Hepatitis News:

February 2007

Heavy Drinking Takes Excessive Toll on Women with Hepatitis C
"Women tend to survive longer than men if infected with the liver-destroying hepatitis C virus (HCV) - but if they drink heavily, that survival advantage completely disappears, according to a new study. Previous studies indicated that alcohol use is a risk factor for HCV disease progression, but they seldom examined the effect on women and men separately," said lead author Chiung Chen. "Even fewer studies were able to examine the effect of alcohol on HCV mortality. Our study provides empirical evidence to fill the gap." Chen is a research analyst at CSR Incorporated, which conducted the study under contract with the National Institute on Alcohol Abuse and Alcoholism."

AstraZeneca Acquires Arrow Therapeutics To Broaden Anti-Infective Capabilities
"AstraZeneca today announced an agreement to acquire Arrow Therapeutics Ltd., a privately owned UK biotechnology company, focused on the discovery and development of anti-viral therapies. The total share capital of Arrow Therapeutics will be purchased for US$150m cash, subject to debt and working capital adjustment."

The American Liver Foundation Warns of an Increase in U.S. Liver Cancer Deaths
"Deaths from liver cancer increased over the past year in both men and women, reported the American Liver Foundation, a national nonprofit organization that provides education, advocacy and research on behalf of the 30 million Americans affected by liver disease. This is despite recent news focusing on the overall decline in the number of deaths due to most cancers."

Copegus Approved in Japan as Combination Therapy With Pegasys for Patients With Chronic Hepatitis C
"Roche and Chugai announced today that the combination of Copegus (ribavirin) plus Pegasys (peginterferon alfa-2a (40KD)) has been approved in Japan following fast track review by the Japanese regulatory agency (MHLW). This is good news for Japanese hepatitis C patients, who now have access to the world's gold standard treatment for the disease."

Patent Issued for Compounds With Potential to Treat BVDV and HCV
"Immtech Pharmaceuticals, Inc. announced today that The United States Patent and Trademark Office ("USPTO") has issued a patent to Immtech's Scientific Consortium related to a compound that may be useful for treating bovine viral diarrhea virus and the hepatitis C virus. The patent, entitled "Compounds, methods and compositions useful for the treatment of bovine viral diarrhea virus (BVDV) infection and hepatitis C virus (HCV) infection," was issued on January 16, 2007."

China Probes Product Over Hepatitis C Fears
"China's food and drug officials are investigating a company suspected of using illegally procured blood stocks to make immunoglobulin and other drugs, infecting patients with hepatitis C. Guangdong Bioyee Pharmaceutical "acted illegally in the production of immunoglobulin and some products had caused hepatitis C infections in patients," the State Food and Drug Administration said in a statement posted on its website. The case is the latest in a series of reports of substandard, bogus or tainted pharmaceuticals that have prompted calls for stricter enforcement of safety standards."

Antipodean Pharmaceuticals Initiates Phase 2 Trial in Hepatitis C : Potential Additional Treatment Strategy to Reduce Liver Damage in Chronic Patients
"Antipodean Pharmaceuticals, Inc. today announced it has initiated a Phase 2 clinical trial of its lead compound MitoQ (mitoquinone) to investigate the drug's efficacy to reduce liver damage in patients with raised liver enzymes associated with the Hepatitis C virus (HCV). The principal investigator for the trial, Dr. Edward Gane, Associate Professor of Medicine, New Zealand Liver Transplant Unit at Auckland City Hospital, enrolled the first patient.

"Although new antiviral agents are in development, therapies are needed to reduce liver injury in patients with chronic hepatitis and to reduce inflammation and fibrosis," said Dr. Gane."

ZymoGenetics Begins Clinical Trial for PEG-Interferon lambda as Potential Treatment for Viral Infection
"ZymoGenetics, Inc.today announced that the company has initiated a Phase 1 safety and pharmacokinetic study of PEG-Interferon lambda (IL-29) in healthy volunteers. The Phase 1 study is part of a clinical development program

designed to evaluate PEG-Interferon lambda as a potential treatment for patients with hepatitis C and other viral diseases."

OctoPlus Initiates Hepatitis C Study - Biopharmaceutical firm OctoPlus has reported the commencement of a phase IIa study with Locteron, its controlled release formulation of alfa interferon for the treatment of hepatitis C.
"OctoPlus believes that Locteron has the potential to induce fewer side effects, improve patient compliance and provide a more convenient once every two weeks dosing schedule compared with current therapies. Locteron combines OctoPlus' PolyActive drug delivery technology with BLX-883, a recombinant alfa interferon produced by OctoPlus' co-development partner Biolex Therapeutics. Results from the phase I study showed that Locteron is both safe and successful in producing a gradual release over two weeks of alfa interferon after a single injection."

Arrow Therapeutics Selects a Further Hepatitis C Clinical Candidate
"Arrow Therapeutics, the London based antiviral drug discovery and development company, has announced that a further Hepatitis C compound, A-689, has entered full preclinical development. A-689 is the second compound from Arrow's broad approach to the NS5a target to enter development. November 2006 saw Arrow's first Hepatitis C compound, A-831, enter Phase I trials. Both compounds target the novel NS5a protein but have completely different chemical structures and bind to the target at different sites."

Presidio Pharmaceuticals Receives Exclusive License to Novel Hepatitis C Technology
"Presidio Pharmaceuticals, Inc. announced today that it has licensed the exclusive worldwide rights to novel hepatitis C virus (HCV) technology from Stanford University. This technology, invented in the lab of Stanford scientist Jeffrey Glenn, targets a specific region found in the HCV proteins NS4B and NS5A, viral proteins that are absolutely required for virus replication. Disrupting the normal function of these two proteins provides for a new method of HCV treatment and should combat the emergence of drug resistance to new HCV polymerase and protease inhibitors that will be on the market in the near future."

Nabi Biopharmaceuticals Announces Initiation of Civacir Phase II 'Proof-of- Concept' Clinical Trial

"Nabi Biopharmaceuticals announced today that it has initiated its Phase II "proof-of-concept" clinical trial for Civacir(R) [Hepatitis C Immune Globulin (Human)]. Civacir, the company's plasma-derived, polyclonal antibody product candidate, when approved, would be the first therapy for the prevention of the recurrence of hepatitis C-related liver disease in hepatitis C virus (HCV) positive liver transplant recipients, or in patients who received an HCV-positive liver. Currently, there are no marketed therapies specifically indicated for prevention of re-infection post-liver transplant in HCV-positive patients."

Roche Diagnostics Submits Hepatitis C Viral Load Monitoring Test To FDA
"Roche Diagnostics announced today that it has submitted its automated test for Hepatitis C viral load monitoring to the U.S. Food & Drug Administration (FDA) for review. The FDA will review the application to determine whether the test can be marketed for diagnostic use in the United States."

Kennewick Man Shares Life Experience
"Years of drug and alcohol abuse combined with homemade tattoos made one Kennewick man very ill.

38-year-old Philip Swanson was diagnosed with liver disease and hepatitis C three years ago. Doctors told him that he would not live more than a year and a half. Swanson changed his diet and lifestyle and today he is still alive."

Relapse of HCV Common in HIV/HCV Coinfected Patients after Liver Transplant
"Every HIV/hepatitis C-coinfected patient who survived liver transplant at a hospital in Barcelona experienced a recurrence of hepatitis C, and only one patient had a virological response to the subsequent use of anti-hepatitis C therapy, according to a study published in Antiviral Therapy. The authors note, however, that all the surviving patients were engaged in their normal daily activities two years after liver transplantation and that anti-HIV therapy was safely and effectively reintroduced within weeks."

OraSure Sees Trials of Oral Hepatitis C Test Ending This Year
"OraSure Technologies Inc.'s chief executive said Thursday he expects clinical trials of a rapid oral test for the detection of hepatitis C to be completed by the end of this year. Once the trials of the test - being jointly developed by OraSure and Schering-Plough Corp. - are completed, the company will apply for marketing approval in the United States and in Europe soon thereafter, CEO Douglas Michels said in an interview."

Incidence of Steatosis in Hepatitis Patients Traced to Race
"White hepatitis C patients are more likely to have a complication known as steatosis than black patients, says a new study. Hepatic steatosis, or fat in the liver, is a condition common among people with the hepatitis C virus. It indicates more advanced disease. In a study published in the January issue of Hepatology, researchers, led by Hari Conjeevaram of the Division of Gastroenterology at the University of Michigan at Ann Arbor, set out to investigate racial differences in steatosis in people with the hepatitis C virus, genotype I."

clinical trials, cohort studies, and pilot studies

Impact of reducing peginterferon alfa-2a and ribavirin dose during retreatment in patients with chronic hepatitis C. Shiffman ML, et al. Gastroenterology. 2007 Jan;132(1):103-12. Epub 2006 Nov 11.

Retinal circulatory changes associated with interferon-induced retinopathy in patients with hepatitis C. Nagaoka T, et al. . Invest Ophthalmol Vis Sci. 2007 Jan;48(1):368-75

Impact of ribavirin dose reductions in hepatitis C virus genotype 1 patients completing peginterferon alfa-2a/ribavirin treatment. Reddy KR, et al. Clin Gastroenterol Hepatol. 2007 Jan;5(1):124-9. Epub 2006 Dec 28.

Liver stiffness measurement versus clinicians' prediction or both for the assessment of liver fibrosis in patients with chronic hepatitis C. Nahon P, et al. Am J Gastroenterol. 2006 Dec;101(12):2744-51.

Induction doses of interferon-alpha-2a in combination with ribavirin and/or amantadine for the treatment of chronic hepatitis C in non-responders to interferon monotherapy: a randomized trial. Salmeron J, et al.

J Viral Hepat. 2007 Feb;14(2):89-95.

The emerging importance of chronic hepatitis C infection in Asian Americans. Cheng JT, Hsien C, Sun HE, Tong MJ. Am J Gastroenterol. 2006 Dec;101(12):2737-43.

Hepatic Steatosis in Genotype 4 Chronic Hepatitis C Is Mainly Because of Metabolic Factors. Tsochatzis E, et al. Am J Gastroenterol. 2007 Jan 11; [Epub ahead of print]

High predictive value of early viral kinetics in retreatment with peginterferon and ribavirin of chronic hepatitis C patients non-responders to standard combination therapy. Moucari R, et al. J Hepatol. 2006 Nov 27; [Epub ahead of print]

Comparative study on the clinical and virological characteristics among patients with single occult hepatitis B virus (HBV), single occult hepatitis C virus (HCV) and occult HBV and HCV dual infection. Castillo I, et al. J Med Virol. 2007 Mar;79(3):236-41.

Alcohol and hepatitis C mortality among males and females in the United States: a life table analysis. Chen CM, et al. Alcohol Clin Exp Res. 2007 Feb;31(2):285-92.

Response to pegylated interferon alpha-2b and ribavirin in children with chronic hepatitis C.

Baker RD, Dee D, Baker SS. J Clin Gastroenterol. 2007 Jan;41(1):111-4.

Outcomes and treatment of acute hepatitis C virus infection in a United States population. Corey KE, et al. Clin Gastroenterol Hepatol. 2006 Oct;4(10):1278-82. Epub 2006 Aug 22

basic and applied science, pre-clinical studies

Clearance of HCV Improves Insulin Resistance, Beta-Cell Function, and Hepatic Expression of Insulin Receptor Substrate 1 and 2. Kawaguchi T, et al. Am J Gastroenterol. 2007 Jan 11; [Epub ahead of print]

A cell-based, high-throughput screen for small molecule regulators of hepatitis C virus replication. Kim SS, et al. Gastroenterology. 2007 Jan;132(1):311-20. Epub 2006 Oct 21.

Development of hepatitis C virus vaccine using hepatitis B core antigen as immuno-carrier.

Chen JY, Li F. World J Gastroenterol. 2006 Dec 28;12(48):7774-8.

Effective induction of type 1 cytotoxic T cell responses in mice with DNA vaccine encoding two hepatitis C virus cytotoxic T lymphocyte epitopes. Shi L, et al. Viral Immunol. 2006 Winter;19(4):702-11.

Detection of auto-antibodies against cytochrome P4502E1 (CYP2E1) in chronic hepatitis C. Vidali M, et al. J Hepatol. 2006 Dec 6; [Epub ahead of print]

The Nonstructural 5A Protein of Hepatitis C Virus Genotype 1b Does Not Contain an Interferon Sensitivity-Determining Region. Brillet R, et al. J Infect Dis. 2007 Feb 1;195(3):432-41. Epub 2006 Dec 18.

hiv/hcv co-infection

Factors associated with seronegative chronic hepatitis C virus infection in HIV infection. Chamie G, et al. Clin Infect Dis. 2007 Feb 15;44(4):577-83. Epub 2007 Jan 10.

The impact of cirrhosis on CD4+ T cell counts in HIV-seronegative patients. McGovern BH, et al. Clin Infect Dis. 2007 Feb 1;44(3):431-7. Epub 2006 Dec 21.

Reasons for discontinuation of nevirapine-containing HAART: results from an unselected population of a large clinical cohort. Maggiolo F, et al. J Antimicrob Chemother. 2007 Jan 25; [Epub ahead of print]

The association between hepatitis C infection and prevalent cardiovascular disease among HIV-infected individuals. Freiberg MS, et al. AIDS. 2007 Jan 11;21(2):193-7.

Survival of persons with and without HIV infection in Denmark, 1995-2005. Lohse N, et al. Ann Intern Med. 2007 Jan 16;146(2):87-95.

Impact of human immunodeficiency virus infection in patients infected with the hepatitis C virus.

Valle Tovo C, et al. Liver Int. 2007 Feb;27(1):40-6.

Estimating the future health burden of chronic hepatitis C and human immunodeficiency virus infections in the United States. Deuffic-Burban S, et al. J Viral Hepat. 2007 Feb;14(2):107-15.

complimentary and alternative therapies

Natural products and chronic hepatitis C virus. Azzam HS, et al. Liver Int. 2007 Feb;27(1):17-25.

Suppression of human immunodeficiency virus type 1 viral load with selenium supplementation: a randomized controlled trial. Hurwitz BE, et al. Arch Intern Med. 2007 Jan 22;167(2):148-54.

BCAA-enriched snack improves nutritional state of cirrhosis. Nakaya Y, et al. Nutrition. 2007 Feb;23(2):113-20.

miscellaneous

Hepatitis C Treatment Candidacy and Outcomes Among 4318 US Veterans With Chronic Hepatitis C Virus Infection: Does a History of Injection Drug Use Matter? Seal KH, et al. J Clin Gastroenterol. 2007 Feb;41(2):199-205.

The Cost-Effectiveness of Two Strategies for Vaccinating U.S. Veterans with Hepatitis C Virus Infection against Hepatitis A and Hepatitis B Viruses. Jakiche R, et al. Am J Med Sci. 2007 Jan;333(1):26-34..

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