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News Review

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HCV ADVOCATE WEEKLY NEWS REVIEW:
A Review of HCV, HBV and HIV/HCV Coinfection Related News and Highlights

Week Ending: July 11, 2009

Alan Franciscus
Editor-in-Chief

To download pdf version click here
 

This Issue:

 

 

July 5, 2009


5,700 may be at risk for hepatitis C in Colorado due to medical tech
http://www.denverpost.com
By Joey Bunch
The Denver Post

A former technician may have exposed patients at RoseMedicalCenter and a Springs surgery facility.

A Rose Medical Center operating room technician who was fired after failing a drug test for a powerful pain medication may have exposed thousands of patients to hepatitis C.

The technician, infected with hepatitis C, is charged with swapping her used dirty syringes, refilled with saline solution, for ones containing the painkiller fentanyl.

Hospital officials said they knew the technician had the virus when she was hired. She began work Oct. 21, 2008. She was fired April 13.

Rose is offering free testing to all people who had surgery in the main hospital or the Wolf Building between those dates. Letters will be sent to more than 4,700 former patients. Maternity and emergency room patients are not affected.

Are you at risk?

  • Did you receive a letter alerting you that you may be at risk of hepatitis C?
  • Did you have surgery at Rose Medical Center between Oct. 21, 2008 and April 13, 2009?
  • Or were you a patient at the Audubon Ambulatory Surgery Center in Colorado Springs between May 4 and June 29?

Rose officials said the state health department had found nine former Rose patients who tested positive for hepatitis C.

Hospital officials stressed at a Thursday night news conference that the employee is not confirmed to be the source of the infection and the Colorado Department of Public Health and Environment is continuing its investigation.

Justice Department paperwork obtained by The Gazette newspaper in Colorado Springs identified the technician as Kristen Diane Parker, 26, of Colorado Springs. She is in federal custody.

Charges against Parker were filed by the U.S. attorney's office in Denver on Thursday. A spokesman for the U.S. attorney's office did not return telephone calls Thursday night.

In a videotaped interview Monday with police, according to the Gazette, Parker told a detective she used heroin from July to September last year.

She allegedly told the investigator she thought she caught the virus from injecting herself with dirty needles.

Parker also might have exposed 1,000 patients at Audubon Ambulatory Surgery Center in Colorado Springs, where she worked after being fired from Rose, according to the charges against her. Hospital officials say she worked there from May 4 until Monday.

Jeff Dorsey, the president and chief executive of Health One, which operates Rose and other hospitals, said he was angered by the surgery technician's breach of trust.

"Someone in this particular case violated the trust everyone has, and that we value," he said Thursday night.

Thousands of deaths
The Centers for Disease Control and Prevention estimates more than 8,000 people a year die from hepatitis C-related liver disease. Hepatitis C can be treated and cured. Most people have no symptoms.

Dorsey said the technician's behavior led to the drug test, which she failed. She was fired immediately. The firing took place before the state health department contacted the hospital about the infections.

Former patients should receive the letter Tuesday or Wednesday at the latest, Dorsey said.

According to The Gazette, Parker told a Denver police investigator in the videotaped interview, "I know I (expletive) up. I can't take back what I did, but I will have to live with it for the rest of my life, and so does everybody else."

She told the investigator she expected to spend the rest of her life in prison.

On her MySpace page, Parker said she is the mother of a young son. She states that she has "a crazy fascination with needles."

Among the artwork on the page is the figure of a man driven full of nails beneath the definition: "Guilt . . . the fact of having done a wrong, especially an act punishable by law."

Staff writer Colleen Sears contributed to this report. Joey Bunch: 303-954-1174 or jbunch@denverpost.com

Hepatitis C

  • Who gets it: An estimated 3.2 million people in the United States have chronic hepatitis C virus infection. Most people don't look or feel sick.
  • What happens: For every 100 people who do contract the disease, 75 to 85 will develop a chronic infection. About 60 to 70 will develop chronic liver disease. About five to 20 will develop cirrhosis over a period of 20 to 30 years. Between one and five will die of liver cancer or cirrhosis.
  • The toll: Chronic hepatitis C-related liver disease accounts for about 8,000 to 10,000 deaths each year in the United States.

Source: Centers for Disease Control and Prevention

Patient care line
Rose patients who receive a notification letter may call 303-329-7500 between 7 a.m. and 7 p.m. Wait for a letter before calling. If operator is not available, please leave your name and number via voicemail. Calls will be returned as quickly as possible.

Audubon Surgical Center patients should not call Rose. The main number for Audubon is 719-867-7500. They plan to establish their own call center by Monday.


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Novel Role Of Gene May Provide Key To Treating Liver And Neurodegenerative Diseases
www.medicalnewstoday.com

Scientists at Singapore's Bioprocessing Technology Institute (BTI) have made a novel discovery about how the gene, "Fas-apoptosis inhibitory molecule" (FAIM), protects both immune and liver cells from apoptosis, or programmed cell death.

Their research is published in the current journal Cell Death and Differentiation.

The scientists, Jianxin Huo, Ph.D., and Shengli Xu, Ph.D., also discovered that this process may possibly be manipulated for clinical application and proposed the first-to-be-published in-animal model to study the role of FAIM in detail.

FAIM triggers a mechanism that ultimately impedes an important pathway to apoptosis, which is mediated by a key protein called Fas. Using their mouse model, the scientists elucidated part of the sequence of molecular events that regulates Fas-mediated apoptosis.

They found that FAIM functioned as a key switch in the Fas cell death circuit, which could be turned up or down to prolong or decrease cell survival.

Therefore, in principle, this gene could make a good target for drug intervention in either liver cirrhosis in which the target is to prolong cell survival, or in cancer in which the goal is to induce tumour cell death.

BTI Scientific Director Lam Kong Peng, Ph.D., who heads the immunology group that conducted the research, said, "We had earlier identified FAIM to be valuable in increasing the yield of biologics, and that had been one of the main focuses of BTI's research until now. We were extremely pleased to be able to establish that FAIM's function is preserved across both liver and immune cells, as this underscores its critical role in regulating cell death in disease."

The immunology team at BTI, one of the research institutes sponsored by Singapore's A*STAR (Agency for Science, Technology and Research), aims to further characterize the role of FAIM in liver cancer and other debilitating diseases.

According to Drs. Huo and Xu, there is also significant existing evidence that FAIM prevents neuron death and promotes neural outgrowth.

They hypothesize that FAIM might play a role in neuron protection, making it a potential therapeutic target for neurodegenerative diseases such as Alzheimer's and Parkinson's. Eventually, the Singapore scientists hope to conduct drug screens on FAIM to determine how it can be used to prolong or delay cell survival, and provide solutions to a wide variety of human diseases.

Drs. Huo and Xu's interest in FAIM was sparked by the work of their colleagues in BTI's animal cell technology group, which since 2007 has been using FAIM to enhance the longevity of biologics-producing cells to increase their yield in bioreactors, which are vessels in which organisms are cultured, and biochemically active substances derived from them.

Biologics are medicinal products such as vaccines, allergenics, tissues and recombinant proteins that can be extracted from natural sources (human, animal, or microorganism) and produced by biotechnology methods.

Curious about FAIM's role in immune cells, particularly its increased expression in activated B cells, key effectors of the human immune system responsible for fighting viruses and other pathogens that invade the body, the two scientists began developing the first in vivo knockout mouse model to closely examine FAIM's role in preventing programmed cell death.

BTI Executive Director Miranda Yap, Ph.D., said, "The Immunology Group's venturing beyond the traditional boundaries of applied science has paid off with their discovery of a second role for FAIM in the seemingly unrelated field of immunology. Their work is indeed a fine example of how our scientists are constantly pushing the envelope to keep at the forefront of biomedical research."

The Cell Death and Differentiation paper, "Genetic deletion of faim reveals its role in modulating c-FLIP expression during CD95-mediated apoptosis of lymphocytes and hepatocytes," is authored by: J. Huo, S. Xu, K. Guo, Q. Zeng and K-P Lam.

Source: Cathy Yarbrough, Agency for Science, Technology and Research (A*STAR), Singapore


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July 6, 2009


Arthur Salm: Hey kids, drugs are cool!
http://www.sdnn.com
By Arthur Salm, SDNN

The Board of Supervisors believes that people are idiots.

The city of San Diego wants kids to use intravenous drugs. To make it easy for them, free needles are dispensed twice a week.

“I think the free needle program particularly sends the right message to our kids,” said Mayor Jerry Sanders. “It sends a message that as city government, by giving out clean needles for illegal drug use, that we condone illegal drug use. And we do. And it’s right.”

Before the attorneys tool up and the lawsuits have actually been filed, let me state that of course Mayor of Jerry Sanders of San Diego did not say that, or anything like it. But Dianne Jacob, who chairs the San Diego County Board of Supervisors, has implied that that’s where Sanders’ heart lies. Because here’s Jacob explaining why the supervisors oppose the needle exchange program (for the fake Sanders quote above, I just changed a few words):

“I think it particularly sends a wrong message to our kids. It sends a message to our kids that as county government, if we gave out clean needles for illegal drug use, that we condone illegal drug use. And we don’t. And it’s wrong.”

There’s no other way to parse it: In Jacob’s view, Sanders and his fellow pushers on the San Diego City Council — we could be kind and call them “enablers,” but we’re in a (drug) war, so no bombast barred - believe that it’s just fine if kids shoot up.  After all, a needle-exchange program is permitted in San Diego; the council is clearly pro-heroin.

Yesterday, in the third of his four-part series on Hepatitis C, KPBS-FM’s Kenny Goldberg pointed out that “People who inject illegal drugs are at highest risk of spreading hepatitis C, H-I-V, and other bloodborne diseases. To reduce that threat, communities all across the country have launched clean syringe exchange programs.” Goldberg cited a 2004 SANDAG study, which found that “clients who visited the exchange were much less likely to share a needle. They also reduced their drug use. In fact, one in five clients said they had entered treatment.”

There followed a remarkable statement: “Jacob doesn’t believe it.”

Goldberg quoted Jacob as saying that she “thinks” there’s research on both sides of the issue, something Steffanie Strathdee, head of the division of global public health at the UCSD School of Medicine, called patently false.

“I’ve been working in this field now for more than 20 years,” Strathdee told Goldberg, “and I can tell you that there’s no scientific evidence that shows that needle exchange causes harm.”

But Jacob and her fellow supervisors prefer what Steven Colbert would likely call the “truthiness” of needle-exchange programs encouraging drug use. Pushy, in-your-face facts get in the way of the supervisors’ anti-drug bluster, so they’re dismissed (”Jacob doesn’t believe it”) and escorted from the chambers.

Goldberg then elicited from Jacob even more remarkable statement. He asked her, “What kind of information might make you reconsider your view on this whole matter?” to which she replied, “I’m not sure any kind of information will, frankly. Because of the fact that philosophically, I believe it’s wrong to in any way to encourage drug use. I think it’s wrong to government to send that message.”

The magnitude of the obtuseness, rigidity — say it! — stupidity of that statement is breathtaking. It recalls the classic from former congressman Earl F. Landgrebe (R-Indiana), who, even when confronted with the cascading, irrefutable evidence of President Richard Nixon’s perfidy in the Watergate scandal, continued to defend him. “Don’t confuse me with facts,” Landgrebe intoned, “I have a closed mind.”

The supervisors’ position would be bolstered if, out of all the intravenous drug users in San Diego County, they could come up with one individual who, dragged into a meeting of the Board of Supervisors, in public, for all the county to see, would declare something like, “Yeah, I was pretty much anti-drug until I heard about the needle-exchange program. I thought, ‘Whoa - free needles! That must mean the city council says it’s okay to mainline! Guess all that other stuff I’ve been hearing all my life was wrong. Sign me up!’ ”

To which you’d have to assign to the supervisors a certain amount of credit for finding without a doubt the dumbest individual in Southern California, because every other individual in Southern California, and probably the northern hemisphere, and for that matter, the southern hemisphere, knows damn well that communities dispense free needles to help prevent the spread of disease, not because communities want to encourage drug use. That one imaginary person at the imaginary supervisors meeting is imaginary because no such person exists.

Someone once accused the great economist John Maynard Keynes of inconsistency. “When I get new information, I change my position,” Keynes replied. “What, sir, do you do with new information?”

We know Dianne Jacob’s answer to that one.


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Hepatitis C: An Epidemic More Widespread than HIV
http://www.kpbs.org/
Kenny Goldberg / KPBS

There's a chronic liver disease that's ten times more infectious than HIV, and more widespread. Hepatitis C is a virus that's spread through IV drug use, like HIV. Left untreated, hepatitis C can cause life-threatening complications, including liver cancer. In this first of a four-part series, KPBS Health Reporter Kenny Goldberg takes a look at the epidemic of hepatitis C.

In 1997, Charlie Navarro began to feel tired and lethargic. He went to his primary care doctor, who recommended a blood test.

Navarro was diagnosed with hepatitis C.

He thinks he became infected back in his college days, when he experimented with shooting drugs.

"This was before we went to a concert, it wasn't in the back of an alley, or it wasn't 50 or 60 times," Navarro remembers. "I was never addicted. All I tried was once, or twice. And unfortunately, with the crowd I was with, we shared needles."

Getting a transfusion or an organ transplant used to be major risk factors for becoming infected with hepatitis C. But since 1992, all blood and blood products in the U.S. have been screened for the virus.

"And that's why now, IV drug use is the main risk factor for contracting hepatitis C," says Dr. Tarek Hassanein, liver specialist at UCSD. "And most of the patients that we see now, are infected because of history of IV drug use, even once or twice in their life", he says.

Hepatitis C is the most common blood-borne infection in the U.S. -- about four million Americans have it. In San Diego County, more than 4,000 people are infected.

The virus often doesn't cause symptoms, so it can linger undetected for years.

Hassanein says once a person becomes infected with hepatitis C, the virus replicates and survives in the liver.

"The ongoing fight between the virus and the immune system leads to injury to the liver," Hassanein points out. "We call it chronic injury because it’s happening every day for 20, 30 years. The liver has the ability to regenerate. But in the process of the fight, the liver needs to heal with scar tissue. That scar tissue within 20, 30 years leads to what we call cirrhosis."

Once cirrhosis sets in, it's very difficult to reverse. That's why early detection and treatment are crucial.

"So welcome to the hepatitis C instruction class. The purpose of this class today is to educate you on what the disease is. We're gonna talk about how we treat hepatitis C."

At UCSD Medical Center in Hillcrest, nurse practitioner Lisa Richards offers a primer on the disease with a class of 12 patients.

All of them have the virus, and they're about to start up to 48 weeks of treatment. The potential cure consists of taking two medications -- one by mouth, and one that's self-injected.

The treatment causes painful, flu-like side effects. But about half of all hepatitis C patients who complete treatment are cured. For those that aren't, their liver slowly deteriorates. About one in five will need a liver transplant.

Nikki is among the unlucky ones. The Oceanside woman recently developed type 2 diabetes, because the hepatitis C also attacked her pancreas.

"I didn't know that I had hepatitis all these years, so I didn't know that I was damaging another part of my body," Nikki says.

Nikki has been on a waiting list for a liver transplant for two-and-a-half years.

Dr. Ajai Khanna is UCSD's director of abdominal transplantation. He says people who need a new liver don't always get one in time.

"The number of patients waiting for liver transplantation with end stage liver disease, they far outnumber the number of donors available," says Dr. Khanna. "So, therein lies the problem. And that's why we lose patients on the waiting list."

Khanna says even if someone does get a donated liver, the operation can cost more than a quarter of a million dollars.

In contrast, there's a really cheap way to prevent the spread of hepatitis C. We'll find about it in part 2 of this series.


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Miami cop-turned-doctor cares for homeless patients
http://www.miamiherald.com
By AUDRA D.S. BURCH
aburch@MiamiHerald.com

As an undercover cop, Pete Gutierrez helped bust some of South Florida's biggest and most-feared drug dealers. Now a doctor running a clinic for the homeless, he helps heal its most vulnerable residents.

Leon Harris, 61 days at the Miami Rescue Mission, nursing a sore jaw and a deep and nasty chest cough, slouches on the examining table, rarely losing eye contact with the floor.

Dr. Pete Gutierrez, director of the mission's brand new medical clinic for the homeless and needy, asks Harris about his drug-use history, but assures him that he will not be judged. Then he waits patiently and looks away -- a technique Gutierrez learned on the streets 20 years ago as a high-stakes, undercover cop.

Finally, the words trickle out. Harris, 56, started smoking marijuana in 1988, then he quickly graduated to heroin and crack cocaine. He has Hepatitis C. And the sore jaw? The result of a street fight months ago.

''The doctor convinced me that you have to be honest with them about your situation if you want help,'' Harris softly says after his examination, his first in years. "It ain't easy telling stuff.''

But Gutierrez, 61, knows the Leons of this tough neighborhood, stretched between downtown Miami and the Design District. He knows the no-talk, no-tell culture of its streets. He knows the fear faced by those struggling with addiction or homelessness, or those who are simply lost -- in need of much more than shelter and a hot shower.

They are who inspired the Miami Rescue Mission to open this five-room clinic six weeks ago. Since then, about 60 patients have walked or wandered in looking for healthcare, advice, and sometimes just someone to listen to their stories.

"So much of our clients' pasts has brought them here,'' Gutierrez says. ``They have lived tough lives that have taken a toll on their minds, souls and bodies. We are here to help them get as healthy as possible. Because someone is poor does not mean they have to deal with below-standard healthcare.''

'Wants to Give Back'
Gutierrez, a Pedro Pan child, now husband and father of three, was a decorated City of Miami police officer for 11 years before he quit to pursue his dream of becoming a doctor. But those blended experiences -- the science of medicine, the street savvy of police work -- make him a natural choice to head up the clinic at Northwest First Avenue and 20th Street, just across the street from the mission.

''This is someone who came here with nothing . . . and served our community as a police officer and a doctor,'' says Ron Brummitt, president of the mission. "And now, with all this passion, he simply wants to give back and make a difference.''

The clinic, a partnership with Miami Dade College's Medical Center Campus, has been in development for almost 10 years. It evolved from the joint health fairs at the mission, which serves about 1,000 men, women and children monthly. The surrounding neighborhoods of Overtown, Wynwood and downtown have been designated by the state as medically underserved.

Brummitt says the clinic will complement services offered at the Camillus House clinic and Jackson Memorial Hospital.

''We have people in our program and in the neighborhood that will never go see a doctor until it becomes a 911 situation, and they are picked up by an ambulance,'' he says. "We have had people literally die on our sidewalks -- not from a gunshot but from untreated medical conditions.''

Early Days in Miami
Pete Gutierrez arrived from Havana on July 15, 1962, after his parents placed him on a Miami-bound jet as part of the Pedro Pan operation. He was 13. ''I came here by myself and grew up in foster care, so I had to quickly learn how to fend for myself,'' he says, shifting the 34 red client folders stacked on an otherwise barren desk in his office. "Only one of the four homes I stayed in was good. I don't want to remember the others.''

He graduated from Miami Senior High School, then enlisted in the Air Force where he started college courses. He later earned a bachelor of science degree from Florida International University, then headed to the Dominican Republic for medical school. A year later, Gutierrez was out of money. He quit school, came home and joined the Miami Police Department in 1978.

'Difficult Time'
Within four years, he was working undercover with an elite, 12-member narcotics squad charged with squashing the relentless drug trade of the ''cocaine cowboys'' era.

''This was a really difficult time for everybody. Every day we went out there, it was like going to war, and you never knew if you were going to make it home,'' he says. "Stressful? These guys were carrying around machine guns. They were armed up to their teeth.''

He was an unassuming guy who worked the streets in fancy rental cars and hooptie sedans, the cast-offs of dope boys. He donned straw hats, fake beards and sometimes carried kilos and cash.

''Working undercover, he had a great gift of gab. But he was also really cool, not bringing too much attention to himself. He wasn't loud or rambunctious but a good actor,'' says Miami Police Maj. Armando Guzman. "But it was also common knowledge that he wanted to become a doctor.''

High-Profile Cases
In 1984, the Florida Retail Federation named him law enforcement officer of the year. Between June 1983 and May 1984, Gutierrez had made more than 100 arrests and confiscated $4 million in narcotics and $500,000 in cash and counterfeit bills.

His case files included the arrest of Rosie Ruiz, the dethroned Boston Marathon champion who cheated to complete the race. She later moved to South Florida and was caught brokering a cocaine deal in secretly taped phone conversations with Gutierrez. He also took down Fidel Castro's sister, Juanita, for selling prescription pills over the counter at her drug store.

After 18 months working in internal affairs, he left the force in order to finish medical school in the Dominican Republic. He then practiced family medicine in Puerto Rico before returning to South Florida in 2005.

'The Right Time'
In 2006, Gutierrez became director of Miami Dade College's Physician Assistant Program, a two-year curriculum. Last year, after meeting with Brummitt and Annette Gibson, a professional colleague, he joined the effort to open the clinic.

''Pete is a mover and a shaker, but most importantly, he is a physician. He was able to give us the clarity and understanding of how to put together a clinic,'' says Gibson, a professor of nursing at Miami Dade College who coordinates the rescue mission's healthcare services. "He came at absolutely the right time.''

The small clinic, open weekdays, is manned by a group of volunteers: Gutierrez, physician assistants, a pediatrician, a podiatrist, gastroenterologist, and medical and nursing students. There is one paid staff member, who is in charge of coordinating patient care.

The clinic will operate on a $100,000 budget funded through grants, donations and in-kind services.

Quick Diagnosis
Tito Oropesa, 63, a two-pack-a-day smoker who used to dabble in crack cocaine, walked into the clinic to see about a rash. He lifted his T-shirt, unveiling a red band of pimples across his lower back that had been there more than a week.

''This looks like shingles,'' Gutierrez says almost instantly, then recommended a complete examination. ''In the meantime, I need you to slow down with the cigarettes.''

Much of the doctor's job is to navigate the moving landscape of homelessness and helplessness. It's sort of like detective work, as Gutierrez tries to decipher how tragedy and circumstances have physically affected his patients. He must deal with patients whose diseases are compounded by drugs and booze and guilt and bad decisions.

Already, he has diagnosed patients with hypertension, pneumonia, diabetes and sexually transmitted diseases.

'A Blessing'
And then there's Willie Rice. Twenty-seven days out of prison, homeless and a bit scared, he has come to the clinic with a bag of empty prescription bottles and complaining of sharp stomach cramps, blood in his vomit, and soreness around old knife wounds from a dice game gone bad.

After a half-hour of poking and prodding, a gentle lecture on smoking and some tough questions, Rice walked out with appointments for gastritis, prostatitis, glucose and cholesterol tests.

He also walked out with hope.

''This place is such a blessing. I don't have to go far to find out what's wrong with me,'' says Rice, 48.
I was just going to pray on my pain to go away.''


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Ignorance fuelling spread of hepatitis B in Asia
http://bdnews24.com

HONG KONG, Oct 30 (bdnews24.com/Reuters) - Ignorance is fuelling the spread of hepatitis B in Asia, where patients are failing to get proper treatment and not enough is done to reduce transmission of the virus from mother to child, an expert said.

The 10th leading cause of death worldwide, chronic hepatitis B affects 360 million people globally.

Of these, 281 million are in Asia, and one out of every four of them will die from either cirrhosis -- scarring of the liver -- or liver cancer later in life.

Symptoms such as jaundice, fatigue, abdominal pain, loss of appetite, nausea and joint pain may not surface in 30 percent of cases, and they are even less common in children.

As such, many people usually don't know they are infected until it is too late, and those who do have little impetus to get treated or have regular check-ups, according to the results of a survey carried out in 10 places in Asia this year.

"Ignorance helps the transmission of the disease and the survey finds this ignorance results in people giving up on the chance of proper treatment ... they don't think it's important to be treated because they don't have symptoms," said Nancy Leung, an expert on the disease and associate professor at the Chinese University's department of medicine and therapeutics.

The survey covered 1,500 people diagnosed with chronic hepatitis B in China, Hong Kong, South Korea, Malaysia, the Philippines, Indonesia, Singapore, Taiwan, Thailand and Vietnam and who were taking anti-viral drugs to suppress the virus.

Although 77 percent of them said they knew "an average or a great deal" about the disease, substantial numbers of them (36 and 27 percent, respectively) were unaware that the main routes of transmission were from mother-to-child and through sex.

Overwhelming numbers mistook hepatitis B for hepatitis A, with 73 percent in China, 70 percent in the Philippines and 63 percent in Singapore thinking that "eating infected food" was the major cause.

Thirty-eight percent did not know how they came to be infected. In China and the Philippines, 53 percent and 46 percent thought they caught the virus from food.

In Indonesia and Vietnam, 57 percent and 44 percent cited "poor health" as the cause.

Highlighting the seriousness of the disease, Leung said 10 percent of Hong Kong's 7 million strong population, or 700,000 people, suffer from chronic hepatitis B. And despite the city's advanced health care system, only a fraction of patients are getting adequate care.

"In Hong Kong, less than 10 percent of patients with chronic hepatitis B are being treated, only 20 percent are being properly monitored and assessed," Leung said.

Almost all chronic hepatitis B sufferers were infected before they were born or when they were very young.

In Hong Kong, 60 percent of sufferers are believed to have been infected by their mothers, while 40 percent were infected when they were very young, usually through blood contact with infected playmates via open sores and small breaks in the skin.

"Infections in adulthood would in all likelihood not be chronic, they would be cured," said Leung, referring to the intense immune response such an infection would trigger in an adult, who would be able to get rid of the virus completely.

Conversely, in an infant or a very young child, they are very often unable to flush out the virus, and it remains in their livers, multiplying and then creating havoc over time.

Pregnant mothers who are carriers of the disease must inform their doctors and infants can be effectively protected if they are given a vaccine and hepatitis B immune globulin within 12 hours after birth. A second dose is given 1-2 months later and a third dose at age 6 months.


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July 7, 2009


ISSTDR 2009: High-Risk Sexual Practices Play Role in New HIV-HCV Co-Infection Epidemic in Amsterdam
http://www.medscape.com
Becky McCall

July 6, 2009 (London, United Kingdom) — Molecular typing of hepatitis C virus (HCV) genotypes found in HIV-positive men who have sex with men (MSM) with recently acquired HCV suggests that high-risk sexual behavior accounts for an increase in cases of co-infection.

A biannual anonymous survey among MSM visiting the Amsterdam Sexually Transmitted Infections Clinic in The Netherlands showed a gradual increase in HCV prevalence among HIV-positive MSM, from 15% in May 2007, to 18% in November 2007, to 21% in April 2008.

In contrast, only 2 (0.4%) of 532 HIV-negative MSM were HCV infected, which equals the estimated HCV prevalence of the general population in Holland.

HCV RNA was detected in 22 of 28 HIV-positive MSM and 2 HIV-negative participants. Only 5 (17.9%) of 28 HIV/HCV co-infected MSM ever injected drugs. In addition, 31.8% of those infected with HCV were unaware of the co-infection.

These results were presented here at the 18th International Society for Sexually Transmitted Diseases Research Congress.

Increasing Number of Acute HCV Cases
Concerns began after the year 2000, when clinicians in Amsterdam began reporting an increasing number of acute HCV cases in HIV-positive MSM. None of these HIV-positive MSM confessed to injection drug use, but many admitted to risky sexual behavior. HCV screening of the Amsterdam Cohort studies among homosexual men confirmed this outbreak and showed a 10-fold increase in HCV incidence among HIV-positive MSM after 2000.

HCV incidence between 1985 and 2000 was 0.08/100 person-years. Between 2000 and 2003, it rose to 0.87/100 person-years. No incident cases were observed among HIV-negative MSM.

Roel A. Coutinho, MD, from the Center for Infectious Disease Control at the Academic Medical Center, University of Amsterdam, conducted a further investigation into this emerging HCV trend in HIV-positive, non-drug-injecting MSM. "We had not seen this before, so it stimulated our group to find out what was happening. We used molecular typing to see if these cases were related to each other and found in Amsterdam that people [with the same genotype] were clustered together, indicating they had infected each other."

To assess the size of the problem as well as the rate and reasons for the reported increase in HCV within the HIV-positive MSM population, Dr. Coutinho and his colleagues surveyed 3125 attendees of the Amsterdam Sexually Transmitted Infections clinic. Participants were interviewed in May 2007, November 2007, and April 2008 about risk factors for blood-borne and sexually transmitted infections, and they were screened for HIV and HCV antibodies. Also, all HIV-positive participants, regardless of HCV antibody status, and all HCV antibody-positive participants were tested for HCV RNA to assess which HCV genotypes were present.

Risky sexual behaviors and HIV-positive status were significantly associated with HCV positivity. "Both this study and other previous studies suggest that [HCV] is more likely to transfer through anal sex, and these people have much higher risk sexual contact than others. They have more unprotected [sexual] contact and use more toys and so on. Overall, risky sex is a factor, but the difficulty is [in] establishing how exactly HCV is being transmitted," Dr. Coutinho told Medscape Infectious Diseases.

Results from analysis of the phylogenetic tree revealed 5 distinct clusters of genotype 1a and 4d. Only 1 HIV-negative MSM and 20 (91%) of 22 HIV-positive MSM were found within these clusters. Dr. Coutinho explained that before 2000, no cases of clustering were found. This changed after 2000, yet hardly anybody in the clusters injected drugs, he noted. "One cluster of 14 cases provided clear evidence these people infected each other. It is highly likely this occurred through sexual transmission."

Acute HCV is asymptomatic, but 60% to 85% of these cases progress to chronic HCV in the HIV-negative population compared with 95% in the HIV-positive population. Screening and detection is important in these patients to enable early treatment, said Douglas T. Dieterich, MD, professor of medicine from the Division of Liver Diseases at Mount Sinai School of Medicine in New York City.

"Remarkable Study"
"I think this is a remarkable study that can help clinicians diagnose and then treat HCV early in the acute phase. There is a new epidemic of sexually transmitted HCV raging in [MSM], and it is vital that the doctors on the ground understand the importance of early diagnosis and treatment. Treatment of HCV in the acute phase is extraordinarily effective, resulting in [a] 70% to 90% cure rate, as opposed to the 30% to 40% [cure rate] in the chronically infected," Dr. Dieterich commented.

Analysis of available historical data based on the distribution of lineage splits within the MSM-specific clusters showed that HCV has spread among HIV-positive MSM mainly after 1996. "That's happened 85% to 100% of the time after 1996, at which point highly active antiretroviral therapy was introduced, strongly suggesting that when risky behavior started to increase among HIV-positive MSM, HCV also started to emerge," said Dr. Coutinho.

Consequences of HCV in HIV-positive patients are serious, emphasized Dr. Coutinho. He explained that the HCV viral load is often higher in these patients, and it often progresses more rapidly to fibrosis and cirrhosis. There is also concern that highly active antiretroviral therapy interferes with HCV therapy. Looking ahead, Dr. Coutinho said he has concerns that HCV may spread to the HIV-negative population, or even to heterosexuals, in which case it could become a major problem for developing countries.

"The message to clinicians at the moment is to ensure counseling [of] HIV-positive MSM, so that they realize sex with other HIV-positive men can expose them to HCV," Dr. Coutinho advised.

There is little evidence to date to show that a similar emergence is happening in the United States, although Dr. Dieterich believes it is present but that further monitoring is needed. "There has been only one sizable cohort in the United States with similar results that was published last year in the Journal of Infectious Diseases by Dan Fierer. The fact is that HCV in HIV-positive MSM is happening in the United States, but no one, except our group at Mount Sinai, is studying it."

18th International Society for Sexually Transmitted Diseases Research Congress: Abstract OS2.7.06. Presented June 30, 2009.


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Seattle doctors try flat-rate no-limit primary care
www.reuters.com
By David Lawsky

SAN FRANCISCO (Reuters) - A Seattle clinic for people fed up with insurance, started by doctors fed up with insurance, has gotten $4 million in private venture capital money to expand, it announced on Monday.

Qliance says it has a profit-making solution to the problems of long waits, rushed doctors and cursory care that bother patients, at the same time that it eliminates the paperwork and pressure that plague primary care doctors.

"If you spent five minutes in my office you would notice there is nobody waiting. We don't have to stack them up like jets over Newark," said Garrison Bliss, a doctor and co-founder of the primary care clinic.

The new venture funding comes from Second Avenue Partners with participation by New Atlantic Ventures and Clear Fir Partners, bringing total capital raised to about $7.5 million.

Co-founder Norm Wu said per-patient revenue is triple that of insurance-based clinics. He said many costs are fixed so the firm, now losing money, will turn to profit as business grows.

More than 50 noninsurance clinics operate in 18 U.S. states, based on different business models, Wu noted.

The backers believe Qliance can grow very profitable, and the clinic uses stock options to attract new doctors. The next step is to open a suburban office.

Qliance says it is a private alternative to the failures of insurance, which have made health care President Obama's top legislative priority in Congress, with a price tag of $1 trillion or more.

Qliance customers pay $99 to join, then a flat monthly rate of $39 to $119, depending on age and level of service. Patients can quit without notice and no one is rejected for pre-existing conditions.

Patients must go to outside brokers and qualify medically to buy catastrophic care. One broker said a 30-year-old could expect to pay $133 per month for such care, and a 60-year-old nearly $400, plus substantial deductibles.

Qliance patients get unrestricted round-the-clock primary care access and 30-minute appointments.

"Why would a doctor not want to see sick people? That doesn't make sense, unless you're an insurance company," Bliss said.

He rejected the idea that unrestricted access causes overuse, calling that "nonsense promoted by insurance companies .... There's nobody I've ever met who gets their pleasure by seeing doctors."

Bliss said dumping rigid, convoluted insurance requirements and paperwork saves large amounts of money.

UnitedHealth, which processes 60 billion health care transactions a year, argued in June that better use of technology would save $332 billion annually, with some going to physicians.

Other big health insurers include WellPoint, Humana, Cigna and Aetna.

(Reporting by David Lawsky; Editing by Richard Chang)


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Pharmasset Nominates PSI-938 as a New Nucleotide Analog Inhibitor of Hepatitis C for Preclinical Development
http://news.prnewswire.com
 
- IND or foreign regulatory equivalent submission anticipated in first half 2010
 
PRINCETON, N.J., July 7 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today the nomination of PSI-352938 ("PSI-938") as a lead development candidate from two series of purine analogs for the treatment of chronic hepatitis C virus (HCV) infection. PSI-938 is a proprietary nucleotide analog polymerase inhibitor of HCV that is being advanced into studies required for submission of an Investigational New Drug (IND) application with the FDA or equivalent foreign regulatory application.

"PSI-938 is particularly interesting to us since it differs from our pyrimidine analogs, R7128 and PSI-7851, because it has a complementary resistance profile and is metabolized through a different phosphorylation pathway," stated Michael Otto, PhD, Pharmasset's Chief Scientific Officer. "These differences may prove to be particularly important as we explore combinations of nucleos(t)ides in clinical development in the future."

Purine nucleos(t)ide analogs have many of the benefits of pyrimidine nucleos(t)ide analogs, like R7128 and PSI-7851, in that they have demonstrated in vitro activity across multiple genotypes, a higher barrier to resistance than other classes of HCV small molecules in development, and the potential to be combined with other direct acting antivirals targeting HCV. In addition, these purine analogs are also active against the S282T resistant variant selected in vitro by the pyrimidine analogs, and are metabolized to the active triphosphate form through a different phosphorylation pathway than the pyrimidines. Given these characteristics, purine and pyrimidine analogs have the potential to be combined as part of a future treatment regimen.


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Presidio Pharmaceuticals, Inc. Selects PPI-461 as a Clinical Candidate in Their Hepatitis C Virus NS5A Program
http://www.businesswire.com

SAN FRANCISCO--(BUSINESS WIRE)--Presidio Pharmaceuticals, Inc. announced today that they have selected one of the lead compounds in their hepatitis C virus (HCV) NS5A program to advance toward clinical development.

Inhibitors of the HCV NS5A protein are novel and distinct from those currently being pursued by others against the two enzymatic targets of HCV, protease or replicase. With response rates of approximately 50% and tolerance issues associated with standard of care treatments involving the combination of pegylated IFN and ribavirin, there is a clear need for potent, small molecule inhibitors that target multiple viral targets and can be administered orally in future combination therapies.

The selected Presidio NS5A inhibitor, PPI-461, exhibits potent and selective activity against all HCV genotypes and showed good oral bioavailability and was well tolerated in animal studies, with elevated liver concentrations relative to serum levels, and potential for once daily dosing in humans. Resistance studies to date suggest that the compound will likely have a high resistance barrier requiring multiple substitutions within the NS5A gene.

IND-enabling studies for PPI-461 are currently underway and the Company expects to commence clinical studies in 2010. Additional preclinical research continues on other distinct classes of compounds in the Company’s NS5A program.

About Presidio
Presidio Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the discovery, in-licensing, development and commercialization of novel therapeutics for viral infections, including HIV-1 and HCV. For more information, please visit our website at www.presidiopharma.com.


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July 8, 2009


US lawmakers seek info from bottled water companies
www.reuters.com

WASHINGTON (Reuters) - U.S. lawmakers requested information on Wednesday from 13 bottled water sellers including PepsiCo and Coca-Cola Co about the source of their water and its testing.

A congressional hearing earlier Wednesday "found that neither the public nor federal regulators know nearly enough about" where bottled water comes from or what measures are taken to make sure it is safe, Democratic Representative Bart Stupak said in a statement.

"The majority of consumers purchase bottled water because of perceived health and safety benefits, but they actually know very little about the quality of the water they are buying," Stupak added.

In letters to the companies, the lawmakers asked for documents related to testing of bottled water and its sources, plus names and locations of each company's water sources.

Companies that received the letters included PepsiCo, Coca-Cola, Dr Pepper Snapple Group Inc and Nestle.

"We do put the source of our water on all of our retail product labels," said Jane Lazgin, spokeswoman for Nestle's water unit, adding that it also puts information online

Representatives for the other companies could not immediately be reached on Wednesday.

The letters were sent by Stupak and House Energy and Commerce Committee Chairman Henry Waxman, a Democrat who has aggressively pursued information from companies on consumer issues. Stupak chairs the committee's investigations panel.

Bottled water makers make millions off people who believe their products are purer than tap water, but consumers do not realize that they are less regulated than plain old tap water, according to a Congressional report released on Wednesday.

At the hearing, lawmakers also heard from the General Accountability Office, which said the U.S. Food and Drug Administration has little power to regulate the safety of bottled water.

"Of particular note, FDA does not have the specific statutory authority to require bottlers to use certified laboratories for water quality tests or to report test results, even if violations of the standards are found," a new GAO report said.

Stupak said that bottled water has been recalled in recent years due to contamination by arsenic, bromate, cleaning compounds, mold, and bacteria.

(Reporting by Lisa Richwine; Editing by Steve Orlofsky)


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Medical examiners went fairly easy on one doctor in hepatitis case
http://www.lasvegassun.com
By Jon Ralston

On its face, the premise is laughable:

A doctor who practiced at and co-owned a surgical center where unsafe medical practices are alleged to have infected patients with hepatitis C had no knowledge of such practices.

Doubly laughable, in fact, because even though he was ignorant of syringe reuse and had no control over the clinic’s employees, as his attorney claimed, the physician supposedly has intimate knowledge that can be useful to regulators and prosecutors looking into the egregious behavior at the Endoscopy Center of Southern Nevada.

But such is the case that the state Board of Medical Examiners has made, amid a torrent of outrage and derision, to justify what amounts to a plea deal with Dr. Eladio Carrera, who is expected to testify in disciplinary, and perhaps criminal and civil, actions against Dr. Dipak Desai, the most vilified figure in the case, and perhaps others. (Full disclosure: I had to be tested because I was one who had a colonoscopy performed by Desai.)

The see-no-evil, hear-no-evil, speak-no-evil doctor who has agreed to tell all that he saw and heard is seen by some as yet another example of a physician coddled by a state board that needs to heal itself of that potent and hoary Nevada injection known as juice. Carrera’s punishment of a public reprimand (don’t you ever do that again!), a $15,000 fine (have to downgrade to a lesser Mercedes) and his returned license (please don’t send me to North Las Vegas) may seem more a love tap than a wrist slap to many.

So why would the board make such a pact with someone many in the public, and certainly the infected patients, see as the devil?

I tried to garner insight from Louis Ling, the medical board’s executive director, on why he would have negotiated this deal with Carrera and how he resolves the contradiction that the doctor has clean hands but knew about the dirty business of double-dipping in drug vials.

“He (Carrera) was one of the doctors performing procedures there,” Ling said Tuesday in an exclusive interview on “Face to Face.” “He was a co-owner of the facility. But, there were certain things, and I can’t get too deep into this, but I guess I can say it this way: There were certain things regarding the management and the management structure of this facility in which Dr. Carrera knew about, but was not actively involved in. He wasn’t invited to participate in some of these things ... He gives us an inside view of this which we can now use to show how the place was really working on a day-to-day basis.”

And this elaboration: “We have a nurse who was in the procedure room who knew what was going on when she was standing in the procedure room. We’ve got some technicians who knew how the equipment was being used and how it was cleaned. All we’ve got is little bits and pieces ... (Carrera) can tie it all together and say, ‘This is how we were running. This is how many procedures we were doing. This is why we were doing these things.'"

It’s a fairly compelling case for making the deal with Carrera, assuming his testimony is equally riveting and damning — and assuming this isn’t a case of letting off the worst guy to get to less culpable actors, which seems unlikely.

Ling says that if people are expecting a Perry Mason moment with Carrera, though, they will be disappointed. “It isn’t going to happen,” Ling said. “There’s probably not going to be the smoking gun to the extent that everybody’s looking for. What everybody wants, I think, is a document written by Dr. Desai that says we’re changing from the small vials to the big vials (where the double-dipping occurred).”

But, Ling reiterated, “we can’t try the case without him.”

That’s the disciplinary case produced by a notoriously weak board. But what about the civil and criminal cases?

“(Carrera attorney Tom) Pitaro is not going to let this guy testify at a board disciplinary hearing if he’s going to expose himself to criminal liability,” speculated Will Kemp, an attorney pursuing civil damages in the hepatitis C scare. “So that leads me to believe there is some deal on the table here that maybe Louis knows or doesn’t know about with the DA’s office where this guy’s agreed to testify to the grand jury.”

Ling insisted he knows of no such deal. But he should hope there is one and that Carrera’s testimony convicts anyone eventually charged in this frightening case. Only then will people stop scoffing at the deal and perhaps acknowledge sometimes a devil in the hand is worth two in the stocks.


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Hepatitis Increase In Mercer County: Health officials warn the public to get vaccinated
http://www.wvnstv.com
Story by Erin Barnett

PRINCETON -- The Mercer County Health Department reports a significant increase in Hepatitis B cases. On average there are 2 to 3 confirmed cases everyday.

Public Health Nurse, Judy Bolton says the facts are alarming.

"Mercer County has the worst case rate of Hepatitis B in the state," said Bolton. "Since the state has had the worst rate in the nation then that makes us number one in the nation."

There is no cure for Hepatitis B, but there is a vaccination for adults and children. The vaccinations are available at health departments across the state and they are strongly advised.

"Everyone needs to get vaccinated. We really have a problem here and we have got to do something to try and get it under hand," said Bolton.

The Mercer County Health Department investigates every case of Hepatitis. They try to pin point the reason for contraction, and they contact all individuals that may have come in contact with the disease.

Bolton says the best thing for people to do is to take caution and consider every blood as being infected.


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The facts on the Hepatitis C virus: Foiling a silent infection
http://www.nydailynews.com
Katie Charles

The Specialist: Dr. Thomas G. Mcginn on Hepatitis C
As the chief of general internal medicine at Mount Sinai, Dr. Thomas McGinn oversees inpatient and outpatient primary-care training and research, and patient care for adults. For the past seven years, he has been exploring methods to raise awareness about hepatitis C and how to best screen people so they can receive effective treatment as soon as possible.

Who’s at Risk
Hepatitis C is one of the most common infections in the world, with doctors estimating that 3% of the population is infected. “The hepatitis C virus causes a chronic infection that slowly damages the body, primarily the liver,” says McGinn. “It may be 15 to 20 years before symptoms start to emerge — which is why screening is so important.”

Hepatitis C can be transmitted sexually, but it is most often transmitted via contact with contaminated blood. “People at risk include patients who had blood transfusions or surgery before 1992, when we started screening for hepatitis C.”

Health care professionals are also at higher risk, because they are more exposed to blood through accidental needle sticks. Currently, the group with the highest risk of hepatitis C infection is intravenous (IV) drug users. Less common causes of exposure to the virus include tattoos and piercings.

“For about 10% of the patients, we just don’t know how they got infected,” says McGinn. There are several different genotypes of the virus, and different versions tend to strike in different geographical areas. People in the U.S. tend to get genotypes that are more difficult to treat.

Signs and Symptoms:
Hepatitis C is known as a silent infection, because it typically shows no symptoms in its earliest stages, while it slowly causes liver damage that becomes apparent in 15 or 20 years. Unfortunately, this means that most patients don’t know they are infected until years after they become infected, making it more likely they might transmit the disease, though unwittingly.

Even after they are diagnosed with hepatitis C, most patients can’t pinpoint exactly when they were infected. Because hepatitis C is so often asymptomatic, screening is vital to catching the disease early. But doctors haven’t reached a consensus about how best to screen the general community. “Some people call for universal screening, while other people call for what’s known as ‘risk-factor screening,’” says McGinn. “In risk-factor screening, we ask a series of questions to see if you have any of the known risk factors, but we don’t actually draw any test blood. As long as you are considered to be at risk for any reason, you probably should be tested at least once a year.”

Screening for hepatitis C is a two-part blood test: The first step tests for the antibody, and if that is positive, a second confirmatory test should be ordered to confirm the virus is present. “The first test is about 90% accurate,” says McGinn. “So while this is a good first test, a positive result should always be confirmed with additional tests and followed up.”

One new area of study is the period of acute infection, which means the first few weeks after infection.

“Sometimes people have a malaise and mild fever in the first weeks after they are infected,” says McGinn. Doctors are paying more attention to this period of acute infection in the hopes that they can catch cases of hepatitis C earlier and get people into treatment when it is most effective.

“The problem is that 15-to 20-year period of silent infection while the liver is being damaged and the patient has no idea that anything is going on,” says McGinn. “We’re trying to catch patients before the damage progresses.”

Traditional Treatment:
For most infected people, hepatitis C develops into a chronic infection that compromises the liver.

“About 80% of people infected develop a chronic infection, which means they are infected for life,” says McGinn. “Of those, only about 20% will advance to serious liver damage.” Twenty percent may not sound like a lot, but so many millions of people are infected that hepatitis C is the No. 1 cause of liver cancer.

The standard treatment for hepatitis C is called interferon alpha-2B therapy and lasts for either 24 or 48 weeks. The therapy consists of a weekly injection of interferon and a medication (ribavirin) taken as a pill twice a day. “Both interferon and ribavirin have side effects, so we monitor patients quite closely,” says McGinn. “After therapy, 50% of people are cured — having a sustained viral response — and the other 50% will continue to be monitored closely by a specialist, who will try different dosages and medications.”

When hepatitis C isn’t caught in time or if the patient doesn’t respond to therapy, it can progress and cause liver cancer, liver failure or cirrhosis. For many patients, liver transplant becomes the best treatment option at this point.

Research Breakthroughs:
One of the biggest problems for hepatitis C is the public’s lack of awareness. “I’m looking at different ways to motivate folks to get screened and, if positive, get into therapy,” says Dr. McGinn. “We’re trying to [compel] people to get screened, tested and treated, and we are also teaming up with mental health professionals to help reduce the fear of being treated.”

There are new medications in the pipeline continually, including some that might make the interferon alpha-2B therapy easier for the patient. “The injection might go down from a weekly dose to every other week,” says McGinn. “We hope that in the future we’ll have an oral version of interferon, with reduced side effects, so we won’t have to inject patients at all.”

Questions for Your Doctor:
If you have any of the risk factors, don’t hesitate to ask your doctor, “Should I get tested for hepatitis C?” If both tests come back positive, the next question is, “What are my treatment options?” McGinn advises that just about everyone should give the standard therapy a shot, but it’s a good idea to know the side effects and to ask if you can

What You Can Do:
Get informed. There’s great information about screening, treatment and clinical trials on the hepatitis C Web sites put together by the National Institutes of Health (health.nih.gov) and the New York City Department of Health and Mental Hygiene (nyc.gov/html/doh).

Know the risk factors. Your risk is higher if you’ve been exposed to contaminated blood — especially through needle-sharing or transfusions and surgeries you had before 1992 — or if you might have been exposed sexually.

Ask your doctor to be screened. And know what the screening entails going in. “Patients should know that they may need a second test if the first is positive to confirm they are truly actively infected,” says Dr. McGinn.


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Hep C falls under U.S. disability law
http://www.denverpost.com
By Michael Booth
The Denver Post

A potential hepatitis C breakout forces Americans to reconsider the delicate balance they've created between personal liberty, employer rights and public safety.

Some Colorado patients and observers are incredulous that suspect Kristen Parker could work in a hospital operating room when her then-employer, Rose Medical Center, knew she had hepatitis C.

But the 1990 Americans With Disabilities Act was written in part to protect employees like Parker, whose job abilities and performance should not have been affected by her viral status. And Parker's alleged switching of dirty syringes to obtain Fentanyl had nothing to do with the kind of accidental transmissions that hospital procedures prepare for, health officials said.

"What we have seen is that good infection-control practices are effective in preventing transmission of hepatitis C and scores of other diseases to patients," said Arjun Srinivasan, medical epidemiologist with the federal Centers for Disease Control and Prevention in Atlanta.

The same hand-washing, sterilization and use of barriers already employed by all hospital workers are enough to prevent transmission by ill employees, Srinivasan said. "We don't recommend any kind of categorical restriction just because of hepatitis C," he said.


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Colorado Hep C victims may sue
http://www.denverpost.com
By Jason Blevins and Jennifer Brown
The Denver Post

A 10th case is identified, and lawyers look at Rose hospital's liability

A 10th case of hepatitis C in Colorado was linked to surgery at Rose Medical Center on Tuesday as the state health department continued to investigate new cases of the blood disease.

The latest victim of the hepatitis C outbreak — tied to a surgical technician accused of stealing syringes of the powerful painkiller Fentanyl and replacing them with her used syringes containing saline — is not one of the patients tested since Rose announced the breach Thursday.

Instead, the hepatitis C confirmation was from a prior test submitted to the state health department, said Ned Calonge, the state's chief medical officer. State investigators are interviewing all new hepatitis C victims to determine whether they had surgery at Rose during the time Kristen Diane Parker worked there.

So far, the 10 cases have been linked only through interviews with the patients and not through genetic sequencing, which the state is seeking from the Centers for Disease Control and Prevention in Atlanta.

Meanwhile, lawyers say they are beginning to hear from people interested in their legal options.

"There is absolutely no excuse for a patient contracting hepatitis from a dirty needle in a hospital," said Jim Leventhal, a Denver lawyer who specializes in medical malpractice and has represented Colorado patients exposed to such deadly diseases as Creutzfeldt-Jakob and HIV during hospital stays.

"There are systems in place to prevent dirty needles in a hospital from ever getting used on patients, and in my opinion, there appears to be a system failure."

As many as 5,700 surgical patients at Rose and Audubon Surgery Center in Colorado Springs could have been exposed to the liver-crushing disease.

Victims could sue, but lawsuit caps apply
"The potential victims of this are petrified. Obviously there is great concern," said Larry Schoenwald, whose Schoenwald & Thompson firm has been contacted by patients who may have been exposed.

Those patients could file malpractice lawsuits against the medical facilities.

"I would not be surprised," said Dr. Eric Steiner, a medical doctor and Denver lawyer specializing in medical malpractice with Denver's Gerash Steiner & Toray firm. "We have to know what procedures were followed and what weren't. There are not enough facts right now to know."

Colorado law caps medical malpractice awards at $300,000 for noneconomic, or "pain and suffering," damages. Total awards are capped at $1 million, but a judge can allow higher awards. A legislative attempt to increase those caps, allowing patients to sue for more, fizzled in May.

Combine the wide-ranging impact of the disease, the speculation in assigning a value to a lifetime of potential care needed to treat and manage it and the fact that Colorado juries tend to eschew large malpractice awards, and there probably won't be record-setting decisions stemming from this case.

"I would say the chances for someone to get multiple millions of dollars from exposure in this situation would be very, very low," Steiner said.

Precautions too weak, lawyer charges
There are still grounds for a lawsuit, Leventhal said.

There are many cases across the country where drug-addicted employees have pilfered narcotics from hospitals, exposing patients to danger. And those cases have led to elaborate regulatory systems that both guard the drugs and protect patients.

There are, for example, hospitals that require signatures for each syringe used and there are needles that can only be used once, Leventhal said.

"There are dozens of different precautions that should have been in place and apparently were not in place that would have prevented this from happening," Leventhal said.

Lawyers say that Parker's pre-employment screening by both Rose and the Audubon Surgery Center, where she worked after Rose, will be closely scrutinized should lawsuits develop. Rose was aware Parker had hepatitis C.

"Did they ever wonder why she had hepatitis C?" Leventhal said. "I mean, look at her Myspace page, where she said she had a fascination with needles."


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July 9 2009


AlphaRx Reports Positive Preclinical Data on GAI-122 against Liver Disease
www.medicalnewstoday.com

AlphaRx Inc. (OTCBB: ALRX) reported positive preclinical results on GAI-122 injectable nano-emulsion in multiple models of acute hepatitis, an inflammatory liver disease.

GAI-122 significantly reduced Aminotransferase (ALT), an enzyme released into the blood that indicates damage to the liver, following IP administration in three different preclinical models of acute liver injury. Very high levels of ALT are usually due to acute hepatitis or a viral infection.

In the a-Fas model of liver injury, GAI-122 markedly reduced ALT levels by 90% from baseline, where control ALT values were ~22,000 IU/L. Significant efficacy was also demonstrated in the rat TNFa/Gln model and in the Drug-induced liver injury (DILI) model.

"DILI accounts for more than 50% of acute liver failure and there are no satisfactory treatment options currently available. The excellent efficacy data demonstrated by these studies suggest that GAI-122 may represent a potential first line treatment option for patients with liver disease", stated Dr. Michael Weisspapir, MD, PhD, Chief Medical Scientist of AlphaRx.

In October 2008, AlphaRx licensed GAI-122 to Gaia BioPharma. Under the terms of the amended agreement, AlphaRx is eligible to receive milestone payments of up to $50 million for the successful development and commercialization of GAI-122, as well as royalties on worldwide sales. In addition, Gaia BioPharma has assumed all development costs.

About AlphaRx Inc.
AlphaRx is a specialty pharmaceutical company dedicated to developing proven therapies by reformulating FDA approved and marketed drugs which through the application of its proprietary site-specific nano drug delivery technology, offers improved medical benefits and a potential for significant commercial product development.

About Gaia BioPharma
Gaia BioPharma Limited, a privately held, early stage biopharmaceutical company focused on hospital-based injectable therapeutics. Gaia BioPharma seeks to address key unmet therapeutic needs by taking established compounds and changing their administration routes to create patent-protected, value-added products.


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Liver Failure: Is Molecular Adsorbent Recirculating System Effective?
www.medicalnewstoday.com

Since its introduction in 1993, molecular adsorbent recirculating system (MARS) albumin dialysis has been a subject of research, with the hope of effectively treating patients with acute liver failure. The impact of MARS treatment on outcome as well as clinical and laboratory variables has been investigated widely in small non-randomized studies. However, larger studies with longer follow-up time are required to determine the true usefulness of MARS treatment in different liver failure etiologies.

The research led by Taru Kantola from Helsinki University Central Hospital, Finland discussed the prognostic factors for survival in patients with acute liver failure. The authors analysed the 1-year outcomes of 188 patients treated with MARS from 2001 to 2007, in an intensive care unit specializing in liver diseases.

They found that the etiology of liver failure was the most important predictor of survival. In acute liver failure (ALF) of toxic etiology (e.g., paracetamol), the grade of encephalopathy before MARS treatment was a significant prognostic factor. In ALF of unknown etiology, coagulation factor 5 and liver enzyme alanine aminotransferase levels were prognostic. According to the results, the MARS treatment of a cirrhotic patient with an acute-on-chronic liver failure is not meaningful in terms of prognosis if the patient is not eligible for transplantation.

Reference: Kantola T, Koivusalo AM, Parmanen S, Höckerstedt K, Isoniemi H. Survival predictors in patients treated with a molecular adsorbent recirculating system. World J Gastroenterol 2009; 15(24): 3015-3024.

Source: Lai-Fu Li, World Journal of Gastroenterology


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'It girl' Jazzy de Lisser, 17, breaks taboos on hepatitis C
http://www.telegraph.co.uk
By Cassandra Jardine

Since birth, 17-year-old Jazzy de Lisser has suffered from the insidious virus hepatitis C, which attacks the liver and often leads to cirrhosis. In order to change people’s perceptions, and raise awareness of the disease, she has made an award-winning film about her life and the debilitating treatment she went through.

Already, at the age of 17, Jazzy de Lisser is used to being described as one of London’s It girls. Gorgeous, wealthy and well-connected, she has every ingredient for the role. Her best friend, Coco Sumner, is Sting’s daughter. Her stepfather is the former racing driver Johnny Dumfries, now the Marquess of Bute. And she lives with her mother, Serena, and various whole, half- and step-siblings, in the kind of pared-down Notting Hill splendour that shouts 'cool’.

But behind the gilded externals of her life, Jazzy has a secret so devastating that she hasn’t yet talked about it with many of her friends. When she was six, and word got out that she had hepatitis C, an infectious, blood-borne virus that attacks the liver, she says, 'People wouldn’t let their children play with me, or come to our house. I’m nervous about how others will react when they know that I have a disease they associate with drug users.’

Maids are bustling about the Butes’ steel and pale-wood kitchen, while Serena Bute – who designs clothes under the label Anonymous – supervises the preparation of organic asparagus and artichokes for supper. Healthy eating is a religion in this household where both mother and daughter need to care for their livers. Jazzy, who is wearing the standard teen uniform of summer dress and biker boots, accessorised with friendship bracelets, sips at a cloudy health drink to help her get over the side-effects of a recent treatment for the hepatitis. Her long blond hair, which this winter fell out in handfuls, is slowly growing back, she says, patting the reassuring little tufty bits. The eczema and rages she suffered from are now mostly gone, though she is still unnaturally tired.

The night before we met, Jazzy confessed to Serena that she felt nervous about speaking publicly about her illness, but she is over those nerves now, talking with a quiet resolution that shows unusual maturity. Retreat is not an option, since she has already made huge strides to raise awareness of hepatitis C, an illness that affects an estimated 466,000 people in Britain, many of whom don’t known they have it until they are aged 30-50 and their livers show the signs of damage that lead to cirrhosis and cancer. Over the past two years, while studying for four A-levels, Jazzy has set up a charity, made an award-winning film and commissioned another. Her latest incarnation is as a party planner, raising funds to support research into liver disease, the fifth biggest cause of death in Britain.

'It started with the film,’ she explains, curled up at the end of the leather sofa in her parents’ sitting-room, under huge old film posters. 'I wanted to make a video diary of the treatment, because I had never met anyone of my own age with the virus. It was a lonely thing. I couldn’t talk to my friends about it. No one my age seems to know anything about the liver, they don’t even know where it is. I want to help other people understand but sometimes,’ she falters, 'it is so hard to press on.’

Her film, My Story of C, takes as its starting point October 2007, when Jazzy, then 15, decides that the time has come to beat the virus with the help of Professor Giorgina Mieli-Vergani, a paediatric hepatologist (liver specialist) at King’s College Hospital in London. 'Three viruses, A, B and C, are responsible for most cases of hepatitis,’ Prof Mieli-Vergani says. 'A is caught from contaminated food and drink, and although the effects are dramatic – sufferers go yellow – it passes. B and C are the dangerous ones. In 30 per cent of cases the hepatitis leads to cancer or severe scarring [cirrhosis], which causes the liver to harden, change shape and not function properly. Of the two, B is much more infectious and highly heritable, but there is a very effective vaccine against hepatitis B that is used in most civilised countries, but not Britain. There is no vaccine against hepatitis C, so it is spreading fast.’ The World Health Organisation estimates that 170 million people around the globe may have hepatitis C.

The treatment prescribed for Jazzy consisted of two drugs: Ribavirin to prevent the virus multiplying, and Interferon to boost her immune system so it could kill off the virus. As she embarks on the weekly injections and blood tests, we see her being told by Prof Mieli-Vergani that the chances of success are 40 per cent. It is enough to give her hope that, by the end of it, she will be able to party, have boyfriends and, one day, children without the threat of damaging herself or passing on the virus.

Jazzy needs to cling to that hope because, as she tells the camera at weekly intervals, the drugs make her feel so weak, and give her such crippling headaches, that she often can’t get out of bed. 'Some days I would just wake up feeling furious and take it out on anyone around, usually my mother. It was really hard on my family.’ At the time she had a boyfriend, but not now. 'It’s difficult knowing at what stage to tell boys. I worry because there is a risk of passing it on, no matter how rare… And I don’t really like talking about it.’

During the treatment, she tried to lead as normal a life as possible, skipping neither school nor parties. 'It was difficult because I wasn’t allowed any alcohol. At my age people get off their faces. I had to learn to be with them and not lose my confidence. The whole experience changed me: when I look at the early parts of the film now, I look so shy and nervous.’

The film, which has just won the Media Trust’s competition for short films by 15-19-year-olds, is unflinchingly honest. It shows Serena accompanying Jazzy to hospital appointments, her brother, Joshua, chiding her for staying out late, and her nine-year-old sister, Lola, being understanding about Jazzy’s grumpiness. There is jubilation when, three months into the treatment, she is told that it has worked, the virus has gone. And despair when, after another blood test, she hears that it has returned. It ends in January 2009 with Jazzy receiving the painful news that there is no point continuing because the virus is not responding. All she can do is wait for a better drug to become available. (Even a liver transplant will not help as the virus would infect the new liver.)

Watching Jazzy’s film, Prof Mieli-Vergani was deeply moved. 'Even though I have been treating her since she was three, I cried,’ she says, as she watched the hope die in this young girl’s eyes. She is not the only one.

'It’s all real, I’m not an actress,’ Jazzy says. 'The hardest part was at the end when she told me it hadn’t worked. I wanted them to turn off the camera and throw the film away. I was really upset, but I realised after a while that I was no worse off than before I started; if I can’t change it or fix it, I’ve just got to live with it. Afterwards, it became even more important to make the film, so that some good would have come out of the treatment.’

What the film doesn’t explain is why Jazzy contracted hepatitis C in the first place, only that she acquired it from her mother. That story begins in the early 1980s, long before Jazzy was born. Joining Jazzy on the sofa, Serena Bute is in tears as she explains the guilt she feels because her own youthful folly has blighted her daughter’s life.

Serena Wendell arrived in London, aged 18, straight from a sheltered childhood in Wales that revolved around ponies and boarding school. With her English-rose looks, she soon found herself in the world of modelling and glamorous, druggy parties. 'I was a bit of a rebel and very shy. When I came across drugs they gave me the confidence I’d been looking for. That period didn’t last long: I went into rehab in 1983, when I was 23, and haven’t had a drink or a drug since. At the time, of course, no one knew about hepatitis C.’ (The virus was discovered in 1989).

As many as half of adults infected appear spontaneously to clear themselves of the virus without treatment, according to an American study cited by Prof Mieli-Vergani. But Serena neither knew that she had it, nor that she could pass it on. A few years later she married a Jamaican and had her son, Joshua, now 20, and then, in August 1991, Jazzy. 'When Jazzy was two, she was ill with bronchitis, so I took her for tests. It was then that I learnt that she had hepatitis C – and so did I. I am lucky. Although I have the virus I have not, so far, had any symptoms: my liver is not badly scarred and I haven’t needed any treatment.

'I know a lot of people with hepatitis C who have not passed it on to their children and, fortunately, my other children are free of it. But somehow I had passed it on to Jazzy, and her liver has already been affected. It is a mother’s worst nightmare. My focus since then has been on getting Jazzy well.’

Four years later she left her husband and returned to Britain so her daughter could be treated at King’s College Hospital, the world’s leading centre for paediatric liver disease. In those days Interferon alone was given to boost the immune system. 'It was horrible for her. “I wish I were a mole and could get away from you,” she once said when I tried to give her her injection. I remember her looking so out of place for hospital visits in a tutu and carrying a fairy wand. But, after two months, her white cell count had dropped so low that the treatment had to stop.’

Jazzy picks up the story again from the time when, aged 13, she went to boarding school, Bryanston, in Dorset. Physically she felt fine. As she explains, 'Liver disease is a silent killer. You don’t feel pain until it is so advanced that it is too late to do anything about it.’ Twice the illness was mentioned in PHSE (personal health and social education) lessons, the first time in relation to drug use, the second time with reference to sexually transmitted diseases. 'I remember sitting there feeling so upset, and not being able to say anything. Afterwards I looked on websites and they were terrifying. They said all the bad stuff that would happen – the cancer and liver failure – and they were so complicated that I couldn’t understand them.’

In her teens, she had further tests on her liver. The news was grim. Jazzy’s liver, according to her mother, is like that of a 55-year-old man who has been drinking and taking drugs for years. 'I was advised to have further treatment but Mum, know-ing how horrible it had been when I was little, wanted to try alternatives. She sent me to Austria, where I had leeches put on my stomach and was wired up to Russian machines. I hated it because all my friends were having fun and I was in this health clinic, living on a very strict diet and taking 40 pills and potions a day.’

Desperate to get rid of the virus, she left Bryanston after her GCSEs and, with her great friend Coco Sumner, studied for her A-levels at the Hampstead College of Fine Arts so she could attend hospital appointments in London. 'I was quite freaked by the idea of taking heavy medical drugs. One evening at home I was talking about it to Mel Agace, a documentary maker, who suggested I make a video diary about the treatment. I’m glad I did. It gave me something else to think about, and a reason to learn more about hepatitis.’

Although hepatitis C is widespread among drug users, and is easily passed by dirty needles, tattooing and shared razors, it is relatively rare to contract it in other ways. 'Hepatitis B and C are both highly infectious through the blood,’ Prof Mieli-Vergani says, 'but B is the one which is much more commonly transmitted through sex and “vertically” from mother to baby. Jazzy has been very unlucky.’

The chance of passing the C virus through sexual contact is 10-20 per cent; from mother to child the infection rate is only six per cent. Yet Jazzy became one of the 200 children under 16 in Britain to be infected. A fifth of babies clear the virus from their system spontaneously, but Jazzy was not one of them. Nor does she have the rare genotype linked to an 80-90 per cent success rate from treatment. It was also unusual that her liver already showed signs of damage during her teens – it is a slow-moving disease.

Rare as her condition is, liver disease in general is a major killer, causing more deaths than diabetes and road accidents combined. Yet, when Jazzy asked strangers in the street about the liver (for the film), she found them 'shockingly’ ignorant. Few knew that it is the biggest organ in the body, weighing 2.5kg when filled with blood, nor of its location under the ribs, or even that it filters the blood. The liver’s ability to regenerate, unique among the body’s organs, is well-known, but it is not known that scarring is irreversible. Although deaths from liver disease have doubled since 1991, Jazzy found no one knew that the liver needs a 48-hour rest from alcohol each week, or that obesity also causes damage.

Aiming to educate her contemporaries, she started a charity – Liver Good Life – and had the idea of making an animation to be circulated to schools. 'Most school science videos are so boring. I really wanted this one to be cool. Coco, who has a recording contract, has done the music, and we raised £55,000 to make it.’ Discussions are now under way with the Department of Health to distribute the animation to schools.

Jazzy is deliberating over whether to make her more personal film, My Story of C, widely available, or to turn her 60 hours of footage into a 45-minute version for television. Right now, raising funds has top priority. 'Coco wanted to hold a party,’ she says. 'I said that we should do it in aid of the charity. Now we are doing two: one for adults and another one for teenagers.’

The committee that she has put together is a coruscating line-up of London’s smart set. From Saffron Aldridge and Solange Azagury-Partridge through Bella Freud and Zac Goldsmith, Jools Holland and Sir Elton John to Rachel Weisz and Trinny Woodall, the 60 names on the list should make for a glitzy evening on September 16 when Christie’s has donated its King’s Street premises for the adult dinner. Liver-friendly food will be provided by Skye Gyngell of Petersham Nurseries and Giorgio Locatelli. Coco is organising the music.

The aim is to raise £1.8 million to reconstruct the immunology laboratories at the Institute of Liver Studies at King’s College Hospital in London. Despite the leading role played by the institute in the study of liver disease Serena Bute was 'shocked’ when she visited their laboratories. 'They are Third World,’ she says.

'It is difficult to get support for research into liver disease since there is a widespread view that it is a self-inflicted condition,’ Prof Mieli-Vergani says. 'Nothing could be so wrong: there are devastating genetic or acquired diseases of the liver, in both children and adults, which have nothing to do with alcohol consumption or drugs. I see 400 children each year with liver disease, none of whom have inflicted it on themselves.’

One day, Jazzy de Lisser may find herself snipping the ribbon at the gala opening of the new, upbeat-sounding Jazzy Lab. But first, after the parties, she plans to take a well-earned gap year: she is going to New York in September to do a short film course, and will then be travelling after Christmas, possibly to Africa for some charity work. Her overriding aim, though, is to get well. Ideally she should give her body three years to recover from the last treatment, but she is already hoping that Prof Mieli-Vergani will find her a new, more powerful drug treatment sooner. 'I have promised myself,’ she says, 'that I will beat this disease by the time I am 21.’


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Leavenworth police warning public of illegal tattoo operators
http://www.kansascity.com
By DAWN BORMANN
The Kansas City Star

Leavenworth police are warning the public about unlicensed tattoo operators in the city.

Leavenworth Police Chief Patrick Kitchens said the illegal operators allegedly tattooed at least four juveniles without parental consent.

Police have identified at least three suspects but have not made any arrests. They decided to alert the public immediately because of the public health risk.

Kitchens said one of the juveniles tested positive for hepatitis C in a preliminary test. However, a final test was negative for hepatitis C. Still, the health scare was reason enough to remind residents of the risk from unlicensed operators.

Tattoo parlors must be licensed by the Kansas Board of Cosmetology and the city of Leavenworth. Also, tattoo artists must receive parental permission before giving a tattoo to someone younger than 18, Kitchens said.

The only licensed operator in Leavenworth is Prison City Tattoos.

Kitchens also has asked for the public’s help. Anyone who received a tattoo from an illegal operator or has information regarding the crime is asked to call 913-651-2260.

“If you have done this, please call us. But even if you’re not willing to call us, for crying out loud, go get yourself tested,” Kitchens said.


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The High Cost of Hepatitis C
http://www.kpbs.org
By Alan Ray, Natalie Walsh

This is the first in a 4 part series on Hepatitis C on Public Broadcasting.. Click here to listen to the 30 minute radio interview

Alan Ray: Hepatitis C is an infectious disease that affects the liver. In its chronic form, it is a serious illness which can result in long-term health problems and even death.

Although it can be contracted in a variety of ways, the main risk factor in the spread of the hepatitis C virus is intravenous drug use.

Hep C is now the most common bloodborne infection in the country, but health care workers say there's a simple way to cut down the spread of the disease. They advocate clean needle exchange programs for I-V drug users.

But what for some is a simple practical solution, is for others, an ideological deal breaker.

Guests

  • Kenny Goldberg, KPBS health reporter whose four-part series on the epidemic of hepatitis C airs this week on KPBS radio.
  • Dr. Anthony Martinez, professor of medicine at UCSD in the Division of General Internal Medicine.

This is the first in a 4 part series on Hepatitis C on Public Broadcasting.. Click here to listen to the 30 minute radio interview.


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Syringe Exchange Widespread in New York City
http://www.kpbs.org/
By Kenny Goldberg

U.S. — New York City has more IV drug users than any other city in the U.S. To prevent the spread of blood-borne diseases like hepatitis C, it has a wide network of clean syringe exchange programs.

In the final part of a four-part series, KPBS Health Reporter Kenny Goldberg travels to New York to look into the situation.

When it comes to distributing clean needles, New Yorkers don't beat around the bush.

"Free condoms, free oral sex protection, free syringes, free services…"

On a rainy day in East Harlem, Ivonne Amador hands out her wares. They're designed to keep injection drug users from spreading diseases like hepatitis C and HIV. Amador says she and her partner give out a lot of clean syringes on a typical day.

"Well so far, we're doing like 4,000," Amador says. "And we do two sites: one on 198th street in the Bronx on Wednesdays, and we also do 104th and 3rd on Saturdays, from 10:30 a.m. to 1 p.m. So there's a great demand for it."

Amador is part of a growing number of New Yorkers who are involved in what's called peer exchange. These specially trained people go to parks, street corners, or wherever drug users hang out, and distribute equipment.

Unlike in San Diego, people in New York can buy syringes over-the-counter at local drug stores. And New York has a wide network of traditional syringe exchange programs.

In a different part of East Harlem, New York Harm Reduction Educators runs an exchange on Saturday mornings. IV drug users are allowed to take as many syringes as they can carry.

A woman named Maggie throws some syringes away, and grabs some clean ones.

"I come here maybe twice a month," Maggie says. "I drop 'em in the bucket, I show my ID card, they don't ask no personal information, you know, they get to know your face. They ask how many you need, you pick whatever, you know, your alcohol pads, the water, they got everything right here for ya."

Maggie has been shooting heroin on and off for 30 years. She says before New York had syringe exchange programs, it was much more dangerous.

"There was times where you had one set, and three or four people sat around a circle and everybody waited for the next guy to finish using, 'cause it got passed around," recalls Maggie.

Sharing needles helped fuel the HIV epidemic. In 1990, 54 percent of injection drug users in New York City were HIV positive.

To combat the disease, state lawmakers legalized clean syringe exchange programs in 1992. By 2001, the HIV rate among IV drug users in the city had fallen to 15 percent.

Today, health officials are hoping they can get a similar reduction in hepatitis C rates.

"Hi, my name is Melissa, and I haven't, I'm glad I'm in the hep C group because I've only been hep C positive for like, I found out two years, maybe I've been longer, maybe not. But when I found out I was really upset."

The Lower East Side Harm Reduction Center holds a hepatitis C support group a couple of times a week. It also runs a syringe exchange.

Daliah Heller is an assistant commissioner with the city's office of drug use prevention. She estimates more than 60 percent of IV drug users in New York are infected with hepatitis C.

"It's of paramount importance that we are able to help people get educated about their risk, or about their possibility that they're infected, and how to prevent transmission of that infection," Heller says.

Heller says clean syringes exchanges are getting the word out about hepatitis C. They provide testing and referrals to treatment, too.

There are 12 exchanges operating throughout the city. They're supported by a combination of public and private funds.

Heller says in a recent one-year period, exchange programs gave out 1.9 million syringes, and collected 1.5 million. She estimates there are between 40,000 and 110,000 IV drug users in the city.

"The truth is people who are injecting drugs are still human beings, and they have the right to stay alive," Heller says. "And you know, as they say, dead addicts can't recover. People deserve an opportunity to have a life, and that's the basic message of harm reduction and syringe exchange."

But are clean syringe exchange programs the answer to the hepatitis C problem? Maybe they would be, if all IV drug users used them. But they don't.

In New York City, officials estimate only about 10 to 20 percent of injection drug users go to syringe exchanges.


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July 10 2009


Vertex to sell rights to hepatitis C drug payments
www.reuters.com

NEW YORK, July 10 (Reuters) - Vertex Pharmaceuticals Inc (VRTX.O) said on Friday it planned to sell rights to future milestone payments tied to progress in Europe for its high-profile experimental hepatitis C drug.

The payments would come from Johnson & Johnson (JNJ.N), which licensed European rights to the drug, telaprevir, three years ago from Vertex. Vertex retains rights to the drug in North America.

The milestones anticipated for telaprevir in Europe include $100 million related to regulatory filing and approval for telaprevir and $150 million related to its launch. Vertex expects to earn these payments before April 2012, based on the drug's projected timeline.

Telaprevir is being studied in three late-stage studies with more than 2,200 patients in the United States and Europe. Data from the studies are expected to be available in mid-2010.

Morgan Stanley is advising to Vertex in connection with the transaction. (Reporting by Lewis Krauskopf; Editing by Derek Caney)


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Time to Hepatitis C Infection in Injection Drug Users Lengthening in Developed Countries
http://www.drugabuse.gov/

Hepatitis C (HCV), a blood-borne infection that can cause liver damage and death, is very common among injection drug users (IDUs) and is transmitted mainly by the sharing of drug preparation or injection equipment. Researchers funded by NIDA have found that the time from onset of injection drug use to HCV infection for IDUs in developed countries has lengthened since 1995.

The researchers analyzed 72 studies of HCV infection in IDUs published between 1989 and 2006. In addition, the researchers compared studies from developed countries (such as the United States) with studies from developing countries. They also compared studies completed before 1995 with studies completed after 1995 to measure the impact of increased HIV/HCV awareness in developed countries.

They found that in developed countries, HCV prevalence in IDUs who had been injecting drugs for less than 2 years had declined from an estimated 53 percent before 1995 to 38 percent more recently.

The prevalence in developing countries remains higher—for example, a 59 percent prevalence of HCV infection at 1 year of drug injection. Whether or not the prevalence in developing countries had decreased at all since 1995 could not be determined because only one study collected data on HCV in developing countries before 1995.

Although the results show that many IDUs avoid HCV infection in the first year of drug injection, a substantial proportion of new injectors still acquire HCV rapidly.

The authors conclude that a heavy investment in public health resources will likely be needed to make further gains in HCV prevention.

Source:
Hagan H, Pouget ER, Des Jarlais DC, Lelutiu-Weinberger C. Meta-regression of hepatitis C virus infection in relation to time since onset of illicit drug injection: The influence of time and place. Am J Epidemiol. 2008;168(10):1099–1109.


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Health GAP Applauds First Step to Remove Ban on Federal Funding for Syringe Exchange Programs
www.commondreams.org

Calls for the Obama Administration to Take Leadership

WASHINGTON - July 10 - Health GAP (Global Access Project) on Friday applauded the courage shown by leaders in the House of Representatives including Chairman David Obey, who removed language from an appropriations bill that, for the past two decades, has banned the use of federal funds for syringe exchange programs. AIDS activists called for the President and his administration to help ensure the bill with Chairman Obey's change becomes law.

"Providing clean syringes is proven to be one of the most effective public health interventions since the polio vaccine. It is clear that it works, and now we urge the Congress to follow Chairman Obey's lead in giving local health experts the freedom to use every possible resource to make it widely available," said Jennifer Flynn, Managing Director of Health GAP. Flynn lost a family member in 2005 to hepatitis C contracted from sharing used syringes. "If needle exchange programs were around when my cousin was injecting heroin, he would be alive today. Rep. Obey has taken the first step now it is up to the rest of the Congress and the administration to see that science and medicine trump ideology," she continued.

On Thursday June 9, 26 AIDS activists from across the Northeast U.S. were arrested during a powerful protest, where they occupied the Capitol rotunda. They were protesting the President's failure to act on his campaign promises to lift the federal ban on funding syringe exchange, and to fully fund lifesaving AIDS programs.

Health GAP called today for President Obama to renew his pledge to lift the ban during the campaign. In recent statements and briefings to AIDS activists the administration has suggested that it was waiting for Congress to take action but has removed references to Mr. Obama's support for needle exchange from the White House web site and back tracked on public support.

"Thousands of people have died in the past decade because clean syringes aren't available," said Jose De Marco, an HIV+ member of ACT UP Philadelphia and Proyecto Sol Filadelphia. "President Obama, who many of us worked to elect, promised to follow the science and lift the federal funding ban on needle exchange. Now that Congress has begun the process we need the President to make good on the promise he has failed to enact thus far."


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