Tuesday, June 28, 2011

Hepatitis C News;Vertex and Merck

From HIV and Hepatitis

Telaprevir Improves Hepatitis C Treatment Response

HCV Drug TMC649128 Enters Phase 1b Trial

Entecavir Effective for Hepatitis B Patients with Liver Cancer

Vertex Tops Merck in Early Hep C Drug Launch‎
US regulators approved Incivek and Victrelis in May just 10 days apart, which means Vertex and Merck began marketing the competing hepatitis C drugs
So far, Vertex is beating Merck, which means the marketing battle between Incivek and Victrelis is playing out largely as expected.
For the week ended June 17 (the most current data available), doctors wrote 460 prescriptions for Vertex's Incivek compared to 160 prescriptions written for Merck's Victrelis, according ..continue reading..

New Vertex ads focus on disease, not treatment
An aging rocker, guitar in hand, peers from a poster mounted inside MBTA buses. “I survived disco,’’ the text reads. “I can fight hepatitis C.’’

On the radio, a reassuring voice says: “Hepatitis C is a serious disease, but it can be cured. You can fight it. Now there’s a program to help you get ready.’’

The poster and radio spots appear to be public service messages about a liver-destroying virus few are aware of. But if you look or listen carefully, you’ll notice the name of the sponsor — Cambridge biotechnology company Vertex Pharmaceuticals Inc., which recently won federal approval to sell a new hepatitis C drug.

Its pill, being sold under the brand name Incivek (pronounced inn-see-veck), is expected to quickly become the biggest selling drug from a Massachusetts company in nearly a decade, with annual sales projected to hit $2 billion within three years. But rather than drum up consumer interest in the product itself, Vertex is conducting a so-called unbranded campaign that doesn’t mention Incivek. The idea, company officials say, is to let more people know about hepatitis C.

Educating the public about the disease also is a priority for pharmaceutical giant Merck & Co., which is selling a hepatitis C drug to compete with Vertex’s and has enlisted legendary rocker Gregg Allman for a similar awareness campaign.

The two companies are promoting information about the illness over their brand-name medicines — at least for now — because many of the 3.2 million Americans believed to carry the virus don’t realize they are infected, according to numbers from the Centers for Disease Control and Prevention in Atlanta.

“Three quarters of the people don’t know they have the disease, and most of the people who know don’t get treated,’’ said Pamela Stephenson, Vertex’s vice president for marketing excellence.

“People out there are searching for information. They can be scared. They can be alone,’’ Stephenson said. “At the core of what we’re trying to do is to find people who have hepatitis C and help them lead a better life.’’

Untreated, hepatitis C can eventually cause cancer or liver scarring, and about 10,000 people die from the disease every year in the United States. Many of those at risk are baby boomers who contracted the virus through intravenous drug use or blood transfusions in the 1960s or 1970s, before the blood supply was safeguarded, and have lived for decades without symptoms.

Incivek is the first drug the 22-year-old Vertex brought to market and sold on its own. While the pill is positioned to become a major success for the company — which last week broke ground for a massive corporate headquarters on the South Boston Waterfront — it will compete with a Merck’s drug, which won Food and Drug Administration approval 10 days before Incivek last month.Continued reading...

New organisation launched to help prevent hepatitis
A new voluntary organisation has been launched to help improve the prevention of the highly-infectious hepatitis B and C viruses.

An estimated 50,000 people in Scotland carry the hepatitis C strain, which can lead to serious illness and even death if untreated.
But it is thought up to 60% of those with hepatitis remain undiagnosed.
The numbers being diagnosed with the viruses are at record levels, with 1,000 new cases identified in 2010.
The new organisation, Hepatitis Scotland, has been established with £200,000 of funding from the Scottish government.
Hepatitis Scotland estimated 1% of the country's population is infected with hepatitis C - double the rate in England.
It said hepatitis C was a major challenge, with many of those infected not realising they had the virus - even though the majority went on to develop chronic symptoms.
Continue reading the main story

Hepatitis statistics
50,000 Scots infected
Up to 60% undiagnosed
1,000 new cases last year
No vaccine for hepatitis C
The viruses are transmitted through blood-to-blood and sexual contact, as well as through the sharing of contaminated needles in drug injecting or unregulated tattooing and body-piercing.

Hepatitis causes inflammation of the liver and can lead to serious illness and death if left untreated.
A vaccine is available for the less common B strain, which affects about 9,000 Scots, but not for hepatitis C.
Hepatitis Scotland aims to increase the number of people diagnosed with both strains of the virus and improve the treatment available.
It will also offer support to patients and their families while they are being treated.
'Gruelling' treatment
David Liddell, director of the Scottish Drugs Forum, which will manage the new organisation, said people needed easy access to a wide range of support.
"In particular, undergoing treatment for Hepatitis C can be gruelling, so patients may need help for social needs arising while they are being treated," he said.
"Hepatitis Scotland will assist the voluntary sector to play a key role in providing this wider support. The aim is to ensure that people who are at risk from, or living with, viral hepatitis get the help they need."
The establishment of Hepatitis Scotland is part of the government's strategy on sexual health and blood borne virus disease.
Public Health Minister Michael Matheson said: "We have led the world in our response to viral hepatitis.
"The new funding awarded to Scottish Drugs Forum for the delivery of Hepatitis Scotland is a key part of our continued commitment to delivering best quality, joined-up treatment and prevention services for those suffering from or at risk of viral hepatitis."

Gene variant increases fatty liver risk and fibrosis progression
PNPLA3 offers potential therapeutic target in chronic hepatitis C liver damage

New research confirms that a variant on the patatin-like phospholipase-3 (PNPLA3) gene increases risk of steatosis and fibrosis progression in patients with chronic hepatitis C virus (HCV). The PNPLA3 single nucleotide polymorphism (SNP) rs 738409 may represent an important genetic predictor and potential therapeutic target in chronic HCV liver damage. Study details are published in the July issue of Hepatology, a peer-reviewed journal of the American Association for the Study of Liver Diseases.

According to a report by the World Health Organization (WHO) roughly 170,000 million individuals worldwide are infected with chronic HCV—a leading cause of liver disease and liver transplantation. Research shows that only 20% of HCV patients develop cirrhosis, but fibrosis progression remains highly unpredictable. A recent study identified a genetic variant in the PNPLA3 gene (rs738409 C>G) associated with fatty liver (steatosis) and was also found to influence fibrosis severity in non-alcoholic fatty liver disease.

The present study led by Christophe Moreno, MD, PhD, from Erasme Hospital and the Université Libre de Bruxelles in Belgium examined the impact of the rs738409 polymorphism and other variants in the PNPLA3 gene on liver damage and response to antiviral therapy in chronic HCV. Researchers recruited 527 Caucasian patients with chronic HCV from centers in Belgium (n=229), Germany (n=171), and France (n=137). More than half of the participants were male with a mean age ranging from 47 to 52 years.

"Our findings show that the PNPLA3 SNP rs738409 favors steatosis and fibrosis progression in chronic HCV," confirmed Dr. Moreno. After adjusting for age, gender, body mass index, alcohol consumption and diabetes, the team determined that carriers of two copies of the rs738409 mutant G allele (i.e. GG homozygotes) remained at higher risk for developing fatty liver, fibrosis, and fibrosis progression, with an odds ratio of 2.55, 3.13 and 2.64, respectively.

Further analysis determined that the SNP rs738409 was not associated with antiviral treatment failure and did not influence clinical or biological variables such as stage of fibrosis, alanine aminotransferase (ALT), viral load, or type 2 diabetes. "This SNP represents a valuable genetic predictor of liver damage," concluded Dr. Moreno. "Further studies are needed to confirm our results and evaluate the PNPLA3 gene variant as a potential therapeutic target in chronic HCV."


This study is published in Hepatology. Media wishing to receive a PDF of the article may contact healthnews@wiley.com .

Full Citation:

"Impact of Patatin-like Phospholipase-3 (rs738409 C>G) Polymorphism on Fibrosis Progression and Steatosis in Chronic Hepatitis C." Eric Trépo, Pierre Pradat, Andrej Potthoff, Yukihide Momozawa, Eric Quertinmont, Thierry Gustot, Arnaud Lemmers, Pascale Berthillon, Leila Amininejad, Michèle Chevallier, Jerome Schlué, Hans Kreipe, Jacques Devière, Michael Manns, Christian Trépo, John Sninsky, Heiner Wedemeyer, Denis Franchimont and Christophe Moreno. Hepatology; Published Online: June 24, 2011 (DOI: 10.1002/hep.24350); Print Issue Date: July 2011. http://onlinelibrary.wiley.com/doi/10.1002/hep.24350/abstract .

About the Journal
Hepatology is the premier publication in the field of liver disease, publishing original, peer-reviewed articles concerning all aspects of liver structure, function and disease. Each month, the distinguished Editorial Board monitors and selects only the best articles on subjects such as immunology, chronic hepatitis, viral hepatitis, cirrhosis, genetic and metabolic liver diseases and their complications, liver cancer, and drug metabolism. Hepatology is published on behalf of the American Association for the Study of Liver Diseases (AASLD). For more information, please visit http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1527-3350   .

About Wiley-Blackwell
Wiley-Blackwell is the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world's leading societies. Wiley-Blackwell publishes nearly 1,500 peer-reviewed journals and 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit www.wileyblackwell.com or our new online platform, Wiley Online Library (wileyonlinelibrary.com), one of the world's most extensive multidisciplinary collections of online resources, covering life, health, social and physical sciences, and humanities.

Active hepatitis C infection and HCV genotypes prevalent among the IDUs of Khyber Pakhtunkhwa
Injection drug users (IDUs) are considered as a high risk group to develop hepatitis C due to needle sharing. In this study we have examined 200 injection drug users from various regions of the Khyber Pakhtunkhwa province for the prevalence of active HCV infection and HCV genotypes by Immunochromatographic assays, RT-PCR and Type-specific PCR.

Our results indicated that 24% of the IDUs were actively infected with HCV while anti HCV was detected among 31.5% cases. Prevalent HCV genotypes were HCV 2a, 3a, 4 and 1a.

Majority of the IDUs were married and had attained primary or middle school education. 95% of the IDUs had a previous history of needle sharing.

Our study indicates that the rate of active HCV infection among the IDUs is higher with comparatively more prevalence of the rarely found HCV types in KPK. The predominant mode of HCV transmission turned out to be needle sharing among the IDUs.

Author: Latif RehmanIhsan UllahIjaz AliImtiaz KhanAqib IqbalSanaullah KhanSher KhanKhaleeq ZamanNajib KhanZahoor SwatiAnila Jahangiri

Credits/Source: Virology Journal 2011, 8:327

Tibotec Pharmaceuticals Announces Agreement With Gilead Sciences to Develop and Commercialize a New Fixed-Dose Combination of PREZISTA® and Cobicistat

By Tibotec Pharmaceuticals
Published: Tuesday, Jun. 28, 2011 - 5:37 am

CORK, Ireland, June 28, 2011 -- /PRNewswire/ -- Tibotec Pharmaceuticals today announced that it has entered into a license agreement with Gilead Sciences, Inc., for the development and commercialization of a new once-daily single tablet fixed-dose antiretroviral combination product containing Tibotec's protease inhibitor PREZISTA® (darunavir) and Gilead's cobicistat, an investigational pharmacoenhancing or "boosting" agent.
PREZISTA, co-administered with ritonavir (PREZISTA/ritonavir), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection. In the United States of America, once daily dosing of PREZISTA is indicated for treatment-naive adult patients and treatment-experienced adult patients with no darunavir resistance associated substitutions. In the European Union, once daily dosing of PREZISTA is recommended for treatment-naive adult patients and may be used in treatment-experienced adult patients with no darunavir resistance associated substitutions and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count greater than or equal to 100 cells x 10(6)/l...continue reading..

Off The Cuff

Doctors Turn Away Insured Patients on Low Payments, Study Finds
U.S. doctors are turning away an increasing number of patients, including those with private insurance, according to a study in the Archives of Internal Medicine.

Physicians were willing to accept about 88 percent of patients who had private insurance in 2008, down from 93 percent in 2005, the study released today found. Patients in Medicare, the U.S. health insurance program for the elderly and disabled, also had a harder time finding a doctor. About 93 percent were accepted by physicians in 2008, down from 96 percent in 2005... continue reading...

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