Monday, December 20, 2010

Morning Hepatitis C News Dec 20th

Triple-Drug Cocktail in the Works for Hepatitis C Therapy
Drugs that are specific to hepatitis C will soon go from trial to clinic, giving more patients hope, but a vaccine is still elusive

People infected with hepatitis C virus (HCV) face a long road of drug treatment that, in the best cases, can cure their infections and allow their livers to recover from HCV-associated liver disease, whose symptoms range from scarring and cancer to organ failure. Unfortunately, for nearly half of those treated for the most common strain of HCV, the standard antiviral drugs do not succeed in clearing the virus. And, even in cases where the drug regime is effective, flulike symptoms, depression and anemia are common side effects during the 48-week treatment period.

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Hepatitis C:Phase 1 Clinical Trial of IMO-2125 in Treatment-Naïve Genotype 1 HCV Patients

Idera Pharmaceuticals Announces Preliminary Data from Phase 1 Clinical Trial of IMO-2125 in Treatment-Naïve Genotype 1 HCV Patients
-Outlines Phase 2 Clinical Development Plan-
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) announced today preliminary data from a 4-week dose-ranging Phase 1 clinical trial of IMO-2125 in combination with ribavirin in 60 treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) infection. In the trial, treatment with IMO-2125 in combination with ribavirin was well tolerated and achieved substantial decline in virus levels at two days after the first dose of IMO-2125 and after four weeks of treatment. IMO-2125 is a Toll-like Receptor 9 (TLR9) agonist which stimulates production of natural interferons and other antiviral cytokines.“In this study, IMO-2125 plus ribavirin was well tolerated with no treatment-related discontinuations, and demonstrated substantial antiviral activity”

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Pharmacodynamics of PEG-IFN alpha-2a and HCV response as a function of IL28B polymorphism in HIV/HCV co-infected patients

Pharmacodynamic analysis showed that genotype-CC conferred increased sensitivity to PEG-IFN, as shown by a lower PEG-IFN-α-2a EC50. These kinetic findings raise the possibility that the IL28B CC-genotype favorably affects viral response by augmenting IFN-λ mediated activation of the IFN signaling cascade, leading to increased effectiveness in blocking virion production/release. Notably, as we approach a new era of combination therapy with PEG-IFN and direct antiviral agents, a better understanding of factors associated with PEG-IFN-related viral kinetics will provide the basis to develop optimal treatment strategies for HCV28, 29. Larger and more detailed studies are needed to confirm these new observations in HIV/HCV co-infected patients."

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Maintenance Peginterferon Therapy and Other Factors Associated with Hepatocellular Carcinoma in Patients with Advanced Hepatitis C

"The Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial.......Analysis of the HALT-C Trial results after 3.5 years of treatment revealed that peginterferon did not reduce the overall risk of liver disease progression.4 A subsequent report focusing on HCC development also showed no difference between the treated and control groups during and immediately after the period of maintenance peginterferon therapy.5 We continued to follow the HALT-C Trial cohort off therapy for a total of up to 8.7 years to monitor for the development of decompensated liver disease and HCC. During the extended follow-up period, the number of patients with HCC increased progressively......

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Early Menopause is Associated with Lack of Response to Antiviral Therapy in Women with Chronic Hepatitis C: "This suggests that CHC in women should be treated early, disregarding the fact that liver disease is milder in women of reproductive age, as this condition will last only as long as the estrogen-exposed period." -

"In this prospective study of 1000 consecutive patients with CHC, we found that menopause is independently associated with the severity of liver damage and with a remarkably lower likelihood of achieving SVR (46% vs 67%)......Recent studies suggest that post-menopausal women have accelerated progression of fibrosis,6,7 which is prevented by long-term estrogen exposure from HRT.7 In this large cohort of female HCV patients, we confirmed that liver inflammation and higher levels of GGT (a known surrogate marker of metabolic alterations and of TNF-α up-regulation)21, are independently associated with severe fibrosis. We also identified the length of estrogen deprivation as a strong independent risk factor for fibrosis: the longer the menopausal period, the higher the risk of severe fibrosis. It was 5-fold higher in women who had been menopausal for more than 10 years in comparison with early menopausal women.....

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Janssen Seeks European Marketing Authorization For Investigational Hepatitis C Treatment Telaprevir
20 December 2010Janssen-Cilag International NV announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for telaprevir, an investigational, oral, direct-acting antiviral for the...
Genetic Variation Links Alcoholics And Liver Cirrhosis In Caucasians
20 December 2010A new study by German researchers found that a variation in the PNPLA3 (adiponutrin) gene was associated with cirrhosis of the liver and elevated transaminase (liver enzyme) levels in alcoholic Caucasians...

Gilead to Buy Arresto Biosciences for $225 Million

Dec. 20 (Bloomberg) -- Gilead Sciences Inc., the world’s biggest maker of AIDS drugs, agreed to buy closely held Arresto Biosciences Inc. for $225 million, gaining experimental medicines for cancer and a fatal lung disease.
The cash deal is expected to close in the first three months of next year, Foster City, California-based Gilead said today in a statement. The transaction includes potential payments based on sales targets, the companies said.

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Bristol-Myers Squibb Company (BMY) and Oncolys BioPharma

Enter Global Licensing Agreement for Investigational HIV Compound Worth $286 Million 12/20/2010NEW YORK & TOKYO--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE:BMY - News) and Oncolys BioPharma Inc., a privately held biotechnology company based in Japan, announced today that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire exclusive worldwide rights to manufacture, develop and commercialize festinavir, a once-a-day, orally available nucleoside reverse transcriptase inhibitor (NRTI) in Phase II development for HIV.

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Is chronic hepatitis B being undertreated in the United States?

Summary Chronic infection with the hepatitis B virus (HBV) is a major risk factor for development of end-stage liver disease, including cirrhosis, liver failure and primary liver cancer. There are now seven antiviral agents approved by the United States Food and Drug Administration (FDA) for the management of chronic HBV infection. Despite the fact that there are between 1.4 and 2 million chronic HBV infections in the United States, fewer than 50 000 people per year receive prescriptions for HBV antiviral medications. This report discusses possible explanations for the disparity between the number of people who are chronically infected and the number of people who receive treatment. Explanations for this incongruence include the potentially large number of infected persons who are unscreened and thus remain undiagnosed, and lack of access, including insurance, education and referral to appropriate medical care, particularly for disproportionately infected populations

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Hepatitis an often-hidden, chronic disease
Unfortunately, most people who contract hepatitis C infection develop chronic infection. For many, the chronic infection is mild, yet for some it can lead to serious complications including the development of cirrhosis and liver failure over time. The progression of the illness from infection to symptomatic liver disease may occur over many years. The risk of progression is accelerated when sufferers of chronic hepatitis C infection have other co-existing causes of liver injury, with alcohol use being most notable.
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Just In On The New Website: Dec 20th
Is IL28B Testing A Threat To Telaprevir Or To Patients ?
Hey, I have a question about this IL28B gene and hepatitis c treatment.....

The brave ones
Outpouring uncovers others fighting their epidemic

By Meg Heckman / Monitor staff
December 20, 2010
Despite what many of you have told me recently, I am not brave. Last week, the Monitor published a series of stories I wrote about living with hepatitis C, or HCV, a common but little-known virus that damages the liver and can lead to serious health problems, including cancer. You read about how I was infected through a blood transfusion at birth, about the stigma often associated with the disease and about my unsuccessful attempt last year to cure myself through a clinical trial.
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Health Overhaul Roundup: Analyzing The Individual Mandate, Watching The Politics Around Reform
December 20th, 2010 by admin
While last week's biggest news focused on the court action surrounding the health law, some reports now analyze the controversial provision at the heart of these cases and what the future could look like if it did or did not survive. But reform news also translates into political news, as PolitiFact pinpoints its "Lie of the Year" and the Atlanta Journal Constitution reports on how federal reforms could influence the state's gubernatorial election.
Principles of Medical EthicsBy George Lundberg, MD, Editor-at-Large,
MedPage Today December 20, 2010

Johnson & Johnson Announces Executive Appointments: Alex Gorsky, Vice Chairman, Executive Committee Sheri McCoy, Vice Chairman, Executive Committee

FDA Approves Prezista®/Ritonavir Once-Daily Dosing for HIV-1 Treatment-Experienced Adults With No Darunavir Resistance-Associated Mutations

A Cure For Diabetes: Medicine's Next Big Thing? In-Depth Doctor's Interview
Donald Jump M.D, from the Oregon State University talks about new discoveries in the world of diabetes.
The diet-based diabetes that these animals are dealing with, have you suppressed a certain enzyme and then re-instituted that enzyme into their bodies?
Dr. Jump: Yes, that is basically the idea. Diabetes suppresses the expression of this enzyme and, in doing so, it causes a decline in liver content of the products of this enzyme. That also shows up in the blood. So, in humans with diabetes and obesity they have low levels of long chain 20 and 22 carbon polyunsaturated fatty acids in their blood. The way we get those 20 and 22 carbon polyunsaturated fatty acids is by taking the essential fatty acids from the diet. The liver then converts them to these long chain guys by the process of elongation and desaturation. We repair that by adding this virus and it corrects the diabetes.
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Examine Your Mouth
While swelling of gums and prolonged pain may be an indication of leukemia, several sexually transmitted diseases could cause lesions on the tongue. Oral inspection may not yield conclusive diagnosis of deadly diseases, but in a country like ours, where blood tests may not be possible on a large population, it serves as an efficient screening process. "The mouth has largely been ignored while doing diagnostic tests for various diseases. Mouth can tell a lot about diseases of several organs," said Dr Carl Allen, professor of oral and maxillofacial pathology at the Ohio State University. "Misdiagnosis of many infectious diseases could be avoided by just examining the oral cavity of the patient. Early signs of cancer are usually found in the mouth. Early diagnosis can prevent it from spreading. There are times when the patient has an oral condition for a long time but come to an oral pathologist very late by which time the cancer is beyond control," said Dr Allen, adding that oral manifestations precede symptoms in other parts of the body. Continue reading...

Drug use patters changing: VIHA report
The findings indicate that while the need for clean needles still exists, the heightened use of crack pipes shows that mouth pieces and other hygienic paraphernalia are crucial to help reduce the risk of communicable diseases such as hepatitis C, Medical Health Officer Murray Fyfe said.
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