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Week Ending: December 3rd, 2005
Alan Franciscus
Editor-in-Chief
To download pdf version click here
This Issue:
• The Deadly Shot
• Valeant Pharmaceuticals Agrees to Acquire Rights to Hep-C Drug Infergen(R) from InterMune
• WILKES-BARRE - A Little Laughter Might Do More Than Just Entertain on Friday. It Might Lead to Education
• Early Treatment of Hepatitis C Effective in HIV-Positive Patients
• Patients with Hepatitis C Using More Healthcare Resources
• Judge Denies New Trial in Hepatitis C Case
• Hepatitis B Knowledge Poor Among Taiwan People
• Woman Completes Journey of Hope After Man's Death from Hepatitis C, Wife Finishes Trek
• Tainted-Blood Victims Speak in Court
• Hepatitis C Leadership Summit Engages HCV Stakeholders to Elevate the Response to the HCV Epidemic; New Opportunities for Action with Currently-Available Resources
• The Bug Stops Here: Force Protection and Emerging Infectious Diseases
• Clinical Care Options Partners with Chinese Hepatitis Foundation to Provide Exclusive Conference Coverage for the 6th Annual Shanghai - Hong Kong International Liver Congress
• Hep C Health Care Resources in the United States
• Idenix Provides Update on Clinical Development Program for Valopicitabine (NM283) for the Treatment of Hepatitis C
• New Insights into Protein Synthesis and Hepatitis C Infections
• North Carolina Hepatitis C/HIV Program Works to Meet Future Community Needs
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November 26th, 2005
The Deadly Shot
http://www.nytimes.com
Millions of people in poor countries get sick and die from a common tool for getting well: the hypodermic syringe. In some countries, most injections are done with needles that are reused without sterilization. Twenty-one million people each year get hepatitis B this way, two million get hepatitis C and 650,000 get infected with H.I.V.
As third-world health problems go, this one seems solvable. Single-use syringes, whose plungers break or are blocked after first use, cost about 6 cents apiece. Countries could simply follow the lead of Botswana and Uganda and ban all other kinds of syringes.
But nothing is ever simple in places where health care is disorganized and threadbare. The biggest problem is that many poor countries are injection-crazy. For every injection given as a vaccination, 20 are given as cures. Many injected medicines are snake oil, and even effective injections are mostly unnecessary, as a pill would work just as well. But patients demand injections because they think the medicine is stronger, and health care workers like to give them because they can charge more.
It is hard for governments to change dearly held beliefs about medicine. Dirty needles kill many years after a shot. In some places, it took a health crisis to bring progress. In Romania, people became aware of the problem of unsafe injection after children in orphanages had been given contaminated blood and vaccinated with dirty needles, resulting in the infamous wave of AIDS infection.
In Burkina Faso, a severe meningitis outbreak helped, paradoxically, by producing an extreme shortage of medicines and syringes. This led the government to reform its medical-supply system. Small pharmacies stocked with essentials including single-shot syringes now exist in health posts throughout the country. From 1995 to 2000, the percentage of injections with reused needles declined in Burkina Faso to 4 percent from 55 percent.
The most direct course is to ban reusable needles. But in countries spending $10 a year per capita on health care, 6 cents a shot is a lot when a traditional syringe can be reused some 200 times.
The Safe Injection Global Network, backed partly by the World Health Organization, is trying to help countries develop educational programs for health care workers and doctors. The Bush administration also works on injection safety as part of its AIDS efforts overseas. But more needs to be done, particularly since such a small amount of money can save so many lives.
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November 28th, 2005
Valeant Pharmaceuticals Agrees to Acquire Rights to Hep-C Drug Infergen(R) from InterMune
SourceURL:http://www.genengnews.com
Valeant Pharmaceuticals International (NYSE:VRX) today announced that it has signed a definitive agreement to acquire the United States and Canadian rights to the hepatitis C drug Infergen(R) (interferon alfacon-1) from InterMune, Inc. (NASDAQ:ITMN). Valeant will pay InterMune $113.5 million in cash upon closing, and subsequent milestone payments of up to approximately $22.5 million. Valeant also will acquire an estimated $6.5 million in inventory from InterMune. The transaction was approved by Valeant's board of directors and is expected to close following the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvement Act of 1976, as amended. Closing is expected in late 2005.
"The acquisition of Infergen will have an immediate sales impact on Valeant and provide us with a valuable addition to one of our core therapeutic areas," said Timothy C. Tyson, Valeant's president and chief executive officer. "In addition, we intend to hire up to 50 of InterMune's sales and marketing force, which will help to provide Valeant with an immediate presence in the hepatitis C market and position us for the anticipated launch of Viramidine(R)." Viramidine, which is currently in Phase 3 clinical trials, is expected to be launched in 2007.
Infergen or consensus interferon, is a bio-optimized, selective and highly potent type 1 interferon alpha originally developed by Amgen and launched in the United States in 1997. It is currently indicated as monotherapy for the treatment of adult patients suffering from chronic hepatitis C viral infections with compensated liver disease and is dosed three times per week. Infergen is the only interferon with data in the label regarding use in patients following relapse or non-response to certain previous treatments.
Infergen is being studied in ongoing clinical trials to establish additional labeling for daily use with ribavirin. Enrollment in the Phase 3 IHRC-001 (DIRECT) trial was completed in mid-2005 with 514 patients at 40 sites in the United States. The DIRECT trial, which should be completed in 2007, is evaluating the safety and efficacy of both 9mcg and 15mcg doses of daily Infergen in combination with ribavirin in non-responders. Management of the DIRECT trial will be transitioned from InterMune to Valeant following the closing of the transaction.
Sales of Infergen were $22 million in 2004. For the first nine months of 2005, sales of Infergen increased by 79 percent to $25.3 million compared to $14.2 million for the first nine months of 2004. The acquisition of Infergen is expected to be neutral in 2005, excluding the impact of acquired in-process research and development, which is estimated to be approximately $45 million, and modestly dilutive in 2006.
According to the Centers for Disease Control and Prevention, an estimated 3.9 million Americans (1.8 percent) have been infected with the hepatitis C virus (HCV). HCV causes an estimated 10,000 to 12,000 deaths annually in the United States and is the leading cause of the need for liver transplants. The prevalence of HCV is increasing and approximately half of all patients with compensated liver disease do not respond to first-line treatment. There are approximately 250,000 of these non-responder patients currently in the U.S. and the number is growing by an estimated 50,000 each year.
Important Safety Information
Alpha interferons, including Infergen, 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 symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping Infergen therapy. The most common side effects are flu-like symptoms (i.e., headache, fatigue, fever, myalgia, and rigors). Physicians and patients can obtain additional prescribing information regarding Infergen, including the product's safety profile and the box warning for all interferon alphas regarding neuropsychiatric, autoimmune, ischemic and infectious disorders, by visiting www.infergen.com.
About Valeant
Valeant Pharmaceuticals International (NYSE:VRX) is a global, research-based specialty pharmaceutical company that discovers, develops, manufactures and markets products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at www.valeant.com.
Viramidine is a registered trademark of Valeant Pharmaceuticals International or its related companies. All other trademarks are the trademarks or the registered trademarks of their respective owners.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within the meaning of the federal securities laws relating to expectations, plans or prospects for Valeant, including our ability to successfully close the transaction with InterMune and integrate Infergen into Valeant's existing product line, obtain approval of other pipeline candidates within the company's estimated timeline or at all, to realize expected results of operations relating to Infergen, and successfully expand the company's infectious disease business. These statements are based upon the current expectations and beliefs of Valeant's management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond Valeant's control, adverse events that would require clinical trials to be prematurely terminated, clinical results that indicate continuing clinical and commercial pursuit of Infergen is not advisable, and the risk factors and other cautionary statements discussed in Valeant's filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on any of the forward-looking statements in this press release, which speak only as of the date of this press release. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.
CONTACT:
Valeant Pharmaceuticals Jeff Misakian (Investors), 714-545-0100, ext. 3309 or Dan Springer (Media), 714-545-0100, ext. 3381
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November 29th, 2005
WILKES-BARRE - A Little Laughter Might Do More Than Just Entertain on Friday. It Might Lead to Education
SourceURL:http://www.citizensvoice.com
Minh Chau, a senior at GAR Memorial High School in Wilkes-Barre, is organizing a comedy show to raise awareness for Hepatitis C, a chronic disease that affects the liver.
There is no cure or vaccine, and if left untreated, the disease can be fatal.
The show will take place Friday, Dec. 2, at 8 p.m. inside the GAR auditorium. Admission is $10 and comedians Mike Morse and Jim Johnson will perform.
Morse is a prop comic who has been seen on America's Funniest People. Johnson was a fixture on the Philadelphia radio station Y-100.
While Chau's participation in the Pennsylvania Governor's School for Health Care led him to organize the benefit, he also has a personal reason for doing it.
"My mom was diagnosed with it a few years ago. We have no idea how she got it," he said.
His mother is not alone. More than 2 percent of the general population is infected with the virus that causes Hepatitis C, the Center for Disease Control said, and in Pennsylvania alone, 220,000 people are infected.
Most people who have it don't know they're infected, since 80 percent of the afflicted have no symptoms, the CDC said. Symptoms include fatigue, abdominal pain, loss of appetite, nausea, and jaundice (yellowing of the skin, fingernails, and whites of the eyes).
Intravenous drug users, those with tattoos or body piercings, children of infected mothers and health care workers are most at risk for Hepatitis C. Anyone who received a blood transfusion before 1992 is also at risk, the CDC said.
Chau's mission is to educate others about the disease and its risk factors.
Any money the benefit raises will be donated to the American Red Cross and the Osterhout Library. Chau hopes they will use the money to purchase educational materials.
Anyone interested in purchasing tickets can call 479-0844. Tickets will also be available at the door the night of the show.
hruckno@citizensvoice.com
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Early Treatment of Hepatitis C Effective in HIV-Positive Patients
www.aidsmap.com
Chris Gadd
Treatment of hepatitis C infection during the early phase of infection can achieve similar response rates to treatment of chronic infection in patients co-infected with HIV, according to two pilot studies presented last week at the Tenth European AIDS Conference / European AIDS Clinical Society in Dublin.
Liver diseases including hepatitis C are an important cause of disease in HIV-positive patients. Although the treatment of chronic hepatitis C infection in HIV-positive patients has been assessed in a number of large prospective clinical trials, the treatment of hepatitis C in the first few months after infection has received limited attention.
Two small studies presented in Dublin assessed the impact of hepatitis C treatment with peginterferon alfa-2a (Pegasys) with or without ribavirin (Copegus / Rebetol) during acute infection. Both studies found high rates of clearance of the hepatitis C virus.
The first study recruited 25 gay men with evidence of acute hepatitis C infection following raised liver enzymes or symptoms of hepatitis C infection, confirmed by detection of hepatitis C virus in the blood. All but one of the patients was taking antiretroviral therapy.
Nineteen of the men were treated for 24 weeks with 180µg peginterferon alfa-2a once a week and 800mg ribavirin once a day. One patient cleared hepatitis C before starting treatment and five refused treatment. The median time from infection to the start of treatment was 14 weeks.
At 24 weeks after the end of treatment, ten (71%) of the 14 patients who had reached this time point had no detectable hepatitis C virus in the blood. Of the four patients who failed to achieve this, one was lost to follow-up, two had virological failure and one had become re-infected after clearing the virus.
Hepatitis C virus treatment was well tolerated with no dose adjustments required because of side-effects. There was also no effect of treatment on CD4 cell counts or HIV viral load.
The second study followed a similar course to the first, recruiting 31 men with known or suspected exposure to hepatitis C virus, detection of hepatitis C antibodies or increased liver enzymes.
At the end of 24 weeks of treatment with peginterferon alfa-2a either alone or with ribavirin, 19 (61%) of the patients had no detectable hepatitis C virus in the blood. Although this study did not report the ‘sustained virological response’ at 24 weeks after the end of treatment, it also suggests that early treatment may be beneficial for HIV-positive patients who are infected with the hepatitis C virus.
The investigators did not find any differences in response rates between genotypes of hepatitis C virus or between patients treated with and without the addition of ribavirin. However, the number of patients treated may be to small for these differences to be detected.
Despite this, the investigators found that successful clearance of the virus by weeks 4, 8 or 12 or treatment, as well as hepatitis C infection less than four months before the start of treatment were linked to a better response rate.
Jürgen Rockstroh, presenting, commented that the response rate observed in this study is similar to those seen in HIV-co-infected patients treated during after long-term infection with hepatitis C. Although larger prospective studies are required to confirm these findings, they suggest that the treatment of acute hepatitis C infection could become a useful strategy for co-infected patients in whom hepatitis C is detected soon after infection.
References
Dominguez S et al. Safety and efficacy of a 24 week course of pegylated interferon-a2a and ribavirin for the treatment of acute HCV infection in HIV positive patients. Tenth European AIDS Conference / European AIDS Clinical Society, Dublin, abstract PS7/6, 2005.
Vogel M et al. Predictive factors in the treatment of acute HCV-infection in HIV-positive individuals interim analysis of a large German multicenter study. Tenth European AIDS Conference / European AIDS Clinical Society, Dublin, abstract PS7/7, 2005.
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Patients with Hepatitis C Using More Healthcare Resources
SourceURL:http://www.eurekalert.org
Aging patient population burdens healthcare system
Use of the nation's health care resources by patients with Hepatitis C has been rising 25 to 30 percent per year says a study in the December 2005 issue of Hepatology, the official journal of the American Association for the Study of Liver Diseases (AASLD). Published by John Wiley & Sons, Inc., Hepatology is available online via Wiley InterScience (http://www.interscience.wiley.com/journal
/hepatology).
Chronic Hepatitis C virus (HCV) affects about 3 million people in the United States. Many patients contracted the disease in the 1970s before testing and safe needle-sharing practices were widespread. As this population ages, experts have predicted an increasing impact on the healthcare system.
To understand how HCV outcomes are evolving, researchers, led by William C. Grant, Ph.D. of Duke University, analyzed hospitalizations, outpatient trends, and prescription drug data. They examined hospitalization trends for HCV-related and liver-related admissions from 1994 through 2001 using the Nationwide Inpatient Sample from the Healthcare Cost and Utilization Project. They tracked HCV-related physicians' visits from 1996 to 2002. They also gathered data on spending for interferon-ribavirin combination therapy between 1998 and 2000 from the Verispan Source Prescription Audit.
The researchers determined that HCV-related hospitalizations, hospital days, total charges, and deaths increased by more than 20 percent per year, three times higher than for all-cause hospitalizations. "The growth patterns were most striking for patients in their forties and fifties," the authors report. Patients in this age group spent more time in the hospital, incurred greater costs, and died more frequently than patients in other age groups. Physician office visits by HCV patients also increased by 36 percent each year. And spending on HCV drug therapy rose dramatically between 1998 and 2000, from $78 per $100,000 in new prescriptions to $259.
"The study documents accelerating use of healthcare resources by patients with HCV," the authors report, with average annual increases of 25 to 35 percent for the primary outcomes of interest, "indicating that the future burden of HCV infection will match and may exceed analysts' forecasts," they say. Their findings corroborate existing concerns over worsening health as HCV patients grow older.
The researchers also noted interesting disparities in HCV progression by gender, with slower disease progression among women. HIV-HCV co-infected patients, and children with HCV are two groups deserving further study.
The authors performed sensitivity analyses to address the possibility of underreported HCV incidence, which remains an important limitation of this study. Still, they conclude, "our findings highlight the urgency concerning HCV outcomes. Across the United States, health care providers are using tremendous amounts of resources for HCV care. As patients continue to age and disease burden progresses, suboptimal decisions regarding HCV treatments will bring increasing opportunity costs for the health care system and society."
Article: "Trends in Health Care Resource Use for Hepatitis C Virus Infection in the United States," William C. Grant, Ravi R. Jhaveri, John G. McHutchison, Kevin A. Schulman, and Teresa L. Kauf, Hepatology; December 2005; (DOI: 10.1002/hep.20941)
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Judge Denies New Trial in Hepatitis C Case
http://www.journalstar.com/
By The Associated Press
FREMONT — A doctor and nurse accused of infecting 99 patients with hepatitis C will not receive a new trial.
Dodge County District Judge John Samson denied a motion filed by attorneys for Dr. Tahir Javed, a former Fremont physician, and nurse Linda Prochaska, his former head nurse.
Greg Thomas, an attorney representing Prochaska, filed the motion, saying the jury could not possibly put aside what they had heard about the case.
The judge also denied a motion seeking to reduce the $685,000 a jury awarded to Robert and Verena Ridder of Fremont in mid-October.
Robert Ridder, 61, was one 99 patients infected with hepatitis C while undergoing chemotherapy at Javed’s Fremont Cancer Center between March 2000 and December 2001. He was among 92 people to file civil suits in Dodge County District Court as a result. Most of them have been settled out of court for undisclosed amounts.
Javed was accused of using unsanitary practices. He and Prochaska have admitted to some negligence, court documents say.
The outbreak, which state officials linked to the clinic in 2002, was the largest of its kind in the United States.
The Ridders sued Javed and Prochaska and originally sought $10 million.
Thomas, Prochaska’s attorney, and an attorney for Javed provided an affidavit from Richard Wiener, a University of Nebraska-Lincoln psychology and law professor who has studied jury bias issues.
Wiener said pretrial publicity surrounding the case since 2003 concluded that the only way for the defendants to have an unbiased trial would be to change the trial venue.
But Joe Muller, one of Ridders’ attorneys, said the court was in the best position to determine whether the defendants could get a fair hearing.
Nothing indicates that the jury considered anything but the facts, he said.
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Hepatitis B Knowledge Poor Among Taiwan People
http://www.cna.com.tw/
Y.F. Low
Taipei, Nov. 29 (CNA) While hepatitis B infection is the main cause of cirrhosis of the liver and liver cancer, the results of a survey released Tuesday show that the public has insufficient knowledge of hepatitis B prevention.
The survey found that 40 percent of the respondents did not know that the hepatitis B virus (HBV) is transmitted mainly through blood or the exposure of wounds to a contaminated source.
Most of the respondents thought HBV is transmissible through saliva, eating contaminated food or drinking contaminated water.
Fifty percent of the respondents were unaware that there are drugs for the treatment of hepatitis B.
While 60 percent of the HBV-infected or HBV-carrying respondents had not taken any medication, more than 20 percent had not received any blood tests or ultrasound examinations for more than one year.
The results were unveiled at a ceremony to mark the establishment of the Taiwan chapter of ACT-HBV, a U.S.-based international organization aimed at advancing the clinical treatment of HBV.
According to Chuang Wan-lung, a leading member of the Taiwan Liver Research Foundation, 15 percent to 20 percent of Taiwan adults, or more than 2.5 million people, are HBV carriers.
Although people born after 1984 have been vaccinated against HBV at birth, 1 percent to 2 percent of people below 20 are HBV carriers, Chuang said.
Pointing out that the probability of HBV carriers getting liver cancer is higher than others, Chuang said HBV carriers must receive regular follow-up examinations.
Patients who have had their HBV brought under control and have normal liver function should receive a blood test every year before the age of 40 and every six months after 40, Chuang said.
Those who have abnormal liver function should receive a blood test every three to six months and an ultrasound examination every six months, he added.
Chang Ting-tsung, chairman of the ACT-HBV's Taiwan chapter, noted that if a newborn is infected with HBV, there is a 90-percent chance that the infection will develop into chronic liver disease, such as cirrhosis of the liver, liver fibrosis or liver cancer.
The probability among children is 40 percent, and that among adults is 5 percent to 10 percent, Chang said.
He said the ACT-HBV's Taiwan chapter will lobby the Bureau of National Health Insurance to provide people aged 20 and over with one free hepatitis B screening every year to facilitate the follow-up and treatment of the disease.
According to data from the World Health Organization, more than 500,000 people die from liver cancer around the world every year, and 80 percent of liver cancer is caused by HBV infection.
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Woman Completes Journey of Hope After Man's Death from Hepatitis C, Wife Finishes Trek
SourceURL:http://www.redorbit.com/
Tom Corwin, Staff Writer
Deborah Simone promised her dying husband she would complete his cross-country trek to raise awareness about hepatitis C. On Thursday, after 10,000 miles and a year after Paul Hagan succumbed to complications of the disease, their trip was finally complete.
"I'm just so thankful to be here, it's been a long and very arduous journey," Dr. Simone said from the office of U.S. Rep. Charlie Norwood, R-Ga., in Washington, D.C.
Part of her mission was to talk to legislators about raising funding for more awareness and treatment of the disease, which affects nearly 4 million people and is the most common blood-borne viral infection in the U.S., according to the Centers for Disease Control and Prevention.
She spoke with staffers for U.S. Sen. Lindsey Graham, R-S.C., and Sen. Edward M. Kennedy, D-Mass., who is co-sponsoring the bipartisan Hepatitis C Epidemic Control and Prevention Act. The act would implement national plans to prevent the infection and educate the public about it.
"When you can do that, then you have taken a powerful step forward in trying to impact the progression of this disease," Dr. Simone said. "If we don't stop this disease now, it will eventually kill more people than AIDS."
She knows something about powerful steps.
Since she and Mr. Hagan launched what they called the Journey of Hope on Sept. 11, 2002, in Augusta, Dr. Simone has walked more than 8,000 miles to the West Coast and back through the Midwest. In September 2004, Mr. Hagan finally grew too sick to continue driving their camper behind her in the St. Louis area, and they went back to Emory Hospital, where he died in November. Dr. Simone relaunched the journey Sept. 11 by bike from St. Louis.
After Mr. Hagan died, " I really didn't think I was going to get to this point," she said. "I didn't see the end of this journey for a while." But she had promised him she would continue his work, and his work, for now, is done.
"Paul may have lost the battle with hepatitis C, but he certainly didn't lose the war," Dr. Simone said. "I'm here to take his place and to fight on."
Reach Tom Corwin at (706) 823-3213 or tom.corwin@augustachronicle.com.
Source: Augusta Chronicle
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Tainted-Blood Victims Speak in Court
SourceURL:http://www.japantimes.co.jp
By TOMOKO OTAKE, Staff writer
Two women infected with the hepatitis C virus through tainted blood products told the Tokyo District Court on Tuesday how they suffer with the life-threatening disease.
The testimony by the two women marks the first time plaintiffs in the Tokyo suit have spoken in court since they filed a damages suit against the government and three drug makers in October 2002.
Similar suits filed by 71 hepatitis C sufferers are pending in district courts in Osaka, Fukuoka, Sendai and Nagoya.
In Tokyo, the 22 plaintiffs, many of whom are women who received blood coagulants during childbirth or surgery, are withholding their names, citing widespread societal prejudice against HCV sufferers.
A 37-year-old mother of two told the court she learned about her HCV infection in 2000, when she was pregnant with her second child.
Two years earlier, she was in a traffic accident and underwent surgery in which she was given HCV-tainted coagulant fibrinogen, distributed by Green Cross Corp., which is now Mitsubishi Pharma Corp.
At the hospital where she gave birth to her second child, staff refused to do her and her baby's laundry, the woman told the court, adding she was also told by a nurse to go to another hospital if she became pregnant again.
The plaintiff said the interferon treatment she took for HCV was so physically, mentally and financially draining that she gave up on it halfway through.
She told the court that every time she received an interferon shot, she suffered influenzalike symptoms, including fatigue, fever and pain in her joints -- all while having to take care of her two small children.
She testified that she spent a total of about 1.5 million yen on medical treatment, only to be told that her liver tests showed the treatment was not working.
The other plaintiff who spoke -- a 43-year-old mother of two -- testified that she was given tainted fibrinogen while giving birth to her first child and suffered so acutely from HCV afterward that she had to be hospitalized for months.
The woman's second child was born with HCV and then her husband died, officially from "karoshi" -- overwork -- she told the court.
She now supports her family by working as a caregiver for the elderly. She has not told her employer that she has HCV.
"For 19 years, I have agonized and searched in vain for an outlet for my pain, sadness and outrage," the woman said.
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November 30th, 2005
Hepatitis C Leadership Summit Engages HCV Stakeholders to Elevate the Response to the HCV Epidemic; New Opportunities for Action with Currently-Available Resources
http://www.genengnews.com
An estimated 4 million Americans have been infected by the hepatitis C virus (HCV). Because no significant new federal resources to fight the HCV epidemic are planned for the near future, improving on the current response requires creative and coordinated leveraging of available assets. The first annual Hepatitis C Leadership Summit (HCVLS) was convened on October 29-30, 2005 in Boston, to explore actionable opportunities to elevate the response to the HCV epidemic using currently identifiable resources.
Though there are certainly a wide array of issues that need attention, the HCVLS explored three specific areas of opportunity:
1. Engaging healthcare insurers, both private and public, on the opportunities available to cost-effectively respond to the HCV epidemic. Because inaction in the face of the epidemic will be vastly more expensive for insurers, a dialogue at the HCVLS engaged insurers in elevating HCV as a priority. Insurers can act as a primary motivator for the identification and treatment of those with hepatitis C, dramatically affecting the current response.
2. Producing better treatment results through a dissemination of physician best practices and care options for a broad array of patient types. The HCVLS also discussed the incorporation of adjunctive nutritional therapies to improve treatment compliance and outcomes, and the use of complementary therapies in conjunction with interferon or as an alternative.
3. Engaging community faith organizations to increase HCV awareness (and thus testing and identification of HCV patients), and to provide support for those patients who have HCV whether or not they are receiving therapy.
"Based upon the feedback from participants, it's clear the HCVLS brought forth both new ideas and new opportunities for action," said Michael J. Russo, Partner at The Bruckner Group (BGI), and developer of the HCVLS concept. "There are a number of specific initiatives and new avenues to explore that are emerging from the HCVLS, and both the HARCP and BGI intend to follow through on them to the best of our abilities."
Attendees at the HCVLS included the majority of the State Hepatitis C coordinators, managed care payers, state Medicaid organizations, the CDC, academic and private practice clinicians, advocates, and pharmaceutical and biotechnology manufacturers. Senator Edward Kennedy (MA), who has taken the lead for more federal resources to fight the HCV epidemic, introduced the conference with a recorded video message welcoming participants and encouraging cross-stakeholder collaboration to produce heightened results.
The HCVLS, initiated and organized by the Healthcare Advocacy and Research Collaboration Project (HARCP) and The Bruckner Group, was sponsored by Roche Pharmaceuticals and The Bruckner Group, with additional support from Schering-Plough Corporation, Valeant Pharmaceuticals International, and Vertex Pharmaceuticals.
About the HARCP:
The Healthcare Advocacy and Research Collaboration Project is a non-profit organization dedicated to improving access to, quality of, and delivery of healthcare services, particularly in under-served disease areas and patient populations. The HARCP conducts research studies and projects, develops and disseminates information, and demonstrates leadership in activities and efforts to fight disease. Current HARCP initiatives include activities in hepatitis C, hemophilia, and autoimmune disorders.
About The Bruckner Group:
The Bruckner Group are healthcare strategy and research consultants with a primary focusin the pharmaceutical and biotechnology industries. BGI are the leading experts in value strategy, helping clients define, prove, and leverage the healthcare value of their therapeutics to build successful product launch strategies and post-launch brand strategies. BGI's strategies emerge from an understanding of the intersection of therapeutic outcomes, healthcare value at the standard of care, and a determination of unmet market needs of payers, physicians, and patients. BGI's unique and systematic approach creates market success by maximally addressing the healthcare value needs in therapeutic markets.
CONTACT:
The Bruckner Group, Inc. David Balekdjian, 781-245-4454, x222 Partner
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The Bug Stops Here: Force Protection and Emerging Infectious Diseases
SourceURL:http://news.yahoo.com
WASHINGTON, Nov. 30 /U.S. Newswire/ -- Over the past thirty years, more than three dozen new and frightening diseases have been identified for the first time. These include the virus that causes hepatitis C, and Marburg hemorrhagic fever viruses, Legionnaires' disease, and most recently, severe acute respiratory syndrome (SARS). At the same time, there has been a reemergence of diseases previously thought to be only a minimal threat to human health. More pervasive is the growing threat of an avian influenza pandemic.
These increasing global infectious disease threats can have a serious effect on the stability of governments worldwide. U.S. national security might be impacted by a disease epidemic in the United States, by military operations in regions where disease activity may prevent the successful completion of a mission, or by an infected soldier carrying a contagious disease back to the United States.
A new study from the National Defense University's Center for Technology and National Security Policy addresses the military operational impact of these new disease threats by looking at risks to service members around the world, and offers practical suggestions that will allow the United States military to maintain its competitive advantage as it provides security for the United States.
Recognizing that infectious diseases have had a significant impact on military operations in our nation's history, this report provides a series of case studies that analyze health threats to each regional combatant command and presents both tactical and strategic recommendations that will better prepare the entire DOD for future outbreaks of disease.
"This is superb, the best military oriented contemporary study I have seen," writes Dr. Robert J. T. Joy, Colonel, U.S. Army (retired), Emeritus Professor of Medical History at the Uniformed Services University of the Health Sciences in Bethesda, Maryland. "This text should be required reading and teaching at all service schools and staff and war colleges." "It is essential that the line commanders get the message that the ultimate responsibility for keeping the troops from becoming patients is theirs!" adds Vice Admiral (retired) James Zimble, former Surgeon General of the Navy.
The study can be found on the Center for Technology and National Security Policy website at: http://www.ndu.edu/ctnsp/
Defense_Tech_Papers.htm
For additional information, the authors can be reached as follows:
Donald Thompson: 202-685-2406
Joel Swerdlow: 202-549-8111
Cheryl Loeb: 202-685-2397
Please contact Cheryl Loeb at 202-685-2397 or loebc@ndu.edu for hard copies of the report.
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Clinical Care Options Partners with Chinese Hepatitis Foundation to Provide Exclusive Conference Coverage for the 6th Annual Shanghai - Hong Kong International Liver Congress
SourceURL:http://biz.yahoo.com
- Agreement Allows for CCO Online and Print Conference Coverage to Be Provided in Mandarin and English -
RESTON, Va., Nov. 30 /PRNewswire/ -- Clinical Care Options (CCO), a leader in the development of innovative interactive medical education for healthcare professionals, has been selected by Cheng Si Yuan (China-International) Hepatitis Research Foundation ("CSY"), a Hong Kong not-for-profit foundation to provide exclusive conference coverage for the Sixth Annual Shanghai - Hong Kong International Liver Congress, which will be held in Shanghai, China March 25 through 28, 2006.
"We selected CCO as our partner because of its longstanding commitment to hepatitis education and its comprehensive and creative approach to conference coverage," said George Lau, M.D., Secretary General of the 2006 Congress. "The Congress attracts 2,500 delegates from the Asian-Pacific region. Our future plans with CCO include broadening this agreement to include the creation and implementation of live education programs on hepatitis that can be conducted throughout China and other parts of Asia to meet the educational needs of physicians."
Through the current collaboration, conference delegates and CCO members will have direct access to the newest generation of online, interactive, multimedia, medical education programs utilizing the latest technology for translating scientific data into clinically useful information.
"We are pleased to see the CCO Conference Coverage model recognized as a premier educational model and look forward to working with CSY on this important conference. By providing the program in both Mandarin and English we will be able to ensure that educational resources are available to a wider network of healthcare providers across Asia and the world," said Jeffrey L. Drezner, M.D., Ph.D., Clinical Care Options' chief executive officer and founder. "Our goal, aligned with CSY, is to support physicians with the information they need to provide state-of-the-art care for people with hepatitis."
Through this collaboration, conference delegates and CCO members will have direct access to the newest generation of online, interactive, multimedia, medical education programs utilizing the latest technology for translating scientific data into clinically useful information.
About Clinical Care Options
Clinical Care Options, the leader in the development of innovative interactive medical education programs for healthcare professionals, creates and publishes original continuing medical education (CME) and information resources that translate the latest developments in science and medicine into treatment options. Utilizing specialty-specific advisory boards comprised of internationally renowned experts, Clinical Care Options develops exceptional editorial content for its proprietary state-of-the-art technology and distributes it online via its own specialty portals in HIV, hepatitis and oncology/hematology. In addition to its industry-leading web-based programs, Clinical Care Options disseminates the latest in medical treatment through live meetings, including the national Annual Clinical Care Options for HIV Symposium, and through print materials including books and monographs. For more information about the company and its programs, visit its World Wide Web site at http://www.clinicaloptions.com
About CSY
CSY is a not-for-profit foundation that is dedicated to helping educate physicians and healthcare clinicians in Asia, as well as Hepatitis B patients and the Asian population, primarily regarding the prevention and treatment of Hepatitis B. For more information about the organization visit its World Wide Web sites at http://www.livercongress.org, http://www.csyfoundation.org and http://www.hepfree.org
Source: Clinical Care Options
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December 1st, 2005
Hep C Health Care Resources in the United States
SourceURL:http://www.gastrohep.com/
December's Hepatology reports that as patients continue to age and disease burden progresses, suboptimal decisions on Hep C treatments will bring opportunity costs for the health care system.
Chronic Hepatitis C virus infection affects approximately 3 million people in the United States and places tremendous demands on the health care system.
As many observers have predicted, the disease burden continues to grow as the infected population ages.
Dr Kevin Schulman and colleagues analyzed inpatient data from the Healthcare Cost and Utilization Project.
The investigators also assessed outpatient data from the National Ambulatory Medical Care Survey, and drug data from the Verispan Source Prescription Audit.
The investigators examined recent growth in the use of health care resources among Hepatitis C patients by age group.
There is an average annual increases of 25% to 30% for hospitalizations and charges – Hepatology
The team found average annual increases of 25% to 30% for hospitalizations, charges, hospital days, and physician visits.
Corresponding time-trend coefficients were positive.
From 1994 to 2001, the team noted the Hepatitis C burden increase among patients aged 40 to 60 years, reflecting the natural history of disease progression.
In sensitivity analysis, Hepatitis C outcome growth rates remained significant, unless more than 3 out of 4 cases were initially underreported.
Also, patients co-infected with HIV and Hepatitis C in 2001 constituted about 8 times as many hospitalizations.
The investigators observed that co-infection during 2001 incurred 3 times the charges in 1994, relative to all HIV hospitalizations and charges.
Dr Schulman's team concludes, "Our findings highlight the urgency concerning Hepatitis C outcomes."
"As patients continue to age and disease burden progresses, suboptimal decisions regarding Hepatitis C treatments will bring increasing opportunity costs for the health care system and society."
Hepatol 2005: 42(6): 1406-13
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December 2nd, 2005
Idenix Provides Update on Clinical Development Program for Valopicitabine (NM283) for the Treatment of Hepatitis C
SourceURL:http://biz.yahoo.com
CAMBRIDGE, Mass., Dec. 2 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc., (Nasdaq: IDIX - News), announced today that the company met with the United States Food and Drug Administration (FDA) on November 30, 2005 to discuss the clinical development program for valopicitabine (NM283) for the treatment of hepatitis C. Based upon this meeting, the company anticipates finalizing the study design for a phase III clinical trial in treatment-refractory patients by the end of the first quarter of 2006 and starting to enroll patients thereafter.
At the meeting, the FDA requested additional information from the two ongoing phase IIb clinical trials evaluating valopicitabine. In response, Idenix plans to provide the FDA with comprehensive 24-week data from the ongoing phase IIb clinical trial in treatment-refractory patients. Idenix also expects to provide initial data from the ongoing phase IIb trial evaluating valopicitabine in treatment-naive patients, which includes a patient cohort receiving valopicitabine 800 mg plus pegylated interferon beginning on day 1 of treatment. This is the treatment regimen that the company currently expects may be evaluated in phase III clinical trials. The company anticipates that it will provide in January 2006 these additional data that have been requested and thereafter meet with the FDA to review such additional data. At that meeting, the company anticipates further discussing with the FDA the proposed phase III clinical trial protocol.
"We are pleased with the interaction we have had with the FDA to date regarding valopicitabine development," said Jean-Pierre Sommadossi, chief executive officer of Idenix. "We are optimistic that we will continue to advance the valopicitabine clinical program, particularly in view of the serious unmet need in the treatment-refractory patient population in hepatitis C," he said.
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 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, with 2.7 million people chronically infected. Chronic HCV infection causes inflammation of the liver, which may cause progressive liver damage that can lead to liver scarring, 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. These "non-responders" or treatment-refractory patients comprise a growing patient population, who have no proven alternative treatments available and who are at risk for progressive HCV-associated liver disease. As the prevalence of severe liver disease attributable to chronic hepatitis C rises, deaths due to complications from hepatitis C infection, currently 8,000 to 10,000 per year in the United States, are expected to increase dramatically over the next 15 to 20 years.
About Idenix
Idenix Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus (HIV). Idenix's headquarters are located in Cambridge, Massachusetts and it has drug discovery and development operations in Montpellier, France and drug discovery operations in Cagliari, Italy. For further information about Idenix, please refer to http://www.idenix.com.
Forward-looking Statements
This press release contains "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward- looking statements can be identified by the use of forward-looking terminology such as, "anticipates," "plans," "expects," "we are optimistic," "will continue to," or similar expressions or by express or implied discussions regarding the company's planned actions in response to the discussions with the FDA, the potential therapeutic benefits and successful development of valopicitabine, or the potential future revenues from valopicitabine. Such forward-looking statements are subject to numerous factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. There can be no guarantee that valopicitabine will be successfully developed or approved for sale in any market, or that it will reach any particular level of revenue. In particular, management's expectations regarding valopicitabine could be affected by risks and uncertainties relating to the results of further discussions with the FDA; the timing and success of any submissions to the FDA and other regulatory bodies around the world; the results of clinical trials and other studies with respect to valopicitabine, including any new clinical data, or additional analysis of existing clinical data; the company's dependence on its collaboration with Novartis Pharma AG; the company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the ability of the company to attract and retain qualified personnel; competition in general; and the company's ability to obtain, maintain and enforce patent and other intellectual property protection for valopicitabine. These and other risks which may impact management's expectations regarding valopicitabine are described in greater detail under the caption "Factors That May Affect Future Results" in the company's quarterly report on Form 10-Q for the quarter ended September 30, 2005 and filed with the Securities and Exchange Commission and other filings that the company makes with the Securities and Exchange Commission.
All forward-looking statements reflect the company's expectations only as of the date of this release and should not be relied upon as reflecting the company's views, expectations or beliefs at any date subsequent to the date of this release. Idenix anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.
Idenix Pharmaceuticals' Contact:
Teri Dahlman: 617-995-9905
Source: Idenix Pharmaceuticals, Inc.
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New Insights into Protein Synthesis and Hepatitis C Infections
http://newswire.ascribe.org/
BERKELEY, Calif., Dec. 2 (AScribe Newswire) -- Scientists have uncovered key new information towards understanding the crucial first step in protein synthesis, the process by which the genetic code, harbored within DNA and copied into RNA, is translated into the production of proteins. This new information also helps to explain how viruses, such as Hepatitis C, are able to highjack protein synthesis machinery in humans for their own purposes.
Biochemist Jennifer Doudna and biophysicist Eva Nogales, both of whom hold joint appointments with the Lawrence Berkeley National Laboratory (Berkeley Lab), the University of California at Berkeley, and the Howard Hughes Medical Institute (HHMI), led a study in which cryo electron microscopy (cryo-EM) was used to create a 3-D model of the protein complex called eukaryotic translation initiation factor 3 (eIF3). The model showed that the eIF3 protein complex employs the same structural mechanics in the loading of either human or viral RNA to ribosomes, the complex machinery in living cells responsible for protein synthesis.
"This is the first insight into how the initiation mechanisms of protein synthesis work specifically for humans, and a step towards understanding at the molecular level what happens when a viral infection occurs," said Doudna, a member of Berkeley Lab's Physical Biosciences Division. "A better understanding of these mechanisms could open the door to new and improved therapies for viral infections."
Said Nogales, also a member of Berkeley Lab's Physical Biosciences Division, "Using cryo-EM, we can reconstruct images of the entire protein ensemble to study the molecular machinery behind the protein synthesis process. We now have the tools to see how the many different parts of the molecular machinery come together."
The results of this study are in the Dec. 2, 2005 issue of the journal Science, in a paper entitled "Structural Roles for Human Translation Factor eIF3 in Initiation of Protein Synthesis." Co-authoring the paper with Doudna and Nogales were Bunpote Siridechadilok and Christopher Fraser of UC Berkeley, and Richard Hall of Berkeley Lab.
Proteins, the curiously-shaped macromolecules that serve as the basic construction material of all living cells, and also initiate and control nearly all cell chemistry, are assembled out of amino acids according to the instructions contained within the genes. These genetic instructions are carried from the DNA inside a cell's nucleus out into the cell's cytoplasm via messenger RNA (mRNA). There the information will be translated to amino-acid carrying transfer RNA (tRNA) via the ribosome, an ancient organelle so highly conserved by evolution that its core components are pretty much the same for all forms of life.
Protein synthesis in mammalian cells begins with the loading of mRNA onto the small ribosome subunit, 40S, which is, in part, one of the responsibilities of the eIF3 complex. The eIF3 complex also interacts with other translation elements that bind at the start of the mRNA, prevents premature joining of the 40S and 60S ribosomal subunits, and helps assemble active ribosomes. Until now, the structural basis for eIF3's multiple activities has been unknown.
At a resolution of 30 angstroms, the cryo-EM reconstructions of Doudna and Nogales and their collaborators show eIF3 to be a particle consisting of five lobes - analogous to a head, and a pair of arms and legs. The study shows that the left arm of the eIF3 complex binds to the eukaryotic protein complex that recognizes the methylated guanosine cap at the 5'-end of the eukaryotic mRNAs (mRNA consists of a coding region sandwiched between a 5'-end and a 3'-end). By drawing the mRNA's 5'-end cap through the ribosome entry site and towards the exit, eIF3 ensures the mRNA is properly positioned for its genetic code to be translated.
Acting like a molecular wrestler, eIF3 will also wrap its arms and legs around a structural element of RNA for the hepatitis C virus (HVC), known as the internal ribosome entry site (IRES), and pin it to the exit site of the 40S ribosome subunit. The IRES leaves through the left arm of the eIF3 complex at the same location where interaction with the human mRNA cap-binding complex takes place.
"This might explain the amazing ability of the HVC IRES to hijack the human ribosome and its associated translation factors," said Doudna.
Said Nogales, "The position of eIF3 in our models also provides a plausible explanation for its role in preventing premature joining of the 40S and 60S ribosome subunits."
Doudna and members of her research group are now working to improve the resolution of these models from 30 angstroms to about 10 angstroms. This would allow them to see secondary protein structures which would give them a better understanding of the chemistry behind eIF3's structural mechanics.
CONTACT: Lynn Yarris, Berkeley Lab Media Relations, 510-486-5375, lcyarris@lbl.gov
ABOUT THE LAB: Berkeley Lab is a U.S. Department of Energy national laboratory located in Berkeley, California. It conducts unclassified scientific research and is managed by the University of California.
Visit our Website at http://www.lbl.gov/ .
NOTE: An html version of this story with images and links to additional information can be viewed at http://www.lbl.gov/Science-Articles/Archive/LSD-protein-synthesis.html
Media Contact: Lynn Yarris, 510-486-5375, lcyarris@lbl.gov
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North Carolina Hepatitis C/HIV Program Works to Meet Future Community Needs
www.prweb.com
An innovative, three-year project to address Hepatitis C and HIV in the Durham, N.C. area has established groundbreaking programs that help people at risk.Durham, NC (PRWEB) December 2, 2005 -- An innovative, three-year project to address Hepatitis C and HIV in the Durham, N.C. area has established groundbreaking programs that help people at risk, says Beth Stringfield, director of the Piedmont HIV Health Care Consortium. She spoke Wednesday to a meeting of partner organizations to present the results of the program and announce future plans.
“Resources for HIV care have been in place, but most people don’t know about the threat of Hepatitis C. Our PHICAS project has helped rally the testing programs, support groups, and community medical training for those co-infected with HIV and Hep C,” Stringfield said. “The PHICAS public service campaign on Hep C testing has raised awareness. People have access to resources through our website, www.phicas.org. It’s now time to build on that foundation to insure that these important services continue.”
The PHICAS project was established under a federal grant designed to coordinate health care services for the uninsured and underinsured. PHICAS partner agencies created a network to provide access to services in Durham, Franklin, Granville, Person, Vance and Warren Counties. As part of the project, a major public awareness campaign was launched in October to encourage people to get tested for Hep C.
“The measure of our success is here today,” Stringfield told the group. “Doctors, health professionals, social workers, educators all have worked together to make sure that the most important people our patients receive the information and the care they need.”
PHICAS developed a managed information system to enable care providers to communicate and eliminate inefficiencies, Stringfield said. “This reduced the administrative burden on agencies and improved the continuity of care.” The program funded free Hep C screening at the Durham County Health Department and offered clinical education programs for medical providers.
One of the challenges the project faced was lack of information, Stringfield said. “Hep C is under-diagnosed, and it is not required to be reported to public health officials. One of our goals was to get a clearer idea of how many people in our target area are impacted, by raising awareness and encouraging testing.”
The culmination of the program will be a statewide symposium on Hepatitis C and HIV, scheduled for March 30 and 31, 2006 in Durham. It is sponsored by PHICAS, North Carolina Department of Health & Human Services HIV/STD Prevention and Care Branch HCV Program, and Wake Forest University.
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