Hepatitis News Ticker- Crossing The Border For Testing-IL28B and New and experimental HCV Treatment

Reading the News 1865 by Edward Lamson Henry


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New and experimental hepatitis C treatment
Up to 83% of individuals with chronic hepatitis C virus achieved a sustained virological response after receiving the investigational drug BMS-790052 in combination with pegylated interferon and ribavirin, results of a study presented to the 51st Interscience Conference on ... The US Food and Drug Administration has approved a new hepatitis C drug


This story is from HepCBC October Newsletter, make sure you check the newsletter in November for part two. Also in the newsletter "New Cure On The Block" by Andrew Chien Truong, M.D. Click here to read the entire newsletter.

QUEST: CROSS-BORDER
TESTING

by Alp
PART I

A certain genetic polymorphism near theIL28B gene found in individuals infected with the most common type of HCV, HCV genotype 1, can aid in predicting those patients who are up to twice as likely to eliminate the HCV virus when treated on a sustained basis with pegylated interferon ribavirin combination therapies (compared to those without this specific polymorphism).

I decided to drive to the U.S. to have a blood test done that is not (yet) available in Canada. What follows is what happened along the way. Sections of dialog are from memory and are not necessarily written exactly as spoken, in its entirety or in the exact sequence things were actually said.

It was clear sailing until I approached the Canadian/U.S. border. An electronic sign said, “40 minute wait time.” As I waited inline I noticed it was moving well enough, stop and go. I thought I might make it through in less than 40 minutes. I then drove past 3 US border personnel who were out looking at traffic a few car lengths before the border booths. As I drove past I noticed in my rear view mirror one of them turned and was following me. I slowed and stopped.“Must be a random check,” I thought."Open your window, hood and trunk. Turnoff your engine". I did so.

"Where are you driving from?"

"Vancouver.""What is the purpose of your trip?"

"I am going for a medical test.""What sort of test?"Oh boy. That was an area I was not comfortable going to. If I mentioned hepatitis C they would think I was a drug user and search the vehicle. I decided to be specific."It is for interleukin 28B. It's a genetic test."

One US customs agent was asking the questions while the other two searched my trunk, back seat area and fluid compartments under the hood. I remained seated behind the wheel."You can't get this test done in Canada?"

"No, it is not available in Canada yet."

"Where are you going for this test?"

"I have to go to a walk-in clinic in Bellingham to see a doctor for a requisition for the test; then I am going to the diagnostic clinic for the blood draw."

"You have a medical problem?"

“Here it comes…” I thought."I have a liver condition.""And how are you going to pay for this?"

"Cash or credit card," I replied."

Are you bringing any merchandise in with you?"

"No".

"Are you going to buy gas?" They had seen the 2 empty gas cans I put in the trunk for the trip."Yes, I was going to get some on the way back," I replied. He seemed satisfied. The other 2 were done looking for whatever. I was waived on. I rejoined traffic toward the customs booth.

At the booth was more of the same.

"Where are you coming from?"

"Where are you going?"

"Purpose of trip?..."

I was asked if I had any papers or medical forms or a letter from a doctor for this test. I replied I did not. I said I had arranged it all by telephone yesterday and I was told I needed a requisition from a U.S. doctor."Why do you need this test?" I told him it was to determine how I would respond to treatment for hepatitis. There.. it slipped out.

"Where is this clinic you are going to?"I read out loud the address of the walk-in clinic I had written on a paper that was in my shirt pocket to the customs agent in the booth.

"What's that?" the agent seemed to be indicating the GPS I had hanging from my rear view mirror."It’s a GPS," I replied."Why do you have it there?" He seemed to be asking why it was hanging from my rear view mirror."So I don't have to hold it," I replied, hoping it didn't sound too cocky. It was a hand held GPS, and I did not have a proper holder for it on my dash.

"How long do you expect to be in the United States?"

"I hope to be back sometime this afternoon."The customs agent scribbled something on an orange pad. He pulled off a page and slapped it on my windshield. It stuck there."Follow the yellow arrows," he said.

This had not happened the few times I had visited the U.S. in the past. This could not be good. I followed the yellow arrows that were painted on the pavement until there were no more. I was at the entrance to what looked like a parking lot. There were several dozen cars parked there. There did not appear to be any sign telling me how to proceed in or any customs agent in sight. I did not know what to do.

Uncertainly, I headed towards a vacant parking spot. As I did so I saw some other people, one who was holding an orange paper just like mine. I parked and walked over. A customs agent was with them. She seemed receptive to my advance and I said, "I was told to follow the yellow arrows, but the arrows have stopped. What should I do?" I was directed to take the orange paper to the building next to the parking area. I was told to leave my car keys on the windshield. I did so and went into the building.

There was a long, long line of people.There must have been a hundred people inline. “Great. I'll be here for hours and the clinics will be closed by the time I get out,” I thought. I noticed there were 2 lines. One had a sign was marked “#3 Referrals." The other was marked "#2 Pedestrians and referrals." I did not notice the lack of a line #1 at the time. Line #2 was WAY shorter than the line #3. It only had about 20 people in it! My hopes went up a notch.

I looked at my orange paper. It said nothing about pedestrians nor referrals. An agent was at a desk near the doorway.There were other agents behind desks but access to them required a lengthy wait in one of the lines. I went to the agent at the door. I handed him the paper. I asked where I should go."Go to line 2," he said."Line 2?" I said hopefully. "Thank you!"I entered line 2. I was in line 2 for no more than about 3 minutes when the customs agent I had spoken to at the customs booth came up beside me and told me to follow him. There was another agent with him who had sunglasses on. I was being led BACK away from the direction of the movement of the line to a different part of the building. There were not travelers here.

The agents directed me to walk down a hallway. They followed me. As we walked I was asked if there was anything in my car that was illegal. "Not to my knowledge," I replied. Was there anything in the car that they should know about? "No." I was told to enter the door on my left down the hall. The agents followed behind. The hallway was stark. The walls were cement blocks painted off-white semi-gloss. The doors were the same color and were offset slightly into the walls. “Great! I am going to get strip-searched and probed,” I thought.

When I got to the door the agent from the booth said I should try to open it, but that it might give me some trouble. I tried to open it. It was locked. The agent brought forth a card and swiped it somewhere. They opened the door for me. I entered….

Will our hero be sent to Guantanamo Bay? Will his car be found to hold illegal metric-size tools? Will he get his blood test done, or will he be permanently deported?
All these will be answered in our next issue.


Media

Lawyers in hepatitis trial blame three firms, ask jury to award $25 million in damages

Lawyers for three people infected in Southern Nevada's hepatitis C outbreak don't deny that nurse anesthetists' risky injection practices played a role in spreading the disease.But in an ongoing product defect trial against the companies that made and sold the drug linked to the outbreak, lawyer Robert Eglet said Wednesday the outbreak wouldn't ...


Transplant


Pregnancy Raises Risk of Liver Graft Loss
BY MITCHEL L. ZOLER
Elsevier Global Medical News
PHILADELPHIA –

Women who become pregnant after receiving a liver transplant face an elevated risk of graft rejection,especially during or immediately after the pregnancy,based on a review of 161 cases.“The data suggest poorer outcomes for both mothers and their newborns in female liver recipients with risk factors for graft loss within 5 years post pregnancy,” Dr. Carlo B.Ramirez said at the American Transplant Congress.“The findings highlight the high-risk nature of this group,warranting closer follow-up of both mother and child,”said Dr. Ramirez, a transplant surgeon at Thomas Jefferson University, Philadelphia.

Of the 161 women who became pregnant following a liver transplant and were enrolled in the National Transplantation Pregnancy Registry, 16 women(10%) lost their graft within 5years following their first post transplant pregnancy. Risk of graft loss was particularly high during pregnancy and for 3 months after, with half of the women who eventually lost their graft experiencing rejection during that time. Ina multivariate model that took into account baseline risk factors, women with a liver transplant faced a 14-fold increased risk for graft loss during the pregnancy, Dr. Ramirez said.“A lot of patients who have a stable equilibrium with their graft may destabilize under stress. It is possible that there is low-grade, clinically insignificant rejection in some of these patients prior to pregnancy”that then becomes exacerbated by the stress of pregnancy, commented Dr. Jean C. Emond, professor of surgery and director of transplantation at Columbia University in New York. Dr. Emond suggested that a liver biopsy prior to pregnancy might be warranted to assess the stability of the transplant.

Other risk factors for graft loss included younger age of the mother and low gestational age at the time of delivery. In the multivariate analysis, the risk for graft loss fell bya statistically significant 26% for each additional year of age for the mother. Graft loss fell by a statistically significant 5% for each additional week of gestational age when delivery occurred.

Among the 16 women who lost their graft during pregnancy or in the following 5 years, their average age when they conceived was 22years old, compared with an average age of 28 years among the 145women who did not lose their graft. Average gestational age at delivery was 33 weeks among the women who lost their graft, and 37weeks among the women who did not lose their graft.The liver transplants had been performed at an average age of 18 years among those who later lost their grafts, versus 23 years for those whore tained their grafts. However, the average time between transplantation and conception was an identical4.3 years in both groups.

The only other risk factor for graft loss that approached statistical significance in the multivariate model was viral hepatitis as the etiologic agent for the liver failure that led to the transplant. Viral hepatitis was the cause of liver failure for six (38%) of the women who lost their grafts following pregnancy,and for 23 (16%) of the women who did not lose their grafts.

In the multivariate model, viral hepatitis as the cause of liver failure was linked with a nearly fourfold increased risk for women losing their graft during or after pregnancy, but this relationship failed to meet the standard criterion for statistical significance,Dr. Ramirez said.

The congress was sponsored by the American Society of Transplant Surgeons. Dr. Ramirez said he had no disclosures.

The National Transplantation Pregnancy Registry has been supported by grants from Novartis, Astellas, Genentech, Pfizer,Teva, and Sandoz.

These data are important. I four goal is to return patients to a normal life after transplant, for women of child bearing age this often includes pregnancy. We need to inform women of the risks, and emphasize the need for ongoing compliance with immuno suppressive medications, with closer monitoring during and just after delivery.Many women are afraid ofthe potential adverse effects of these medications on their fetus,and perhaps part of the risks seen in this study are related to medication noncompliance or changes in drug metabolism that could be improved with education and monitoring.

DR. ROBERT S. BROWN JR.,AGAF, is the Frank Cardile Professor of Medicine and Surgery and Chief of the Center for Liver Disease and Transplantation at Columbia University College of Physicians and Surgeons, New York.

This month's American Journal of Transplantation provides summary recommendations on influenza vaccination in the organ transplant recipient.

Influenza virus causes a spectrum of illness in transplant recipients with a high rate of lower respiratory disease.

Dr Deepali Kumar and colleagues Canada investigated seasonal influenza vaccination as an important public health measure recommended for transplant recipients and their close contacts.

Vaccine has been shown to be safe and generally well tolerated in both adult and pediatric transplant recipients.

Seasonal influenza vaccine has demonstrated safety
American Journal of Transplantation

However, responses to vaccine are variable and are dependent on various factors including time from transplantation and specific immunosuppressive medication.

The research team reported that seasonal influenza vaccine has demonstrated safety and no conclusive evidence exists for a link between vaccination and allograft dysfunction.
Annually updated trivalent inactivated influenza vaccines have been available and routinely used for several decades, although newer influenza vaccination formulations including high-dose vaccine, adjuvanted vaccine, quadrivalent inactivated vaccine and vaccine by intradermal delivery system are now available or will be available in the near future.
Safety and immunogenicity data of these new formulations in transplant recipients requires investigation.

Dr Kumar's team commented, "In this document, we review the current state of knowledge on influenza vaccines in transplant recipients and make recommendations on the use of vaccine in both adult and pediatric organ transplant recipients."
Am J Transplant 2011: 11(10): 2020–2030


Survival outcomes good for split liver transplants

Reuters Health • The Doctor's Channel Daily Newscast

video


NEW YORK (Reuters Health) – Split liver transplantation results in “excellent” patient and graft survival for both pediatric and adult patients, according to the authors of a new single-center retrospective review. While postoperative morbidity was high, “this is justifiable owing to limited resources,” Dr. Parsia A. Vagefi of the University of California San Francisco and his colleagues conclude in the September issue of the Archives of Surgery.


In a split liver transplant, or partial graft, the donor organ is divided and transplanted into one adult recipient and one child. There are two approaches to the surgery: ex vivo, in which the liver is divided after removal from the donor; and in situ, which involves dividing the liver while it is still in the donor’s body, similar to the protocol used in a living donor transplant. While split liver transplantation has been in use for decades, it still has not gained wide acceptance, Vagefi and his team note; just 3 percent of donor livers are split.

The UCSF researchers conducted a review of 106 patients treated at their center between 1993 and 2010 in order to assess outcomes and compare results with ex vivo and in situ procedures. Vagefi and his colleagues perform the ex vivo procedure exclusively, but 20 patients in the study did receive donor organs that had been removed using the in situ technique at a different center.

Among the 63 adult recipients, one-, five-, and ten-year survival were 93 percent, 77 percent, and 73 percent; overall graft survival was 89 percent, 76 percent, and 65 percent, respectively. After in situ procedures, one-year survival for both patient and graft were 94 percent, and five-year survival was 75 percent. There were no significant differences in survival for the adults who received ex vivo or in situ transplants. Overall one-, five-, and ten-year survival was 84 percent, 75 percent, and 69 percent for pediatric patients, while overall graft survival was 77 percent, 63 percent, and 57 percent. Survival for ex vivo and in situ split grafts was not significantly different.

Twenty-nine percent of adult patients developed biliary complications, while 11 percent had vascular problems and 11 percent required unplanned exploratory surgery. Eight percent developed incisional hernia, while one patient each had small for size syndrome, required a shunt when the transplant was performed, or had primary nonfunction of the donor organ. In the pediatric patients, there was one case of primary nonfunction, while 40 percent of patients developed biliary complications and 26 percent had vascular complications.

“We recognize that there is a higher risk associated with split liver transplantation in terms of potential complications, and we inform our patients that it’s a decision they have to make,” Vagefi told Reuters Health. “If they’re willing to assume that extra risk with the hope of getting transplanted earlier, these are the patients who choose to consent for split liver transplant.”

The current findings can’t show whether ex vivo or in situ splitting is best, Vagefi noted in an interview. “Whichever technique people become comfortable with being able to apply, that is only going to be able to help more recipients in the end.” Dr. Johnny C. Hong, director of the Living Donor Transplantation Program at the David Geffen School of Medicine in at UCLA, agreed. “Whatever is your comfort zone that will allow you to achieve the best results, then you should practice that,” said Hong, who co-authored an editorial accompanying the new study.

In order to expand the use of split liver transplantation, Hong noted in an interview, it will be necessary to train more surgeons to do it, and identify a learning curve for the procedure. “It’s a technically very highly demanding procedure,” he said. “You don’t want people to start doing this Rambo-style. It would cost people’s lives and waste organs.”
Reference: Outcomes With Split Liver Transplantation in 106 Recipients
Archives of Surgery, September 2011.


Hepatitis C Virus Core Protein Induces Fibrogenic Actions
Chronic HCV infection is a major cause of liver fibrosis, yet little is known about HCV-specific steps in its pathogenesis. What is the role of HCV in establishing a profibrogenic state?


Pharmaceuticals


Congress Probes Distributors Over Drug Shortages
Secondary drug distributors are now the focus of a congressional probe in the worsening prescription drug shortage. Elijah Cummings, the ranking Democrat on the House Oversight and Government Reform Committee, has given five distributors two weeks to respond to questions after hospitals have complained that they have received offers of hard-to-find meds at huge mark-ups.

The move comes shortly after the Associated Press reported that shortages are responsible for at least 15 patient deaths and that secondary distributors are selling drugs for chemotherapy, anesthesia and infections for inflated prices; in some cases, at up to 80 times the normal price...


Cancer


Older cancer survivor population to increase substantially
6-Oct-2011
PHILADELPHIA — Over the next decade, the population of cancer survivors over 65 years of age will increase by approximately 42 percent.

"We can expect a dramatic increase in the number of older adults who are diagnosed with or carry a history of cancer," said Julia Rowland, Ph.D., director of the Office of Cancer Survivorship in the Division of Cancer Control and Population Sciences at the National Cancer Institute (NCI). "Cancer is largely a disease of aging, so we're seeing yet another effect of the baby boom generation and we need to prepare for this increase."

Rowland's report is part of the special focus on cancer survivorship, published in the October issue of Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research. Rowland and colleagues analyzed data from the NCI Surveillance, Epidemiology and End Results Program. This report on cancer survivorship statistics will be updated and published on an annual basis.

They found that in 1971, the year the National Cancer Act was signed, the survivor population was approximately 3 million, which increased to nearly 12 million in 2008, the last year data are available.

In 2008, 60 percent of the cancer survivors were at least 65 years old. The NCI projects this number will increase to 63 percent by 2020.

The most common diagnosis among cancer survivors includes female breast cancer (22 percent), prostate cancer (20 percent) and colorectal cancer (9 percent). Researchers attribute this high survival to improved detection and screening. Lung cancer, which is by far the most diagnosed cancer in men and women, is much lower in the survivor population at just 3 percent.

Rowland said the health care community needs to prepare for the coming wave of cancer survivors who will present some unique challenges. As a population, the number of oncologists and geriatric specialists is decreasing just as the need for these specialists is increasing.

"We may be fortunate in that the aging population is healthier than in previous generations, and new technologies could allow for better communication and follow-up," she said.

Follow the AACR on Twitter: @aacr #aacr

Follow the AACR on Facebook: http://www.facebook.com/aacr.org

The first clinical uses of whole-genome sequencing show just how challenging it can be.

The first thing Debbie Jorde noticed about her newborn daughter was that her arms were bent at unnatural angles. She had other problems, too: a cleft palate, eight fingers, eight toes and no lower eyelids. She would eventually be diagnosed with Miller syndrome, a disease so rare that doctors have long assumed that each case arises through spontaneous mutation, rather than being passed down through families. Doctors told Jorde that her chances of having a second child with the syndrome were less than one in a million.

They were wrong. Jorde's son, born three years after his sister, had the same features. Lynn Jorde, Debbie's current husband and a geneticist at the University of Utah in Salt Lake City, still cringes when Debbie recounts what the doctors had told her. "The right answer for that situation is that there have been so few cases that we really can't predict the risk," he says......


For Your Reading Pleasure


Grand Rounds
Grand Rounds is a weekly summary of the best health blog posts on the Internet. Each week a different blogger takes turns hosting Grand Rounds, and summarizing the best submissions for the week.


A few submissions from this weeks grand rounds below, to read more click here

Henry Stern of InsureBlog brings us an interview with the whistleblower who has brought a lawsuit against LabCorp for allegedly charging a lower price to United HealthCare than to Medicare. The post is particularly interesting because Hank adds his own thoughts after the interview, and he sees things a little differently than Andrew Baker (the whistleblower). Hank agrees that it does look like LabCorp lowered their fees for UHC, but they charged the allowable amount to Medicare; Hanks position is that the UHC-LabCorp deal could be seen as a discount-for-volume arrangement and that it shouldn’t impact their business with Medicare. Andrew feels that Medicare should also have received the lower rate and thus saved taxpayers money. Read through the interview and Hank’s follow-up and see what you think. Definitely an interesting look at where the free market and healthcare collide.

Allison from Diabetes Mine gives us the details on a new continuous glucose monitor that will talk to your iPhone, call someone if the alarm sounds and you don’t respond, and doesn’t puncture the skin. It’s worn on a belt under your shirt and the sensor works by just being next to your skin. Allison notes a few downsides – including the $4000 price tag – but it sounds like this device will be helpful to a lot of people, especially if they can extend the battery life (or provide several back-up batteries) and make it a bit easier to wear.


In Memory


Apple Founder Steve Jobs Dies at 56
Tech Innovator Had Been Battling Pancreatic Cancer for Years
Matt McMillen

October 5, 2011 — Steve Jobs, the visionary co-founder of Apple Inc. who revolutionized the way we use technology, died today after fighting advanced pancreatic cancer since 2004. The death was announced by the company he helped found.

"Apple has lost a visionary and creative genius, and the world has lost an amazing human being," Apple stated in a note on its web site. "Those of us who have been fortunate enough to know and work with Steve have lost a dear friend and an inspiring mentor. Steve leaves behind a company that only he could have built, and his spirit will forever be the foundation of Apple."

Unlike many famous people diagnosed with cancer or other fatal illnesses, Jobs revealed few details about his health after he was diagnosed with pancreatic cancer.

That was also true when he resigned from the company in August 2011. Jobs shed little insight on his condition in this excerpt from his letter to the Apple Board of Directors:

“I have always said if there ever came a day when I could no longer meet my duties and expectations as Apple’s CEO, I would be the first to let you know. Unfortunately, that day has come.

"I hereby resign as CEO of Apple. I would like to serve, if the Board sees fit, as Chairman of the Board, director and Apple employee.”

He was, however, willing to talk about death, as he did in this 2005 commencement speech at Stanford University. He shared his relief at the time that he was diagnosed with a rare form of pancreatic cancer — one did not mean an immediate death sentence. Yet he was realistic about his future:

“Remembering that I’ll be dead soon is the most important tool I’ve ever encountered to help me make the big choices in life. Because almost everything — all external expectations, all pride, all fear of embarrassment or failure — these things just fall away in the face of death, leaving only what is truly important. Remembering that you are going to die is the best way I know to avoid the trap of thinking you have something to lose. You are already naked. There is no reason not to follow your heart.”

Legendary Career

In his nearly four-decade career, Jobs oversaw the development of some of the most iconic tech products of the past half century.

He co-founded Apple Computer Inc. in 1976. Based in Cupertino, Calif., the company developed one of the first commercially successful personal computers, the Apple II. Less than 10 years after its founding, though, Apple’s business had lost its momentum, and, in 1985, Jobs was forced to resign.

A year later, Jobs helped found Pixar, the independent animation studio that produced Toy Story and its two sequels, Monsters Inc., Ratatouille, and a host of others Academy Award-winning computer-animated films.

Jobs returned to Apple in 1996. The following year he was named CEO, a position he resigned in August 2011


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