April 20, 2012

Seven steps to a healthy liver

liver

Dr Paramesh Rangesh, April 21, 2012

Liver is the one of the most important organs in the body and plays a pivotal role in overseeing almost all bodily functions. Weighing about 1.5 kilograms, it stores minerals, vitamins and manufactures new proteins when needed. The liver also produces bile, which aids in the process of fat digestion. The organ is responsible for breaking down therapeutic ingredients in medicine, so that it can be quickly absorbed by the body. Its supportive role in building coagulation capability helps in forming blood clots.

Interestingly, the liver can also completely regenerate itself. From just 25 per cent functionality, it can still rebuild itself into a fully-functional liver. Here are some healthy factors that will nurture the liver:

* Healthy diet: a diet rich in magnesium, iron, and carbohydrates will keep the liver healthy and help in detoxifying the body. Drinking plenty of water throughout the day is also essential.

* Avoid alcohol: Consuming large amounts of alcohol can lead to three serious conditions — alcoholic hepatitis, alcoholic cirrhosis and a fatty liver. Keep alcohol intake to a bare minimum or avoid alcohol altogether.

* Avoid drugs: recreational drugs severely damage liver cells. Some prescription drugs can also be hepatotoxic, so do not exceed the recommended dosage of medication, unless advised by a doctor.

* Organic foods: organic fruits and vegetables are high in antioxidants that protect the liver as well as help in its cleansing processes. Try to include organic foods in your diet.

* Avoid environmental pollutants: toxic fumes from paint thinners, bug sprays and other aerosols can enter the body through tiny blood vessels in your lungs and are carried to your liver, which can cause injury to the organ. Wear a protective mask when using these products.

* Exercise

* Get vaccinated: remember to vaccinate yourself against viral liver disease like hepatitis A and B.

The liver loves...

* Garlic: it is known to activate liver enzymes that flush away toxins from the body.

* Green, leafy vegetables: they are high in chlorophylls —spinach, mustard greens, broccoli and cabbage are great detoxifiers. Others like chicory and bitter melon help in increasing bile production.

* Turmeric: it is not only good for your curries, but boosts liver detoxification by flushing out known dietary carcinogens.

* Lemon and lime: they contain very high amounts of Vitamin C, which aids the body in synthesising toxic material into substance that can be absorbed by water. Drinking freshly-squeezed lemon or lime juice in the morning helps stimulate the liver.

* Beets and carrots: they help the liver by eliminating toxins like heavy metals from the body. They are also high in plant-flavanoids and beta-carotene that improve overall health.

Source

EASL 2012: Oral HCV Combo Effective for Genotype One

Medpage

By Michael Smith, North American Correspondent, MedPage Today

Published: April 20, 2012

Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania.

 

Action Points

  • This study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
  • In this small study, a combination oral therapeutic regimen, without interferon-alfa, including a investigational protease inhibitor and an investigational polymerase inhibitor was well tolerated and very effective in treatment of naive noncirrhotic patients with genotype 1 HCV.

An all-oral treatment regimen for hepatitis C had high response rates among patients with a hard-to-treat type of virus, a researcher reported.

After 12 weeks of therapy with two investigational direct-acting agents and ribavirin, 91% of patients with genotype one virus went on to have a sustained virologic response (SVR) 24 weeks later, according to Eric Lawitz, MD, of Alamo Medical Research in San Antonio.

It's the first time such a regimen -- given without interferon-alfa -- has shown such high response rates among patients with that type of HCV, Lawitz said at the meeting of the European Association for the Study of the Liver in Barcelona.

The regimen included one standard drug, ribavirin, as well as ABT-450/r, which is given with ritonavir (Norvir) and inhibits the viral NS3 protease inhibitor, and ABT-072, a non-nucleoside NS5B polymerase inhibitor.

In a small study of 11 patients who had not previously been treated for the virus, all showed sharp declines in hepatitis C RNA within three weeks of starting the 12 weeks of therapy and all had undetectable virus from week five through the end of treatment.

One patient relapsed by week eight after the end of treatment, but 91% were still virus-free at week 24 post-therapy and 82% were still clear by 36 weeks, Lawitz said.

He did, however, flag one case of a patient relapsing after the 36-week mark -- a case that has raised eyebrows at the meeting.

Lawitz said the drug's makers are not worried that the case will affect development of the drug, other experts said it may raise a red flag about approvals based on relatively short follow-up times.

"I suspect there are, or will be, others," according to Paul Pockros, MD, of the Scripps Clinic in La Jolla, Calif., who was not part of the study. "If it is one-off, the FDA will say it's fine, but if there are more, it could negatively affect" approvals for all of the new direct-acting agents, Pockros told a reporter.

Until recently, drug studies in hepatitis C used relatively long follow-ups, but in 2011, the FDA said future trials could use SVR 12 weeks after the end of therapy as an endpoint, because relapse usually occurs within that time.

Among the 10 patients with 48-week data available, there have been no more relapses, Lawitz reported.

The drug combination was well-tolerated. Most reported adverse events were mild and the most common were headache, fatigue, nausea, and dry skin. No patient stopped therapy because of adverse events.

There were two cases of transient bilirubin elevation, which took place during the first week of therapy but returned to normal with continued treatment.

The study was sponsored by Abbott Laboratories.

Several authors are employees of the company, which took part in data interpretation and approval of the presentation.

Primary source: EASL
Source reference:
Lawitz E, et al "A 12-week interferon-free regimen of ABT-450/r, ABT-072, and ribavirin was well tolerated and achieved sustained virologic response in 91% treatment-naïve HCV IL28B-CC genotype-1-infected subject" EASL 2012.

Source

Janssen launches EMEA division to market hepatitis C drug

Published: 20/04/2012

Janssen Pharmaceutica has set up a new division to market its hepatitis C product TMC435 to patients in Europe, the Middle East and Africa.

Janssen, which is itself a subsidiary of healthcare giant Johnson & Johnson (J&J), said the Janssen Therapeutics EMEA division will be based in Beerse, Belgium, and will bring together experts from across the region to tackle the disease.

At the heart of this will be the development and commercialisation of TMC435, an investigational protease inhibitor that the company is developing with its partner Medivir as a new class of hepatitis C treatment.

It is currently in late phase III clinical development in combination with current treatment option pegIFN/ribavirin.

Jane Griffiths, Janssen EMEA company group chair said: “The World Health Organization describes hepatitis C as a ‘viral time bomb’.

“That is why we have created a dedicated division, which will commercialise TMC435 and help meet hepatitis C patients’ needs. Janssen Therapeutics EMEA is on a mission to bring new options to successfully treat patients with this devastating disease.”

Outside the EMEA, J&J’s other subsidiary Tibotec plans to market the drug if approved.

The launch of Janssen Therapeutics EMEA coincides with European Association for the Study of the Liver (EASL) International Liver Congress 2012 in Barcelona.

At the congress, Janssen presented new retrospective analysis of phase III data for its other hepatitis C treatment Incivo (telaprevir).

The drug, which is approved in Europe to treat chronic hepatitis C in combination with pegIFN/ribavirin, demonstrated that a similar sustained virologic response (SVR) rate was achievable even if the dosage of ribavirin was lowered.

This could have benefits for people with hepatitis C, according to Janssen, as ribavirin is linked to incidents of anaemia in patients taken the combination of treatments.

Professor Mark Sulkowski, professor of medicine at Johns Hopkins University School of Medicine, Baltimore, said: “These results demonstrate that the reduction of ribavirin to help manage treatment-related anaemia when treating with telaprevir did not compromise the chance of clearing the virus.”

There will be an interview with Jane Griffiths in the May issue of Pharmaceutical Market Europe.

Source

J&J Open to Expanding Hepatitis C Cooperation With Vertex

By Makiko Kitamura on April 20, 2012

Johnson & Johnson (JNJ) (JNJ)’s Janssen unit said it may explore widening cooperation on hepatitis C withVertex Pharmaceuticals Inc. (VRTX) (VRTX) that may develop in tandem with a separate partnership with Medivir AB (MVIRB) on the disease.

“We remain open to see if we can expand our collaboration,” Gaston Picchio, vice president of Janssen’s global clinical virology and hepatitic disease area, said in an interview today in Barcelona, where he’s attending the European Association for the Study of the Liver annual meeting. “Vertex has announced plans for developing interferon-free therapies. We are partners, so that puts us in a better position to be a part of that,” should studies prove to be promising.

Vertex said on April 18 that it will start enrolling patients in a mid-stage study combining three medicines, excluding interferon, a core component of the current standard of care. Vertex and competitors including Gilead Sciences Inc. (GILD) (GILD),Bristol-Myers Squibb Co. (BMY) (BMY) and Abbott Laboratories (ABT) (ABT) are racing to develop next-generation treatments for hepatitis C that exclude interferon because of flu-like side effects.

Vertex and J&J collaborated to develop telaprevir, marketed as Incivek by Vertex in North America and as Incivo by Janssen in other regions including Europe. The drug was approved by regulators last year as a treatment for hepatitis C in combination with interferon and ribavirin.

Medivir Project

J&J, which has its headquarters in New Brunswick, New Jersey, is also developing the protease inhibitor TMC435 with Huddinge, Sweden-based Medivir, which has said mid-stage trials of the drug in interferon-free combinations with Gilead’s 7977 and with Bristol-Myers’s daclatasvir experimental drugs are starting in the second quarter.

While J&J and Medivir are also developing the TMC647 polymerase inhibitor, Vertex’s VX-222 compound in the same class of drugs is further along in development. VX-222 is one of the three drugs included in Cambridge, Massachusetts-based Vertex’s mid-stage interferon-free treatment study.

Meanwhile, J&J is also “committed” to improving the labeling of Incivo by conducting further trials that examine less frequent dosage as well as efficacy in patients also infected by the HIV virus and those who have had liver transplants, Picchio said.

To contact the reporter on this story: Makiko Kitamura in Barcelona via mkitamura1@bloomberg.net 

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

Source

Partner Up or Get Passed Up

By Brian Orelli, The Motley Fool

Posted 9:26AM 04/20/12 Posted under: Investing

I can only imagine the conversation:

Bristol-Myers Squibb (NYS: BMY) : "Hey partner, we've got a new hepatitis C drug candidate from our acquisition of Inhibitex. Want to combine it with your drug?"

Johnson & Johnson (NYS: JNJ) : "Sure, why not? Maybe it'll give us an edge against Gilead Sciences (NAS: GILD) , the front-runner in the quest for an all-oral hepatitis C treatment. But make sure you give it a really complicated name; INX-189 was too easy."

BMS: "Already done."

The duo expanded their partnership beyond combining BMS' daclatasvir with J&J's TMC435 to include a combination of TMC435 with BMS-986094, the compound formally known as INX-189. The companies also agreed that if daclatasvir and TMC435 work well in a phase 2 trial, they'll move it into a phase 3 trial.

The quest for an all-oral hepatitis C treatment to replace Merck's (NYS: MRK) PegIntron and Roche's Pegasys, which have to be injected, will likely require multiple drugs from different drugmakers. Hepatitis C drugs come in different classes that disrupt the virus in different ways. A few companies -- Gilead and Roche, for instance -- seem to have a drug in enough categories to develop a cocktail on their own, but that assumes they have the best (or at least good enough) drugs to get a decent cure rate. The current standard of care that combines an injectable drug with Vertex Pharmaceuticals' (NAS: VRTX) Incivek cures around 70% of patients, so any all-oral treatment would have to meet or exceed that.

Flying solo also poses a problem for timing. Gilead, for instance, is reportedly considering going it alone even though its GS-7977 works really well with Bristol's daclatasvir, as it has a drug of its own in the same class as daclatasvir. That choice will likely result in getting to the market slower.

Sure, combining drugs means sharing profits, but I think that's a good trade-off for the potential to be best in class and not let any other combination products pass you up.

Now if we can just get easy-to-remember trade names for all these drugs.

Source

World Liver Day 2012: Things you ought to know about your liver

liver

Dr Ashwin Mallya, Apr 19, 2012 at 8:03 AM

Your liver is a one and a half kg organ that sits behind your right rib cage. If you did not have your liver, you would not be able to process nutrients like carbohydrates, proteins, fats, vitamins and minerals from your food. Your body would not get rid of all the toxins and microbes. Your blood would probably never clot! The liver plays a vital role in maintaining the body’s metabolic balance.

As the liver performs a variety of important functions it is extremely vulnerable to a variety of metabolic, toxic, microbial, circulatory and cancerous insults. Awareness of the liver’s functions and what all can cause liver disease can help you take the road to great health.

Let’s start with a few commonly known diseases that can affect the liver:

  1. Fatty Liver: This disease was traditionally known to occur in association with excessive alcohol intake but now the non-alcoholic variant is reaching epidemic proportions in the developed countries. Known to occur in association with metabolic syndrome consisting of hypertension, diabetes, obesity and hyperlipidemia this disease occurs because of faulty fat metabolism in the liver. Prevention is the best treatment and if uncontrolled can even end up in liver failure.
  2. Viral hepatitis is an infection of the liver that is caused by a group of viruses that have particular affinity for the liver. Out of these, hepatitis A and E are caused by eating food contaminated with the virus. Hepatitis B, C and D are acquired through blood, body fluids and by unprotected sexual contact.
  3. Alcoholic hepatitis is inflammation (swelling) of the liver due to ingestion of alcohol.
  4. Cirrhosis or scarring of the liver is caused mostly due to alcohol intake, viral infection due to hepatitis B and C , bile duct disease or iron overload. It is among the top 10 causes of death in the world. The liver ceases to function normally due to irreversible damage. It progresses gradually and can lead to end stage liver disease.
  5. Drug induced damage caused due to the various medicines we take and chemicals we are exposed to. As liver is the major detoxifying organ in the body, it is subject to an enormous variety of drugs and chemicals. Always be careful when consuming medicines. Even over the counter medications like paracetamol can cause fulminant liver failure. Never take medications beyond the recommended dosage. It is always better to consult a doctor before taking medications and follow up at the slightest evidence of ill health. Certain herbal medications could also cause damage to the liver and so can medications for tuberculosis.
  6. Liver cancer can be caused by many factors including viral infections (hepatitis B and C), chronic alcoholism, certain food contaminants, genetic factors, cirrhosis of the liver.

What are the symptoms of liver disease?

This depends on the onset and rapidity of progression of liver damage.

In case of acute liver damage (due to drugs, toxins, viral hepatitis A, B or E), there may be fever with yellowish discoloration of sclera (the white of the eye), skin and urine. In most cases this may be self-limiting. In a small percentage, this may progress to fulminant liver failure leading to coma, altered blood clotting, kidney failure, secondary infections and may even require liver transplantation.

In chronic liver damage (due to hepatitis B, C or alcohol), the symptoms would be more gradual in onset:

  • Jaundice or yellowish discoloration of skin and the white of the eye.
  • Swelling especially in the legs and feet due to low protein levels.
  • Enlargement of breasts known as gynecomastia (in a male).
  • Reddish spider like discolorations (spider nevi) beneath the skin especially over the chest.
  • Accumulation of fluid (ascites) in the abdomen giving it a protruded appearance.
  • Problems with clotting of blood
  • Vomiting of blood or blood in stools
  • Altered senses with change in behavior, confusion, forgetfulness and other symptoms related to the brain also known as hepatic encephalopathy.
  • Gradual worsening of kidney function

The above symptoms are not comprehensive and it is best to consult a doctor at the earliest onset of any of the above.

Tips for a healthy liver:

Diet and Alcohol: A balanced diet with low fat content would be well suited to prevent fatty liver. Alcohol is best avoided.

Exercise: Plays a role in controlling cholesterol and in the metabolism of fat thus indirectly protecting the liver.

Vaccination: Hepatitis B is preventable by vaccination. Three shots of the hepatitis B vaccine taken over three months can provide long term protection against the dreaded disease.

Hygienic food and drinking water: Hepatitis A and E are known to spread via the oral route. Think twice before having road side delicacies! Boil the water that you intend to drink. It is the best way to prevent communicable diseases.

Avoid self-medication: Various drugs can damage the liver if taken indiscriminately

Regular check-ups: Once diagnosed with liver disease, be regular in follow ups with the doctor. Reversible damage can become irreversible if neglected.

This World Liver day, let’s strive not to abuse our liver, one of the most useful organs that we have. Let’s treat it with the love and respect it deserves.

Source

Patients seek refuge from overpriced treatment of hepatitis

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Blame doctors, health officials and pharmaceutical companies of fleecing patients.

By Our Correspondent

Published: April 21, 2012

ISLAMABAD: Patients suffering from hepatitis B and C demanded on Friday that the government fix the price of Pegasys injection at Rs5,000, to preclude doctors and pharmacies from exploiting them.

A protest against the artificial price of life saving drugs including Pegasys was held outside the National Press Club on Friday.

The protest was attended by a large number of patients and human rights activists.

They said the actual price of the injection, manufactured by a multinational company, is not more than Rs3,000. However it is being sold in the market at inflated prices of Rs13,000.

They claimed the doctors prescribing the injection were receiving half of the price as kickbacks, while the rest of the money is distributed among importers, health officials, distributors and retailers.

“This is an organised crime against helpless patients who cannot afford four doses per month,” they asserted.

Over 10% of the county’s population is suffering from the deadly disease, which is mostly caused by reusing disposable syringes, transfusion of unscreened blood and use of unsterilised equipment in hospitals and clinics.

Pharmaceutical companies take full advantage of the situation by selling their drugs at exorbitant rates and barring the entry of affordable medicines in the market at the same time, the protesters said.

In addition, these companies have been found to be ignorant towards conducting research to produce cheaper medicines, claimed a protester.

Addressing the procession, Sawera Foundation Patron-in-chief Mian Ahmed said the government has been unable to control the pharmaceutical industries, which have been resisting development of indigenous drugs manufacturing.

He suggested allowing medicines to be imported from India and China would increase competition and hence fair valuation of medicines. “The same injection will cost Rs1,500 if we import it from India,” said Ahmed.

Nineteen-year-old Parveen, a resident of katchi abadi in F-11, said she was diagnosed with hepatitis C during pregnancy last year but could not afford the expensive treatment.

Parveen got the disease when she had her tooth removed from a roadside dentist in Golra Sharif.

“I will continue living with the disease for the rest of my life as I make only Rs3,000 per month,” she added.

Published in The Express Tribune, April 21st, 2012.

Source

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Abstract

Title
Safety OF TELAPREVIR or Boceprevir IN COMBINATION WITH Peginterferon alfa/Ribavirin, in CIRRHOTIC NON RESPONDERS. FIRST RESULTS OF THE FRENCH EARLY ACCESS PROGRAM (ANRS CO20-CUPIC)

Speaker:
Christophe Hezode

Author:
C. Hezode
1*, C. Dorival2, F. Zoulim3, T. Poynard4, P. Mathurin5, S. Pol6, D. Larrey7, P. Cacoub4, V. de Ledinghen8, M. Bourlière9, P.H. Bernard10, G. Riachi11, L. Alric12, D. Samuel13, Y. Barthe2, H. Fontaine6, F. Carrat2, J.-P. Bronowicki14, ANRS CO20 CUPIC study group

Affiliation:
1Hôpital Henri Mondor, Inserm U955, Université Paris-Est, Creteil, 2Hôpital Saint-Antoine, Inserm U707, UPMC-Paris6, Paris, 3Hospices Civils de Lyon, Lyon, 4Hôpital de la Pitié-Salpêtrière, Paris, 5Hôpital Claude Huriez, Lille, 6Hôpital Cochin, Inserm U1016, Université Paris Descartes, Paris, 7Hôpital Saint-Eloi, Montpellier, 8Hôpital Haut-Lévèque, Pessac, 9Fondation Hôpital Saint Joseph, Marseille, 10Hôpital Saint André, Bordeaux, 11Hôpital Charles Nicolle, Rouen, 12Hôpital Purpan, Toulouse, 13Hôpital Paul Brousse, Villejuif, 14Hôpital de Brabois, Nancy, France. *christophe.hezode@hmn.aphp.fr

Phase III trials have shown that Telaprevir (TVR) is associated with frequent dermatological disorders and anemia, whereas Boceprevir (BOC) is associated with frequent anemia. However, few cirrhotic patients were included in these trials. We report the safety profiles of TVR or BOC in combination with peginterferon (PEG-IFN) and ribavirin (RBV) in the French Early Access Program for the use of protease inhibitors (PI).

Methods: Patients with compensated child A cirrhosis, HCV genotype 1 infection and prior relapse or partial response to PEG-IFN/RBV regimen were prospectively included to receive either 12 weeks of TVR, PEG-IFN-alfa2a/RBV and 36 weeks of PEG-IFN-alfa2a/RBV, or 4 weeks of PEG-IFN-2b/RBV and 44 weeks of BOC, PEG-IFN-2b/RBV without randomization which precludes any comparison between the two molecules. Safety analysis is restricted to patients with at least 8 weeks of treatment.

Results: Female-to-male ratio was 0.4 and mean age was 57 years in each group. Safety profiles are summarized in the table.

Conclusions: The safety profile of TVR or BOC with PEG-IFN/RBV in cirrhotic patients was poor and associated with increased SAE rates (30% to 51%) compared to those reported in phase III trials (9% to 14%). These data strongly suggest that triple therapy must be administered cautiously with intensive safety monitoring in these patients.

  TVR n=169 BOC n=138
Median treatment / PI duration (days) 112.0 / 85.0 113.0 / 84.0
Serious adverse events (SAE) / Discontinuation(AE) 87 (51%) / 20 (12%) 41 (30%) / 10 (7%)
Death 3 (2%) 1 (1%)
Anemia Grade 2(8.0-<10.0g/dL) / Grade 3-4(<8.0g/dL) 54 (32%) / 23 (14%) 39 (28%) / 8 (6%)
EPO use / Blood transfusion 94 (56%) / 32 (19%) 71 (51%) / 8 (6%)
Neutropenia Grade3-4(<1000/mm3) / G-CSF use 21 (12%) / 5 (3%) 14 (10%) / 7 (5%)
Thrombopenia Grade 3-4(<50000/mm3) / Thrombopoietin use 37 (22%) / 1 (1%) 10 (7%) / 1 (1%)
Rash Grade 3 / SCAR 11 (7%) / 0 (0%) 1 (1%) / 0 (0%)
Grade 3-4 infection / other AEs 4 (2%) / 90 (53%) 1 (1%) / 44 (32%)
[safety profile]

Source

EASL 2012: Poster Presentations, Slides and Press Releases


 
All links will open into a new window taking you to the NATAP website

  1. EASL: The efficacy and safety of the interferon-free combination of BI 201335 and BI 207127 in genotype 1 HCV patients with cirrhosis: Interim analysis from SOUND-C2 - (04/20/12)

  2. EASL: GS-7977 + PEG/RBV in HCV Genotype 1: The ATOMIC Trial An End To Response-Guided Therapy - (04/20/12)

  3. EASL: GS-7977 Phase 2 Trials: Concordance of SVR4 with SVR12 and SVR24 in HCV Genotypes 1-3 - (04/20/12)

  4. EASL: Peginterferon Lambda-1A (Lambda) Compared With Peginterferon Alfa-2A (Alfa) in Treatment- Naive Patients With HCV Genotypes 2 or 3: First SVR24 Results From EMERGE Phase IIb - (04/20/12)

  5. EASL: Dual Oral Therapy with NS5A Inhibitor Daclatasvir (BMS-790052) and NS3 Protease Inhibitor Asunaprevir (BMS-650032) in HCV Genotype 1b-Infected Null Responders or Patients Ineligible/Intolerant to Peginterferon/Ribavirin - (04/19/12)

  6. EASL: TMC435 with peginterferon and ribavirin in treatment-experienced HCV genotype 1 patients: the ASPIRE study, a randomised Phase IIb trial - (04/19/12)

  7. EASL: TMC435 in patients infected with HCV genotype 1 who have failed previous pegylated interferon / ribavirin treatment: Virologic analyses of the ASPIRE trial - (04/19/12)

  8. EASL: Potent Viral Suppression With the All-Oral Combination of Daclatasvir (NS5A Inhibitor) and GS-7977 (Nucleotide NS5B Inhibitor), +/- Ribavirin, in Treatment-Naive Patients With Chronic HCV GT1, 2, or 3 (100% SVR gt1, 91% gt2) - (04/19/12)

  9. EASL: A 12-Week Interferon-Free Regimen of ABT-450/r, ABT-072, and Ribavirin was Well Tolerated and Achieved Sustained Virologic Response in 91% Treatment-Naïve HCV IL28B-CC Genotype-1-Infected Subjects - (04/19/12)

  10. EASL: All-Oral Combination of Investigational Hepatitis C (HCV) Compounds Daclatasvir and GS-7977 Achieved Sustained Virologic Response (SVR4) in 100% of Genotype 1 and 91% of Genotype 2 and 3 Treatment-Naïve Patients in Phase II Study - press release - (04/19/12)

  11. EASL: Gilead Announces Early Sustained Virologic Response Rates for GS-7977 Plus Ribavirin in Genotype 1 Treatment-Naïve Hepatitis C Patients - press release - (04/19/12)

  12. EASL: Gilead Announces Sustained Virologic Response Data for 12-Week Regimen of GS-7977 Plus Pegylated Interferon and Ribavirin in Genotype 1 Hepatitis C Patients - press release - (04/19/12)

  13. EASL: Gilead Announces Early Sustained Virologic Response Rates for GS-7977 Plus Ribavirin in Genotype 1 Treatment-Naïve Hepatitis C Patients - press release - (04/19/12)

  14. EASL: Viral cure achieved without interferon in up to 82% of hepatitis C patients (GT-1a & -1b*): protease inhibitor BI 201335 and the polymerase inhibitor BI 207127, both with and without ribavirin (Boerhinger Ingelheim) - press release - (04/19/12)

  15. EASL: First ever data investigating interferon-free treatment in hepatitis C patients who have liver cirrhosis shows high viral cure rate: protease inhibitor BI 201335 plus the polymerase inhibitor BI 207127 plus ribavirin (Boerhinger Ingelheim) - (04/19/12)

  16. EASL: Confirmation That Quadruple Therapy With Daclatasvir (NS5A Inhibitor), Asunaprevir (NS3 Inhibitor) and Peginterferon/Ribavirin Results in a High Rate of SVR4 in HCV Genotype 1 Null Responders - (04/19/12)

  17. EASL: Abbott Presents Positive Results from Interferon-Free Phase 2 "Co-Pilot" Study for the Treatment of Hepatitis C - Press Release - (04/19/12)


EASL 2012: Video Chronic Hepatitis C: A Global Public Health Crisis





Published on Apr 20, 2012 by

Chronic hepatitis c is a viral infection of the liver that affects approximately 130 to 1170 million people around the world.

If left untrated, Hcv infection is potentially serious disease that can damage the liver over time and lead cirrhosis, end stage liver disease and liver cancer.

Victrelis -boceprevir is approved for treatment of Hcv genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.


EASL 2012: New data provides hope for HCV non-responders

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Provided by News-Medical.Net

Published on April 20, 2012 at 8:35 AM

New data from a number of clinical trials presented for the first time at the International Liver Congress- 2012 provides hope for previously difficult to treat hepatitis C (HCV) patient populations.

In the first multicentric study of the efficacy and safety of the protease inhibitors (PI) Boceprevir or Telaprevir in patients with severe HCV genotype 1 (GT1) recurrence after liver transplantation, results show that 57% of patients achieve undetectable hepatitis C viral loads 24 weeks after treatment (SVR24) with pegylated Interferon-alfa-2b (PegIFN-α-2b), ribavirin (RBV) and either Boceprevir or Telaprevir. Interactions between immunosuppressants and PIs were easily controlled.

Further new data shows that, in HCV GT1 and HIV co-infected patients, the addition of Boceprevir to PegIFN-α-2b and RBV results in higher rates of undetectable HCV RNA levels compared to treatment with only PegIFN-α-2b and RBV alone. At the end of treatment (week 48), 63.9% of patients receiving Boceprevir, PegIFN-α-2b and RBV had undetectable HCV RNA, compared to 29.4% in the control arm. The study found the safety and tolerability profile of Boceprevir, PegIFN-α-2b and RBV was consistent with that observed in HCV-monoinfected patients.

The combination of these findings provides new hope for various difficult to treat hepatitis C populations. Professor Mark Thursz, EASL's Secretary General commented on the exciting new data: "Patients with HIV co-infection and patients who have been transplanted for HCV infection often have more aggressive disease and have been harder to treat. Worries about drug-drug interactions have caused concern about the use of protease inhibitors in these groups. The new trial data shows that the benefits of direct anti-virals can now be experienced by a wider group of patient populations."

In a study of chronic HCV GT1 patients previously unresponsive to treatment with PegIFN and RBV alone , new data shows TMC435 - an oral, once-daily, investigational HCV NS3/4A protease inhibitor - combined with PegIFN-alfa-2a and RBV achieves significantly higher SVR24 rates compared with placebo. In the hardest to treat group of prior null-responders with cirrhosis, TMC435, PegIFN-alfa-2a and RBV treatment shows 61-80% SVR24 compared to 23% with placebo.

In other exciting data presented at the congress, the authors of a study on PSI-7977, a uridine nucleotide analog, propose that it may signal an end to response guided therapy in HCV GT1 patients. Response-guided therapy is a paradigm for treating chronic HCV infections in which treatment decisions are based on how rapidly HCV responds to treatment. With response-guided therapy, patients who rapidly clear virus from their bloodstream are eligible to receive a shorter duration of therapy, while slower responders receive standard or extended durations of therapy.

In earlier studies, PSI-7977 has been associated with greater than 90% SVR (sustained virological response undetectable HCV RNA level 24 weeks after treatment) in HCV GT1, GT2, or GT3 patients, independent of predictors of poor responsiveness to interferon. In new data presented at the congress, the study authors show HCV GT1, GT4, or GT6 patients treated with PSI-7977 and PEG/RBV achieved 97% RVR (rapid virological response - undetectable HCV RNA level after four weeks of treatment), with no viral breakthrough or relapse observed to date in subjects completing at least 10 weeks of PSI-7977.

Source: European Association for the Study of the Liver

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New Drug Combination Possible For Hepatitis C

from Patricia: I love what Dr. Friedman has to say here about the behavior of Gilead and BMS in light of the excellent trials results released yesterday at the International Liver Conference. He has hit the nail on the head. They are playing with people’s lives here …

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Submitted by Annabel Tautou on Fri, 04/20/2012 - 07:57

It has been recently revealed in a report that there has been a new drug combination made that can effectively treat hepatitis C in the time to come. This has even proved to work well in a small scale trial. This means that in the time to come, it might surely be able to prove its worth as a potential way to treat or at least work towards securing the body, when it comes to the affliction of this disease.

“The only appropriate motivation should be what is the best and fastest way to get cures, not what is best for the shareholders”, revealed Dr. Scott Friedman, chief of liver diseases at the Mount Sinai School of Medicine in New York.

Though it is too early to jump to any conclusions as of now, it might still be a very positive step in the time to come. It might be able to form an effective way to cure the disease and might even prevent it from occurring in the time to come.

There are currently a number of companies trying their best to formulate such medicines that work towards eradicating this disease from the world. There is however need for more efforts to be made by one and all for collectively being able to fight the disease in the time to come, rather than fighting on which company has been able to form the drug.

The cure percentage for the drug has been greatly improved by the introduction of the pills by Vertex Pharmacy firm, which gave out its drug last year. It remains to be seen how the firms trying to develop cures shall be able to find it in the time to come and how cure methods can be made better for the disease.

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Also See:

  1. Have BMS and Gilead found the 'killer app' for hep. C?
  2. Collaboration on Hepatitis Drugs Lags
  3. Gilead, Bristol Put Profits Ahead of Best Care for Hep C Patients

Have BMS and Gilead found the 'killer app' for hep. C?

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Marc Iskowitz

April 19, 2012

Scientists are getting closer to finding the killer app in treating hepatitis C, but it may be too soon to pick a winner.

Bristol-Myers Squibb and Gilead said this morning that an all-oral therapy joining together two drugs the companies are each developing suppressed the virus in more than 95% of patients across a broad spectrum of genotypes.

The drug combo of daclatasvir from BMS and Gilead's GS-7977 reached a 100% sustained virologic response (SVR), or cure rate, at week four in one common subgroup, genotype 1 patients who have not been previously treated with interferon—an injectable associated with flu-like side effects.

The 100% cure rate held even when ribavirin, another traditional mainstay of treatment, was left out of the mix, bettering a roughly 90% SVR rate seen for an Abbott triple therapy in a trial a few weeks ago.

“It obviously doesn't get any better than this,” cheered ISI analyst Mark Schoenebaum in a quick note to investors this morning after BMS and Gilead announced their results. Data from the Phase II combo trial are “best case,” he added, in that only 2% of respondents to an informal survey he fielded earlier this month said they expected the 100% SVR rate.

The findings accelerated momentum in an already fast-moving category, in which drugmakers are swooping up assets to pad HCV pipelines and experimenting with a variety of regimens and combinations. Last November Gilead agreed to pay almost $11 billion for biotech firm Pharmasset's GS-7977, and BMS in January said it was buying Inhibitex for about $2.5 billion and getting access to that firm's potential HCV drug, INX-189.

The direct-acting antivirals (DAAs) from BMS, Gilead and Abbott are showing the best efficacy and tolerability to date.

Not that there haven't been speed bumps along the way. In February, Gilead's ‘7977 had come under assault when data showed that six out of six subjects treated with the pipeline drug, who were prior null responders to other HCV therapy, had experienced a relapse of their disease.

Analysts had predicted that patients who are naïve to therapy would be easier to treat with a non-interferon regimen than null responders, and the Gilead/BMS data furthered this notion. Several analysts now believe daclatasvir, an NS5a inhibitor, and ‘7977, a nucleotide analog (or “Nuc” as the class is called), may form the best treatment “backbone” option across all genotypes.

“It appears that the ‘killer app' in HCV is probably an NS5A plus a nuc without ribavirin,” Schoenebaum declared.

The newer protease inhibitors—Vertex's Incivek and Merck's Victrelis, both launched in 2011—look like they will be vulnerable to the all-oral regimens, but not for a few years.

“These results obviously reinforce the expectation that DAA-only (IFN and RBV-sparing) regimens will likely quickly supplant current HCV treatments when they become available in the 2015/2016 timeframe,” wrote Deutsche Bank's Barbara Ryan in a note today.

In a Thursday dispatch to investors, Credit Suisse's Catherine Arnold said the data also “takes a little shine off” Abbott's HCV program, “but we still view it as a competitive presence.” The triple therapy combines the firm's protease inhibitor ABT-450 + non-nucleoside polymerase inhibitor ABT-333 + ribavirin.

While the Gilead/BMS combination sets the bar high for competitors, scientists are still debating where the best treatment synergy lies, and firms are awaiting more data before finalizing their commercial plans.

The Gilead/BMS combo “represents the most compelling all-oral, interferon-free data in the highly visible [HCV] marketplace,” noted Arnold. “Despite this strong data,” she added, “a partnership is unlikely in the near term as both companies wait for additional data sets related to their HCV assets to fully evaluate their options.”

Ryan cautioned that other factors—side effects, dosing convenience and, of course, cost—“will be important considerations in determining market share. In our opinion, it is premature to conclude who the ultimate winners and losers will be in the ‘new' HCV market on the basis of the data available to date.” Ryan doesn't think any one or two players will dominate the field. Null and non-responders could also be a factor in determining long-term HCV dominance.

Results from a cocktail joining Gilead's ‘7977 and ribavirin also surprised, hitting an SVR rate of 88%—far better than the 50% the Street had expected, according to Schoenebaum. Abbott's all-oral triple combo may be another good backbone option, while daclatasvir so far looks like a solid add-on option—one that has pan-genotype efficacy and excellent tolerability—and BMS is exploring multiple pairing options (including with its own Nuc, INX-189).

Other Nucs in development include Vertex's ALS-2200 and ALS-2158, and biotech firm Idenix's IDX184, which can be combined with its NS5A inhibitor, IDX719.

Source

Also See:

  1. Collaboration on Hepatitis Drugs Lags
  2. Gilead, Bristol Put Profits Ahead of Best Care for Hep C Patients

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PRESS RELEASE

April 20, 2012, 4:00 a.m. EDT

Data presented at the International Liver Disease Meeting demonstrated that the ALFApump System significantly decreases the need for Large Volume Paracentesis and can reduce hospital visits

ZURICH, Apr 20, 2012 (BUSINESS WIRE) -- Sequana Medical announced that initial results from the PIONEER Clinical Study of its ALFApump System were presented today at the 47th annual European Association for Study of the Liver Meeting in Barcelona. The data demonstrated that the ALFApump System is a safe and effective device for management of ascites in patients with advanced cirrhosis. The PIONEER study is a prospective, multi-centre, open label study of patients with refractory ascites due to liver cirrhosis conducted at nine centres in four European countries. Sequana Medical's ALFApump System is the first and only system for the automatic and continual removal of ascites. Refractory ascites affects over 100,000 patients in Europe and the US every year and the number of patients is growing at an annual rate of 10% due to the accelerating incidence of hepatitis and obesity-related liver disease.

Dr. Jose Such, Chief of Hepatology at the Hospital General, University de Alicante, Spain, presented initial data in a session entitled "Description of an Automated Low-Flow Ascites (ALFA) pump system for the treatment of ascites in patients with cirrhosis. Preliminary Report". In addition to safety and efficacy, the data showed that the ALFApump System significantly reduced the median number of paracentesis procedures from 3.4 in the month prior to pump implant to just 0.2 per month and there was a 91% reduction in the volume removed by paracentesis.

Ascites is a common complication among patients with late-stage liver disease and is the leading reason for hospitalization among patients with cirrhosis. Paracentesis, which involves inserting a large-bore needle into the abdomen to drain 5-10 litres of accumulated ascites, is the most common procedure for the treatment of ascites. However, paracentesis has to be repeated frequently, often every 7-10 days, as it doesn't prevent the re-accumulation of ascites. This repeated procedure is burdensome both to the patient and healthcare service provider.

"The ALFApump System was developed to bring significant benefits to both patients and physicians, and has the potential to become the new standard of care for management of refractory ascites", said Dr. Noel L. Johnson, CEO of Sequana Medical. "I am quite pleased that the EASL Board selected the abstract describing the initial data from the ALFApump Pioneer Study for oral presentation at this year's International Liver Congress."

The ALFApump System consists of a subcutaneously implanted battery-powered pump connected to a catheter placed in the abdominal cavity which automatically and continually collects ascites and moves it to the bladder, where it is eliminated from the patient through normal urination.

"I am delighted to have had the opportunity to present these promising results from the Pioneer Study at the EASL congress", stated Dr. Jose Such. "The ALFApump System is proving to be a safe and efficacious device that will improve the lives of thousands of patients with refractory ascites by freeing them from the burden of repeat visits to the hospital for paracentesis."

The ALFApump System was granted CE Mark in 2011 and is currently being introduced into leading hepatology centres across Europe.

About Sequana Medical:

Founded in 2006, Sequana Medical AG is a Swiss medical device company backed by NeoMed Management, VI Partners, Biomed Invest, Capricorn Health Tech and Entrepreneur's Fund, dedicated to improving patient lives through innovative technologies to manage fluid overload in patients suffering from liver disease, cancer and congestive heart failure.

SOURCE: Sequana Medical

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