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Hepatitis News:

November 2007


IN THE NEWS


Innogenetics Concludes Settlement and Licensing Agreement in the Field of Hepatitis C Diagnostics
“ Innogenetics announced today an agreement with Novartis on major licensing terms in the field of Hepatitis C Virus (HCV) diagnostics. According to the license agreement, Novartis grants Innogenetics a license to its Hepatitis C patent rights in the field of HCV immunodiagnostics in certain territories. In parallel, a settlement agreement was reached thereby terminating the ongoing patent litigation between the parties. The agreements maintain Innogenetics commercial rights in those territories where it has a business interest.”

Westbrook Warm to Needle Exchange: A program based in Portland [Maine] wants to expand to Westbrook, where many of its clients live. “Needle exchanges have been criticized by people who believe such programs condone and even increase drug use. Operators of a needle-exchange program in Portland are looking to open a satellite operation in Westbrook. While the program for injection drug users is operated by Portland's Public Health Division, it is a regional resource funded by state money and foundation grants. A survey of clients revealed that many live in Westbrook, though the exact number was not available on Tuesday.”

Scientists Discover Better Treatment for Hepatitis C
“Biologists at the University of California San Diego have announced the discovery of a completely new mechanism that mammalian cells use in their fight against Hepatitis C virus infections, which can lead to cirrhosis of the liver or liver cancer. This is a widespread problem, affecting about 2.7 million Americans and 170 million world wide. They believe that this discovery could be the answer to improving the current antiviral treatments or could even lead to new treatments that will be more effective and have fewer side effects.”

ACG: Gene Expression Predicts Sustained Response in Chronic Hepatitis C
“A panel of gene expression biomarkers can identify patients with chronic hepatitis C genotype 1 who are likely to achieve sustained virologic response to interferon-based therapy, results of a study reported here suggest. Action Points Explain to interested patients that genetic testing might help identify patients with the most common type of hepatitis C infection who are likely to respond to treatment.”

Initial Results of Phase II Study with HCV Protease Inhibitor Boceprevir in Treatment-Naive Hepatitis C Patients Show a High Rate of Early Virologic Response
“ Schering-Plough Corporation today provided an update on the clinical development program for boceprevir, its investigational oral hepatitis C protease inhibitor. Initial results from an ongoing Phase II study in treatment-naive (previously untreated) hepatitis C patients showed boceprevir (800 mg TID) in combination with PEGINTRON(TM) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) achieved a high rate of early virologic response, with up to 79 percent of patients having undetectable virus (HCV-RNA) at week 12 of boceprevir treatment compared to 34 percent of patients receiving PEGINTRON and REBETOL alone.”

Discovery of New Antiviral Mechanism in Mammals May Improve Treatment of Hepatitis C Infections
“A team of researchers led by biologists at the University of California, San Diego has discovered a completely new mechanism that mammalian cells employ to fight infections of the Hepatitis C virus, which affects approximately 2.7 million Americans and 170 million people worldwide. The achievement, detailed in a paper published in the October 18 issue of the journal Nature, could improve current antiviral regimens or result in new treatments that are more effective and possess fewer detrimental side effects for those with the Hepatitis C virus infection, which frequently leads to liver cirrhosis and/or liver cancer.”

[United Kingdom] ACTION is Being Taken to Combat the Rising Number of Hepatitis C Infections in Herefordshire
“Herefordshire Community Safety and Drugs Partnership is raising awareness across the county and encouraging people to find out if they have contracted the virus.The organisation joined the Drugs Advisory Service Herefordshire (DASH) on Monday and set up a stand in High Town to give information and advice to the public as part of a countywide campaign which also provides information to all Herefordshire GPs, pharmacies and community centres.”

Cubist Gets Option to Acquire Illumigen
“In what could become a lucrative deal for some local biotech investors, Cubist Pharmaceuticals bought an exclusive option to acquire Illumigen Biosciences, a Seattle firm working on a product to treat hepatitis C infections. Cubist will pay $4.7 million for the option and $1 million to help further the therapy's development. If the pharmaceutical, based in Lexington, Mass., decides to buy closely held Illumigen, it will pay shareholders $9 million and up to $75.5 million in milestone payments related to the progress of the hepatitis treatment.”

Hepatitis C: A Challenge to Physicians The disease is often asymptomatic, there's no vaccine and it kills 8,000 to 10,000 people a year
“ A disease that afflicts as many as 4 million Americans is the most common cause of chronic liver disease, but it produces no symptoms in about 80 percent of its victims. People who have liver failure associated with hepatitis C account for about half of the liver transplants performed every year in the United States, Dr. Aijaz Ahmed said during a presentation Tuesday at the Smullin Center at Rogue Valley Medical Center. The disease also kills 8,000 to 10,000 Americans annually.”

Japan Probes Failure to Notify Patients at Risk of Hepatitis C from Tainted Blood
“The Japanese government is investigating why more than 400 people exposed to hepatitis C-tainted blood products at least 5 years ago were never informed, officials said Tuesday.Drug maker Mitsubishi Pharma Corp. provided the Health Ministry with documents in 2002 on 418 patients exposed to the virus due to use of its tainted blood products, said Kumiko Saika, spokeswoman for the company, which earlier this year became Mitsubishi Tanabe Pharma Corp.”

Hepatitis C Testing Recommended For Anyone With A Tattoo
“The connection between tattoos and hepatitis C virus (HCV) has long been suspected but never completely substantiated. Tattoos and the connection to the disease were clouded by a perceived propensity to other risk factors, such as injection drug use. “Other studies did not exclude patients with other risk factors for hepatitis C,” explains principal investigator Dr. Edmund Bini, “which made it difficult to assess the association between HCV and tattoos. The strength of that association surprised us.””

[Australia] Hep C Infection After Test Missed
“A patient has contracted Hepatitis C from an organ transplant after a test that would have detected the disease was not performed until after the operation. The nucleic acid test (NAT) was not done before the transplant because it was not available after hours. Had the test been done before the operation, the patient would not have had the transplant and would not have contracted Hepatitis C, a spokeswoman for NSW Health has admitted.”

The Basics: The Asterisk on Cancer Deaths
“There was good news about cancer last week, a report that death rates in the United States have begun falling by 2.1 percent a year, nearly twice the rate of previous declines. But the same report, by the American Cancer Society and other groups, also said certain cancers seem to be becoming more common - not hugely so, but noticeable. Among those increasing in men and women are myeloma and cancers of the thyroid and kidney. In women, melanoma and cancers of the bladder have increased; in men so have cancers of the liver and esophagus.”

Watchdog Blood Database Set Up
“A database has been established to gather information on an ongoing basis from patients who are infected by hepatitis C through blood or blood products in Ireland. A database has been established to gather information on an ongoing basis from patients who are infected by hepatitis C through blood or blood products in Ireland.”

[EU] Experts Caution Against Hidden Hepatitis C Spread
“The Eurasian Harm Reduction Network (EHRN; formerly the Central and Eastern European Harm Reduction Network - CEEHRN) has warned of a hidden hepatitis C epidemic. Only between 10% and 40% of European hepatitis C virus (HCV) carriers know about their infection, according to an EHRN report published on 1 October, World Hepatitis Awareness Day (WHAD).”

[Tasmania] Tassie Turns Blind Eye to Hep C
“A national poll shows Tasmanians are dangerously ignorant about hepatitis C, says the Tasmanian Council on AIDS, Hepatitis and Related Diseases. TasCAHRD said the State Government continued to bury its head in the sand, with no funding for an agreed program on the virus. “The results of this poll demonstrate a disturbing lack of hepatitis awareness in our community,” said TasCAHRD chief executive officer Kevin Marriott. “More than 3400 Tasmanians have been exposed to the virus yet we continue to be ignorant about simple things like how the virus is transmitted, how it affects the body and treatment options.””

Vertex Hep C Drug Shows Real Promise, Limitations
“A closely watched hepatitis C drug being developed by Vertex Pharmaceuticals Inc continues to promise improvement over current treatments, according to analysts who have viewed brief summaries of data from highly anticipated clinical trials. The summaries, known as abstracts, of data to be presented in full next month at the American Association for the Study of Liver Diseases annual meeting also suggest some limitations and side effects from the drug, telaprevir, analysts said. “The incremental information provided by Vertex and the (study's) investigators continues to suggest that telaprevir will deliver a sustained virological response (SVR) of 70 percent, or thereabouts, in real world efficacy,” Geoff Porges, an analyst with Sanford Bernstein, wrote in a research note.”

New Therapeutic Vaccine May Offer Hope for Chronic Hepatitis C Patients
“According to a press release, everything is ready and set to test a new vaccine that may offer hope for people who suffer from Hepatitis C and have relapsed after standard treatment. Standard treatment consists of treatment with Ribavirin and Pegylated-Interferon Alpha for about six months. Some patients may fail at this standard treatment and may have a relapse in the disease. Additionally, and according to the press release, standard treatment is effective in 50% of the patients completing therapy, is lengthy and often poorly tolerated.”

Hepatitis C Testing in Nottingham Marks World Hepatitis Awareness Day
“For the first time in the UK today, members of the public will be able to drop in and get a test for hepatitis C in a local branch of Boots. The project, a unique collaboration between Nottingham University Hospitals NHS Trust, Boots and national patient charity the Hepatitis C Trust, was instigated by the late Dame Anita Roddick, who campaigned to raise awareness of hepatitis C.”

Safe Syringes Could Avert 1.3 million Deaths a Year: WHO
“Safer syringes could avert 1.3 million deaths a year, especially in poorer countries where 40 percent of all injections involve unsterilized reused needles, the World Health Organisation (WHO) said on Tuesday. In a statement, the U.N. agency linked 33 percent of new hepatitis B infections and 2 million new cases of hepatitis C each year to unsafe injections and needle-stick injuries by health workers.”


CLINICAL TRIALS, COHORT STUDIES, AND PILOT STUDIES


Interferon-induced prolonged biochemical response reduces hepatocarcinogenesis in hepatitis C virus infection. Arase Y, et al. J Med Virol. 2007 Oct;79(10):1485-90.

Adverse effects during the treatment with pegylated interferon and ribavirin in children with chronic hepatitis C. Kowala-Piaskowska A, et al. Pharmacoepidemiol Drug Saf. 2007 Oct;16(10):1095-103.

Efficacy of interferon alpha-2b induction therapy before retreatment for chronic hepatitis C. Carr C, et al. Liver Int. 2007 Oct;27(8):1111-8.

Steatohepatitis is associated with diabetes and fibrosis in genotype 1b HCV-related chronic liver disease. Masarone M, et al. J Viral Hepat. 2007 Oct;14(10):714-20.

Early virologic response after peginterferon alpha-2a plus ribavirin or peginterferon alpha-2b plus ribavirin treatment in patients with chronic hepatitis C. Di Bisceglie AM, et al. J Viral Hepat. 2007 Oct;14(10):721-9.

Hepatic steatosis as a possible risk factor for the development of hepatocellular carcinoma after eradication of hepatitis C virus with antiviral therapy in patients with chronic hepatitis C. Tanaka A, et al. World J Gastroenterol. 2007 Oct 21;13(39):5180-7.

Clinical trial: comparison of weekly once versus twice half-dose weekly administration of pegylated interferon alpha 2b in combination with ribavirin for the treatment of HCV-1 positive patients with chronic hepatitis C. Sebastiani G, et al. Aliment Pharmacol Ther. 2007 Oct 1;26(7):1077-82.

Prevalence of hepatic iron overload and association with hepatocellular cancer in end-stage liver disease: results from the National Hemochromatosis Transplant Registry. Ko C, Siddaiah N, et al. Liver Int. 2007 Oct 10; [Epub ahead of print]

Response of combination therapy on viral load and disease severity in chronic hepatitis C. Kumar D, et al. Dig Dis Sci. 2007 Oct 13; [Epub ahead of print]

Hepatitis C virus and risk of non-Hodgkin lymphoma in British Columbia, Canada. Spinelli JJ, et al. Int J Cancer. 2007 Oct 12; [Epub ahead of print]

Hepatitis C virus infection in Italian patients with fibromyalgia. Palazzi C, et al. Clin Rheumatol. 2007 Oct 18; [Epub ahead of print]

31P MR spectroscopy in assessment of response to antiviral therapy for hepatitis C virus-related liver disease. Lim AK, et al. AJR Am J Roentgenol. 2007 Oct;189(4):819-23.

Predicting efficacy and safety outcomes in patients with hepatitis C virus genotype 1 and persistently 'normal' alanine aminotransferase levels treated with peginterferon alpha-2a (40KD) plus ribavirin. Snoeck E, et al. Liver Int. 2007 Oct 26; [Epub ahead of print]

Detection of HCV by PCR in serum and PBMC of patients with hepatitis C after treatment. Cavalheiro Nde P, Filgueiras et al. Braz J Infect Dis. 2007 Oct;11(5):471-4

UK prospective study of change in visual function in patients treated with Peginterferon alpha for hepatitis C. Malik NN, et al. Br J Ophthalmol. 2007 Oct 25; [Epub ahead of print]

Association of chronic hepatitis C with major depressive disorders: irrespective of interferon-alpha therapy. Carta MG, et al. Clin Pract Epidemol Ment Health. 2007 Oct 23;3(1):22 [Epub ahead of print]

Pegylated interferon alpha-2b plus ribavirin in patients with genotype 4 chronic hepatitis C: The role of rapid and early virologic response. Kamal SM, et al. Hepatology. 2007 Oct 17; [Epub ahead of print]

Long-term phlebotomy with low-iron diet therapy lowers risk of development of hepatocellular carcinoma from chronic hepatitis C. Kato J, et al. J Gastroenterol. 2007 Oct;42(10):830-6. Epub 2007 Oct 15.

Liver cancer and hepatitis B and C in New South Wales, 1990-2002: a linkage study. Amin J, et al. Aust N Z J Public Health. 2007 Oct;31(5):475-82.

Phase 1B, randomized, double-blind, dose-escalation trial of CPG 10101 in patients with chronic hepatitis C virus. McHutchison JG, et al. Hepatology. 2007 Oct 10;46(5):1341-1349 [Epub ahead of print]

Clinical trial: pharmacodynamics and pharmacokinetics of re-treatment with fixed-dose induction of peginterferon alpha-2a in hepatitis C virus genotype 1 true non-responder patients. Diago M, et al. Aliment Pharmacol Ther. 2007 Oct 15;26(8):1131-8.

Effects of a 24-week course of interferon-alpha therapy after curative treatment of hepatitis C virus-associated hepatocellular carcinoma. Jeong SC, et al. World J Gastroenterol. 2007 Oct 28;13(40):5343-50.

Accordion Index: A new tool for the prediction of the efficacy of peg-interferon-alpha-2b and ribavirin combination therapy for chronic hepatitis C. Satoh T, Masumoto A. Hepatol Res. 2007 Oct 10; [Epub ahead of print]

The impact of hepatitis C virus infection on survival in dialysis patients: meta-analysis of observational studies. Fabrizi F, et al. J Viral Hepat. 2007 Oct;14(10):697-703.


BASIC AND APPLIED SCIENCE, PRE-CLINICAL STUDIES


Relationship of peripheral blood CD4-positive T cells to carcinogenesis in patients with HCV-related chronic hepatitis and liver cirrhosis. Matsui T, et al. Cancer Chemother Pharmacol. 2007 Oct 12; [Epub ahead of print]

Life style-related diseases of the digestive system: cell culture system for the screening of anti-hepatitis C virus (HCV) reagents: suppression of HCV replication by statins and synergistic action with interferon. Ikeda M, Kato N. J Pharmacol Sci. 2007 Oct;105(2):145-50. Epub 2007 Oct 6.

HCV-specific T-cell response in relation to viral kinetics and treatment outcome (DITTO-HCV project). Pilli M, et al. Gastroenterology. 2007 Oct;133(4):1132-43. Epub 2007 Jul 3.

Vaccination Against Hepatitis C Virus With Dendritic Cells Transduced With an Adenovirus Encoding NS3 Protein. Zabaleta A, et al. Mol Ther. 2007 Oct 9; [Epub ahead of print]

Interactive effects of immunoglobulin gamma and human leucocyte antigen genotypes on clearance and persistence of infection with hepatitis C virus. Pandey JP, et al. Clin Exp Immunol. 2007 Oct 9; [Epub ahead of print]

Innate immunity in hepatitis C virus infection: Interplay among dendritic cells, natural killer cells and natural killer T cells. Kanto T, Hayashi N. Hepatol Res. 2007 Oct;37 Suppl 3:S319-26.

Hepatitis C virus NS3/4A protein interacts with ATM, impairs DNA repair and enhances sensitivity to ionizing radiation. Lai CK, Virology. 2007 Oct 9; [Epub ahead of print]

Comparative Studies on Expression of alpha-Smooth Muscle Actin in Hepatic Stellate Cells in Chronic Hepatitis B and C. Chu CM, et al. Dig Dis Sci. 2007 Oct 13; [Epub ahead of print]

Hepatitis C virus cell-cell transmission in hepatoma cells in the presence of neutralizing antibodies. Timpe JM, et al. Hepatology. 2007 Oct 16; [Epub ahead of print]

Altered expression of glucagon-like peptide-1 and dipeptidyl peptidase IV in patients with HCV-related glucose intolerance. Itou M, et al. J Gastroenterol Hepatol. 2007 Oct 17; [Epub ahead of print]

Effects on protease inhibition by modifying of helicase residues in hepatitis C virus nonstructural protein 3. Dahl G, et al. FEBS J. 2007 Oct 19; [Epub ahead of print]

Increased T-Cell Sinusoidal Lymphocytosis in Liver Biopsies in Patients With Chronic Hepatitis C and Mixed Cryoglobulinemia. Carmack S, et al. Am J Gastroenterol. 2007 Oct 26; [Epub ahead of print]

Clonal expansion of IgM+CD27+ B cells in HCV-associated mixed cryoglobulinemia. Charles ED, et al. Blood. 2007 Oct 17; [Epub ahead of print]

Mutations in the interferon sensitivity determining region (NS5A aa 2209-2248) in patients with hepatitis C 1b infection and correlating response to combined therapy of pegylated interferon and ribavirin.Yen YH, et al. Aliment Pharmacol Ther. 2007 Oct 26; [Epub ahead of print]


HIV/HCV CO-INFECTION


Safety and efficacy of an induction dose of pegylated interferon alpha-2a on early hepatitis C virus kinetics in HIV/HCV co-infected patients: the CORAL-1 multicentre pilot study. Tural C, et al. J Viral Hepat. 2007 Oct;14(10):704-13.

Characteristics and survival of HIV-infected patients not screened for hepatitis C virus infection in a hospital-based cohort. Bénet T, et al. J Viral Hepat. 2007 Oct;14(10):730-5.

Cryoglobulinaemia associated with hepatitis C virus: influence of HCV genotypes, HCV-RNA viraemia and HIV coinfection. Ramos-Casals M, et al. J Viral Hepat. 2007 Oct;14(10):736-42.

Awareness of Hepatitis C Infection Among Women With and At Risk for HIV. Cohen MH, et al. J Gen Intern Med. 2007 Oct 9; [Epub ahead of print]

Increase in newly acquired hepatitis C in HIV positive men who have sex with men across London and Brighton, 2002-2006. Is this an outbreak? Giraudon I, et al. Sex Transm Infect. 2007 Oct 11; [Epub ahead of print]

Influence of concomitant antiretroviral therapy on the rate of sustained virological response to pegylated interferon plus ribavirin in hepatitis C virus/HIV-coinfected patients. Pineda JA, et al. J Antimicrob Chemother. 2007 Oct 14; [Epub ahead of print]

Treatment of hepatitis C virus in human immunodeficiency virus infected patients in "real life": Modifications in two large surveys between 2004 and 2006. Cacoub P, et al. J Hepatol. 2007 Oct 2; [Epub ahead of print]

Managing symptomatic drug-induced liver injury in HIV-hepatitis C virus-coinfected patients: a role for interferon. McGovern BH, et al. Clin Infect Dis. 2007 Nov 15;45(10):1386-92. Epub 2007 Oct 15.

Impact of hepatitis C virus coinfection on immune restoration during successful antiretroviral therapy in chronic human immunodeficiency virus type 1 disease. Santin M, et al. Eur J Clin Microbiol Infect Dis. 2007 Oct 16; [Epub ahead of print]

Assessing the impact of substance use and hepatitis coinfection on atazanavir and lopinavir trough concentrations in HIV-infected patients during therapeutic drug monitoring. Slish J, et al. Ther Drug Monit. 2007 Oct;29(5):560-5.


COMPLEMENTARY AND ALTERNATIVE THERAPIES


Plasmatic vitamin C in nontreated hepatitis C patients is negatively associated with aspartate aminotransferase. Souza Dos Santos RM, et al. Liver Int. 2007 Oct 10; [Epub ahead of print]

Inhibition of HCV Replicon Cell Growth by 2-Arylbenzofuran Derivatives Isolated from Mori Cortex Radicis. Lee HY, et al. Planta Med. 2007 Oct 18; [Epub ahead of print]

Milk thistle for alcoholic and/or hepatitis B or C virus liver diseases. Rambaldi A, et al. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003620.

Bile acids for viral hepatitis. Chen W, et al. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD003181.

L: -Carnitine Treatment Reduces Steatosis in Patients with Chronic Hepatitis C Treated with alpha-Interferon and Ribavirin. Romano M, Dig Dis Sci. 2007 Oct 16; [Epub ahead of print]

Antioxidant therapy for chronic hepatitis C after failure of interferon: results of phase II randomized, double-blind placebo controlled clinical trial. Gabbay E, et al. World J Gastroenterol. 2007 Oct 28;13(40):5317-23.


MISCELLANEOUS WORKS


Gauging acceptance of a hepatitis C test by family planning clinic attendees in Glasgow, UK. Sharp L, et al. J Fam Plann Reprod Health Care. 2007 Oct;33(4):263-6.

Assessment of the PHQ-9 as a Screening Tool for Depression in Patients with Chronic Hepatitis C. Dbouk N, et al. Dig Dis Sci. 2007 Oct 13; [Epub ahead of print]

A Cost-Identification Analysis of Screening and Surveillance of Hepatitis C Infection in a Prospective Cohort of Dialysis Patients. Somsouk M, et al. Dig Dis Sci. 2007 Oct 13; [Epub ahead of print]

The Accuracy of Sonography in Predicting Steatosis and Fibrosis in Chronic Hepatitis C. Chen CH, et al. Dig Dis Sci. 2007 Oct 16; [Epub ahead of print]

Bacterial and viral contamination of reusable sharps containers in a community hospital setting. Runner JC. Am J Infect Control. 2007 Oct;35(8):527-30.

Epidemiology of needlesticks and other sharps injuries and injection safety practices in the Dominican Republic. Moro PL, et al. Am J Infect Control. 2007 Oct;35(8):552-9.

Hepatitis C and HIV risk behaviors in polydrug users on methadone maintenance. Willner-Reid J, et al. J Subst Abuse Treat. 2007 Oct 9; [Epub ahead of print]

Recruitment and follow-up of injecting drug users in the setting of early hepatitis C treatment: insights from the ATAHC study. Nguyen OK, et al. Int J Drug Policy. 2007 Oct;18(5):447-51. Epub 2007 Feb 21.

HCV synthesis project: preliminary analyses of HCV prevalence in relation to age and duration of injection. Hagan H, et al. Int J Drug Policy. 2007 Oct;18(5):341-51. Epub 2007 May 2.

Evaluation of the available anti-HCV antibody Detection Tests and RT-PCR assay in the Diagnosis of Hepatitis C Virus Infection. Tashkandy MA, et al. Saudi J Kidney Dis Transpl. 2007 Oct-Dec;18(4):523-31.

Meta-analyses of Fibrotest diagnostic value in chronic liver disease. Poynard T, et al. BMC Gastroenterol. 2007 Oct 15;7(1):40 [Epub ahead of print]

Low perceived benefits and self-efficacy are associated with hepatitis C virus (HCV) infection-related risk among injection drug users. Cox J, et al. Soc Sci Med. 2007 Oct 5; [Epub ahead of print]

Noninvasive diagnosis of hepatic fibrosis in patients with chronic hepatitis C by splenic Doppler impedance index. Liu CH, et al. Clin Gastroenterol Hepatol. 2007 Oct;5(10):1199-1206.e1.

Deaths from chronic liver disease and viral hepatitis, Multnomah County, Oregon, 2000. Thomas AR, J Clin Gastroenterol. 2007 Oct;41(9):859-62.

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