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Week Ending: May 21st, 2005
Alan Franciscus
Editor-in-Chief
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This Issue:
• Hepatitis C: Small Molecules, Big Business
• FDA Approves Pegasys(R) as the First and Only Pegylated Interferon for the Treatment of Chronic Hepatitis B
• Medical Breakthrough - Help for Hepatitis C
• New Strategies for Patients with Viral Hepatitis
• Pegasys(R) Findings Suggest New Approaches to Maximize Hepatitis C Therapy
• Festival Raises Money for Hepatitis C Treatment
• UCLA Study Assesses Cost-Effectiveness of Hepatitis B Drugs
• InterMune Presents Encouraging HCV Drug Data
• Liver Disease Is a Major Cause of Death in HIV and Hepatitis Co-Infections
• Liver Transplants Work Better from Live Donor – Study
• Vertex Says Drug Quickly Treats Hepatitis C
• At Least 11 People Developed Fulminant Hepatitis after Taking Medication or Consuming
• Coley Reports Positive Results from Phase Ib Study of Actilon(TM) for Hepatitis C at Digestive Disease Week Meeting
• Hepatitis C Drug Rocks Virus in Early Test
• Terrence Higgins Trust Launches Hepatitis A, B and C Campaign
• Chiron, Enanta Sign Hepatitis C Agreement
• Health Worker Has Hepatitis C
• Hepatitis C Conference in New York City, May 26-27
• (China) Hepatitis C Detection Kit Developed by Company in Hunan Province
• Hepatitis C Waiting to Explode
May 13th, 2005
Hepatitis C: Small Molecules, Big Business
http://www.pharmaceutical-business-review.com
13 May 2005, 16:44 GMT - Although interferons and ribavirin currently dominate the hepatitis C treatments market and soon-to-be-launched products will predominantly be improvements to these types of drugs, small molecule antivirals are expected to gain a much greater footing in the long-term. Indeed, the launches of the first two hepatitis C virus (HCV)-specific small molecule antiviral drugs, expected in 2011 and 2012, are predicted to be instrumental in helping to grow the value of the HCV pharmaceutical market in the next decade.
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FDA Approves Pegasys(R) as the First and Only Pegylated Interferon for the Treatment of Chronic Hepatitis B
SourceURL:http://www.rednova.com
NUTLEY, N.J., May 13 /PRNewswire/ -- Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Pegasys(R) (peginterferon alfa-2a), the most prescribed hepatitis C medication in the United States, for the treatment of chronic hepatitis B (CHB). Pegasys is the first and only pegylated interferon approved for the treatment of chronic hepatitis B, including both variations of the virus - HBeAg-positive and HBeAg-negative chronic hepatitis B.
"Chronic hepatitis B infection is a serious disease that causes more than 5,000 deaths in the United States each year," said Salvatore Badalamenti, M.D., Medical Director, Roche. "Pegasys now offers hepatitis B patients a treatment option that is taken for a fixed duration of 48 weeks with the goal of providing a lasting response after treatment is completed."
The Centers for Disease Control estimates that 1.25 million people in the United States are chronically infected with hepatitis B. Chronic hepatitis B can lead to cirrhosis, hepatocellular carcinoma and death.
"This approval provides another important option for the treatment of hepatitis B," said Frederick G. Thompson, President and CEO of The American Liver Foundation. "We commend Roche for its extensive research and commitment to treating people with chronic liver diseases."
Pegasys was approved in 2002 by the FDA for use alone and in combination with Copegus(R) (ribavirin, USP) for the treatment of adults with chronic hepatitis C. In February 2005, Pegasys became the first and only FDA-approved therapy alone and in combination with Copegus for the treatment of chronic hepatitis C in patients coinfected with hepatitis C and HIV whose HIV is clinically stable.
Pegasys has a dual mode of action; it slows replication of the hepatitis B virus and boosts the immune system.
Pivotal Studies
The two large-scale multinational phase III trials, in more than 1,500 patients with both the HBeAg-positive and HBeAg-negative variations of chronic hepatitis B, demonstrated that 24 weeks after a defined 48 week period of therapy, more patients achieved a sustained response with Pegasys than with lamivudine. These studies demonstrated that the addition of lamivudine to Pegasys did not improve response rates over Pegasys alone.
Specifically, hepatitis B patients treated with Pegasys had higher rates of:
- HBV seroconversion in HBeAg positive patients (32% Pegasys vs. 19% lamivudine)
- HBV DNA response (32% Pegasys vs. 22% lamivudine in HBeAg positive patients and 43% Pegasys vs. 29% lamivudine in HBeAg negative patients)
- ALT normalization in HBeAg negative patients (59% Pegasys vs. 44% lamivudine)
Conclusions regarding comparative efficacy of Pegasys and lamivudine treatment based upon the end of follow-up results are limited by the different mechanisms of action of the two compounds. Most treatment effects of lamivudine are unlikely to persist 24 weeks after therapy is withdrawn.
Recent results from a long-term follow up study presented at the annual meeting of the European Association for the Study of the Liver (EASL, April 13-17) indicate that patients with HBeAg-negative chronic hepatitis B who responded to treatment with Pegasys maintained the benefit for at least a year after treatment.
The phase III study results in HBeAg-negative chronic hepatitis B were published in September 2004 in the New England Journal of Medicine. The results of the phase III study in patients with HBeAg-positive chronic hepatitis B were presented at the 2004 annual meeting of EASL. Lead investigators of both studies stated that the results of the trials warrant Pegasys becoming a first-line treatment for HBeAg-positive and HBeAg-negative chronic hepatitis B.
Roche was granted approval by the EU Commission in late February 2005 to market Pegasys for the treatment of chronic hepatitis B. Pegasys is the only pegylated interferon with this indication in the EU.
About Chronic Hepatitis B
In the U.S., the most common modes of transmission of the hepatitis B virus are through sexual and blood-to-blood contact, although the disease can also be transmitted from pregnant women to their infants.
The number of new infections in the U.S. has decreased in recent years, in part due to the introduction of the hepatitis B vaccine in 1982. Almost all (90-95 percent) adults who contract hepatitis B clear the virus from their systems within a few months and develop immunity. The remainder of the infections become chronic, which is when the virus stays in the blood, infecting liver cells and possibly damaging them.
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.
Roche has backed Pegasys with the most extensive clinical research program ever undertaken in hepatitis C, with major studies initiated to advance treatment for hepatitis C patients with unmet needs, including patients co- infected with HIV and HCV, African Americans, patients with cirrhosis, and patients who have failed to respond to previous therapy.
Please see attached additional information about Pegasys indication and safety.
About Roche - 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/).
Facts About Pegasys (Peginterferon alfa-2a) in Combination with Copegus
PEGASYS, alone or in combination with COPEGUS, is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that is clinically stable (eg, antiretroviral therapy not required or receiving stable antiretroviral therapy).
Pegasys is indicated for the treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation
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 COPEGUSR, may cause birth defects and/or death of the fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in complete product information).
PEGASYS is contraindicated in patients with hypersensitivity to PEGASYS or any of its components, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment. Pegasys is also contraindicated in hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during treatment. PEGASYS is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is associated with an increased incidence of neurological and other complications in neonates and infants, which are sometimes fatal. PEGASYS and COPEGUS therapy is additionally contraindicated in patients with a hypersensitivity to COPEGUS or any of its components, in women who are pregnant, men whose female partners are pregnant, and patients with hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).
COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE
PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO INITIATION OF THERAPY. Women of childbearing potential and men must use two forms of effective contraception during treatment and during the 6 months after treatment has concluded. Routine monthly pregnancy tests must be performed during this time. If pregnancy should occur during treatment or during 6 months post-therapy, the patient must be advised of the significant teratogenic risk of COPEGUS therapy to the fetus. Healthcare providers and patients are strongly encouraged to immediately report any pregnancy in a patient or partner of a patient during treatment or during 6 months after treatment cessation to the Ribavirin Pregnancy Registry at 1-800-593-2214.
Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including PEGASYS. Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART. During treatment, patients' clinical status and hepatic function should be closely monitored, and PEGASYS treatment should be immediately discontinued if decompensation (Child-Pugh score greater than or equal to 6) is observed.
Exacerbations of hepatitis during hepatitis B therapy are not uncommon and are characterized by transient and potentially severe increases in serum ALT. Patients experiencing ALT flares should receive more frequent monitoring of liver function. Pegasys dose reduction should be considered in patients experiencing transaminase flares. If ALT increases are progressive despite reduction of Pegasys dose or are accompanied by increased bilirubin or evidence of hepatitic decompensation, Pegasys should be immediately discontinued.
The most common adverse events reported for PEGASYS and COPEGUS combination therapy observed in clinical trials (N=451) 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%). The adverse event profile of hepatitis B patients treated with Pegasys was generally similar to that shown for hepatitis C patients treated with Pegasys monotherapy except for exacerbations of hepatitis.
Serious adverse events included neuropsychiatric disorders (suicidal ideation and suicide attempt), serious and severe bacterial infections (sepsis), bone marrow toxicity (cytopenia and rarely, aplastic anemia), cardiovascular disorders (hypertension, arrhythmias and myocardial infarction), hypersensitivity (including anaphylaxis), endocrine disorders (including thyroid disorders and diabetes mellitus), autoimmune disorders (including thrombotic thrombocytopenic purpura, psoriasis and lupus), 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).
Roche
CONTACT: Mike Nelson, Roche, +1-973-562-2409, or mike.nelson@roche.com;or David Freundel, Manning Selvage & Lee, +1-212-468-3982, or david.freundel@mslpr.com, for Roche
Web site:
http://www.roche.com/
http://www.roche.us/
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May 14th, 2005
Medical Breakthrough - Help for Hepatitis C
SourceURL:http://www.wqad.com/
A new drug may help millions of Americans dealing with Hepatitis C.
Nearly four-million Americans deal with the deadly disease.
A new drug could be the Medical Breakthrough patients have been waiting for.
Superstar Billy Graham took home the Worldwide Wrestling Federation Title in 1977. But what happened in the ring brought him a challenge he never expected.
"We cut our foreheads to produce blood to make the match look more authentic," says Billy.
Graham thinks that may be how he contracted Hepatitis C -- the disease is most commonly spread through blood.
"Hepatitis C is a virus that can infect the liver and cause Cirrhosis if it is untreated, " says Dr. Vijayan Balan, a liver specialist working on a new treatment.
"I think there is significant hope in conquering this disease," he says.
Right now, pateints must take medication once a week that can induce days of flu-like symptoms. Now a new drug Albuferon is only taken once a month and causes fewer side effects.
"They get the drug more continuously for a longer period of time."
Albuferon is a combination of interferon, which helps fight infection and Albumin which allows the medication to stay in the body longer.
"You don't have the peaks and valleys with this new drug."
Studies show the drug is safe. Soon it will be tested in up to one-thousand people across the country.
Graham says a drug that's easier to handle would have had him back in the gym sooner and able to focus on the good times.
The first phase of the study showed Albuferson is safe and well tolerated by patients.
Right now, more than 100 people are taking it.
Log on to www.ivanhoe.com for more information.
Watch the latest Medical Breakthrough every Monday, Wednesday and Friday on NewsChannel 8 at 5 and every Tuesday and Thursday on NewsChannel 8 at 10.
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May 15th, 2005
New Strategies for Patients with Viral Hepatitis
The Manila Bulletin Online
http://www.mb.com.ph
The first International Conference on the Management of Patients with Viral Hepatitis recently held in Paris, reviewed the current information about viral hepatitis B and C as among the most frequent viral infections in the world, but have seen major advances in their treatment in recent years.
"Today, hepatitis B can be brought under control and hepatitis C can actually be cured. The objective of the international meeting, was to give leading international specialists an opportunity to explain today’s level of clinical knowledge in clear terms that physicians can apply directly to their practice and therefore benefit patients," says Professor Patrick Marcellin of the Liver Unit, hôpital Beaujon in Clichy, France.
"Management of patients with hepatitis C is probably the area where the most significant strides have been made. A combination of pegylated interferon and ribavirin has been shown to have the greatest efficacy and is currently the standard of care," says Prof. Trépo of the Hôpital Hôtel-Dieu in Lyon, France.
Some 170 million people are infected by the hepatitis C virus across the globe. It is the cause of 60 percent of primary liver cancers and the number one cause of liver transplants in the world. It is also the cause of more than one million deaths worldwide each year.
Acute hepatitis B is often asymptomatic, but nearly one in 10 of those infected develops a chronic infection with a risk of spreading it to others. Due to the asymptomatic nature of the disease and lack of routine screening among high-risk populations, diagnosis often comes too late.
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May 16th, 2005
Pegasys(R) Findings Suggest New Approaches to Maximize Hepatitis C Therapy SourceURL:http://www.prnewswire.com
Starting treatment earlier and staying on treatment longer may increase treatment response rates for certain hepatitis C patients
CHICAGO, May 16 /PRNewswire/ -- Starting hepatitis C treatment before liver disease progresses and identifying the correlation between early response and sustained virological response, are two potential approaches that may optimize treatment outcomes in certain patients according to data from two Pegasys(R) (peginterferon alfa-2a) studies presented today at the Digestive Disease Week (DDW) Meeting, May 14-19, in Chicago, Illinois.
These findings were from pooled analyses of data from Pegasys pivotal trials in patients with genotype 1 hepatitis C, the most prevalent and difficult to treat strain of the virus in the United States. Pegasys is the most prescribed hepatitis C treatment in the United States and is approved for use alone and in combination with Copegus(R) (ribavirin, USP).
"Studies have shown that approximately 50 percent of genotype 1 hepatitis C patients respond to 48 weeks of treatment with Pegasys combination therapy," said Mitchell Shiffman, MD, Chief of Hepatology, VCU Medical College of Virginia. "This research suggests that we may be able to improve those odds by treating hepatitis C earlier in the course of the disease, and extending treatment for patients who have a delayed response to therapy."
Treatment Efficacy Linked to Liver Damage
An analysis of data from 328 patients treated for 48 weeks with Pegasys and Copegus showed that patients with the genotype 1 hepatitis C, who had no or little liver damage (no fibrosis or portal fibrosis) had higher sustained virological response rates compared to patients with more advanced liver disease (incomplete septa or cirrhosis). Response rates were 56 percent vs. 42 percent. The authors concluded that therapy should not be delayed for patients until liver damage progresses because it reduces the patients' chance of responding to treatment.
Longer Therapy for Late Responders
Results from an analysis in 569 treatment-naive patients infected with hepatitis C genotype 1 and treated for 48 weeks with Pegasys and ribavirin showed that sustained virologic response rates were highest among patients who had undetectable HCV RNA levels at weeks 4 or 12. However patients classified as late responders with a delayed viral clearance had the lowest sustained virological response rate, indicative of a high relapse rate according to the study authors. The authors suggested that additional prolonged therapy may benefit these patients, but that a prospective trial would be needed to confirm this.
Pegasys and Copegus(R) (ribavirin, USP) are approved by the U.S. Food and Drug Administration for the treatment of chronic hepatitis C and are the only combination regimen FDA-approved for the treatment of chronic hepatitis C in patients coinfected with hepatitis C and HIV whose HIV is clinically stable.
Hepatitis C is a blood-borne virus that chronically infects an estimated 2.7 million Americans. The virus is a leading cause of cirrhosis and liver cancer and is 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 the first and only pegylated interferon approved by the U.S. Food and Drug Administration for the treatment of hepatitis C in patients infected with HIV, and for the treatment of chronic hepatitis B.
Pegasys is dosed at 180mcg as a subcutaneous injection taken once a week. Copegus is dosed at 1000 to 1200 mg daily and is administered orally. Roche has backed Pegasys with the most extensive clinical research program ever undertaken in hepatitis C, with major studies initiated to advance treatment for hepatitis C patients with unmet needs, including patients co-infected with HIV and HCV, African Americans, patients with cirrhosis, and patients who have failed to respond to previous therapy.
SOURCE Roche
Web Site:
http://www.roche.com
http://www.roche.us
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Festival Raises Money for Hepatitis C Treatment
SourceURL:http://www.news8austin.com
By: Bob Robuck
The Liver Foundation of Central Texas held a crawfish boil Sunday to raise money for uninsured Hepatitis C patients.
In a corner of La Zona Rosa, where the event was held, people had their blood tested for the disease.
More than 360,000 Texans are victims of Hepatitis C, the most serious form of Hepatitis.
Hepatitis is inflammation of the liver. It's primarily transmitted by direct blood contact, such as a blood transfusion or and contaminated needles.
Doctors say Hepatitis C is treatable if detected early enough.
"The standard care for people entering our office is a weekly injection, plus an antiviral, which is a retrovirus, for about 24 or 48 weeks of treatment depending on which sub-type of Hepatitis C," gastroenterologist Dr. Kevin Hsu said.
The concert raised money to offset the cost of Hepatitis C treatment.
Just ask Jerialice Arsenault, a musician who played for the event and has Hepatitis C. She has just three months left in her treatment.
"The Hepatitis is gone," said Arsenault. "So, I'm here to tell everybody it works. You just get in there and get started."
But not everyone can afford the treatment. That's why the Liver Foundation threw the party to raise money.
Entertainers Ray Benson and Marcia Ball were just some of the headliners at the fifth annual event.
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UCLA Study Assesses Cost-Effectiveness of Hepatitis B Drugs
SourceURL:http://www.newswise.com
Source: University of California, Los Angeles (UCLA), Health Sciences
Newswise — Researchers at UCLA and the Veterans Affairs Greater Los Angeles Healthcare System conducted the largest and most comprehensive study in comparing the cost-effectiveness of current modern drugs for treating hepatitis B -- a disease affecting 350 million worldwide.
Published in the May 17 Annals of Internal Medicine, the study may help physicians worldwide in making treatment decisions. Researchers note that a degree of uncertainly exists on how to best initiate hepatitis B treatment due to a constant influx of newer, more expensive drugs that all have varying risks and benefits.
“We need to develop a more calculated approach and establish guidelines for the most cost-effective treatment,” said Dr. Fasiha Kanwal, first author and research fellow, Division of Digestive Diseases, David Geffen School of Medicine at UCLA and Veterans Affairs Greater Los Angeles Healthcare System.
Researchers performed an economic analysis comparing the cost-effectiveness of five competing drug treatment strategies for chronic hepatitis B: 1) No treatment at all 2) Interferon alone 3) Lamivudine alone 4) Adefovir alone 5) Beginning therapy with lamivudine, but changing to adefovir if viral resistance is encountered.
Investigators found that the newest drug therapy -- adefovir was not cost-effective when taken alone. However, adefovir was very cost-effective when reserved as a second-line agent in people who develop viral resistance for lamivudine a therapy that has been available for over 15 years.
The study notes that interferon the oldest of all available therapies -- may still be preferred in health care systems with limited resources and is especially cost-effective with “e-antigen negative” patients, which is a more serious type of hepatitis B.
“We found that the newer, more ‘sexy’ drugs are too expensive and better to use only after other first line therapies have failed,” said Dr. Brennan M. R. Spiegel, study author and co-director, Center for the Study of Digestive Healthcare Quality and Outcomes and assistant professor of medicine, David Geffen School of Medicine at UCLA and VA Greater Los Angeles Healthcare System. “The combined treatment strategy of lamivudine and adefovir is also a very viable option. This is part of a trend that we’re seeing in other areas of medicine as well to use “hybrid” treatments that reserve expensive yet effective drugs for specific patients who have shown no success with other treatments.”
Spiegel notes that the general cost-effectiveness standard accepted by society and many insurers for treating a chronic condition like hepatitis B is roughly $50,000 or less per quality-adjusted life-year gained, which is a standard measure used in assessing the outcome of health care procedures or services.
According to Kanwal, the study showed that only two strategies fell well within this accepted standard: Interferon cost an incremental $6,337 to gain an additional quality-adjusted life-year, compared to receiving no treatment at all. Compared with interferon, the hybrid strategy of lamivudine and adefovir cost an incremental $8,446 per quality-adjusted life-year.
In comparison, treatment with adefovir alone cost over $90,000 for each quality-adjusted life-year gained for patients with the e-antigen negative hepatitis B and would not be considered cost-effective according to researchers.
The comprehensive economic model adjusted for various patient scenarios including viral resistance, development of cirrhosis and other factors affecting treatment. Health costs included physician visits, diagnostic tests and complications of chronic liver disease.
Investigators based the model on average 40-year old patients with the most common type of chronic hepatitis B -- with elevated liver enzymes but no liver cirrhosis. Investigators also took into consideration the two types of hepatitis B -- either e- antigen positive or e-antigen negative -- which require different treatment approaches.
Hepatitis B is the most common serious liver infection in the world. The virus attacks liver cells and chronic hepatitis B disease can lead to liver failure, cirrhosis or cancer of the liver. About 90 percent of healthy adults who are infected with Hepatitis B recover with no problems, but 10 percent develop chronic disease. In children who have been infected, 60 percent develop chronic disease.
Other authors include Dr. Ian M. Gralnek, MSHS, Dr. Gareth S. Dulai, MSHS, and Mary Farid, Division of Gastroenterology, VA Greater Los Angeles HealthCare System and Division of Digestive Diseases, David Geffen School of Medicine at UCLA, Center for the Study of Digestive Healthcare Quality and Outcomes, Los Angeles, California; and Dr. Paul Martin, Mount Sinai School of Medicine, New York, New York.
No outside source of funding was used in the study. Martin is a consultant and on the speaker’s bureau for Gilead Sciences, Inc. manufacturer of adefovir. Martin has also received grant support and honoraria from GlaxoSmithKline, manufacturer of lamivudine and Schering Plough, manufacturer of interferon.
Spiegel is a consultant for Novartis that manufactures the drug telbivudine and has also received grant support from Gilead Sciences, Inc. These companies did not have any role in the study.
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InterMune Presents Encouraging HCV Drug Data http://www.drugresearcher.com
16/05/2005 - InterMune has announced the results of preclinical data on the specificity and tolerability of two potent and selective small molecule inhibitors of the hepatitis C virus (HCV). The findings are significant, as they have previously been shown to be highly potent, metabolically stable and orally available.
The news gains special importance as individuals who have been infected for more than 20 years is increasing. The peak incidence of infection occurred in the mid-1980's. As complications from HCV take 20 to 30 years to develop, the number of people requiring treatment is predicted to dramatically increase. Hospitalisation and death rates are projected to triple over the next 10 to 15 years, mostly affecting people who are currently unaware of their status.
Scientists from InterMune and Array BioPharma's stable collaborated on the preclinical study. In vitro studies showed that the two compounds were stable on incubation with human liver cells and displayed a high degree of selectivity. Neither compounds showed significant inhibition of cytochrome P450 isoforms (liver enzymes that break down toxins and other substances processed in the liver) or hERG channel-blocking activity (a complication that can lead to abnormal cardiac rhythm).
"We were very encouraged to find that these two novel HCV NS3/4 protease inhibitors selectively targeted the liver, did not adversely impact the heart or liver and were well tolerated," said Dan Welch, president and CEO of InterMune.
"Based on these new data, we are moving these compounds into IND-enabling toxicology studies in order to select the most appropriate clinical candidate," he added.
In preclinical models, both compounds showed concentrations in the liver in orders of magnitude above the EC50 level (the concentration that leads to 50 per cent maximal response and a measure of the potency of a drug). The two compounds were well tolerated after seven days of dosing. No change in weight, abnormalities in clinical chemistries or hematology tests or mortality were observed.
"We are very pleased that data from these preclinical models support once- or twice-daily dosing in the clinical setting," said Lawrence Blatt, senior vice president of preclinical and applied research at InterMune.
He added: "Furthermore, these two compounds were highly concentrated in the liver and at levels in excess of the amounts required for HCV RNA decreases."
The progress of InterMune's HCV research program has made significant progress over the past three years and they are amongst a handful of companies with similar research interests. InterMune launched its drug discovery program with Array BioPharma in September 2002 to pursue small molecule therapeutics targeting HCV.
In November 2004, InterMune and Array announced an extension of their collaboration, under which Array will perform process development research and cGMP scale-up through Phase I clinical trials of drug candidates resulting from the program. In September 2004, InterMune entered into a nonexclusive licensing agreement with Chiron Corporation granting InterMune a license to discover, develop and commercialise small molecule therapeutic agents against certain HCV targets that Chiron currently holds under patent protection.
As reported last week, Vertex Pharmaceuticals announced the latest results of its investigational oral hepatitis C virus (HCV) protease inhibitor VX-950, which was found to be well tolerated, demonstrating potent antiviral activity in a Phase Ib clinical trial.
Likewise, in November last year, Pharmasset of the US received at least $168 million (?131.8m) in upfront and milestone payments after licensing its preclinical hepatitis C drug programme to Swiss drug giant Roche.
According to the Centers for Disease Control and Prevention (CDC), an estimated 3.9 million Americans (1.8 per cent) have been infected with HCV, of whom 2.7 million are chronically infected, and the prevalence of chronic HCV is increasing. Currently available therapies are insufficient, creating a need for the development of novel therapeutic approaches.
Protease inhibitors represent a promising class of drugs for HCV, and the HCV NS3/4 protease is an attractive drug target because of its involvement in viral replication and suppressive effects on host response to viral invasion.
The new data were presented Sunday at the Digestive Disease Week (DDW) meeting in Chicago as part of InterMune's protease inhibitor program.
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May 17th, 2005
Liver Disease Is a Major Cause of Death in HIV and Hepatitis Co-Infections
Source: www.gastrohep.com
Liver disease a leading cause of death among HIV-Hepatitis C co-infected patients and increasing among HIV-Hepatits B co-infections, with the highest risk in infections with both Hepatitis C and Hepatitis B, finds the most recent issue of the Journal of Hepatology.
Dr Salmon-Cerona and colleagues analyzed the characteristics of HIV infected patients who died from liver disease, focusing on hepatitis virus co-infection.
The research team reported that 185 French hospital departments involved in HIV/AIDS management prospectively notified all deaths occurring in 2000.
The team classified patients whose Hepatitis C and Hepatitis B serostatus was known.
The main causes of death for HIV-Hep C co-infections is liver disease at 31% - Journal of Hepatology
The researchers classified the patients into 4 groups as being infected by Hepatitis C alone, Hepatits B alone, both Hepatitis C and Hepatitis B, or neither.
The team found that among 822 HIV infected patients, 29% were infected by Hepatitis C alone, 8% by Hepatitis B alone, and 4% by both Hepatits C and Hepatitis B.
The researchers noted that the most frequent causes of death were liver disease at 31% of cases and AIDS at 29% among HIVHepatitis C co-infected patients.
The team observed that the causes of death among HIV-Hepatitis B co-infected patients were AIDS at 38% and liver disease at 22%.
Liver disease was a more frequent cause of .death among patients co-infected by both Hepatitis C and Hepatitis B with 44% of cases.
The research team reported that hepatocellular carcinoma was present in 15% of patients who died from liver disease, and was associated with Hepatitis B co-infection.
Nearly half the patients who died from liver disease had more than 200 CD4/mm3.
Dr Salmon-Cerona concludes, “Liver disease is now a leading cause of death among HIV-Hepatitis C co-infected patients and is becoming an important cause of death among HIV-Hepatits B co-infected patients.”
“The risk of death from liver disease is highest in patients co-infected by both Hepatitis C and Hepatitis B.”
J Hepatol 2005: 42(6): 799
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Liver Transplants Work Better from Live Donor - Study
SourceURL:http://www.reutershealth.com
CHICAGO (Reuters) - Children who receive a section of transplanted liver from a live donor have a better chance of survival than those whose organ comes from a deceased donor, researchers said on Monday.
Living donor grafts, in which a section of an adult liver is transplanted, were successful 73 percent of the time compared to a 63 percent success rate when the liver came from a deceased donor, according to 17 years of U.S. data.
The reasons for the better success rate with live donors had less to do with the original health of the graft as it did with the relative health of the recipients and the shortened time between procurement and implantation when the livers were without their own blood supply.
"Although (live donor liver transplant) poses risk to the donor, it is, as practiced, a valuable technique in pediatric transplantation to help overcome the critical organ shortage," wrote study author Mary Austin of Vanderbilt University Medical Center in Nashville, Tennessee.
Livers can regenerate, allowing transplants from live donors, especially to children who do not need a full-sized adult liver, said the report published in the Archives of Surgery. The risks to donors include infection and bleeding.
The study examined 8,771 pediatric liver transplants performed in the United States between 1987 and 2004. Of those, 81 percent were whole livers from a deceased donor, 8 percent were split livers from a deceased donor, and 11 percent were split livers from living donors.
The overall failure rate was 35 percent, with many of those patients receiving another donated liver, while 1,329 children died.
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Vertex Says Drug Quickly Treats Hepatitis C
SourceURL:http://www.alertnet.org
Source: Reuters
By Ransdell Pierson
NEW YORK, May 17 (Reuters) - Vertex Pharmaceuticals Inc. <VRTX.O> on Tuesday said half of hepatitis C patients taking a specific dose of its experimental drug in an early-stage trial tested negative for the virus 14 days after beginning treatment, a speed unmatched by any existing medicine.
The tiny U.S. biotechnology company said the patients received a 750-milligram dose of its medicine, called VX-950, every eight hours during the two-week Phase 1 trial.
Results of the 34-patient study, which was conducted among patients with the hardest-to-treat genotype 1 strain of the virus, were presented at the annual Digestive Disease Week scientific meeting being held in Chicago.
"The big surprise is that half of patients in 14 days in this drug group went below levels of virus detection," Vertex Chief Executive Officer Joshua Boger told Reuters.
By contrast, he said current two-drug treatments typically must be taken for three months before half of patients reach undetectable levels of the virus. They must then be taken another nine months to make sure the virus does not re-emerge.
"Our drug by itself appears to be dropping the virus to undetectable levels dramatically quicker than standard combination treatments," Boger said, and without the flu-like side effects or other problems seen with existing medicines.
Another patient in the Vertex-sponsored trial also tested negative for the virus after receiving a different dose of VX-950.
The virus returned to detectable levels in five patients a month after the Vertex trial concluded, but virus levels remained more than 90 percent below original levels in two of them, the company said.
Boger said he is hopeful longer treatment in larger future trials will prevent the virus from re-emerging after it is knocked down.
Consequently, he said several Phase 2 trials that could begin late this year will last one to three months, testing the drug by itself and with at least one interferon used in current combo treatments, sold by Schering-Plough Corp. <SGP.N> and Roche Holding AG <ROG.VX>. .
"We believe it will take weeks or months to defeat the virus, and we'll conduct the studies to find out," said Boger, who noted that standard treatments last almost a full year.
Shares of Vertex closed up 22 cents, or 1.7 percent, at $13.20 on the Nasdaq.
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At Least 11 People Developed Fulminant Hepatitis after Taking Medication or Consuming ...
SourceURL:http://asia.news.yahoo.com
(Kyodo) _ At least 11 people developed fulminant hepatitis after taking medication or consuming health-food products in 2003, and eight of them died, a government research showed Tuesday.
A team of the Health, Labor and Welfare Ministry released the finding after conducting research on 621 hospitals nationwide.
Kenji Fujiwara, head of Yokohama Rosai Hospital and a member of the research team, said elderly with underlying diseases such as lifestyle-related diseases and mental diseases have a tendency to develop fulminant hepatitis.
"The mechanism of how fulminant hepatitis could be developed should be studied in terms of regular use of medicines and humans' immune functions," Fujiwara said.
The research found a total of 97 cases broadly defined as fulminant hepatitis.
Forty-seven or 50 percent of the 97 cases were fulminant hepatitis caused by a virus, such as hepatitis B, while 11 cases or 12 percent were induced by medication or health-food products, the research showed. Two cases or 2 percent were related to autoimmunity.
The survey showed no specific causes had been pinpointed in 34 other cases but patients in many of the cases were found to have taken medication on a regular basis.
Five of the 11 patients diagnosed as having drug-induced fulminant hepatitis were found to have used prescribed anti-inflammatory agents, which in two cases were over-the-counter cold medicine and in four cases Chinese herbal medicine or health-food products, according to the survey.
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Coley Reports Positive Results from Phase Ib Study of Actilon(TM) for Hepatitis C at Digestive Disease Week Meeting
SourceURL:http://biz.yahoo.com
New Drug Candidate Relatively Well Tolerated At Active Antiviral Doses
CHICAGO, May 17 /PRNewswire/ -- Coley Pharmaceutical Group, Inc. today announced at the Digestive Disease Week conference that Actilon(TM) (CPG 10101) was relatively well tolerated and showed antiviral activity in the company's Phase Ib clinical study in chronic Hepatitis C patients.
In this Phase Ib study forty-two adult patients with chronic Hepatitis C virus, or HCV, were enrolled. These patients had previously failed to achieve a sustained viral response after 24-48 weeks of standard therapy with interferon-alpha plus ribavirin or were intolerant of interferon-alpha and all but two were virus genotype 1. Patients receiving 20 mg of Actilon subcutaneously twice weekly achieved a maximum 1.4 mean log decrease (96%) of virus within 4 weeks. Five of the six patients receiving the 20 mg dose of Actilon achieved at least a one log (90%) reduction of virus while on therapy.
Actilon showed good safety and tolerability, pharmacodynamic immune responses consistent with the drug's mechanism of action, and dose-related blood pharmacokinetics when given to HCV patients, as had been previously shown in Coley's Phase Ia clinical trial in normal volunteers. Initial antiviral activity was observed in this double-blind trial after only 1 mg of Actilon given twice weekly, and dosing has been increased to 20 mg with acceptable tolerability. Measurements of biomarker responses in blood indicated that Actilon stimulates the innate immune system and immune activation induced by Actilon correlates with partial clearance of virus. Decreases in HCV RNA levels began to be observed after a single dose and were observed to be dose dependent.
"We are very encouraged by the results of this Phase Ib study showing antiviral effects with Actilon given to patients with relapsed or treatment resistant genotype 1 Hepatitis C," said John Whisnant, M.D., Senior Vice President, Drug Development of Coley Pharmaceutical Group. "Actilon's observed ability to direct the immune system therapeutically is consistent with its mechanism and with our experience with other Coley TLR Therapeutics in clinical development."
Data from the Phase Ib study were presented by Dr. Bruce Bacon, Professor of Internal Medicine at Saint Louis University School of Medicine in an oral presentation entitled "Safety and Pharmacodynamic (PD) and Pharmacokinetic (PK) Profiles of CPG 10101 (Actilon(TM)), a Novel TLR9 Agonist: Comparison in Normal Volunteers and HCV-Infected Individuals". Interim results from this study were presented previously at The American Association of Liver Disease (AASLD) meeting in November 2004.
About the Study
The Phase Ib double-blind study was designed to assess antiviral responses, safety and tolerability of Actilon over an 80-fold dose range. Forty-two adult subjects with chronic Hepatitis C virus were enrolled; virtually all were virus genotype 1 patients who had previously failed to achieve a sustained viral response after 24-48 weeks of standard therapy with interferon-alpha plus ribavirin. Patients were randomized to receive placebo or Actilon in sequentially higher dose cohorts (0.25, 1, 4, 10 and 20 mg) by twice weekly subcutaneous injections for four weeks.
Researchers observed responses in immune system markers including drug- related increases in interferon-alpha plasma levels and other markers indicative of antiviral activity. Actilon was relatively well tolerated at all doses in most patients, including 20 mg, the highest dose cohort completed, with no dose limiting toxicities. Mild to moderate injection site reactions and mild flu-like symptoms were consistent with the expected pharmacological mode of action of Actilon.
About Actilon(TM)
Actilon is a member of a new class of investigational medicines known as TLR Therapeutics(TM) being developed by Coley and its partners for the treatment of major medical conditions including cancers, infectious diseases, allergy and asthma. TLR Therapeutics target Toll-like receptors (TLRs) which act as immune system sentinels that recognize the distinct molecular patterns characteristic of foreign pathogens. Coley is focusing its efforts initially on the discovery and development of TLR Therapeutics which target and stimulate Toll-like receptor 9 (TLR9), which is found in a subset of dendritic and B cells.
Coley believes that Actilon stimulates TLR9, targeting dendritic cells and B cells, to induce both early and long term immune responses. The short-term innate immune response is thought to drive rapid reductions in viral load in the blood. Longer term, Actilon is thought to promote virus-specific adaptive immunity, including strong T cell responses, to provide sustained anti-viral effects.
About Hepatitis C Virus
Hepatitis C virus, which infects the liver and certain immune cells, leads to serious liver diseases such as cirrhosis and liver cancer more frequently than any other form of hepatitis. HCV is an RNA virus known to undergo a high rate of mutation that may help it both to avoid control by the immune system and to develop resistance to direct antiviral medications. According to the World Health Organization, HCV infects approximately 170 million people worldwide, including at least 2.7 million in the United States, and 10-20 percent of those chronically infected with HCV will ultimately develop liver cirrhosis, making HCV the leading cause of liver transplants in the United States. The Hepatitis Foundation International estimates that between 8,000 and 10,000 people die annually from HCV-related cirrhosis or liver cancer.
Coley believes, there is an unmet need for therapies with better side effect profiles and equivalent or superior efficacy, especially in the difficult-to-treat population of genotype 1 patients, who have failed to achieve a sustained virologic response following interferon-alpha and ribavirin therapy.
About Coley Pharmaceutical Group
Coley Pharmaceutical is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics(TM), a new class of investigational drug candidates that direct the human immune system to treat cancers, infectious diseases, asthma and allergy. Coley has established a pipeline of four TLR Therapeutic product candidates currently advancing through clinical development either independently or with partners, and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Chiron, the United States Government and GlaxoSmithKline.
Safe Harbor Statement
Certain statements in this news release concerning Coley's business are considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, those relating to the timing and results of future clinical development of Actilon and the ability of Actilon to achieve a sustained virologic response in patients with HCV and other infectious diseases. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Coley might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; uncertainties as to the future success of ongoing and planned clinical trials; and the unproven safety and efficacy of products under development. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Coley undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
Source: Coley Pharmaceutical Group, Inc.
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May 18th, 2005
Hepatitis C Drug Rocks Virus in Early Test
SourceURL:http://www.foxnews.com/
By Daniel J. DeNoon
In early tests on humans, a new hepatitis C drug had the most powerful punch yet seen against this major cause of liver cancer.
The drug, from Vertex Pharmaceuticals, is code-named VX-950. Liver specialist Henk W. Reesink, MD, of academic Medical Center in Amsterdam, Netherlands, presented the findings at Digestive Disease Week 2005, the annual meeting of several major medical specialty societies.
"This is really a breakthrough in the treatment of hepatitis C virus," Reesink tells WebMD. "This first human study was very successful. In the first two or three days of treatment there is a very rapid [1,000-fold] decline in hepatitis C virus levels. Then, over two weeks, there are further declines -- in some dosage groups, about a 25,000-fold reduction in viral levels. That has never been shown with any other drug."
Reesink warns that VX-950 is in the very earliest stage of human studies. Nobody knows if it will prove safe over time. Nobody knows whether its effects will continue long enough to cure hepatitis C virus infection.
And while the drug appears exquisitely effective against genotype 1 -- the most difficult-to-treat strain of hepatitis C virus and the one most common in the U.S. and Europe -- it's not clear whether it will work against other strains.
Despite being highly preliminary, Reesink's report excited the assembly of specialists, says Eugene R. Schiff, MD, chief of hepatology and director of the Center for Liver Diseases at the University of Miami School of Medicine.
"I was impressed, and everybody in the audience was impressed," Schiff tells WebMD. "Yes, this is preliminary, but this is an important advance. It is the most important paper presented at this meeting. They showed -- with an oral agent -- that they could drop hepatitis C viral levels, some to undetectable levels, in a relatively short period of time."
Most of the patients in the Reesink study already had failed state-of-the-art treatment for hepatitis C. That treatment is a combination of a highly active form of interferon plus an antiviral drug called ribavirin. This treatment offers long-term viral suppression -- what many experts call a cure -- in about half of patients. But this treatment takes nearly a year, and the side effects often are very difficult to endure.
VX-950: Protease Inhibitor Targets Hepatitis C Virus
VX-950 is a designer drug discovered only after huge effort. It targets a key hepatitis C protein. That protein is called protease, an enzyme the virus needs to reproduce.
It's not the first time a hepatitis C protease inhibitor has been tested in humans. Recently, an experimental hepatitis C protease inhibitor called BILN 2061 showed promising results in short-term human trials. But that drug had to be put on hold when monkey studies suggested it was toxic to the heart.
Schiff says that "seven or eight" pharmaceutical companies are nearing clinical trials of their own protease inhibitors against hepatitis C virus. He estimates that more than 20 companies are developing new "small molecule" drugs designed as oral hepatitis C treatments.
The term "protease inhibitor" may sound familiar. Drugs targeting HIV protease were a huge breakthrough for AIDS therapy. However, HIV rapidly develops resistance to these drugs. That's why AIDS drugs have to be taken in powerful combinations.
Whether hepatitis C virus will develop resistance to VX-950 or other protease inhibitors isn't known. Schiff notes that unlike HIV, the hepatitis virus doesn't hide inside cells where drugs can't reach it. So if the drug keeps viral levels low, there's a good chance the virus won't become resistant. It's even possible, Schiff says, that hepatitis C protease inhibitors will work all by themselves, without the need for combination therapy.
Shorter, Easier Hepatitis C Treatment?
In the Reesink study, the most effective dose of VX-950 was a three-times a day treatment. Four of eight patients receiving this dose for 14 days had about a 25,000-fold drop in hepatitis C virus levels. The virus became undetectable in two patients. Larger doses given twice a day didn't work as well, nor did lower doses given three times a day.
In this short study, no serious side effects seemed to happen. Possible side effects included headache, diarrhea, nausea, frequent urination, and sleepiness/drowsiness. All these side effects were mild.
It's not at all clear whether VX-950 really will work all by itself or whether it will work best in combination with other drugs. Unlike current hepatitis C treatments, it's an oral drug. That raises hopes for a much easier-to-take -- and, perhaps, shorter -- treatment regimen.
"It is difficult to say at this moment how long VX-950 treatment would take," Reesink says. "But from this first-phase trial, one can speculate -- and this is just speculation -- that the treatment duration may be substantially shorter than the current standard of therapy."
"You will see combination treatments with this drug," Schiff predicts. "But if you end up with a combination of oral agents, instead of the current medications with this big side-effect profile, that would still be much better for patients."
Message to Patients: Don't Stop or Delay Current Treatment
Reesink and Schiff both warn patients with chronic hepatitis C infection not to stop their current treatment or to delay starting current therapies. Even if everything goes perfectly -- and drug development rarely does -- it would be more than five years before VX-950 could be available to patients.
"It would be a mistake for people to stop their current treatment to wait for this stuff," Schiff says. "That would be a big mistake. What we heard today could represent a major advance in treatment. But I used to chair an FDA drug-approval committee, and I can tell you that when a new drug comes along everybody gets turned on -- and then they find side effects of something and the drug has to be withdrawn. I don't think that is going to happen here, but it's too soon to tell."
By Daniel J. DeNoon, reviewed by Brunilda Nazario, MD
SOURCES: Digestive Disease Week 2005, Chicago, May 14-17, 2005. News release, Vertex Pharmaceuticals. Henk W. Reesink, MD, associate professor of internal medicine and hepatology, Academic Medical Center, Amsterdam, Netherlands. Eugene R. Schiff, MD, chief of the division of hepatology; director, Center for Liver Diseases, University of Miami School of Medicine.
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May 19th, 2005
Terrence Higgins Trust Launches Hepatitis A, B and C Campaign
SourceURL:http://www.medicalnewstoday.com
Terrence Higgins Trust (THT) is launching a new awareness campaign --A, B, C is just the start -- to encourage gay men to visit THT's updated hepatitis B web site, which now includes full information on hepatitis A, B and C. The move follows increases in diagnoses of hepatitis B and C, and calls from gay men for clarity on how hepatitis C is transmitted.
The campaign will include adverts in the gay press and online banner adverts linking through to the new website. Outreach workers will also be taking the campaign materials to gay venues across England and Wales.
The website clearly explains the difference between the three most common types of hepatitis, how to prevent them and where to go for a test or treatment. Increasingly, many gay men are seeking information about Hepatitis C, for which there is currently no preventative vaccine.
Common ways of transmitting hepatitis A, B and C include:
-- Hepatitis A is transmitted through rimming, sharing sex toys and fingering (then putting fingers in mouth)
-- Hepatitis B is transmitted through sharing needles, razors, sucking and unprotected fucking.
-- Hepatitis C is transmitted through sharing needles, razors, snorting pipes, unprotected fucking and fisting.
Will Nutland, Head of Health Promotion at Terrence Higgins Trust said:
"Hepatitis A and B are easily avoided through vaccinations offered to all gay and bisexual men at sexual health clinics. However we know from research that only 50% of gay men have completed a course of vaccinations against hepatitis B.
"We want to encourage all gay men to get vaccinated for hepatitis A and B, and find out more about the condition by visiting http://www.hepinfo.org."
tht.org.uk/press_desk/HepatitisABC.htm
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Chiron, Enanta Sign Hepatitis C Agreement
SourceURL:http://eastbay.bizjournals.com/
Chiron Corp. and Enanta Pharmaceuticals Inc. announced Thursday that the companies have signed an exclusive agreement for the development and commercialization of Chiron's hepatitis C virus protease inhibitors.
Financial terms of the deal were not made public.
The deal gives Massachusetts-based Enanta a nonexclusive license to Chiron's hepatitis C technology. And, the company will have exclusive rights to develop and commercialize Chiron's hepatitis C protease inhibitors.
Enanta will make payments upon the achievement of development milestones and pay royalties on commercial sales.
Chiron (NASDAQ: CHIR), a biotechnology company based in Emeryville, will retail certain co-development and commercialization opt-in rights worldwide, excluding Asia.
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Health Worker Has Hepatitis C
SourceURL:http://www.sunherald.com/
Dear Dr. Sangani:
In my department we have a person with hepatitis C who weekly climbs into auto accidents to assist the victims. As safety chief of the department, I am concerned with letting this person work on patients with open wounds and all the sharp metal edges and broken glass at an accident scene. The only protection this person uses is rubber gloves. Besides blood, what other fluids would be a concern? My city does not think this is a risk to the public. I would appreciate additional avenues of research on your opinion. Thank you.
- Confused City Official
Dear City Official:
I have invited Dr. Alfred McNair, a board-certified gastroenterologist practicing on the Gulf Coast, to answer your question. Due to the length of his responses, we will break this column into two parts. Be sure and check next week for the rest of the column.
A: The risk to the public in the scenario you cite above is the constant exposure to patients with open wounds, sharp objects and broken class. An open wound exposure may occur in an auto accident. This is obviously a very important issue for any medical personnel, doctors, nurses, EMT's etc. We are all potentially around environments where patients can get infected, because we are all exposed to open wounds and possible needle sticks, maybe not as exposed to glass or sharp objects as you would in an accident environment.
Q: What is the incidence of hepatitis C?
A: Your question is a very good one. As you know there are more than 3.9 million Americans affected with hepatitis C. Of that number 2.7 million go on to develop chronic infection so over 75-80 percent go on to develop chronic disease. Most of these patients are not yet diagnosed. They do not know they have the disease. Most of these patients are asymptomatic, thus there are very few symptoms or no symptoms to suggest it unless they are tested.
Q: What are the recommendations for someone who has hepatitis C?
A: In addition to the medical personnel one of which you know has hepatitis C, others could have it and not know it because they have not been tested. The other possibility is a patient you might see in the environment of the accident could very well have hepatitis C themselves, thus being at high risk for exposure for our medical personnel themselves. The current recommendations are that these people with known hepatitis C should double glove in a situation where they are dealing with open wounds and potentially sharp objects such as broken glass or needles. In the event there is a crack in the glove, the gloves should be immediately changed. These recommendations are for all medical personnel including a dentist, EMT, physician, nurse, etc.
Q: What treatment is available for hepatitis C?
A: If indeed there is any question as to whether the victim has hepatitis C themselves or contaminated by health care employee, then the current treatment would be close observation, appropriate blood work and in the case of known hepatitis C exposure starting these patients on treatment with Interferon and Ribavirin prior to the return of the blood work to prevent the onset of hepatitis C. This is as good as you can do.
Q: What precautions should be taken to prevent transmission of hepatitis C?
A: You have to remember that every precaution should be taken on both sides of the fence. Both the medical personnel and being very careful with any patient that has open wounds. I think if we are lucky we know we have the disease such as this healthcare worker because they know what precautions to take to protect themselves and to protect the public. If they follow these precautions incidences of transmission to our patients and for employees, it is extremely uncommon.
Q: What are the benefits of treatment?
A: The other question I have on this, is has this person been treated? Depending on the genotype of hepatitis C, the cure rate, with the use of the current medications Interferon and Ribavirin approaches between 50-80 percent. Therefore, it is very important that a person has been treated because it could possibly lead to a cure.
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Hepatitis C Conference in New York City, May 26-27
SourceURL:http://www.advocate.com
The Hepatitis C Harm Reduction Project is holding a hepatitis C-related conference, titled "Drug Using Communities and Hepatitis C: Practice, Research, and Policy," May 26-27 in Brooklyn, N.Y. Organizers expect 300 social service providers, medical professionals, researchers, and people living with or affected by hepatitis C to attend. The event will include presentations on hepatitis C prevention, testing, treatment, research, policy, and alternative therapies. Break-out sessions will include "Integrating Hepatitis C Into HIV Programs" and "HIV and Hepatitis C Coinfection." The conference will be held each day from 9 a.m. to 5 p.m. at the Marriott Hotel, 333 Adams St. A suggested registration donation of $25 is suggested, but organizers say those who cannot afford to pay will not be turned away. For more information, visit the Harm Reduction Coalition's Web site at www.harmreduction.org, send e-mail to Ramirez@harmreduction.org, or call (212) 213-6376, ext. 46.
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May 20th, 2005
(China) Hepatitis C Detection Kit Developed by Company in Hunan Province
SourceURL:http://www.biotecheast.com/
(BiotechEast staff)
Mainland China's State Food and Drug Administration recently issued approval of production of hepatitis C test kit by Chinese company Hunan Jingda Bioengineering Co., Ltd. The development of the technology, which has been strongly promoted by mainland Chinese authorities, could shorten the time required to detect hepatitis C infection.
According to Hunan Jingda, the time required for detection of hepatitis C with this test kit has been shortened to 14 days, down from the standard 50 to 70 days. Early detection will allow for early stage treatment of hepatitis C patients as well as improved blood selection for the blood preparation industry.
As early as 2001, the National Development and Reform Commission and the Ministry of Science and Technology had determined that key support and priority should be given to development of this high-tech industrialization project.
There are about 170 million people worldwide infected by hepatitis C, with between 40 million- 60 million sufferers living in China alone. According to 2003 and 2004 statistics released by China’s Ministry of Health, viral hepatitis cases in China had ranked first among all other infectious diseases, with hepatitis C prominent among them.
This article comes from BiotechEast - Biotechnology, medical devices and pharmaceuticals in Taiwan and Greater China
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May 21st, 2005
Hepatitis C Waiting to Explode
SourceURL:http://www.theaustralian.news.com.au/
Adam Cresswell
A SPECK of blood - maybe on a toothbrush she shared with her partner, maybe on a razor blade - was probably Michelle Morrison's undoing. She can't be sure exactly when it happened, or how.
The first thing the 38-year-old professional dressmaker and former Tax Office clerk knew about it was a letter received from the Red Cross in 1994, dropping the bombshell that the blood she had donated a couple of weeks before had tested positive for hepatitis C.
"I didn't take it very well," Morrison recalls now. "Shock was the initial reaction. When I went to see my GP, even with further tests I was still denying it was happening. I couldn't work it out, because I didn't feel sick. It didn't make any sense to me."
She saw a specialist, and had further tests, including a liver biopsy, which showed scarring already apparent.
But the damage wasn't so advanced that treatment was considered appropriate, and -- being as she says now "in denial" about her condition -- she proceeded to live life pretty much unchanged.
She changed jobs, and then cities. But five or six years after the diagnosis the symptoms began: intolerance to alcohol and fatty foods, and depression.
"I've never experienced anything like that ... it took me by surprise," she says.
It led to a year-long treatment program, involving a weekly injection of slow-release interferon and twice-daily tablets of an antiviral drug called ribavirin, that's due to finish in two weeks' time. If successful it will mean she is clear of the virus for good.
Unfortunately, while 250,000 other Australians are estimated to have the infection, hardly any -- fewer than 1300 in 2003 -- are receiving treatment, creating a potential time bomb of more serious illness.
On Wednesday, federal Health Minister Tony Abbott will launch an awareness campaign on hepatitis C that aims to increase the public's understanding of the disease, and treatments available.
It is a debilitating condition that can leave those affected so sick they can't work or even do basic household tasks.
Although only identified in 1989, it is now thought Hepatitis C was being widely transmitted by blood-to-blood contact in Australia from the early 1970s -- creating a substantial pool of chronic infection.
This means drug users were passing it among themselves, but there were other routes too. It is estimated that between 3500 and 8000 people were affected through infected blood and blood products before checks were introduced in February, 1990, to ensure these were clean.
The large number of people infected is a major issue. Although hep C rarely kills - the mortality rate is less than 5 per cent - even in the short term it causes chronic, debilitating fatigue, flu-like symptoms, nausea, depression, and joint and muscle pain, among other effects.
On average 25 per cent of people who contract hep C will clear the infection naturally within a year. But the other 75 per cent will have an ongoing infection.
And for a small proportion of this group, the long-term effects can be grim: 7 per cent of those who have hep C for 20 years may develop cirrhosis of the liver, and 1 per cent may have liver failure or liver cancer. Among those with the disease for 40 years, it's even worse: 20 per cent may develop cirrhosis and 4 per cent may develop liver failure or liver cancer.
With so many people infected with the hep C virus, and so few being treated, this means tens of thousands of Australians may be heading for serious liver problems in later life -- especially as on current projections the number of people infected by 2020 is anywhere between 321,000 and 836,000, depending on what assumptions are made about patterns of injecting drug use.
Th costs are potentially immense: it's conservatively estimated that hep C cost the community $125 million in 1996-97 in direct and indirect costs, and lifetime costs rise by $46.6 million for every 1000 extra people infected.
Helen Tyrrell, chief executive of the government-funded Australian Hepatitis Council (AHC), says although the federal Government earmarked $15.4 million for education and prevention programs from July 2003 to June 2007, there was nothing extra for hep C programs in the recent 2005/06 budget, even though the first national hep C strategy launched in 2000 expired in mid-2004.
A draft replacement strategy has been drawn up and awaits government approval. The AHC is pressing for it to be implemented in full, with an extra commitment for a public awareness campaign to tackle myths about the illness.
People with hep C often experience stigma over their condition, due to the associations between hep C and drug use. But Tyrrell says while injectable drug use is the main cause of new cases, there are others -- such as tattooing and body piercing, mother-to-baby transmission, and household transmission (as in Morrison's case). Sexual transmission is rare.
The common notion that someone who has injected drugs is a "junkie" is wide of the mark.
"A lot of people in their youth may have dabbled in drugs, maybe once, maybe a few times - and then 20 years later find out they have Hep C," Tyrrell says.
"We have people who are top public servants, journalists, teachers, doctors, mothers who pick up their kids at three o'clock. The disease doesn't discriminate - it's people that do."
Bob Batey, area director of drug and alcohol services at Hunter New England area health service in NSW, says barriers to treatment - such as the existing requirement for patients to have a liver biopsy before qualifying for subsidised drugs - need to be relaxed so the current low treatment rates can be increased.
Professor Batey says cure rates have improved in recent years -- up to 90 per cent for one virus sub-type. There have also been improvements in side effects, which vary between individuals but can include nausea, thinning hair, skin irritation and sleep loss.
Morrison - who now hopes to be declared clear of the virus in December - has no regrets about having treatment.
"People need to know that access to treatment has improved, that cure rates have improved, that side effects have improved," she says. "This has been a wake-up call for me ... I will treat my body better, because I now appreciate what an amazing machine it is. But you've only got one of 'em."
Australian Hepatitis Council
www.hepatitisaustralia.com
Awareness Week
www.hepcawareness.net.au
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