hepatitis Fellowship Programme open for entries
New treatments reach 90 day milestone
Prison report and guidance published by The Hepatitis C Trust

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Liver Lowdown is the monthly general interest e-newsletter of the American Liver Foundation.

March Newsletter - Check Back 

 In The News: American Liver Foundation Seeks to Address Current Issues in Liver Health 

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 Blogs Around The Web


Daryl Luster- President of Pacific Hepatitis C Network. Advocate for people living with HCV.

Make your voice heard
Hepatitis C has an impact on so many aspects of life, and we want to better understand what it’s like for you. Participate in the Hepatitis C in America survey.
LEARN MORE
Heart Problems with Hepatitis C
By Karen Hoyt - March 3, 2016
One symptom of hepatitis C that can be hard to diagnose is heart problems. I will admit that the complaints about heart problems to my doctor might have seemed a little vague....
READ MORE
Skin Issues and Hepatitis C
By Jenelle Marie Davis - March 2, 2016
The diagnosis of a hepatitis C infection can feel traumatic. One of the early questions many have is regarding the way the world will see them. Will everybody know just by looking...
READ MORE

Benefits of Exercise with Hepatitis C
By Karen Hoyt - March 1, 2016
The benefits of exercise are numerous! But when you’re all down and out with hepatitis C, you wonder if it can work for you. Stick with me, and I will cover all...
READ MORE
Thoughts and Reflections
By Daryl Luster - February 29, 2016
As I sit down to write these pieces I often don’t always know exactly what I am going to write about other than a few words that may be...
READ MORE

Cured Now
By Daryl Luster - February 28, 2016
Firstly, I want to say congratulations to anyone who is now able to say, “I am cured” of hepatitis c. Very good news indeed! Wow! For most people it is a time...
READ MORE

Socially accessible
We’re active on your social network.

  


About Karen Hoyt
Karen Hoyt offers a no nonsense approach to living with Cirrhosis. A Hepatitis C treatment survivor, she created a liver loving diet and lifestyle that allows her to create awareness and advocate for her Best Friends at http://www.ihelpc.com

Courage and Confidence with Liver Cancer
During my battle with liver cancer, I loved reading all of your personal cards, emails, and messages. How could I possibly respond back? (Picture me typing all night.) Instead, I folded strong words into my heart and recited them to me when I needed them. (Daily, hourly) Little love letters.One morning after my liver transplant, while poring over more of your emails and messages, one word kept popping up – Brave. I remember my face felt hot. I didn’t feel brave at all. I was terrified. I needed courage and confidence with liver cancer.

HIV and ID Observations
An ongoing dialogue on HIV/AIDS, infectious diseases, all matters medical, and some not so medical.

Paul E. Sax, MD
Contributing Editor
NEJM JOURNAL WATCH
INFECTIOUS DISEASES

Really Rapid Review — CROI 2016, Boston
The Conference on Retroviruses and Opportunistic Infections (CROI) returned to Boston last week, bringing together over 4000 HIV researchers and clinicians from all over the world.

And note I put “researchers” first — this is certainly the only conference I attend where we are asked to list published papers as part of the registration process! You can almost imagine the program committee reviewing the papers we enter, calculating impact factor and counting first- and last-author contributions.
Continue reading...



The Hepatitis B Foundation is a national nonprofit organization dedicated to finding a cure for hepatitis B and helping to improve the lives of those affected worldwide through research, education and patient advocacy.

Blog Updates
Make a Vine Video with #HepBUnite for the 2016 Hepatitis B Awareness Campaign!
Join Hep B United for a national hepatitis B awareness campaign. Create an action-oriented awareness message about hepatitis B through a six-second Vine ​video! Hep B United will use selected video entries in its social media efforts in May 2016 to help promote Hepatitis Awareness Month. Your video could be included in its national awareness campaign!
A few weeks ago, an ill-informed New England governor proclaimed illegal immigrants were bringing in infectious diseases, including hepatitis, HIV, and tuberculosis. Recently, similar anti-immigration, fear-mongering from presidential candidates has filled the airways.

Diagnosed With Chronic Hepatitis B? What Does Your HBV DNA Test Tell You?
If you have been diagnosed with chronic hepatitis B, your doctor has probably run several blood teststhat show if the infection is harming your liver and identify what stage of infection you are in. Doctors consider all of these results when deciding if you need treatment and how often you should be monitored.

View all entries, here.



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
The 2016 Hepatitis C Treatment Research Pipeline
February 16, 2016 • Benjamin Ryan
The extraordinarily lucrative hepatitis C virus (HCV) treatment market has inspired a frantic level of competition between a handful of pharmaceutical companies. Since releasing Sovaldi (sofosbuvir) in late 2013 and Harvoni (ledipasvir/sofosbuvir) in late 2014, Gilead has dominated the field, and appears poised to continue doing so in 2016 as the company awaits the U.S. Food and Drug Administration’s (FDA) mid-year decision about yet another new treatment.
Continue reading...   


Blogs At HepMag.com


Greg Jefferys
My Hep C Travel Diary, Hepatitis C Advocate
From a Hep C Patient in Mexico
Mar 4
As I have mentioned in other parts of this blog one of the services that I happily provide for free is to give people contact details for honest and reliable suppliers of Hep C generics around the world. There are good contacts for Hep C generics in India, Bangladesh, Thailand, Australia and also now Honduras. So for many people, those who live in countries where mail order importation if difficult or prohibited, flying to another country to buy their generic Hep C treatment is the best of options.
Continue reading...

Greg Jefferys
From England to India: a Hep C Journey
Mar 1
A lot of folk are flying to India to pick up the generic Hep C medicines themselves. Some just fly in and fly out. One guy I know jumped on a plane from Alaska, flew to India, met a supplier I put him in contact with there, stayed one night and flew back to Alaska with 6 months supplier of generic Indian Harvoni. He was away from home for four days and changed his life entirely.

David Pieper
HIV/Hep C activist. Cured of Hep C.
Hepatitis, Liver Disease Support Coach
One giant leap in community pharmacy dispensing
Mar 3
To access to Direct Acting Antivirals to treat hepatitis C you need a doctor to prescribe them for you. You also need a pharmacy, or drug store, to dispense the drugs. Drugs to treat chronic conditions like hepatitis C have always been dispensed in Australia through the Section 100 – Highly Specialised Drugs Program. Because of their clinical use or other special features, medications like interferon and ribavirin are restricted to supply through public and private hospitals with appropriate specialist facilities. Medical practitioners are required to be affiliated with these specialist hospital units to prescribe these drugs under the scheme.
Continue reading..

Connie M. Welch
Passionate Encourager for Christ, Writer, Speaker, and Hep C Warrior
FDA Approves Changes to Hep C Treatment Harvoni to Expand Treatment Options
Mar 2
The FDA approved changes February 12, 2016 to Hep C treatment Harvoni (ledipasvir and sofosbuvir), a fixed dose treatment primary to treat chronic hepatitis C genotype 1, to now include liver transplant patients, genotype 4 liver transplant patients without cirrhosis or with compensated cirrhosis, and genotype 1 patients with decompensated cirrhosis.
Continue reading....

Lucinda K. Porter, RN
Author, Hepatitis C Advocate, Health Educator
Leaping Ahead with Hepatitis C Treatment Data
Feb 29
Leap Day is an important day in my house. On February 29, 1980, I asked my now-husband to marry me. My husband is an introvert, and I was not going to leave the timing of that question to him.
Continue reading...

Of Interest 

ASK HEP
How do I handle dating and sex, and when is the right time to say I have hep C?
Relationships are complicated enough, but having hepatitis C virus (HCV) adds another level of complexity. Start by knowing the facts about HCV transmission. The risk of passing HCV sexually is low, especially heterosexually and between women. The risk increases in men who have sex with men. Properly used barrier protection reduces the risk of sexual transmission of HCV.
Continue reading.....

Connect With Us On Twitter and Facebook
 

Healthy You

Eat your broccoli to protect against liver cancer
Mar 04
A new study in mice suggests that consuming broccoli as part of a regular diet protects against liver cancer. Researchers say adding the vegetable to meals is a good idea.
Continue reading....

 High-salt diet may harm liver
Previous studies have already suggested that too much sodium can damage the liver. In the new study, the researchers wanted to look in more detail at what happens at the level of cells.The team carried out experiments where they fed adult mice on a high-salt diet and exposed chick embryos to a salty environment.

The results showed that too much sodium led to a number of changes in the liver - such as misshapen cells, higher rates of cell death and lower rates of cell division - all of which can lead to liver fibrosis....
​
High Cholesterol Intake Linked to Higher Liver-Related Deaths in Women with Hepatitis C
A high consumption of cholesterol may lead to an increased risk for liver-related death and transplants among women who are infected with hepatitis C, according to a recent university study.

The Benefits of Walking 
Thinking about adding more physical activity to your day? Walking can be a great way to get more active.

Walking is the most popular physical activity among adults, and it’s easy to see why. It requires no special clothes or equipment, and it’s free.

Regular walking can have many health benefits. It may lower your risk of high blood pressure, heart disease, and diabetes. It can strengthen your bones and muscles. It may help you maintain a healthy weight. It might also help lift your mood.

Make walking fun by going to places you enjoy, like a shopping center or park. Bring along someone to chat with, or listen to some of your favorite music (but keep the volume low enough to hear the sounds around you).

Think about safety as you plan when and where to walk. Walk with others when possible, and take a phone and ID with you. Let someone know your walking time and route. If it’s dark outside, wear a reflective vest or brightly colored clothing. And always be aware of your surroundings.

Try these tips to help make walking a part of your daily routine.

Enjoy the weekend!
Tina
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Friday, March 4, 2016

Watchdog/Hepatitis C drugs now covered by Medicaid

Hepatitis C drugs now covered by Medicaid

GRAND HAVEN, MICH. - Good news for some Michigan Hepatitis C patients: as of March, Medicaid will pay for new costly drugs that could cure the disease. 
It’s an update to a WZZM 13 Watchdog story last month about the cost of the drugs that in some cases can go as high $100,000. Covered drugs include antivirals, like Sovaldi and Harvoni, for Hepatitis C patients who have severe liver disease. 
As we told you in our story last month, the drugs can cost more than $1,000 a pill. Finding a way to pay the medications has been a challenge for state Medicaid programs.
Continue reading...


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Thursday, March 3, 2016

New York attorney general probes insurers over hepatitis C drug coverage

New York attorney general probes insurers over hepatitis C drug coverage
By: Joe Barber

New York Attorney General Eric Schneiderman has subpoenaed 16 insurers to determine whether they are inappropriately denying patients access to new hepatitis C drugs. According to sources, the attorney general's office has requested information on patients who were denied coverage for the medicines. People familiar with the matter noted that the initial two subpoenas specifically requested documentation regarding coverage of Gilead Sciences' Harvoni (ledipasvir/sofosbuvir), while the remaining subpoenas did not mention a specific drug.

Continue reading....

Related News
Massachusetts Attorney General considering legal action against Gilead over drug prices
US lawmakers allege Gilead used "revenue-driven" pricing model for hepatitis C drugs
Gilead's hepatitis C drug Harvoni selected by health insurer Anthem
Wider Reach Is Sought for Costly New Hepatitis C Treatments
Actavis sued by New York Attorney General over planned Namenda switch

Reference Articles
New York Said to Investigate Insurers Over Hepatitis C Drugs - (Bloomberg)
New York’s attorney general is going after a new target in the debate over costly drugs - (Daily News)
New York's attorney general is investigating whether insurance companies may be unfairly limiting coverage for a costly drug - (Business Insider)
Insurers Probed on Hepatitis C Drug Coverage - (The Wall Street Journal)
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Tuesday, March 1, 2016

FDA Update - OLYSIO (simeprevir) label revised to include pharmacokinetic, safety and efficacy data in treatment-naïve adult patients of East Asian ancestry with chronic hepatitis C virus genotype 1 infection.

OLYSIO 
The OLYSIO (simeprevir) label was updated to include pharmacokinetic, safety and efficacy data in treatment-naïve adult patients of East Asian ancestry with chronic hepatitis C virus genotype 1 infection.
Patients of East Asian ancestry exhibit higher simeprevir plasma exposures but no dosage adjustment is required based on race.
In a Phase 3 trial conducted in China and South Korea, the mean plasma exposure of simeprevir in East Asian HCV infected subjects was 2.1 fold higher compared to non Asian HCV infected subjects in a pooled Phase 3 population from global trials
Adverse Reactions in East Asian Subjects
OLYSIO in combination with Peg IFN alfa and RBV was studied in a Phase 3 trial conducted in China and South Korea in treatment naïve subjects with chronic HCV genotype 1 infection (TIGER). The safety profile of OLYSIO in East Asian subjects was similar to that of the pooled Phase 3 population from global trials; however, a higher incidence of the laboratory abnormality hyperbilirubinemia was observed in patients receiving 150 mg OLYSIO plus Peg IFN alfa and RBV compared to patients receiving placebo plus Peg IFN alfa and RBV. Elevation of total bilirubin (all grades) was observed in 66% (99/151) of subjects treated with 150 mg OLYSIO plus Peg IFN alfa and RBV and in 26% (40/152) of subjects treated with placebo plus Peg IFN alfa and RBV. Bilirubin elevations were mainly Grade 1 or Grade 2. Grade 3 elevations in bilirubin were observed in 9% (13/151) of subjects treated with 150 mg OLYSIO plus Peg IFN alfa and RBV and in 1% (2/152) of subjects treated with placebo plus Peg IFN alfa and RBV. There were no Grade 4 elevations in bilirubin. The bilirubin elevations were not associated with increases in liver transaminases and were reversible after the end of treatment.
Treatment Naïve East Asian Subjects with HCV Genotype 1 Infection
TIGER was a Phase 3, randomized, double blind, placebo controlled trial in HCV genotype 1 infected treatment naïve adult subjects from China and South Korea.
In this trial, 152 subjects received 12 weeks of once daily treatment with 150 mg OLYSIO plus Peg IFN alfa 2a and RBV, followed by 12 or 36 weeks of therapy with Peg IFN alfa 2a and RBV in accordance with protocol defined RGT criteria; and 152 subjects received 12 weeks of placebo plus Peg IFN alfa 2a and RBV, followed by 36 weeks therapy with Peg IFN alfa 2a and RBV. These 304 subjects had a median age of 45 years (range: 18 to 68 years; with 2% above 65 years); 49% were male; all were East Asians (81% were enrolled in China, and 19% in South Korea); 3% had a body mass index (BMI) greater or equal to 30 kg/m2; 84% had baseline HCV RNA levels greater than 800000 IU/mL; 82% had METAVIR fibrosis score F0, F1 or F2, 12% METAVIR fibrosis score F3, and 6% METAVIR fibrosis score F4 (cirrhosis); 1% had HCV genotype 1a, and 99% HCV genotype 1b; less than 1% of the overall population had Q80K polymorphism at baseline; 79% had IL28B CC genotype, 20% IL28B CT genotype, and 1% IL28B TT genotype. Demographics and baseline characteristics were balanced across the OLYSIO 150 mg and placebo treatment groups.
SVR12 rates were 91% (138/152) in the OLYSIO 150 mg treatment group and 76% (115/152) in the placebo treatment group
You can view the complete label at drugs@fda or dailymed.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
For more information about the Hepatitis Liaison Program visit the FDA Patient Network
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FDA Approves Gilead's Second TAF-Based Single Tablet Regimen Odefsey®

U.S. Food and Drug Administration Approves Gilead's Second TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection
Date(s): 1-Mar-2016 2:06 PM

For a complete listing of our news releases, please click here

- Odefsey is the Smallest Single Tablet HIV Regimen -
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 1, 2016-- Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Odefsey® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients. Emtricitabine and tenofovir alafenamide are from Gilead Sciences and rilpivirine is from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). Odefsey is Gilead's second TAF-based regimen to receive FDA approval and represents the smallest pill of any single tablet regimen for the treatment of HIV.
Odefsey is indicated as a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older who have no antiretroviral treatment history and HIV-1 RNA levels less than or equal to 100,000 copies per mL. Odefsey is also indicated as replacement for a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey. No dosage adjustment of Odefsey is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute.
Odefsey has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B. See below for important safety information.
Photos and multimedia gallery available at www.GileadHIVMedia.com.
TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead's Viread® (tenofovir disoproxil fumarate, TDF). TAF has also demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose and there is 90 percent less tenofovir in the bloodstream.
"As people are living longer with HIV, there is an increasing need to develop new treatments that are tolerable and help address long-term health for patients," said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. "Odefsey's safety, efficacy and tolerability profile offers a new treatment option to support the needs of a range of patients and represents Gilead's commitment to innovation in the field of HIV."
The approval is supported by a bioequivalence study demonstrating that Odefsey achieved similar drug levels of emtricitabine and TAF in the blood as Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) and similar drug levels of rilpivirine as Edurant® (rilpivirine 25 mg). The safety, efficacy and tolerability of Odefsey is supported by clinical studies of rilpivirine-based therapy (administered as R+F/TDF or R/F/TDF) and F/TAF-based therapy (administered as E/C/F/TAF) in a range of patients with HIV, including treatment-naïve adults and adolescents, virologically suppressed adults who switched from PI-, NNRTI- and INSTI-based regimens and virologically suppressed adults with mild-to-moderate renal impairment.
The Odefsey approval is part of an ongoing development and commercialization agreement between Gilead and Janssen, first established in 2009. Under this agreement, Gilead is responsible for the manufacturing, registration, distribution and commercialization of the product in most countries, while Janssen will distribute it in approximately 17 markets and have co-detailing rights in several key markets, including the United States. The original agreement was established for the development and commercialization of Complera®, marketed as Eviplera® in the European Union, and expanded in 2014 to include Odefsey.
Odefsey does not cure HIV infection or AIDS.
Patient Assistance Programs
Gilead's U.S. Advancing Access® program provides assistance to appropriate patients in the United States who are uninsured, underinsured or who need financial assistance to pay for their medications, including Odefsey.
The program offers information and assistance for patients, including:
  • Access to agents who can provide information related to coverage and insurance-related questions.
  • The Advancing Access Copay Coupon Program, which provides co-pay assistance for eligible patients with private insurance who need assistance paying for out-of-pocket medication costs.
  • The Advancing Access Patient Assistance Program and Truvada® Medication Assistance Program, which will provide Gilead medications at no charge for eligible patients with no other insurance options.
Additionally, Gilead is working closely with the ADAP Crisis Task Force, as the company has done for each of its other HIV medications, to provide discounts to state AIDS Drug Assistance Programs (ADAPs) that will help ensure access to Odefsey for patients who receive medications through these programs.
Information about how to apply for any of these forms of assistance can be found at www.GileadAdvancingAccess.com or by calling 1-800-226-2056 between 9:00 a.m. and 8:00 p.m. EST.
Important U.S. Safety Information for Odefsey
BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs in combination with other antiretrovirals.
  • Odefsey is not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of Odefsey have not been established in patients coinfected with HIV-1 and HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of Odefsey. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Odefsey. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Contraindications
  • Coadministration: Do not use with drugs that induce CYP3A or increase gastric pH as this may lead to loss of efficacy and possible resistance to Odefsey or the NNRTI class. Do not use with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, proton pump inhibitors (e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole), systemic dexamethasone (>1 dose) and St. John's wort.
Warnings and precautions
  • Skin and hypersensitivity reactions: Severe skin and hypersensitivity reactions have been reported with the use of rilpivirine-containing regimens, including cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). In rilpivirine clinical trials, most rashes were Grades 1-2 and occurred in the first 4-6 weeks of treatment; Grades 2-4 rash occurred in 1% of subjects. Discontinue Odefsey immediately if severe skin or hypersensitivity reactions occur, including severe rash or rash accompanied by fever, blisters, mucosal involvement, conjunctivitis, facial edema, angioedema, hepatitis or eosinophilia. Monitor clinical status including laboratory parameters and initiate appropriate therapy.
  • Loss of virologic response due to drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during Odefsey therapy and monitor for adverse reactions.
  • Prolongation of QTc interval: Rilpivirine doses 3 and 12 times higher than the recommended dose can prolong the QTc interval. Consider alternatives to Odefsey in patients at higher risk for Torsade de Pointes or when coadministered with a drug with known risk of Torsade de Pointes.
  • Depressive disorders: Evaluate patients with severe depressive symptoms to assess if symptoms are due to Odefsey and if the risks of continued treatment outweigh the benefits. In rilpivirine adult clinical trials (N=686), the incidence of depressive disorders was 9%, Grades 3-4 depressive disorders was 1%, discontinuation due to depressive disorders was 1%, and suicidal ideation and suicide attempt was reported in 4 and 2 subjects, respectively. In a rilpivirine adolescent clinical trial (N=36), the incidence of depressive disorders was 19%, Grades 3-4 depressive disorders was 6%, and suicidal ideation and suicide attempt were reported in 1 subject.
  • Hepatotoxicity: Hepatic adverse events have been reported, including cases of hepatic toxicity, in patients without pre-existing hepatic disease or other identifiable risk factors. In patients with hepatic abnormalities (e.g., hepatitis, elevated liver-associated tests), order laboratory tests before starting treatment and monitor for hepatotoxicity during treatment; consider testing and monitoring in all patients.
  • Fat redistribution or accumulation has been observed in patients receiving antiretroviral therapy.
  • Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
  • New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of emtricitabine and tenofovir alafenamide with elvitegravir and cobicistat, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate Odefsey in patients with estimated creatinine clearance (CrCl) <30 mL/min. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue Odefsey in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
    Renal monitoring: In all patients, monitor CrCl, urine glucose, and urine protein prior to initiating and during therapy. In patients with chronic kidney disease, additionally monitor serum phosphorus.
  • Bone loss and mineralization defects: Decreases in bone mineral density (BMD) have been reported with the use of tenofovir prodrugs. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss. Mineralization defects, including osteomalacia associated with PRT, have been reported with the use of TDF-containing products.
Adverse reactions
  • Most common adverse reactions with rilpivirine (incidence =2%, Grades 2-4) are depressive disorders (2%), insomnia (2%) and headache (2%); and with emtricitabine and tenofovir alafenamide (incidence =10%, all grades) is nausea (10%).
Drug interactions
  • Prescribing information: Consult the full prescribing information for Odefsey for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
  • Metabolism: Drugs that induce CYP3A or P-gp and drugs that increase gastric pH can decrease the concentrations of components of Odefsey. Drugs that inhibit CYP3A or P-gp can increase the concentrations of components of Odefsey.
  • QT prolonging drugs: Consider alternatives to Odefsey in patients taking a drug with known risk of Torsade de Pointes.
  • Drugs affecting renal function: Coadministration of Odefsey with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and tenofovir and the risk of adverse reactions.
Dosage and administration
  • Dosage: Patients 12 years and older (=35 kg): 1 tablet taken orally once daily with a meal.
  • Renal impairment: Not recommended in patients with CrCl <30 mL/min.
  • Testing prior to initiation: Test patients for HBV infection and assess CrCl, urine glucose and urine protein.
  • Testing after initiation: In virologically-suppressed patients, additional monitoring of HIV-1 RNA and regimen tolerability is recommended.
Pregnancy and lactation
  • Pregnancy: There are insufficient data on the use of Odefsey during pregnancy. In animal studies, no adverse developmental effects were observed with the components of Odefsey. An Antiretroviral Pregnancy Registry has been established.
  • Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.
About Gilead
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians may not see the benefits of prescribing Odefsey. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
U.S. Full Prescribing Information, including BOXED WARNING, for Odefsey is available at www.gilead.com.
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Physicians Greet New HCV Drug Zepatier Cautiously

Medscape Medical News
Clinician Insights
Physicians Greet New HCV Drug Zepatier Cautiously
Robert Lowes

The debut of a new drug called elbasvir/grazoprevir (Zepatier, Merck) for adults infected with chronic hepatitis C virus (HCV) genotypes 1 and 4 has not generated much excitement among physicians, at least not yet, according to a Medscape Medical News survey.

Only 11% of physicians said they would prescribe the new drug, touted for cure rates topping 90%, to at least half of their patients who meet the indication in the first year. And although 17% said they felt comfortable with elbasvir/grazoprevir compared with other HCV drugs and would quickly start prescribing it, the majority of physicians expressed a more cautious approach.

These patterns also held true among gastroenterologists, who treat slightly more patients with HCV than their peers and claim to know more about the new drug, although they were slightly more likely (16%) to prescribe it for a majority of their eligible patients in the coming 12 months.

Lack of familiarity with the drug and its cost, as well as the availability of rival therapies, may help explain the quiet reception of elbasvir/grazoprevir, several experts toldMedscape Medical News.



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