Wednesday, July 13, 2011

Hepatitis News;Telaprevir, boceprevir, cytochrome P450 and immunosuppressive agents - A potentially lethal cocktail

Video From Medscape
Telaprevir for Hepatitis C: Moving Toward a Cure

From NATAP

Executive Director: Jules Levin
Telaprevir, boceprevir, cytochrome P450 and immunosuppressive agents - A potentially lethal cocktail (see article below editorial) - Editorial
"Finally, telaprevir has not been studied in pre-, post-, or peritransplant patients. The degree of the interaction with calcineurin inhibitors reported here suggests potential implications for patient safety. Telaprevir should not be administered to these patients, because the required studies have not been completed to understand appropriate dose adjustments needed for safe coadministration of telaprevir with cyclosporine or tacrolimus, and regulatory approval has not been obtained."......

Racial differences in hepatitis C treatment eligibility
"the findings that nearly 25% of patients presenting to medical centers for treatment of hepatitis C were ineligible for PEG-IFN/RBV and that black Americans were 65% more likely than nonblack Americans to be ineligible for therapy have important public health implications, particularly in the context of the Institute of Medicine report on viral hepatitis and liver cancer in the U.S.......

Risk factors for infection in chronic hepatitis C: A high prevalence of sexual exposure among human immunodeficiency virus-coinfected women
We considered the risk factor for HCV infection to be sexual exposure (SEXEXP) only in patients who fulfilled the following criteria: (1) a negative history for intravenous drug use (IDU), inhalatory drug use (INHDU), or blood transfusions (BTs) before 1994 and (b) a sexual partner who was recognized to be anti-HCV-positive.....

Check Out The New HIV and Hepatitis
Our new design enables us to offer multimedia content and faster news reports and conference coverage.

We have already started featuring work by new writers, and we will soon offer video content as well as text.

Our mission remains the same as it was when Ronald Baker founded HIVandHepatitis.com in 1999: to produce high-quality, accurate, and timely online information about treatment, management, and prevention of HIV infection, chronic hepatitis B and C, HIV/HBV and HIV/HCV coinfection, and related infectious diseases.

Earlier this year, after more than a decade, Ron decided to retire from his work with HIVandHepatitis.com. The role of editor-in-chief and publisher was assumed by Liz Highleyman, senior writer for the site since 2006. Liz got involved with AIDS activism in ACT UP/Boston in the late 1980s and has been a freelance medical writer focusing on HIV and hepatitis for more than 10 years.

HIV treatment has advanced remarkably since the 1990s. Today, in addition to following experimental drugs in development, much of our HIV/AIDS content focuses on management of associated conditions such as cardiovascular disease and other age-related issues -- as well as the renewed search for a cure.
With the approval last month of the first direct-acting drugs for hepatitis C, treatment for that disease, too, is undergoing a revolutionary shift. HIVandHepatitis.com will continue to bring you news of the latest developments in that area, as well as treatment for hepatitis B and HIV/hepatitis coinfections.
Please bear with us, as the new website is a work in progress. Over the next several months we will be adding more legacy content from the original site. If you are seeking specific older content, such as prior year conference coverage, you can still reach the old site at http://hivandhepatitis.com/legacysite.

We hope you enjoy the new HIVandHepatitis.com and find it useful. Send us email, visit our Facebook page, follow our Twitter feed, and watch our YouTube channel using the icons in the top menu bar on each page. Don't hesitate to send us feedback and suggestions for improvements!

A Trio of New Hepatitis C Drugs Being Tested
Hoping to simplify and improve Hepatitis C treatment, Achillion is testing several proprietary compounds - including the recent start of a Phase 1 trial to assess ACH-2684.

Achillion Pharmaceuticals Inc. (ACHN) Begins Dosing for Hepatitis C Treatment, Prepares for Clinical Milestones

By QualityStocks July 12, 2011
Achillion Pharmaceuticals Inc., focused on developing treatments for infectious disease, today announced it has begun dosing in a phase 1 clinical trial of ACH-2684 for the treatment of chronic hepatitis C virus (HCV) infection.

The study is a randomized, double-blind, placebo-controlled trial designed to determine the safety, tolerability, pharmacokinetic profile and antiviral activity of ACH-2684, and will include up to 78 healthy volunteers and up to 40 HCV-infected patients.

"This first-in-human clinical trial will be instrumental in establishing the safety profile of ACH-2684 in humans," Elizabeth A. Olek, D.O., vice president and chief medical officer of Achillion stated in the press release. "It will also provide Achillion with important preliminary efficacy data against HCV genotypes 1 and 3, and help us to select doses for subsequent clinical development."

Continue reading this entire article:
http://hken.ibtimes.com/articles/177911/20110712/achillion-pharmaceuticals-inc-achn-begins-dosing-for-hepatitistreatment-prepares-for-clinical-milest.htm

Pharmaceutical

J&J's success with Hep C partners might hit a snag
Johnson & Johnson ($JNJ) is one of the best in the business at tapping outside developers for new drugs, but the Big Pharma's success on this front in the hepatitis C arena appears have brought with it some controversy.

Even though its Hep C drug is still in late-stage development, Swedish biotech Medivir isn't comfortable with the fact that its partner J&J is promoting Vertex Pharmaceuticals' ($VRTX) hot drug against the liver disease, Incivek, Medivir CEO Ron Long told Bloomberg. And Long wants J&J to resolve the potential conflicts of having one company promote two different drugs for the same disease to the same doctors.
Read more


Dear J&J, This Is How You Tick Off Your Partner
In some circles, when a big pharma works with two different companies simultaneously to develop and sell a drug to combat the same disease, the strategy might be called hedging your bets. After all, what if one drug fails? But what if you happen to run one of those smaller companies and your big pharma partner is about to launch the same type of drug with that other company? What do you do?
Well, Ron Long has an answer. He tells the big pharma, which in this case is Johnson & Johnson, to be prepared to make a choice. Long, you see, is chief executive of Medivir, which is working on a hepatitis C tablet called TMC435 and he is concerned that J&J is about to help Vertex Pharmaceuticals market its new Incivek med, which was approved by the FDA two months ago.
Read More...


FDA proposes targeted drug testing guidelines
Reuters) - Targeted drugs or therapies up for regulatory approval would have to be reviewed simultaneously with the diagnostic devices they rely on, according to a proposed policy issued on Tuesday.

So-called targeted treatments or personalized medicines are tailored to a person's genetic makeup and are being increasingly developed by drug companies.
The Food and Drug Administration proposed rules saying these personalized treatments would gain approval only after their accompanying diagnostic devices also receive approval -- unless the treatment is for a serious or life-threatening condition.

Diagnostic tests, known as companion diagnostics, improve the effectiveness of targeted treatments by determining if a patient is a genetic fit with a therapy. They can help doctors identify which patients are most likely to benefit from a new drug, or experience debilitating side effects, and help save enormous cost by eliminating people who would not be helped.
Pfizer's experimental drug crizotinib, for example, is designed to target a specific genetic mutation prevalent in nonsmokers with non-small cell lung cancer. Crizotinib, which is being reviewed on a priority basis by U.S. regulators, has a companion test developed by Abbott Laboratories, which partnered with Pfizer about two years ago.

The FDA's proposed rules outlined only two exceptions when a new targeted drug or therapy could receive approval without FDA also approving its companion diagnostic.
One is for new treatments of serious or life-threatening conditions that have no other satisfactory treatments and only if the new treatment shows "pronounced" benefits that outweigh the risks. The second is for labeling changes to already-approved therapies to address safety concerns.
The FDA is now seeking public comment on the proposal.

Healthy You

OMEGA-3 REDUCES ANXIETY AND INFLAMMATION IN HEALTHY STUDENTS
COLUMBUS, Ohio –
A new study gauging the impact of consuming more fish oil showed a marked reduction both in inflammation and, surprisingly, in anxiety among a cohort of healthy young people.
The findings suggest that if young participants can get such improvements from specific dietary supplements, then the elderly and people at high risk for certain diseases might benefit even more.

The findings by a team of researchers at Ohio State University were just published in the journal Brain, Behavior and Immunity. It is the latest from more than three decades of research into links between psychological stress and immunity.
Read More.....

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