A Call For Pricey Treatment For Millions With Hepatitis-C

Provided by Kaiser Health News

By Richard Knox
April 9th, 2014, 8:43 AM

Authors of the first-ever global hep-C guidelines went big Tuesday, advocating for worldwide use of two of the most expensive specialty drugs in the world.

The new guidelines, from the World Health Organization, give strong endorsement to the two newest hep-C drugs. Gilead Science’s Sovaldi costs $1,000 per pill/$84,000 for a 12-week course of treatment and Olysio, Janssen Pharmaceuticals, $66,360 for its three-month course.

The prices have ignited a firestorm of objection. In the United States, doctors and insurers worry that the cost of the drugs  will make their widespread use impossible. And critics say even if the prices are heavily discounted, the drugs will still be unaffordable in most of the world.

The WHO’s recommendation that all 150 million people around the globe with chronic hep-C infection “should be assessed for antiviral treatment” was made “without taking resource use into consideration.” That’s because the price of the drugs outside the U.S. was unknown in December, when the WHO panel wrapped up its work.

Authors of the report are quick to acknowledge neither the assessment nor the actual treatment would happen anytime soon.

“A lot has to happen for this to really take off in a big way,” the guidelines’ chief architect, Dr. Stefan Wiktor, said. “Even if prices came down dramatically tomorrow, that doesn’t mean there would be an immediate rush to treatment.”

Screening programs for hep-C need to be ramped up. Labs to determine the genetic type of the virus (crucial in choosing treatment regimens) have to be built and staffed. Medical personnel need to be able to assess when viral liver damage has progressed to the point when treatment is urgent. And hep-C drugs have to be chosen wisely and administered carefully.

Fewer than a quarter of Americans with chronic hep-C currently have had or are getting any treatment. In Europe, treatment has reached only 3.5 percent. And in most countries, Wiktor says, “hardly anyone is getting treatment.”

The WHO guidelines are setting a deliberately high standard in the hope, Wiktor says, of replicating the remarkable dissemination of antiviral therapy for HIV.

Starting from a similar point of little distribution 15 years ago, antiviral treatment for HIV now reaches around 10 million people, most of them in the poorest countries of sub-Saharan Africa. HIV infects more than 35 million people globally (and almost a third of those also have hep-C). That makes chronic hep-C infection at least four times more prevalent.

But HIV requires lifelong antiviral treatment. The big difference with hep-C is that suddenly there are drugs that can actually cure more than 90 percent of patients with a three-month regimen. “Treatments are getting better, shorter and safer,” Wiktor says.

The controversy over the cost is apparently beginning to have an effect on pricing. Egypt, which has the world’s highest hep-C infection rates – somewhere around 20 percent of the population – has negotiated a 99 percent discount on Sovaldi, to $900 for a 12-week course.

Gilead, Sovaldi’s maker, is “tiering” its price for the drug in other countries too — $55,000 in Canada, $66,000 in Germany, and reportedly around $2,000 for a generic version that may be licensed to several Indian companies.

But those discounts don’t impress some critics, such as Rohit Malpani of Doctors Without Borders. “When you’re starting from such an exorbitant price in the US, the price Gilead will offer middle-income countries like Thailand and Indonesia may seem like a good discount, but it will still be too expensive for many of these countries to scale up treatment.”

Other forces may drive prices lower. “A number of other (hep-C) medicines are coming down the pike,” WHO’s Wiktor notes. “At least 20. That in itself will provide competition as companies try to assure market share.”

A flood of new data on the effectiveness of new medicines is expected this week at an International Liver Congress in London, where the new WHO guidelines were unveiled.

“The dynamism around hep-C is really remarkable,” Wiktor says. “Once you know you can cure somebody, that really changes the tone of the conversation.”

But until the prices fall, and until (or unless) pressure develops to shake loose massive new amounts of funding to pay for access to the new drugs, hard choices loom.

For instance, the WHO guidelines say that treatments will have to be rationed, starting with patients whose livers are heavily scarred or frankly cirrhotic – putting them at high risk for liver cancer or the need for liver transplants.

“We don’t have reliable figures, but about 20 percent of people with chronic hep-C are in that stage,” he replied. “That would be 26 to 30 million people globally.”

Or around three times the number receiving HIV treatment.

This entry was posted on Wednesday, April 9th, 2014 at 8:43 am.

Source

Also See: WHO issues its first hepatitis C treatment guidelines for the screening, care and treatment of persons with Hepatitis C at EASL

Preparing Providers for Hepatitis Patients: Online Hepatitis Program for Primary Care Providers Launches

ALEXANDRIA, Va., April 9, 2014 /PRNewswire/ -- The American Association for the Study of Liver Diseases (AASLD) launched ACT-First: A Practical Introduction to Liver Disease. "ACT" stands for AASLD Curriculum and Training" and "First" refers to first-line providers.  This educational program for primary care and other interested health care providers consists of a web-based curriculum in hepatology that will be provided free of cost to any interested healthcare provider in or out of the United States. The curriculum launched at the annual meeting of the American College of Physicians (ACP). 

"We need this program because there is a shortage of providers treating patients with liver diseases," said Guadalupe Garcia-Tsao, MD, Professor of Medicine at Yale University and a key contributor to ACT-First. The curriculum will cover most of the common liver diseases and, given the number of affected patients, the first two available units are dedicated to hepatitis B and hepatitis C, respectively.

Providers undergoing the pilot program will be able to recognize patients at risk for hepatitis B and C and will be able to screen and evaluate patients with positive viral serologies and determine those who are appropriate candidates for antiviral therapy. "AASLD knows there is a need to make available an easily accessible hepatology curriculum that would guide primary care providers -- many of whom may not feel comfortable treating patients with liver disease -- through the identification, evaluation, and treatment of patients with liver disease," said Dr. Garcia-Tsao.

Recent policy developments and scientific breakthroughs have created the need for a program such as this:

1. The Centers for Disease Control and Prevention (CDC) recommended a one-time, age-based screening for hepatitis C in 2012.
2. The US Preventive Services Task Force gave hepatitis C a grade of "B" in 2013 allowing for payment by Medicare and private insurers for testing with no copayment by patient.
3. Interferon-free, antiviral, oral medicines were approved by the Food and Drug Administration (FDA) in 2013.

The age-based screening of baby boomers is predicted to diagnose around 800,000 patients with hepatitis C. AASLD is a medical society of specialists that understands the need for the primary care community to become more aware of these new developments and to increase the workforce of healthcare providers involved in the care of patients with viral hepatitis. FDA approval of these new drugs and the promise of numerous drugs about to be approved prompted AASLD to partner with the Infectious Disease Society of America and the International Antiviral Society-USA to develop a hepatitis C practice guidance. That guidance is available on the Web free of charge and received 65,000 unique visitors since it was published online on January 29, 2014.

AASLD produced ACT-First in association with the ACP, CDC, Project ECHO (Extension for Community Healthcare Outcomes), and the U.S. Department of Veterans Affairs (VA). Addressing AASLD's collaboration in developing ACT-First, Dr. Garcia-Tsao said, "One of the strengths of this curriculum is that we got the point of view and input from primary providers themselves by collaborating with ACP, CDC, Project ECHO and VA. By collaborating, we were able to tailor the curriculum to the needs of primary care providers."

AASLD is the leading medical organization for advancing the science and practice of hepatology. Founded by physicians in 1950, AASLD's vision is to prevent and cure liver diseases.

Visit www.aasld.org for more information.

Media Contact: Gregory Bologna
gbologna@aasld.org
Telephone: (703) 299-9766

This release was issued through The Xpress Press News Service, merging e-mail and satellite distribution technologies to reach business analysts and media outlets worldwide. For more information, visit http://www.XpressPress.com.

SOURCE American Association for the Study of Liver Diseases (AASLD)

RELATED LINKS
http://www.aasld.org

Source

EASL – Cost tops the agenda as hepatitis C enters post-interferon world

Provided by EP Vantage

Date April 09, 2014

Scientific questions usually dominate medical meetings – except for the hepatitis C field, in which a long-awaited drug costs $1,000 a day and has cast a long shadow over global access. So it is with Europe’s main liver disease meeting, where specialists are openly wondering about how to deliver the best treatments to patients in even the richest countries of the West.

Gilead Sciences’ Sovaldi can cure as many as nine out of 10 hep C patients, depending on genotype and stage, but its cost has provoked pushback from payers around the world. With even pharmacy benefit managers in the US objecting, this has raised questions about whether this time rich nations will be able to subsidise delivery of a much-needed new drug to developing nations, as has happened in the past.

“This is based on an old model; the HIV model,” said Jean-Michel Pawlotsky, Director of the French National Reference Centre for Viral Hepatitis B, C and delta. “I think the rich will no longer be able to pay for the poor.”

Continue reading full article here ……

EASL 2014: International Liver Congress Starts this Week in London

Provided by HIVandHepatitis.com

Details Category: HBV Treatment Published on Tuesday, 08 April 2014 00:00 Written by HIVandHepatitis.com

The European Association for the Study of the Liver's International Liver Congress (EASL 2014) takes place April 9-13 at the ExCel Centre in London. The annual conference is one of the key annual scientific meetings covering viral hepatitis and its complications. Also on Thursday, the World Health Organization (WHO) will release new global guidelines for hepatitis C.

With next-generation direct-acting antivirals exiting the development pipeline or in the final stages of testing, new treatments for hepatitis C will be a key theme of the meeting, in particular long-awaited interferon-free regimens. New data will be presented on several approved or Phase 3 drugs -- many with cure rates in the 90% to 100% range -- including:

• Gilead Sciences' sofosbuvir (Sovaldi) plus ledipasvir coformulation used alone or with ribavirin or a third DAA.
• Janssen's protease inhibitor simeprevir (Olysio) in interferon-free regimens.
• AbbVie's "3D" combination containing ABT-450, ABT-333, and ABT-267.
• Bristol-Myers Squibb's daclatasvir and asunaprevir.
• Merck's MK-5172 and MK-8742.
• Boehringer Ingelheim's faldaprevir.

Continue reading full article here

WHO joins clamor to make new hepatitis C pills affordable

By Ben Hirschler
LONDON  Wed Apr 9, 2014 4:37pm IST

The World Health Organization (WHO) headquarters are pictured in Geneva November 9, 2009.
Credit: Reuters/Denis Balibouse

(Reuters) - The World Health Organization wants a "concerted effort" to drive down the cost of new hepatitis C drugs that offer a cure for the liver-destroying virus but are unaffordable for most infected people worldwide.

The forthright comments from the UN agency on Wednesday add to pressure on drugmakers such as Gilead Sciences - which is already facing protests in the United States over its $1,000-a-day pill - to do more to improve access.

In its first-ever treatment guidelines for the disease, issued at a meeting of international liver experts in London, the WHO strongly recommended new drugs from Gilead and Johnson & Johnson - with a big caveat on their cost.

Treating the approximately 150 million people in the world living with chronic hepatitis C infection is the new front-line in the battle over access to medicines.

As with AIDS 15 years ago, modern drugs are transforming the ability to fight hepatitis C because pills such as Gilead's Sovaldi are far more effective and better-tolerated than older injection regimens, with cure rates well above 90 percent in many cases.

"These drugs are fantastic - they are a real breakthrough," Markus Peck-Radosavljevic, a professor of medicine in Vienna and secretary-general of the European Association for the Study of the Liver, told Reuters. "But the prices are too high."

Pharmaceutical companies say they need to charge high prices on new successful drugs to cover the huge cost of development, including of those that fail to make it to the market.

A record number of promising results from late-stage clinical trials on a range of new oral medicines will be showcased at the International Liver Congress this week.

Hepatitis C virus, or HCV, is spread through blood, often via contaminated needles. It causes cirrhosis and liver cancer. The vast majority of cases are in poorer countries where the complexity, cost and side effects of current treatments have made treatment impractical.

The arrival of simple pills, taken for as little as a couple of months, could revolutionize therapy, if the price is right.

By giving governments a plan setting out how to test for, treat and prevent HCV, the WHO is laying foundations for tackling the disease, while spurring demand and sending a strong message on price.

"I hope these guidelines will help to promote a reduction in price and thereby an increase in access," said Stefan Wiktor, who leads the WHO hepatitis programme.

COMPULSORY LICENCES?

Drawing a clear parallel with the experience of HIV/AIDS, the WHO believes a "multi-pronged" approach is needed. This could include tiered price discounts by branded drugmakers, voluntary licensing and also compulsory licensing.

Voluntary licensing involves a patent owner agreeing to license its drug to generic manufacturers, while a compulsory license is issued by a government without any such agreement - something the pharmaceuticals industry is keen to avoid.

After dragging their feet for years over access to AIDS drugs in Africa, pharmaceuticals makers are trying to take the initiative this time. Market leader Gilead recently agreed a 99 percent price discount for Egypt and plans to grant voluntary licenses to several Indian generics firms.

J&J has also promised to work on access and others entering the area - such as AbbVie, Bristol-Myers Squibb and Merck & Co - are expected to follow suit.

But campaigners want more. The Medecins Sans Frontieres group believes a 12-week course of treatment and diagnosis should cost no more than $500. That compares with the $84,000 and $66,000 charged by Gilead and J&J respectively for their drugs in the United States.

There is also a big concern about middle-income countries such as China, India and Russia, which are home to most cases of HCV worldwide but where drug companies are more reluctant to accept rock-bottom prices than in the poorest nations.

Charles Gore, president of the patient-led World Hepatitis Alliance, welcomed the WHO guidelines but said international funding along the lines of the Global Fund to Fight AIDS, Tuberculosis and Malaria was now needed.

When it comes to profits, drug companies are expecting to make most of their money in the United States, where medicines traditionally fetch a premium.

But the scale of the expected demand for new hepatitis C drugs - which industry analysts believe will translate into annual sales of $9.1 billion for Sovaldi alone by 2017, according to Thomson Reuters data - means the industry is under fire.

U.S. lawmakers asked Gilead last month to explain the $84,000 price tag on Sovaldi, hitting shares in the firm and raising fears across the biotech sector.

"Until we develop a better model, we are still in the situation where investors in pharma want to recompensed on the winners for all the losers - and there have been a lot of losers in hepatitis C over the years," said Gore.

(Reporting by Ben Hirschler; editing by David Stamp)

Source

Also See: WHO issues its first hepatitis C treatment guidelines for the screening, care and treatment of persons with Hepatitis C at EASL

WHO issues its first hepatitis C treatment guidelines for the screening, care and treatment of persons with Hepatitis C at EASL

News release

The World Health Organization (WHO) has issued its first guidance for the treatment of hepatitis C, a chronic infection that affects an estimated 130 million to 150 million people and results in 350 000 to 500 000 deaths a year.

9 April 2014 | London, United Kingdom - WHO has issued its first guidance for the treatment of hepatitis C, a chronic infection that affects an estimated 130 million to 150 million people and results in 350 000 to 500 000 deaths a year.

The publication of the "WHO Guidelines for the screening, care and treatment of persons with hepatitis C infection" coincides with the availability of more effective and safer oral hepatitis medicines, along with the promise of even more new medicines in the next few years.

“The WHO recommendations are based on a thorough review of the best and latest scientific evidence,” says Dr Stefan Wiktor, who leads WHO’s Global Hepatitis Programme. “The new guidance aims to help countries to improve treatment and care for hepatitis and thereby reduce deaths from liver cancer and cirrhosis.”

WHO will be working with countries to introduce the guidelines as part of their national treatment programmes. WHO support will include assistance to make the new treatments available and consideration of all possible avenues to make them affordable for all. WHO will also assess the quality of hepatitis laboratory tests and generic forms of hepatitis medicines.

“Hepatitis C treatment is currently unaffordable to most patients in need. The challenge now is to ensure that everyone who needs these drugs can access them,” says Dr Peter Beyer, Senior Advisor for the Essential Medicines and Health Products Department at WHO. “Experience has shown that a multi-pronged strategy is required to improve access to treatment, including creating demand for treatment. The development of WHO guidelines is a key step in this process.”

Nine key recommendations

The new guidelines make nine key recommendations. These include approaches to increase the number of people screened for hepatitis C infection, advice as to how to mitigate liver damage for those who are infected and how to select and provide appropriate treatments for chronic hepatitis C infection.

Screening

WHO recommends a screening test for those considered at high risk of infection, followed by another test for those who screen positive, to establish whether they have chronic hepatitis C infection.

Mitigating liver damage

Since alcohol use can accelerate liver damage caused by hepatitis C, WHO now advises that people with chronic hepatitis C infection receive an alcohol assessment. The Organization also recommends providing counseling to reduce alcohol intake for people with moderate or high alcohol use. In addition, the guidelines provide advice on the selection of the most appropriate test to assess the degree of liver damage in those with chronic hepatitis C infection.

Treatment

The guidelines provide recommendations on existing treatments based on interferon injections as well as the new regimens that use only oral medicines. WHO will update recommendations on drug treatments periodically as additional antiviral medicines are registered on the market and new evidence emerges.

Prevention

The 2014 recommendations also summarize for policy makers and health care workers interventions that should be put in place to prevent transmission of hepatitis C, including measures to assure the safety of medical procedures and injections in health care settings and among persons who inject drugs. Rates of new hepatitis C infections remain unacceptably high in many countries because of the reuse of injection equipment and lack of screening of blood transfusions.

“Many people remain unaware - sometimes for decades - that they are infected with hepatitis C,” says Dr Andrew Ball, Senior Advisor for Policy, Strategy and Equity for WHO’s HIV/AIDS Department where the Global Hepatitis Programme is housed. “Today’s launch highlights the need for more awareness and education on hepatitis for the general public. Greater awareness on the risks associated with hepatitis C should lead to a demand for services and expansion of laboratory capacity and clinical services so that more people can be tested, treated and cured.”

There are five main hepatitis viruses, referred to as types A, B, C, D and E. Hepatitis B and C have the greatest public health impact because they cause chronic infection which can progress to cirrhosis and liver cancer. Hepatitis A and E, spread though unsafe water and contaminated food, have the potential to cause outbreaks in certain populations.

Hepatitis C virus is most commonly transmitted through exposure to contaminated blood. Those at risk include people undergoing invasive medical procedures and therapeutic injections where there is poor infection control. Also at risk are those exposed to contaminated injecting and skin piercing equipment, including through injecting drug use, tattooing and body piercing.

The WHO Guidelines for the screening, care and treatment of persons with hepatitis C infection were launched on the eve of the opening of the 2014 International Liver Congress, attended by around 10 000 delegates in London.

For more information, contact

Glenn Thomas
Mobile: +41 79 509 0677
Telephone.: +41 22 791 3983
Email: thomasg@who.int

Tunga Namjilsuren
WHO Information manager
Telephone: + 41 22 791 1073
Email: namjilsurent@who.int

Source

---

Guidelines for the screening, care and treatment of persons with hepatitis C infection

Authors: WHO

Publication details

Number of pages: 124
Publication date: April 2014
Languages: English
ISBN: 978 92 4 154875 5

Downloads

Guidelines pdf, 1.77Mb

Overview

These are the first guidelines dealing with hepatitis C treatment produced by the World Health Organization (WHO) and complement existing guidance on the prevention of transmission of bloodborne viruses, including HCV. They are intended for policy-makers, government officials, and others working in low- and middleincome countries who are developing programmes for the screening, care and treatment of persons with HCV infection.

These guidelines serve as a framework that can allow the expansion of clinical services to patients with HCV infection, as they provide key recommendations in these areas and discuss considerations for implementation. The guidelines are also intended for health-care providers who care for persons with HCV infection in low- and middle-countries and provide them guidance in the management of patients infected with HCV.

Source

EASL publishes online recommendations on the management of hepatitis C

PUBLIC RELEASE DATE: 9-Apr-2014 Contact: Courtney Lock
courtney.lock@cohnwolfe.com
44-789-438-6422
European Association for the Study of the Liver

London, UK, Wednesday 9 April 2014: The European Association for the Study of the Liver (EASL) will this week be announcing new on-line recommendations on the management of hepatitis C (HCV) at the International Liver Congress™ (ILC). These EASL recommendations reflect the approval of three new direct-acting antivirals (DAAs) during 2014 by the European Medicines Agency.

It is estimated that approximately 185 million people are infected with HCV on a global scale, with approximately 150 million people living with chronic infection. In Europe, between 7.3 million and 8.8 million people are infected with HCV and approximately 3-4 million people become newly infected each year.

Three new HCV DAAs that are more efficacious and better-tolerated, will be on the European market in the first half of 2014, for use as part of combination therapies for HCV infection. Sofosbuvir, a nucleotide analogue inhibitor of HCV ribonucleic acid (RNA)-dependent RNA polymerase, was approved in January 2014. Simeprevir, a second-wave, first-generation NS3/4A protease inhibitor will be approved in May 2014. Daclatasvir, an NS5A inhibitor, is likely to be approved in August or September 2014.

Coordinator of the recommendations and Director of the French National Reference Centre for Viral Hepatitis Professor Jean-Michel Pawlotsky said: "Since EASL published the HCV Clinical Practice Guidelines in 2013, the treatment paradigm for HCV has changed with three additional direct-acting antivirals - sofosbuvir, simeprevir and daclatasvir –scheduled for approval this year for use in patients infected with HCV genotype 1."

"These groundbreaking drugs continue to revolutionise treatment for HCV patients, including those who failed to respond to previous therapies. The new on-line recommendations provide essential information on the recommended use of these new compounds with and without interferon to help prescribers deliver optimal care for their HCV patients."

Based on a systematic review of existing literature, the new recommendations provide best practice on a number of key areas:

• Indications for treatment: who should be treated?
• Available drugs (approved by EMA before the end of 2014)
• Treatment of chronic hepatitis C
• Treatment monitoring
• Measures to improve treatment adherence
• Post-treatment follow-up of patients who achieve an SVR
• Retreatment of non-sustained virological responders
• Treatment of patients with severe liver disease
• Treatment of special groups

Commenting on the new on-line recommendations, EASL Governing Board member and recommendation panel member Dr. Alessio Aghemo said: "These new EASL on-line recommendations on the management of HCV reflect how the treatment landscape has evolved for this disease, and will further help physicians and other healthcare providers optimise management of patients with acute and chronic HCV."

The new EASL on-line HCV management recommendations will be presented during a session at the ILCTM in London on Saturday 12th April 2014 from 14:00 to 15:00.

###

Disclaimer: the data referenced in this release is based on the submitted abstract. More recent data may be presented at the International Liver Congress™ 2014.

Notes to Editors

About EASL

EASL is the leading European scientific society involved in promoting research and education in hepatology. EASL attracts the foremost hepatology experts and has an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.

EASL's main focus on education and research is delivered through numerous events and initiatives, including:

• The International Liver CongressTM which is the main scientific and professional event in hepatology worldwide
• Meetings including Monothematic and Special conferences, Post Graduate courses and other endorsed meetings that take place throughout the year
• Clinical and Basic Schools of Hepatology, a series of events covering different aspects in the field of Hepatology
• Journal of Hepatology published monthly
• Participation in a number of policy initiatives at European level

  About The International Liver CongressTM 2014

The International Liver Congress™ 2014, the 49th annual meeting of the European Association for the study of the Liver, is being held at ExCel London from April 9 – 13, 2014. The congress annually attracts in excess of 9000 clinicians and scientists from around the world and provides an opportunity to hear the latest research, perspectives and treatments of liver disease from principal experts in the field.

For further information on the guidelines, or to request an interview, please do not hesitate to contact the EASL Press Office on:
Email: easlpressoffice@cohnwolfe.com

Helena Symeou +44 7976 562 430
Courtney Lock +44 7894 386 422

1.World Health Organization. WHO Guidelines for the Screening, Care and Treatment of Persons with Hepatitis C Infection. 2014.
2. European Association for the Study of the Liver. Clinical Practice Guidelines - Update on the management of hepatitis C virus infection. Journal of Hepatology, 2014.
3. WebMD. Hepatitis Health Center. Available at http://www.webmd.com/hepatitis/ Accessed 01.04.14

Source

Gilead aims to license hepatitis C drug to 3-4 Indian firms

By Ben Hirschler
LONDON  Tue Apr 8, 2014 11:42am EDT

(Reuters) - Gilead Sciences aims to license its new hepatitis C drug Sovaldi to three or four Indian generic manufacturers to allow sales of the medicine at lower prices in some 60 developing nations.

Clifford Samuel, head of access operations and emerging markets at the U.S. drugmaker, told Reuters he expected to have deals in place shortly with the Indian firms, which would be able to produce the drug in high volumes and at low margins.

Gilead is under pressure to address the high cost of its breakthrough pill, which is the first of a new wave of drugs that have been shown to raise cure rates and cut treatment duration without the side effects of current injections.

"We're in the midst of discussions right now. We're nailing down the geographical scope, and we should have these licenses in place and ready to go in short order," Samuel said on a visit to London for an international liver conference.

He said Gilead was looking to strike deals with firms that had proven experience in producing generic versions of its HIV/AIDS drugs, such as the Indian division of Mylan.

The Foster City, California-based company has been operating a similar voluntary licensing programme for many years for low-cost HIV drugs, which covers 112 countries.

Under the hepatitis C plan, Indian-made generics would be available in most of sub-Saharan Africa, selected Asian countries including India, Pakistan and Myanmar, and some smaller developing nations.

Gilead is also working to establish "tiered pricing" for Sovaldi in other low- and middle-income countries, Samuel said.

The company struck the first such tiered pricing deal last month in Egypt, where it has agreed to supply the government at just over 1 percent of the U.S. price, or $300 for a 28-day bottle against $28,000.

For India, the company is currently discussing a price of $2,000 based on 24 weeks of treatment, although no final deal has been reached, Samuel added.

Egypt has the world's highest prevalence of the liver-destroying hepatitis C virus, which is spread through blood, making it an obvious first market for more affordable, tiered pricing.

"We're targeting key, high-prevalence countries like India, Pakistan and Egypt. We are sitting down with them and looking at differential pricing," Samuel said.

Gilead's tiered pricing will not apply, however, to some large middle-income countries with significant hepatitis C populations such as Ukraine and China, which are viewed as commercial market opportunities.

In the United States, Sovaldi's price tag of $84,000 for a 12-week course of treatment has been described by one health provider as "outrageous", while U.S. lawmakers have written to the firm demanding an explanation of the price.

(Editing by Jane Baird)

Source

Hep C Therapies to Hog Spotlight at EASL

Published: Apr 8, 2014

By Michael Smith, North American Correspondent, MedPage Today

LONDON -- New treatments for hepatitis C virus (HCV) will have most of the limelight this week at the annual meeting of the European Association for the Study of the Liver.

A tidal wave of novel direct-acting agents has been building for several years and is set to break here, according to the association's secretary-general, Markus Peck, MD, of the Medical University of Vienna in Austria.

"What strikes you most," Peck told MedPage Today, "is first of all the number of phase III trials that are being presented ... the most phase III data you will ever see in a liver meeting."

That's because several companies are rushing to get novel regimens approved and into the clinic, he said.

Indeed, of the 18 abstracts in the first three general sessions of the meeting, nine have to do with new treatments for HCV, as do half of the late-breaking oral presentations. There are also several parallel sessions devoted to HCV therapy.

But equally important, he said, are the "consistently positive results ... more or less independent of what kind of patients you are looking at: treatment-naive patients, previously treated patients, patients with advanced liver disease -- it's always working."

"It's fascinating and fantastic at the same time," he said. Even a year ago, Peck added, experts would not have expected to "treat patients for 3 months -- maybe even 2 months -- and cure 95% or 98% of them."

The direct-acting agents are so-called because they work on aspects of the virus itself, unlike the two drugs that until very recently were the mainstays of HCV therapy -- pegylated interferon-alfa and ribavirin.

Peginterferon is a general immune system booster with a range of unpleasant side effects, while ribavirin is a general antiviral drug with its own drawbacks. Cure rates with the combination -- the so-called sustained virologic response or SVR -- vary depending on the HCV genotype of the patient but are generally regarded as low.

A major goal of recent research, including much to be presented here, has been to combine different direct-acting agents in order to avoid using peginterferon. In addition, some of the trials to be reported here have also examined ribavirin-free regimens.

Studies of other forms of viral hepatitis are also being reported here, Peck said, "but nothing can match the success of HCV treatment at the moment."

For instance, there will be data on hepatitis B therapy that is "interesting ... but nothing game-changing" but Peck said future meetings are likely to see more work on HBV once the furor over HCV dies down.

Researchers also will detail some early investigations into hepatitis D and E, he said.

Other aspects of liver disease are also under examination here, including what is touted as the first phase III trial in 20 years for a new drug -- obeticholic acid -- to treat primary biliary cirrhosis.

"This is something that is very new," Peck said. While the condition is not common, it accounts for between 4% and 5% of liver transplant patients, he added, and "everyone who's treating people for liver disease has several patients."

And Spanish researchers are to present data form a phase III trial on the use of statins in patients with portal hypertension that is likely to draw some attention, Peck said, if only because it's something other than viral hepatitis.

In all, more than 1,000 abstracts are to be presented, Peck said.

Source

Idenix Announces Promising Clinical Data and Continued Progress in Nucleotide Prodrug Development Programs for the Treatment of Hepatitis C

• Idenix Reports Positive Proof-of-Concept Data for Lead Nucleotide Prodrug, IDX21437
• Idenix on Track to Initiate All-Oral Pan-Genotypic Phase II Combination Clinical Study of IDX21437 and Samatasvir in mid-2014
• Idenix Initiates Phase I Clinical Trial of Follow-on Nucleotide Prodrug, IDX21459
• Idenix to Host Conference Call / Webcast at 8:00 a.m. ET today

CAMBRIDGE, Mass., April 7, 2014 (GLOBE NEWSWIRE) -- Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced continued progress of the Company's program to develop nucleotide prodrug inhibitors for the treatment of hepatitis C virus (HCV) infection. Idenix is reporting potent antiviral activity of mean maximum 4.2-4.3 log₁₀ IU/mL reductions for patients infected with HCV genotype 1, 2 or 3 receiving 300 mg once daily of IDX21437 in the seven-day proof-of-concept portion of a phase I/II clinical trial. Based on this progress, the Company's goal is to initiate a combination clinical trial of IDX21437 and samatasvir, a pan-genotypic NS5A inhibitor, in mid-2014. In addition, Idenix has selected a follow-on uridine-based nucleotide prodrug, IDX21459, from its ongoing nucleotide discovery program and initiated enrollment for the healthy volunteer portion of a phase I clinical trial.

"As more all-oral regimens become available to treat hepatitis C, an increased number of patients will be diagnosed and treated. It will be important to have simple, short duration options for our patients. These early data for IDX21437 support its potential to be part of future treatment combinations." said Professor Edward Gane, MD, Deputy Director and Hepatologist, New Zealand Liver Transplant Unit, Auckland City Hospital in New Zealand, and a clinical investigator in the IDX21437 proof-of-concept study. "Nucleotide-based treatment combinations are favored because of safety, efficacy, high barrier to resistance and low drug-drug interaction potential and we look forward to seeing further results from studies with IDX21437."

"We are very pleased with these positive data for IDX21437 and we are excited to have two nucleotide prodrug candidates in the clinic," said Ron Renaud, Idenix's President and Chief Executive Officer.  "With the initiation of the phase II study of IDX21437 and samatasvir later this year, we will be one of a few companies with an all-oral, pan-genotypic, nucleotide-based combination approach in the clinic. We believe this regimen has the potential to play a significant role in advancing HCV care for the benefit of patients, physicians and payers."

IDX21437: Topline 7-Day Phase I/II Clinical Results

In January 2014, Idenix initiated the seven-day proof-of-concept portion of a phase I/II clinical trial for IDX21437. The trial completed enrollment of 44 treatment-naïve, genotype (GT) 1, 2 or 3 HCV-infected patients. Patients were randomized to receive once-daily doses of placebo, 50 mg, 150 mg, or 300 mg of IDX21437 for seven days. The topline clinical results include:

• IDX21437 was well-tolerated with no observed pattern of adverse events or laboratory abnormalities.
• Treatment with IDX21437 exhibited potent pan-genotypic activity in a dose-dependent manner:

• In GT 1 HCV-infected patients (n=8), the mean maximal viral load reduction was 4.2 log₁₀ IU/mL in the 300 mg arm.

• The mean maximal viral load reduction of 4.3 log₁₀ IU/mL was achieved in GT 2 and 3 HCV-infected patients in the 300 mg arm (n=10).

• More detailed findings are expected to be presented at a future scientific meeting.
• Based on these findings, the 300 mg dose of IDX21437 has been chosen for the anticipated phase II combination study with samatasvir.

IDX21459: Phase I Clinical Program

In April 2014, Idenix initiated enrollment for the healthy volunteer portion of a phase I clinical trial of IDX21459 in Europe. This portion of the study is expected to enroll approximately 50 healthy volunteers and will evaluate once-daily doses of IDX21459 ranging from 10 mg - 300 mg. The proof-of-concept portion of the study is expected to enroll a total of 40 treatment-naïve, genotype 1 HCV-infected patients who will receive once-daily doses of placebo, 50 - 300 mg of IDX21459 for seven days. IDX21459 has shown a favorable preclinical profile including potent, pan-genotypic activity and favorable safety with respect to cardiac, mitochondrial and genotoxicity assessments.

Additional Nucleotide Candidates

Idenix's primary efforts in nucleotide development will continue to focus on its lead candidate, IDX21437, and follow-on prodrug candidate, IDX21459, as well as earlier-stage nucleotide prodrugs. An important objective for the discovery program is to identify nucleotides offering distinct resistance profiles that can be combined with one of the Company's current nucleotide clinical candidates to treat HCV. Idenix also announced today that the Company has elected not to continue its clinical development program for HCV nucleotide prodrug, IDX20963, previously placed on clinical hold by the U.S. Food and Drug Administration (FDA).

CONFERENCE CALL AND WEBCAST INFORMATION

Idenix management will host a conference call at 8:00 a.m. ET today. To access the call, please dial (877) 640-9809 (U.S./Canada) or (914) 495-8528 (International) and enter passcode 26004979. A live webcast will be available through the Investor section of the Idenix website at www.idenix.com under "Events & Presentations". The archived webcast will be available for two weeks following the call on the Idenix website.

ABOUT IDX21437

IDX21437, Idenix's lead uridine-based nucleotide prodrug inhibitor, has completed the single-dose and seven-day proof-of-concept portions of a phase I/II clinical trial. Extensive preclinical testing for IDX21437 has demonstrated favorable antiviral activity across genotypes 1-6 and a safety profile which supported advancement into clinical trials. Based on this progress, the Company's goal is to initiate an Idenix-sponsored combination clinical trial of IDX21437 and samatasvir in mid-2014.

ABOUT SAMATASVIR

Samatasvir is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro. To date, samatasvir has been safe and well-tolerated after single and multiple doses of up to 150 mg in healthy volunteers up to 14 days duration, and in HCV-infected patients up to 12 weeks duration. Samatasvir has demonstrated potent pan-genotypic antiviral activity in HCV-infected patients with mean maximal viral load reductions up to approximately 4.0 log₁₀ IU/mL across HCV genotypes 1-4 in a proof-of-concept, three-day monotherapy study.

Under a non-exclusive collaboration with Janssen Pharmaceuticals, Inc., Idenix is evaluating all-oral, direct-acting antiviral HCV combination regimens including samatasvir, simeprevir (TMC435), a once-daily protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB, and TMC647055/r, a once-daily non-nucleoside polymerase inhibitor boosted with low-dose ritonavir being developed by Janssen. In this program, Idenix is conducting two ongoing phase II 12-week clinical trials, HELIX-1 and HELIX-2.

ABOUT HEPATITIS C

Hepatitis C virus is a common blood-borne pathogen infecting three to four million people worldwide annually. The World Health Organization (WHO) estimates that more than 150 million people worldwide are chronically infected with HCV, representing a nearly 5-fold greater prevalence than human immunodeficiency virus.

ABOUT IDENIX

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical Company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with hepatitis C infection. For further information about Idenix, please refer to www.idenix.com.

FORWARD-LOOKING STATEMENTS

This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the Company's future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential pipeline candidates, including any expressed or implied statements regarding the efficacy and safety of samatasvir, IDX21437, IDX21459 or any other drug candidate; the successful development of novel combinations of direct-acting antivirals for the treatment of HCV; and the likelihood and success of any future clinical trials involving samatasvir, IDX21437, IDX21459 or our other drug candidates. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's annual report on Form 10-K for the year ended December 31, 2013 as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report that the Company files with the SEC.

All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.

CONTACT: Idenix Pharmaceuticals Contact:
Teri Dahlman (617) 995-9807

Source: Idenix Pharmaceuticals

Source

Gilead Announces U.S. FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Chronic Hepatitis C Genotype 1 Infection

PRESS RELEASE  April 7, 2014, 8:35 a.m. ET

-- Final FDA Decision Anticipated by October 10, 2014 --

FOSTER CITY, Calif.--(BUSINESS WIRE)--April 07, 2014--

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the company's New Drug Application (NDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults. Gilead filed the NDA for LDV/SOF on February 10, 2014, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of October 10, 2014.

The FDA has also assigned LDV/SOF a Breakthrough Therapy designation. The FDA grants Breakthrough Therapy designation and priority review status to investigational medicines that may offer major advances in treatment over existing options. The data submitted in the NDA are from three Phase 3 studies, ION-1, ION-2 and ION-3, and support the use of LDV/SOF in adults with genotype 1 HCV infection, with a treatment duration of eight or 12 weeks depending on prior treatment history and whether they have cirrhosis. Approximately 75 percent of people infected with HCV in the United States have the genotype 1 strain of the virus.

A marketing application for LDV/SOF is also under review in the European Union, and was validated by the European Medicines Agency (EMA) on March 27, 2014. The agency has accepted Gilead's request for accelerated assessment of LDV/SOF, a designation that is granted to new medicines of major public health interest. If accepted, accelerated assessment could shorten the EMA's review time of LDV/SOF by two months, although it does not guarantee a positive opinion from the Committee for Medicinal Products for Human Use or approval by the European Commission.

LDV/SOF is an investigational product and its safety and efficacy have not yet been established.

SOF as a single agent was approved by the FDA under the tradename Sovaldi(R) on December 6, 2013 and by the European Commission on January 17, 2014.

About Gilead Sciences

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 worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.

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 the FDA, EMA and other regulatory agencies may not approve LDV/SOF fixed-dose combination in the currently anticipated timelines or at all, and that any marketing approvals, if granted, may have significant limitations on its use. Further, additional studies of LDV/SOF, including results from the 24-week arms of ION-1, may produce unfavorable results. As a result, Gilead may not be able to successfully commercialize LDV/SOF, and may make a strategic decision to discontinue its development if, for example, the market for the product fails to materialize as expected. 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, 2013, 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 for Sovaldi is available at www.gilead.com.

Sovaldi is a registered trademark of Gilead Sciences, Inc.

For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Source

Bristol-Myers Squibb Submits NDAs for Daclatasvir and Asunaprevir to US FDA for the Treatment of Hepatitis C

U.S. application submission marks third major daclatasvir regulatory milestone globally, follows E.U. and Japan

Monday, April 7, 2014 8:00 am EDT

PRINCETON, N.J..--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) "These FDA submissions represent a major step towards offering daclatasvir-based regimens to U.S. HCV patients, many of whom continue to have high unmet medical needs"

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that they have submitted new drug applications (NDAs) with the U.S. Food and Drug Administration (FDA) for the investigational products daclatasvir (DCV), an NS5A replication complex inhibitor, and asunaprevir (ASV), a NS3 protease inhibitor. The data submitted in the NDAs support the use of DCV+ASV in patients with genotype 1b hepatitis C (HCV). The DCV NDA also seeks approval for use of this compound in combination with other agents for multiple genotypes. The submissions are subject to FDA review for acceptance for filing.

“These FDA submissions represent a major step towards offering daclatasvir-based regimens to U.S. HCV patients, many of whom continue to have high unmet medical needs,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “We are excited to have achieved this milestone and, looking forward, will continue to innovate and invest in daclatasvir in a range of patient types and regimens.”

These submissions follow the recent announcement that the FDA granted the investigational DCV Dual Regimen (DCV+ASV) Breakthrough Therapy Designation. In 2013, the investigational all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325) also received Breakthrough Therapy Designation, and the company anticipates submitting this regimen for FDA review in Q1 2015.

In January 2014, the European Medicines Agency (EMA) validated the company’s marketing authorization application for the use of DCV in combination with other agents for the treatment of adults with HCV with compensated liver disease, including genotypes 1, 2, 3, and 4, and this application is under accelerated review. In addition, NDAs for DCV and ASV are under priority review by Japan’s Pharmaceutical and Medical Devices Agency for patients with chronic HCV genotype 1b, classified as either interferon-ineligible naïve/intolerant or non-responders to interferon and ribavirin.

About Hepatitis C

Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. Approximately 170 million people worldwide are infected with hepatitis C, with an estimated 2.7–3.9 million chronically infected in the United States. Up to 90 percent of those infected with hepatitis C will not spontaneously clear the virus and will become chronically infected. According to the World Health Organization, up to 20 percent of people with chronic hepatitis C will develop cirrhosis; of those, up to 25 percent may progress to liver cancer.

About Bristol-Myers Squibb’s HCV Portfolio

Bristol-Myers Squibb’s research efforts are focused on advancing late-stage compounds to deliver the most value to patients with hepatitis C. At the core of our pipeline is daclatasvir (DCV), an investigational NS5A replication complex inhibitor that has been studied in more than 5,500 patients as part of multiple direct-acting antiviral (DAA) based combination therapies. DCV has shown a low drug-drug interaction profile, supporting its potential use in multiple treatment regimens and in people with co-morbidities.

DCV is currently being studied in the ongoing Phase III UNITY Program, where it is being investigated as part of an all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325). Study populations include non-cirrhotic naïve, cirrhotic naïve and previously treated patients. The 3DAA Regimen is being studied as a fixed-dose-combination treatment with twice daily dosing.

Daclatasvir is also being investigated in combination with sofosbuvir in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients, and patients with genotype 3, as part of the ongoing Phase III ALLY Program.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

Bristol-Myers Squibb Forward Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that clinical trials of these compounds will support regulatory filings, or that DCV or any other compounds mentioned in this release will receive regulatory approval or, if approved, that they will become commercially successful products. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2013 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact:

Bristol-Myers Squibb
Media:
Carrie Fernandez,
Office: +1-609-252-4831; Cell: +1-215-859-2605
carrie.fernandez@bms.com
or
Investors:
Ranya Dajani, 609-252-5330, ranya.dajani@bms.com
Ryan Asay, 609-252-5020, ryan.asay@bms.com

Source

Risk Factors for Hepatitis C Infection Among Vietnam Era Veterans Versus Nonveterans: Results from the Chronic Hepatitis Cohort Study (CHeCS)

Journal of Community Health
March 2014

Joseph A. Boscarino, Alexandra Sitarik, Stuart C. Gordon, Loralee B. Rupp, David R. Nerenz, Vinutha Vijayadeva, Mark A. Schmidt, Emily Henkle, Mei Lu

Abstract

Research suggests that Vietnam era veterans have a higher prevalence of hepatitis C virus (HCV) than other veterans and nonveterans. However, the reasons for this are unclear, since this research has been conducted among Department of Veterans Affairs (VA) patients and most veterans do not use the VA. The current study compares HCV risk factors between the Vietnam era veterans and nonveterans seen in 4 large non-VA systems to explain this disparity. A total of 4,636 HCV patients completed surveys in 2011–2012. Vietnam era veterans were defined as those who served in the military any time between 1964 and 1975. Bivariate tests followed by logistic regressions, and multivariable modeling were conducted to study risk factors among Vietnam era veterans and nonveterans. Since few veterans were female (~2 %), they were excluded. Among male respondents (N = 2,638), 22.5 % were classified as Vietnam era veterans. Compared to nonveterans, these patients were older (p < 0.001), more educated (p < 0.001), less often foreign born (p = 0.009), more often married (p < 0.001), less often employed, and less likely to have a history of drug abuse treatment (p < 0.001). Comparison of specific risk factor differences for HCV infection by veteran status suggested that while injection drug use approached statistical significance (nonveterans = 46.1 % vs. Vietnam era veterans = 41.4 %, p = 0.06), only reported sex with men was significant (nonveterans = 2.4 % vs. Vietnam era veterans = 0.6 %, p = 0.013). In multivariate logistic regression controlling for age, education, country of birth, marital status and study site, no HCV risk factor was associated with Vietnam era veteran status. However, veterans were more likely to report “other” exposures were the source of infection than nonveterans (p < 0.001). While Vietnam era veterans seen in non-VA facilities do not report a higher prevalence of common HCV risk factors, such as injection drug use, they are more likely to report “other” exposures, typically associated with military service, as the source of HCV infection.

Source

HHS Dr Koh releases update to National Viral Hepatitis Action Plan & highlights 10 big advances propelling progress

Provided by The Huffington Post

Updated Viral Hepatitis Action Plan Released

Dr. Howard K. Koh
Assistant Secretary for Health, U.S. Department of Health and Human Services

Posted: 04/02/2014 4:18 pm EDT Updated: 04/03/2014 9:59 am EDT

Today we are pleased to release an updated version of the nation's first comprehensive cross-governmental action plan to combat chronic viral hepatitis, initially launched in 2011. The Action Plan for the Prevention, Care and Treatment of Viral Hepatitis (2014-2016) builds upon the substantial progress accomplished over the past three years by agencies and offices across the Department of Health and Human Services - as well as within the Departments of Justice and Veterans Affairs. (Read a brief factsheet about the updated plan.)

Chronic viral hepatitis (hepatitis B [HBV] and hepatitis C [HCV]) is a largely preventable and treatable disease. Yet it affects between 3.5 and 5.3 million Americans, most of them unaware of their infection. As a result, untreated chronic viral hepatitis represents the leading cause of liver cancer and the most common reason for liver transplantation in the United States. In addition, it is a leading infectious cause of death in the U.S., claiming the lives of 12,000-18,000 Americans each year.

But we are making progress against this "silent epidemic." The release of the first Action Plan has galvanized progress on many fronts. Here are just 10 of the recent accomplishments in the field:

1. Establishment of National Hepatitis Testing Day. The original Action Plan called for the establishment of this annual observance, which we've now observed on May 19th each year since 2012. National Hepatitis Testing Day raises greater awareness among both health care providers and communities and we look forward to another outstanding observance next month.

2. New hepatitis C testing recommendations. Both the CDC and the U.S. Preventive Services Task Force have issued recommendations to test all individuals born between 1945 and 1965. As these so-called "Baby Boomers" are five times more likely to be infected with hepatitis C, this single recommendation could save over 120,000 lives. The alignment of these CDC and USPSTF recommendations and their widespread dissemination were called for in the 2011 Action Plan.

3. Expanded, culturally appropriate hepatitis B outreach and educational materials. Produced by CDC in partnership with community organizations, the Know Hep B campaign materials, available in several Asian languages, enable health care providers and community organizations to reach more individuals at risk about the importance of testing for HBV.

4. Greater attention to hepatitis C among persons who inject drugs (PWID). Of new cases of HCV infection reported to the CDC, injection drug use represents the most commonly identified risk factor. An estimated 64 percent of PWID are chronically infected with HCV, and 2.7-11 percent are chronically infected with HBV. Recent consultations and research funding announcements are strengthening our understanding of this problem. We are identifying better ways to prevent new infections in this vulnerable population.

5. Opposing discrimination against health care professionals and students with chronic hepatitis. In a great example of the cross-agency collaboration fostered by the Action Plan, the Offices of Civil Rights from the Departments of Justice, Education, and Health and Human Services sent a joint letter last year to health professions schools. The letter highlighted new CDC guidance on the management of health care professionals and students with chronic HBV and outlined steps to eliminate discrimination against those infected.

6. Greater attention to the elimination of perinatal hepatitis B transmission. We have the tools to further reduce the number of infants perinatally infected with HBV. Motivated and active partners have engaged to ensure the administration of a dose of HBV vaccine to all newborns before discharge from hospitals or birthing centers.

7. New hepatitis C treatments. Late last year, the FDA approved two new HCV treatments, which are simpler to use, require a shorter treatment duration, and have fewer side effects than earlier treatment regimens. These treatments lead to a cure in more than 90 percent of patients who complete them - a major advance. Our FDA colleagues are working along with the pharmaceutical industry to make new HCV therapies available safely and as quickly as possible by using the Fast Track program. This special designation facilitates development and review of drugs with the potential to address unmet medical needs in those with serious conditions.

8. Affordable Care Act. The Affordable Care Act is contributing to efforts to combat chronic viral hepatitis in the U.S. For example, because the law prohibits most plans from denying health coverage based on preexisting conditions, those with chronic viral hepatitis who had previously been uninsured will now have the opportunity to get covered and obtain access to needed prevention, care and treatment services. Moreover, hepatitis vaccinations and testing for HBV for pregnant women are among the covered preventive services that must be offered free of cost-sharing or co-pays. Later this year, one-time HCV screening for persons born between 1945 and 1965 will be added to this list. In addition, the law calls for a substantial investment in the HHS community health center program, which is a vital partner in delivering viral hepatitis prevention, diagnosis, care and treatment to vulnerable populations.

9. World Hepatitis Day proclamations from the President. President Obama has lent his support to the global observance of World Hepatitis Day for the past three years, issuing annual proclamations. The White House has also hosted events to commemorate these observances, helping to raise awareness and mobilize action to address viral hepatitis not only in the U.S. but around the globe.

10. An updated Action Plan for the Prevention, Care, & Treatment of Viral Hepatitis. Now, the updated Action Plan will build upon all the important advances noted above, and identify further opportunities for public and private sector stakeholders. So many can engage in efforts to break the silence surrounding viral hepatitis and improve prevention, diagnosis, care and treatment.

New partners have joined in launching the updated Action Plan. We are pleased that from the federal government, the Department of Housing and Urban Development and the White House Office of National Drug Control Policy have joined our efforts along with the HHS Office of Disease Prevention and Health Promotion, Office of Population Affairs, and our Regional Health Administrators. Many others can join as well. As my colleague Dr. Ronald Valdiserri, Deputy Assistant Secretary for Health, Infectious Diseases observes, "Active involvement by a broad mix of partners from various sectors, both public and private, is essential to fully realizing the potential of this plan. The updated plan provides a framework around which all of us can engage in aligned and focused action."

I hope you, too, will join us in this important moment. It is a critical time. We have the potential to save many lives. The era of health care reform provides a historic setting to strengthen the rapid progress we're making in the diagnosis and treatment of chronic hepatitis. Working together, we can successfully leverage all of our resources to help the nation become fully committed to combating the silent epidemic of viral hepatitis.

Share your ideas about how you or your organization can contribute to this national effort in the comments section below or on social media using the hashtag #ViralHepAction.

Follow Dr. Howard K. Koh on Twitter: www.twitter.com/@HHS_DrKoh

Source

Also See: Updated Action Plan to Combat Viral Hepatitis Released

The next frontier in 3-D printing: Human organs

By Brandon Griggs, CNN
updated 9:43 AM EDT, Thu April 3, 2014

(CNN) -- The emerging process of 3-D printing, which uses computer-created digital models to create real-world objects, has produced everything from toys to jewelry to food.

Soon, however, 3-D printers may be spitting out something far more complex, and controversial: human organs.

For years now, medical researchers have been reproducing human cells in laboratories by hand to create blood vessels, urine tubes, skin tissue and other living body parts. But engineering full organs, with their complicated cell structures, is much more difficult.

Enter 3-D printers, which because of their precise process can reproduce the vascular systems required to make organs viable. Scientists are already using the machines to print tiny strips of organ tissue. And while printing whole human organs for surgical transplants is still years away, the technology is rapidly developing.

"The mechanical process isn't all that complicated. The tricky part is the materials, which are biological in nature," said Mike Titsch, editor-in-chief of 3D Printer World, which covers the industry. "It isn't like 3-D printing plastic or metal. Plastic doesn't die if you leave it sitting on an open-air shelf at room temperature for too long."

Lawrence Bonassar, a professor of biomedical engineering at Cornell University, with an artificial ear made via 3-D printing and injectable molds.

The idea of printing a human kidney or liver in a lab may seem incomprehensible, even creepy. But to many scientists in the field, bioprinting holds great promise. Authentic printed organs could be used for drug or vaccine testing, freeing researchers from less accurate methods such as tests on animals or on synthetic models.

Then there's the hope that 3-D printers could someday produce much-needed organs for transplants. Americans are living longer, and as we get deeper into old age our organs are failing more. Some 18 people die in the United States each day waiting in vain for transplants because of a shortage of donated organs -- a problem that Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine and a pioneer in bioprinting, calls "a major health crisis."

An 'exciting new area of medicine'

Bioprinting works like this: Scientists harvest human cells from biopsies or stem cells, then allow them to multiply in a petri dish. The resulting mixture, a sort of biological ink, is fed into a 3-D printer, which is programmed to arrange different cell types, along with other materials, into a precise three-dimensional shape. Doctors hope that when placed in the body, these 3-D-printed cells will integrate with existing tissues.

The process already is seeing some success. Last year a 2-year-old girl in Illinois, born without a trachea, received a windpipe built with her own stem cells. The U.S. government has funded a university-led "body on a chip" project that prints tissue samples that mimic the functions of the heart, liver, lungs and other organs. The samples are placed on a microchip and connected with a blood substitute to keep the cells alive, allowing doctors to test specific treatments and monitor their effectiveness.

"This is an exciting new area of medicine. It has the potential for being a very important breakthrough," said Dr. Jorge Rakela, a gastroenterologist at the Mayo Clinic in Phoenix and a member of the American Liver Foundation's medical advisory committee.

One of Organovo's engineers oversees the construction of a vascular tissue construct on a Novotel bioprinter.

"Three-D printing allows you to be closer to what is happening in real life, where you have multiple layers of cells," he said. With current 2-D models, "if you grow more than one or two layers, the cells at the bottom suffocate from lack of oxygen."

To accelerate the development of bioprinted organs, a Virginia foundation that supports regenerative medicine research announced in December it will award a $1 million prize for the first organization to print a fully functioning liver.

One early contender for the prize is Organovo, a California start-up that has been a leader in bioprinting human body parts for commercial purposes. Using cells from donated tissue or stem cells, Organovo is developing what it hopes will be authentic models of human organs, primarily livers, for drug testing.

The company has printed strips of human liver tissue in its labs, although they are still very small: four by four by one millimeter, or about one-fourth the size of a dime. Each strip takes about 45 minutes to print, and it takes another two days for the cells to grow and mature, said Organovo CEO Keith Murphy. The models can then survive for about 40 days.

Organovo has also built models of human kidneys, bone, cartilage, muscle, blood vessels and lung tissue, he said.

"Basically what it allows you to do is build tissue the way you assemble something with Legos," Murphy said. "So you can put the right cells in the right places. You can't just pour them into a mold."

Ethical concerns

Not everyone is comfortable with this bold new future of lab-built body parts, however.

A research director at Gartner Inc., the information-technology research and advisory firm, believes 3-D bioprinting is advancing so quickly that it will spark a major ethical debate by 2016.

A 3-D printer at Cornell University produces an artificial ear.

"Three-D bioprinting facilities with the ability to print human organs and tissue will advance far faster than general understanding and acceptance of the ramifications of this technology," Pete Basiliere said in a recent report.

"These initiatives are well-intentioned, but raise a number of questions that remain unanswered," Basiliere added. "What happens when complex 'enhanced' organs involving nonhuman cells are made? Who will control the ability to produce them? Who will ensure the quality of the resulting organs?"

Bioprinted organs are also likely to be expensive, which could put them out of reach of all but the wealthiest patients.

Murphy said Organovo only uses human cells in creating tissues, and doesn't see any ethical problems with what his company is doing.

"People used to worry about doing research on cadavers ... and that dissipated very quickly," he said. "We don't think there's any controversy if you're producing good data and helping people with health conditions."

Most experts, including Wake Forest's Atala, don't think we'll see complex 3-D-printed organs, suitable for transplants, for years if not decades. Instead, they believe the next step will be printing strips of tissue, or patches, that could be used to repair livers and other damaged organs.

Organovo also uses the Nuveen MMX Bio printer, which is small enough to fit into a cabinet.

"We are very eager to put pieces of tissue to work for surgical transplants," said Organovo's Murphy, who hopes his company will be ready to begin clinical trials within five years.

Of course, any use of 3-D-printed tissue in surgical procedures would require approval by the U.S. Food and Drug Administration. That review process could take up to a decade.

By then, the notion of a surgeon putting a 3-D-printed kidney into a patient may not seem so bizarre. Then again, this swiftly evolving technology may create new moral conundrums.

"The ethical questions are bound to be the same concerns we have seen in the past. Many major medical breakthroughs have suffered moral resistance, from organ transplants to stem cells," said Titsch of 3D Printer World.

"Will only the rich be able to afford it? Are we playing God? In the end, saving lives tends to trump all objections."

Source

Updated Action Plan to Combat Viral Hepatitis Released

FOR IMMEDIATE RELEASE
April 3, 2014

Contact: HHS Press Office
(202) 205-0143

A statement by Deputy Assistant Secretary for Health, Infectious Diseases,
Ronald O. Valdiserri, MD, MPH

Today, federal partners launched an updated Action Plan for the Prevention, Care and Treatment of Viral Hepatitis (2014-2016), building upon the nation’s first comprehensive cross-agency action plan to combat viral hepatitis.

The three-year renewal of the Action Plan builds upon the substantial progress accomplished since 2011 by agencies and offices from across the Department of Health and Human Services, as well as with our partners at the Departments of Justice, Housing and Urban Development, and Veterans Affairs, to prevent new infections and improve the diagnosis, care and treatment of individuals living with chronic hepatitis C in the United States.

Between 3.5 and 5.3 million Americans are living with chronic viral hepatitis, and most of them do not know that they are infected. Viral hepatitis is the leading cause of liver cancer and the most common reason for liver transplantation in the United States. In addition, it is a leading infectious cause of death in the U.S., claiming the lives of 12,000–18,000 Americans each year.

In recent years we have made significant progress in addressing these challenges.  With the new advances in hepatitis C treatment, more widespread availability of safe and effective vaccines for hepatitis A and B, and more opportunities for testing for hepatitis C under the Affordable Care Act, we have arrived at a critical moment. By harnessing these and other developments, we have the potential to reduce the toll of viral hepatitis in the U.S. and save many lives.

Thanks to the outstanding commitment of our public and private partners, we are closer than ever to realizing the potential of this plan.

To access the full Action Plan for the Prevention Care and Treatment of Viral Hepatitis (2014-2016) visit www.aids.gov/hepatitis.

For more information on viral hepatitis, see http://www.cdc.gov/hepatitis/.

Follow the conversation on social media using #ViralHepAction.

###

Note: All HHS press releases, fact sheets and other news materials are available at http://www.hhs.gov/news.

Like HHS on Facebook , follow HHS on Twitter @HHSgov , and sign up for HHS Email Updates.

Follow HHS Secretary Kathleen Sebelius on Twitter @Sebelius .

Last revised: April 3, 2014

Source

Also See: Updated Action Plan to Combat Viral Hepatitis Released

FDA approves new hand-held auto-injector to reverse opioid overdose

FDA NEWS RELEASE

For Immediate Release: April 3, 2014
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

First naloxone treatment specifically designed to be given by family members or caregivers

The U.S. Food and Drug Administration today approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet.

It is intended for the emergency treatment of known or suspected opioid overdose, characterized by decreased breathing or heart rates, or loss of consciousness.

Drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. In 2013, the Centers for Disease Control and Prevention reported the number of drug overdose deaths had steadily increased for more than a decade.

Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for overdose. However, existing naloxone drugs require administration via syringe and are most commonly used by trained medical personnel in emergency departments and ambulances.

“Overdose and death resulting from misuse and abuse of both prescription and illicit opioids has become a major public health concern in the United States,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia, and Addiction Products in the FDA’s Center for Drug Evaluation and Research. “Evzio is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a health care setting. Making this product available could save lives by facilitating earlier use of the drug in emergency situations.”

Evzio is injected into the muscle (intramuscular) or under the skin (subcutaneous). Once turned on, the device provides verbal instruction to the user describing how to deliver the medication, similar to automated defibrillators. Family members or caregivers should become familiar with all instructions for use before administering to known or suspected persons to have had an opioid overdose. Family members or caregivers should also become familiar with the steps for using Evzio and practice with the trainer device, which is included along with the delivery device, before it is needed. 

Because naloxone may not work as long as opioids, repeat doses may be needed. Evzio is not a substitute for immediate medical care, and the person administering Evzio should seek further, immediate medical attention on the patient’s behalf.

In one pharmacokinetic study of 30 patients, a single Evzio injection provided equivalent naloxone compared to a single dose of naloxone injection using a standard syringe. The use of Evzio in patients who are opioid dependent may result in severe opioid withdrawal. Abrupt reversal of opioid depression may result in nausea, vomiting, sweating, accelerated heart rate (tachycardia), increased blood pressure, uncontrollable trembling (tremulousness), seizures and cardiac arrest.

The FDA reviewed Evzio under the agency’s priority review program, which provides for an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. The product was granted a fast-track designation, a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Evzio is being approved ahead of the product’s prescription drug user fee goal date of June 20, 2014, the date the agency was originally scheduled to complete review of the drug application.

Evzio’s approval is also the result of efforts by several federal agencies. Naloxone has been a part of the White House’s Office of National Drug Control Policy’s National Drug Control Strategy since 2012. The FDA co-chairs an HHS inter-departmental working group on naloxone, which helped coordinate an April 12, 2012, meeting regarding access to naloxone products.

Evzio is manufactured for kaléo, Inc., of Richmond, Va. 
For more information:

Information on Opioid Medications

FDA: Approved Drugs

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

# # #

Read our Blog: FDA Voice

Visit the FDA on Facebook, Flickr, YouTube, and Twitter

RSS Feed for FDA News Releases

Source SDA