April 9, 2014

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.

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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.

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

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)

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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 SciencesSovaldi 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

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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

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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

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

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

Authors: WHO

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

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.

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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.

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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

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