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Week Ending: February 5th, 2005
Alan Franciscus
Editor-in-Chief
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This Issue:
• Commission Sides with Fired Restaurant Staffer
• Inmate Head: Tattoos No Luxury
• Texas Troubadour Facing the Music
• Joslin Diabetes Center Scientists Discover 'Master Switch' that Triggers Insulin Resistance and Type 2 Diabetes; Salicylate Blocks the Inflammatory Cascade
• First Viruses Added to Cancer List
• The Perils of Needles to the Body
• Nationwide Hep C Study Launched
• B.C. Patient Access to Critical Hepatitis C Treatment Stalled: Province Slow to Act on Common Drug Review Formulary Recommendations
• Anadys Initiates Phase I Clinical Trial of Oral Prodrug for Hepatitis C
• Pegasys Combination Therapy Approved for the Treatment of Hepatitis C and HIV Co-Infection in Europe
• Letters Sent
• Hepatitis Fear Over Infected Worker
January 29th, 2005
Commission Sides with Fired Restaurant Staffer
SourceURL:http://www.canada.com/
Broadcast News
The Manitoba Human Rights Commission says a Brandon restaurant was wrong to fire an employee when she told the boss she had Hepatitis C.
The restaurant fired the woman in 2001, even though a public health nurse visited the restaurant and explained the disease.
Hepatitis C is transmitted when people share blood or body fluids and cannot be spread through day-to-day contact.
The commission ordered the restaurant to pay the woman two-thousand dollars.
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January 30th, 2005
Inmate Head: Tattoos No Luxury
SourceURL:http://www.abbynews.com
By CHERYL WIERDA
Abbotsford News
Inmates at Matsqui Institution are welcoming a pilot tattoo project that is intended to reduce the high rates of HIV and Hepatitis C in prisons.
"The inmates' feelings are pretty good," said inmate committee chairman Bobby Ross, who sat in on an information session about the pilot project last week.
At Matsqui, home to approximately 270 offenders, "almost half" of the population is infected with Hep C, and Ross welcomes anything to minimize the risk of spreading the disease.
Ross has been an advocate for harm-reduction measures in the prison, including safe tattooing.
In addition to the effect on infection rates the project is hoped to have, Ross points to the "residual effects" of the pilot program.
If caught with tattoo paraphernalia, inmates are charged and fined.
Ross said the program will cut down on the charges and help keep inmates on track with their correctional plan.
While Abbotsford MP Randy White feels efforts would be better spent dealing with drug issues, rather than cleaning up illegal tattooing, Ross said tattooing is more prevalent.
"There's more tattoos than intravenous drug users," Ross said.
"They (intravenous drug users) are now kinda looked on as society looks at smokers.
"They're a small group and getting much smaller," he said, noting "almost everybody" has a tattoo.
He feels that many inmates will take advantage of the program, rather than continuing with illegal tattooing.
Illegal tattooing requires a "six" man (someone to keep watch), inmates need to get the materials for the tattoo on the black market and there are the dangers of dealing with an unscrupulous tattoo artist, Ross said.
Add that to the penalties of being caught, and Ross feels that the tattoo project will be used.
He counters criticism over the inmates being provided a "luxury" and the low price of the tattooing - $5 per two-hour session.
"We want to keep it in perspective," Ross said.
"I clear $53 a pay period."
His monthly pay is just over $100, whereas Ross notes the "average guy in the street" makes about $100 per day.
As well, many tattoos can't be done in two hours; the artwork on his back took 40 hours to create.
Despite the cost, "I can foresee a ton of requests coming in for tattoos," he said.
Training for the pilot project is under way and an officer has been hired to oversee the program, which officially begins April 1.
Matsqui is one of six prisons piloting the program.
Fraser Valley Institution, also in Abbotsford, is another.
The female inmates there want to learn more about the program before commenting.
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Texas Troubadour Facing the Music
SourceURL:http://www.suntimes.com
MARY HOULIHAN Staff Reporter
Nearly four years ago, Alejandro Escovedo celebrated the release of his album, "The Man Under the Influence," with a four-night, multi-club event in Chicago. On April 25, 2001, the Texas singer-songwriter began the series of sold-out shows with an intimate performance at the Hideout. In a room lit only by dozens of candles, he solidified his status as a Chicago favorite and one of the more creative artists to come out of Austin.
Escovedo continued to ride this wave of creativity and critical success until 2003, when, during that same week in April, writing, recording and touring were put on hold when he collapsed after a performance in Phoenix. Rushed to a local hospital, he was diagnosed with cirrhosis of the liver caused by hepatitis C.
The past 20 months have been a test for Escovedo. For the first time since he picked up a guitar and joined a rock 'n' roll band, the accomplished Texas troubadour faced life without the music that has been a large part of his complex existence for three decades. From that day forward, everything changed for the soft-spoken singer-songwriter, who says he looks at life differently now.
"If that hadn't happened to me, I'd be on the same trip," said Escovedo, in a phone interview from his home outside San Antonio. "But everything was taken away. I had a chance to finally look at what I had accomplished and where I was going and what was possible if I survived this whole thing."
Escovedo embarked on an intense treatment, a caustic combination of interferon and ribavirin, which "really messes you up." He stopped taking the drugs about six months ago and, in recent months, has performed once a month in or around Austin, including Willie Nelson's tsunami benefit.
While Escovedo may be ready to perform on a limited basis, he admits he's not sure about touring. He's testing the waters with three shows next weekend in Chicago, his only scheduled performances outside Texas. Unfortunately for his legions of die-hard fans, the performances, one at FitzGerald's and two at the Old Town School of Folk Music, quickly sold out.
Chicago has long been Escovedo's second home. He has recorded for the locally based roots label Bloodshot Records and has built a solid fan base performing at a variety of clubs over the past decade. He is among a group of singer-songwriters (Billy Joe Shaver, Joe Ely, Jimmie Dale Gilmore, Slaid Cleaves) who have blazed a well-worn trail between Austin and Chicago.
"I think he appreciates what Chicago has to offer," said Bill FitzGerald, who has booked Escovedo into his Berwyn roadhouse many times. "He knows audiences here are sophisticated. When he plays a club, he creates these singular, intimate moments, and I think that's what gets to people."
Nan Warshaw, co-founder of Bloodshot, agrees: "Alejandro's live shows are always so intense. The songs are beautiful and dark and the shows are incredibly dynamic -- from sweet, intimate orchestral pieces to all-out gritty punk rock. Once you experience them, you become a fan forever."
'Music was everywhere'
Over the years, Escovedo, 54, gained notice for his work with a number of punk and roots-rock bands. When he finally went solo in the early '90s, he forged an eclectic musical style, from hard-core rock to cello-enhanced quartet to thoughtful musical theater ("By the Hands of the Father"). At moments, it seemed he was making up for lost time.
Escovedo, the seventh of 12 children in a musical family, didn't pick up a guitar until he was 24. His father sang in mariachi and swing bands; six of his brothers had varied success on the Latin jazz and rock scenes. When Escovedo was 8, the family relocated to Southern California. Music wasn't on his mind then; he wanted to be a baseball player.
But music was everywhere in his life, and eventually Escovedo took notice. "I was very lucky," he said. "My formative years were spent in California when the '60s hit, and all this great music was everywhere. I had a wonderful music education that I wouldn't trade for anything. I had my brothers to turn me on to things like jazz and Latin music, and from my father I learned about Mexican music and country music."
The trail to Escovedo's success stretched through a legendary series of bands. The first, the Nuns, was a scrappy quartet that became a driving force on the West Coast punk scene. "We knew the music had to be something angry and loud because that was the whole purpose of us being a band," said Escovedo, laughing.
On a tour of the East Coast with the Nuns, Escovedo left the band when he became enamored with the Manhattan art-rock scene. It was a heady time for the young artist, who was meeting people like Andy Warhol, Brian Eno, John Cale and David Johansen. For a short while, he played in a band with the singer Judy Nylon, until he got a call from Chip Kinman, formerly of the Dils, who, along with his brother Tony, was interested in starting a new band. Escovedo signed on and the cowpunk group Rank and File was born.
A cross-country tour with a stop in Texas reacquainted him with the town that would become his new musical home: "We went through Austin and that's how I got back in touch with my Texas roots," said Escovedo. "Austin was beautiful because you'd go to someone's house for a party and there was always a guitar and someone would hand it to you. Well, I wasn't used to that because in punk rock there weren't sing-alongs. Suddenly, I was naked with only an acoustic guitar; I didn't have the amp and the feedback to hide behind. I pretty much just had to sing the song, and that was my education into songwriting."
As time went on, Rank and File's focus increasingly turned to the Kinman brothers, sidelining Escovedo's songwriting. He faced an emotional hurdle when he decided to leave the band, which was gaining notice alongside bands like the Blasters and the Long Ryders.
But Escovedo already had his eye on another prize. Hooking up with his brother Javier, he started the True Believers, arguably the best rock band ever born out of the eclectic mix of music found in Austin and the one that would gain him national notice. The band's self-titled 1985 album received rave reviews, but after EMI refused to release a second disc, the band folded in 1988, but not before many memorable nights of rock 'n' roll.
If you had told Nuns-era Escovedo that one day he would have a cello, viola and tuba in his band, he would have thought you loco. But that's exactly what happened when he finally embarked on a solo career that resulted in a series of sophisticated albums that incorporated small-string arrangements into a roots-rock context. He called the band the Alejandro Escovedo Orchestra.
But Escovedo admits he was "scared to death" about embarking on a solo career.
"I remember playing a benefit where I was on the verge of running out when they announced me and I had to get up there," Escovedo said with a soft laugh. "But then shortly after that, I met Chris Knight and J.D. Foster and we started the orchestra, which changed the direction of my songwriting."
Suddenly, Escovedo had a lot of freedom. He took songs and put them in completely different formats with horns, strings and percussion. The orchestra was a sprawling collective, often featuring Austin's musical elite sitting in. "I had all these wonderful musicians who loved playing and it just grew into this beautiful thing," said Escovedo. "Before it was all about the lifestyle. Now the music was the turn-on. It's been a wonderful musical journey."
'One day at a time'
As a solo artist, Escovedo, has made 10 albums, the high point being No. 9, "A Man Under the Influence." He still refers to his band as the orchestra but it's not as quirky, now more of a sturdy rock band with a touch of strings. Members for the Chicago shows are Jon Dee Graham (guitar), Brian Standefer (cello), Susan Voelz (violin), Hector Munoz (drums), Andrew Duplantis (bass) and Bruce Salmon (keyboards).
During his treatment and recovery period, Escovedo had little interest in songwriting. However, along with his fourth wife Kim Christoff, he did manage to create the soundtrack for the indie film "Robbing Peter" and to write a song for the soundtrack of "The Manchurian Candidate" remake. Now he's working on new material, some of which he hopes to perform in Chicago.
Fans were stunned by Escovedo's sudden absence from the musical picture, but they did not forget. Like many musicians, Escovedo had no health insurance, and benefit concerts were held around the country, including two in Chicago organized by Bloodshot Records. And "Por Vida," a CD featuring Escovedo's music sung by many new and old friends, also generated funds.
These were gestures that Escovedo says he will never forget: "It really isn't even about money. It's about how much people care, and that in itself is a great, great, great benefit."
Asked about the future, Escovedo pauses and admits he has no sure answer to the question.
"Writing and performing have been a part of my life for so many years and I've missed them dearly," he said. "But now it's one day at a time, one gig at a time. And we'll see what happens after that."
THE EVOLUTION OF ESCOVEDO
Few fans can claim to have seen Alejandro Escovedo in all his incarnations. Here the singer-songwriter comments on the bands that sustained him over the years:
The Nuns: "We just wanted to make noise and told club owners that we had this huge following when we really hadn't even played a real gig. So we handed out tickets to all the interesting characters in North Beach [San Francisco] and our audience became all the strippers, the transvestites, all the free poets and artists. But to be honest, the Nuns were a pretty horrible band. I don't think I would be alive if I had stayed with it for much longer. But that band did get me started."
Rank and The True Believers: "It was like playing with Mott the Hoople, the New York Dolls and the Band all at once. It was fun and debauched rock 'n' roll, and a hell of a band on most nights. Those were great times. But we wore ourselves out touring."
The Alejandro Escovedo Orchestra: "That was a revolving door, more like a workshop. We'd put the word out about a gig and whoever was around would show up. Sometimes there would be five people, sometimes 15, but always a weird array of instruments, and we'd just improvise. It was quite a sight. I developed the best music of my career with this group."
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Joslin Diabetes Center Scientists Discover 'Master Switch' that Triggers Insulin Resistance and Type 2 Diabetes; Salicylate Blocks the Inflammatory Cascade
SourceURL:http://home.businesswire.com
BOSTON--(BUSINESS WIRE)--Jan. 30, 2005--Scientists at Joslin Diabetes Center have discovered why excess weight leads to low-grade inflammation, which hampers the body's ability to use insulin. They found that the "master switch" of this inflammation is activated in the liver by weight gain. And they showed it can be turned off by salicylates, a class of drugs that includes aspirin.
The Joslin study, published in the February edition of Nature Medicine, is a major milestone in understanding why being overweight can lead to a host of health problems, including type 2 diabetes and heart disease. An estimated 18 million Americans have type 2 diabetes, including an increasing number of young people. They are two to four times more likely to have cardiovascular disease.
"We zeroed in on a factor called NF-kB," said principal investigator Steven E. Shoelson, M.D., Ph.D., Helen and Morton Adler Chair and head of the Section on Cellular and Molecular Physiology at Joslin, and Professor of Medicine at Harvard Medicine School. Other researchers included Dongsheng Cai, M.D., Ph.D., Minsheng Yuan, Daniel F. Frantz, Peter A. Melendez, Lone Hansen and Jongsoon Lee. This study was funded by the National Institutes of Health and the American Diabetes Association.
"When we activated this factor in the liver of laboratory animals, it stimulated a cascade of inflammatory responses," said Dr. Shoelson. "The result was dramatic -- including insulin resistance consistent with type 2 diabetes.
"We previously knew that in obesity, the liver becomes fatty and that it accumulates fat faster than other organs and tissues," Dr. Shoelson continued. "But until now, we didn't know fat in the liver could orchestrate the entire inflammatory process that results in insulin resistance, both locally and throughout the body."
The researchers were inspired by previous clinical studies of human patients at Joslin, driving them to seek answers in the laboratory. Those studies had shown that overweight people who have insulin resistance had slightly higher activity levels of NF-kB and other substances normally found in inflammation. Intrigued that fatty tissue may activate a small but measurable level of inflammation, they set out to discover the cellular pathway.
They focused on healthy lean mice -- with no weight problems predisposing them to type 2 diabetes. Using genetic techniques, the research team turned on the gene that expresses NF-kB. They then measured the insulin levels in the bloodstream; if higher than normal, it's a telltale sign of insulin resistance because the body is not using the available insulin. They also measured blood glucose levels to see if they were higher, consistent with diabetes. And they looked for substances produced along the inflammation pathway.
"Unlike in an acute infection, when NF-kB levels shoot up about 50-fold, the inflammation seen in these mice just simmered -- only about 3-fold," said Dr. Shoelson. "But their insulin levels and blood glucose levels were high, what we'd expect in type 2 diabetes. In effect, we had induced diabetes by turning on low-grade inflammation." Among the markers in the cascade was C-reactive protein, now the focus of considerable interest in cardiovascular research.
The Joslin researchers also found that the NF-kB "master switch" could be inhibited by the salicylate family of drugs. "These drugs -- among the safest drugs known -- can do a surprisingly good job of toning down this inflammation," said Dr. Shoelson.
"But more studies need to be done before we can make recommendations to patients," he cautions. "For now, the best advice for preventing the onset of type 2 diabetes is to shed those extra pounds, eat a healthy diet and exercise regularly."
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January 31st, 2005
First Viruses Added to Cancer List
SourceURL:http://www.cbsnews.com
WASHINGTON
The U.S. government on Monday added 17 substances to the official list of cancer-causing agents, including the first viruses: hepatitis B and C and some human papillomaviruses that cause common sexually transmitted diseases.
Lead and lead compounds, X-rays, compounds found in grilled meats and various substances used in textile dyes, paints and inks are among the other new listings, the Department of Health and Human Services said in releasing the 11th edition of the federal Report on Carcinogens.
The additions bring to 246 the total number of substances that either are "known to be human carcinogens" or "reasonably anticipated to be human carcinogens." The report now lists 58 "known" — including the viruses — and 188 "reasonably anticipated" substances.
Hepatitis B and C, which cause liver disease, were added because studies in humans show that chronic infections cause liver cancer. Some of the human papillomaviruses, which are sexually transmitted, were included because studies show they cause cervical cancer in women, the department said.
Federal law requires the HHS secretary to publish the report every two years.
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February 1st, 2005
The Perils of Needles to the Body
SourceURL:http://www.goupstate.com
By LORRAINE KREAHLING
New York Times
At a tattoo and piercing parlor on St. Mark's Place in Manhattan recently, Young-Cho, an experienced tattoo artist, applied a small winged horse to Mara Fallon's shoulder.
He dipped his buzzing instrument into a small plastic cup of blue ink and then appeared to draw with the electric needle on Ms. Fallon's shoulder.
"It feels like when you pull hairs out when you rip off a Band-Aid," she said.
In another cubicle, Tino, a piercer, disinfected the skin on a young woman's abdomen and marked two dots on either side of her navel. He held her flesh with forceps and pierced the marks with a hollow needle, then threaded a surgical steel rod through the four holes and attached two small steel spheres to each end, making the jewelry into a tiny barbell.
Tattoos and body piercings have become so common that they hardly attract notice. One recent study of 7,960 college students in Texas found that one in five had at least one tattoo or piercing of a body part other than the earlobe.
But health officials say they are increasingly worried about the health risks posed by such body modification practices, including physical disfigurement and bacterial and viral infections, and not only from needles that draw blood in potentially unsanitary conditions.
The primary concern is infection with blood-borne pathogens like HIV and the C and B forms of the hepatitis virus. But doctors say that tongue and genital piercings can also provide channels for bacteria and viruses to enter the bloodstream after the piercing procedure. Bacteria that live on the skin, including some penicillin-resistant forms of staphylococcus, are easily spread by unsterilized instruments or ungloved hands. And bacterial infections - or the body's reaction to the insertion of a foreign object - can cause deformities at piercing sites.
Last month, Senator Charles E. Schumer, Democrat of New York, joined with health officials from Long Island to express concern over a growing number of hepatitis C cases, linking the increase in part to body piercings and tattoos. The potentially fatal virus can live in the body for decades without symptoms.
Studies have not conclusively demonstrated a connection between body modification and hepatitis C. The Texas study, sponsored by the Centers for Disease Control and Prevention, found that college students with piercings, tattoos or both were no more likely than other students to have been exposed to the hepatitis C virus. But an earlier study reported that of 626 patients at an orthopedic clinic, those with tattoos were seven to eight times as likely to have subclinical hepatitis C infections.
"Regardless of whether or not we can demonstrate that bacteria or viruses are spread in this manner, anything that pierces the skin and has blood on it can potentially spread an infection," said Dr. Miriam Alter, associate director for science at the CDC's division of viral hepatitis and the agency's lead scientist on the Texas study. "The moment you pierce the skin barrier, there is risk for transmission of a disease."
Licensing requirements for tattoo and piercing establishments, the growth of professional organizations for practitioners and the growing sophistication of Internet-educated consumers have increased safety. Most people who seek tattoos know that they should see the artist remove a new needle and tube setup from sealed plastic and that fresh ink from disposable containers should be used.
But Dr. David Graham, director of public health for the Suffolk County, said that it was impossible to police everyone.
"There will always be someone driven by profit who will avoid regulatory guidelines and licensing fees," he said. And even establishments that use fresh needles and surgical gloves, spray disinfectants and heat-sterilizing autoclaves are of concern, scientists say.
It is estimated that 1 piercing in 10 becomes infected. Staphylococcus bacteria, which can live on the skin and in the nose, is a frequent cause, said Dr. Scott Hammer, professor of medicine at Columbia College of Physicians and Surgeons.
"If you disinfect the surface of the skin, but use a forceps that has not been sterilized, you are risking spreading infection," Dr. Hammer said.
"You don't need a puncture; you only need an abrasion for the organism to cause an infection."
People who have piercings should also be aware that a penicillin-resistant strain of the bacterium Staphylococcus aureus has cropped up in the last two years, Dr. Hammer said. Once rarely seen outside medical settings, the strain recently has been traced to group settings like sports and fitness clubs and military barracks.
In Oregon, new laws regulating piercings were drafted in response to an outbreak of an antibiotic resistant strain of the bacterium Pseudomonas aeruginosa in ear cartilage. Health officials traced it to a piercing gun at a jewelry kiosk. Four people were hospitalized; permanent ear deformities, including the removal of ear cartilage, resulted.
Experts warn that such infections are more common - and more difficult to treat - in ear cartilage because of its limited blood supply. They also advise against the use of piercing guns that crush flesh rather than lacerate it and that cannot be properly sterilized.
Unlike most tattoos, which scab over and heal in one to two weeks, piercings can pose problems in the long haul. Nipple piercings that go too deep have damaged tissue and led to problems in breast-feeding after the jewelry was removed.
Stud earrings can become embedded in nipples, navels or elsewhere when the body tries to "heal over" the piercing site. Clothing can catch on navel jewelry, causing irritation, infections and tears.
Keloids, the overgrowth of scar tissue, can also cause disfigurement, including tumorlike growths.
Some styles of mouth and genital piercing carry other dangers. Dr. Jay Gohel, a dentist at the Smile Institute in Manhattan, said tongue rings could cause trauma and breakage of the upper teeth, including the lingual cuspids and molars.
"Every time you move the tongue it's banging on the teeth," Dr. Gohel said. "It's like tapping on glass over and over again. It finally breaks."
He said he had restored several teeth broken in this way.
Dr. Gohel and other experts have also seen infections from tongue piercings. One study reported on the case of a 25-year-old man with a potentially fatal disease of the heart's inner lining that was traced to his tongue piercing. Many people use antibiotics as a preventive measure before dental surgery because of congenital heart disease, heart defects or repaired heart valves. Dr. Nieca Goldberg, chief of women's cardiac care at Lenox Hill Hospital in New York, said that people in high-risk categories might not realize that they should also take protective medication before piercings.
"You may think of a piercing as cosmetic, but if you have mitral valve prolapse, a heart murmur or other conditions that require antibiotics before dentistry, you should be treating a piercing the same way," Dr. Goldberg said.
Many middle-aged doctors seem unaware that tongue and genital piercing are often done for additional stimulation in sex, oral sex in particular. Genital piercings not only run the risk of tearing condoms, but they may also tear or abrade the flesh during sexual intercourse, allowing disease transmission through blood or other body fluids.
While most piercings will close up or leave minimal scarring over time once jewelry is taken out, tattoo removal is often costly and painful. At the Skin Institute of New York, removing a tattoo takes 6 to 10 sessions, at a cost of $300 to $800 each, said Dr. Lance H. Brown, clinical assistant professor of dermatology at the New York University School of Medicine.
He uses a Q-switch laser to break down the pigment in the tattoo ink. The switch allows him to adjust the laser wavelength to match the wavelength of the pigment he is attacking. "The laser explodes particles of ink, then the body's macrophages come and essentially eat up the debris," Dr. Brown said. The sessions stretch over weeks because the body can only absorb so much waste at one time.
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February 2nd, 2005
Nationwide Hep C Study Launched
Australian Associated Press
Hepatitis C virus researchers are asking people with HCV to enroll in a large Australia-wide study to improve treatment of the disease. Eighty-five percent of people with hepatitis C could be cured if treatment were begun early enough, said Dr. Stephen Pianko, a liver specialist at Melbourne's Alfred Hospital. However, people with genotype 3 tend to have higher viral concentrations, and only about 70 percent can be cured. About 38 percent of Australians with HCV have genotype 3.
The trial will enroll 624 participants from 30 sites across Australia. Its aim is to improve the cure rate among patients with HCV genotype 3 by increasing the treatment time from 24 weeks to 48 weeks, said Pianko. "We believe that by extending treatment we may be able to push those cure rates up from 70 percent back to that 85 percent that the overall group can expect," said Pianko.
"There is treatment and they really should seek it," said Pianko, encouraging people with HCV to volunteer for the study. "In the next 10 years we believe that the number of patients dying of liver failure and liver cancer is going to double and it's a major public health problem," he said.
In Australia, 150,000 people have chronic HCV infections and 14,000 are newly infected each year.
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B.C. Patient Access to Critical Hepatitis C Treatment Stalled: Province Slow to Act on Common Drug Review Formulary Recommendations
Source: http://groups.yahoo.com/group/hepcan/
VANCOUVER, Feb. 2 /CNW/ - Today the B.C. hepatitis C community is calling on Health Minister Shirley Bond to directly intervene to provide immediate access to the latest hepatitis C treatment, Pegasys(R) RBV(TM) (PEGASYS(R) (peginterferon alfa-2a) in combination with COPEGUS(R) (ribavirin)).
The new treatment is now available in Ontario, Alberta, Saskatchewan, and Nova Scotia and, in February, in Quebec. The federal drug plans and 90 per cent of private payers also fund the treatment.
Unlike cancer or HIV patients, most hepatitis C patients have only one chance at therapy, so it is very important that the treatment provided is best suited to their specific situation. While some patients may do well on the existing interferon combination therapy, the clinical evidence supports choosing Pegasys RBV for others. Clinical studies show that Pegasys RBV has improved sustained viral response rates (SVR) in all patient sub-groups, especially in the most difficult-to-treat group (genotype 1/high viral load patients) over the currently reimbursed comparator. Without provincial approval for Pegasys RBV, some patients, especially those with cirrhosis or advanced fibrosis, do not have access to the best option for treatment.
"Why is B.C. the only major province where some hepatitis C patients must choose between two undesirable options: accepting a treatment that their physician considers to be less than optimal; or waiting for access to the best option but risking increased liver damage, which will reduce their chances of clearing the virus?" asked Ken Thomson, of the B.C. Hepatitis C Collaborative Circle.
Health Canada approved Pegasys RBV for the treatment of adults with chronic hepatitis C including those with compensated cirrhosis in May 2004. In October 2004, the Common Drug Review (the interprovincial body that reviews drugs for funding) concluded the treatment was effective and cost-effective and should be included in the provincial drug plans.
B.C. Urged to Follow Lead of Other Provinces
In B.C. there are 44,000 people with a positive hepatitis C diagnosis, and it is estimated that when those who have yet to be diagnosed are included, the number is as high as 65,000, the highest rate in Canada.
Treatment is extremely cost-effective; every dollar invested in treatment returns $4 in healthcare savings. With the new combination therapy, up to 80 per cent of those treated can eliminate the virus from their body.
About one-third of untreated patients will progress to end-stage liver disease and most others will suffer irreparable damage to their health. Because Pegasys RBV represents no increase in cost of treatment, the delay in providing provincial fund is inexcusable.
"In some cases, physicians and patients have been delaying start of treatment for years, anticipating approval for Pegasys RBV, putting patients at risk for progressive damage to their liver. Time, patience, and hope are running out for these patients. Could someone please clarify why it takes the bureaucracy in B.C. so much longer than its counterparts in other provinces to list a new treatment, especially after the drug has already been recommended by the Common Drug Review?" asked Dr. Durhane Wong-Rieger of the Canadian Hepatitis C Network.
The hepatitis C community is appealing directly to Minister Bond to live up to her own January 28 statement to the Vancouver Sun that "the best way for provincial drug plans to deal with them (newly approved drugs) is to abide by the rulings of the Common Drug Review." Hepatitis C patients in B.C. deserve the same standard of care as those in the rest of Canada.
For further information: or an interview, please contact: Dr. Durhane Wong-Rieger, Canadian Hepatitis C Network, Cell: (647) 221-5176
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Anadys Initiates Phase I Clinical Trial of Oral Prodrug for Hepatitis C
SourceURL:http://news.yahoo.com/
Local - San Diego Daily Transcript
Anadys Pharmaceuticals Inc. (Nasdaq: ANDS) announced Wednesday that it has initiated a Phase I clinical trial of a drug that has the potential to become an orally administered frontline treatment for chronic hepatitis C patients by activating innate immunity.
The trial will be conducted on ANA975, an oral prodrug of Anadys' proprietary small molecule compound isatoribine. Anadys said results from clinical trials of isatoribine have demonstrated a statistically significant viral load reduction in hepatitis C patients by activating innate immunity.
"We expect that ANA975 will provide the same combination of anti-viral effect and tolerability as observed with isatoribine, but with the added advantage of oral administration," said Steve Worland, Ph.D., Anadys' executive vice president of Research and Development, in a written statement.
The company said the Phase I clinical trial is designed to evaluate the safety, tolerability and pharmacokinetics of ANA975 in healthy volunteers. The study is an open-label, ascending single-dose evaluation of ANA975 to be administered orally to a total of 18 subjects in three cohorts at 400 mg, 800 mg and 1,200 mg doses. The trial is being conducted in the United Kingdom.
Anadys is a biopharmaceutical company committed to advancing patient care by discovering, developing and commercializing novel small molecule medicines for the treatment of hepatitis C virus (HCV), hepatitis B virus (HBV) and bacterial infections.
Anadys shares were at $8.37, down 14 cents, during midday trading on Wednesday.
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February 3rd, 2005
Pegasys Combination Therapy Approved for the Treatment of Hepatitis C and HIV Co-Infection in Europe
Source: www.roche.com
Pegasys becomes the first and only approved hepatitis C treatment in Europe for patients suffering from both hepatitis C and HIV
Roche announced today that the European Medicines Agency (EMEA) has approved Pegasys – (peginterferon alfa-2a) and ribavirin for the treatment of chronic hepatitis C (HCV) in clinically stable patients co-infected with HIV. This European Commission Decision comes only one month after the Positive Opinion was granted by the European Medicines Agency (EMEA), and Pegasys combination therapy is now the first hepatitis C treatment to be indicated in HIV-HCV co-infected patients in the European Union.
Roche submitted a file with the FDA in August 2004 for an indication for Pegasys and Copegus (ribavirin, USP) for the treatment of chronic hepatitis C in patients co-infected with HIV. The file has been granted priority review by the FDA because the indication would address an important unmet medical need.
It is estimated that 30 percent of people infected with HIV are also co-infected with hepatitis C. Currently, no HCV therapies have been approved in the U.S. for the treatment of chronic hepatitis C in co-infected patients.
The European approval and U.S. file are based on the findings from APRICOT (AIDS Pegasys Ribavirin International Co-infection Trial), the largest study conducted to date evaluating chronic hepatitis C. The safety and efficacy findings from this study can only be applied to Pegasys and Copegus.
“Given the unique and complex medical challenges that people with HIV face, making evidence-based treatment decisions for this population is particularly important. Roche is dedicated to continuing its hepatitis C research to provide data to better guide treatment decisions for patients, particularly those with unmet needs,” said Juan Carlos Lopez-Talavera, M.D., Ph.D., Senior Medical Director, Roche.
Facts About Pegasys (Peginterferon alfa-2a) in Combination with Copegus
Indication
Pegasys®, a pegylated alpha interferon, alone or in combination with Copegus® (ribavirin, USP) is indicated for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A).
Dosing and Administration
Pegasys, a premixed solution, is dosed at 180mcg as a subcutaneous injection once a week. Copegus, available as a 200mg tablet, is administered at 800 to 1200mg taken twice daily as a split dose. The two products are sold separately.
Combination Therapy Clinical Studies
The two combination therapy pivotal study findings:
Study 5, published in the March 2, 2004 Annals of Internal Medicine, including 1,284 patients receiving medication, showed that patients with certain genotypes (strains) of the hepatitis C virus should be treated with different dosing regimens of Pegasys and Copegus. The treatment regimens and resulting sustained virological response rates for these groups treated with Pegasys and Copegus therapy were:
Genotype 1: 48 week duration with 1000 – 1200mg Copegus: 51 percent
Genotype non-1: 24 week duration with 800mg Copegus: 82 percent
Study 4, published in the September 26, 2002 New England Journal of Medicine, including 1,121 patients receiving medication, showed that Pegasys and Copegus combination therapy is a more effective treatment for chronic hepatitis C than interferon alfa-2b and ribavirin. The sustained virological response rate in the Pegasys and Copegus treated patients was 53 percent compared to 44 percent in the interferon alfa-2b and ribavirin group. Sustained virological response refers to a patient’s continued undetectable serum hepatitis C RNA levels 24 weeks after finishing a course of treatment.
Adverse Events
Alpha interferons, including Pegasys, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping Pegasys therapy (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE EVENTS in complete product information).
Use with Ribavirin. Ribavirin, including Copegus may cause birth defects and/or death of the fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease. Ribavirin is genotoxic, mutagenic, and should be considered a potential carcinogen (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE EVENTS in complete product information).
Pegasys is contraindicated in patients with hypersensitivity to Pegasys or any of its components, autoimmune hepatitis, and decompensated hepatic disease (Child-Pugh class B and C) before or during treatment with Pegasys. Pegasys is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol has been reported to be associated with an increased incidence of neurological and other complications in neonates and infants, which are sometimes fatal. Pegasys and Copegus therapy is additionally contraindicated in patients with a hypersensitivity to Copegus or any of its components, women who are pregnant, men whose female partners are pregnant, and patients with hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).
COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO INITIATION OF THERAPY. Women of childbearing potential and men must use two forms of effective contraception during treatment and during the six months after treatment has concluded. Routine monthly pregnancy test must be performed during this time. If pregnancy should occur during treatment or during six months post-therapy, the patient must be advised of the significant teratogenic risk of Copegus therapy to the fetus. Physicians and patients are strongly encouraged to report any pregnancies that do occur to Roche by calling 1-800-526-6367.
The most common adverse events reported for Pegasys and Copegus combination therapy, observed in clinical trials (n=451), were fatigue/asthenia (65%), headache (43%), pyrexia (41%), myalgia (40%), irritability/anxiety/nervousness (33%), insomnia (30%), alopecia (28%), neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia (24%), injection site reaction (23%), arthralgia (22%), depression (20%), pruritus (19%) and dermatitis (16%).
Serious adverse events include neuropsychiatric disorders (suicidal ideation and suicide attempt), serious and severe bacterial infections, bone marrow toxicity (cytopenia and rarely, aplastic anemia), cardiovascular disorders (hypertension, arrhythmias and myocardial infarction), hypersensitivity (including anaphylaxis), endocrine disorders (including thyroid disorders and diabetes mellitus), autoimmune disorders (including psoriasis and lupus), pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis), colitis (ulcerative and hemorrhagic/ischemiccolitis), pancreatitis, and opthalmologic disorders (decrease or loss of vision, retinopathy including macular edema and retinal thrombosis/hemorrhages, optic neuritis and papilledema).
The complete package inserts for Pegasys and Copegus are available at www.pegasys.com, or by calling 1-877-PEGASYS.
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Letters Sent
SourceURL:http://icayrshire.icnetwork.co.uk
LETTERS have been sent out to hundreds of women treated by a former health care worker who was found to have hepatitis C.
The ex-Ayrshire and Arran member of staff is believed to be a surgeon who worked in obstetrics and gynaecology at Ayrshire Central and Crosshouse Hospitals from May 21, 1990 to June 9, 1991.
Two years ago, 432 patients in Kent, Berkshire and Essex were tested as a precautionary measure following the discovery that the health professional had contracted hepatitis C.
No positive cases were found but a patient from outside the notified group now has the hepatitis C virus.
Former patients in Ayrshire and Arran are receiving information, advice, and the opportunity to have a blood test.
A telephone helpline has been set up on 0870 0501999.
Dr Maida Smellie, consultant in public health medicine, NHS Ayrshire & Arran, said: “Only certain operations carry an increased risk, such as Caesarian sections and hysterectomies.”
“I understand that this news may cause anxiety to some people, but I want to emphasise that the risk is very small, and that we are offering screening purely as a precaution.”
In virtually every case the hepatitis C virus is transmitted by blood-to-blood contact. Ordinary social contact does not pose a risk.
Hepatitis C is a virus. Some people who are infected with the virus may develop inflammation of the liver and any inflammation of this organ is known as hepatitis.
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Hepatitis Fear Over Infected Worker
SourceURL:http://icbirmingham.icnetwork.co.uk
Letters have been sent to more than 500 women treated at a Midland hospital after a health care worker was diagnosed with hepatitis C.
Bosses at Hereford Hospitals NHS Trust have issued warnings to patients who were treated in its obstetrics and gynaecology unit between 1988 and 1990.
The letter, sent out as a precautionary measure to 562 people, says that if the employee was infected at the time they were treated they only face a remote risk of developing the disease.
Some infected people can become carriers, which may lead to an increased lifetime risk of liver disease.
The letter asks patients to contact the hospital so staff can arrange for them to go for a blood test.
Hepatitis C can lead to inflammation of the liver but it often has no symptoms.
Peter Harper, medical director of Hereford Hospitals NHS Trust, said: "We do not know if the healthcare worker had the infection when he worked here back in the 1980s.
"It is difficult to pass hepatitis C from person to person and there are very few known cases where this has happened.
"In virtually every case the virus is transmitted by blood to blood contact, ordinary social contact does not pose a risk.
"Nevertheless we are offering screening as a precaution.
"I hope people will decide to take up this offer of a blood test to set their mind at rest."
Eight other NHS trusts across Britain are also involved in the incident and are working with the Health Protection Agency to review patient records. They are: St Helen's and Knowsley Hospital NHS Trust, in the Northwest; NHS Ayrshire and Arran, in Scotland; Mid Yorkshire Hospitals NHS Trust, in Yorkshire; North Middlesex University Hospital Trust and St George's Healthcare Trust, in London; Dartford and Gravesham NHS Trust and Medway NHS Trust, in Kent; and Luton and Dunstable Hospital Trust in Bedfordshire.
The Hereford Hospitals Trust has worked closely with the HPA and Herefordshire Primary Care Trust to identify anyone who may have been exposed to any risk.
Any patients who have not received a letter yet should be reassured that they are not part of this exercise, a spokesman said. n Anyone who has general concerns about hepatitis C can call NHS Direct on 08458 50 98 50 for information and advice
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