Sunday, April 13, 2014

HCV Newsletters Updated - 'Mix-and-match` approach to new hepatitis C drugs

Good morning folks, hope everyone is enjoying this fine weekend.

Since our spring summary of news, and related April HCV Newsletters; The HCV Debate - To Treat Or Defer, ALF published a list of frequently asked questions about liver transplantation, answered by Dr. Gordon the medical director of liver transplantation and hepatology at Lahey Hospital and Medical Center.

In addition new guidelines released at EASL 2014 is suggesting that physicians mix and match HCV agents in order to achieve the most potent interferon-free regimens, view the update provided further down this post.

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

 April 2014 Edition 

In This Issue

Approximately 6,000 liver transplants are performed in the U.S. each year. How do you prepare for a transplant and what is life like after? ALF sits down with a renowned transplant surgeon to help you find the answers.

Many people may not realize that livers can come from a live donor. It’s an exciting area and with the shortage of cadaver organs, it can help patients desperately waiting for new livers. Read about one young man’s story of survival and friendship.

ALF patient advocates and staff participates in events across the country to raise much-needed funds for our public education and research programs. Here is what we have been up to during the last month.

The American Liver Foundation is making national news on topics including liver wellness, disease prevention, screening and treatment.

Should you get tested for hepatitis C? Do you want to know about our upcoming webinars or participate in our Faces of Liver Disease campaign? Here is some information you should know.

ALF hosts a number of events throughout the year to support liver disease awareness.

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Hepatitis C Trust released a news update in April, and also in March which announced a study exploring the issue of late diagnosis. The Hepatitis C Trust needs your input to help understand why people in the UK are not being tested, this information can be used to raise HCV awareness and improve testing strategies.

Have you been diagnosed with hep C in the last 2 years? Do you think you contracted it more than 15 years ago? If you answer yes to these two questions we would love to talk to you.  

If you are interested in participating please get in touch with Emma Ward by email  or call 020 7089 6220.

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View all April newsletters, here.

Annual Meeting/The International Liver Congress™ 2014
April 9-13

European Medicines Agency (EMA) released new recommendations on the treatment of hepatitis C at the EASL International Liver Congress 2014 meeting, the World Health Organization (WHO) issued its first guidance for the treatment of hepatitis C earlier this week.
Read more here....... 

'Mix-and-match` approach to new hepatitis C drugs
EASL 2014 recommendations for use of new direct-acting antivirals receiving European approval in 2014

Recommendations ranked by strength of clinical trial evidence (A1 – C2)

EASL is also encouraging European physicians to combine products from different pharmaceutical companies to achieve the most potent interferon-free regimens, often in advance of full phase III trial data, in its new hepatitis C treatment guidelines issued on Friday at the International Liver Congress in London.

The guidelines move beyond US recommendations issued in January, which incorporated a small number of off-label uses not included in the US licenses for sofosbuvir and simeprevir.The new guidelines also include daclatasvir, a NS5A inhibitor that is likely to receive approval in Europe later this year.

Guidelines panel chair Professor Jean-Michel Pawlotsky, director of the French National Reference Centre for Viral Hepatitis B, C and Delta told reporters that the EASL guidelines were designed to accommodate the diversity of European populations and reimbursement practices. The guidelines were also designed to empower physicians to obtain permission to use new agents under compassionate access arrangements, prior to licensing, said Dr Alessio Aghemo, a member of EASL’s Scientific Committee and a professor of medicine at the University of Milan.

The EASL guidelines are another sign that when making prescribing decisions for patients with hepatitis C, physicians do not intend to be constrained by licensing indications or the quest of pharmaceutical companies to deliver `exclusive` drug combinations that require prescribers to use co-formulated direct-acting antivirals from one company.

The guidelines make recommendations for all genotypes, and include all direct-acting antivirals that are expected to be licensed in Europe during 2014, including the protease inhibitor simeprevir (Olysio) and the NS5A inhibitor daclatasvir. Simeprevir is likely to receive marketing approval in May 2014 and daclatasvir in September 2014. Bristol-Myers Squibb, the developer of daclatasvir, has anticipated the European move towards a `mix-and-match` approach by applying for a license for daclatasvir alone in Europe. In the United States it is seeking a license for daclatasvir in combination with asunaprevir.

The guidelines recommend that the first-generation protease inhibitors telaprevir or boceprevir should be used for treatment of genotype 1 infection only when newer options are not available. For other genotypes, the combination of pegylated interferon and ribavirin is described as `acceptable` where newer options are not available.

The guidelines will be updated as soon as approval dates for new interferon-free combinations of sofosbuvir/ledipasvir (Gilead Sciences) and ABT-450/ritonavir, ombitasvir and dasabuvir (AbbVie) are known. These are likely to be approved in early 2014.


EASL Updates
This forty minute EASL video highlights data on new drugs to treat hepatitis C presented at this months conference, progressions in treating genotype 4, as well as Hepatocellular Carcinoma (HCC) and cirrhosis.

Stay Updated
Categorized by antiviral agent and pharmaceutical company.

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