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Week Ending: January 16, 2010
Alan Franciscus
Editor-in-Chief
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This Issue:
January 9, 2010
Treatment of Hepatitis C within a Methadone Maintenance Program Yields Results Comparable to Treatment via Other Models of Care
http://www.jointogether.org
Hepatitis C virus (HCV) affects more than 4 million people in the US, 60% of whom have a history of injection drug use (IDU). Concerns over treatment adherence, psychiatric comorbidity, ongoing drug use, and optimal timing of HCV treatment initiation have resulted in unwillingness on the part of many physicians to treat HCV in patients with IDU.
This retrospective study investigated outcomes in patients with co-occurring HCV infection and opioid dependence (N=73) treated for HCV within an ongoing methadone maintenance program. At treatment initiation, 49% of patients had continuing drug use, 67% had psychiatric comorbidity, and 32% had HIV co-infection. Treatment for HCV was delivered by internists via standardized protocol with pegylated interferon and ribavirin. Main outcome measures were undetectable viral load at the end of treatment and at 6 months following treatment completion.
- Eighty-six percent of patients completed at least 12 weeks of HCV treatment.
- Fifty-five percent of patients had an undetectable viral load at the end of treatment, and 45% had an undetectable viral load 6 months post-treatment.
- Thirty percent of patients continued to use illicit substances during treatment, and 23% received a methadone dose increase.
Comments by James Harrison, MHS, CADC
Unwillingness to treat co-occurring HCV in people with IDU is inappropriate in some cases. Hepatitis C and addiction are both treatable diseases, and the sustained viral response among methadone patients treated for HCV in this study clearly demonstrates that treatment can work. These results provide compelling evidence that patients with opioid dependence should be treated with the same respect and breadth of care as non-IDU patients.
Reference:
Litwin AH, Harris KA Jr, Nahvi S, et al. Successful treatment of chronic hepatitis C with pegylated interferon in combination with ribavirin in a methadone maintenance treatment program. J Subst Abuse Treat. 2009;37(1):32–40.
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The Hepatitis C Generation: Are Baby Boomers More Prone To Hepatitis C?
Newsweek.com
Thanks to a disease that lays dormant for up to 30 years, Baby Boomers well past their wild years are starting to suffer the consequences.
When Alan Franciscus was diagnosed with hepatitis C in 1996, his first question was, "Am I going to die?" When his doctor assured him that many treatment options were available, he had a second question: "What is hepatitis C?" Looking back, Franciscus, a 61 year-old San Francisco resident says: "One of the most disturbing things to me was I had never heard of it. I really did not know a thing about it."
Franciscus' question, it turns out, is not such a bizarre one to ask. Despite affecting 1 percent of the population, hepatitis C remains a disease generally misunderstood by the general public with little in financial commitments from the federal government. The CDC's National Center for HIV/AIDS, Viral Hepatitis, Sexually Transmitted Diseases, and Tuberculosis Prevention had a budget of almost $1 billion for 2008. Only 2 percent of that was allocated to hepatitis B and hepatitis C despite both viruses being five times more prevalent. "No one really knew what hepatitis C was," Franciscus remembers. "A bunch of coworkers thought I got it from eating bad food."
A newly-published Institute of Medicine Report on hepatitis B and C, published today, underscores how this lack of understanding and attention has played out. Although the risk factors for hepatitis C are widely known and completely preventable, the IOM estimates that between 2.7 million and 3.9 million Americans have contracted hepatitis C. (from Jules: Brian Edlin's study presented at AASLD in 2008 reports 5 million have HCV. Other CDC research reports do not include homeless, incarcerated etc).
But the most startling detail about hepatitis C may not be its prevalence, but the population it affects. Two-thirds of those with the virus are Baby Boomers, adults in their 50s or 60s who may have experimented with intravenous drugs decades ago. For many of them, the Summer of Love is a hazy, distant memory from their youth. But hepatitis C, which is transferred by contact with infected blood, has a particularly long incubation period, often 20 or 30 years. That means that the side effects of one drug use in the 1970s could now start to show. "Even though Boomers moved on with their lives, they could be living with an infection that happened many years ago," says John W. Ward, division director for the Center for Disease Control's Division of Viral Hepatitis. "Now, they're aging into a period of their lives when Hepatitis C could become manifest through physical symptoms." One study published last May estimates that, in the next 20 years, total medical costs for Hepatitis C patients will nearly triple, from $30 to $85 billion.
Hepatitis C is a serious challenge for both doctors and public health officials, largely because of its long incubation period. An individual infected with hepatitis C can live the majority of their life not knowing they were infected. In fact, the new IOM report suggests this is usually the case: 75 percent of those with hepatitis C don't even know they have it. And unlike other forms of the hepatitis virus, like A and B, there is no known vaccine. So the virus continues to be transmitted through exposure to infected blood, often injection drug use. Boomers may have also become infected by a blood transfusion or organ transplant before 1992, when officials began screening the blood supply for the disease.
Of those infected with the virus, about 60-70 percent will develop chronic liver disease. For about 40 percent, a months-long regimen of shots and pills will eradicate the virus. But many will continue to live with the disease as a chronic condition; 1 to 5 percent will die of the consequences of liver disease. Some expect to see these conditions become significantly more prevalent as Boomers' cases move from virus to disease. One study, a Milliman Report published in May 2009, predicted that the number of patients with advanced liver disease will be four times greater than it is today by 2029. Cases of cirrhosis, scaring of the liver, will also quadruple.
This means that right now, before that wave hits, is a particularly critical juncture for early detection and treatment of hepatitis C, particularly among the Boomer population. "There's a window of opportunity to identify the disease early," says Ward. Hepatitis C is usually diagnosed with a simple blood test and patients found positive have a number of options in disease management. They can monitor levels of certain liver enzymes, charting any advancement in liver disease, and make lifestyle adjustments to manage the disease such as eliminating alcohol.
So, if the test is so easy, and the risk largely pooled in a specific demographic, why do so many cases go decades undiagnosed? Doctors say it has a lot do with the stigma surrounding liver disease. "If Uncle Bernie says he has cirrhosis, it's like, 'well how much was he drinking?' says Allan Wolkoff, chairman of the American Liver Society and a professor at the Albert Einstein School of Medicine in New York City. "We need to work on that. Good people get liver disease; kids get liver disease. You can get liver disease through little or no fault of your own." In a study of patients in a liver clinic in Iowa, 57 percent of Hepatitis C-positive people reported having experienced stigma associated with their infection. Given that, it's easy to see why well-to-do Boomers rarely get tested for a disease often associated with junkies and alcoholics: neither they, nor their doctors, think to even ask.
Both the IOM and CDC want to change that. The IOM report recommends a comprehensive public education and surveillance campaign, as to increase awareness of the disease, following in the model of HIV/AIDs public awareness campaigns in the 1990s. "As in the case of HIV/AIDS," the report concludes, "increasing general public knowledge about hepatitis B and hepatitis C can be expected to reduce discrimination toward infected people, reduce transmission, and increase early diagnosis and treatment that ultimately save lives." A lot of this, says Wolkoff, hinges on doctors: "there's a certain amount of physician education necessary. Even a small rise in physicians talking about this, talking about it with their patients, could make a big difference.
The CDC may also play a role, particularly in the testing of Boomers. Right now, the organization recommends that anyone who ever tried injected illegal drugs or had a blood donation prior to 1992 be tested. But patients may make compliance with such a regulation difficult -- they may not, for example, volunteer information about that one time at Woodstock -- the CDC is considering a blanket, age-based screening recommendation. "We're launching studies to see if it's feasible and makes sense," says Ward, the CDC official. "Just like everyone over 50 should have a check for colon cancer, it might fit into an age-based checklist of preventative services."
Franciscus did not know much about hepatitis C when he was diagnosed. But he quickly learned one thing: there was not nearly enough information available to patients like him. So he founded the HCV Advocate, a newsletter that now gets 400,000 visits online each month and is his new, full-time job. He regularly speaks across the country, to health providers and educators, on the subject. "The key is going to be public awareness and educating medical providers, to ask questions and get people tested," says Franciscus. "If you catch it early, nobody will die from Hepatitis C."
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Hepatitis C Group Launches to Aid Thousands of Edinburgh Victims
http://news.scotsman.com
By Adam Morris
A NEW support service for hepatitis C sufferers in the Capital is to launch after it emerged there could be as many as 6,000 affected people in Edinburgh.
Latest figures show that more than 3,000 people are known to be living with the potentially deadly infection in the Lothians, with the same number probably undiagnosed.
Now the Hepatitis C Trust – until now predominantly an England-based charity – has sourced a Capital base and will officially open later this month.
It is hoped the headquarters, in Charlotte Square, will not only help those living with the disease, but raise sufficient awareness of the illness and its symptoms to unearth others who have unwittingly contracted it.
Removing the stigma around the disease and the lifestyle of those who catch it is also a pressing matter.
Charles Gore, chief executive of the organisation, which is staffed and governed almost entirely by patients, said: "We are delighted to celebrate the launch of the Hepatitis C Trust's first Scottish office.
"The trust is committed to raising the awareness of the disease and highlighting the advantages of getting tested for hepatitis C.
"If undiagnosed and not successfully treated, hepatitis C can cause cirrhosis and liver cancer."
Health Protection Scotland recently revealed the scale of the disease in the Lothians.
Although the number of new cases each year fluctuates – there were 200 last year – it is thought there are more people than ever living with it in the area.
Intravenous drug use is a main cause of the disease, which can also be sexually transmitted and passed through blood under other circumstances.
The charity's Scottish officer, Petra Wright, herself a sufferer, explained that the disease can catch up on people years after they come into contact with it.
The 55-year-old from Bo'ness caught it after "stupid" drug use in her youth, and she was working in marketing 25 years later when the diagnosis was made.
She said: "It was a real shock for me because I had no idea.
"I'd been healthy, and all of a sudden it catches up on you and you never think it would.
"I decided to work for the organisation and be quite public and open about it, just to try and reduce some of the stigma surrounding it and help other people.
"I felt quite alone at the time and one of the reasons I've helped set up (the organisation] in Scotland is so people can know more about it, and not be shy to face up to it.
"We're not saying it's a great thing to have it, but if you're diagnosed it is by no means a death sentence.
"There is good treatment around, and more on the horizon."
• www.hepctrust.org.uk
• www.hps.scot.nhs.uk
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After Years of Drugs, Stealing Dayton Native Turned Life Around, Became Nurse
http://www.daytondailynews.com
By Laura A. Bischoff, Staff Writer
Woman looks back on her life as a young mother on welfare
Margaret Olson married at 15 while still a student at Colonel White High School in Dayton. By 18, she was a mother and a divorcee headed toward a decade of drug abuse and a long run from the law.
At age 23, Olson pleaded guilty to grand theft, forgery and petty theft. And then skipped town.
“I was a young mother on welfare. I had been on my own for quite a while. Really, I had no means of supporting myself,” said Olson, now 50. “I had a daughter with leukemia. Bottom line: I didn’t handle it well. Every time I thought my life couldn’t get any worse, it did.”
Her daughter succumbed to leukemia at age 6.
Arrested in 1988 in Indiana, Olson returned to Ohio for sentencing on the theft and forgery charges. She got five years probation but left the state again, moving to Arizona without reporting to authorities.
Something was different this time, though. She said good-bye to cocaine and other drugs. “Finally, I realized I’d end up in prison or dead,” she said.
It was the turning point that led to Olson to join a church, enter nursing school, get remarried and add a baby girl to her family of three boys.
In 2000, she voluntarily called Ohio authorities to admit she had never served her probation. Olson said the court dismissed her probation in May 2000 after she explained her situation and paid restitution.
It was important to confront that part of her life, she said, but she also couldn’t get a nursing license in Arizona until five years after the case had been terminated.
In 2004, she earned her associate degree in nursing and landed a nursing assistant job, and in May 2009 she earned her bachelor of science degree in nursing.
At one point, she wanted to return to the Miami Valley to be near her oldest son, who is a Dayton firefighter, but she learned she would not be allowed a nursing license in Ohio with a felony record.
“It still follows you forever. It’s terrible,” Olson said of her record.
She works as a registered nurse in oncology at Banner Good Samaritan Hospital in Phoenix. It’s a job she loves.
She doesn’t hide her past from friends or co-workers. They know Gov. Ted Strickland granted her a pardon in November.
“I’m going to frame it. Everybody at work, when I walk by, they say ‘pardon me.’ It’s a little joke.”
Olson, who suffers from end-stage liver disease caused by hepatitis C, advises people not to give up when adversity hits.
“Not everybody is as hard-headed as me to fight and struggle for what they want,” she said. “I do understand how people go back to being a drug addict or criminal. It’s very, very hard.”
Looking back, she’s amazed she made it.
“I just feel really blessed that I was able to accomplish the things I have done,” Olson said. “I’m very, very grateful the governor acknowledged that I have made changes in my life.”
Contact this reporter at (614) 224-1624 or lbischoff@DaytonDailyNews.com.
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January 11, 2010
Achillion Announces Additional Positive Phase 1b Data with ACH-1625 to Treat Hepatitis C
http://money.cnn.com
Second Dosing Cohort Achieves 4.25log10 Viral Load Reduction With Continued Safety and Tolerability
NEW HAVEN, Conn., Jan. 11, 2010 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today reported additional preliminary data from its on-going phase 1b clinical trial of ACH-1625 which demonstrated that the second dosing cohort receiving treatment with ACH-1625 achieved a mean 4.25 log10 reduction in HCV RNA after five-day monotherapy, with continued good safety and tolerability in patients with hepatitis C (HCV). ACH-1625 is an inhibitor of HCV NS3 protease that was discovered and is being developed by Achillion.
Proof-of-Concept Study Results
Today, Achillion announced additional results from a phase 1b clinical study of ACH-1625. HCV-infected subjects in this second dosing cohort (n=9, randomized to 6 active drug, 3 placebo) received doses of 500 mg BID of ACH-1625. Preliminary results showed that a mean reduction in viral load of 4.25 log10 was achieved in the treatment group, as compared to a mean reduction of 0.29 log10 in the placebo group. Safety results from this dosing group were similar to those observed in both the phase 1a segment of the trial and in the first cohort of HCV-infected subjects. Sustained viral suppression was also similar to the first cohort, with patients maintaining a mean reduction of more than 3.0 log10 from baseline through day 12, 7 days after dosing was completed and the last day of viral load measurement in the study.
In December 2009, Achillion announced proof-of-concept data from this phase 1b study. Subjects in the first dosing cohort of HCV-infected patients received doses of 600 mg BID (n=9, randomized to 6 active drug, 3 placebo). Preliminary results showed that a mean reduction in viral load of 3.94 log10 was achieved in the treatment group, as compared to a mean reduction of 0.22 log10 in the placebo group. All subjects in the treatment group had viral load decline between 3.0 and 4.5 log10, and two subjects reached undetectable levels of HCV RNA. Safety results from this dosing group were similar to those observed in the phase 1a segment of the trial. There were no serious adverse events, no clinically significant changes in vital signs, electrocardiograms (ECGs), or laboratory evaluations. All reported adverse events were classified as mild or moderate, were transient and showed no apparent dose relationship. Furthermore, all patients had viral loads that remained suppressed for at least 7 days after dosing was completed, maintaining a mean reduction of more than 2.0 log10 from baseline through day 12, the last day of viral load measurement in the study.
"We are quite pleased to see that these data corroborate and support the preliminary positive data from the first cohort of the study even at this lower dose. ACH-1625 continues to demonstrate a dramatic reduction in viral load after 5 days of monotherapy, and importantly, showed continued suppression of viral load after drug discontinuation. This is significant as it could be a distinguishing feature and competitive advantage for our compound in comparison to other HCV therapeutics," said Michael D. Kishbauch, Chief Executive Officer of Achillion.
"With continued robust antiviral activity even at this lower dose, we are encouraged now to explore both lower doses and different dosing schedules. We expect to conduct studies of additional doses under this protocol over the next few months and to release additional data thereafter, potentially at the upcoming EASL (European Association for the Study of Liver Disease) meeting in April 2010 in Vienna," added Dr. Elizabeth Olek, Chief Medical Officer of Achillion.
About ACH-1625
ACH-1625 is an HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. With its rapid and extensive partitioning to the liver, as well as high liver/plasma ratios demonstrated in preclinical studies, Achillion believes that ACH-1625 has the potential for once daily dosing. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50~1nM.
In phase 1a safety studies with ACH-1625, subjects in the single ascending dose (SAD) segment of the study received single doses ranging from 50 mg to 2000 mg. Subjects in the phase 1a multiple ascending dose (MAD) segment of the study received 5 days of ACH-1625 up to a maximal dose of 2000 mg per day. Preliminary data from the SAD and MAD trial segments demonstrated ACH-1625 was well tolerated at all doses and there were no serious adverse events, no clinically significant changes in vital signs, electrocardiograms (ECGs), or laboratory evaluations. All reported adverse events were classified as mild or moderate, were transient and showed no apparent dose relationship.
About Achillion
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease -hepatitis C, resistant bacterial infections and HIV. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
ACHN-G
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Idenix Pharmaceuticals Highlights Progress in Three HCV Programs
http://www.prnewswire.com
- Interim analysis of 50 mg cohort demonstrates potent HCV antiviral activity at 14 days for IDX184, a nucleotide polymerase inhibitor, in combination with PegIFN/Ribavirin
- IDX375, a non-nucleoside polymerase inhibitor, exhibited favorable pharmacokinetic properties in a Phase I healthy volunteer study
- Clinical Trial Application filed in December 2009 for IDX320, a next-generation protease inhibitor
CAMBRIDGE, Mass., Jan. 11 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced significant progress in three HCV programs. Idenix will provide a business update on these three HCV development programs and on its partnered programs during a presentation by Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer, to financial analysts and investors at the 28th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 14 at 8:00 a.m. PST.
IDX184: Nucleotide HCV Polymerase Inhibitor
The phase II clinical trial, initiated in the fourth quarter of 2009, is a randomized, double-blind, placebo-controlled, sequential dose-escalation study evaluating the safety, tolerability, pharmacokinetics and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naive HCV genotype 1-infected patients. Patients will receive a daily dose of IDX184 or placebo plus pegylated interferon and ribavirin for 14 days and then continue on pegylated interferon and ribavirin for an additional 14 days. Antiviral activity will be assessed at the 14-day and 28-day timepoints. Four dosing regimens of IDX184 ranging from 50 to 200 mg per day will be evaluated. In the 100 mg and 200 mg cohorts, QD and BID regimens will be compared. Each cohort includes 20 patients randomized 4:1, IDX184:placebo. This study is being conducted at multiple centers in the United States and Argentina.
Median ALT and AST levels, markers of liver injury, improved during treatment. There were no serious adverse events on treatment, no treatment discontinuations and laboratory profiles were comparable to standard PegIFN/Ribavirin treatment.
"We are very encouraged by these interim data for IDX184 combined with pegylated interferon and ribavirin and look forward to seeing additional data as the study progresses," said Douglas Mayers, M.D., Idenix's executive vice president and chief medical officer.
IDX375: Non-Nucleoside HCV Polymerase Inhibitor
A Phase I single ascending dose study evaluating the safety, tolerability and pharmacokinetics of IDX375 in healthy volunteers is ongoing. The first five cohorts (25 mg QD, 50 mg QD, 100 mg QD, 200 mg QD and 200 mg BID; 6 active:2 placebo) in this double-blind, placebo-controlled study have been completed. Data suggest favorable plasma exposure of IDX375 with a long elimination half-life of 32-40 hours demonstrating the potential for once- or twice-daily dosing in patients. IDX375 was generally safe and well tolerated. There were no significant lab abnormalities. The most common adverse event was mild diarrhea (3/30 subjects). Additional cohorts with higher single and multiple doses are planned.
IDX320: HCV Protease Inhibitor
A Clinical Trial Application for a new protease inhibitor clinical candidate, IDX320, was filed in December 2009. IDX320 is a non-covalent macrocyclic inhibitor with nanomolar potency, broad genotypic coverage and a favorable preclinical pharmacokinetic profile supporting the potential for once-daily dosing in man.
"We are pleased with these early data from our clinical programs and look forward to their continued advancement throughout the year," said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. "In addition, we are excited about our new protease inhibitor clinical candidate, IDX320, and expect to begin a phase I clinical trial soon. With three promising clinical programs that span major HCV drug classes, Idenix is well positioned to play an important role in the transformation of the HCV treatment paradigm."
2009 Financial Guidance
Idenix today reported that it ended 2009 with approximately $48.1 million of cash, cash equivalents and marketable securities. The company's 2009 financial results have not yet been audited.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of infections caused by hepatitis C virus. For further information about Idenix and to access the webcast of the J.P. Morgan presentation, please refer to www.idenix.com.
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Vertex to Ask for Telaprevir OK Later in 2010
http://abcnews.go.com
Vertex Pharmaceuticals to seek regulatory OK for telaprevir hepatitis drug in 2nd half of 2010
Biotechnology company Vertex Pharmaceuticals Inc. said Monday it plans to seek regulatory approval of the experimental hepatitis C drug telaprevir as scheduled during the second half of 2009.
Telaprevir is one of several potential hepatitis C treatments in development. If approved, it could face competition from Schering-Plough Corp.'s experimental hepatitis C drug boceprevir.
Meanwhile, the company will tell investors at a conference it expects a loss of less than $650 million in fiscal 2009, versus a loss of $459.9 million in fiscal 2008, or $397.5 million on an adjusted basis.
Vertex has about $1.3 billion in cash, cash equivalents and marketable securities.
The company will report 2009 financial results and provide a 2010 outlook on Feb. 4.
Shares of Vertex rose $1.28, or 3.2 percent, to $41.95 in midday trading.
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My Turn: What Happens after Hepatitis
http://www.newsweek.com
By Michelle Silverthorne
Years after my wild-child days, my past caught up with me in the form of a diagnosis of a chronic disease. I could have given up. Instead I chose to embrace the future.
On Aug. 14, 2001, I went with a friend to a clinic for my annual HIV test. After my blood was drawn, I met with Jose, a counselor at the clinic. He explained that I was being tested for the antibodies present for HIV and also for hepatitis C. Jose reviewed HIV transmission and then discussed how hepatitis C is spread. He spoke about blood-to-blood contact, transfusions, tattoos, and needles. And although I had encountered some of those situations during my wild days, there was obviously no need to listen because I hadn't done anything remotely classified as high-risk for nearly a decade and I didn't feel sick. Instead I admired the abdominal muscles of the men on the HIV posters while he talked.
A week later, I got a call from the clinic. The nurse informed me that I didn't have HIV but that I did test positive for hepatitis C. I flashed back to the conversation with Jose; although I had paid attention to very little of it, I did manage to pick up the idea that this was a serious disease. (After flashing back over my life, I also realized I probably acquired hepatitis C from a dodgy tattoo of a Matisse print I received when I was 23.)
"Do you have any questions?" asked the nurse.
I was speechless.
Immobilized by shock, I sat in my chair until I was able to move to a computer and look up hepatitis C on the Internet. Four million Americans are infected with hepatitis C, and approximately 10,000 people die annually from the disease, which attacks the liver and is transmitted via blood-to-blood contact. In 2001 my treatment options included 48 weeks of a combination of interferon and ribavirin. Ribavirin is an antiviral drug, and interferon is commonly used to treat melanoma and is described as a "chemo-light" drug. (Treatment options have since increased: for instance, one option is a protease inhibitor used in conjunction with ribavirin and interferon, which involves a shorter treatment period.)
In October, I finally went to a doctor. At my first appointment, I learned two things. First, there were far worse diseases that I could have. My doctor then suggested that I refrain from telling people what I had because of the social stigma attached to hepatitis C as well as the general lack of public knowledge about the disease. He told me that I would have to curb my drinking, as my liver would now react to one drink as if it were three. He also said that in terms of transmission, unless I had an open, bleeding wound on my hand and shook someone else's open, bleeding hand, I wasn't going to give hep C to anyone else (assuming I also refrained from the risk factors Jose had mentioned at my first visit, of course).
Despite my doctor's warnings, I told pretty much anyone that I came into contact with about my health condition because it was all that I thought about. What I found was that some people had no reaction, as if I had just shared that I had a hangnail or a bad haircut, while other people, mostly those in the medical profession, looked at me with horror and sadness as if I had just been selected to be stoned to death or torn apart by a pack of wild dogs the following day.
Two years after my diagnosis, I began treatment due to an increase in my viral load—because the treatment is so difficult, doctors recommend waiting until the illness progresses, measured, in part, by an increased viral load. The side effects of both drugs rendered the next 48 weeks an absolute hell. I lived with mood swings, irritability, irrational thoughts, and brain fog, along with rapid weight loss (the one really good side effect), unrelenting rashes on my hands and feet that made sleeping difficult, hypothyroidism, hair loss, and a host of other bizarre and equally annoying symptoms. I became prone to crying fits both in public and private. I cried everywhere: at work, at Starbucks, while getting a manicure, at parties, and very commonly at the doctor's office. This was a side effect of the treatment, but also an indicator of the frustration and fear associated with both the treatment and my illness. However, the clear winner for the worst side effect goes to the grand mal seizures, which resulted in one shoulder dislocation and the loss of my driver's license for six months. Not being able to drive in Houston is like not being able to walk in New York City. At 33, I was a physical and emotional wreck whose only mode of transportation was a used bicycle.
And then something unexpected happened. Each side effect renewed my determination to stick with the treatment. As far as I was concerned, they were going to have to pry my weekly injection from my cold dead hands before I would quit, no matter how bad things got. In addition, having a disease gave me a sense of purpose, something I hadn't possessed since I was a teenager and determined to become the coolest juvenile delinquent in all of Washington, D.C. My new sense of purpose involved beating hepatitis C and helping others do the same.
Thanks to the treatment, I ended up with a nondetectable viral load, the closest thing to a cure one can hope for, although one is never really cured of hep C. And my experience with hepatitis has steered me toward an interest in public health: while still living in Texas, where I was diagnosed, I volunteered at the American Liver Foundation and started a hep C support group. In 2004 I was accepted to graduate school at the Columbia University School of Public Health, where I received my master's degree,. The tears, it turned out, were well worth it.
—Michelle Silverthorne received a master's in public health from Columbia University in 2007 and is currently living and working in New York City's West Village as a freelance writer and a full-time mother.
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Human Genome Sciences Reports Increasing Momentum toward Commercialization
http://www.benzinga.com
Human Genome Sciences, Inc. (Nasdaq: HGSI) will announce its priority goals for 2010 and report on the Company’s increasing momentum toward commercialization of late-stage products for systemic lupus and chronic hepatitis C in a presentation by H. Thomas Watkins, President and Chief Executive Officer, to financial analysts and investors at the 28th Annual JPMorgan Healthcare Conference in San Francisco.
“2010 will be another pivotal year for HGS,” said Mr. Watkins. “In 2009, we and our partners successfully completed Phase 3 development of BENLYSTA for systemic lupus and ZALBIN for chronic hepatitis C. In the fourth quarter of 2009, we submitted a Biologics License Application (BLA) for ZALBIN in the United States, and Novartis submitted a Marketing Authorization Application (MAA) under the brand name JOULFERON in Europe. We and GSK plan to submit marketing applications for BENLYSTA in the U.S. and Europe in the second quarter of 2010. We have the potential for regulatory approval of two major products in the U.S. before the end of this year, both directed to large and growing markets that represent significant medical need. We greatly strengthened our cash position in 2009 with two successful public offerings of common stock. Even with our expected ramp of investment in commercial build-out and pre-launch manufacturing, we expect to end 2010 with between $840 million and $890 million in cash and investments.”
In July and November 2009, HGS and GSK announced that BENLYSTA (belimumab) met the primary efficacy endpoints in BLISS-52 and BLISS-76 – thus becoming the first drug for lupus to achieve positive results in Phase 3 trials. BENLYSTA is being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.
“Based on the Phase 3 results, BENLYSTA could become the first new approved drug in more than fifty years for people living with systemic lupus,” said Mr. Watkins. “We and GSK plan to submit marketing applications in the second quarter of 2010, following discussions with regulatory authorities in the United States and Europe.”
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Reinfection after Liver Transplantation
www.newsrx.com
New findings from J. Madill and co-authors describe advances in hepatitis C virus
According to a study from Toronto, Canada, "Hepatitis C virus (HCV) reinfection after liver transplantation is universal and progresses to cirrhosis in 10% to 30% of patients. Several risk factors are associated with progression."
"Oxidative stress may be involved because it has a role in the pathogenesis of HCV. To determine whether HCV liver recipients with disease recurrence are more oxidatively stressed than those with no recurrence. were performed at 12 months posttransplantation, and in a subgroup of patients at 6 months.
Liver lipid peroxidation (LPO), antioxidant potential, plasma vitamin E, retinol, and vitamin C were measured. Demographic data, pretransplantation viral load, anthropometry, and 3-day food records were also obtained. Data were log-transformed; analysis was performed using the independent t test, Pearson correlation, and multivariate regression analysis. Recipients of HCV livers with recurrence (n = 21) had higher liver LPO (mean [SEM] micromoles of malondialdehyde per gram of liver tissue, 1.66 [0.28]) vs those with no recurrence (n = 16; 0.88 [0.13]) (P = .02).
A significant relationship was found between liver LPO and HCV recurrence, and this significance continued when accounting for pretransplantation viral load and donor age. Six patients with recurrence and 11 with no recurrence also had measurements obtained at 6 months posttransplantation. Those with recurrence at 12 months had significantly higher hepatic LPO at 6 months (1.86 [0.62]) compared with those with no recurrence (0.75 [0.14]) (P = .04).
Recipients of HCV livers with recurrence are more oxidatively stressed at 6 and 12 months compared with those with no recurrence. Accounting for viral load and donor age, oxidative stress was independently associated with recurrence," wrote J. Madill and colleagues.
The researchers concluded: "More research is needed to confirm this association."
Madill and colleagues published their study in Transplantation Proceedings (Hepatic Lipid Peroxidation and Antioxidant Micronutrients in Hepatitis Virus C Liver Recipients With and Without Disease Recurrence. Transplantation Proceedings, 2009;41(9):3800-3805).
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Virtual Liver Offers Better Chance of Life
www.medicalnewstoday.com
Odysseus has developed systems to construct 3D images of individual patients' livers, with their tumours or other pathologies, from MRI or CT-scans. The reconstructions can be transmitted to external experts in any location, for consultation in real time just before surgery. Collaborative decisions can be made and optimal therapy planned with the best possible diagnostic support, before real surgery is attempted. Simulation of laparoscopic and robotic surgery, with tissue resistance, can be used either to practise the exact surgery proposed for an individual patient, or also for training several surgeons simultaneously.
Medical imaging of organs and tissues has contributed greatly to diagnosis and therapy planning, especially in the treatment of cancers, which are the major cause of deaths worldwide. However the 2D scanning images possible until now have been difficult to interpret, and it has not been possible to consult others who are not present in person. The EUREKA project Odysseus has developed software for 3D-imaging of the blood vessels of a patient's liver which has materially advanced medical understanding of how the liver is segmented. Until now, liver surgery has been based on the anatomy classically described by Couinaud in 1957. But the 3D modelling has shown that up to 50% of patients have a significantly different liver structure from the Couinaud description. "Thanks to the 3D modelling," says Professor Luc Soler of the Institut de Recherche pour les Cancers de l'Appareil Digestif (IRCAD), "the future of liver surgery has gained more precision through accurate definition of the liver's blood vessels."
Multiple skills
But this is only one part of the achievements of Odysseus. The project brought together partners with expertise in tumour detection, endoscopy, virtual simulation and specialised software for image transmission and reconstruction at a distance, in real time. The products developed as a result comprise a whole set of interrelated technologies which together will help medical specialists to take the best informed decisions on diagnosis and treatment.
Virtual Patient Modelling (VR-Anat, formerly known as 3D-VPM) uses patient-specific data to enable pre-operative assessment. Diagnosis and Virtual Planning (VR Planning, formerly 3D DVP) is software which enables navigation and tool positioning within 3D images that can be reconstructed from any multimedia-equipped computer. These two sets of software were developed by IRCAD in collaboration with the French Institut National de Recherche en Informatique et Automatique (INRIA), and tested in five hospitals in France, Switzerland and Canada.
France Telecom, also a partner in the Odysseus project, developed the communication system called Argonaute, allowing several practitioners in different places to interact and advise on the images simultaneously. The unlimited laparoscopic simulator (ULIS) and the robotic surgery simulator (SEP Robot) added realistic physical properties of texture and tissue resistance to the 3D model of the patient, allowing surgical intervention to be simulated before real surgery. These simulations were developed respectively by the German endoscope manufacturer Karl Storz and by SimSurgery of Norway. Luc Soler holds that it is now difficult to tell the difference between photos of real surgery and the simulator images.
Reaching the market
The products developed during the Odysseus project are already contributing to new employment and this will increase once trials are complete and production is under way. IRCAD is now working with the major services company Altran to develop an online service based on the patient modelling and surgical planning systems, VR Anat and VR Planning. A new company, Digital Trainers, has been set up to take forward production of the ULIS laparoscopic simulator, and Karl Storz is expecting to market it before the end of 2009. SEP Robot was added to the SimSurgery's current Surgical Sim Education Platforms. France Telecom software has been installed in all French regions and will enable surgical teams throughout France to work together. France Telecom has also set up a new commercial system with Orange for medical data communication and distance working.
Better prospects for patients
The products of Odysseus will make a very significant contribution to the accuracy of tumour diagnosis in the liver and its treatment. Once trials and validation are complete, their use will enable more accurate diagnosis of secondary liver tumours so they can be removed completely; and reduce the size of liver segments that need to be resected. Because the success of liver surgery depends on the minimum volume of liver that can safely remain after surgery, accurate knowledge of the topology of the individual liver should significantly increase the number of patients who are eligible for surgery.
Odysseus research has led to a new major research project, Passport, within the EU Seventh Framework Programme. FP7 includes the Virtual Physiological Human initiative, developing tools for modelling and simulation of most human physiology and disease-related processes. Passport, partially funded by the European Commission, will extend the Odysseus prototype software to a professional standard, achieving CE marking in 2010. Passport will add patient-specific biological, mechanical, dynamic and appearance modelling to the geometric modelling. Through Passport, IRCAD has already developed the rendering software further (VR Render) and made it freely available on the internet.
Professor Soler greatly values that Odysseus was a EUREKA project. It was not instrumental in finding partners, as they were already known to each other, but it did enable development of the project with just a few partners, allowing flexibility and efficiency.
Source: Piotr Pogorzelski
EUREKA
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Coffee Cuts Liver Scarring in Hepatitis C
http://www.medicinenet.com
-- Robert Preidt
FRIDAY, Jan. 8 (HealthDay News) -- Caffeine in coffee reduces the severity of liver fibrosis in patients with chronic hepatitis C virus, a new study has found.
Liver fibrosis (scarring of the liver) is the second stage of liver disease during which liver function declines because of accumulated connective tissue.
The new U.S. National Institutes of Health study included 177 patients, mean age 51, whose daily consumption of caffeine from food and beverages was tracked for two years.
Patients who consumed more than 308 milligrams of caffeine from coffee per day had milder liver fibrosis than other patients. The daily amount of caffeine intake found to be beneficial is equivalent to 2.25 cups of regular coffee. For each 67-milligram increase in caffeine consumption (about one half cup of coffee), there was a 14% decrease in the odds of advanced fibrosis for patients with hepatitis C virus.
Other sources of caffeine -- such as soft drinks, tea, caffeine-fortified drinks and caffeine pills -- didn't have the same helpful effect, according to the study published in the January issue of the journal Hepatology.
The researchers said further research is needed to determine whether the protective effects of coffee/caffeine increase at levels beyond normal daily intake.
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January 12, 2010
Hepatitis B and C Often Ignored as Health Threat to Blacks
http://www.thegrio.com
By theGrio
WASHINGTON (AP) - They're the overlooked viruses: Hepatitis B and C together infect three to five times more Americans than the AIDS virus does, and most don't know it.
In the next 10 years, these two liver-damaging infections will kill about 150,000 people in the U.S. alone, says a new report Monday from the prestigious Institute of Medicine of the National Academies.
It calls for a major public health push to decrease the stigma of these simmering viruses, which are to blame for nearly half the liver transplants performed every year.
"We have allowed gaps in screening, prevention and treatment to go unchecked," said report chairman R. Palmer Beasley of the University of Texas, Houston.
Some people can fight off hepatitis B or C, but it becomes a chronic, incurable infection in anywhere from 3.5 million to 5.3 million Americans, the report estimates. While anyone can be infected, the viruses disproportionately affect blacks, Asians and Pacific Islanders.
Among the report's recommendations:
- Wider use of a vaccine for hepatitis B. Three states - Alabama, Montana and South Dakota - don't require hepatitis B vaccination before entering day care or school. Also, about 1,000 babies born to infected mothers each year develop hepatitis B themselves. Vaccinating at-risk newborns in the delivery room, instead of within 12 hours of birth as is done today, might protect more of them.
- Improve public awareness. People at highest risk for hepatitis B include those born in parts of Asia and Africa where the virus is particularly widespread, infants born to infected mothers, sexual partners of the infected, and injecting drug users. At-risk adults can seek vaccination. Those at highest risk for hepatitis C include current or former injecting drug users and people who received a blood transfusion before 1992.
- Increase research into a vaccine for hepatitis C.
- Improve health services for hepatitis patients and encourage more testing of the at-risk, with special attention to stigma. Immigrants in particular may be reluctant to seek testing given attitudes in their home countries; in China, for example, hepatitis patients face strong job and social discrimination.
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IOM & Viral Hepatitis
http://www.cdc.gov
Institute of Medicine (IOM) to address Prevention and Control of Viral Hepatitis Infections in the United States
CDC, along with other partners, commissioned the IOM to examine the prevention and control of viral hepatitis infections in the United States. The committee met during 2009 and released the report on January 11, 2010.
The IOM Report, which contains the committee’s findings and recommendations in detail, is available at: http://www.iom.edu/Reports/2010/
Hepatitis-and-Liver-Cancer-A-National-Strategy-
for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx
CDC’s Press Statement is available at: http://www.cdc.gov/nchhstp/Newsroom/
CDC Foundation Launches Viral Hepatitis Action Coalition - Coalition will respond to the Institute of Medicine Report on Viral Hepatitis and support CDC research and programs. CDC Foundation News Release is available at: http://www.cdcfoundation.org/pr/2010/
CDCFoundationLaunchesViralHepatitisAction
Coalition.aspx
Key findings and recommendations from the Institute of Medicine’s Report:
Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C
The committee identified the underlying factors that impeded current efforts to prevent and control these diseases. Three major factors were found:
- There is a lack of knowledge and awareness about chronic viral hepatitis on the part of the health-care and social-service providers
- There is a lack of knowledge and awareness about chronic viral hepatitis among at-risk populations, members of the public and policy-makers
- There is insufficient understanding about the extent and seriousness of the public health problem, so inadequate public resources are being allocated to prevention, control and surveillance programs
Surveillance Recommendations
2-1: The Centers for Disease Control and Prevention should conduct a comprehensive evaluation of the national hepatitis B and hepatitis C public health surveillance system.
2-2: The Centers for Disease Control and Prevention should develop specific cooperative viral hepatitis agreements with all state and territorial health departments to support core surveillance for acute and chronic hepatitis B and hepatitis C.
2-3: The Centers for Disease Control and Prevention should support and conduct targeted active surveillance, including serologic testing, to monitor incidence and prevalence of hepatitis B virus and hepatitis C virus infections in populations not fully captured by core surveillance.
Knowledge and Awareness Recommendations
3-1: The Centers for Disease Control and Prevention should work with key stakeholders (other federal agencies, state and local governments, professional organizations, health care organizations and educational institutions) to develop hepatitis B and hepatitis C educational programs for healthcare and social service providers.
3-2: The Centers for Disease Control and Prevention should work with key stakeholders to develop, coordinate, and evaluate innovative and effective outreach and education programs to target at-risk populations and to increase awareness in the general population about hepatitis B and hepatitis C.
Immunization Recommendations
4-1: All infants weighing at least 2,000 grams and born to hepatitis B surface antigen-positive women should receive single-antigen hepatitis B vaccine and hepatitis B immune globulin in the delivery room as soon as they are stable and washed. The recommendations of the Advisory Committee on Immunization Practices should remain in effect for all other infants.
4-2: All states should mandate that the hepatitis B vaccine series be completed or in progress as a requirement for school attendance.
4-3: Additional federal and state resources should be devoted to increasing hepatitis B vaccination of at-risk adults.
4-4: States should be encouraged to expand immunization-information systems to include adolescents and adults.
4-5: Private and public insurance coverage for hepatitis B vaccination should be expanded.
4-6: The federal government should work to ensure an adequate, accessible and sustainable hepatitis vaccine supply.
4-7: Studies to develop a vaccine to prevent chronic hepatitis C virus infection should continue.
Viral Hepatitis Services Recommendations
5-1: Federally funded health insurance programs – such as Medicare, Medicaid and the Federal Employees Health Benefits Program – should incorporate guidelines for risk-factor screening for hepatitis B and hepatitis C as a required core component of preventive care so that at-risk people receive serologic testing for hepatitis B and hepatitis C virus and chronically-infected patients receive appropriate medical management.
5-2: The Centers for Disease Control and Prevention, in conjunction with other federal agencies and state agencies, should provide resources for the expansion of community-based programs that provide hepatitis B screening, testing and vaccination services that target foreign-born populations.
5-3: Federal, state and local agencies should expand programs to reduce the risk of hepatitis C virus infection through injection-drug use by providing comprehensive hepatitis C virus prevention programs. At a minimum, the programs should include access to sterile needle syringes and drug preparation equipment because the shared use of these materials has been shown to lead to transmission of hepatitis C virus.
5-4: Federal and state governments should expand services to reduce harm caused by chronic hepatitis B and hepatitis C. The services should include testing to detect infection, counseling to reduce alcohol use and secondary transmission, hepatitis B vaccination and referral for or provision of medical management.
5-5: Innovative, effective, multicomponent hepatitis C virus prevention strategies for injection drug users and non-injection drug users should be developed and evaluated to achieve greater control of hepatitis C virus transmission.
5-6: The Centers for Disease Control and Prevention should provide additional resources and guidance to perinatal hepatitis B prevention program coordinators to expand and enhance the capacity to identify chronically infected pregnant women and provide case management services, including referral for appropriate medical management.
5-7: The National Institutes of Health should support a study of the effectiveness and safety of peripartum antiviral therapy to reduce and possibly eliminate perinatal hepatitis B virus transmission from women at high risk for perinatal transmission.
5-8: The Centers for Disease Control and Prevention and the Department of Justice should create an initiative to foster partnerships between health departments and corrections systems to ensure the availability of comprehensive viral hepatitis services for incarcerated people.
5-9: The Health Resources and Services Administration should provide adequate resources to federally funded community health facilities for provision of comprehensive viral hepatitis services.
5-10: The Health Resources and Services Administration and the Centers for Disease Control and Prevention should provide resources and guidance to integrate comprehensive viral hepatitis services into settings that serve high-risk populations such as STD clinics, sites for HIV services and care, homeless shelters and mobile health units.
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IOM Recommends National Strategy for Hepatitis B and C
www.medscape.com
Laurie Barclay, MD
January 11, 2010 — The Institute of Medicine (IOM) issued a report today recommending a national strategy for the prevention and control of hepatitis B and C virus infection, which disproportionately affect minorities and often lead to liver cancer and death. The IOM held a telephone briefing today to discuss the report, which is posted online at http://books.nap.edu/openbook.php?
record_id=12793&page=R1.
"Although hepatitis B and C are preventable, the rates of infection have not declined over the past several years, underscoring the conclusion that we have allowed gaps in screening, prevention, and treatment to go unchecked," committee chair R. Palmer Beasley, MD, professor of epidemiology and disease control at the University of Texas School of Public Health in Houston, said in a news release. "This report outlines the additional resources and actions needed to reduce the unacceptably high burden of liver disease and cancer associated with these viruses."
Public Health Burden of Hepatitis B and C
Chronic hepatitis B and C virus infection are among the leading causes of preventable deaths worldwide. Up to 1 in 50 Americans has chronic viral hepatitis, with estimated US prevalence of chronic hepatitis B at 800,000 to 1.4 million, and of chronic hepatitis C at 2.7 million to 3.9 million. However, about half of infected individuals are unaware of their diagnosis until they become symptomatic with liver cancer or liver disease. Among high-risk populations, rates of testing for hepatitis infection, or even of receiving information on reducing risk for infection, are very low.
Groups at high risk for hepatitis B virus infection are infants born to women with the disease, sexual contacts of infected persons, injection drug users, and immigrants from countries in which hepatitis B and C are endemic, particularly East and Southeast Asia and sub-Saharan Africa. Although Asians and Pacific Islanders constitute only 4.5% of the US population, they account for more than half of chronic hepatitis B cases.
Persons at highest risk for hepatitis C virus infection are those who received a blood transfusion before 1992 and past or current users of injection drugs, with prevalence approaching 90% among long-term users. Hepatitis C mortality is increasing and is greatest among middle-aged men, non-Hispanic blacks, and American Indians.
Further compounding the problem of undiagnosed hepatitis B and C infection is the generally low level of knowledge about these infections among healthcare workers and social service providers. Many providers do not comply with guideline recommendations for hepatitis B and C screening, prevention, treatment, and follow-up services.
Each year, thousands of cases of liver cancer, liver disease, and mortality, and nearly half of liver transplantations, are attributable to chronic hepatitis B and C, particularly among Asians, Pacific Islanders, and blacks in the United States. Although chronic viral hepatitis B is preventable through a vaccine, chronic hepatitis B or C infection accounts for 78% of cases of primary liver cancer (hepatocellular carcinoma) and 57% of cases of cirrhosis.
Healthcare Funding Insufficient for Hepatitis B and C
Despite the significant public health burden posed by hepatitis B and C, current resources and efforts to curb this problem are inadequate for chronic viral hepatitis prevention, control, and surveillance programs and are notably less than those targeting other infectious diseases that have a similar effect on public health, according to the IOM report.
The Centers for Disease Control and Prevention's (CDC's) Division of Viral Hepatitis, a division of the National Center for HIV/AIDS, Viral Hepatitis, Sexually Transmitted Disease (STD), and Tuberculosis Prevention (NCHHSTP), administers most programs related to chronic viral hepatitis. These programs include surveillance and epidemiologic studies, clinical and laboratory research, national and local viral hepatitis programs, public dissemination of hepatitis-related information, and development of guidelines for prevention and control.
In fiscal year 2008, the Division of Viral Hepatitis' budget allocation was $17.6 million, or 2% of the entire NCHHSTP budget, whereas domestic HIV activities received 69%, STDs received 15%, and tuberculosis received 14% of the NCHHSTP 2008 budget. These discrepancies are particularly striking in light of the observation that HIV/AIDS affects 3 to 5 times fewer Americans than viral hepatitis.
In the United Kingdom, the National Health Service (NHS) has considered the use of hepatitis B vaccine in newborns to prevent liver cancer but decided that this strategy was not cost-effective, according to Professor Sir Michael Richards, National Cancer Director for the NHS. He spoke at the 2010 School of Pharmacy lecture in London on January 7, and he contrasted this decision with that made more recently for the use of the human papillomavirus (HPV) vaccine for preventing cervical cancer, which was judged to be cost-effective; a national HPV immunization program is now in place in the United Kingdom.
In the World Health Organization Western Pacific region, where hepatitis B is highly endemic in many countries, 23 of 26 countries have introduced hepatitis B vaccine starting at birth.
Hepatitis B and C Strategies Recommended by IOM
Strategies recommended by the new IOM report to address discrepancies in healthcare allocation and to reduce the substantial public health burden associated with hepatitis B and C are more inclusive vaccination requirements, increased provision of resources for prevention and treatment, and a public awareness campaign similar to that implemented for HIV/AIDS.
Despite the availability of an effective hepatitis B vaccine that has significantly reduced transmission, approximately 1000 infants born to infected mothers develop chronic hepatitis each year, and this incidence has not declined during the past decade. A new recommendation is that all full-term newborns born to hepatitis B–positive mothers be vaccinated once they are stable and before leaving the delivery room, rather than up to 12 hours after birth.
Although most states mandate hepatitis B vaccination for children entering daycare or school, Alabama, Montana, and South Dakota still do not. The IOM report therefore recommends that all states require hepatitis B vaccination for school attendance and that health plans fully cover the costs of vaccination. Each year, approximately 40,000 to 45,000 people legally immigrate to the United States from hepatitis B–endemic countries, and children in these groups should be highlighted for screening and vaccination campaigns.
Because healthcare and social services targeting viral hepatitis are sparse and spread out among providers and organizations, opportunities are often missed to prevent transmission and to reduce the effect of chronic infections. The IOM report therefore recommends better coordination of hepatitis-related healthcare through strategies to identify more infected individuals, to reduce the stigma of infection via social and peer support, and to provide medical management for patients with chronic hepatitis B or C. These recommendations target groups that provide services to at-risk populations, including prisons and jails, HIV and STD clinics, shelter-based programs, and mobile health units, as well as health professionals based in hospitals and physician's offices.
Following the model of the HIV/AIDS public awareness initiative, the IOM report recommends developing and disseminating to all health professionals and social service providers educational programs and materials describing risk factors for viral hepatitis and recommendations for vaccination, prevention, and proper monitoring of infected persons.
A significant barrier to overcome through this public awareness initiative is the stigma associated with viral hepatitis, which may foster reluctance to seek testing and treatment, particularly among immigrants from countries with negative perceptions about hepatitis B. For example, chronic hepatitis B in persons living in China may be associated with discrimination both in the work force and socially. Negative attitudes about illicit drug users, who make up the highest proportion of those infected with hepatitis C, may affect their access to quality healthcare or their willingness to seek care.
Specific recommendations in the IOM report include the following:
- The CDC should perform a comprehensive evaluation of the national hepatitis B and hepatitis C public health surveillance system and develop specific cooperative viral hepatitis agreements with all state and territorial health departments to support core surveillance for acute and chronic hepatitis B and hepatitis C.
- The CDC should support and perform serologic testing and other targeted active surveillance to monitor incidence and prevalence of hepatitis B and C virus infections in populations not fully captured by core surveillance.
- The CDC should work with key stakeholders (other federal agencies, state and local governments, professional organizations, healthcare organizations, and educational institutions) to develop hepatitis B and C educational programs for healthcare and social service providers. These programs should also target at-risk populations and increase awareness in the general population about hepatitis B and C.
- All infants weighing at least 2000 g and born to hepatitis B surface antigen–positive women should receive single-antigen hepatitis B vaccine and hepatitis B immune globulin in the delivery room as soon as they are stable and washed. All other infants should be vaccinated in accordance with the recommendations of the Advisory Committee on Immunization Practices.
- All states should require that the hepatitis B vaccine series be completed or in progress before school attendance.
- Additional federal and state resources should be allocated to increasing hepatitis B vaccination of at-risk adults. States should be encouraged to expand immunization information systems to include adolescents and adults. Private and public insurance coverage for hepatitis B vaccination should be expanded.
- The federal government should work to ensure an adequate, accessible, and sustainable supply of hepatitis B vaccine, and research should continue to develop a hepatitis C vaccine.
- Federally funded health insurance programs should incorporate guidelines for risk-factor screening for hepatitis B and C as a required core component of preventive care.
- The CDC, in conjunction with other federal and state agencies, should provide resources to expand community-based programs providing hepatitis B screening, testing, and vaccination services targeting foreign-born populations.
- Federal, state, and local agencies should expand prevention programs to reduce the risk for hepatitis C virus infection through injection drug use. These programs should include access to sterile needle syringes and drug preparation equipment.
- Federal and state governments should expand testing, counseling, vaccination, and management services to reduce the harm caused by chronic hepatitis B and hepatitis C.
- Innovative, effective, multicomponent hepatitis C virus prevention strategies for injection and noninjection drug users should be developed and assessed to achieve greater control of hepatitis C virus transmission.
- The CDC should provide additional resources and guidance to perinatal hepatitis B prevention program coordinators to improve the identification of chronically infected pregnant women and to provide case management services.
- The National Institutes of Health should support a study of the effectiveness and safety of peripartum antiviral therapy to reduce or possibly eliminate perinatal hepatitis B virus transmission from women at high risk.
- The CDC and the Department of Justice should create an initiative to foster partnerships between health departments and corrections systems to ensure the availability of comprehensive viral hepatitis services for people in prison.
- The Health Resources and Services Administration should provide federally funded community health facilities with adequate resources to provide comprehensive viral hepatitis services.
- The Health Resources and Services Administration and the CDC should provide resources and guidance to integrate comprehensive viral hepatitis services into settings that serve high-risk populations (eg, STD clinics, sites for HIV services and care, homeless shelters, and mobile health units).
Responses of Other Organizations
In response to the IOM report, the CDC Foundation (an independent nonprofit partner of the CDC), in partnership with the CDC's Division of Viral Hepatitis, has launched a Viral Hepatitis Action Coalition. The coalition includes private-sector organizations such as Gilead Sciences, Inc; Merck & Co, Inc; OraSure Technologies, Inc; and Vertex Pharmaceuticals that support and fund high-priority research, education, and program evaluation projects begun by the CDC's Division of Viral Hepatitis.
"The ongoing challenge of preventing and controlling viral hepatitis requires a multifaceted response. CDC cannot do the job alone and is pleased to join with industry partners through the Viral Hepatitis Action Coalition to put forth a collective effort," John Ward, MD, director of the Division of Viral Hepatitis, NCHHSTP, told Medscape Infectious Diseases. "The coalition will help jump start priority viral hepatitis research and programs here at CDC and will use the IOM report to help identify those areas — like building awareness and improving surveillance — where CDC science, combined with resources and expertise from industry, can make the biggest impact."
The first 2 designated priority projects for the coalition are the Birth-Cohort Evaluation to Advance Screening and Testing for Hepatitis C (BEST-C) study and a national hepatitis education campaign. Additional goals of the coalition are to share research data and feedback regarding information and tools needed in the field to respond to the IOM recommendations.
The release of the IOM report has prompted the National Viral Hepatitis Roundtable (NVHR) to once more urge the Obama administration, Congress, and the US healthcare system to act quickly and forcefully against the threat posed by hepatitis B and C. The NVHR is a coalition of more than 150 public, private, and voluntary organizations using strategic planning and legislation to reduce the incidence of infection, morbidity, and mortality from viral hepatitis in the United States.
In particular, NVHR is hopeful that the IOM will spur urgent congressional action on the bipartisan Honda-Dent legislation that quickly would help implement many of the IOM report's recommendations," said NVHR Chair Lorren Sandt. "We are in the grips of a public health crisis that cannot be ignored."
The Viral Hepatitis and Liver Cancer Control and Prevention Act, recently introduced in Congress by Representatives Mike Honda (D-Calif.) and Charles Dent (R-Pa.) calls for an initial $90 million in funding in 2011, and additional funding subsequently, for comprehensive prevention, research, and medical management referral programs for chronic viral hepatitis B and C infection.
"The [IOM] report highlights many important issues we see in our clinics," said NVHR Steering Committee Member Andrew Muir, MD, clinical director of hepatology at the Duke University School of Medicine in Durham, North Carolina. "Too many patients are unaware they have viral hepatitis, and this makes it difficult to control the spread of these infections and provide appropriate treatment to those infected. Too many patients present to our clinics in the late stages of cirrhosis or with advanced liver cancer. If we could identify these patients sooner, we have effective treatment strategies to help them avoid these devastating complications. We need coordinated surveillance and educational programs to aid us in these efforts."
The IOM report was sponsored by the US Centers for Disease Control and Prevention, the US Department of Health and Human Services' Office of Minority Health, the US Department of Veterans Affairs, and NVHR.
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InterMune Updates Development Program of Protease Inhibitor RG7227 for Treatment of Hepatitis C – Update
http://www.rttnews.com
(RTTNews) - Biotechnology company InterMune Inc. (ITMN: News ), Monday reported preliminary results from two cohorts of the Phase 1b multiple-ascending-dose study for protease inhibitor RG7227 for the treatment of patients chronically infected with the hepatitis C virus or HCV. The company also reported guidance for the 2010 milestones and key events for RG7227.
The company said that the majority of patients for the 15 days study administered twice daily with 100 mg RG7227, formerly referred to as ITMN-191, along with low-dose ritonavir in combination with standard of care or SOC, or 200 mg RG7227 once-daily were found to be HCV RNA negative at the end of therapy. The ritonavir-boosted regimen provided more favorable pharmacokinetic profile compared to 900 mg RG7227 administered twice-daily with, SOC and without ritonavir. No drug related serious adverse events have been reported to date.
Brisbane, California-based InterMune said it expects to begin Phase 2b triple combination study by third quarter of 2010. Positive Phase 1b results, the company decided to terminate its previously planned 24-week un-boosted part of the on-going Phase 2b study.
The enrollment for the Phase 2b trial was started in August 2009 for RG7227 in combination with Pegasys or pegylated interferon alfa-2a and copegus or ribavirin to study both 600 mg and 900 mg q12h given twice daily and three-times-daily regimens 300 mg q8h for 12-week and 24-week treatment durations. InterMune on November 17, 2009 said that three patients in the blinded 900 mg q12h dosage cohort experienced an ACTG Grade 4 elevation in ALT levels, one of whom experienced an elevation of total bilirubin while also receiving concomitant allopurinol.
The study's independent Data Monitoring Committee or DMC after reviewing the un-blinded data recommended the discontinuation of 900 mg q12h cohort.The company said that the enrollment of all remaining cohorts was completed in November of 2009.
In addition, the companies plan to amend the on-going Phase 1b MAD 15-day ritonavir boosting study to evaluate 12 weeks of RG7227 ritonavir-boosted therapy plus SOC. Earlier, the company reported positive results of a Phase 1 study of ritonavir-boosted RG7227 in healthy volunteers.
Looking ahead, InterMune expects results for the un-blinded rapid virologic response and early virologic response data from the on-going Phase 2b study of RG7227 plus SOC in the late first quarter or early second quarter of 2010.
The company estimates that the initiation of INFORM-2 program based ritonavir-boosted RG7227 plus RG7128 will be in the first quarter and initiation of longer duration DAA study to evaluate SVR ritonavir boosted in the second quarter. The initiation for the new study of Phase 2b study of ritonavir-boosted RG7227 plus SOC will be in the third quarter of 2010.
ITMN is currently trading at $14.85, down $0.07 or 0.50% on a volume of 518,481 million shares on the Nasdaq.
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Liver Lines
http://www.antonnews.com
Written by David Bernstein
What does 2010 have in store for people with hepatitis C? For the patient, it will likely be a year to wait and observe what happens with many of the new medications being evaluated in clinical trials. From the provider side, 2010 will be an exciting year. There are several new medications being introduced into clinical trials and some of the more advanced new medications are likely to complete their pre-approval evaluation this year.
While there is lots of chatter regarding new medications for hepatitis C, it is important to understand that the new medications are in addition to the current therapies. They are not replacement therapies. This means that the current standard treatment of interferon and ribavirin will not disappear. Future treatment regimens will be comprised of at least three drugs, interferon, ribavirin, plus a third or perhaps a fourth new agent. While the current interferons that are currently approved for therapy are pegylated interferon alfa 2a or 2b, newer interferons and new delivery systems of already approved interferons are being introduced as well into the research arena.
Most of the new clinical trials are evaluating previously untreated patients with genotype 1. Unfortunately, there are limited studies being planned for previous non-responders to pegylated interferon or for relapsers to the same regimen despite the vast number of patients who fall in to these categories. The good news is these patient populations have been studied with a treatment regimen of three drugs including interferon, ribavirin and a protease inhibitor with excellent outcomes. There are also limited data available for the use of any of these new compounds in genotypes other than type 1.
When can the public expect that these new medications will become available? While we are not able to assure when the next agent will be approved by the FDA, two different protease inhibitors seem poised to be approved for the treatment of hepatitis C in the latter half of 2011. Both of these agents are oral agents which will be used in combination with pegylated interferon and ribavirin; and the sustained viral response rates with the triple therapy is significantly better than with dual therapy, although the side effect profile with the three drugs is greater. Therefore, the use of these products requires significant experience by the physicians and their staffs. These agents also offer hope for the non-responder and relapse patient, and hopefully, their approval will offer the chance of a sustained viral response to many patients with hepatitis C.
In addition to these new agents, the team at Duke has identified a genetic polymorphism near the IL28B gene which can predict response to therapy with standard pegylated interferon and ribavirin. If this proves to be a real finding and a commercial assay can be developed, it may become available for routine testing which would allow physicians to predict response to therapy prior to initiating treatment. This would differentiate those patients requiring the new triple therapies versus those who will do well with standard dual therapy.
So what are patients to do in the interim? My suggestion is to continue current evaluations and discussions of what therapies are available now and what may be best for the individual patient in the future. For some, watchful waiting may be appropriate, while in others, initiation of treatment at this time may be the best treatment course. Either way, a little education will go a long way in best understanding and treating hepatitis C.
Dr. Bernstein is the director of Hepatology for the North Shore-Long Island Jewish Health System. You may write to Dr. Bernstein, c/o Anton Community Newspapers, 132 E. Second Street, Mineola, NY 11501 or email dbernste@nshs.edu
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January 13, 2010
Mayor Newsom Convenes Task Force to Address Hepatitis C Epidemic
Press Release
January 12, 2010 -- San Francisco Mayor Gavin Newsom has established the San Francisco Mayor’s Hepatitis C Task Force. The task force, composed of 32 advocates including medical and social service providers, public health officials, and people living with hepatitis C will create a comprehensive set of policy and funding recommendations on fighting the hepatitis C epidemic in the city. The task force will also create educational, public awareness, and prevention campaigns and will organize community forums and events to inform at-risk populations and the general public about hepatitis C and the impact on San Francisco.
“Mayor Newsom has demonstrated great leadership by convening this vital task force,” said Dominique Leslie, Task Force co-chair. “We are eager to shed light on this silent epidemic and identify specific recommendations for the Mayor to develop a comprehensive plan to fight this disease which has caused much suffering and death.”
An estimated 2 to 3 million Americans are living with chronic hepatitis C (HCV), many of whom are not aware of their status. HCV disproportionately affects African-American, Latinos, veterans, people involved with the criminal justice system, injection drug users, men who have sex with men, people with HIV, immigrants, and low-income residents. HCV can lead to liver disease, cirrhosis, liver cancer, liver failure and death. It is also the leading indication for liver transplantation in the United States. However, many people at risk for or infected with HCV are neither tested nor treated due to lack of public awareness and lack of access to care and services.
San Francisco has been hit particularly hard by the hepatitis C epidemic, with an estimated 12,000 people infected with HCV. According to the Centers for Disease Control and Prevention (CDC), liver cancer from hepatitis B and C kills more people in the San Francisco Bay Area than anywhere else in the country.
The Task Force is even more vital following the January 11, 2010 release of the Institutes of Medicine (IOM) report Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. In this report, the IOM highlighted the severity of the hepatitis B and C epidemics in the United States, serious deficiencies in knowledge about the diseases among health and social service providers, at-risk populations, and the general public, and outlined a series of recommendations that would lead to a national effort to prevention, control, and care for chronic hepatitis B and C.
“San Francisco has an opportunity to address the serious gaps in hepatitis C awareness and services outlined in the IOM report,” said Randy Allgaier, Task Force co-chair. “Our task force can also serve as a model for other jurisdictions to combat this growing epidemic and end needless suffering and death caused by a preventable disease.”
The Task Force has elected three co-chairs to lead the group’s efforts: Randy Allgaier, Dominique Leslie, and Emalie Huriaux (who represents the San Francisco Department of Public Health). The Task Force’s work is divided into five committees: Care and Treatment, Research/Evaluation, Prevention/Education and Testing, Community Awareness, and Public Policy. The Task Force will organize community forums and provide other opportunities for the public to provide input to its policy recommendations and other activities.
For more information, contact Ryan Clary, chair of the Task Force’s Public Policy committee, at (415) 558-8669, x224 or rclary@projectinform.org
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Smithfield Officer Kurt Beach Wants Workers' Compensation Law Changed
http://www.dailypress.com
By Allison T. Williams
ISLE OF WIGHT — This time last year, Smithfield police Lt. Kurt Beach was fighting for his life.
Now Beach — who received a lifesaving liver transplant last April — is fighting to change the workers' compensation law that restricts the time workers have to file claims for certain illnesses contracted in the line of duty.
Beach's health problems were intensified with red tape, created by a state law that requires workers' compensation claims to be filed within five years of the worker's exposure to the disease. Now he is working to make sure no first responder — including police officers, firefighters or paramedics — dealing with a medical problem contracted through work is trapped in the same insurance maze.
"This law needs to be rewritten with the statue of limitations removed," said Beach. "I have difficulty believing they want to keep that old law on the books. It's almost like keeping a horse and buggy law on the books."
He plans to rally grass-roots support from other first responders to lobby their respective lawmakers to bring change to the current law.
Del. William K. Barlow, D-Smithfield, said he plans to introduce a bill giving workers exposed to certain diseases — including hepatitis, meningococcal meningitis or tuberculosis — more time to file workers' compensation claims. But a similar bill he introduced last year died in committee, Barlow said.
"It's extremely hard to get workers' compensation laws changed to provide greater coverage to the workers because it results in higher costs for the employers," he said.
He estimates there is only a 50 percent chance the bill would pass if it makes it to the floor of the General Assembly.
Although Beach still takes daily anti-rejection drugs and has to undergo monthly medical testing, he looks healthy and is back at work.
"I'm doing great. I am so blessed," said Beach.
Beach's outlook wasn't so sunny last fall, when his wife, Kathie Beach, made a public plea for a living donor — someone who would be willing to donate part of his liver — to save her husband's life.
Beach's liver problems were traced to 1988, when the rookie police officer contracted hepatitis C after giving mouth-to-mouth resuscitation to a dying infant. But it wasn't until 1995 — eight years later — that Beach, while donating blood, learned he had hepatitis C.
All his workers' compensation claims related to the hepatitis since 1995 were denied, Beach said. Last year, the legislature awarded him $250,000 to help pay mounting medical expenses — $50,000 on Aug. 1, 2009, with the remainder to be awarded in 10 annual installments of $20,000.
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Doctor: Drug War Waged against Wrong People
http://www.seattlepi.com
By Joel Connelly
Seattlepi.Com Staff
Vancouver physician will speak in Seattle Thursday
As a physician who treats patients at North America's only safe injection site, Dr. Gabor Mate has no patience for warrior bureaucrats who waste billions and jail thousands trying to curb illegal drug use.
"The whole 'War on Drugs' is making war on people who were most abused in the first place," Mate said in a telephone interview from the Vancouver, British Columbia, center, named Insite. Mate is campaigning to end the costly, ineffectual war. He will appear at Town Hall Thursday night with former Seattle Police Chief Norm Stamper, a fellow supporter of drug policy reform.
As they speak, a drive gaining momentum in Washington would lift criminal penalties for those possessing small amounts of marijuana. Bills have been introduced in the Legislature, with an initiative campaign just announced.
In the background is a growing feeling among some experts that priority response to hard drugs should move from enforcement to treatment and harm reduction.
Mate, the physician, came to Canada as a boy when his parents escaped Communist-ruled Hungary. In a series of books -- the latest, In the Realm of Hungry Ghosts -- he has sought to draw a map for human understanding of people scorned, neglected and persecuted by society (unless they are celebrities who can afford high-priced addiction spas).
"I have yet to have a (drug) patient who was not sexually abused as a child," said Mate. "If you look at hard-core injection addicts, these are people invariably abused as children. Childhood adversity is the greatest causal factor of addition.
"These people carry a lot of shame, personal failure. Drugs numb their feeling, take them away from reality. They just don't make that connection. They are surprised when it is pointed out to them.
"They have been taught they are bad people. They see themselves as failures who have screwed up their lives."
The establishment of a safe injection center in Vancouver has injected America's tough guys into the Canadian city's debate on how to treat addiction in the Downtown East Side.
U.S. Drug Enforcement Administration chief John Walters appeared before the Vancouver Board of Trade to warn of tighter border restrictions. Ex-New York Mayor Rudy Giuliani, visiting British Columbia in 2008 to give a speech, said his way of dealing with heroin addiction was "arresting drug dealers."
Giuliani added: "I think heroin is a very deadly, very deadly drug. I don't think anyone should be encouraged to use it or assisted in using it." Blocked by courts from shutting down the injection center -- or arresting its patrons -- the government of Canada's Prime Minister Stephen Harper has miscast its mission. It has refused to permit establishment of a second center.
"Allowing and/or encouraging people to inject heroin into their veins is not harm reduction, it is the opposite . . . We believe it is a form of harm addition," in the words of then-Health Minister Tony Clement.
A quiet walk on the Downtown East Side might teach Harper's cabinet ministers a thing or two about public health. Harper sent Parliament packing for five weeks, and is headed to the 2010 Winter Olympics. He might stop to see the suffering as well as doing photo-ops with medalists.
Addicts are present in numbers large enough to draw visits from Seattle TV stations during sweeps months. They used to die in large numbers, from overdoses as well as diseases contracted from needle sharing.
"What the center does is not to stop addiction, but to make it safer," Mate argued. "People do not transmit the HIV/AIDS virus or Hepatitis C."
"Certainly lives have been saved. Given the percentage of overdosed who die, they've probably saved 25 to 30 lives: The problem is the safe injection site is only a small part of the overall injection level in Vancouver. The problem is not concept, but that the facility is not large enough."
Vancouver and British Columbia are officially moving toward a "Four Pillars" approach to drug use. The pillars are harm reduction, treatment, prevention and enforcement.
Mate pillories officialdom, however, for talking a better game than it plays.
"It's a nice idea, but we're not doing it," he said. "We actually have one pillar and three toothpicks. Pillars of equal strength are needed to hold up a house, or it collapses. All the money is still going into enforcement."
He is a provocative, passionate man with much to fuel his passion.
At the edge of Chinatown, on a winter night eight years ago, I watched an emaciated young woman named Sheila roll up her shirt sleeve as a prelude to injection. An addict, eating lunch at St. James Anglican Church, shook so hard that soup spilled down his shirt.
A French photographer, Marc Josse, spent months on the Downtown East Side, producing a gallery of human subjects, in his words, "suffering and dying of indifference."
Former Vancouver Mayor Larry Campbell was a cop on the Drug Squad, but later became British Columbia Chief Coroner . . . and a passionate advocate for giving addicts a place with clean needles, but also the chance to clean up their lives.
What changed him, I asked. Campbell gave a simple answer: "I became a coroner. My goal was not enforcement. It became saving peoples' lives."
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January 14, 2010
A Novel and Simple Formula to Predict Treatment Success in Chronic Hepatitis C
www.eurekalert.org
The likelihood of treatment success of 48 wk peg-interferon (PEG-IFN) plus ribavirin (RBV) therapy for chronic hepatitis C may be predicted by viral kinetics on therapy. In particular, recent studies have shown that sustained virological response (SVR) can be predicted by a rapid virological response (RVR), and an early virological response (EVR). Nevertheless, the current dosing regimens could potentially under-treat some patients and additional measurements of viral response is needed to facilitate individualization of therapy. Among predictive factors already reported, many are not readily available from daily clinical assessment, because they require genomic analyses and/or advanced experimental methods. The prediction with simply available data may be useful.
A Clinical research article to be published on January 7, 2010 in the World Journal of Gastroenterology suggested a novel but easily available on-treatment formula, which predicted SVR of patients who received PEG-IFN/RBV for 48 wk better than viral kinetics. The analysis was performed using the data of 176 patients with chronic hepatitis and hepatitis C virus genotype 1 who received 48 wk standard therapy. The formula was constructed using data from the first 100 patients enrolled and validated using data from the remaining 76 patients.
The predictive potential was very high, as judged by area under the curve of receiver operating characteristic (AUC) analysis, which was more than 0.8 from week 4. In particular, the validity at week 24 was more than 0.85 of AUC. The positive predictive value (PPV) of the formulae were better at weeks 12 and 24 than the prediction with viral kinetics, and the negative predictive value (NPV) of the formulae were better at weeks 4 and 12. Evaluation of the formulae using data from the test patients revealed a very high AUC value of more than 0.85. These results suggest that formulae based on simple clinical data are superior to prediction by viral kinetics.
The formula can be made with a personal computer using statistical software to create a logistic regression model. The formula was made for every cohort of patients affiliated to a hospital, and the prediction made is suitable for every cohort. The concept that extension of treatment duration can reduce relapse rates should be adopted only for a limited proportion of type 1-infected patients. The formulae we suggest might be helpful for patients who are expected to achieve SVR but do not do so. For those individuals, the method based on logistic regression analysis will show a clear direction of therapy in each case and enable the best tailored treatment. Further prospective studies should be performed to determine whether this approach really increases the SVR rate by selection of patients and extension of treatment duration up to week 72.
Reference:
Saito H, Ebinuma H, Ojiro K, Wakabayashi K, Inoue M, Tada S, Hibi T. On-treatment predictions of success in peginterferon/ribavirin treatment using a novel formula. World J Gastroenterol 2010; 16(1): 89-97 http://www.wjgnet.com/1007-9327/16/89.asp
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Hepatitis E: A Public Health Concern
http://www.empowher.com
Maryann Gromisch
Hepatitis E (HEV) is an inflammatory disease of the liver and is caused by the hepatitis E virus. First recognized as a distinct human disease in 1980, HEV antibodies have been detected in primates, such as pigs, cows, sheep, goats and rodents. The disease is transmitted by the fecal-oral route. Hepatitis E is a waterborne disease. Consumption of fecal contaminated drinking water has resulted in epidemics of HEV. The ingestion of raw shellfish has been the source of sporadic cases in epidemic areas. HEV does not appear to be transmitted from person to person.
The highest incidence of HEV is in areas of the world where substandard sanitary conditions exist. Sporadic cases have been reported elsewhere and evidence suggest a global distribution of strains of hepatitis E of low pathogenesis (development of disease).
In general, HEV is a self-limiting viral infection, not a chronic infection and is followed by recovery. Occasionally, a fulminant (sudden and severe) form develops, more frequently during pregnancy and regularly induces a mortality rate of 20% among pregnant women in the third trimester.
The incubation period following exposure to HEV ranges from 3 to 4 weeks. HEV infection is most common in young adults, ages 15 to 40 years old. Typical symptoms include jaundice (yellow discoloration of the skin and sclera of the eye), dark urine, and pale stools. Patients experience anorexia (loss of appetite). Other signs are hepatomegaly (an enlarged, tender liver), abdominal pain and tenderness, nausea and vomiting, and fever. Although the occurrence of HEV is frequent in children, it mostly asymptomatic or causes a very mild illness that goes undiagnosed.
Diagnosis of HEV is made by blood tests that detect elevated antibody levels of specific antibodies to HEV. Unfortunately, such tests are not available worldwide. Currently, no commercially available vaccine exists for the prevention of hepatitis E. Good personal hygiene, high quality standards for public water supplies and proper disposal of sanitary wastes have resulted in a low prevalence of HEV in many well developed countries.
Travelers to countries in Central and South-East Asia, North and West Africa and to Mexico should avoid drinking water and using ice of unknown purity and eating uncooked shellfish and uncooked fruits and vegetables that are not peeled or prepared by the traveler.
Hepatitis E is a viral infection and antibiotics are of no value as treatment. Hospitalization is required for fulminant hepatitis E and should be considered for infected pregnant women. Prevention is the most effective approach against the disease.
Article source: World Health Organization www.who.int
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New HIV and Hepatitis C Treatment Centre Opens in Waterloo
http://news.therecord.com
By Johanna Weidner, Record staff
WATERLOO — Patients dealing with HIV and hepatitis C will be able to get care closer to home with an innovative new treatment centre in Waterloo.
The Guelph-based Masai Centre and Sanguen Health Centre opened the local satellite office to treat the many patients travelling from Waterloo Region and to reach more people needing specialized support.
“We want to be able to provide those people with the opportunity to get care here. We have the expertise,” said Dr. Chris Steingart, clinic director of Sanguen and a specialist in HIV and hepatitis C.
Combining services for both infectious diseases is an entirely new approach, but logical since many people with HIV also have hepatitis C.
“What we’re doing here is unique,” he said. “It just doesn’t exist anywhere else, but it’s necessary.”
The Masai Centre has a multidisciplinary approach, providing health care as well as support services including education, counselling, and nutrition advice. Steingart wants to develop the same comprehensive approach for hepatitis C, an underserviced area despite its prevalence locally and across the province.
Waterloo Region has about 500 HIV patients compared to about 3,500 to 4,500 with hepatitis C, and a third of people with hepatitis C don’t know they have the serious liver disease, he said. Steingart was the medical director of infection and prevention control at Kitchener’s two hospitals until summer 2008, when he left to start the Sanguen Health Centre.
He joined the Masai Centre at its opening in 2005, an initiative of Dr. Anne-Marie Zajdlik. Her goal was not just providing care locally, but also globally with a centre in Lesotho, Africa, where 21,000 people are treated for HIV/AIDS.
Zajdlik was once the only doctor in the area providing HIV care. When she opened the Guelph Masai centre, her roster of 70 patients jumped to 400 within a year. At about 600 now, more are expected with the opening of the Waterloo satellite office.
Steingart and Zajdlik, along with Cambridge physician Dr. Keith Hankinson, will offer care at the Guelph and Waterloo offices. Patients started coming to the new Waterloo office at the beginning of January and the official opening is on Jan. 26.
Many people go outside the region for care to Toronto, Hamilton and London, and many get none at all, in particular marginalized groups such as the homeless.
Helping people with HIV and hepatitis C is difficult because the medical treatment is complex, and it’s combined with social and emotional issues that need to be addressed.
There’s “a lot of challenges for these people,” Steingart said. “When someone’s on this treatment, we can keep them well, but it doesn’t make everything else go away.”
The goal is to help people live as normal a life as possible.
The Masai Centre was the first HIV clinic in the province to link with the local AIDS committee to provide support. Now the Waterloo office is working closely with the AIDS Committee of Cambridge, Kitchener and Waterloo.
Some provincial funding comes to the Masai centre, but it relies heavily on fundraising and donations. So far $1.3 million has been raised through the Bracelet of Hope campaign for both the local and African clinics.
The Sanguen Health Centre is planning on fundraising to add services to the sparse government and private dollars covering a nurse and nutritionist, and ACCKWA has federal funding for an outreach worker. Steingart wants to tap into existing services and build a comprehensive centre for hepatitis C patients like that for the HIV patients.
With the funding shortfall, the doctors themselves are helping cover costs at the centres. They know treatment for HIV and hepatitis C works best at a centre dedicated to the infectious diseases.
“You need to develop the expertise,” Steingart said. “It’s a rapidly developing area of medicine.”
He is excited to finally open the office in Waterloo after years of planning, adding to the care already offered in Guelph.
“That’s going to help a lot of people.”
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AASLD Applauds Landmark IOM Study That Shows the Path to Eradicate Hepatitis B and C
www.medicalnewstoday.com
The American Association for the Study of Liver Disease (AASLD) reacted favorably to the release by they Institute of Medicine (IOM) of the report of "Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C." This landmark study evaluated the burden from viral hepatitis and current preventive and management practices and recommended ways to reduce new cases of hepatitis B and C and morbidity and mortality from chronic disease.
"We welcome this report," said Dr. Arun Sanyal, President of AASLD, adding, "It is an important first step in the effort to eradicate hepatitis B and C." AASLD has long advocated for a comprehensive national program to prevent new infections and limit the spread of infection through early identification and treatment of infected individuals. This will reduce the burden of end stage liver disease and liver cancer, which are projected to kill about 150000 Americans according to the IOM report.
"We will continue to work closely with the Division of Viral Hepatitis within the CDC, National Institutes of Health, Department of Veterans Affairs, and other federal and state agencies to act on the recommendations of the IOM report," Dr. Sanyal continued. "Specifically, AASLD and its membership will remain the vanguard in the development of new knowledge and educational programs on viral hepatitis that will advance the recommendations of the IOM."
Among the key findings by the IOM are that one in fifty Americans has viral hepatitis and the majority of such individuals remain unaware of their disease. While some populations are disproportionately affected, individuals from all segments of society can get the disease. A relative lack of funding for disease surveillance and educational efforts is a major barrier towards eradication of hepatitis B and C.
Among the recommendations made by the nonpartisan, scientific panel are that major new efforts must include increased funding for research and education of the population, policy makers, and the medical community. In addition, the IOM recommends that there be new, adequately funded programs for surveillance and identification of those with viral hepatitis.
In anticipation of the IOM report, AASLD has planned a focused symposium in collaboration with the CDC to determine novel strategies to educate the community and to reduce the impact of viral hepatitis on society at AASLD's Annual Meeting in October 2010.
AASLD supports "The Viral Hepatitis and Liver Cancer Control and Prevention Act," introduced in Congress by Representatives Mike Honda (D-CA) and Charles Dent (R-PA). It will continue to advocate for additional legislative efforts to implement the recommendations of the IOM and to ensure that all Americans with viral hepatitis have access to affordable and effective treatments.
Finally, AASLD will work with sister societies and community-based organizations to develop educational materials to increase awareness of viral hepatitis and promote surveillance and immunization.
AASLD is the premier liver organization that is dedicated to the study of the liver and the diseases that affect the liver. Eradication of viral hepatitis is an important long-term goal for the AASLD.
Source: AASLD
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January 15, 2010
Government Appoints New Clinical Director for Liver Diseases
http://www.egovmonitor.com
Source: Department Of Health
Dr Martin Lombard has been appointed the first National Clinical Director for Liver Disease the Department of Health announced today.
Dr Lombard, a Consultant Hepatologist at Royal Liverpool University Hospital NHS Trust will take up this new role on 18 January 2010, leading the development of a National Liver Strategy for England. The strategy will bring together NHS services and builds on the Department’s commitment to tackle the growing levels of Liver disease.
Liver disease is now one of the most common causes of death in England and if action is not taken to combat the disease, it could overtake stroke and coronary heart disease as a cause of death within the next 10-20 years. The growth in liver disease is largely fuelled by lifestyle factors such as excessive drinking, risk taking behaviour leading to transmission of Hepatitis C, and obesity and could easily be prevented.
Health Minister Ann Keen said:
“Liver disease is the only one of the top causes of death in this country which is affecting more people every year at an increasingly young age. We know that by identifying people earlier, encouraging them to change their behaviour and making sure the right services are in place, we can improve the quality of care and prevent the rise in this disease.
“Dr Lombard is a highly-respected clinical expert in this field and I am pleased to welcome him to the Department to lead our National Liver Strategy.
“I am confident that Dr Lombard will build on the work already underway to make a real difference for patients and for the healthcare staff working in this area.”
Dr Lombard said:
“I’m delighted to be able to take up this very important role. Liver disease is a growing problem for society and for the NHS, with viral hepatitis and obesity starting to catch up with alcohol as root causes of the disease.
“I’m looking forward to leading the Department of Health’s work with staff across the NHS, patients and patient groups to develop a National Liver Strategy and provide real advances in the quality of care across this important area of medicine.”
Dr Lombard will remain active in clinical medicine and will continue to work part-time at the Royal Liverpool University Hospital NHS Trust.
The Department of Health recognises the importance of managing lifestyle factors in preventing a number of diseases. That is why we have already launched two major campaigns, Know Your Limits and Change4Life, investing £372m to address obesity and to prevent people becoming obese in the first place.
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Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Rolaids Recall
http://www.medicinenet.com
By Daniel J. DeNoon
WebMD Health News
Reviewed By Louise Chang, MD
Containers' Moldy Odor to Blame for Recall of 60 Million Over-the-Counter Products
Jan. 15, 2010 -- Because of a sickening smell in some containers, 54 million packages of 27 different over-the-counter remedies now are being recalled.
Products include various types of child and/or adult Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Rolaids, and Simply Sleep. This adds to the 6 million packages of Tylenol recalled late last year, bringing the total number of recalled products to 60 million.
A musty, moldy odor coming from the products has sickened at least 70 people with nausea, stomach pain, vomiting, and diarrhea. The symptoms go away by themselves and no one has been seriously injured.
The FDA says Johnson & Johnson's McNeil Consumer Health Care knew of the problem for more than a year. When the company did act in November and December 2008, it did too little too late, said Deborah M. Autor, director of the FDA's Office of Compliance.
"When something smells bad, literally or figuratively, companies must aggressively investigate and take all actions necessary to solve the problem," Autor said at a news conference. "McNeil should have acted faster."
The odor comes from a chemical, 2,4,6-tribromoanisole or TBA. TBA is produced when fungi break down a commonly used fungicide called 2,4,6-tribromophenol. The full health effects of TBA are not known.
Before being filled with product, product containers were stored on wooden pallets apparently treated with the fungicide. TBA seems to have infiltrated the product containers before they were filled.
The FDA inspected McNeil's main plant at Las Piedras, Puerto Rico, and was not happy with what it found. The FDA says McNeil began receiving complaints in May 2008, but failed to investigate fully or to warn consumers in a timely manner.
The FDA has given McNeil 15 days to respond to its seven-point warning letter. In addition to the contamination issue, the FDA says there are product-quality issues with some Motrin products.
Specific products included in the recall include:
- Children's Motrin
- Children's Tylenol
- Extra Strength Tylenol
- Regular Strength Tylenol
- Tylenol 8 Hour
- Tylenol Arthritis
- Tylenol PM
- Benadryl
- Motrin IB
- Rolaids
- Simply Sleep
- St. Joseph Aspirin
A complete list of the recalled products, including package sizes, product types, lot numbers, and UPC codes, can be seen at www.mcneilproductrecall.com. Consumers with question can call McNeil at 888-222-6036.
Consumers who think they may have suffered ill effects from the products should contact the FDA at www.FDA.gov/medwatch.
SOURCES:
-
FDA news conference with Deborah M. Autor, director, Office of Compliance (OC), Center for Drug Evaluation and Research (CDER), FDA; Jason Woo, MD, associate director for medical and scientific affairs, OC, CDER, FDA, and Karen Hirshfield, acting branch chief, Recalls and Shortages Branch, OC, CDER, FDA.
- PR Newswire, Jan. 15, 2009
- News release, J&J McNeil Consumer Healthcare.
- FDA warning letter to McNeil, Jan. 8, 2009.
- Marc Boston, spokesman, McNeil Consumer Healthcare.
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HCV Found in Carotid Atherosclerosis Plaques of Chronic Hepatitis C Patients
www.hivandhepatitis.com
By Liz Highleyman
SUMMARY: Hepatitis C virus (HCV) was detected in arterial plaques in the carotid arteries of chronic hepatitis C patients with heart disease, according to a study in the January 2010 Journal of Clinical Virology. While the implications of this novel finding are not yet clear, it is possible that HCV may have a direct influence on atherosclerosis.
Research indicates that chronic hepatitis C is associated with increased risk of cardiovascular disease in both HCV monoinfected and HIV/HCV coinfected people, even though HCV infection tends to lower blood lipid levels. Some evidence suggests HCV infection may promote accumulation of carotid artery plaques, or build-up of cholesterol and other substances on the walls of the arteries in the neck that supply the brain.
Maria Boddi from the University of Florence, Italy, and colleagues conducted a study to evaluate the presence of HCV genomic sequences and replicative intermediates in artery plaque tissues. The HCV genome is a positive-strand RNA that serves as the viral genetic "blueprint," while a replicative intermediate is a negative-strand RNA utilized in the copying process.
The researchers analyzed a cohort of chronic hepatitis C patients seen at the University Hospital in Florence who had chronic ischemic heart disease, in which the heart is deprived of oxygen due to atherosclerosis.
Results
- Positive-strand HCV RNA was found in 7 carotid plaque tissue samples obtained from HCV antibody positive patients.
- Positive-strand HCV RNA was not detected, however, in the 9 carotid plaque samples from HCV antibody negative patients.
- 3 patients had HCV RNA detectable in carotid plaque but not in blood serum.
- Negative-strand HCV replicative intermediates were detected in 3 plaque samples.
- Direct sequencing of HCV RNA from plaque and serum samples showed HCV genotypes 2 (5 cases) and 1 (2 cases).
"The novel finding of HCV RNA sequences in plaque tissue strongly suggests an active local infection," the study authors concluded. "This in turn makes it conceivable that the virus may exert local action in carotid atherosclerosis."
Clinica Medica Generale e Cardiologia, Department of Medical and Surgical Critical Care, University of Florence, Italy.
Reference
M Boddi, R Abbate, B Chellini, and others. Hepatitis C virus RNA localization in human carotid plaques. Journal of Clinical Virology 47(1): 72-75 (Abstract). January 2010.
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Canadian Safe-Injection Site to Remain Open
http://www.washingtonpost.com
By Jeremy Hainsworth
The Associated Press
VANCOUVER, British Columbia -- British Columbia's top court on Friday rejected an attempt by the Canadian government to close North America's first safe injection site for drug users.
The site, where people can inject illegal drugs with clean needles under a nurse's supervision, has operated since 2003 under a temporary exemption. It was opened as part of a harm-reduction plan to tackle an epidemic of HIV-AIDS and drug overdose deaths.
The exemption was scheduled to end in 2008, but a trial court allowed it to remain open. The Conservative government appealed Justice Ian Pitfield's ruling last year that allowed Insite, as the site is known, a constitutional exemption from Canadian drug laws.
In the May 2008 ruling, Pitfield said Insite - operated by the Portland Hotel Society in conjunction with the Vancouver Coastal Health Authority - provided important health care resources to addicts.
The British Columbia Court of Appeal rejected the federal government's bid to overturn the lower court's ruling that said Insite provided a needed medical service.
The three-member appeals court panel, which was split in its ruling, said Insite is a health facility and falls under provincial and not federal Canadian jurisdiction.
"Like palliative care, it is a form of harm reduction with benefits for both the patient and the community," said Justice Carol Huddart in the split decision. "The lure of safe injection gets those addicts into Insite so health care may be delivered."
David Thomas, a spokesman for Health Canada, said that while the federal government respects the court's decision, it is disappointed with the outcome.
Thomas said the government is reviewing the decision carefully. He did not indicate whether the government planned to appeal to the Supreme Court of Canada.
"Until this review is complete, it would be inappropriate to speculate on future action on the part of the Government of Canada," said Thomas.
Insite spokesman Mark Townsend said the ruling means "chronic addiction is not a death sentence."
Insite sits in the middle of Vancouver's notoriously squalid Downtown Eastside, a neighborhood riddled with addicts, prostitutes and people carrying conditions such as HIV-AIDS and hepatitis C.
Insite opened in September 2003 under the approval of the former federal Liberal Party government. That approval made it exempt from drug possession and trafficking laws.
Dr. Julio Montaner, director of the B.C. Centre for Excellence in HIV-AIDS, said the decision sends a clear message that Prime Minister Stephen Harper should abandon "his draconian, ideologically motivated public health policy-making."
Montaner, who is also president of the International AIDS Society, said he has had discussions with officials in Montreal, Toronto, Victoria, B.C., and San Francisco about opening clinics modeled after Insite.
"There is tremendous interest in a number of cities around the world based on the fact that not only have we piloted this initiative but the supervised injection site is the best studied in the world," he said.
Insite supervises about 500 injections a day. Addicts shoot up at 12 booths with mirrors on the walls so nurses on a raised platform can see them.
There have been about 1,200 overdoes since Insite opened. No one has died.
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Adding Ketoprofen to Treatment for Chronic Hepatitis C: A Phase II Study
http://www.physorg.com
The current standard treatment for chronic hepatitis C with pegylated-interferon (PEG-IFN) and ribavirin is effective in approximately 50%-60% of patients, so that a substantial proportion of patients remain unresponsive. A rational approach to develop alternative therapeutic strategies for patients with chronic hepatitis C virus (HCV) infection demands a detailed knowledge of how the different drugs affect viral kinetics and IFN intracellular signaling. Non-steroidal antiinflammatory drugs (NSAIDs) have been demonstrated to amplify the IFN signaling pathways and to enhance the anti-viral effect of IFN.
Based on previous data, a research team from Italy evaluated the safety of adding ketoprofen to pegylated-interferon (PEG-IFN) with or without ribavirin and the effect on viral kinetics, signal transducer and activator of transcription 1 (STAT1) activity and expression of 2'-5'-oligoadenylate synthetase (2'-5'OAS) in genotype 1 chronic hepatitis C in a phase Ⅱ study. Their study will be published on December 21, 2009 in the World Journal of Gastroenterology.
Their research found that the addition of ketoprofen to the conventional combination therapy is associated with better viral kinetics and early activation of the IFNa signaling pathway, thus improving virological response rates. The authors postulated that a larger trial should be done with this three-drug combination, compared to the standard of care.
More information:
Gramenzi A, Cursaro C, Margotti M, Balsano C, Spaziani A, Anticoli S, Loggi E, Salerno M, Galli S, Furlini G, Bernardi M, Andreone P. Ketoprofen, peginterferon 2a and ribavirin for genotype 1 chronic hepatitis C: A phase II study. World J Gastroenterol 2009; 15(47): 5946-5952 http://www.wjgnet.com/1007-9327/15/5946.asp
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