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Week Ending: November 12th, 2005
Alan Franciscus
Editor-in-Chief
To download pdf version click here
This Issue:
• Seale Success Supports Need for Organ Donors
• Data on Schering-Plough's Oral HCV Protease Inhibitor to Be Presented for First Time at American Association for the Study of Liver Diseases (AASLD) Meeting
• Job Helps Eileen Cope with Hepatitis
• Hepatitis C Often Untreated and Outcomes Lag behind Trials in Clinical Practice: Presented at ACG
• iQur Ltd Closes B#2.6 Million Investment, Wins Major DoH Award for Healthcare New Hampshire Public Radio Series Examines 'Building Wave' of Hepatitis C in State
• New Hampshire Public Radio Series Examines 'Building Wave' of Hepatitis C in State
• Health Care Workers Want Safety Needles Made Mandatory in British Columbia
• Veterans at Risk: Hepatitis C Still Serious Risk
• ViroPharma Announces that Treatment with HCV-796 Reduces Hepatitis C Virus Levels
• Alcohol Use Progresses Hep C-Related Cirrhosis
• Preventing Hemodialysis after Liver Transplant
• AASLD Issues Call for Americans to Fight Liver Disease as Screening Reveals Alarmingly High Prevalence of Hepatitis B Among Asian Americans
• Ascites Impairs Gastric Function in Cirrhosis
• Vertex Applies to Take Hepatitis C Drug to Phase II Trials
• Major Milestone Reached in Hepatitis C Vaccine Program
• New Studies with Pegasys plus Copegus in Hepatitis C Treatment to be Presented at AASLD Annual Meeting
• Cambridge Biotech Develops Hepatitis C Pill
• Pine Man Alerts Rim Country Residents about Hepatitis C
• Valopicitabine (NM283) Combined with Pegylated Interferon Demonstrated Significantly Greater Suppression of Hepatitis C Virus (HCV) Replication in Treatment-Refractory Patients Compared to Retreatment with Ribavirin Plus Pegylated Interferon
• Calif. Liver Program Closed after Decertification
• Peg-Intron® and Rebetol® Combination Therapy Demonstrates Consistently High Response Rates across Patient Weight Groups in “Real-Life” Treatment Setting
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November 7th, 2005
Seale Success Supports Need for Organ Donors
http://www.corsicanadailysun.com
LOYD COOK
The thought of donating your organs makes you squeamish? You want to take them with you when you die?
The Seale family of Kerens is happy one caring person didn't feel that way, donating organs that will help not only oldest child John David who got two lungs, but others who will use that person’s eyes, liver, heart and kidneys to live on.
“I know it was an answer to a prayer,” Becky Seale, John’s mother, said this week. “I know God works his miracles too ... but we needed a donor.”
Pam Silvestri, the community/media services director for the Southwest Organ Bank, said this region saw a 28 percent increase in donations from 2002 to 2003 and then another 7 percent increase in 2004.
“(But) there are still more than 90,000 people waiting and while an average of 70-plus people get transplants daily, an average of 17 people die each day before the organs they need become available,” Silvestri wrote in an e-mail to the Daily Sun Thursday.
Silvestri listed several misconceptions related to organ donation that many people believe.
• If a person designates that he or she wants to be a donor “they” won't try to save his life but will let him or her die in order get the organs. “Hospitals are there only to save lives ... and only if a life can't be saved will that person be referred for donation,” Silvestri wrote. “And the family sill has to say ‘yes.’”
• That some people are too old, too sick or “had too much fun in life” to be considered for organ donation. “Folks shouldn't rule themselves out, the health of the organ is more important than age,” she wrote. “Many cancer survivors rule themselves out, and many diabetics, or those with hepatitis ... none are ‘rule outs’.”
• Organ donation rules out a normal funeral service because a donor will be too cut up. “Not true,” Silvestri explained in the e-mail. “All we do is make a midline incision and carefully remove the organs, then suture the incision.”
• Organ donation costs the donor’s family money. “It doesn’t ... organ donation agencies pick up all costs and those costs are passed along to organ recipients and their insurance companies,” Silvestri stated.
• Organ recipients can’t be organ donors. “They can and many already have been,” she added.
Silvestri stressed it is important for people interested in donating organs to talk with their families about it to make sure their wishes are honored.
Becky Seale said they know nothing about the donor who passed his or her lungs along to her son. They only know at this time that those lungs had to be flown into Dallas for John David’s transplant surgery. But, she said, the family of the donor has a year to contact the Seale family if they want to.
“It’s sad that someone had to die for John to live,” Becky said. “But their (the donor’s) legacy lives on in John. They’re not jest put in the ground, they get to live on.
“I know it was an answer to prayer ... God works his miracles too ... but we had to have a donor.”
For more information about organ donation, call (800) 788-8058 or visit www.organ.org on the Internet.
Loyd Cook may be contacted via e-mail at loydcook@corsicanadailysun.com
Transplant facts: Why donate?
• A single donor can save or enhance the lives of up to 50 people
• Approximately 74 organ transplants take place every day in the United States.
• A living donor can supply a kidney or a portion of their liver, lung, pancreas or intestine.
• About three-quarters of all living donors are relatives of their recipient, most commonly siblings.
• The number of unrelated living donors has nearly tripled since ’98.
• An average of 17 patients a day die waiting for a transplant.
• About 118 people are added to the nation’s transplant waiting list each day; one every 10 minutes.
• More than 90,000 people are currently waiting for an organ transplant in the U.S.; about 600 of them are 5 years old or younger.
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Data on Schering-Plough's Oral HCV Protease Inhibitor to Be Presented for First Time at American Association for the Study of Liver Diseases (AASLD) Meeting
SourceURL:http://biz.yahoo.com
Final Results of PEG-INTRON(R) Combination Therapy Studies Also Presented
KENILWORTH, N.J., Nov. 7 /PRNewswire-FirstCall/ -- Important new data on Schering-Plough's investigational oral protease inhibitor in development for treating hepatitis C virus (HCV) infection will be presented for the first time at the 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) at the Moscone West Convention Center, San Francisco, Calif., November 11-15, 2005.
Study investigators will report Phase I clinical study results with protease inhibitor SCH 503034 capsules, both as monotherapy and in combination therapy with PEG-INTRON® (peginterferon alfa-2b), in patients with chronic hepatitis C genotype 1 who were nonresponders to previous therapy, including previous peginterferon combination therapy. Currently, there are no products approved for treating patients who failed previous therapies, representing an area of great unmet medical need.
Investigators also will present final results of major clinical studies with PEG-INTRON and REBETOL® (ribavirin, USP) combination therapy in patients with HCV, as well as results of large-scale prospective and retrospective analyses of "real-world" treatment data with PEG-INTRON combination therapy. Pharmacoeconomic analyses of the cost-effectiveness of PEG-INTRON combination therapy also will be presented.
In total, 67 abstracts involving Schering-Plough hepatitis therapies will be presented at AASLD, including eight oral presentations.
Hepatitis C is the most common blood-borne infection in America and the most common form of liver disease, affecting nearly 4 million people -- or one in 50 adults -- in the United States and 200 million people worldwide.
HCV Protease Inhibitor (SCH 503034)
Oral Presentations
Anti-Viral Activity of SCH 503034, a HCV Protease Inhibitor, Administered as Monotherapy in Hepatitis C Genotype-1 (HCV-1) Patients Refractory to Pegylated Interferon (Peg-IFN-a), Zeuzem S. et al. Presidential Plenary I, Moscone West General Session Room, Monday, Nov. 14, 8:45 - 9:00 am.
Combination Therapy with the HCV Protease Inhibitor, SCH 503034, plus PEG-INTRON in Hepatitis C Genotype-1 PEG-INTRON Nonresponders: Phase Ib Results, Zeuzem S. et al. Parallel Session 29, Moscone West Rooms 3016/3018/3020, Tuesday, Nov. 15, 11:45 - 12:00 pm.
Poster Presentations
Single Dose Pharmacokinetics of a Novel Hepatitis C Protease Inhibitor, SCH 503034, in an Oral Capsule Formulation, Zhang J. et al. Moscone West Exhibit Hall, Monday, Nov. 14, 8:00 am - 6:30 pm.
SCH 503034, a Mechanism-Based Inhibitor of Hepatitis C virus (HCV) NS3 Protease Suppresses Polyprotein Maturation and Enhances the Antiviral Activity of Interferon alfa-2b (INF), Malcolm B.A. et al. Moscone West Exhibit Hall, Monday, Nov. 14, 8:00 am - 6:30 pm.
Modeling of Hepatitis C Viral Dynamics During Combination Therapy with Peginterferon alfa-2b (PEG-INTRON) and the NS3 Protease Inhibitor SCH 503034, Malcolm B.A. et al. Moscone West Exhibit Hall, Tuesday, Nov. 15, 8:00 am - 12:30 pm.
PEG-INTRON and REBETOL Combination Therapy
Oral Presentations
Weight-Based Ribavirin Dosing (WBD) Increases Sustained Viral Response (SVR) in Patients with Chronic Hepatitis C (CHC): Final Results of the WIN-R Study, a US Community Based Trial, Jacobson I. et al. Parallel Session 33, Moscone West General Session Room, Monday, Nov. 14, 3:00 - 4:45 pm.
Double-Dose Peginterferon Alfa-2b with Weight-Based Ribavirin Improves Response for Interferon/Ribavirin Nonresponders with Hepatitis C: Final Results of "RENEW", Gross J. et al. Parallel Session 08, Moscone West General Session Room, Sunday, Nov. 13, 6:00 - 6:15 pm.
Poster Presentations
PEG-INF alfa-2b (1.5 mcg/kg/wk) + ribavirin (800-1400 mg daily) is Significantly More Effective than PEG-INF alfa-2b (1.0 mcg/kg/wk) + ribavirin (800-1400 mg daily) in men with G1 and women with G2/3: Final Results of a Prospective, Randomized, Controlled Trial, Flamm S.L. et al. Moscone West Exhibit Hall, Tuesday, Nov. 15, 8:00 am - 12:30 pm.
Efficacy of PEG-IFN Alfa-2b vs. PEG-IFN Alfa-2a + Ribavirin Regimens in Treatment-Naïve Chronic HCV Patients: A Cumulative Meta-Analysis of Retrospective Data from 6 Clinic Sites, Almasio P. and the HCV Meta-Analysis Working Group. Moscone West Exhibit Hall, Tuesday, Nov. 15, 8:00 am - 12:30 pm.
PEG-INTRON Prospective Optimal Weight-Based Dosing Response Program (POWER): Preliminary Results, Abadir N. et al. Moscone West Exhibit Hall, Tuesday, Nov. 15, 8:00 am - 12:30 pm.
A Pharmacoeconomic Analysis of the Registration Trials: Peginterferon Alfa-2a plus Ribavirin versus Peginterferon Alfa-2b plus Ribavirin for Treatment of Genotype 1 Chronic Hepatitis C, Kamal A. et al. Moscone West Exhibit Hall, Saturday, Nov. 12, 2:00 - 8:00 pm.
Cost-Effectiveness of Peginterferon Alfa-2b plus Ribavirin for Chronic Hepatitis C in HIV/HCV Co-Infected Patients, Wong, J.B. et al. Moscone West Exhibit Hall, Tuesday, Nov. 15, 8:00 am - 12:30 pm.
Important Information Regarding U.S. Labeling for PEG-INTRON and REBETOL
WARNING
Alpha interferons, including PEG-INTRON, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping PEG-INTRON therapy.
Ribavirin causes hemolytic anemia. Anemia associated with REBETOL therapy may exacerbate cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with REBETOL. It is advised that complete blood counts (CBC) be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically indicated.
REBETOL and combination REBETOL/PEG-INTRON therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and during the 6 months after stopping therapy. REBETOL and combination REBETOL/PEG-INTRON therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use effective contraception (at least two reliable forms) during treatment and during the 6-month post-treatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of REBETOL. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064.
PEG-INTRON
There are no new adverse events specific to PEG-INTRON as compared to INTRON® A (interferon alfa-2b, recombinant) for Injection, however, the incidence of some (e.g., injection site reactions, fever, rigors, nausea) were higher. The most common adverse events associated with PEG-INTRON were "flu-like" symptoms, occurring in approximately 50% of patients, which may decrease in severity as treatment continues. Application site disorders were common (47%), but all were mild (44%) or moderate (4%) and no patient discontinued, and included injection site inflammation and reaction (i.e., bruise, itchiness, irritation). Injection site pain was reported in 2% of patients receiving PEG-INTRON. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEG-INTRON.
Psychiatric adverse events, which include insomnia, were common (57%) with PEG-INTRON, but similar to INTRON A (58%). Depression was most common at 29%. Suicidal behavior including ideation, suicidal attempts, and completed suicides occurred in 1% of patients during or shortly after completing treatment with PEG-INTRON.
PEG-INTRON/REBETOL is contraindicated in patients with autoimmune hepatitis, decompensated liver disease, and in patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).
The following serious or clinically significant adverse events have been reported at a frequency less than 1% with PEG-INTRON or interferon alpha: severe decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia, hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, some resulting in patient deaths), urticaria, angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages, and cotton wool spots.
In the PEG-INTRON/REBETOL combination trial the incidence of serious adverse events was 17% in the PEG-INTRON/REBETOL groups compared to 14% in the INTRON A/REBETOL group. The incidence of severe adverse events in the PEG-INTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL group and 31-34% in the PEG-INTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEG-INTRON (1.5 mcg/kg)/ REBETOL and in 34% of those receiving INTRON A/REBETOL.
REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.
Schering-Plough Corporation is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company's Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: This press release contains "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, related to the market for PEG-INTRON and REBETOL combination therapy and the market for drugs to treat hepatitis C. Forward-looking statements relate to expectations or forecasts of future events and not to historical information. Schering-Plough does not assume the obligation to update any forward-looking statement. There are no guarantees about the market performance of PEG-INTRON and REBETOL combination therapy, Schering-Plough stock or Schering-Plough's business. Actual results may vary materially from Schering-Plough's forward-looking statements due to many factors and uncertainties, which include the market acceptance of PEG-INTRON and REBETOL combination therapy, trade buying patterns, the introduction and performance of competitive products in the market, legislation that may impact the pricing/availability of PEG-INTRON and REBETOL combination therapy and other uncertainties. For further details about these factors and other risks and uncertainties that may impact Schering-Plough's forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including the company's third quarter 2005 10-Q.
Source: Schering-Plough Corporation
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November 8th, 2005
Job Helps Eileen Cope with Hepatitis
SourceURL:http://icsurreyonline.icnetwork.co.uk/
A NURSE living with hepatitis C says her job has helped her cope with the disease - despite having caught it while treating a patient.
Previously a fit and healthy bodybuilding and fencing enthusiast, Eileen Rendle, from Sutton, says the illness has left her 80 per cent less active because of chronic fatigue.
But she remains positive and said: "I have never let it rule my life. You just have to bounce back and get on with it."
Eileen, 56, caught the chronic liver disease in 1987, but it remained undiagnosed for almost 10 years until she cut her finger on a needle after injecting a patient.
A new test for hepatitis C showed she had the disease but, as the patient did not, she believes she caught it from a similar accident in 1987.
As the virus does not usually affect people until they have had it for 15 or 20 years, Eileen's condition went unnoticed, and even after she was diagnosed it was another eight years before she really felt the effects.
After undergoing surgery for lifelong heart problems in February 2003, Eileen noticed she was becoming more tired and the medication for her heart troubles started to affect her liver. The treatment, similar to chemotherapy, disagreed with Eileen and she only managed three months of it from February 2004 before she had to be taken off it.
She said: "It was terrible, absolutely horrendous. After three months I had anaemia because all my red blood cells had been eaten up.
"I nearly died from septicaemia and spent four months in St Helier Hospital. I've just had an ultrasound and the results aren't very good. I will have to have more treatment because the next stage of the illness is cirrhosis of the liver and then maybe a transplant"
The illness is now beginning to take its toll on Eileen.
She said: "You might be out shopping and all of a sudden it feels like someone has pulled the plug on you, then you are too tired to do anything for days."
However, Eileen is still unfazed by the disease and puts her ability to cope down to a combination of her previous healthy lifestyle and spending her time helping others who are worse off as a part-time nurse at the Royal Marsden cancer hospital.
She said: "It all depends on lifestyle. If you've always eaten junk food, drank, or taken drugs it will probably affect you worse and your liver may not be treatable. Luckily, I have always eaten healthily and loved exercise."
And she has some helpful advice for anyone else living with the illness.
She said: "As much as you may feel like staying in bed you have to get out and do things to feel normal. If you can't work, do some volunteer work because helping others means you're not focusing on yourself all the time.
"If I wasn't a nurse I don't know how I would cope because I see so many young people worse off than me and it puts it into perspective.
Now she is taking part in a national campaign called Face It which aims to raise the profile of hepatitis C using photos of sufferers taken by photographer Michele Martinoli who was treated for the illness.
Eileen said: "This exhibition is proof that it affects people from all walks of life. If there is a stigma that hepatitis C is a drug user's illness, the exhibition is helping erode it."
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November 9th, 2005
Hepatitis C Often Untreated and Outcomes Lag behind Trials in Clinical Practice: Presented at ACG
SourceURL:http://www.docguide.com/
By Paula Moyer
HONOLULU, HI -- November 9, 2005 -- When patients with hepatitis C go on antiviral therapy, the likelihood of a response may be half of that seen in clinical trials, according to investigators who presented their findings here at the 70th annual meeting of the American College of Gastroenterology (ACG).
The research was presented on November 2nd by Ramsey C. Cheung, MD, Chief of Hepatology, Veterans Affairs Palo Alto Health Care System, and Associate Professor of Medicine, Stanford University Medical School, Stanford, California, United States.
"A lot of people with a diagnosis of hepatitis C are not being treated for multiple reasons," Dr. Cheung, MD, said in an email. "When we decide to treat a patient and when the patient decides to go on treatment, the probability of achieving a cure is important to both parties."
However, he added, his study showed that the response rate is much lower in clinical practice than has been seen in the registration trial. "It is important for the treating physician and the patient to know what the response rate is likely to be, not what has been reported in registration trial."
He noted that studies of patients with hepatitis C within the Veterans Affairs system showed that the sustained viral response rate was low. The investigative team conducted the current study to see if the same results would be seen in a community cohort.
The team reviewed several databases of selected sites within the Kaiser Permanente Northern California Health System, and identified 1470 patients with chronic hepatitis C who were seen within the system from 1999-2004. They obtained demographic information from administrative files on age, gender, and ethnicity and patients' laboratory records.
The system's pharmacy records held data on patients' treatment with interferon combined with ribavirin or pegylated interferon combined with ribavirin, along with information regarding the patients' use of erythropoetin (Procrit), filgrastim (Neupogen), antidepressants, and transfusions.
Results show that 246 (16.5%) underwent treatment; 65.3% of these patients were men. Data were completely evaluable for 242 patients; 119 of these were treated with interferon plus ribavirin, and 123 were treated with pegylated interferon plus ribavirin. Patients were an average of 47.1 years old (range 33.3-60.91).
The vast majority of treated patients (72.4%) had HCV genotype I, while 24% had HCV genotypes II and III, and 3.6% had HCCV genotypes IV-VI.
Patients were treated for an average of 29.2 weeks. A sustained virologic response occurred in 19.8% of treated patients, including 11.8% of those who received interferon plus ribavirin, and 27.6% of those treated with pegylated interferon plus ribavirin.
In clinical trials, sustained viral response rates have reached more than 70%, Dr. Cheung said.
Although the reasons for the gap are unclear, these findings may help physicians and patients have more realistic expectations of treatment, Dr. Cheung said.
[Presentation title: Practice Patterns and Treatment of Outcomes in the Management of Chronic Hepatitis C (CHC) Infection in a Large Managed Care Cohort. Abstract 785]
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iQur Ltd Closes B#2.6 Million Investment, Wins Major DoH Award for Healthcare Innovation & Signs Pipeline Agreement on Anti-Fibrosis IP
SourceURL:http://www.prnewswire.com
iQur Establishes Position as Leading Liver Disease Company
2005 Medical Futures Department of Health Award for the Best National Healthcare Innovation
GBP2.6 Million in New Investment Secured
SOUTHAMPTON, England, November 9 /PRNewswire/ -- Pipeline Agreement for Fibrosis Therapeutics Signed with University of Southampton-
Advances announced today by the UK-based Company iQur, reinforce its position as a world leader in the development of new treatments for liver disease. It has been chosen as the 2005 winner of the Medical Futures Department of Health Award for Best National Healthcare Innovation for its Hepatitis C genotyping service, that can revolutionise the cost effectiveness of treatment for Hepatitis C. Previously trading as HepCgen, iQur also announced today the final close of an oversubscribed GBP2.6 million follow-on financing, as well as the signing of a major licensing deal with the University of Southampton for its patent estate in the treatment of liver fibrosis.
Commenting on these significant announcements, Paul Colford, CEO, said: "I am delighted that iQur's ground breaking research into the diagnosis, treatment and monitoring of major liver diseases has been recognised on such a wide range of fronts, by the Department of Health, the investment community and the University, and underlines our company's goal to become THE liver disease company."
Referred to as the "Oscars of Healthcare", the Medical Futures Innovations Awards are the most prestigious in the industry. iQur was presented with the Department of Health Award for Best National Health Innovation 2005 for its research into the detection, treatment and monitoring of Hepatitis C and other liver diseases at the Awards ceremony in London by supermodel Caprice.
Accepting the Award, Professor William Rosenberg, iQur's founding CSO said:
This award is testament to the importance and success of our diagnostic services. iQur is the first Southampton based company to be recognised at this level and we achieved this as a result of our expert team and their tremendous dedication to develop better care for the increasing threat of Hepatitis C across the globe. iQur's strategies enable therapies to be tailored to the individual patient - potentially reducing treatment time and side effects, saving the NHS millions of pounds in clinical and pharmaceutical expenses. Following this innovation will be our simple blood test to reduce the requirement of serial liver biopsy across Europe, then the introduction of better treatment for HCV.
As well as recognition within the medical community, iQur has also attracted positive attention from the investment community, and has successfully raised further investment of GBP2.6 million in an oversubscribed funding round. [PC1] The funding will be used to establish the company's Diagnostic Services business, the iQur(R) Speciality Pharmaceutical distribution division and grow various therapeutic in-licensing agreements.
Commenting on the investment and Award, Board Director, David Norwood and CEO of IP2IPO, a major investor in iQur said: "UK universities are originators of some of the best novel intellectual property in the world, and the University of Southampton and the progress of the iQur team to deliver innovation to the global problem of liver disease, specifically, Hepatitis C, is an inspiration to all our portfolio companies, and fully reflective of our mission. iQur's progress is underlined by the success of this financing round."
In addition, the Company has also extended its focus and pipeline beyond Hepatitis C into liver fibrosis and secured a licensing deal with The University of Southampton. Liver fibrosis is the result of fatty liver disease, obesity, hepatitis, alcoholic liver disease and others. Over the last 20 years, the University has achieved an international reputation for its study of the pathology of fibrosis, cirrhosis, then cancer of the liver.
Colford adds: " We have seen some compelling evidence that the progress of fibrosis can be halted, and perhaps even reversed, with the intellectual property we have licensed. In the best case, we can arrest the progression of liver disease regardless of its cause. More conservatively, we hope to introduce a liver protectorant that can perhaps provide precious additional time to those 25,000 patients currently on waiting lists for transplantation."
Speaking on behalf of The University of Southampton, Dr. Tony Raven, Director of the Centre for Enterprise and Innovation (CEI) said, "Winning this very prestigious and hotly contested award is a fitting tribute to the work of Professor Rosenberg and his scientific team at iQur Limited."
About iQur - http://www.iQur.com
iQur Ltd, previously HepCgen Ltd, founded by liver disease specialist Professor William Rosenberg, scientific advisor to the NHS National Screening committee and diagnostics and imaging panel, specialises in developing novel diagnostics and treatments for chronic liver disease. Its initial focus was on Hepatitis C detection and genotyping. The Company has developed a proprietary genetic test that rapidly determines the genetic subtype of Hepatitis C infection and thus enables treatment regimes to be tailored appropriately.
The Company raised seed finance of GBP350,000 primarily from IP2IPO, a majority owned subsidiary of Evolution Group plc, the investment bank and fund management group, and has subsequently completed a GBP1.6m series A financing, attracting institutional and private investors, and now a GBP2.6 million financing from private equity investors.
Board Of Directors:
Non-executive Chairman, Jack Boyer
Director & CEO, Paul Colford
Non-Executive Director, Founder and CSO, Professor William Rosenberg
Non-Executive Director, David Norwood
Company Secretary, John Brooks
Management:
CEO, Paul Colford
Founder & CSO, Professor William Rosenberg
Director of Operations, Diane Sheridan
About Hepatitis C
For further information on Hepatitis C please click: http://www.iqur.com/templates/
home.asp?ParamReload=true&PageId=6
About Medical Futures - http://www.medicalfutures.com
The Medical Futures Innovation Awards represent a national showcase of clinical, academic and commercial innovative excellence, and this year attracted more than 1200 entries. Forty teams from across the UK were short-listed for presentation to a panel of judges earlier in the autumn, and the finalists displayed their ideas at the Innovators' Gallery, Old Billingsgate in London on 3rd November, before the announcement of the winners.
SOURCE iQur
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New Hampshire Public Radio Series Examines 'Building Wave' of Hepatitis C in State
SourceURL:http://www.medicalnewstoday.com/
New Hampshire Public Radio's "NHPR News" last week aired a two-part series, titled "Hepatitis C: The Uncounted Disease," that examined a "building wave" of the disease that is hitting the state's health care system. NHPR requested from the New Hampshire Center for Public Policy Studies data on New Hampshire hospital discharges from 1996 to 2003. An analysis of the data found that the number of hospital visits by patients with hepatitis C increased an average of 24% annually and total hospital charges rose from less than $2 million annually to more than $17 million annually. New Hampshire is "one of only a handful of states" that does not track hepatitis C or require physicians to report newly diagnosed cases. The segment includes comments from Aydamir Alrakawi, a physician in the gastroenterology department at Dartmouth-Hitchcock Manchester; Tom Mock, director of ACORN, an HIV/AIDS counseling center in Lebanon, N.H.; New Hampshire state epidemiologist Jose Montero; and Gary Sobelson, president of the New Hampshire Medical Society (Greenberg, "NHPR News," NHPR, 11/2). A transcript of part one is available online. The complete segment is available online in Windows Media. (See also, Hepatitis C: The Uncounted Disease—Parts 1 & 2
N.H. Outreach 'Several Years Behind' Neighboring States
The second segment in the series examined how New Hampshire remains "several years behind its regional neighbors" in its hepatitis C outreach and early detection efforts. CDC estimates that the number of hepatitis C-related deaths will triple in the next decade, primarily because of infections that occurred 20 or 30 years ago. According to national statistics, 60% of new hepatitis C cases are transmitted through injection drug use. However, most of the large increase in hospital charges for patients with the disease in New Hampshire can be attributed to residents who received a blood product or transfusion before 1992, the first year that the blood supply was tested for the virus. Other states -- including Maine, Massachusetts and Rhode Island -- have launched public information campaigns to involve health care providers in identifying residents who might not be aware they are infected, while New Hampshire public health officials have focused their outreach and early detection strategies on injection drug users, HIV/AIDS clinics and prisons. The segment includes comments from Marie Gavin, a nurse who helps run the hepatitis program at the Manchester VA Medical Center; Paul Kuehnert, director of public health emergency preparedness for Maine; Paul Loberti, chief administrator of the Office of HIV/AIDS for the Rhode Island Department of Health; Montero; and Kevin O'Conner with CDC (Greenberg, "NHPR News," NHPR, 11/3). A transcript of part two is available online. The complete segment is available online in Windows Media. The complete table of New Hampshire hospital charge trends is available online.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports
/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation
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Health Care Workers Want Safety Needles Made Mandatory in British Columbia
SourceURL:http://news.yahoo.com
CAMILLE BAINS
BURNABY, B.C. (CP) - Unions representing nurses and other health-care workers are demanding the Workers' Compensation Board mandate the use of safety needles to protect employees from contracting potentially deadly diseases like HIV-AIDS and hepatitis B and C.
Saskatchewan and Manitoba are currently the only provinces where hospital workers use safety needles to prevent workers from accidentally jabbing themselves with a needle containing the blood of a patient who has a potentially fatal disease.
B.C. Nurses' Union president Deb McPherson told a news conference Wednesday that 6,800 hospital employees are injured every year in British Columbia when they poke themselves with a needle or sharp medical device.
"Each one of these 6,800 accidents is a devastating injury for a worker in our system and their families," said McPherson, who called the matter a life-death issue.
She said such injuries cost the health-care system $13.6 million annually for testing and preventative treatment.
Health Services Minister George Abbott said three of B.C.'s six health authorities are currently converting to needles that retract into a barrel after use to prevent injury.
Abbott said he expects the new technology to be implemented in hospitals across the province next year.
While such needles cost more money, Abbott said the health-care system would save money in the long run from reduced injuries to workers.
But McPherson said a coalition of five unions wants the WCB to implement regulations that compel not only hospitals but long-term care facilities, clinics and non-health-care settings to protect employees.
They include people who clean sewer drains, for example, and regularly come in contact with needles discarded by drug users and may end up making a WCB claim.
Nurse Julie Savard contracted hepatitis C at Vancouver General Hospital in January when she was drawing blood from a patient who had the disease.
"You don't really think it could happen," Savard told the news conference. "You hear about it. I just couldn't believe it was me."
Savard, who has since returned to her hometown of Winnipeg, said the diagnosis has devastated her and she has put her plans to have a baby on hold.
There's a small chance her body has spontaneously cleared the virus but she is still undergoing blood tests, Savard said.
Julia Aguilar, who has worked as a nurse for 16 years, accidentally jabbed herself with a needle in May when she was treating an HIV-positive patient.
"At the time it was kind of a shock for me because I knew that the patient was HIV positive," she said.
Aguilar was forced to immediately undergo treatment with antiretroviral drugs that caused severe side effects like nausea, vomiting and diarrhea as she waited to find out whether she had HIV.
The first two tests she's had have turned up negative but she won't know if she's off the hook until next May - a year after she came in contact with contaminated blood.
Besides nurses, who have the highest incidence of poking themselves with needles, other hospital workers are also at risk when they jab themselves with improperly disposed needles that end up in bed linen and bedside trays.
Housekeeper Elton Nordmarken has poked himself with a needle 13 times since 1990.
"I have the positive antibodies for hepatitis C," Nordmarken said. "What's going to happen, I don't know."
Nordmarken has been off work five times for 28 days each time while he's being treated.
The WCB is presenting a proposal on safety needles to its board of directors next week but any new devices must be selected in consultation with various work sites, McPherson said.
"We want the necessary regulations passed quickly before another life is in danger."
McPherson also wants a log to be maintained of all injuries sustained by workers from needles and other sharp medical devices.
Since 2001, when the United States passed the Needle-stick Safety and Prevention Act, 24 states have mandated the use of safety-engineered needles to prevent costly injuries to health-care workers.
McPherson said Canada needs to implement a similar policy to protect workers.
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Veterans at Risk: Hepatitis C Still Serious Risk
http://www.newswise.com
Source: Saint Louis University Health Sciences Center
Every Nov. 11, Americans take time to remember our nations’ veterans and their extraordinary sacrifices. But we should also remember the serious health problems some of those heroes face on a daily basis, says a Saint Louis University hepatologist.
Newswise — Every Nov. 11, Americans take time to remember our nations’ veterans and their extraordinary sacrifices. But we should also remember the serious health problems some of those heroes face on a daily basis, says a Saint Louis University hepatologist.
Claus Fimmel, M.D., professor of internal medicine in the division of gastroenterology and hepatology at Saint Louis University School of Medicine and GI section chief at the John Cochran VA Medical Center, is available to discuss the challenges facing veterans with hepatitis C.
“There is never a bad time to educate the public and our nation’s veterans on liver disease,” Fimmel says. “But Veterans’ Day is a particularly good time to raise hepatitis C awareness, and to let veterans know that help is available for them.”
Hepatitis C affects approximately 5.4 percent of all veterans nationwide, more than two times the rate in the general population. Veterans at particularly high risk include those who served during the Vietnam era; the greatest risk factors for infection are a history of intravenous drug use or blood transfusions.
“Patients who come to see us for hepatitis C infection frequently have advanced liver disease and multiple associated medical problems, which makes their treatment very challenging,” Fimmel says. “We have seen a dramatic increase in referrals of patient with liver cirrhosis and liver cancer, the most dangerous complications of chronic hepatitis C.”
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November 10th, 2005
ViroPharma Announces that Treatment with HCV-796 Reduces Hepatitis C Virus Levels
SourceURL:http://www.primezone.com
Source: ViroPharma Incorporated
EXTON, Pa., Nov. 10, 2005 (PRIMEZONE) -- ViroPharma Incorporated (Nasdaq:VPHM) today announced preliminary results from a Phase 1b proof of concept study with HCV-796, an orally dosed hepatitis C (HCV) 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 (NYSE:WYE). In this trial, HCV-796 demonstrated antiviral effects in adult patients with chronic hepatitis C infection. The patient cohort with the highest exposure to HCV-796 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.
"Hepatitis C is a devastating disease, and a difficult target for anti-viral medicines. With our partners at Wyeth, we have now demonstrated anti-HCV activity with HCV-796, the only non-nucleoside polymerase inhibitor to have positive clinical antiviral data," commented Colin Broom, ViroPharma's chief scientific officer. "This potentially opens up new treatment possibilities for patients suffering from the disease. These new data suggest that HCV-796 has a good tolerability profile, favorable pharmacokinetics, and the potential to improve on the level of virologic response across multiple HCV genotypes, including genotype 1, which is the most common strain in the U.S. and the least responsive to currently available therapies. In the future, as antiviral compounds become available, patients suffering with hepatitis C will likely be treated with various combination therapies, analogous to the treatment paradigm for HIV infected patients."
Clinical Trial Description
The Phase 1b proof of concept study was a randomized, double blind, placebo-controlled study of HCV-796 administered orally for 14 days to patients with chronic HCV infection who were naive to treatment. Patients were enrolled in sequential, ascending-dose cohorts of up to 16 patients (12 receiving HCV-796 and 4 receiving placebo) per cohort. Inclusion criteria in this trial include documented history of HCV infection for greater than 6 months, and HCV RNA levels of greater than 104 IU/mL at the screening evaluation. Subjects were permitted to participate in only 1 cohort. The trial was conducted at a single U.S. site.
The objectives of this trial were to compare the safety and tolerability of ascending multiple oral doses of HCV-796 with those of a placebo in subjects with chronic HCV infection, to characterize the pharmacokinetic profile of multiple oral doses of HCV-796, and to compare the antiviral effect of HCV-796 with that of a placebo on plasma HCV RNA concentrations.
Clinical Results
Preliminary results are available for patients in six cohorts (twice-daily oral administration of 50, 100, 250, 500, 1000, and 1500 mg). Seventy two percent of all patients were infected with HCV genotype 1.
HCV-796 was generally well tolerated across the treatment groups, and no dose-limiting toxicity was identified. Mild to moderate headache was the most frequent adverse event reported overall. There were no treatment-emergent serious adverse events. A single patient withdrew from each of the top three cohorts due to non-serious adverse events, two were considered possibly related to therapy (bilirubin elevation and TSH elevation) and the other considered non-related to therapy (loss of hypertension control).
HCV-796 exhibited favorable pharmacokinetics with an estimated mean elimination half-life of 42-54 hours across dose groups. HCV-796 drug levels increased less than proportionally with increasing dose, and appeared to reach a plateau at the 1000 mg cohort.
Through the first five cohorts, dose related responses to HCV-796 as measured by reduction in plasma HCV RNA levels were observed. In the 1000 mg cohort, the mean reduction in HCV RNA was 1.4 log10 (96 percent) on day four, 1.3 log10 (95 percent) on day seven, and 0.7 log10 (80 percent) at day 14. At day four, 83 percent of patients in this cohort had reductions from baseline greater than 1.0 log10 on day four; 33 percent of these subjects had reductions greater than 1.5 log10; 25 percent of these subjects had reductions greater than 2.0 log10. On day 14, 17 percent of subjects in this group had reductions from baseline greater than 2.0 log10.
Viral reduction curves were of a similar pattern across all cohorts. Maximal antiviral effects were observed at approximately study day four, when peak mean reductions in HCV RNA ranged from 0.3 to 1.4 log10 (50 to 96 percent) across all doses. At day seven of treatment, mean HCV RNA levels were 0.3 to 1.3 log10 (50 to 95 percent) below baseline. At day 14 of treatment, mean HCV RNA levels were 0.2 to 0.7 log10 (37 to 80 percent) below baseline. For patients receiving placebo, mean plasma HCV RNA increased 0.1 log10 compared to baseline on day four, and was unchanged from baseline on day 14. Antiviral activity appeared similar among patients infected with HCV genotype 1 compared to those with non-genotype 1 infection, although fewer subjects were infected with non-genotype 1 HCV. Further analysis, including pharmacodynamic/pharmacokinetic correlation and viral genetic sequencing, is planned.
Next Steps
ViroPharma and Wyeth plan to assess the antiviral activity, pharmacokinetics and tolerability of HCV-796 in combination with pegylated interferon. These data are expected at the beginning of the second quarter of 2006. If these data are supportive, the companies will determine the next steps, including progression to a Phase 2 study.
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 committed 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 www.viropharma.com.
Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties, including those relating to the company's anticipated schedule relating to its HCV clinical development program as well as its 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. Conducting clinical trials for investigational pharmaceutical products is subject to risks and uncertainties. The data that is described in this press release is preliminary and full analysis of the data, or further testing such as the planned clinical studies of HCV-796 with pegylated interferon, may not support any or all of the statements in this press release. There can be no assurance that 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 quarterly report on Form 10-Q for the quarter ended September 30, 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.
CONTACT: ViroPharma Incorporated
Vincent J. Milano
Vice President, CFO and Treasurer
(610) 321-6225
Will Roberts
Director, Corporate Communications
(610) 321-6288
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Alcohol Use Progresses Hep C-Related Cirrhosis
SourceURL:http://www.gastrohep.com
Evidence in the latest issue of Clinical Gastroenterology & Hepatology shows a worsened outcome for those with chronic Hepatitis C and concurrent alcohol use.
A convincing, yet inconsistent, pattern has emerged that demonstrates increased progression of Hepatitis C-related liver disease with heavy alcohol use.
Dr Sharon Hutchinson and colleagues from England quantified the effect of alcohol on cirrhosis risk in patients with Hepatitis C.
The research team performed a meta-analysis of 20 articles, involving more than 15,000 Hepatitis C infected persons, published between 1995 and 2004.
The team explored the relationship between advanced liver disease and the consumption of alcohol.
The relative risk for cirrhosis associated with alcohol intake of 210-560 g per week was 2.3 – Clinical Gastroenterology & Hepatology
The pooled relative risk of cirrhosis associated with heavy alcohol intake, of at least 210-560 g per week was 2.3 by the random effects model.
The researchers found that the risk of Hepatitis C-related liver disease associated with heavy alcohol intake increased with severity of the outcome.
The lowest and highest pooled relative risk estimates were obtained for advanced fibrosis and decompensated cirrhosis, respectively.
The team noted, however, that the regression effect of alcohol might be underestimated in studies investigating the risk of Hepatitis C-related cirrhosis.
This may be because these studies necessarily include patients undergoing liver biopsy and could therefore under-represent heavy alcohol users.
Dr Hutchinson's team concluded, "The evidence overwhelmingly shows a worsened outcome for those with chronic Hepatitis C and concurrent alcohol use."
"Studies varied widely in their definition of significant alcohol intake, and so the true threshold above which alcohol accelerates Hepatitis C disease progression remains uncertain."
"Alcohol consumption should be minimized as much as possible in those who have chronic Hepatitis C until a safe threshold is more definitively determined."
Clin Gastroenterol Hepatol 2005: 3(11): 1150-9
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Preventing Hemodialysis after Liver Transplant
SourceURL:http://www.gastrohep.com
Continuous infusion of synthetic human atrial natriuretic peptide may be effective for preventing acute renal failure requiring hemodialysis after liver transplantation, finds the most recent issue of Transplantation.
Acute renal failure occurring immediately after liver transplantation and requiring hemodialysis is a major problem resulting in a poor prognosis.
Dr Nobuhisa Akamatsu and colleagues investigated the efficacy of human atrial natriuretic peptide.
Atrial natriuretic peptide has potent natriuretic and protective effects for glomeruli in preventing acute renal failure after liver transplantation.
The researchers included 37 patients who underwent live donor liver transplantation with model for end-stage liver disease scores greater than 15.
Subjects were prospectively randomized into 2 groups.
There were 19 patients in Group1 who received synthetic human atrial natriuretic peptide infusion.
2 receiving atrial natriuretic peptide required hemodialysis after transplant vs 7 controls – Transplantation
Group 2 included 18 patients who received conventional diuretics, furosemide and potassium canrenoate.
Peri- and postoperative changes in hemodynamic status and renal function were compared between the 2 groups.
The researchers found no statistical differences in the changes in hemodynamic status between groups.
The team noted that hemodialysis was required after liver transplantation in 9 patients, 2 in Group 1 and 7 in Group 2.
Postoperative creatinine clearance was higher in Group 1.
In addition, the researchers noted that aldosterone level was suppressed in Group 1.
Dr Akamatsu's team concludes, "Continuous infusion of synthetic human atrial natriuretic peptide might be effective for preventing acute renal failure requiring hemodialysis after liver transplantation."
Transplant 2005: 80(8): 1093-8
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AASLD Issues Call for Americans to Fight Liver Disease as Screening Reveals Alarmingly High Prevalence of Hepatitis B Among Asian Americans
SourceURL:http://biz.yahoo.com
More Than 30 Million Americans Are Affected by Liver Disease
SAN FRANCISCO, Nov. 10 /PRNewswire/ -- In response to an alarming rise in liver disease, today the nation's leading liver doctors called on all Americans to talk to their physicians about liver screening and other tests they should consider to detect, treat and prevent liver disease.
At their annual meeting in San Francisco, the American Association for the Study of Liver Diseases (AASLD) issued a call to action for a reinvigorated fight against liver disease, particularly Hepatitis B among high risk groups such as Asian Americans.
A study being released at the AASLD meeting this week showed the results of a mass screening in New York City that revealed 21 percent of the Asian American population tested positive for Hepatitis B infection -- a rate 50 times higher than the general public.
"All of us in the liver community have been aware that liver disease is more common among certain populations, but this study presents new data that serves as a wake-up call for the entire country," said AASLD President Teresa Wright, M.D. "We need to increase the level of education and awareness about liver disease among both health professionals and patients and head off this emerging health crisis."
"The hepatology community has the tools to prevent, detect, and treat even the most devastating forms of liver disease, including Hepatitis B," said Dr. Wright. "Unfortunately, because there are often no obvious symptoms of liver disease, people tend to overlook this essential organ."
Despite Hepatitis B being both preventable and treatable, only 20 percent of people with Hepatitis B know they are infected and only three percent receive the treatment they need. Lack of awareness of Hepatitis B is leading to unnecessary complications and death for the 1.25 million individuals with chronic Hepatitis B in the United States.
"Every at-risk American should know their viral hepatitis status," said Dr. Wright. "Awareness of hepatitis infection allows patients to modify their lifestyle, prevent transmission to others, and seek treatment if appropriate."
Today also marks the launch of the American Liver Foundation's T.H.I.N.K. B (The Hepatitis Information You Need to Know) program of public education and screening for Hepatitis B. Simultaneous events will be held in San Francisco, Los Angeles, and New York.
"Here in San Francisco, we need to be even more diligent in detecting and treating liver disease because the Asian American and GLBT communities are disproportionately affected," said Dr. Wright.
More than 30 million Americans, one in 10, are or have been afflicted with liver diseases ranging from viral hepatitis to autoimmune conditions. Liver disease is a top 10 cause of death in the United States and is now the leading cause of death for people who are HIV-positive. The annual economic impact of liver disease is estimated at $35.1 billion.
Worldwide, liver disease affects more than half a billion people, and liver cancer is the fifth most common cause of cancer death.
The AASLD Annual meeting will include the presentation of promising research for the prevention and treatment of several forms of liver disease.
Promising Research: Key Abstracts
Hepatitis B Prevalence
* Mass screening in New York City reveals extraordinarily high prevalence of hepatitis B in an urban Asian population Mass screening in the New York Asian American population for Hepatitis B reveals a prevalence of 21 percent, markedly higher than previously estimated and 50 times higher than the general population which is .4 percent.
Hepatitis B Treatment
* Telbivudine (LdT) vs. Lamivudine for Chronic Hepatitis B: First-Year Results from the International Phase III GLOBE Trial Results from a phase III trial of telbivudine, a new drug against hepatitis B, show telbivudine is better than standard therapy (lamivudine) in lowering serum levels of HBV DNA and is associated with less viral resistance than lamivudine.
* Maximal early HBV suppression is predictive of optimal virology and clinical efficacy in nucleoside-treated hepatitis B patients: Scientific observations from a large multinational trial
A study comparing telbivudine and lamivudine shows that best outcomes occur when level of HBV is decreased quickly after starting treatment.
Oral Therapy for Hepatitis C
* Anti-viral Activity of SCH 503034, a HCV Protease Inhibitor, Administered as Monotherapy in Hepatitis C Genotype-1 (HCV-1) Patients Refractory to Pegylated Interferon Patients receiving the highest dose of the study drug, a protease inhibitor, achieved a more than 100 fold reduction in the level of hepatitis C viral RNA from baseline after only 14 days despite not responding to standard treatment with interferon.
* Final Results of a Phase 1B, Multiple-dose Study of VX-950, a Hepatitis C Virus Protease Inhibitor Results from an initial study of a new protease inhibitor show every patient achieved a 100 fold reduction in the serum level of hepatitis C virus after only 14 days of treatment. Among those receiving the highest dose, there was a more than 10,000-fold reduction (4.4 log10) at the end of 14 days of dosing.
* Randomized Trial of Valopicitabine (NM283), Alone or with Peg-Interferon, vs. Retreatment with Peg-Interferon plus Ribavirin (PegIFN/RBV) in Hepatitis C Patients with Previous Non-Response to PegIFN/RBV: First Interim Results Results from a phase II study of the combination of an HCV polymerase inhibitor (NM283) and interferon show that 55 percent of patients who had not responded previously became negative for hepatitis C viral RNA when re-treated with this combination.
AASLD is the leading organization of physicians focused solely on advancing the science and practice of hepatology, and has been at the forefront of investigating and treating liver diseases. The American Liver Foundation (ALF) is the nation's leading patient advocacy organization promoting liver health and disease prevention.
For more information please visit the AASLD web site at http://www.AASLD.org, the American Liver Foundation web site at http://www.liverfoundation.org and the T.H.I.N.K. B web site at http://www.THINKB.org.
CONTACT: Jaymie Gustafson
202-431-9478
jaymie.gustafson@zenogroup.com
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November 11th, 2005
Ascites Impairs Gastric Function in Cirrhosis
SourceURL:http://www.gastrohep.com/
Postprandial gastric volumes and accommodation ratios are reduced in cirrhosis and ascites, and large-volume paracentesis increases fasting gastric volumes as well as caloric intake, finds the latest issue of Clinical Gastroenterology & Hepatology.
Protein calorie malnutrition and weight loss are common among patients with cirrhosis and ascites.
The cause of these symptoms is unclear, with several putative mechanisms proposed.
Dr Ernest Bouras and colleagues from Florida compared gastric volumes between patients with cirrhosis complicated by ascites and controls.
The investigators evaluated the effect of large-volume paracentesis in the patient group.
Patients with cirrhosis and ascites underwent assessment of gastric volumes as measured by single-photon emission computed tomography.
Gastric sensation was assessed by a validated nutrient drink test, and a 3-day assessment of caloric intake before and after large-volume paracentesis.
Gastric volumes were increased by about 312 mL post- vs 241 mL pre-paracentesis – Clinical Gastroenterology & Hepatology
The team used age- and sex-adjusted linear regression models to compare gastric volumes and accommodation ratios between patients and healthy volunteers.
Paired Wilcoxon rank-sum tests were used to compare gastric measures before and after paracentesis among the patient group.
The investigators compared 15 patients with a median age of 54 years with 112 healthy age- and sex-matched controls.
Median postprandial gastric volumes and gastric accommodation were reduced significantly in patients compared with healthy controls.
The investigators found that fasting gastric volumes were increased by a median of 312 mL post- vs 241 mL pre-paracentesis.
Patients tolerated ingestion of larger maximum volumes of a median 964 mL post- vs 738 mL pre-paracentesis.
The team noted that caloric intake was increased at a median 34% kcal post- vs 3110 kcal pre-paracentesis.
Dr Bouras' team commented, "Postprandial gastric volumes and accommodation ratios are reduced in patients with cirrhosis and ascites compared with healthy controls."
"In addition, large-volume paracentesis increases fasting gastric volumes, volumes ingested until maximal satiation, and caloric intake."
Clin Gastroenterol Hepatol 2005: 3(11): 1095-100
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Vertex Applies to Take Hepatitis C Drug to Phase II Trials
SourceURL:http://boston.bizjournals.com
Vertex Pharmaceuticals Inc. announced Friday is has filed an application with federal regulators to pursue Phase II, or mid-stage, clinical trials for VX-950, a potentially new treatment for hepatitis C.
The Cambridge, Mass. biotechnology company (Nasdaq: VRTX) said Phase I trials involving a small number of people produced positive results.
Vertex's application to advance to Phase II reflects an accelerated timeline for VX-950 based on promising test results released earlier this year. Vertex now hopes to file for FDA approval by 2008, company president, chairman and CEO Joshua Boger said earlier this year.
Phase III is the last set a clinical trials a drug must pass before a company can file for U.S. Food and Drug Administration approval.
Vertex also plans to expand in nearly 150,000 square feet of space at 675 West Kendall in Cambridge to help support accelerated clinical development of the compound. In 2004, Vertex backed out of occupying the building as part of a restructuring effort.
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Major Milestone Reached in Hepatitis C Vaccine Program
SourceURL:http://www.biotech-intelligence.com
Select Vaccines (AUSTRALIA)
11 November 2005: Melbourne-based biotechnology company, Select Vaccines Ltd (ASX:SLT), today announced positive results from its first pre-clinical studies of a potential vaccine against hepatitis C.
The results followed nine months of animal studies and represent a major advancement of the hepatitis C vaccine program.
Managing Director of Select Vaccines, Dr Martin Soust, said "We obtained good results in our early studies in the laboratory and in a pilot study and, on the strength of these results, we initiated a dose ranging study in mice."
"We observed very strong immune responses after just one small dose of less than one microgram of this hepatitis C vaccine," said Associate Professor David Anderson, Chief Scientific Officer with Select Vaccines.
Hepatitis C specific antibodies were produced by all 46 animals injected with the hepatitis C vaccine, even at the lowest dose studied which was 0.2 micrograms. There was also the induction of significant levels of hepatitis C specific T cells, which suggests the vaccine may promote better overall control of infection.
An immune response of this strength in mice suggests a very strong likelihood that a similarly strong response will be produced in a larger animal species that will be studied in the next round of investigations.
The results exceeded the company's expectations and suggest that the prospects of developing a human vaccine with a good safety profile are excellent.
"The commercial potential of a vaccine against hepatitis C is substantial. Globally, there are almost 300 million people currently infected with hepatitis C and up to 10 million new infections each year. The market for a vaccine against hepatitis C has been estimated to be worth more than $US500 million. The company is pursuing the development of this vaccine as there is currently no vaccine available" said Dr Soust.
"The next steps in our hepatitis C vaccine program are very clear," Anderson said. "We plan to undertake further studies in larger animals and to produce purified injectable material under GLP conditions for use in a preclinical toxicology study before moving into a phase I clinical trial." Professor Anderson explained.
Select Vaccines is developing the hepatitis C vaccine with its proprietary vaccine technology that employs virus-like particles to generate a protective immune response against infection. The platform technology involves producing virus-like particles into which specific vaccine antigens of interest, in this case an envelope protein from hepatitis C virus, have been inserted.
"We have been waiting for the outcome from these initial animal studies before considering a very substantial longer-term commitment to vaccine development. With this proof of the VLP platform in hand we have a very strong indication that we may be able to develop vaccines against other infectious diseases and we will look to accelerate and expand our work accordingly." said Dr Soust.
Further details of the results from these studies will be provided in a market update.
For Further Information Call:
Martin Soust
Select Vaccines
03 8508 8250
Tim Allerton
City PR
02 9267 4511
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New Studies with Pegasys plus Copegus in Hepatitis C Treatment to be Presented at AASLD Annual Meeting
http://www.medadnews.com
SAN FRANCISCO, November 11, 2005 /PRNewswire/ -- A series of studies related to the treatment of hepatitis C with Pegasys(R) (peginterferon alpha-2a) plus Copegus(R) (ribavirin, USP) will be presented at the 56th American Association for the Study of Liver Disease (AASLD) annual meeting, which begins here today. The following study highlights will be presented. Roche continues to support Pegasys with the most extensive development program ever undertaken in hepatitis C, including major studies initiated to advance treatment for hepatitis C patients whose infections are considered challenging to treat.
Roche will also present interim results from its study showing that re-treatment with Pegasys plus Copegus reduced viral levels in hepatitis C patients for whom treatment with Peg-Intron(R) (peginterferon alpha-2b) plus Rebetol(R) (ribavirin, USP) had failed. Interim study results from the REPEAT (REtreatment with PEgasys in pATients Not Responding to Peg-Intron Therapy) study will be presented here on Nov. 14, 2005.
In addition to the initial REPEAT study information released today, presented at the AASLD annual meeting are studies that:
* Evaluated accelerated response rates in treatment of a sub-group of individuals with the most common form of hepatitis C in the U.S.
* Assessed the rate of persistence in patients taking Pegasys versus those taking Peg-Intron.
* Compared the economic and handling aspects of the Pegasys prefilled syringe versus the Peg-Intron Redipen in patients who started hepatitis C therapy in Germany.
* Evaluated the effectiveness of Pegasys in individuals who had not tolerated treatment with Peg-Intron.
Among the studies being presented at the meeting include the following:
*Two Studies Examining Genotype 1 Patients Who Experienced a Rapid Virologic Response:
* Two studies examined the treatment of genotype 1 "super-responders," defined as patients in whom treatment with Pegasys and Copegus led to a rapid virologic response (RVR). RVR refers to patients with HCV RNA levels less than 50 IU/mL after 4 weeks.
-- The first study, "Rapid Virological Response at Week 4 (RVR) of Peginterferon alfa-2a (PEGASYS(R)) plus Ribavirin (COPEGUS(R)) Treatment Predicts Sustained Virological Response (SVR) after 24 Weeks in Genotype 1 Patients," analyzed data from 729 patients in the United States. The study identified 146 patients (20 percent) who had a rapid virologic response. The objective was to see if patients with an RVR were more likely to experience a sustained virologic response after 24 weeks of treatment than those without an RVR, because of lower relapse rates.(1) Dr. Donald Jensen will present this poster on Tuesday, Nov. 15, from 8:00 a.m. - 12:30 p.m.
-- The second study, "Is Shorter Treatment with Peginterferon alfa-2a (40KD) (PEGASYS(R)) Plus Ribavirin (COPEGUS(R)) Possible in HCV Genotype 1 'Super-Responders'? Preliminary Results of a Prospective Randomized Clinical Trial," based in Austria, comprised 366 patients. Seventy-nine of these were classified as "super-responders" and assigned to receive 24 weeks of therapy. Preliminary results will be presented on the 48 patients who have completed the study to date. Dr. Peter Ferenci will present this study on Sunday, Nov. 13, from 4:45 - 6:15 p.m.
"Persistence with Hepatitis C Therapy in the Department of Veterans Affairs (VA)"
* This study analyzed persistence in 5,611 patients in the VA who received Pegasys with Copegus or Peg-Intron with Rebetol. Persistence is defined as the period from the date of the first peginterferon prescription filled to the date of the last prescription filled. Dr. Sheikh Usman will present this poster on Tuesday, Nov. 15, from 8:00 a.m. - 12:30 p.m.
"Economic evaluation of standard-therapy (ST) for chronic hepatitis C (CHC) with Peginterferon alfa-2a (40KD) (PegIFN 2a) plus Ribavirin versus Peginterferon alfa-2b (12KD) (PegIFN 2b) plus Ribavirin: Ready-to-use syringe (SYR) versus Injector (INJ) (SPRINT)"
* The SPRINT study compared the economic and handling aspects of the Pegasys prefilled syringe versus the Peg-Intron Redipen among 75 patients who started hepatitis C therapy in Germany. In this study, 37 patients used the Pegasys prefilled syringe, and 38 used the Peg-Intron Redipen. Dr. Hans-Deiter Janisch will present this poster on Tuesday, Nov. 15, from 8:00 a.m. - 12:30 p.m.
"Interim Analysis of the Safety and Efficacy of Peginterferon Alfa-2a plus Ribavirin in Chronic Hepatitis C Patients Unable to Tolerate or Nonresponsive to Treatment with Peginterferon Alfa-2b plus Ribavirin"
* The Rescue study evaluated the efficacy and safety of Pegasys with Copegus in patients with genotype-1, the most difficult to treat form of hepatitis C, who had previously taken Peg-Intron with Rebetol without success. Patients were either intolerant to Peg-Intron due to depression, fatigue, flu-like symptoms or injection site reactions, or did not have an early virologic response (EVR). EVR is defined as undetectable RNA levels after twelve weeks. Dr. Vinod Rustgi will present this poster on Tuesday, Nov. 15, from 8:00 a.m. - 12:30 p.m.
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 for Hepatitis C
Pegasys, a pegylated alpha interferon, and Copegus are indicated 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 include 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 administered orally at doses of 800-1200 mg daily.
Please see attached additional information about Pegasys indication and safety.
About Roche - More Than a Century in the U.S. and the World
Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is one of the world's leaders in diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on many fronts to improve people's health and quality of life. Roche employs roughly 65,000 people in 150 countries, including approximately 15,000 in the United States.
Roche's U.S. operations celebrate their American Centennial in 2005. In another milestone this year, Roche was named in January to Fortune magazine's list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado, Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation, dermatology and influenza. Roche's Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our worldwide and U.S. websites (Global: http://www.roche.com and U.S.: 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 (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy).
Alpha interferons, including PEGASYS(R) (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(R), 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 (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) "Rapid Virological Response at Week 4 of Peginterferon alfa-2a (40KD) (Pegasys) plus Ribavrin (RBV, Copegus) Treatment Predicts Sustained Virological Response (SVR) after 24 Weeks in Genotype 1 Patients, 2005, D. Jensen, et al.
CONTACT: Bob Madison of Roche, +1-973-919-7085 (mobile), +1-973-562-2231(office); or David Freundel of MS&L for Roche, +1-917-806-6625 (mobile)
Web site: http://www.roche.com/ http://www.roche.us/
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Cambridge Biotech Develops Hepatitis C Pill
www.bostonherald.com
By Jessica Heslam
A Cambridge biotech company has developed a pill its scientists argue could cure more people with hepatitis C a virus that attacks the liver without the debilitating side effects caused by the only other treatment on the market.
“It exceeded our expectations. We think this is the most exciting drug possibility out there for all drugs,” said Joshua Boger, president and chief executive of Vertex Pharmaceuticals Inc.
While Boger cautioned there’s still a lot more work to do, Vertex has been working on developing the drug called VX-950 for 11 years.
The results of a recent study to be presented Monday at an international liver disease conference come as researchers say the number of Americans infected with hepatitis C has been underestimated by about 1 million.
Many people with chronic hepatitis C don’t choose to get the current therapy because of horrible side effects that include flu symptoms, depression and anxiety.
The current treatment is toxic and is a combination therapy that involves injections of the protein interferon for up to a year. Also, it only works in about half of all patients.
In a study in Europe, a group of patients with hepatitis C took VX-950 for two weeks. The drug dropped the virus in the blood from 1 million copies per drop of blood to as few as 100. Four people completely lost the virus and the drug was well-tolerated, said Dr. Nezam Afdhal, chief of hepatology at Beth Israel Deaconess Medical Center.
If the new drug is correctly combined with other drugs, there’s a potential it could shorten treatment and cure more people with hepatitis C, Afdhal said.
Researchers will soon begin a new trial and Afdhal will oversee study participants in Boston.
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Pine Man Alerts Rim Country Residents about Hepatitis C
SourceURL:http://www.paysonroundup.com
By Nancy Wright, Roundup Staff Reporter
Jan Alley and David Halchishick are on a mission. They want to get a message out to the community about the seriousness of hepatitis C. They should know -- Dave has been diagnosed terminal with the disease.
He doesn't want your pity. He wants drug users to stop, and warns teenagers never to start.
"When I was in the service in the 1960s, after boot camp I messed around with IV drugs. As a result of that, I got real sick. I went to a hospital and they told me I had hepatitis. They thought they had treated it, and in my mind they had, and nothing happened for about 35 years. I dodged the bullet for a long time," said Halchishick.
Halchishick admits he used drugs off and on even after that hospital stay. He says he's been off drugs now since 1984. He put himself through college and became a certified drug and alcohol counselor in Phoenix and in Payson. He was in remission for more than 30 years.
"About two years ago, I read an article about a drug and alcohol counselor diagnosed with it (hepatitis C), and six months later he died.
"So I went to my doctor and asked to have certain blood tests. We learned I had liver disease. I was very weak and my skin itched a lot," he said.
County has its share of cases
Bill Hyer is HIV coordinator for Gila County with the health department. He says hepatitis C is a virus that destroys the liver. "If the individual doesn't change their behavior, then it can kill them," he said.
"Recently, the physical symptoms were minimal -- itchy skin, aches and pains in my legs, which I blew off since I like to play a lot of golf and I'm a tall and skinny guy," Halchishick said.
The Arizona Department of Health Services said, as of October, there were 443 cases of hepatitis C in Gila County. "It's pervasive here. There are two problems -- those who have it and don't know it and may be spreading it further; and those with it who moved to Payson or Globe, and are not seeing doctors or reporting their condition," Hyer said.
The virus is spread in a variety of ways, but according to Hyer, generally it's spread from people sharing needles, or snorting drugs through straws or other things that can cut the inside of the nose, spreading tiny droplets of blood from person to person.
Hyer and Halchishick believe Payson has a high number of methamphetamine users. They say those people have an incredibly high chance of getting hepatitis C because, they say, they often make bad choices. They say a person snorting a drug through a straw or a dollar bill can catch hepatitis nearly as easy as someone who uses intravenous drugs.
Hyer recently applied for a three-year federal grant of $167,000 to expand the health department's ability to diagnose people with hepatitis C, educate the public about the virus and treat patients with the illness. He expects to learn in January whether the department will get the grant. In the meantime, he says the department does not have testing capabilities, but he does community outreach programs to educate people of all ages about the disease.
Recently, a doctor told Halchishick he probably only has a couple of weeks to live. He and his wife, Jan, want to spend his last weeks getting the word out about this disease.
"Our goal is not to say, 'poor us' -- we want an awareness in this community about this virus. If his death can save one life -- we've succeeded," said Alley.
Halchishick and Alley would like to thank the medical professionals and counselors in Payson who have stood by them through these last couple of years.
"We want to thank everyone who has helped us. You're on God's mission," said Halchishick.
The choice is yours
"You have a choice. If you're an IV user, it's like you're getting on a bus headed toward trouble. If you keep using drugs, you'll ride that bus to where I'm at now. And you won't have a chance to get off that bus," Halchishick said.
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Valopicitabine (NM283) Combined with Pegylated Interferon Demonstrated Significantly Greater Suppression of Hepatitis C Virus (HCV) Replication in Treatment-Refractory Patients Compared to Retreatment with Ribavirin Plus Pegylated Interferon
SourceURL:http://biz.yahoo.com/
SAN FRANCISCO, Nov. 11 /PRNewswire-FirstCall/ -- Valopicitabine combined with pegylated interferon demonstrated significantly greater viral suppression after 12 weeks of treatment compared to retreatment with ribavirin plus pegylated interferon in chronic hepatitis C, genotype 1 patients who were non- responders to previous therapy. Dr. Christopher O'Brien, Professor of Clinical Medicine at the University of Miami and a principal investigator in an ongoing phase IIb clinical trial of valopicitabine, will present 12-week data from this phase IIb clinical trial on Monday, November 14, 2005 at 9:00 a.m. (PST) at the 56th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) held in San Francisco. Valopicitabine, a novel polymerase inhibitor, is being developed by Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases.
"At 12 weeks, the combination of valopicitabine plus Pegasys® produced a statistically significant improvement in suppression of hepatitis C virus (HCV) replication and a significantly higher proportion of patients achieving an early virologic response (EVR) compared to patients retreated with Pegasys® and ribavirin," said Dr. O'Brien. "These are promising results, particularly for the many treatment-refractory patients in urgent need of new therapeutic options," he said.
The phase IIb clinical trial in treatment-refractory patients is designed to evaluate different dosing regimens of valopicitabine in combination with pegylated interferon and to compare this combination with the combination therapy of pegylated interferon plus ribavirin. At 12 weeks of treatment, the two higher-dose arms of valopicitabine plus Pegasys® showed significantly greater suppression of serum HCV RNA compared to the ribavirin plus Pegasys® retreatment arm (p = 0.01). At week 12, mean HCV RNA reductions in the two high-dose arms of valopicitabine plus Pegasys® were 2.5 log10 and 2.8 log10, with 63 percent and 71 percent of patients achieving an EVR. In comparison, patients in the Pegasys® plus ribavirin retreatment control arm showed a mean HCV RNA reduction of 1.9 log10, with 41 percent of patients achieving an EVR. EVR is defined as a greater than 2 log10 reduction in viral load from baseline.
"These encouraging data support continued evaluation of combination treatment with valopicitabine and pegylated interferon in both treatment- refractory and treatment-naive hepatitis C patients," commented Nathaniel Brown, M.D., executive vice president of clinical development and chief medical officer of Idenix. "We look forward to initiating our phase III program for valopicitabine in treatment-refractory patients in early 2006."
In the phase IIb clinical trial, valopicitabine has demonstrated satisfactory safety and tolerance overall. A low percentage of patients on valopicitabine have discontinued due to adverse events. Two serious adverse events were considered attributable to combination treatment with valopicitabine plus pegylated interferon (anemia and dehydration) and both resolved. To date, there has been no predominant treatment-limiting adverse event or laboratory abnormality observed for combination treatment with valopicitabine and pegylated interferon.
Idenix's Hepatitis C Clinical Development Program
At the end of November, Idenix anticipates reviewing with the FDA the available data from the valopicitabine clinical development program, including data from this phase IIb clinical trial during an end-of-phase II meeting. This meeting will help the company define the optimal protocol for the phase III program for valopicitabine in treatment-refractory patients. Idenix currently anticipates initiating a multinational phase III program in treatment-refractory patients in the first quarter of 2006. A 48-week phase IIb clinical trial evaluating valopicitabine in treatment-naive patients is currently ongoing and enrollment is expected to be completed by year end 2005.
About Valopicitabine
Valopicitabine, which is administered orally once a day, is intended to block HCV replication by specifically inhibiting the HCV RNA polymerase, the enzyme that makes new copies of the HCV viral chromosome inside infected cells. Initial phase I clinical trials sponsored by Idenix showed that valopicitabine is active in patients infected with the genotype 1 strain of HCV, the strain that infects the majority of patients in North America, Europe, and Japan. The ongoing clinical trials are designed to evaluate the combination of valopicitabine and pegylated interferon in hepatitis C, genotype 1 patients who previously failed to respond to antiviral treatment, as well as in genotype 1 patients who have not been treated previously. Preliminary results from phase II clinical trials to date have demonstrated that the antiviral effect of valopicitabine is enhanced when this agent is used in combination with pegylated interferon.
About Hepatitis C
Hepatitis C is an infectious liver disease caused by the hepatitis C virus. The World Health Organization estimates that 170 million individuals worldwide carry chronic HCV infection, with 3 to 4 million new infections occurring globally each year. It is the most common chronic blood-borne infection in the United States. The Centers for Disease Control and Prevention estimates that 4 million Americans have been infected with HCV, and 2.7 million of these persons have chronic HCV infections. Chronic HCV infection causes inflammation of the liver, which may cause progressive liver damage that can lead to cirrhosis (liver scarring), hepatocellular carcinoma (liver cancer), liver failure, and death. Patients infected with HCV genotype 1 are difficult to treat, with half or fewer such patients achieving sustained responses to current standard treatment regimens involving a combination of pegylated interferon plus ribavirin | 
