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Week Ending: May 6th, 2006
Alan Franciscus
Editor-in-Chief
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April 24th, 2006
Scavello Promotes Hepatitis Awareness
HARRISBURG – May is Hepatitis Awareness Month, and Rep. Mario Scavello (R-Monroe) has sponsored a resolution to call attention to a devastating health problem and communicable disease.
“If left untreated, the Hepatitis virus can be fatal, causing liver cancer and requiring liver transplants,” said Scavello. “These viruses tax the health care system and can ultimately cost our society through emergency treatment for those who are uninsured and not aware of the warning signs.”
Hepatitis comes in five forms, A, B, C, D and E and is often asymptomatic, appearing first as an inflammation of the liver. It is contracted from contaminated food and water. Hepatitis C is the leading cause of liver transplantation, and affects 280,000 Pennsylvanians. A vaccine is readily available for Hepatitis B. Hepatitis B and C are considered by the World Health Organization as a disease of primary concern for humanity.
The resolution calls on state agencies, health care providers and Pennsylvania residents to learn and educate others about the disease so that the causes, symptoms, diagnosis and treatment of hepatitis can occur in a timely fashion.
Howard Kindred, CEO and founder of the Northeastern Pennsylvania Transplant Support
Group, Inc. and recipient of a liver transplant in 1995, said, “I contracted Hepatitis C from a blood transfusion in 1971 and I was not diagnosed until 1993. I was fortunate to receive a liver transplant, but I went all those years not knowing that I had this virus. Testing has been available for about 17 years, and I would encourage all people in high risk categories to be tested and seek treatment.”
People at risk of contracting hepatitis include:
• People who had blood transfusions before 1992.
• People who have frequent exposure to blood products, including patients with hemophilia, solid organ transplants, chronic renal failure or cancer requiring chemotherapy.
• Health care workers who suffer needle sticks.
• People who have injected drugs, even once.
• People who engage in high-risk sexual behavior, have multiple sex partners or sexually transmitted diseases.
• People who are or have been on hemodialysis.
• People who have their body pierced or have tattoos.
• People who use cocaine, particularly with intranasal administration, using shared equipment
For more information about the Northeastern Pennsylvania Transplant Support Group, visit www.nepatsg.org.
House Resolution 721 passed the House unanimously.
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April 29th, 2006
New Oral Polymerase Inhibitor Shows Promising Results in Chronic Hepatitis C Patients
SourceURL:http://biz.yahoo.com
- Results Strengthen Pipeline for Next Generation of Roche Therapies -
VIENNA, Austria, April 29 /PRNewswire/ -- R1626, one of a new class of hepatitis C therapies called polymerase inhibitors, demonstrates an antiviral effect by achieving clinically significant viral load reductions in chronic hepatitis C patients with genotype 1, the most difficult to treat genotype, according to preliminary data presented at the 41st Annual Meeting of the European Association for the Study of the Liver (EASL). Further trials are planned to study how well R1626 works in combination with PEGASYS® (peginterferon alfa-2a) and COPEGUS® (ribavirin).
"Data from this study evaluating R1626 are encouraging," said Frederick G. Thompson, President and Chief Executive Officer of the American Liver Foundation. "Since genotype 1 patients are the most common in the United States and also the most difficult to treat, there is a real need for a product that could potentially improve treatment outcomes."
About the study
In this phase I study, patients are randomized to receive either oral treatment with R1626 or placebo for 14 days with 14 days of follow-up. Preliminary data were presented on the 18 patients who received 500 mg or 1,500 mg twice daily doses of R1626. The study is still ongoing and higher doses of R1626 are being evaluated.
The study found:(1)
* At the 1,500 mg twice daily dose, R1626 was associated with clinically significant reductions from baseline in serum HCV RNA (a measure of how much virus is in the blood) of 1.2 log(10) (group mean).
* At both 500 mg and 1,500 mg twice daily, R1626 was well tolerated in patients, with no serious adverse events and no premature withdrawals.
"Development of R1626 demonstrates our commitment to developing additional treatments for patients living with hepatitis C," said James A. Thommes, M.D., Senior Medical Director, Roche. "PEGASYS is the preferred pegylated interferon for the management of hepatitis C in the United States today. Furthermore, we are undertaking additional collaborations and partnerships with other companies to continue to seek improvements of treatment outcomes."
Additional data reported at EASL related to partnerships include Vertex Pharmaceutical's VX-950, a protease inhibitor, which, in combination with PEGASYS and COPEGUS, showed a significantly increased antiviral effect in patients with hepatitis C. Subsequent studies will evaluate whether VX-950, in combination with PEGASYS and COPEGUS, may clear the hepatitis C virus with shortened treatment duration.(2)
About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver, is transmitted through body fluids, primarily blood or blood products, and by sharing needles. Hepatitis C chronically infects an estimated 2.7 million Americans and 170 million people worldwide and is the leading cause of cirrhosis and liver cancer and the number one reason for liver transplants in the U.S.
About Pegasys
Pegasys, a pegylated alpha interferon, and Copegus were approved by the FDA in December 2002 for use in combination for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis.
Pegasys is dosed at 180mcg as a subcutaneous injection taken once a week. Copegus is available as a 200mg tablet, and is administered orally two times a day as a split dose. Roche has backed Pegasys with the most extensive clinical research program ever undertaken in hepatitis C, with major studies initiated to advance treatment for hepatitis C patients with unmet needs, including patients co-infected with HIV and HCV, African Americans, patients with cirrhosis, and patients who have failed to respond to previous therapy.
Please see attached additional information about Pegasys indication and safety.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or http://www.roche.us.
IMPORTANT SAFETY INFORMATION
PEGASYS, alone or in combination with COPEGUS, is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that is clinically stable (eg, antiretroviral therapy not required or receiving stable antiretroviral therapy).
Alpha interferons, including PEGASYS® (Peginterferon alfa-2a), may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in complete product information).
Use with Ribavirin. Ribavirin, including COPEGUS®, may cause birth defects and/or death of the fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in complete product information).
PEGASYS is contraindicated in patients with hypersensitivity to PEGASYS or any of its components, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment. Pegasys is also contraindicated in hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during treatment. PEGASYS is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is associated with an increased incidence of neurological and other complications in neonates and infants, which are sometimes fatal. PEGASYS and COPEGUS therapy is additionally contraindicated in patients with a hypersensitivity to COPEGUS or any of its components, in women who are pregnant, men whose female partners are pregnant, and patients with hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).
COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO INITIATION OF THERAPY. Women of childbearing potential and men must use two forms of effective contraception during treatment and during the 6 months after treatment has concluded. Routine monthly pregnancy tests must be performed during this time. If pregnancy should occur during treatment or during 6 months post-therapy, the patient must be advised of the significant teratogenic risk of COPEGUS therapy to the fetus. Healthcare providers and patients are strongly encouraged to immediately report any pregnancy in a patient or partner of a patient during treatment or during 6 months after treatment cessation to the Ribavirin Pregnancy Registry at 1-800-593-2214.
Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including PEGASYS. Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART. During treatment, patients' clinical status and hepatic function should be closely monitored, and PEGASYS treatment should be immediately discontinued if decompensation (Child-Pugh score greater than or equal to 6) is observed.
The most common adverse events reported for PEGASYS and COPEGUS combination therapy observed in clinical trials were fatigue/asthenia (65%), headache (43%), pyrexia (41%), myalgia (40%), irritability/anxiety/nervousness (33%), insomnia (30%), alopecia (28%), neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia (24%), injection-site reaction (23%), arthralgia (22%), depression (20%), pruritus (19%) and dermatitis (16%). The adverse event profile of coinfected patients treated with PEGASYS and COPEGUS was generally similar to that shown for monoinfected patients. Events occurring more frequently in coinfected patients were neutropenia (40%), anemia (14%), thrombocytopenia (8%), weight decrease (16%) and mood alteration (9%).
Serious adverse events included neuropsychiatric disorders (homicidal ideation, suicidal ideation, suicide attempt and suicide), serious and severe bacterial infections (sepsis), bone marrow toxicity (cytopenia and rarely, aplastic anemia), cardiovascular disorders (hypertension, supraventricular arrhythmias and myocardial infarction), hypersensitivity (including anaphylaxis), endocrine disorders (including thyroid disorders and diabetes mellitus), autoimmune disorders (including idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, psoriasis, lupus, rheumatoid arthritis and interstitial nephritis), pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis), colitis (ulcerative and hemorrhagic/ischemic colitis), pancreatitis and ophthalmologic disorders (decrease or loss of vision, retinopathy including macular edema and retinal thrombosis/hemorrhages, optic neuritis and papilledema).
(1) Roberts S, Cooksley G, et al. Interim results of a multiple ascending dose study of R1626, a novel nucleoside analog targeting HCV polymerase in chronic HCV patients. Presented at the 41st European Association for the Study of the Liver. April 29, 2006.
(2) Reesink HW, Forestier, N, et al. Initial Results Of A 14-Day Study Of The Hepatitis C Virus Inhibitor Protease VX-950, In Combination With Peginterferon-Alfa-2a. Presented at the 41st European Association for the Study of the Liver. April 29, 2006.
Source: Roche
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Coley Pharmaceutical Group Presents Data from Clinical Study of ACTILON(TM) for Hepatitis C at the European Association for the Study of the Liver Meeting
SourceURL:http://www.boursorama.com
WELLESLEY, Mass., April 29 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. today announced positive four- and twelve-week treatment data from the company's five-arm Phase Ib clinical study of ACTILON(TM) (CPG 10101) alone and in combinations with pegylated interferon and/or ribavirin, among treatment-refractory patients chronically infected with Hepatitis C virus (HCV). Results indicate that the combination of ACTILON plus pegylated interferon and ribavirin achieved greater rates of HCV RNA undetectability (defined as less than lower limit of detection of 50 IU/mL) and improved Rapid and Early Virological Responses (RVR and EVR, defined as a greater than 2 log reduction in plasma HCV RNA levels at four and twelve weeks respectively) compared with pegylated interferon and ribavirin alone.
At twelve weeks, 50 percent (7 of 14) of treatment-refractory patients in the ACTILON-pegylated interferon-ribavirin arm of the study achieved HCV RNA undetectable levels, or viral negativity, versus 13 percent (2 of 13) of those patients who received pegylated interferon and ribavirin alone (p=0.050). Early Virological Responses were achieved in 86 percent (12 of 14) of patients who received ACTILON, pegylated interferon and ribavirin, compared to 60 percent (9 of 15) who received pegylated interferon and ribavirin alone. The triplet combination of ACTILON with pegylated interferon and ribavirin resulted in a 3.3 mean log reduction in HCV RNA levels, versus a 2.3 mean log reduction (p<0.050) among patients receiving the control combination.
At four weeks, 50 percent (7 of 14) of the patients in the ACTILON-pegylated interferon-ribavirin arm of the study achieved RVR, versus 13 percent (2 of 13) of those patients who received pegylated interferon and ribavirin alone (p=0.050). Coley believes these positive results at four weeks, combined with the increased incidence of viral negativity at twelve weeks, to be highly encouraging, since these outcomes have been reported in a variety of HCV patient populations as positive predictors for Sustained Virological Responses (SVR), which is continued viral clearance after cessation of treatment.
These data were presented in a late-breaker session at the European Association for the Study of the Liver (EASL) meeting in Vienna, Austria by John McHutchison, M.D., Medical Director of Gastroenterology & Hepatology Research at the Duke Clinical Research Institute and lead investigator for the study.
"The ability of ACTILON to improve the number of patients with HCV RNA undetectable levels and Early Virological Responses in a relapsed, treatment-refractory patient population is noteworthy as these patients lack alternative treatment options. Of the approximately 50 percent of chronic Hepatitis C patients who fail initial treatment with pegylated interferon and ribavirin, re-treatment is typically unsuccessful. The higher incidence of early responses observed in this study suggests that the triplet combination including ACTILON now requires further exploration and confirmation in subsequent clinical trials in terms of safety and efficacy," said Dr. McHutchison.
Study Details and Results
The Phase Ib clinical study enrolled 74 evaluable genotype 1 patients chronically infected with Hepatitis C virus. Subjects had all previously received at least 24 weeks of treatment with the standard of care (pegylated interferon and ribavirin), but subsequently relapsed within six months of treatment. Patients in the study were randomly assigned to one of five groups, receiving 12 weekly doses of: ACTILON alone, ACTILON in combination with pegylated interferon, ACTILON with ribavirin, ACTILON with pegylated interferon and ribavirin, or pegylated interferon and ribavirin. ACTILON was administered by subcutaneous injection at a dose of 0.2 mg/kg once-weekly. Patients who achieved a greater than 2 log (>99%) reduction in HCV RNA were eligible to continue on ACTILON therapy for a total of 48 weeks and be followed for an additional 24 weeks to monitor for Sustained Virological Responses.
At twelve weeks, patients receiving ACTILON plus pegylated interferon achieved a 2.4 mean log reduction in plasma HCV RNA levels, 31 percent (5 of 16) achieved Early Virological Responses and 13 percent (2 of 16) were HCV RNA undetectable. These results were comparable to those found in the control arm. Twenty percent (3 of 15) of patients in the ACTILON plus ribavirin arm of the study achieved an Early Virological Response. As expected in this study design, patients receiving a low dose of 0.2 mg/kg of ACTILON alone did not achieve Early Virological Responses.
The ACTILON combinations were generally well tolerated. Adverse events were similar to pegylated interferon and ribavirin treatment and were predominantly mild-to-moderate in intensity and consisted of flu-like symptoms, headache and injection site reactions.
About ACTILON and TLR Therapeutics(TM)
Coley's proprietary TLR Therapeutics(TM) act through a specific class of targets, called Toll-like receptors, or TLRs, found in and on immune system cells which, in turn, direct the immune system to fight disease. ACTILON acts through the Toll-like receptor 9 (TLR9) found in dendritic cells and B cells and is designed to induce a durable and natural immune response to treat viral infections such as Hepatitis C. The compound stimulates the body's own production of antiviral cytokines and chemokines, such as interferons, and is designed to drive both early and sustained virus-specific memory immune responses to help clear infection.
In addition to the study reported above, Coley is currently conducting a randomized, controlled, 48-week Phase II clinical study of ACTILON in combination with pegylated interferon and ribavirin. The study is designed to enroll 90 treatment-refractory patients with genotype 1 Hepatitis C virus who have failed to demonstrate a response to treatment with the current standard of care.
About Hepatitis C
Hepatitis C virus, or HCV, is a blood-borne infectious disease of the liver. According to the World Health Organization, HCV infects approximately 170 million people worldwide, including at least 2.7 million in the United States. Ten to twenty percent of those chronically infected with HCV will ultimately develop liver cirrhosis, making HCV the leading cause of liver transplants in the United States. The Hepatitis Foundation International estimates that between 25,000 and 30,000 Americans contract HCV each year and that between 8,000 and 10,000 people die annually from HCV-related cirrhosis or liver cancer. Currently, the standard of care for treating HCV patients is a combination regimen of long-acting interferon alpha and ribavirin. These therapies may be limited by toxicities and by viral resistance among some patients.
About Coley Pharmaceutical Group
Coley Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics(TM), a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases, asthma and allergy. Coley has established a pipeline of four TLR Therapeutic product candidates currently advancing through clinical development either independently or with partners, and additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoSmithKline and the United States government. For further information on Coley Pharmaceutical Group please visit http://www.coleypharma.com/.
Safe Harbor Statement
Certain statements in this news release concerning Coley's business are considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, those relating to the future clinical evaluation of a triplet combination therapy including ACTILON for the treatment of HCV, and the design and enrollment of Coley's Phase II study of ACTILON in combination with pegylated interferon and ribavirin. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Coley might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; uncertainties as to the future success of ongoing and planned clinical trials; and the unproven safety and efficacy of products under development. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Coley undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
Coley Pharmaceutical Group, Inc.
CONTACT:
Charles H. Abdalian, Jr., Senior Vice President and CFO of Coley Pharmaceutical Group, +1-781-431-9044, cabdalian@coleypharma.com;
or Karen L. Bergman, kbergman@bccpartners.com,
or Michelle Corral, mcorral@bccpartners.com, of BCC Partners (US) for Coley Pharmaceutical Group, +1-650-575-1509 or +1-415-794-8662
Web site: http://www.coleypharma.com/
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April 30th, 2006
A Need for Needles: Addicts Flood State's Four Exchange Programs
By Laura Crimaldi
http://news.bostonherald.com
The four needle-exchange programs in the state are being flooded by out-of-town addicts who sometimes travel miles for potentially life-saving clean needles, which can stave off HIV and hepatitis, a Herald review has found.
Law enforcement officials in three of the four municipalities that permit needle swaps say they are not worried about the junkie influxes. But because no cities or towns beyond Boston, Cambridge, Provincetown and Northampton likely will approve such a program, clean needles remain hard to come by in Massachusetts.
"All these people in the suburbs love to have these needle programs in Cambridge and Boston, but they don't want it in their city," said Cambridge police spokesman Frank Pasquarello.
Advocates say a bill making clean needles available through pharmacies - which is allowed in 47 states - may be the last realistic way to reach Bay State addicts who otherwise would risk disease by reusing tainted hypodermics.
The so-called pharmacy access bill "has to pass or we'll file it again," said Denise McWilliams, director of public policy for the AIDS Action Committee.
Of the nearly 18,000 people enrolled in the state's four needle programs, about 12,500 come from outside the four municipalities where needles are distributed lawfully. The numbers don't show how many drug addicts use dirty needles because they don't have easy access to needle exchanges.
"Many people who are using drugs out there, they don't leave the corner they're on," said Gary Langis, HIV program manager at CAB Health & Recovery Services in Lynn and a longtime activist who has been arrested for running underground needle exchanges. "They are not going to go to East Boston from 4 to 6 on Tuesday night to get clean needles."
Attempts to establish needle-exchange programs in Lynn, Worcester, Springfield, Holyoke and Westport have failed since the state gave local communities the right to decide whether to hand out syringes in the 1990s.
House lawmakers last November approved the bill that would allow pharmacies to sell hypodermic needles to anyone older than 18.
The bill is vehemently opposed by anti-needle-exchange activists who scoff at evidence that the sale of clean needles can reduce disease transmission. They also argue needle exchanges encourage drug use and increase crime.
"It's absolutely asinine from my point of view that they would want to put more needles on the street," said Lea Polleria Cox, the Bay State delegate for Drug Watch International.
Northampton police Chief Russell Sienkiewicz, who supports the city's needle-exchange program, opposes selling needles in drug stores.
He fears drug store sales would flood the streets with dirty needles and keep addicts from the health care that needle-exchange programs provide.
"There will be a huge impetus for them not to discard dirty needles," Sienkiewicz said.
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Tainted Blood Victims 'Were Not Informed'
SourceURL:http://observer.guardian.co.uk/
Lorna Martin, Scotland editor
The Observer
Concerns about Britain's contaminated blood scandal escalated yesterday after it emerged that thousands of people who were infected with hepatitis C have still not been informed.
The Observer has obtained evidence from solicitors representing scores of victims which appears to confirm claims that efforts to trace those infected with the deadly virus from transfusions and blood products were 'restrictive, passive and inadequate'. It has also emerged that no efforts were made to contact relatives of those who died as a result of the disaster despite the fact they could have unknowingly passed it on. The virus can lie dormant for over 20 years, but then lead to severe liver damage and cancer.
Solicitors acting for some of the 30,000 people in the UK believed to have been infected with hepatitis C by contaminated blood and products during the 1980s said only about 15 per cent had been contacted as part of the official 'lookback' programme.
'Nearly every week I receive clients who inform me that they have just found out, usually because of incidental treatment, that they have hepatitis C,' said Frank Maguire, a legal adviser for the Haemophilia Forum.
Routine donor screening began in 1991 and a two-year 'look back' exercise began four years later to trace those infected. But it focused on those who returned to the blood transfusion service. Charles Gore, chief executive of the Hepatitis C Trust, said: 'It is absolutely appalling that health and government officials are deliberately not doing anything about this and are deliberately letting people die. It is a major public health issue.'
In another development, The Observer has seen documents which reveal panic and chaos in the transfusion service as the scale of contamination emerged. In a letter of May 1991, the director of the transfusion service in Newcastle said that since the ability to test for hepatitis C was available it would be 'indefensible' not to introduce it immediately. In a response, another regional director stated that such 'unilateral action is both disgraceful and mischievous'.
A Department of Health spokeswoman said there was great sympathy for people who were infected with hep C and HIV from contaminated blood during the 1970s and 1980s. Those patients who were considered to be most at risk were counselled, offered testing and referred for further assessment. She added: 'It is our belief that everything was done to identify and trace patients who had received blood before September 1991.'
In Scotland, Health Minister Andy Kerr is still considering calls from the influential health committee to hold an independent inquiry into the scandal.
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May 1st, 2006
Liver Transplants Can Be Successful in HIV Patients with Hepatitis B
SourceURL:http://www.eurekalert.org/
A new study on HIV patients who also had Hepatitis B virus (HBV) found that better outcomes are possible if they are referred early for transplant and treated with a combination of drugs for HBV. It is essential to monitor the HBV status of these patients, however, in order to control the emergence of drug-resistant HBV infection.
The results of this study appear in the May 2006 issue of Liver Transplantation, the official journal of the American Association for the Study of Liver Diseases (AASLD) and the International Liver Transplantation Society (ILTS). The journal is published on behalf of the societies by John Wiley & Sons, Inc. and is available online via Wiley InterScience at
http://www.interscience.wiley.com/journal
/livertransplantation.
In the past, HIV patients were largely excluded from consideration for liver transplants due to high death rates from HIV-related complications. However, in recent years HIV-related deaths have declined due to the development of highly active antiretroviral therapy (HAART). At the same time, a greater number of deaths are due to liver complications (such as those caused by HBV) have been seen in HIV-infected persons. Simultaneously, there have been advances in immunosuppression and the treatment of post-transplant complications, leading to an increasing number of transplant centers performing liver transplants on HIV-infected patients. Outcomes for HBV patients undergoing liver transplants have improved, overall, in recent years, but until now it was not known how HIV patients with HBV fared when undergoing liver transplantation.
In the first study to assess the outcomes of HBV-HIV liver transplant candidates, researchers led by Norah A. Terrault of the University of California in San Francisco, followed 35 HBV-HIV patients referred to UCSF for liver transplantation between July 2000 and September 2002. Of these, nine (26 percent) were wait-listed, 10 (28 percent) were not eligible for transplant for various reasons, 9 (26 percent) were too early in the course of their liver disease for a transplant, 3 (9 percent) were too sick for a transplant and four (11 percent) died during the evaluation process. The prolonged use of the drug lamivudine, which is used to treat both HIV and HBV, has led to lamivudine resistance in recent years and 67 percent of the referred patients had lamivudine-resistant HBV. Almost half of these patients were taking additional anti-HBV medications (tenofovir and/or adefovir) that are effective against lamivudine-resistant HBV. After the initial referral, 10 patients died of liver-related complications (the median follow-up was 7.5 months), the majority within three months of referral. A total of four patients ultimately underwent liver transplants and all of them survived and are without evidence of HBV recurrence.
"Our limited experience indicates patients with HIV-HBV coinfection can successfully undergo liver transplantation without progression of viral (HBV) disease, even in the setting of lamivudine resistance," the authors state. They suggest that the low rate of eligible candidates may be partially due to a lack of knowledge on the part of referring physicians about the indications and timing for liver transplants for HBV-HIV-infected patients. Patients taking tenofovir and/or adefovir were more likely to survive with or without a transplant, indicating that controlling HBV is an important factor in HIV-infected patients with liver disease. The authors conclude: "Ongoing close monitoring of HBV replication status in HBV-HIV coinfected patients will be essential in identifying the emergence of drug-resistant HBV and in making therapeutic decisions to minimize the risk of liver-related complications."
In an accompanying editorial in the same issue, Didier Samuel and Jean-Charles Duclos-Vallee of the Centre Hepatobillaire in Villejuif, France note that since liver transplants in HIV patients are relatively new, questions about several issues have been raised, such as the ideal timing in HIV-HBV or HIV-HCV (Hepatitis C) patients, the risk of HIV progression after transplant, and the risk of liver toxicity with HAART. They note that although the current study is small, its message is important, particularly with regard to the fact that many potential candidates die either while on the waiting list or while being evaluated for transplant. "A particular effort should be made to inform physicians caring for HIV patients of the possibility of liver transplantation in this patient population and the importance of a prompt referral to liver transplantation centers," the authors state. They also suggest that studies need to be conducted to determine factors that might indicate a poor prognosis in these patients. "In conclusion, liver transplantation for HIV patients is an emerging field with good preliminary results in HIV-HBV infected patients and pending results in evaluation of HIV-HCV patients," the authors state. They add that discussions among hepatologists, transplant physicians and HIV specialists need to take place regarding the best timing for liver transplantation and the choice of HAART in order to avoid the emergence of drug-resistant HBV.
References:
Article: "Outcome of Patients with Hepatitis B Virus and Human Immunodeficiency Virus Infections Referred for Liver Transplantation," Norah A. Terrault, Jonathan T. Carter, Laurie Carlson, Michelle E. Roland, Peter G. Stock, Liver Transplantation; May 2006 (DOI: 10.1002/lt.20776).
Editorial: "The Difficulty in Timing for Liver Transplantation in Cirrhotic Patients Coinfected with HIV: In Search for a Prognosis Score," Didier Samuel, Jean-Charles Duclos-Vallee, Liver Transplantation; May 2006 (DOI: 10.1002/lt.20790).
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Human Genome Updates Albuferon Data
SourceURL:http://biz.yahoo.com/
Human Genome Sciences Reports Positive Data on Albuferon With Ribavirin in Hepatitis C Patients
ROCKVILLE, Md. (AP) -- Biotech company Human Genome Sciences Inc. provided updated results Monday of its mid-stage clinical trial for interferon product Albuferon in hepatitis C patients who had been previously been treated for the disease.
The company followed 71 patients and found that 22 patients, or 31 percent, given Albuferon along with ribavirin had undetectable levels of the virus after 48 weeks of treatment. Ribavirin is the active ingredient in Roche Holding Group's Copegus hepatitis C treatment.
Twelve weeks after treatment ended, 14 out of the 22 patients remained with undetectable levels, or about 20 percent of all patients.
The company plans to enter late stage clinical trials for Albuferon by the end of the year.
In March, the company reported early results that 30 percent of those taking Albuferon with ribavirin had undetectable levels of the virus after 48 weeks of treatment, and that 18 percent had undetectable levels 12 weeks after treatment stopped.
Human Genome Sciences shares rose 59 cents, or 5.2 percent, to $12 in premarket activity.
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ViroPharma Announces Presentation of Pharmacokinetic Data From HCV-796 Phase 1a Study
SourceURL:http://www.finanznachrichten.de/
EXTON, Pa., May 1 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nachrichten) today announced that pharmacokinetic (PK) data from a Phase 1a trial of HCV-796, an orally dosed non-nucleoside viral polymerase inhibitor with the potential to interfere with the replication of hepatitis C virus, that is being co-developed with Wyeth Pharmaceuticals, a division of Wyeth , were presented at the 2006 European Association for the Study of the Liver (EASL) meeting in Vienna, Austria, which concluded yesterday. These data concluded that the safety and PK profile of the compound supported additional clinical evaluation. HCV-796 is currently in Phase 1b testing in combination with PEG-interferon.
"These initial Phase 1a data were the first set of data from our human clinical analyses of HCV-796, and important in that they set the stage for our ongoing multiple dose studies," commented Steve Villano, ViroPharma's vice president of clinical research and development. "Overall, the findings demonstrate that the absorption and elimination profile, distribution, half life, and tolerability of HCV-796 are acceptable, and supportive of our ongoing clinical development."
Trial Description
This Phase 1a study was an ascending single dose, placebo-controlled trial designed to assess the safety and tolerability of HCV-796 in healthy adult volunteers. Fasting healthy subjects were randomly assigned to receive 25, 50, 100, 250, 500, 1000, or 2000 mg oral doses of HCV-796 or placebo (six active, two placebo per dose group). Subjects in the 100-mg dose cohort received HCV-796 in a fasting and fed state.
Results
The safety profile from this study indicates that single oral doses of HCV-796 are generally well tolerated with no serious treatment-emergent adverse events. Mild to moderate headache was the most frequently reported adverse event. There were no apparent dose-related increases in frequency for any adverse event. There were no significant differences in the rate of adverse events between patients on drug compared to placebo. The PK data showed that the maximum concentration (Cmax) and drug exposure as measured by the area under the curve (AUC) increased less than proportionally with increasing dose, and appeared to reach a plateau at the 1000 mg cohort. HCV- 796 displayed a long half life. When dosed with food at the 100 mg dose level, drug exposure as measured by AUC increased approximately 1.4 fold, providing the first evidence that systemic exposure to the drug may be increased by dosing with food and leading to an additional study designed to specifically assess the potential enhancement of drug exposure when dosed with food.
HCV-796 is an investigational non-nucleoside polymerase inhibitor compound for the treatment of hepatitis C that is being evaluated in ongoing clinical trials in combination with PEG-Interferon by ViroPharma and Wyeth. In previously disclosed results from the Phase 1b study of HCV-796 as a monotherapy, the patient cohort with the highest exposure to drug achieved a peak mean HCV viral load reduction of 1.4 log10, or 96 percent, on day four of a 14-day dosing period. HCV-796 was found to be generally well tolerated, with favorable pharmacokinetics and no dose-limiting toxicities. Mild to moderate headache was the most frequent adverse event reported overall. There were no treatment-emergent serious adverse events.
About Hepatitis C
Hepatitis C is a blood-borne virus recognized as a major cause of chronic hepatitis worldwide. The World Health Organization estimates that 170 million persons worldwide are chronically infected with HCV, and three to four million persons are newly infected globally each year. According to the U.S. Centers for Disease Control and Prevention (CDC), about four million people in the U.S., or 1.8 percent of the population, are infected with HCV.
Currently, there is no specific antiviral agent directed against HCV that is commercially available, and no vaccine for prevention of HCV infection. Several interferon (IFN) products are available worldwide, but there are substantial limitations to the use of these products when given as monotherapy or in conjunction with ribavirin in the treatment of chronic HCV infection. In addition to the relatively poor treatment response in patients infected with genotype 1 HCV, the most common strain in the U.S., Western Europe and Japan, the considerable side effects frequently associated with the use of IFN can lead to discontinuation of therapy in approximately 20% of patients.
About ViroPharma Incorporated
ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin- resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/docs/pulvules_pi.pdf). ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the company's website at http://www.viropharma.com/.
Certain statements in this press release may contain forward-looking statements that involve a number of risks and uncertainties, including those relating to our anticipated continued development of HCV-796 and our ability to find an effective small molecule antiviral treatment for HCV disease. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. The development and commercialization of pharmaceutical products is subject to risks and uncertainties. There can be no assurance that Wyeth and ViroPharma's additional HCV studies will yield positive results, or that ViroPharma will be successful in gaining regulatory approval of any of its HCV product candidates. These factors, and other factors, including, but not limited to those described in ViroPharma's annual report on Form 10-K for the year ended December 31, 2005 filed with the Securities and Exchange Commission could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.
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Senate Battle Set on Sale of Syringes
SourceURL:http://www.boston.com
By Matt Viser, Globe Staff
Political lines drawn on Mass. legislation
State senators are preparing to begin debate this week on a bill that would legalize over-the-counter sales of hypodermic needles in an effort to stem the spread of HIV, hepatitis C, and other blood-borne infections that can be transmitted through dirty needles.
The bill, which has already been approved by the House, could potentially stage a political showdown with Governor Mitt Romney and Senate Republicans over whether a new law would help save lives or promote drug use.
Proponents of the bill contend that making it easier to obtain clean syringes would help curb the spread of disease, put Massachusetts in line with 47 other states, and eventually cut down on the state's healthcare costs.
Opponents counter that making it more convenient for addicts to obtain needles would be indirectly sanctioning illegal activity and could lead to more drug use and crime. They also say that drug users would still use dirty needles, even if clean ones were more readily available.
''We would be saying to people, 'What you are doing is illegal. But we'll at least give you the needle to do it,' " said Senate minority leader Brian P. Lees, an East Longmeadow Republican. ''I don't think we would be sending the right message."
Senator Susan C. Fargo, a Lincoln Democrat, disagreed.
''People who are addicted to drugs will [use drugs] anyway -- and we need better provisions for them to stop using drugs," said Fargo, chairwoman of the Joint Committee on Public Health. ''But a clean-needles bill doesn't encourage drug use, it doesn't encourage crime. It just makes sense."
Fargo, one of the lead proponents of the bill, said the measure would be supported by a veto-proof majority and predicted it would receive ''overwhelming support" in a Senate vote, which could come as early as Wednesday.
Eric Fehrnstrom, the governor's spokesman, said yesterday that Romney is likely to veto the bill if it ends up on his desk.
''Governor Romney believes that removing prescription controls on hypodermic needles is a bad idea," he said. ''It encourages heroin use, and because there is no system for the safe disposal of used syringes, it threatens to litter our parks, beaches, and neighborhoods with dirty needles."
Senate Republicans are planning to meet with the governor this week and hold a caucus to decide what tack they plan to take on the issue.
''It's still up in the air on whether I'll use parliamentary procedures to stall the bill," Lees said.
The House version of the bill would allow anyone 18 or older to buy a syringe from a pharmacy without a prescription. It also would decriminalize possession of a hypodermic needle, a misdemeanor in Massachusetts. It would also require pharmacists to hand out information about treatment programs and about proper use and disposal of syringes to anyone who buys needles.
Although much of the debate has centered on drug users, proponents of the bill say a new law would also make it more convenient for diabetics and others with health-related needs to buy needles without a prescription.
The House approved the measure, 115 to 37, in November, after nearly three hours of impassioned debate. Senate President Robert E. Travaglini told the State House News Service Friday that he could bring the issue up for a vote this week. He did not return phone calls yesterday.
Rebecca Haag, executive director of the AIDS Action Committee of Massachusetts and one of the primary advocates of the bill, said Travaglini's office had told her that a vote could come on Wednesday or Thursday.
If the state approves the bill, Massachusetts will become the 48th state to allow over-the-counter sales; New Jersey and Delaware are the only other states where the sale is currently illegal.
In the mid-1990s, the Bay State began allowing cities and towns to set up needle-exchange centers in their communities, where used needles could be traded for clean ones.
In most communities where the issue has been raised, residents opposed it because they feared that the centers would increase crime and drug use, though four communities -- Boston, Cambridge, Northampton, and Provincetown -- are running the needle-exchange centers.
''There's been no problems with these programs, but unfortunately there's a perception that people don't want them in their communities," said Haag, whose group lobbied for the current bill after unsuccessful attempts to open more needle-exchange centers throughout the state. ''Sixty-eight percent of HIV infections in Fall River are related to needles -- a huge number -- but people in Fall River don't want one of these programs."
Supporters of the bill acknowledge that a new law may not help curtail the number of drug users, and they instead are casting the debate as a public health issue that would help stem the spread of disease among drug users as well as their friends, families, and partners.
Of nearly 15,000 people in Massachusetts with HIV, about 39 percent were infected because they or their partners used a dirty needle, according the Massachusetts Department of Public Health.
By reducing the number of people infected with HIV, proponents of the bill say, taxpayers would also save money. Proponents did not present exact figures, but the estimated lifetime treatment cost for someone infected with HIV is $400,000, Haag said.
The bill is backed by four district attorneys, including Martha Coakley of Middlesex County and Daniel F. Conley of Suffolk County, who testified last year at a legislative hearing.
Several health organizations, including the state's Department of Public Health, have also endorsed the bill.
Matt Viser can be reached at maviser@globe.com.
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May 2nd, 2006
FDA Grants Orphan Drug Designation to Nexavar for the Treatment of Hepatocellular Carcinoma
SourceURL:http://www.therapeuticsdaily.com
WEST HAVEN, Conn. and EMERYVILLE, Calif., April 26 /PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. announced today that Nexavar(R) (sorafenib) tablets has been granted orphan drug status for the treatment of hepatocellular carcinoma (HCC), or liver cancer, by the U.S. Food and Drug Administration (FDA). A similar designation has been granted by the European Commission.
"We are very encouraged by the collaboration of the FDA as well as the European Regulatory bodies in our research surrounding this highly fatal disease," said Susan Kelley, M.D., vice president, Oncology, Bayer Pharmaceuticals Corporation. "It fuels our efforts to strive toward a novel therapy for liver cancer patients worldwide."
At the 16th American Association for Cancer Research-National Cancer Institute-European Organization for Research and Treatment of Cancer (AACR-NCI-EORTC) meeting in 2004, investigators reported that in a Phase II single agent study, 43 percent of patients treated with Nexavar experienced stable disease for at least four months and an additional nine percent of patients experienced tumor shrinkage. The most common grade 3/4 drug-related toxicities were fatigue (9.5 percent), diarrhea (8 percent), and hand-foot skin reaction (5 percent). The toxicity profile of Nexavar was similar to previously reported safety analysis in patients with renal cell carcinoma.
A Phase III trial of Nexavar administered as a single agent is ongoing. It is designed to measure differences in overall survival, time-to-symptom progression and time-to-tumor progression of Nexavar versus placebo in liver cancer patients. A randomized Phase II trial for liver cancer patients to evaluate the efficacy of Nexavar in combination with the chemotherapeutic agent doxorubicin is also ongoing.
"Liver cancer is such an aggressive disease that patients diagnosed with it rarely live beyond two years," said Dr. Jordi Bruix, head of the Barcelona Clinic Liver Cancer Group at the University of Barcelona in Spain. "The global medical community recognizes the need for new treatments in liver cancer and I am hopeful of the potential of Nexavar in this patient population." Dr. Bruix is co-primary investigator of the Phase III trial along with Dr. Josep Llovet, senior scientist of the division of liver disease at Mount Sinai School of Medicine in New York.
In December 2005, Nexavar received approval from the FDA to treat patients with advanced renal cell carcinoma (RCC), or kidney cancer. The European Commission has also granted an orphan medicinal product designation for Nexavar in renal cell carcinoma and a Marketing Authorization Application (MAA) had been submitted to the European Medicines Agency (EMEA) in September 2005 for treatment of patients with kidney cancer with Nexavar within the European Union.
Orphan Drug Designation in the United States
In the United States, the Orphan Drugs Act (ODA) provides for the orphan drug designation which aims to encourage the development of drugs involved in the diagnosis, prevention or treatment of a medical condition affecting fewer than 200,000 people in the country. The designation grants U.S. market exclusivity to a drug for a particular indication for a seven-year period if the sponsor complies with certain FDA specifications. Additional incentives for the sponsor include tax credits related to clinical trial expenses and a possible exemption from the FDA-user fee. The designation does not shorten the duration of the regulatory review and approval process.
About Nexavar
Nexavar is the first oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. In preclinical models, Nexavar targeted members of two classes of kinases known to be involved in both tumor cell proliferation (tumor growth) and tumor angiogenesis (tumor blood supply) -- two important cancer growth activities. These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-B, KIT, and FLT-3.
Nexavar is currently in Phase III clinical trials for the treatment of liver cancer, metastatic melanoma, or skin cancer, and non-small cell lung cancer (NSCLC), and has been studied in more than 20 tumor types and in more than 8,000 clinical trial patients. In addition to company-sponsored trials, there are a variety of Nexavar studies being sponsored by government agencies, cooperative groups and individual investigators.
About Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC), also known as primary liver cancer, is the most common form of liver cancer and is responsible for 80 percent of the primary malignant liver tumors in adults. It is the fifth most common cancer in the world. HCC disproportionately affects men, with four times as many men developing the disease as women. In 2002, approximately 626,000 cases of HCC were reported worldwide (15,000 in the United States and 53,600 in Europe), and more than 600,000 deaths (about 13,000 Americans and 57,000 Europeans) due to HCC were reported. The five-year relative survival rate is about seven percent.
Important Safety Considerations for U.S. Patients Taking Nexavar
Based on the current, approved package insert for the treatment of patients with advanced kidney cancer, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. Incidence of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo. Most common treatment-emergent adverse events with Nexavar were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia, and nausea. Grade 3/4 adverse events were 38% for Nexavar vs. 28% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.
For U.S. Nexavar prescribing information, visit http://www.nexavar.com/ or call 1.866.NEXAVAR (1.866.639.2827).
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is engaged in the development of novel cancer therapies that target the molecular basis of cancer. With its collaborators, the company is developing small molecule drugs, including Nexavar with Bayer Pharmaceuticals Corporation. For more information about Onyx's pipeline and activities, visit the company's web site at:
http://www.onyx-pharm.com/ .
About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation (http://www.bayerpharma.com/) is part of the worldwide operations of Bayer HealthCare AG, a subsidiary of Bayer AG.
Bayer HealthCare AG, with sales of approximately 9.4 billion Euros in 2005, is one of the world's leading, innovative companies in the healthcare and medical products industry. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals divisions. Bayer Pharmaceuticals Corporation is part of the new Global Pharmaceutical Division, established January 1, 2006, which consists of the former Biological Products and Pharmaceutical Division and now comprises three business units: Hematology/Cardiology; Oncology and Primary Care. Bayer HealthCare AG employed 33,800 people worldwide in 2005.
Bayer HealthCare AG's aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.
Forward Looking Statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including its Form 20-F). Bayer assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
This news release also contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the timing, progress and results of the clinical development, regulatory processes, and commercialization efforts of Nexavar. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2005, filed with the Securities and Exchange Commission under the heading " Risk Factors" and Onyx's Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date of this release except as required by law.
Nexavar(R) (sorafenib) tablets is a registered trademark of Bayer Pharmaceuticals Corporation.
Bayer Pharmaceuticals Corporation; Onyx Pharmaceuticals, Inc.
CONTACT: Mark Bennett of Bayer Pharmaceuticals Corporation,
+1-203-812-2160, or Dr Michael Diehl of Bayer HealthCare Communications,
+49-214-30-58532, or Julie Wood of Onyx Pharmaceuticals, Inc.,
+1-510-597-6505, or Geoff Curtis of GCI Group, +1-312-229-8702
Web Sites:
http://www.nexavar.com/
http://www.onyx-pharm.com/
http://www.bayerpharma.com/
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Hepatitis C Patients Benefit from Combination of VX-950 and Pegylated Interferon
SourceURL:http://www.medicalnewstoday.com
By Jill Stein
The experimental oral protease inhibitor VX-950, dosed in combination with pegylated interferon alfa-2a (PegasysR; peg-IFN), is potent and well tolerated in patients with chronic genotype 1 hepatitis C virus (HCV) infection, researchers announced at the 41st Annual Meeting of the European Association for the Study of the Liver (EASL).
Henk W. Reesink, MD, with the Academic Medical Center in Amsterdam, the Netherlands, reported phase 1b results in 20 patients who were treated with a tablet formulation of VX-950 at a dose of 750 mg every eight hours in combination with a standard dose of peg-IFN, the same dose of VX-950 administered alone, or a standard dose of peg-IFN alone. Patients had not undergone prior treatment with interferon and/or ribavirin.
In a 14-day study reported previously, VX-950 was well tolerated and had substantial antiviral effects. All patients had at least a 2-log decrease in viral load in two days and a decrease in median HCV RNA of 4.4-log10 at the end of dosing in the best dose group
In the present trial, the median baseline viral load for the entire cohort was 6.65 log10 IU/mL HCV RNA, or about 4.4 million IU/mL.
Results showed that the combination treatment yielded an initial median reduction in plasma HCV RNA that exceeded 3 log10 in the first two days.
Antiviral results after 14 days of dosing showed a median 5.5 log10 reduction in HCV RNA in patients receiving VX-950 and peg-IFN; six of eight patients had viral levels below the limit of quantitation (30 IU/mL) at 14 days, and four of eight also achieved viral levels below the limit of detection (10 IU/mL).
A median 4.0 log10 reduction in HCV RNA was observed in patients receiving VX-950 alone; one of eight patients had viral levels below the limit of detection (10 IU/mL).
A median 1.0 log10 reduction in HCV RNA was documented in patients receiving peg-IFN alone; no patient had viral levels below the limit of quantitation (30 IU/mL) at 14 days.
All patients completed dosing, and no serious adverse events were reported. All adverse events in the group who received VX-950 were mild.
Following the completion of this study, patients were offered a full course of treatment with peg-IFN and ribavirin.
All eight patients in the combination group opted to receive treatment with peg-IFN and ribavirin. After three months, all eight patients were shown to have undetectable levels of HCV RNA.
The continued viral suppression during follow-on therapy points to the robustness of the viral response to VX-950 and peg-IFN and is encouraging for the design of future VX-950 studies that assess the potential for short-course, curative therapy, Dr. Reesink said.
With a growing number of HCV patients seeking treatment as their disease progresses, there is an urgent need for improved therapies, he added.
Finally, he said that future studies will assess whether VX-950 combined with peg-IFN will permit HCV eradication with significantly shorter length of treatment.
The study was funded by Vertex Pharmaceuticals Incorporated in Cambridge, Massachusetts.
Jill Stein is a Paris-based freelance medical writer.
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The Ticking Time Bomb of Liver Disease
SourceURL:http://www.timesonline.co.uk/
Dr Thomas Stuttaford
A new form of treatment for hepatitis C promises a cure within 24 weeks
Last week, amid the former imperial glories of Vienna, and its still glorious shops and cafés selling sacher torte and other cakes oozing cream, hepatologists from all over the world gathered for the annual meeting of the European Association for the Study of Liver Diseases. Between mouthfuls of cream they discussed the prognosis of patients suffering from hepatitis C infection and the incidence of alcoholic hepatitis and cirrhosis in young South Asians who drink only in moderation.
The incidence of cirrhosis is increasing and greater knowledge of its pathology has shown that, contrary to popular opinion, most cirrhosis is not the result of excessive alcohol. Research has also emphasised the difficulty of knowing which drinkers will suffer alcoholic cirrhosis and the variability of the amount of alcohol needed to cause it. Forty years ago hepatitis A, B, C (in all there are six genotypes of hepatitis C), D, E and G were all lumped together under the diagnosis of viral hepatitis or viral jaundice. Once hepatitis A and B had been recognised the rest were known as hepatitis non A and non B. Hepatitis C was identified only in 1989.
Hepatitis A, the most common hepatitis caused by virus, can be totally disabling in its acute phase, but it is clinically less important as sufferers recover and it never leads to cirrhosis. Immunisation against it is possible and indicated for all those who travel overseas.
Hepatitis B is a problem that was previously confined to those in the developing world, or to people whose work exposed them to contaminated blood or body fluids. Easy travel and mass migration has now made this a global problem and the immunisation programme needs to take account of these changes.
Delegates at the conference heard that an increasing number of patients are showing a long-term sustained response to treatment -- the earlier it is started the better -- with a comparatively new drug, Pegasys. Fortunately, therefore, treatment of hepatitis B is improving just as its pathology in the UK is altering for the worse.
The great worry is now the ubiquitous but frequently hidden hepatitis C. Between 270 million and 300 million people worldwide, 3 per cent of the world's population, are infected with one of the six genotypes of hepatitis C. The numbers in the UK are unknown as nine out of ten people carrying the virus are unaware that they have it. It is estimated that there are at least 450,000 people with it.
Most are unaware that they have hepatitis C because its onset is insidious, hence the comparison with a ticking time bomb. Twenty to 50 years after some long-forgotten exposure to someone else's blood or body fluid, 20 to 30 per cent of infected cases will suddenly find out the cause of their symptoms. Initially these may be no more troublesome than tiredness, increasing lethargy and general listlessness. Only when these feelings of general malaise are investigated by a blood test will the true diagnosis be made and treatment started.
The severity of the hepatitis C infection and its ease of treatment is likely to be related to the genotype. Genotype 1 is the most common in Britain and is also the most difficult to treat. Type 2 and 3, sometimes referred to as non-type 1 hepatitis C, respond more rapidly and more completely to modern treatment. Genotype 4, like genotype 1, is difficult to treat.
The good news announced in Vienna is that research has shown that the long-term treatment of genotype 2 and 3 with Pegasys (peginterferon alfa-2a) and Ribavirin will now give optimum results with only 24 weeks' treatment. This combination will, in two thirds of cases, clear the virus from the blood of a patient with hepatitis C. In patients who haven't genotype 1 or 4, results of combination therapy are even better. In some trials more than 80 per cent of cases have now been cured. Eight years ago the overall percentage of cures when considering all the genotypes combined was only 6 per cent.
The next stage in beating hepatitis C is to produce an approved programme that will detect the disease at an earlier stage. We can learn from other countries where early diagnosis of hepatitis C is much better. This is one disease where early treatment would be a saving.
More prompt diagnosis would not only spare the minority who are going to develop cirrhosis and eventually die from liver failure after years of ill health; it would also save the NHS the bills that are associated with any chronic disease, and the social services the cost for caring for patients when they are no longer capable of work.
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Vaccine for Hepatitis C in Clinical Trial
SourceURL:http://www.upi.com
ST. LOUIS, May 3 (UPI) -- Saint Louis University Center for Vaccine Development is conducting a human clinical trial involving investigational vaccines to prevent Hepatitis C.
Two hundred volunteers are needed, and SLU is the only site in the United States conducting the study.
"Sixteen years ago, the hepatitis C virus had not even been identified and now there are an estimated 170 million people around the world infected," said Dr. Sharon Frey, professor of internal medicine in the division of infectious disease at Saint Louis University School of Medicine.
"It is critical that we develop a vaccine to combat this growing health problem."
The Centers for Disease Control and Prevention in Atlanta estimates that approximately 40,000 new cases of hepatitis C infections occur every year, and it is responsible for almost half of the 4,000 liver transplants each year.
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Chronic Hepatitis in Pediatric Liver Transplant Patients
SourceURL:http://www.eurekalert.org
A new study on the long-term outcome of children undergoing liver transplants found that chronic hepatitis (CH) was common and that it was not detectible using standard blood tests. The presence of autoantibodies (antibodies that attack the body's own tissues) in these patients indicates that although not fully understood, CH may be related to the immune response.
The results of this study appear in the May 2006 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD). Published by John Wiley & Sons, Inc., Hepatology is available online via Wiley InterScience at
http://www.interscience.wiley.com/journal
/hepatology.
Children normally undergo liver transplants for diseases that do not recur and are potentially curable by the procedure. Although their long-term survival rates are over 80 percent, little is known about tissue changes that occur over time in these young patients. "An important question within the field of paediatriac liver transplantation is whether children who have undergone successful transplantation can expect a normal life expectancy or whether there will be a gradual decline in liver function and eventual graft loss," the authors write.
Led by Helen M. Evans of the Birmingham Children's Hospital in Birmingham, United Kingdom, the study involved children who received liver transplants at the hospital's Liver Unit between 1983 and 1996. Patients underwent standard liver function tests, sonograms and liver biopsies at approximately 1, 5 and 10 years following transplant, and autoantibodies were measured at 5 and 10 years. A total of 113 children had liver biopsies at the one year mark, 135 had biopsies after 5 years, and 64 underwent biopsies at 10 years.
The results showed that there was a decrease over time in the proportion of biopsies considered to be normal, with chronic hepatitis being the most common abnormality (22 percent at 1 year, 43 percent at 5 years, 64 percent at 10 years). While liver function tests at 5 years were not significantly different in children who had CH, the presence of autoantibodies was significantly higher at 5 and 10 years in children with CH (72 percent and 80 percent respectively). In addition, there was a strong association between the presence of CH and the development of progressive fibrosis (the formation of scar-like tissue). The authors note that "the finding of increasing fibrosis in children with chronic hepatitis has not been reported before and has potentially important implications for long term graft function."
The authors note that transient autoantibody production following transplant sometimes occurs during episodes of rejection. In addition, late rejection may be associated with tissue changes that are different to those normally seen in acute rejection but more closely resemble those seen in chronic viral or autoimmune hepatitis. "It is therefore possible that some cases of otherwise unexplained chronic hepatitis in the liver allograft may represent a form of late cellular rejection," the authors suggest.
The results of the present study indicate that important tissue abnormalities can be detected in biopsies obtained from children who are clinically well and have normal liver function tests, the authors state. "Screening for chronic allograft hepatitis using liver biochemistry is therefore not possible and may instead require regular measurement of autoantibodies," they conclude.
Article: "Progressive Histological Damage in Liver Allografts Following Pediatric Liver Transplantation," Helen M. Evans, Deirdre A. Kelly, Patrick J. McKiernan, Stefan G. Hubscher, Hepatology; May 2006 (DOI: 10.1002/hep.21152).
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Community Health Centers Urge Screening and Awareness as National Hepatitis Awareness Month Kicks Off
SourceURL:http://news.yahoo.com
WASHINGTON, May 2 /U.S. Newswire/ -- More than 800 new cases of hepatitis C (HCV) have been diagnosed in six Community Health Centers as part of a pilot initiative which began less than one year ago. Community Health Centers across the country are urging early screening, diagnosis and treatment of the disease as National Hepatitis Awareness Month kicks off today.
There are approximately 30,000 cases of acute hepatitis C each year in the U.S. Around 55 percent to 85 percent of people who are exposed to the virus become chronically infected. The Centers for Disease Control and Prevention ( CDC) estimates that the number of deaths from end-stage liver disease in the U.S. alone will reach 30,000 to 40,000 annually by the year 2010.
Hepatitis C is spread primarily by direct contact with blood of an HCV infected person. The majority of new infections are acquired through intravenous drug use. Hepatitis C testing is recommended for persons who ever injected illegal drugs, received blood products or organs before 1992, were treated with hemodialysis, have had a needlestick injury in a workplace setting, born to a mother with hepatitis C, or have undiagnosed liver disease.
Many people are unaware of their infection because chronic hepatitis C is often asymptomatic over many years, and for this reason, it is under-diagnosed. Untreated, hepatitis C can lead to cirrhosis and liver cancer, either of which can be fatal. The CDC estimates that nearly 4 million Americans are infected with the virus.
The National Association of Community Health Centers, Inc. (NACHC) piloted a state-of-the-art clinical education and training program in July 2005 to better prepare primary care clinicians at community health centers to diagnose and treat Hepatitis C.
According to Thomas Curtin, MD, NACHC chief medical officer, "There is no question that hepatitis C is prevalent within the community health center patient populations. It is important that these centers play a vital role in identifying at-risk patients and include liver wellness as part of the regimen. Lifestyle changes, and treatment when indicated, can make a difference in the progression of their liver disease."
NACHC has focused energy and resources, through a grant from Roche, to initiate an HCV treatment program at six pilot sites in 2005 and currently is planning for an additional 12 health centers to participate in 2006 - 2007.
"It's staggering, the number of cases we're seeing," says Paul Stabile, PA-C, director of Clinical Care at William F. Ryan Community Health Center in New York City, a participating health center in the NACHC HCV Initiative. "In order for us to successfully combat this disease, people need to be screened for risk factors, tested for the disease, diagnosed, educated and treated if applicable."
Linda Norris, the project manager for the NACHC HCV Initiative says, "While the major focus of the NACHC HCV Initiative is on clinical education and training of health center providers to keep the treatment of HCV at the patients' medical homes, we are equally concerned with prevention, screening and awareness and are taking steps to educate our patients and the public about this growing threat to public health."
During the month of May, and all year long, Community Health Centers encourage individuals who may be at risk, to get screened for Hepatitis C by their primary care physician and if necessary, get treatment as soon as possible. For more information visit http://www.nachc.com
EDITOR'S NOTE: Individuals quoted in this release are available for interviews upon request. Call 301-347-0400 for Tom Curtin, M.D., and Linda Norris. For Paul Stabile, contact 212- 749-1820.
Established in 1971, NACHC is a non-profit organization whose mission is 1) to represent the interests of federally supported and other federally qualified health centers and 2) to serve as an information source concerning issues of health care for poor and medically underserved populations in the United States.
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May 3rd, 2006
Hospital Mishap May Have Exposed 300 Patients to HIV or Hepatitis
SourceURL:http://www.sfgate.com/
By THOMAS WATKINS, Associated Press Writer
State health officials are investigating a mishap at Scripps Memorial Hospital that may have exposed nearly 300 obese patients who underwent stomach-reduction surgery to hepatitis or HIV.
Scripps officials said Wednesday the patients had a "very low" risk of infection because a registered nurse had knowingly violated operating room procedures. The female nurse, whose name was not released, failed to fully clean a gastroscope, which is used to retrieve other surgical instruments from the stomach.
The nurse worked at the hospital from September 2004 until last month when she resigned after hospital officials confronted her about the issue.
"This employee was aware of the procedures and chose not to follow them, which is something we do not tolerate," said Scripps spokesman Don Stanziano.
The hospital has contacted 250 of the 299 patients at risk, many of whom reside outside Southern California.
Lea Brooks, a spokeswoman for Department of Health Services, said investigators would examine what happened and what Scripps is doing to ensure problems are fixed. The hospital will have to prepare a plan of corrective action, Brooks said.
The state Department of Consumer Affairs will decide whether to initiate disciplinary action against the nurse.
Stanziano said the chances of infection were remote because the gastroscopes had undergone preliminary washes and rinses, although they were not sterilized with chemicals.
"We have been assured by both local and national experts the risk of infection is very low," said Stanziano. "HIV is a fragile virus so it is unlikely to have survived the process."
Brooks added that Hepatitis B and C viruses pose a slightly higher risk of transmission, but the risk remains low.
Patients undergoing stomach-reduction or bariatric surgery are considered morbidly obese -- more than 100 pounds overweight. The procedure is also known as stomach stapling.
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Idenix Obtains Promising Hepatitis Trial Data
SourceURL:http://www.pharmaceutical-business-review.com
By Helen Marshall
Idenix Pharmaceuticals has reported positive preliminary results from an ongoing phase IIb clinical trial investigating a 200mg/day dose of valopicitabine plus pegylated interferon in hepatitis C patients.
Valopicitabine (NM283) 200mg/day demonstrated comparable antiviral activity to the results obtained in the 800mg/day-containing arms in a preliminary analysis of an ongoing phase IIb clinical trial in treatment-naive genotype 1 patients at 12 weeks of treatment.
To date in this clinical trial, the 200mg/day dose has also demonstrated improved tolerability compared to the 800mg/day dose.
"More than 70% of patients receiving this regimen achieved viral clearance at week 12 utilizing the Amplicor assay's lower limit of quantification of 600 copies/mL, which is substantially higher than we generally see in clinical practice in HCV genotype 1 patients," noted Dr Douglas Dieterich, professor of medicine at the Mt Sinai School of Medicine, New York and an investigator in the study.
In the 200mg/day arm, 87% of patients achieved an early virologic response (EVR), defined as greater than or equal to 2 log10 (100-fold) reduction in virus after 12 weeks of treatment, compared to 88% in the pooled 800mg/day arms.
At 12 and 16 weeks, 71% and 73%, respectively, of patients in the 200mg/day arm reached undetectable virus levels below 600 copies/mL compared to 73% and 74% in the pooled 800mg/day arms.
After 12 and 16 weeks, 45% and 62%, respectively, of patients in the 200mg/day arm reached undetectable virus levels below 20 copies/mL, compared to 56% and 61% in the pooled 800mg/day arms.
In addition, through 12 weeks of treatment, in the ongoing phase IIb clinical trial, discontinuations in the 200mg/day arm occurred at a rate significantly less than the higher dosing regimens, at 6% and 22%, respectively. Through week 12, a total of 24 patients discontinued for adverse events, with two occurring in the 200mg/day arm.
Idenix is developing valopicitabine, and other hepatitis drug candidates, in collaboration with Novartis Pharma.
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May 4th, 2006
XTL Biopharm:Dosing Begins in Phase 1 Hepatitis C Trial
SourceURL:http://www.therapeuticsdaily.com/
Dow Jones Newswires
XTL Biopharmaceuticals Ltd. (XTLB) began patient dosing in a Phase 1 clinical trial of XTL-2125 for the treatment of chronic hepatitis C.
XTL, Rehovat, Israel, said the trial is a placebo-controlled, randomized, dose-escalating study, which will evaluate the safety, tolerability and anti-viral activity of single and multiple doses of XTL-2125.
Each patient will receive a single dose, followed by a 14-day multi-dosing regiment beginning one week after the single-dose administration.
Jonathan Vuocolo; 201-938-5400; AskNewswires@dowjones.com
(END) Dow Jones Newswires
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Employer Pays $24,000 for Hepatitis C Firing
SourceURL:http://www.belleville.com
Associated Press
ST. LOUIS - A former convenience store employee who was fired for having Hepatitis C has been awarded $24,000 in a lawsuit settlement, the U.S. Equal Employment Opportunity Commission said Thursday.
The EEOC sued Hoffmann Oil Co. in September for violating the Americans with Disabilities Act with the dismissal. The gas station and convenience store in Montgomery City agreed to pay the cashier $24,000, according to the EEOC.
Barbara Seely, an EEOC attorney, said she could not release the employee's name. A message left by The Associated Press with an owner at Hoffmann Oil was not immediately returned Thursday.
The lawsuit said Hoffmann Oil fired the woman on March 5, 2003, one day after she started her job, when it learned she had Hepatitis C. The company in the small town between Columbia and St. Louis recruited the woman after a supervisor observed her doing a good job at another convenience store.
The company was afraid she would spread the virus to customers and other employees, the EEOC said, but the county health department said that wouldn't happen if she took normal precautions.
The Centers for Disease Control has stated in a similar case that the possibility of transmission is slight and that employees should not be dismissed on that basis, the commission said.
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Hepatitis C Awareness Tour Stops at Rooster’s Roadhouse in Alameda, CA
http://www.prweb.com/
Kelly's Lot and HCVAdvocate.org are reaching out to folks near Alameda, CA with a concert at Rooster’s Roadhouse, Thursday, May 11, 10 p.m. $7 Cover (1700 Clement Ave., Alameda 510-337-9190). The Alameda concert is part of a California tour that brings Kelly’s Lot to the steps of the State Capitol as well as concerts in Paradise and Yuba City.
Alameda, CA (PRWEB) May 5, 2006 -- National spokesband for the national Hep C Coalition, So Cal blues and roadhouse rock band Kelly’s Lot, is reaching out to Northern California with a series of Hep C events and concerts bringing them to Rooster’s Roadhouse, Thursday, May 11, 10 p.m. $7 Cover (1700 Clement Ave., Alameda 510-337-9190). The Alameda concert will follow a successful California tour that brings Kelly’s Lot to the steps of the State Capitol as well as concerts in Paradise and Yuba City. The bands performance at Roosters is dedicated to the Hepatitis C Support Project based in San Francisco, CA. and those who come out to see Kelly's Lot in Alameda will receive a free CD.
Los Angeles-based Kelly's Lot was formed by lead singer Kelly Zirbes. After losing a friend to Hep C, Kelly decided to use her music to raise awareness of this serious and stigmatized illness. "A spoon full of music helps the awareness go down," say Zirbes. "After using music to educate the public for over 5 years I have realized it works and am excited to work with The Hepatitis C Support Project to raise awareness in Northern California."
The Hepatitis C Support Project (www.hcvadvocate.org) is a registered national non-profit under the direction of Alan Franciscus. The goal of the organization is to provide education and support to people with Hepatitis C (HCV) and HIV/HCV coinfection and help them partner with medical professionals to make informed decisions for disease management and treatment. Services provided by HCSP include a comprehensive Web site (www.hcvadvocate.org), various publications and educational materials, and a national HCV training program.
Hepatitis C is a systemic blood borne virus that primarily attacks the liver. One in 50 Americans have HCV yet two out of three of them do not know it. There is no vaccine for Hepatitis C.
You may have been exposed to Hepatitis C and should get tested if you have:
- received blood, blood products, or an organ transplant prior to 1992
- ever shared drug paraphernalia, either by injecting or snorting
- ever been stuck by a used blood needle
- been on kidney dialysis
- had a tattoo or body piercing
- had sexual activity that involves contact with blood
- shared personal care items (razors, toothbrushes, etc.) with other people
- been incarcerated
- are a war veteran (especially Vietnam)
Get tested now: www.hcvadvocate.org
National Hep C Spokesband Kelly’s Lot
Brings Awareness Tour to Rooster’s Roadhouse
Thursday, May 11, 10 p.m.
Concert to Bring Awareness to San Francisco's
Hepatitis C Support Project
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