Hepatology News and Research

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Hepatology is the branch of medicine that incorporates study of liver, gallbladder, biliary tree and pancreas as well as management of their disorders.

Vertex submits NDA for telaprevir for treating hepatitis C

Vertex Pharmaceuticals Incorporated announced that it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for telaprevir, Vertex's investigational treatment for people with hepatitis C.

23 Nov 2010

Lower VAT on alcohol served in pubs may deliver health benefits

Alcoholic drinks served in pubs should be taxed at a lower level than drinks bought from shops, says an expert in this week's BMJ.

20 Nov 2010

Vertex to enroll additional treatment arm in telaprevir/VX-222 Phase 2 clinical trial for HCV

Vertex Pharmaceuticals Incorporated today announced plans to enroll an additional treatment arm as part of its ongoing Phase 2 clinical trial evaluating 12-week regimens of Vertex's lead investigational hepatitis C virus (HCV) protease inhibitor, telaprevir, in combination with its lead investigational HCV polymerase inhibitor, VX-222.

10 Nov 2010

Hyperion HPN-100 phase III pivotal study for urea cycle disorders meets primary endpoint

Hyperion Therapeutics, Inc. today announced that the Company's phase III pivotal study of glycerol phenylbutyrate (HPN-100), an investigational drug for the treatment of urea cycle disorders (UCDs), met its primary endpoint. The non-inferiority study, conducted under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA) in June 2009, evaluated the ammonia control of glycerol phenylbutyrate as compared to sodium phenylbutyrate (BUPHENYL®).

3 Nov 2010

Combining telaprevir regimen with standard therapy improves SVR rate in hepatitis C

For patients with the most common form of hepatitis C being treated for the first time, the addition of an investigational hepatitis C-specific protease inhibitor called telaprevir to the current standard therapy markedly improved their sustained viral response (SVR or viral cure) rate.

3 Nov 2010

ADVANCE Phase 3 study confirms clinical benefits of telaprevir regimen in patients with HCV infection

The Phase 3 results from the ADVANCE study confirm the clinical benefits of telaprevir-based combination therapy regimens. The study reports an improvement in treatment discontinuation rates due to adverse events compared to Phase 2 studies, and demonstrates an increase in sustained viral response (SVR) in patients with hepatitis C virus (HCV). The primary endpoint for this study was SVR 24 weeks after last treatment.

2 Nov 2010

Boceprevir combinational therapy improves SVR rate in patients with HCV genotype 1

The final results of the RESPOND-2 trial demonstrated that combination therapy with Boceprevir yields higher sustained virologic response (SVR) rates for patients with hepatitis C virus (HCV) genotype 1 who did not respond to or relapsed after treatment with peginterferon alpha 2b and Ribavirin.

2 Nov 2010

Telbivudine prevents HBV transmission from mothers to newborns: Study

Researchers studied the treatment of pregnant women with hepatitis B virus (HBV) with Telbivudine in their second to third trimesters. The study concluded that both the mothers benefited from treatment and no transmission of HBV to newborns was detected at 28 weeks postbirth.

1 Nov 2010

Vertex reports superior SVR rates with telaprevir-based combination therapy in Phase 3 studies for hepatitis C

Vertex Pharmaceuticals Incorporated today announced new data from its Phase 3 studies of people with genotype 1 chronic hepatitis C who have not been treated previously. In these studies, the majority of people achieved superior sustained viral response (SVR or viral cure) rates with a telaprevir-based combination regimen, compared to current therapies, regardless of race/ethnicity or stage of liver fibrosis (factors known to limit response to current hepatitis C treatments).

1 Nov 2010

Medivir's partner Tibotec reports Week 24 interim results from TMC435 Phase 2b study in HCV

Medivir AB, the research-based speciality pharmaceutical company focused on the development of high-value treatments for infectious diseases, notes that its development partner, Tibotec Pharmaceuticals, has announced the results of a Week-24 planned interim analysis of the Phase 2 response-guided PILLAR study for TMC435, Medivir's key pipeline asset, a hepatitis C protease inhibitor dosed once-daily.

1 Nov 2010

Intentional foreign body ingestion results in over $2 million hospital costs: Study

A new study from Rhode Island Hospital found that 33 individuals were responsible for 305 cases of medical intervention to remove foreign bodies that were intentionally swallowed, resulting in more than $2 million in estimated hospital costs. The findings appear in the November issue of Clinical Gastroenterology and Hepatology.

1 Nov 2010

Study determines long-term clinical outcome of patients posttransplant after anitviral therapy

Researchers from the University of Bari, Italy, concluded that treating patients after transplantation with antiviral therapy creates a sustained viral response (SVR) and protects them from liver-related deaths. The purpose of this study was to determine the long-term clinical outcomes of patients posttransplant who underwent antiviral therapy for recurrent hepatitis C virus (HCV) infection of the liver graft.

1 Nov 2010

Tibotec to present Week-24 interim analysis of PILLAR study for chronic HCV treatment at AASLD Meeting

Tibotec Pharmaceuticals announced today the company will present the results of a Week-24 planned interim analysis of the phase 2 response-guided PILLAR study in treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, MA., USA. The data will be presented as part of a late-breaker oral presentation on Monday, November 1.

1 Nov 2010

Researchers generate bioengineered human liver organoid using bioscaffold

Researchers at Wake Forest University Baptist Medical Center's Institute for Regenerative Medicine demonstrated the generation of a bioengineered human liver organoid using a liver bioscaffold made from an intact liver extracellular matrix, and filled (seeded) with primary human liver progenitor and endothelial cells.

1 Nov 2010

Vertex initiates OPTIMIZE Phase 3b study in patients infected with genotype 1 HCV

Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 3b study called OPTIMIZE that will evaluate twice-daily (BID) dosing of a telaprevir-based combination regimen in people chronically infected with genotype 1 hepatitis C virus (HCV) who have not been treated previously. This is the first Phase 3 study to evaluate twice-daily dosing of a protease inhibitor for the treatment of hepatitis C. OPTIMIZE will not include a control arm of pegylated-interferon and ribavirin alone.

26 Oct 2010

Boston Scientific's Advanix Biliary Plastic Stents receive FDA 510(k) clearance and CE Mark approval

Boston Scientific Corporation today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration and CE Mark approval to market its Advanix™ Biliary Plastic Stents for the treatment of biliary strictures, including biliary stone disease, benign biliary strictures, and suspected and confirmed malignancies in the biliary system. The product is now available in Europe and other international markets; the Company plans to launch it in the U.S. this quarter.

21 Oct 2010

Study finds adipose dysfunction linked to steatosis, necroinflammation in G1 CHC patients

Researchers at the University of Palermo in Italy provide the evidence that a higher visceral adiposity index score-a new index of adipose dysfunction-has a direct correlation with viral load and is independently associated with both steatosis and necroinflammatory activity in patients with genotype 1 chronic hepatitis C (G1 CHC).

20 Oct 2010

Protein hormone inhibits leptin-induced migration of liver cancer cells

A research team from Emory University School of Medicine investigated the role between adiponectin and leptin in obesity-related carcinogenesis. Their findings, published in the November issue of Hepatology, suggest that the protein hormone adiponectin has potential for inhibiting the oncogenic actions of leptin, namely in hepatocellular carcinoma (HCC), and could offer a promising therapy for the disease.

19 Oct 2010

An overview on American College of Gastroenterology's Annual Scientific meeting

The association between obesity and gastrointestinal-related cancers and coronary artery disease; the link between an overweight or obese body mass index and the severity of Crohn's disease; and whether inflammatory bowel disease is an independent risk factor for coronary artery disease, were among the highlights of new research that was presented this week at the American College of Gastroenterology's (ACG) 75th Annual Scientific meeting in San Antonio.

19 Oct 2010

Researchers report breakthrough studies in liver cell transplantation

Two research teams from the Okayama University Graduate School of Medicine (Okayama, Japan) have reported breakthrough studies in liver cell transplantation.

19 Oct 2010

Hepatology News and Research

Further Reading

Vertex submits NDA for telaprevir for treating hepatitis C

Lower VAT on alcohol served in pubs may deliver health benefits

Vertex to enroll additional treatment arm in telaprevir/VX-222 Phase 2 clinical trial for HCV

Hyperion HPN-100 phase III pivotal study for urea cycle disorders meets primary endpoint

Combining telaprevir regimen with standard therapy improves SVR rate in hepatitis C

ADVANCE Phase 3 study confirms clinical benefits of telaprevir regimen in patients with HCV infection

Boceprevir combinational therapy improves SVR rate in patients with HCV genotype 1

Telbivudine prevents HBV transmission from mothers to newborns: Study

Vertex reports superior SVR rates with telaprevir-based combination therapy in Phase 3 studies for hepatitis C

Medivir's partner Tibotec reports Week 24 interim results from TMC435 Phase 2b study in HCV

Intentional foreign body ingestion results in over $2 million hospital costs: Study

Study determines long-term clinical outcome of patients posttransplant after anitviral therapy

Tibotec to present Week-24 interim analysis of PILLAR study for chronic HCV treatment at AASLD Meeting

Researchers generate bioengineered human liver organoid using bioscaffold

Vertex initiates OPTIMIZE Phase 3b study in patients infected with genotype 1 HCV

Boston Scientific's Advanix Biliary Plastic Stents receive FDA 510(k) clearance and CE Mark approval

Study finds adipose dysfunction linked to steatosis, necroinflammation in G1 CHC patients

Protein hormone inhibits leptin-induced migration of liver cancer cells

An overview on American College of Gastroenterology's Annual Scientific meeting

Researchers report breakthrough studies in liver cell transplantation

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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