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  Who Tattoos? Anyone who wants to, say critics seeking better regulations

Liver Biopsy Not Foolproof

Treatment-related Depression Is the Most Significant Factor Affecting Health-related Quality of Life in Chronic Hepatitis C

Risk Factors for Graft Survival After Liver Transplantation From Donation
After Cardiac Death Donors: An Analysis of OPTN/UNOS Data

Does Use of Complementary Treatments with Peginterferon plus Ribavirin Combination Therapy Provide a Benefit to Patients with Chronic Hepatitis C?

Blacks with HCV Genotype 1 (but Not Genotypes 2 or 3) Have a Lower SVR Rate Than Non-Blacks That Is Not Related to Dose Reductions of Interferon and Ribavirin

What Actually Happens to Patients Newly Diagnosed with Hepatitis C Virus Infection?

“A la Carte” Hepatitis C Therapy

 

Who Tattoos? Anyone who wants to, say critics seeking better regulations
By Michael Andersen
Apr 11, 2006


When Linda Keller wanted to become a manicurist, she had to prove she'd
taken 500 hours of beauty school classes and pass a written test
administered by the state of Washington.

When the cosmetologist, who works at Contempo Designs in West Kelso, decided
to add tattoos to her repertoire, she didn't need to prove she knew a thing.

In Washington, said Keller, "anybody can do tattooing."

As tattoos -- ink patterns injected on the body by repeatedly puncturing the
skin with clusters of needles --- become more and more common in modern
culture, some citizens and tattoo artists have begun to call for tighter
regulation of the age-old practice.

Like a manicure or any other open wound, an unsafe tattoo can become a
portal for viruses such as Hepatitis B, which can survive on a surface for
months and, upon infection, seriously damage the liver. But such risks
haven't stopped tattoos from surging in popularity since the 1970s.

Some say Washington has failed to keep up with the times.

"Your state, for want of a better word, just wants to put their head in the
mud," said Bill Johnson of Orlando, Fla., secretary of the Alliance of
Professional Tattooists. In February, the state Senate unanimously approved
a bill that would have required inspections and licenses for all tattoo and
piercing shops, at an estimated annual cost to taxpayers of $1 million. The
measure died in the House.

"Many in the Legislature feel that the time is right to regulate the
tattooing and piercing industry," said Brad Benfield, a spokesman for the
Washington Department of Licensing. "They just couldn't agree on how this
year."

While many health officials and tattoo artists say the industry needs more
oversight, they're not sure how to do that. Should the government require
licenses? Perform inspections? Up the penalties for violating current law?
Wait for their industry to solve its own problems?

Tattoo artists frequently argue that even under current law, the best
parlors are as safe and clean as a doctor's office. The problem, they say,
lies with the bad ones.

"Eight-five percent of the shops in the state are scary to walk into," said
Sean Gilhuly, owner of Outside the Box in Longview.

Like most tattooists, Gilhuly is passionate that the worst parlors must
improve. Like many, he's open to increased regulation, but isn't quite sure
how it would work. He's more comfortable talking about the ways his
colleagues could better regulate one another: requiring longer
apprenticeships, keeping consumers better informed.

[A previous version of this story, and today's print edition, misattributed
the last two paragraphs to another local tattooist.]

But others think that system has failed.

For Allen Reay of Longview, whose underage granddaughter says she was
illegally tattooed by a man working out of his kitchen, one key is to keep
tattoos out of private homes. He plans to ask the city of Longview to
require this of tattooists.

It's impossible, Reay believes, to guarantee that any part of a home could
be fully sterile. "It's a legitimate business," he said. "They should have a
legitimate store."

Still others, like Jason Goodrow of Punktured Tattoo in Longview, say
current laws might be enough if enforcement were stricter.

A 2001 state law required the state to set sanitation standards for
tattooists. For example, artists are now forbidden from reusing needles,
required to put their equipment through regular spore tests, and must
sterilize their ink barrels in a steam autoclave or dry-heat sterilizer.

But the rules rely on local police for enforcement. All violations are
merely misdemeanors, which makes them a low priority for many departments.
And even if a tattooist is convicted, the state can't threaten to pull a
nonexistent license.

If laws are flawed, it's because the state needs time to work the kinks out,
said Troy Amundson, a Seattle body artist.

"Our industry is new," said Amundson, who has led body artists' recent
lobbying efforts in Olympia. "We will have to get some laws in place, work
with them for a little while."

Rapidly tightening the laws might be dangerous, Amundson said. The more the
state requires of legitimate artists, the more it invites others to operate
beneath the radar.

Amundson believes his industry will gradually develop better
"self-regulation," developing schools and national networks to share safe
practices. In the meantime, he thinks good tattooists tend to be cleaner
than many dental assistants, barbers and, yes, manicurists.

"There are plenty of exposures that people don't think about," he said.

Finally, there are tattooists like Keller, who now offers cosmetic tattoos
such as lip and eyelash accents. She says she keeps her clients
well-informed of her rigorous sanitary procedures.

But when it comes to regulation, she sounds like almost any other small
businesswoman.

"I think we're OK the way we are," she said. "I just hate for government to
step in too much."
------------------------------------------------------------------------------------------------------------------------------------
Tattoo safety

The Daily News asked three local tattooists Jason Goodrow of Punktured
Tattoo and Piercing, Sean Gilhuly of Outside the Box, and Linda Keller of
Contempo Designs, for advice on choosing a good shop.

• Ask the artist to describe, in detail, how, when and where he or she
learned to tattoo. Ask if the artist has been tattooing continuously since.
• Ask to see certificates from a blood-borne pathogen class, from the Red
Cross or Alliance of Professional Tattooists.
• Look for a separate sterilization area, used for nothing but cleaning and
set off from the client by a wall and a good deal of space.
• If the shop reuses any equipment involved in the tattoo process, it should
have an autoclave. You want one that looks like a small oven, not a campfire
stove.
• Disposable plastic barrels are safer than metal ones.
• Ask to watch the artist open the disposable needles. Reusing needles is
illegal.
• Carpets can't be fully cleaned.
• Wastebaskets should be covered.
• If the artist invites you into the sterilization area to show you all
this, that's trouble. Clients shouldn't be allowed in there.
• Ask when the equipment went through its last spore test: more than six
months is bad news.
• Most tattoo infections don't come from the shop itself, they come from
unsafe practices after you leave. A shop should keep a prepared list of
rules for you to follow when you get home.

http://www.tdn.com/articles/2006/04/11/top_story/news01.txt

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MSNBC.com.
http://www.medpagetoday.com/Gastroenterology/Hepatitis/tb/3063

Full text:

ACP: Liver Biopsy Not Foolproof


By Peggy Peck, Senior Editor, MedPage Today
Reviewed by Robert Jasmer, MD; Assistant Professor of Medicine, University
of California, San Francisco
April 10, 2006
MedPage Today Action Points
* Explain to patients who ask that despite any failings, the liver biopsy
remains the gold standard for assessing chronic liver disease.

Review
PHILADELPHIA, April 10 - Liver biopsy is considered a gold standard for
staging chronic liver disease, but this gold standard is sometimes fool's
gold, according to data reported here.


Because the biopsy relies on needle placement liver disease may be missed,
said K. Rajender Reddy, M.D., director of hepatology and medical director of
the liver transplantation program at the Hospital of the University of
Pennsylvania.


For example, Dr. Reddy said at the American College of Physicians meeting,
in one series cirrhosis was missed in up to 20% of biopsies and the grade of
inflammation or state of fibrosis was consistently underscored.


He illustrated his point with a slide of a cross-sectional sample from a
cirrhotic liver on which he overlaid biopsy needle placement. Needles placed
in one location completely missed cirrhotic tissue, while a needle placed
just a few millimeters away detected advanced cirrhosis.


As a result, "a patient may be told at one point that he or she has mild
disease, only to find out a year later that the liver is cirrhotic," he
said.


The risk of error can be reduced, he told internists attending a "Multiple
Small Feedings of the Mind" hepatology update, by attention to specimen size
and number of specimens.


"Adequate specimens are at least 1.5 cm long, but accuracy is better for
specimens 2 cm long and the best results are obtained with specimens that
are at least 2.5 cm long," he said. Likewise, specimens should be at least 1
mm wide but 1.4 mm is better and 2.0 mm is the best.


Moreover, he said that at least six portal triads are needed but "11 is
better."


Dr. Reddy acknowledged that because liver biopsy is an invasive procedure
both referring physicians and referred patients are often reluctant to
undergo biopsy.


But the alternative, which would be use of indirect markers, "is not ready
for prime time."


However, Dr. Reddy offered some tips about interpretation of those markers.
The most common, he said, is the ratio of aspartate aminotransferase (AST)
to alanine aminotransferase (ALT) ratio. "When AST is higher, it suggests
cirrhosis," he said.


Another non-invasive marker than may have some utility is AST:platelet ratio
index, which is calculated as follows: AST:platelet ratio index =
[(AST/ULN)/platelet count] X 100 where the platelet count is expressed as
cells/uL and ULN stands for upper limit of normal. But this index has not
been validated in clinical trials.

There are a number of tests of which the best known are FibroTest and
ActiTest, both made by Oneida TheraDiagnostics Ltd. Both tests are
recommended for use in assessing liver status following diagnosis of
hepatitis C, but the tests are not intended as a substitute for liver
biopsy.


Primary source: American College of Physicians
Source reference:
Reddy, I L ³Multiple Small Feedings of the Mind: Hepatology, Infectious
Diseases in the Office, Update on Treatment of ACS and CHF² MSFM

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Treatment-related Depression Is the Most Significant Factor Affecting Health-related Quality of Life in Chronic Hepatitis C

Individuals with chronic hepatitis C who are treatment-naïve frequently experience a diminishment of their health-related quality of life (HRQL). When these individuals initiate anti-HCV therapy, their HRQL commonly worsens.

In the current study, published in the March 2006 issue of the Journal of Hepatology, researchers examined the association of HRQL with treatment-related anemia and depression.

Two hundred and seventy-one HCV patients who received pegylated interferon alfa-2b (PegIntron) and ribavirin were included. The researchers collected data on HRQL, depressive symptoms, laboratory values and socio-demographic characteristics.

Results

Seventy-three percent of study participants were White, 31% were female and the mean age was 47.1 years.

HRQL declined during the course of therapy but according to the authors, "returned to or exceeded baseline levels within 24 weeks of completion."

Anemia and depression were both associated with HRQL impairment.
" The effects of depression on HRQL were significant; when depression scores were included, "other factors were no longer significant."

Depressive symptoms tended to increase during the first half of the course of treatment.

Women and patients with higher body mass index (BMI) and cirrhosis reported more impaired HRQL.

HRQL scales were generally not associated with alcohol abuse, age, race, ALT, or HCV RNA levels.

Based on these findings, the researchers conclude, "Anti-viral therapy for HCV is associated with diminished HRQL. Although anemia and depression [also] were associated with this impairment, depression was the most consistent predictor."

"Future studies are needed to see whether proactive management of these side effects can improve patients' HRQL and the efficacy of antiviral therapy for hepatitis C."

03/21/06

Reference
A Dan, LM Martin, C Cron and others. Depression, anemia and health-related quality of life in chronic hepatitis C. Journal of Hepatology 44(3): 491-498. March 2006.

 

From American Journal of Transplantation

Risk Factors for Graft Survival After Liver Transplantation From Donation
After Cardiac Death Donors: An Analysis of OPTN/UNOS Data

Posted 04/03/2006

R. Mateo; Y. Cho; G. Singh; M. Stapfer; J. Donovan; J. Kahn; T.-L. Fong; L.
Sher; N. Jabbour; S. Aswad; R. R. Selby; Y. Genyk

Abstract and Introduction
Abstract
Due to increasing use of allografts from donation after cardiac death (DCD)
donors, we evaluated DCD liver transplants and impact of recipient and donor
factors on graft survival. Liver transplants from DCD donors reported to
UNOS were analyzed against donation after brain death (DBD) donor liver
transplants performed between 1996 and 2003. We defined a recipient
cumulative relative risk (RCRR) using significant risk factors identified
from a Cox regression analysis: age; medical condition at transplantation;
regraft status; dialysis received and serum creatinine. Graft survival from
DCD donors (71% at 1 year and 60% at 3 years) were significantly inferior to
DBD donors (80% at 1 year and 72% at 3 years, p < 0.001). Low-risk
recipients (RCRR ¡Ü 1.5) with low-risk DCD livers (DWIT < 30 min and CIT <
10 h, n = 226) achieved graft survival rates (81% and 67% at 1 and 3 years,
respectively) not significantly different from recipients with DBD
allografts (80% and 72% at 1 and 3 years, respectively, log-rank p = 0.23).
Liver allografts from DCD donors may be used to increase the cadaveric donor
pool, with favorable graft survival rates achieved when low-risk grafts are
transplanted in a low-risk setting. Whether transplantation of these organs
in low-risk recipients provides a survival benefit compared to the waiting
list is unknown.

Introduction
Worldwide, limitations on the availability of suitable donor organs continue
to adversely affect mortality rates in candidates on the waiting list for
organ transplantation. Methods and techniques for expanding the organ donor
pool for liver transplantation include the use of split and living donor
allografts, extended criteria or marginal donors and non-heart
beating/donation after cardiac death (DCD) donors, while multiple incentives
to improve living and cadaveric donation rates are under study.[1] Grafts
from DCD donors are procured after cessation of cardiopulmonary function in
the donor, and can occur in a controlled setting, after a planned withdrawal
of life support, or in an uncontrolled situation with the onset of sudden
cardiac arrest. Early reports of single-center experience in the use of
liver allografts from DCD donors provided evidence for acceptable outcomes.
Although liver, kidney, lung[2] and pancreas[3] grafts have been procured
from DCD donors and successfully transplanted, long-term graft and patient
survival rates from these procedures have been reviewed only recently. We
examined the UNOS database with the objective of determining risk factors
affecting graft survival rates after liver transplantation from the use of
DCD allografts.

FULL TEXT: http://www.medscape.com/viewarticle/528068?src=mp

 

Does Use of Complementary Treatments with Peginterferon plus Ribavirin Combination Therapy Provide a Benefit to Patients with Chronic Hepatitis C?

Pegylated interferon and ribavirin combination therapy, the current standard-of-care for treatment for chronic hepatitis C, produces a cure in about half of all patients. However, the success of this combination comes at the cost of numerous sometimes severe drug-related adverse events and side effects, especially hematologic and psychiatric.

This review appears in the February 20, 2006 issue of Gastroenterology and Clinical Biology. The article focuses on complementary treatments, primarily erythropoietin, G-CSF, vitamin E, glutathion, ursodeoxycholic acid, and antidepressants. According to the authors, these complementary therapies are “likely to bring a benefit in maintaining adequate interferon and ribavirin dosages and in improving quality of life.”

This review was accomplished by using the Medline(R) database and data from laboratories that commercialized these molecules.

It is the view of the authors that erythropoietin, G-CSF and antidepressants are the best tools for optimizing peginterferon/ribavirin combination therapy in relation to dosing and the duration of therapy and also for improving the quality of life in chronic hepatitis C patients.

Service d'Hepatologie et de Soins Intensifs Digestifs, Service d'Hepatologie, Hopital Universitaire Jean Minjoz, Besancon. tthevenot@chu-besancon.fr

04/07/06

Reference
T Thevenot, V Di Martino, F Lunel-Fabiani, and others. Complementary Treatments of chronic viral hepatitis C [Article in French]. Gastroenterology and Clinical Biology 30(2):197-214. February 20, 2006.

FDA-approved Monotherapies for HCV
Intron A
Roferon

Infergen
Pegasys
PEG-Intron

 
FDA-approved Combination Therapies for HCV
Pegasys + Copegus
PEG-Intron + Rebetol
Intron A + Rebetol
Roferon A + Ribavirin

 

 

http://www.hivandhepatitis.com/

 

Blacks with HCV Genotype 1 (but Not Genotypes 2 or 3) Have a Lower SVR Rate Than Non-Blacks That Is Not Related to Dose Reductions of Interferon and Ribavirin
 

Prior studies have shown that Blacks experience a lower sustained viral response rate (SVR) from treatment with interferon/ribavirin (RBV) than non-Blacks. In addition, Blacks have shown a higher frequency of infection with HCV genotype 1 (GT-1) infection, the most difficult-to-treat type of hepatitis C virus infection.

In the current prospective, community-based study at multiple US medical centers, researchers sought to determine whether Blacks have a lower SVR rate independent of their HCV genotype (emphasis added--Ed).

Results

785 patients were enrolled (24.8% Black, 71.5% White, 3.7% others).

Participants received conventional interferon alfa-2b (Intron A) 3 MU three times weekly + RBV 1000–1200 mg/day for 24 weeks (GT-2/3) or 48 weeks (GT-1).

Black patients were more commonly infected with GT-1 (86.8%vs 64.8%, P < 0.001) and less frequently had an SVR compared with non-Black patients (8.4%vs 21.6%, P < 0.001).

Within GT-1, Black patients had a lower SVR rate than non-Black patients (6.1%vs 14.1%, P = 0.004) but not within GT-2/3 (50.0%vs 36.5%, P = 0.47).

Black patients had lower baseline hemoglobin levels (14.8 vs 15.3 g/dL, P < 0.001) and neutrophil counts (2900 vs 4100/mm3, P < 0.001) and required more frequent dose reductions of RBV (29.8%vs 18.5%, P < 0.001) and interferon (4.7%vs 1.6%, P = 0.012).

However, dose reductions were not associated with lower SVR rates while early treatment discontinuations were (2.9%vs 25.7%, P < 0.001).

Independent predictors of SVR were GT-1 (P < 0.001), Black race (P = 0.030), and advanced fibrosis, stages 3 + 4 (P = 0.023).

In conclusion, the authors write, “Black patients infected with HCV GT-1 (but not GT-2/3) have a lower SVR rate than non-Black patients. This is not explained by their lower baseline hemoglobin levels and neutrophil counts that lead to higher rates of ribavirin and interferon dose reductions.”

04/04/06

Reference
N Bräu, EJ Bini, S Currie and others (The VA-HCV-001 Study Group). Black patients with chronic hepatitis C have a lower sustained viral response rate than non-Blacks with genotype 1, but the same with genotypes 2/3, and this is not explained by more frequent dose reductions of interferon and ribavirin. Journal of Viral Hepatitis 13(4): 242-249. April 2006

.http://www.hivandhepatitis.com/

 

What Actually Happens to Patients Newly Diagnosed with Hepatitis C Virus Infection?
 

For optimal management, individuals who are infected with hepatitis C virus (HCV) require referral to the care of a specialist. The objective of the present study was to determine whether patients newly diagnosed as anti-HCV positive are appropriately referred for further investigation and management, and if not, to determine why not.

The researchers studied patients tested for antibodies to HCV by Nottingham Public Health Laboratory (Nottingham, UK) in a 2-year period (2000-2002). The progress of newly diagnosed anti-HCV positive patients into specialist clinics for further management was documented.

For patients not referred for specialist care, a questionnaire was sent to the clinician requesting the initial anti-HCV test, to identify reasons for non referral. The answers to these questions were used as the basis for this published report, which appears in the April 2006 issue of The Journal of Viral Hepatitis.

Results

11,177 were tested for anti-HCV; 256 (2.3%) were newly diagnosed as being anti-HCV positive.

Two percent of samples sent from primary care were anti-HCV positive, compared to 18.8, 18.9 and 1.3% sent from prison, drug and alcohol units, and secondary care, respectively.

About 64.3% of positive patients diagnosed in primary care were referred to specialist care, compared to 18.4, 42.4 and 62.6% of patients diagnosed in the other three settings.

One hundred and twenty-five (49%) newly diagnosed patients were referred appropriately for further management.

68 of these attended clinic, 45 underwent liver biopsy and 26 (10%) began treatment.

One hundred and thirty-one patients (51%) were not referred.

In 54 cases, there was no evidence that the anti-HCV positive result reached the patient.

In 15, referral was considered but rejected, and 20 patients were referred to non-HCV-specialists (their general practitioners or to genito-urinary medicine).

The study authors conclude, "…Less than 50% of newly diagnosed anti-HCV positive patients are referred to an appropriate clinic for further investigation and management. [The] reasons for this are multifarious and complex, reflecting both systems failure and patient choice.

"Unless these are understood and addressed, the Department of Health Hepatitis C Strategy (2002) and Action Plan for England (2004) will fail to achieve their intended objectives.

04/04/06

Reference
WL Irving, S Smith, R Cater, and others. Clinical pathways for patients with newly diagnosed hepatitis C - What actually happens. Journal of Viral Hepatitis 13 (4): 264-271. April 2006

http://www.hivandhepatitis.com/hep_c/news/2006/040406_b.html

 

“A la Carte” Hepatitis C Therapy
Given the variable response to hepatitis C treatment, researchers have taken an interest in individualized therapy tailored to specific patients. In the March 2006 Journal of Viral Hepatitis, C. D’Arondel and colleagues reported on an assessment of “a la carte” therapy with pegylated interferon (Peg-Intron) plus ribavirin in patients with chronic hepatitis C. A total of 96 patients began taking the combination regimen. After 24 weeks, those who still had detectable HCV RNA stopped treatment (based on the fact that few patients who do not respond by 12¾or even 4¾weeks will go on to become sustained responders). For the remaining patients, the researchers looked at five risk factors for relapse to determine whether to continue treatment: patient sex, age, HCV genotype, baseline HCV viral load, and fibrosis stage. Those with two or more risk factors (88%) continued therapy for an additional 24 weeks. The researchers used the noninvasive FibroTest and ActiTest to assess whether treatment improved liver histology. At the conclusion of the study period, 73% of patients overall achieved sustained virological response (SVR; 85% for genotypes 2/3, 64% for other genotypes); 20% were nonresponders and 7% were relapsers. The noninvasive assays showed significantly decreased fibrosis and inflammatory activity at the 12-week follow-up visit; improved inflammatory activity was seen even in virological nonresponders. The authors concluded that assessment of several risk factors is an efficient way to tailor HCV treatment for individual patients.

http://www.hcvadvocate.org/news/newsRev/2006/HJR-3.6.html#1

 

 

 

 
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Reviewed April 13 2006