IAC Express
Immunization news from the Immunization Action Coalition

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Issue Number 835
November 16, 2009

CONTENTS OF THIS ISSUE

1. FDA approves expanded age indication for both of CSL's
inactivated influenza vaccines
2. FDA approves ID Biomedical's injectable H1N1 influenza
vaccine
3. New: IAC develops form for healthcare employees to sign
if declining H1N1 influenza vaccination
4. New: AMA fact sheet has Q&As about using CPT codes for
providing and administering H1N1 vaccine
5. FDA commissioner's letter to healthcare professionals
provides information on the safety of H1N1 vaccines
6. MMWR Dispatch reports on 2009 mumps outbreak in New York,
New Jersey, and Quebec
7. NCIRD director's letter to providers underscores the need
for PPSV vaccination for adults
8. Update on recent U.S. influenza activity indicates 2009
H1N1 influenza virus is causing significant disease
9. CDC updates its H1N1 web section with information on
pregnancy and H1N1 infection, importance of PPSV
vaccination, and more
10. Two more hospitals added to IAC's Honor Roll for Patient
Safety; NEJM article discusses mandatory HCW vaccination
11. IAC'S Video Of The Week highlights the impact of
rotavirus vaccine in the developing world
12. CDC experts review and update three of IAC'S online "Ask
The Experts" Q&A sections
13. Online, year-end sale! Get laminated child/teen and adult
U.S. immunization schedules for $1 each when you buy 11
or more!
14. Laminated seasonal influenza vaccine pocket guides--
FREE!--from the National Influenza Vaccine Summit
15. CDC reports on the effectiveness of 2008-09 inactivated
influenza vaccine in protecting against 2009 H1N1
influenza
16. National Influenza Vaccination Week set for December 6-
12; be sure to submit your organization's event plans
17. National Immunization Conference abstract deadline is
December 11; early-bird registration ends February 19
18. Website of the Global Polio Eradication Initiative is
worth exploring


[Non-text portions of this message have been removed]

Albert Einstein College of Medicine and Vindico Medical
Education CME activity on PediatricSuperSite.com
Pediatric Immunization:
Meeting the Challenges of the 21st Century



Overview

Pediatricians must be familiar with the continuously evolving pediatric
immunization schedule. This monograph will review the current immunization
schedule, along with the safety, efficacy, and immunogenicity of some of the
vaccines on the schedule. The advantages of using combination vaccines and their
effects on vaccine coverage will also be discussed. Lastly, barriers to optimal
vaccine coverage of children, as well as strategies to overcome these barriers,
will be presented.

Educational Objectives

At the conclusion of this activity, participants should be able to:

  Describe current immunization schedules for influenza, hepatitis A and B,
rotavirus, varicella, Haemophilus influenzae Type b (Hib), diphtheria, tetanus,
acellular pertussis (DTaP), pneumococcal, measles, mumps, rubella (MMR), and
meningococcal vaccines.

  Discuss safety, efficacy, and immunogenicity of current and emerging monovalent
and combination vaccines, including vaccines for DTaP, poliomyelitis, hepatitis
A and B, Hib, MMR, varicella, and meningitis, to select the most appropriate
vaccine for different patient populations.

  Explain the benefits and risks of immunization to parents of pediatric and
adolescent patients, including the importance of completing immunization
schedules, so that parents can make informed decisions regarding immunization.

Implement strategies to overcome the barriers to completing immunization
schedules.


Earn CME Credits Today
Click here to view the monograph
http://www.pediatricsupersite.com/cmecenter/pedss/payment/rid/641/?sid=641


  Course Chair
Robert B. Belshe, MD
Faculty
Stan L. Block, MD, FAAP
Gary S. Marshall, MD
Marguerite M. Mayers, MD
Keith S. Reisinger, MD



Albert Einstein College of Medicine is accredited by the Accreditation Council
for Continuing Medical Education to provide continuing medical education for
physicians. Albert Einstein College of Medicine designates this educational
activity for a maximum of 1.25 AMA PRA Category 1 Credit™. Physicians should
only claim credit commensurate with the extent of their participation in the
activity. This enduring material is approved for 1 year from the date of
original release, August 2009 to August 2010.

Assessing Best Practices in
HBV Therapy
2009 CME/CE
Newsletter Update
October 30 - November 3, 2009, Boston, MA



Access this certified CME/CE newsletter from the 60th Annual Meeting of the
American Association for the Study of Liver Disease. During this conference many
issues were addressed that clinicians face when they care for patients with
chronic hepatitis B infection including:



What are the optimal antiviral therapies and treatment strategies?




•
When is a liver biopsy needed and are any of the non-invasive approaches to
detecting liver disease accurate enough for clinical use?




•
What are the effective treatment approaches for patients who have previously
failed treatment?









To access this newsletter and
obtain CME/CE credit,
CLICK ON THE BUTTON TO THE RIGHT.
























Sponsored for CME credit
by Rush University Medical Center
Rush University Medical Center is accredited by the Accreditation Council for
Continuing Medical Education to provide continuing medical education for
physicians. Rush University Medical Center designates this educational activity
for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should only claim
credit commensurate with the extent of their participation in this activity.








The University of South Florida College of Nursing is accredited as a provider
of continuing nursing education by the American Nurses Credentialing Center’s
Commission on Accreditation. This activity is for 1 contact hour.








The University of Florida College of Pharmacy is accredited by the Accreditation
Council for Pharmacy Education as a provider of continuing pharmacy education.








Supported by an independent educational grant from Gilead Sciences Medical
Affairs.







*This coverage is not sanctioned by the conference organizers and is not an
official
part of the conference proceedings from the 60th AASLD.

http://doctor.ndtv.com/faq/ndtv/fid/24183/Is_chronic_hepatitis_B_curable-.html

Is chronic hepatitis B curable?

Answered by : Dr Anil Handoo
Consultant, Department of Haematology, B L Kapoor Memorial Hospital, New Delhi


Q. Can chronic hepatitis B virus be treated? If yes, how long will it take to
eliminate the virus from the blood? Can the patient get antibody after the
treatment? If yes, how long will it take? What food should be he avoided during
treatment? Is travelling advisable?


A.  The main goal of treatment of chronic hepatitis B is to suppress HBV
replication and to induce remission of liver disease before development of
cirrhosis and hepatocellular carcinoma. There is "NO CURE" as of now. Therapy is
done using interferon-a, oral lamivudine and oral adefovir. On therapy, the
virus will still remain in the body, however, as mentioned earlier, active
replication of the virus would hopefully cease. To assess the response to
treatment one has to have undetectable HBV DNA (< 105 copies/mL) in serum,
sustained loss of HBeAg with or without detection of anti-HBe (HBeAg
seroconversion), and improvement in liver disease, normalization of
aminotransferases and decrease in necroinflammation or fibrosis progression
halted. Depending upon the drug used the response time varies between 4 months
to a year’s time. There, however, still will some cases which do not show a
favourable response and in some there would be drug resistance. If no
seroconversion (i.e.: loss of HBeAg) is seen after 1 year of oral medication the
decision whether to continue treatment will be influenced by the costs (higher
for adefovir) and the risk that drug resistance (higher for lamivudine) will
develop. Again, seroconversion itself does not mean, “cure”, assessment of HBV
DNA is also required. If Viral load becomes significantly low or undetectable,
patients should be referred directly for liver transplantation.
I would suggest to get in touch with a good gastroenterologist and hepatologist
to guide you appropriately.
As far as avoidance of food is concerned, the liver that normally functions as
the body’s filtering system is not working up to par. The hepatitis diseased
liver is unable to break down potentially toxic molecules and byproducts from
substances you ingest. With a faulty filtering system, dangerous levels of
everything from alcohol to protein, fats and certain vitamins and minerals may
accumulate in the body, with potentially serious adverse consequences to the
liver. This doesn’t mean you must eat a bland diet or obsess about every morsel
of food. But by avoiding or moderating your intake of foods that may potentially
harm the liver while choosing foods that help it. Avoid alcohol intake and high
protein diets. It has been seen in various studies that there is long term help
in liver function by dietary restriction of total calories, fat, iron, and
protein. While travelling is not contraindicated in Hep B infection, working in
other countries will depend upon the company policies and regulatory issues in
the respective countries.

http://www.communitynewswire.press.net/article.jsp?id=6288848

BOY GEORGE AND SADIE FROST BACK HEPATITIS C CAMPAIGN
BackPrintDownloadBy Simon Monk, Community Newswire
HEALTH Hepc, 13 Nov 2009 - 13:26

Singer Boy George and model Sadie Frost are among a host of stars who will
appear at a party to launch the Hepatitis C Trust's Get Tested! 2010 campaign on
November 26.
The trust is aiming to raise £200,000 to pay for a bus to tour the country with
a nurse to test people who may have contracted the virus. It will work as a
mobile clinic, regularly touring the country to help the Get Tested! campaign.
The trust are collaborating with two DJs known as Cover To Cover to run the
launch event at The Paradise in West London.
The launch is aiming to promote the Get Tested 2010! Mission, which involves
groups of youngsters being sponsored to travel from the UK to Ibiza in May to
coincide with Radio 1 DJ Pete Tong's International Music Summit.
They will travel in unusual vehicles such as Silver Bullet caravans, completing
a series of secret challenges along the way.
The Hepatitis C Trust spokesperson Gemma Peppe said: "If you think you've done
anything to put yourself at risk, then you should definitely get yourself
tested. This could be sharing a toothbrush, having medical treatment abroad,
having a tattoo or piercing, or sharing notes or needles to take drugs.
"Studies have estimated that there are around 500,000 people in the UK walking
around with hepatitis C, and only 10% have been diagnosed. That's why it's so
important to get yourself tested."
"One reason that there are so many undiagnosed is that there is a real lack of
awareness surrounding hepatitis C.
"Another is that often it is symptomless. And a lot of the possible symptoms are
very woolly. For example, a lot of people feel tired all the time, especially
when they are getting older.
"So they have no idea that they may be suffering from hepatitis C."
Sadie Frost said: "I love performing and if you can possibly raise some extra
awareness for such a good cause at the same time - it sounds like a great double
act "
Eliza Doolittle, who will also be performing, said: "It's so important for
people to know whether they are healthy or not, so if worst comes to worst they
can diagnose their illness and work on feeling better and living a happy, worry
free life."
Cover to Cover is the brainchild of Sean Rowley and Christian Laing, two DJs who
play to crowds of thousands on a regular basis.
Together they have organised a wide range of artists who will perform their
favourite covers. Upstairs the likes of Boy George, Sadie Frost and singer David
McAlmont will perform covers of their favourite songs backed by a live band.
Downstairs DJs such as Sean Rowley, Christian Laing and Ed Simons from The
Chemical Brothers will be playing their favourite cover records.
Tickets will be £10 in advance from www.wegottickets.com, and for £15 on the
door. To find out more, visit www.theparadise.co.uk.
The Hepatitis C Trust supports those with the illness - a blood-borne virus that
mainly infects the cells of the liver. It can also effect the digestive system,
the lymphatic system, the immune system and the brain. To find out more visit
www.hepctrust.org.uk.

http://www.wlos.com/template/inews_wire/wires.regional.nc/22d3ab9c-www.wlos.com.\
shtml

State says insured NC kids must pay for vaccines
November 13, 2009 07:57 EST

RALEIGH, N.C. (AP) -- North Carolina will no longer cover the cost of 11
childhood vaccines for families with insurance as part of an effort to help pay
for vaccines for uninsured children.

WRAL-TV reported Friday that the change will go into effect on December 1 and
will apply to vaccines including combination shots, Hepatitis A and the second
dose of the chicken pox shot. The vaccines can cost more than $100 each.
Officials say the change will save about $4 million for the state's $18-million
immunization program.

The state health director says families with financial resources are being asked
to contribute more during the recession.

Native American children and those eligible for Medicaid will continue to
receive free vaccines.
------
Information from: WRAL-TV, http://www.wral.com

http://www.pittsburghlive.com/x/pittsburghtrib/news/s_653051.html

Government hepatitis liability ends with $44 K payout to veteran
    About the writer
Walter F. Roche Jr. can be reached via e-mail or at 412-320-7894.

By Walter F. Roche Jr.
TRIBUNE-REVIEW
Friday, November 13, 2009

The federal government is paying $44,000 to end its liability in the case of
Army nurse anesthetist Jon Dale Jones, who infected 16 patients in a Texas
military hospital with hepatitis, a potentially fatal liver disease.
Court records in Texas show the government has agreed to pay the money to
veteran Daniel Henry of El Paso.
Seven other victims will receive nothing from the federal government, but will
share an estimated $1 million from an insurance policy covering Jones. Each of
the seven is expected to get about $72,000 after expenses and legal fees are
paid.
The eight remaining unidentified victims, who never sued, apparently will
receive nothing.
All 16 victims are veterans, active-duty soldiers or members of their immediate
families.
One victim, Steven Damron of Missoula, Mont., said he still suffers side effects
from hepatitis treatments. And he is not pleased with the insurance settlement.
"I'm very upset about it," he said in a telephone interview. "I have a disease
that will affect me for the rest of my life. I can't get rid of it. It's changed
my whole life. I can't be a medic anymore."
He said he was told that if he didn't agree to the settlement, "I could lose
everything."
Damron said he came under Jones' care when he underwent back surgery in 2004 at
Beaumont Army Medical Center. Later, when Damron was reactivated and about to
head for Iraq, blood tests showed he had hepatitis. Subsequent tests led to the
conclusion that Damron was infected by Jones.
Jones pleaded guilty to reduced criminal charges of infecting one of the
patients. He is scheduled to be sentenced next month.
Records in the criminal case show that Jones was stealing anesthesia intended
for patients by injecting it into a hidden vial. The vial, however, became
infected from a patient with hepatitis. Jones contracted the disease himself,
then passed it on to 15 patients.
Legal experts say the federal government's civil liability is limited in such
cases, in part because of the Feres Doctrine — which stems from a 1950 Supreme
Court ruling that bars malpractice and other tort claims by active members of
the military.
Henry, a veteran, was not active military when he was infected.
Texas attorney Dean Swartz, who has a pending federal case involving military
medical malpractice, said the Feres Doctrine was a likely factor in the limited
number of cases filed — despite Jones' guilty plea.
"The Feres Doctrine is a huge hurdle to overcome," Swartz said.
Attorneys involved in the civil cases either refused to return calls or declined
comment pending the filing of final settlement papers. Details of the insurance
coverage were revealed in a separate suit, in which the insurance company sought
to limit or eliminate its responsibility.
Because of the 1950 court ruling, the federal government was a named defendant
in only one civil case — that of retired veteran Henry, who was awarded
$112,000. The federal government will pay $44,000, while Jones, as an
individual, will pay a little less than $40,000.
The company that hired Jones — Columbia Healthcare-Arora Joint Venture — has
agreed to pay about $29,000, court records show.

http://www.thenews.com.pk/print1.asp?id=208445



Remedial steps to control hepatitis urged

Saturday, November 14, 2009
By Our correspondent

Islamabad
Professor and In-charge of Pathology Department at Hayatabad Medical Complex
Peshawar Dr Fazal-e-Razak has said that there is need to take remedial measures
for controlling growing prevalence of Hepatitis in Pakistan.
He speaking while inaugurating a private setup for conducting Polymerase Chain
Reaction (PCR) screening and testing facilities for hepatitis diagnosis here in
Rawalpindi. He said that in Pakistan most infections are transmitted from
percutaneous or parenteral contact with inflected blood.
He said that hepatitis B and C virus infections are major health problem, which
can result in acute and/or chronic liver diseases. “Infection may result in a
chronic state, which may lead to Hepatocellular carcinoma or other chronic liver
complications.”
On the occasion, other speakers stated that health is one of the most neglected
areas in Pakistan. Infrastructure of health sector covers establishment of
hospitals, dispensaries, basic health units, maternity child health care
centres; and their staff composing doctors, dispensers, nurse, lady health
visitors (LHV’s) and midwives.
The existing national network of health services in the public sector consists
of 950 hospitals, 4,794 dispensaries, 561 rural health centres (RHCs) and 5,310
basic health units (BHUs). The total availability of beds in these health
facilities is estimated to be 103,037. By all standards, this infrastructure is
inadequate to meet the needs of about 160 millions people of Pakistan, they say.
The health experts further stated that a large number of problems and
inadequacies in the health sector relate to the lack of adequate finances. The
party explains the poor quality of health services, over-burdened outdoor
departments, out of order equipment, insufficient medicines, and the relatively
small number of beds, doctors and paramedic staff for patients in the hospitals.
At the same time, however, there is a whole set of problems, which relates to
the utilisation of resources that are made available. It is widely believed that
whatever limited resources are allocated to the health sector they are not
efficiently and optimally utilised.
They said that the only feasible means of preventing the spread and outcome of
chronic hepatitis B infection is active vaccination. Unfortunately, a preventive
vaccine for hepatitis C does not exist. Treatment options available revolve
around anti-viral therapy and interferon injections, which are quite costly.
Physicians need to adjust doses of interferon depending on the viral load that
is determined through the Polymerase Chain Reaction (PCR) testing, said experts.

http://www.watoday.com.au/breaking-news-national/hep-c-in-kids-goes-undetected-s\
tudy-20091115-ig1n.html



Hep C in kids goes undetected: study


November 15, 2009 - 9:04AM
Australia's system of health screening for mums on methadone is allowing many of
their children to slip through with undetected cases of hepatitis C, doctors
have warned.

While almost all pregnant women being treated for drug addiction receive a test
to detect the virus, research shows a follow-up test to determine its
transmissibility was often missed.

Mums carrying the virus also show declining rates of attendance at necessary
check-ups after they give birth, says Dr Ralph Nanan who is Professor of
Pediatrics at the University of Sydney.

"Screening for (Hepatitis C virus) HCV infection in the high-risk population of
pregnant women on methadone maintenance treatment and their infants is
inadequate," said Dr Nanan in a paper published in the Medical Journal of
Australia.

"This could lead to a significant under-detection of active HCV infection in
this high-risk population, and their infants.

"Current screening guidelines may need to be revised."

Dr Nanan, and colleagues, reviewed the cases of almost 300 pregnant women who
were on methadone programs as they attended one of three hospitals across NSW
from 2000 to 2006.

More than 80 per cent of the women were found to carry the virus. However, the
screening process detected just a single case of mother-to-child hepatitis C
transmission.

"We would have missed about 10 cases," Dr Nanan said.

"... Although the prevalence of HCV infection in children in Australia is
unknown, it has been estimated that 75 to 100 new cases of vertically acquired
(mum to child) HCV occur each year," he said.

"The much lower reported number of cases... implies that childhood HCV infection
is under-diagnosed."


[Non-text portions of this message have been removed]

American Association for the Study of Liver Diseases
Boston, MA • October 30 - November 3, 2009
» Forward this to a colleague



High SVR Rates Seen with Telaprevir for Hepatitis C
BOSTON -- Availability of direct antiviral drugs for hepatitis C virus (HCV)
infection moved another step closer to realization, with favorable results
reported here for telaprevir in two Phase II studies.
http://www.medpagetoday.com/MeetingCoverage/AASLD/tb/16859



Liver Reserve Measured in Breath Test
BOSTON -- A simple breath test gives a good overall measure of liver function in
patients with chronic viral hepatitis and could help in evaluating potential
liver transplant candidates, a researcher said here.
http://www.medpagetoday.com/MeetingCoverage/AASLD/tb/16856



Treating Before Transplant Cuts HCV Recurrence
BOSTON -- In patients with advanced liver disease related to hepatitis C, a
course of pegylated interferon and ribavirin (Rebetol) before liver transplant
may help them avoid recurrence of infection, a researcher said here.
http://www.medpagetoday.com/MeetingCoverage/AASLD/tb/16848



NASH Patients Perk Up with Vitamin E
BOSTON -- Vitamin E and, potentially, pioglitazone (Actos) may become the first
effective treatments for nonalcoholic steatohepatitis (NASH), a researcher said
here.
http://www.medpagetoday.com/MeetingCoverage/AASLD/tb/16846



HCV Response Linked Strongly to Gene Variant
BOSTON -- Additional analysis has confirmed that a polymorphism in an
interferon-related gene is strongly associated with responses to standard
treatments for hepatitis C virus (HCV) infection, a researcher said here.
http://www.medpagetoday.com/MeetingCoverage/AASLD/tb/16829



Direct Antivirals Can Beat HCV Without Interferon
BOSTON -- The first clinical trial of direct antiviral drugs against hepatitis C
virus (HCV) without interferon was a success, researchers said, though the FDA
currently won’t permit such a strategy in the U.S.
http://www.medpagetoday.com/MeetingCoverage/AASLD/tb/16818



HCV Now an STD in New York
BOSTON -- HIV-infected men in New York City are facing a new threat, researchers
said here -- a new form of hepatitis C virus (HCV) that rapidly damages the
liver and is transmitted primarily through sex with other men.
http://www.medpagetoday.com/MeetingCoverage/AASLD/tb/16812



Antibiotics Top Cause of Drug-Induced Liver Failure
BOSTON -- Antimicrobial agents are the most common cause of drug-induced liver
failure, with most cases ending in death or transplant, a researcher said here.
http://www.medpagetoday.com/MeetingCoverage/AASLD/tb/16791



Liver Transplants Okay in Superobese Patients
BOSTON -- Liver transplants can work as well in extremely fat patients as in
anyone else, although the surgery and post-transplant management is more
complex, researchers said here.
http://www.medpagetoday.com/MeetingCoverage/AASLD/tb/16783



Once-Daily HCV Protease Inhibitors Show Early Promise
BOSTON -- Two investigational drugs targeting the hepatitis C virus (HCV)
protease enzyme helped patients clear the virus with once-daily dosing, in
contrast with the three-times-per-day schedule needed for similar drugs in
development.
http://www.medpagetoday.com/MeetingCoverage/AASLD/tb/16766



New Drug Boosts HCV Clearance
BOSTON -- Most hepatitis C patients who are initially unresponsive to standard
therapy were able to achieve sustained virologic responses when the
investigational drug boceprevir was added, a researcher reported here.
http://www.medpagetoday.com/MeetingCoverage/AASLD/tb/16763



Survival Lower in HCV-Infected Women after Liver Transplant
BOSTON -- Women undergoing liver transplant as a result of hepatitis C virus
(HCV) infection show poorer long-term survival rates and more frequent failure
of the donor liver, compared with male recipients.
http://www.medpagetoday.com/MeetingCoverage/AASLD/tb/16735

[Non-text portions of this message have been removed]

http://www.sciencedaily.com/releases/2009/11/091111123614.htm

  Largest-ever Database For Liver Proteins May Lead To Treatments For Hepatitis
ScienceDaily (Nov. 13, 2009) — Scientists at a group of 11 research centers in
China are reporting for the first time assembly of the largest-ever collection
of data about the proteins produced by genes in a single human organ. Their
focus was the liver, and their massive database in both protein and transcript
levels could become a roadmap for finding possible new biomarkers and treatments
for liver disease.

Those include hepatitis and liver cancer, which is at epidemic levels in China
and affects millions of people worldwide.

Part of the China Human Liver Proteome Project, which was officially launched by
the Ministry of Science and Technology of China (MOST) and chaired by Fuchu He,
the study appears online in ACS' Journal of Proteome Research.

He and colleagues point out that the liver plays many essential roles in the
body, such as producing digestive enzymes, hormones, most of the proteins in the
blood, storing carbohydrates for use in supplying energy to the muscles, and
activates and breaks down drugs. Despite that key role, huge gaps likely exist
in scientific knowledge about proteins involved in these activities.

Using 10 tissue samples of healthy liver from volunteers, they identified 6,788
non-redundant proteins in the liver samples, the largest group of proteins ever
identified by scientists in any human organ. Half of the proteins have never
been seen in the human liver before. One intriguing and unexplained discovery:
Many of the new-found proteins appear related to diseases in the nervous system.

--------------------------------------------------------------------------------

Journal reference:
1.Chinese Human Liver Proteome Profiling Consortium. First Insight into the
Human Liver Proteome from PROTEOMESKY -LIVERHu 1.0, a Publicly Available
Database. Journal of Proteome Research, 2009 [link]
Adapted from materials provided by American Chemical Society, via EurekAlert!, a
service of AAAS.

http://www.businesswire.com/portal/site/google/?ndmViewId=news_view&newsId=20091\
110006789&newsLang=en

Aduro Biotech Completes Series A-1 Financing

Company Will Use Funds to Advance Vaccine Platform for Infectious Disease and
Cancer Immunotherapy

BERKELEY, Calif.--(BUSINESS WIRE)--Aduro BioTech, a privately held biotechnology
company focused on the development of therapeutic and prophylactic vaccines
based on proprietary recombinant strains of the bacterium Listeria
monocytogenes, today announced completion of its Series A-1 financing.
Individual investors, including senior management of the company, provided a $2
million equity round. Aduro has also secured an additional $2.7 million in
funding through grants and contracts from the Department of Defense for
development of a therapeutic vaccine for Hepatitis C, and from the National
Institute of Allergy and Infectious Diseases (via the University of New Mexico)
for the development of a prophylactic vaccine against the bio-terror agent that
causes tularemia.
Aduro will use the new capital to complete the acquisition of key intellectual
property from Cerus Corporation and the former Anza Therapeutics, and to support
late stage pre-clinical development prior to initiating clinical trials. Aduro
anticipates filing an investigational new drug (IND) application with the FDA in
fourth quarter of 2010 to begin Phase 1 clinical trials in patients chronically
infected with the Hepatitis C virus. Anza Therapeutics previously conducted
three FDA approved Phase 1 clinical trials, including two cancer trials, and
Aduro will expand upon these programs in its future clinical studies.
“The current round of funding will allow us to advance our therapeutic vaccines
program, which is currently focused on the treatment of Hepatitis C infection
and prostate cancer,” said Stephen T. Isaacs, Aduro’s President and Chief
Executive Officer. “We believe these two important diseases are appropriate for
the initial application of the Listeria technology, and we plan to leverage this
versatile platform for many other applications.
Mr. Isaacs added, “We’re very pleased to have raised the necessary capital to
continue this promising program started by Cerus and Anza, especially given the
current economic environment. The willingness of our investors to support our
efforts is a testament to the scientific team and the potential of the Listeria
platform.”
Dr. Mike Powell, general partner of Sofinnova Ventures and a former board member
and Chairman of Anza Therapeutics added, “I’m very pleased that Aduro has
acquired the Listeria vaccine technology, and I believe the company is in a
strong position to move it forward. The Listeria approach is potentially very
powerful, and may indeed have blockbuster potential.”
Aduro has developed a proprietary approach to therapeutic vaccines that the
company believes will enable it to quickly and efficiently produce a portfolio
of promising vaccines for both cancer and infectious diseases. Aduro anticipates
entering human clinical trials within twelve months and providing important
human proof-of-concept results by 2011.
Key to Aduro’s approach is the intracellular bacterium Listeria monocytogenes,
which Aduro scientists have genetically engineered to enhance both safety and
efficacy. Listeria is an ideal delivery platform to enable the human immune
system to recognize a specific antigen and rally an attack against it. The
Listeria approach overcomes many of the current limitations of other therapeutic
vaccine platforms by potentially providing superior potency, the ability for
repeat administration, and low manufacturing costs. Aduro has demonstrated
strong immune responses against multiple targets following a series of
vaccinations in animal models, including demonstrated efficacy for both
prevention and treatment in multiple tumor models. A further advantage is the
ability to use the same proprietary Listeria strain to construct multiple
vaccines, which can potentially simplify development and regulatory review,
thereby accelerating time to product approval.
“There are obvious advantages to Aduro’s technology, in that Listeria vaccines
stimulate both the innate and adaptive arms of the immune system, which make
them extremely potent agents. And significantly, the Listeria vaccines have
demonstrated the key ability to break tolerance in rigorous pre-clinical disease
models” said Drew Pardoll, MD, PhD, the co-director of the Sidney Kimmel Cancer
Center and Seraph Professor of Medicine at The Johns Hopkins University. Dr.
Pardoll, who will chair Aduro’s Scientific Advisory Board and who has been
associated with the Listeria program since 2002, added, “I’m very pleased that
Aduro has acquired the Listeria technology and I look forward to working with
the Aduro scientific team to further develop this important vaccine platform.”
Joining Dr. Pardoll on the Scientific Advisory Board are Dr. Daniel Portnoy, who
is Professor of Biochemistry and Molecular Biology at the University of
California at Berkeley, and Dr. Thomas Dubensky, Chief Scientific Officer of
Immune Design Corporation, both of whom have worked with the Aduro team for
several years in developing the Listeria vaccine platforms and advancing product
candidates to human clinical trials.
About Aduro Biotech
Aduro is a privately held biotechnology company committed to developing safer
and more effective options for patients in disease areas with substantial unmet
medical needs. Aduro’s current focus is to develop novel therapeutic and
prophylactic vaccine technologies based on the intracellular bacterium Listeria
monocytogenes, which are being designed to harness the power of the immune
system against cancer and infectious disease. Aduro’s active development
programs include therapeutic vaccines against Hepatitis C and prostate cancer. A
recent television story concerning Aduro’s vaccine development program was
presented by KTVU and may be viewed at
http://www.ktvu.com/news/21567552/detail.html.

Contacts
Aduro BioTech
Nancy Kaplan, 510-848-4400 ext. 101

Permalink: http://www.businesswire.com/news/google/20091110006789/en

http://www3.interscience.wiley.com/journal/122675108/abstract

Hepatology
Early View (Articles online in advance of print)
Published Online: 9 Nov 2009
Copyright © 2005 American Association for the Study of Liver Diseases


  Viral Hepatits
Lamivudine maintenance beyond one year after HBeAg seroconversion is a major
factor for sustained virologic response in HBeAg-positive chronic hepatitis B

Hyun Woong Lee 1 2 3, Heon Ju Lee 3 4, Jae Seok Hwang 3 5, Joo Hyun Sohn 3 6,
Jae Young Jang 7, Ki Jun Han 8, Jun Yong Park 1 3 9, Do Young Kim 1 3 9, Sang
Hoon Ahn 1 3 9, Yong Han Paik 1 3 9, Chun Kyon Lee 3 10, Kwan Sik Lee 1 3 9,
Chae Yoon Chon 1 3 9, Kwang-Hyub Han 1 3 9 *

1Department of Internal Medicine, Yonsei University College of Medicine, Seoul,
Korea
2Department of Internal Medicine, Chung-Ang University College of Medicine,
Seoul, Korea
3Liver Cirrhosis Clinical Research Center, Seoul, Korea
4Department of Internal Medicine, Yeungnam University College of Medicine,
Seoul, Korea
5Department of Internal Medicine, Keimyung University School of Medicine, Seoul,
Korea
6Department of Internal Medicine, Hanyang University College of Medicine, Seoul,
Korea
7Department of Internal Medicine, Soonchunhyang University Hospital, Seoul,
Korea
8Department of Internal Medicine, Kwandong University College of Medicine,
Seoul, Korea
9Department of Internal Medicine, Yonsei Institute of Gastroenterology, Seoul,
Korea
10Department of Internal Medicine, National Health Institute Corporation Ilsan
Hospital, Seoul, Korea

email: Kwang-Hyub Han (gihankhys@...)
*Correspondence to Kwang-Hyub Han, Department of Internal Medicine, Yonsei
University College of Medicine, 250 Seongsanno, Seodaimun-gu, Seoul 120-752,
Korea
Potential conflict of interest: Nothing to report.
fax: 82-2-312-7833.
Funded by:
  Good Health R&D Project, Ministry for Health, Welfare and Family Affairs,
Republic of Korea; Grant Number: A050021

Abstract
The reported durability of virologic response after successful lamivudine
monotherapy is variable, and the question remains as to whether virologic
responses can be maintained over an extended follow-up period. The aim of this
study was to investigate posttreatment durability, the optimal duration of
additional treatment after HBeAg clearance or seroconversion, and determinants
for sustained virologic response (SVR) following lamivudine monotherapy in
patients with HBeAg-positive chronic hepatitis B (CHB). From January 1999 to
August 2004, 178 Korean patients with HBeAg-positive CHB were treated with
lamivudine and achieved complete responses, defined as a loss of serum HBeAg and
hepatitis B virus DNA, and alanine aminotransferase normalization. The mean
duration of lamivudine monotherapy was 26 months (range, 12-77). SVR was
maintained in 138 patients (77.5%). Host and viral factors were compared between
138 patients with SVR and 40 patients whose response was not sustained. The
cumulative relapse rates increased from 15.9% at 1 year to 30.2% at 5 years,
with a mean time to relapse after cessation of lamivudine of 12 months (range,
7-42). Most relapses occurred within 2 years after discontinuation of lamivudine
(33/40, 82.5%). On multivariate analysis, age 40 years and additional treatment
for more than 12 months after HBeAg clearance or seroconversion were independent
factors for SVR. Conclusion: The lamivudine-induced virologic response was
durable in patients under 40 years old and those receiving lamivudine for more
than 12 months after HBeAg clearance or seroconversion. Age and additional
treatment were major predictive factors for SVR. (HEPATOLOGY 2010.)
--------------------------------------------------------------------------------
Received: 30 January 2009; Accepted: 10 September 2009
Digital Object Identifier (DOI)
10.1002/hep.23323

http://www.journalofclinicalvirology.com/article/PIIS1386653209004958/abstract?r\
ss=yes

Hepatitis C virus RNA localization in human carotid plaques

Maria Boddia, Rosanna Abbateb, Benedetta Chellinia, Betti Giustib, Carlo
Gianninic, Giovanni Pratesid, Luciana Rossib, Carlo Pratesid, Gian Franco
Gensiniae, Laura Paperettia, Anna Linda Zignegoc

Received 15 April 2009; received in revised form 8 September 2009; accepted 7
October 2009. published online 06 November 2009.
Corrected Proof

Abstract

Background
Hepatitis C virus (HCV) infection has certain characteristics that enable it to
play an important role in atherosclerosis. Some studies report its association
with an increased risk of carotid artery plaque.
Objectives
The aim of this study was to evaluate the presence of HCV genomic sequences and
replicative intermediates in plaque tissues.

Study Design
A cohort of consecutive, prospectively recruited patients with HCV infection and
chronic ischemic heart disease from the Cardiology, Vascular Surgery and
Hepatology Units of a University Hospital in Florence, Italy, were studied.

Results
Positive-strand HCV RNA was detected in seven carotid plaque tissues from
anti-HCV-positive patients and was not detected in the nine carotid plaque
tissues obtained from anti-HCV-negative patients. In three patients, HCV RNA was
found in carotid plaque and not in serum. HCV replicative intermediates were
detected in three plaque samples. Direct sequencing of HCV RNA from the plaque
and serum showed HCV genotypes 2 (five cases) and 1 (two cases).

Conclusions
The novel finding of HCV RNA sequences in plaque tissue strongly suggests an
active local infection. This in turn makes it conceivable that the virus may
exert local action in carotid atherosclerosis.


a Clinica Medica Generale e Cardiologia, Department of Medical and Surgical
Critical Care, University of Florence, Italy
b Thrombosis Centre, Azienda Ospedaliero-Universitaria Careggi, Florence and
Center for the Study at Molecular and Clinical Level of Chronic, Degenerative
and Neoplastic Diseases to Develop Novel Therapies, University of Florence,
Italy
c Center for Systemic Manifestations of Hepatitis Viruses (MASVE), Department of
Internal Medicine, University of Florence, Viale Morgagni 85, 50134 Florence,
Italy
d Unit of Vascular Surgery, Department of Medical and Surgical Critical Care,
University of Florence, Italy
e Fondazione Don Carlo Gnocchi, Centro S. Maria degli Ulivi, Firenze, Italy
Corresponding author. Tel.: +39 055 4271077; +39 055 7947335.
PII: S1386-6532(09)00495-8
doi:10.1016/j.jcv.2009.10.005
© 2009 Published by Elsevier Inc.

http://www3.interscience.wiley.com/journal/122612552/abstract

Hepatology
Early View (Articles online in advance of print)
Published Online: 29 Sep 2009
Copyright © 2005 American Association for the Study of Liver Diseases

  Viral Hepatitis
Prevalence of hepatitis B surface antigen among refugees entering the United
States between 2006 and 2008

David B. Rein 1 *, Sarah B. Lesesne 1, Ann O'Fallon 2, Cindy M. Weinbaum 3

1RTI International, Atlanta, GA
2Association of Refugee Health Coordinators, Minnesota Department of Health, St.
Paul, MN
3Division of Viral Hepatitis, Centers for Disease Control and Prevention,
Atlanta, GA

email: David B. Rein (drein@...)
*Correspondence to David B. Rein, RTI International, 2951 Flowers Road, Suite
119, Atlanta, GA 30341
Potential conflict of interest: Nothing to report.
fax: 770-234-5030

Funded by:
  Centers for Disease Control and Prevention's Division of Viral Hepatitis; Grant
Number: contract number 200-2003-02489, Task Order 7

Abstract
The Centers for Disease Control and Prevention recommends hepatitis B surface
antigen (HBsAg) testing to identify chronic hepatitis B virus infection for
foreign-born persons from countries or regions with HBsAg prevalence of 2%.
However, limited data exist to indicate which countries meet this definition. To
address this data gap, we estimated the HBsAg prevalence among refugees entering
the United States between 2006 and 2008. We contacted state refugee health
coordinators and asked them to report the number of refugees, country of origin,
and HBsAg prevalence among refugees screened in their jurisdiction during the
most recently available 12-month period prior to August 2008. We pooled data
across jurisdictions and calculated the prevalence for any country with more
than 30 refugees entering the United States, and where this level of data was
not available by country, continents were considered. Of the 47 jurisdictions
contacted, we received basic information from 31, with nine jurisdictions
reporting HBsAg prevalence by country of origin applicable to 31,980 refugees
(approximately 42% of refugees entering the United States during the observation
period). We estimated an HBsAg prevalence of 2.8% (95% confidence interval
2.6%-3.0%) for refugees overall. Of the 37 countries with 30 or more refugees
entering the United States, 25 had a prevalence of 2%. Prevalence was highest
among refugees from Africa and Southeast Asia, and lowest among refugees from
the Middle East and South/Central America. In the eight countries for which we
had comparison data, six had lower HBsAg prevalence than in 1991. (HEPATOLOGY
2009.)
--------------------------------------------------------------------------------
Received: 22 June 2009; Accepted: 23 September 2009
Digital Object Identifier (DOI)
10.1002/hep.23353

http://www.journalofclinicalvirology.com/article/PIIS1386653209005009/abstract?r\
ss=yes


Description of liver disease in a cohort of HIV/HBV coinfected patients

P. Selliera, N. Schnepfb, I. Jarrina, M.-C. Mazeronb, G. Simoneaua, M.
Parrinelloc, J. Evansd, C. Lafuente-Lafuentea

Received 16 June 2009; received in revised form 5 October 2009; accepted 7
October 2009. published online 09 November 2009.
Corrected Proof


Abstract

Background
Factors associated with advanced liver disease have been incompletely explored
in HIV/HBV coinfected patients.
Objectives

To describe liver-related morbidity, mortality, and related risk factors, in
HIV/HBV coinfected patients.

Study design
We followed-up 107 consecutive HIV/HBV coinfected patients. Clinical, biological
and virological data were collected every 3 months. Liver-related mortality and
a composite score were used to define advanced liver disease.

Results
The patients were mainly sub-Saharan Africans (61%) or Europeans (33%).
Forty-four percent of patients had liver biopsy, 78% of patients received
lamivudine. Advanced liver disease (ALD) was diagnosed in 19/107 patients during
follow-up (mean 4.8 years): 10 extensive fibrosis, 5 cirrhosis, 3 hepatocellular
carcinoma resulting from cirrhosis, and 1 fulminant hepatitis following
lamivudine withdrawal. Eleven patients died, 4 from HBV-related liver disease.
In univariate analysis, male gender, mean HIV and HBV viral loads, and raised
AST/ALT transaminases were associated with increased risk of ALD. The strongest
associations, in a multivariate model, were mean AST transaminase and cumulated
time receiving lamivudine, with a favourable effect. 39% of patients with
increased mean AST presented with ALD, versus 7% when normal mean AST (Relative
Risk 5.5).

Conclusions
During HIV/HBV coinfection, transaminase levels are strongly associated with
ALD. Normal mean AST has a high negative predictive value, contrary to
previously reported data in HIV/HCV patients.

a Service de Médecine Interne A, Hôpital Lariboisière, Assistance
Publique-Hôpitaux de Paris, 2 rue Ambroise Paré, 75010 Paris, France
b Service de Bactériologie – Virologie, Hôpital Lariboisière, Assistance
Publique-Hôpitaux de Paris, France
c Centre d’Informations et de Soins de l’Immunodéficience Humaine, Hôpital
Lariboisière, Assistance Publique-Hôpitaux de Paris, France
d Immeuble SCOR, 1, avenue du General de Gaulle, Paris la Défense Cedex, France
Corresponding author. Tel.: +33 1 49 95 63 39; fax: +33 1 49 95 63 40.

PII: S1386-6532(09)00500-9
doi:10.1016/j.jcv.2009.10.010


© 2009 Elsevier B.V. All rights reserved.

Summary
Expert Opinion on Investigational Drugs
November 2009, Vol. 18, No. 11, Pages 1655-1666 , DOI 10.1517/13543780903241599

Monotherapy versus combination therapy for the treatment of chronic hepatitis B

Ivana Carey� & Phillip M Harrison�†

King's College London, Division of Gene and Cell-Based Therapy, Department of
Liver Studies and Transplantation, Denmark Hill Campus, Bessemer Road, London
SE5 9PJ, UK +44 0 20 3299 3169; +44 0 20 3299 3167;

phillip.Harrison@...
†Author for correspondence


Background: Nucleos(t)ide analogues, active against hepatitis B polymerase,
suppress viral replication and improve clinical outcome. However, the emergence
of drug-resistant mutants can result in treatment failure. Objectives: We
describe how the choice of first-line therapy is critical to long-term treatment
success. Methods: A review of current drug therapies is provided.
Results/conclusions: Monotherapy with early-generation drugs (lamivudine or
adefovir) was associated with a high rate of viral drug resistance and
combination therapy with these agents was shown to reduce the incidence of
resistance. The latest-generation drugs (entecavir and tenofovir) are potent
inhibitors of viral replication and, in treatment-naive subjects, viral
resistance to entecavir is uncommon and is not yet reported to tenofovir.
Therefore, monotherapy with either entecavir or tenofovir is the current
preferred option in treatment-naive patients. Combination therapy is appropriate
in those with drug-resistant HBV infection, where drug choice is guided by the
viral drug-resistance genotype/phenotype. Although combination therapy has been
advocated in other patient groups (e.g., those with decompensated cirrhosis and
following liver transplantation), there are, as yet, no data to mandate the use
of combination therapy in such patients and any perceived benefit must be
weighed against increased cost and risk for toxicity.

Full Text | PDF (312 KB) | PDF Plus (313 KB)

http://www3.interscience.wiley.com/journal/122679630/abstract?CRETRY=1&SRETRY=0

Cancer
See Also:
Cancer Cytopathology
CA: A Cancer Journal for Clinicians
Early View (Articles online in advance of print)
Published Online: 6 Nov 2009
Copyright © 2009 American Cancer Society

Original Article
Hepatitis B virus reactivation and role of antiviral prophylaxis in lymphoma
patients with past hepatitis B virus infection who are receiving
chemoimmunotherapy

Yu Xuan Koo 1, Daniel S. W. Tan, MBBS, MRCP 2, Iain B. Tan, MBBS, MRCP 2, Miriam
Tao, MBBS, MRCP 2, Wan Cheng Chow, MBBS, MRCP 3, Soon Thye Lim, MBBS, MRCP 2 *

1Yong Loo Lin School of Medicine, National University of Singapore, Singapore
2Department of Medical Oncology, National Cancer Center Singapore, Singapore
3Department of Gastroenterology and Hepatology, Singapore General Hospital,
Singapore

email: Soon Thye Lim (dmolst@...)
*Correspondence to Soon Thye Lim, Department of Medical Oncology, National
Cancer Centre Singapore, 11 Hospital Drive, Singapore S(169610)
Fax: (011) 65 6225 6283

Abstract

BACKGROUND:
Individuals who had past hepatitis B virus (HBV) infection appeared to clear
their serum hepatitis B surface antigen (HBsAg) while producing antibody to the
hepatitis B core antigen (HBcAb), which is detectable in their serum. Currently,
it is uncertain whether patients with past HBV infection require routine
antiviral prophylaxis during chemotherapy, although some cancer agencies
recommend its routine use. The objective of the current study was to determine
the prevalence of past HBV infection in patients with lymphoma and its relevance
in terms of HBV-related complications.

METHODS:
The authors reviewed 430 patients with lymphoma from May 2006 to May 2008.

RESULTS:
Among the 430 patients, 233 had both the HBsAg and HBcAb tests performed,
whereas 197 had only the HBsAg test performed. Among those with both tests
performed, 34.3% (80 of 233) were HBcAb positive only. Of these 80 patients, 58
had a concomitant HBV DNA level test, which was positive in 3 (5.2%). Of the 67
patients with past and 26 with chronic HBV infection who received chemotherapy,
HBV reactivation occurred in 1.5% and 42.3% of patients, respectively (P<.0001).
Prophylactic lamivudine was administered in 7 (10.4%) patients with past HBV
infection and in 18 (69.2%) with chronic HBV infection.

CONCLUSIONS:
The low rate of HBV reactivation reported in our study coupled with the high
prevalence of past HBV infection in an endemic area suggests that routine usage
of antiviral prophylaxis may not be required for all patients with past HBV
infection. Close surveillance remains a reasonable and viable option for the
majority of patients. Cancer 2009. © 2009 American Cancer Society.
--------------------------------------------------------------------------------
Received: 8 January 2009; Revised: 7 May 2009; Accepted: 11 May 2009
Digital Object Identifier (DOI)
10.1002/cncr.24742

http://jama.ama-assn.org/cgi/content/short/302/18/1949?rss=1

Silent Epidemic of Viral Hepatitis May Lead to Boom in Serious Liver Disease
Bridget M. Kuehn

JAMA. 2009;302(18):1949-1954.

  Since this article does not have an abstract, we have provided the first 150
words of the full text and any section headings.



Washington, DC
More than 500 million persons worldwide are infected with hepatitis B or C
virus, estimates the World Health Organization, and more than 5 million US
residents have such infections, according to the US Centers for Disease Control
and Prevention (CDC). Yet these infections often go undetected and untreated
because patients and physicians may be unaware of who is at risk or may fail to
pursue testing.

As more individuals immigrate to the United States from regions where hepatitis
B virus infection is prevalent, US physicians may see higher rates of
complications from such infection.

Although prevention efforts have helped dramatically reduce the incidence of
hepatitis B and C viral infections in the general US population, demographic
shifts are leading to growing numbers of chronically infected patients who may
develop severe complications such as cirrhosis and hepatic cell carcinoma.

CME/CE-CERTIFIED MANAGEMENT SERIES
Understanding and Implementing the AASLD’s 2009 Practice Guidelines* on the
Diagnosis, Management, and Treatment of Hepatitis C: An Update







Revised treatment guidelines from the American Association for the Study of
Liver Diseases (AASLD) address the significant advances that have taken place in
the field of hepatitis C. In this CME/CE-certified program, CCO's expert faculty
members discuss how to incorporate these guidelines into daily practice.
Click here to review this program or select an activity below.
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In an engaging, interactive format, you are invited to respond to various
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answers with those of your colleagues, as expert faculty comment on the options.



Click here to review the 3 Interactive Virtual Presentations and download
accompanying slidesets by Ira M. Jacobson, MD; John G. McHutchison, MD, FRACP;
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CCO expert faculty members present 6 unique and challenging patient cases in
which you make treatment decisions that determine how the cases unfold.
Click here to begin an Interactive Case Challenge.
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HCV Management Algorithm
This downloadable worksheet is a quick reference guide derived from the AASLD’s
HCV Practice Guidelines Update.

To download this worksheet, click here.

This Clinical Management Series program is located online at:
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idelines.aspx













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http://www.hivandhepatitis.com/2009icr/aasld/docs/111309_a.html

HIV and Hepatitis.com Coverage of the
60th Annual Meeting of the American Association
for the Study of Liver Diseases (AASLD 2009)
October 30 - November 3, 2009, Boston, MA

Oral HCV Polymerase Inhibitor RG7128 plus Protease Inhibitor RG7227 (ITMN-191)
Suppresses HCV Viral Load without Interferon or Ribavirin

   SUMMARY: Combination hepatitis C treatment using the nucleoside analog
hepatitis C virus (HCV) polymerase inhibitor RG7128 (formerly R7128) plus the
HCV NS3/4A protease inhibitor RG7227 (formerly R7227, also known as ITMN-191)
produced potent antiviral activity in a 2 week study, researchers reported this
month at the 60th Annual Meeting of the American Association for the Study of
Liver Diseases (AASLD 2009) in Boston. If confirmed in larger studies, these
findings from the INFORM-1 trial -- the first to test an all-oral combination
anti-HCV regimen -- suggest that effective treatment may be possible without
interferon or ribavirin.


By Liz Highleyman
Combination therapy consisting of pegylated interferon plus ribavirin is the
current standard of care for chronic hepatitis C, but there is a need for
treatments that are more effective, easier to administer (oral rather than
injected), and have fewer side effects.
The INFORM-1 trial -- conducted by Roche in collaborations with InterMune and
Pharmasset -- tested a combination regimen consisting of 2 directly targeted
oral anti-HCV agents without interferon or ribavirin. As with antiretroviral
therapy for HIV, combining agents targeting multiple steps of the viral
lifecycle may offer greater potency and reduce the emergence of drug resistance.
In this Phase 1 double-blind, ascending-dose trial, 64 adults with genotype 1
chronic hepatitis C were randomly assigned (8 per cohort) to receive various
combinations of RG7128 and RG7227 (or placebo) for up to 14 days. Some
participants were treatment-naive and others were treatment experienced,
including some who had a null response to previous interferon-based therapy (HCV
RNA decrease <1 log10 in 4 weeks or <2 log10 in 12 weeks).
The first 2 study cohorts received low-dose monotherapy with either 500 mg
RG7128 twice-daily or 100 mg RG7227 3-times-daily on days 1-3. Both cohorts then
received a combination of both drugs on days 4-7. Next, additional cohorts
received escalating doses of RG7128 (500 or 1000 mg twice-daily) plus RG7227
(600 or 900 mg twice-daily, or 100 or 200 mg 3-times-dialy) for 14 days.
None of the participants took pegylated interferon or ribavirin during
RG7128/RG7227 dosing, but did received standard of care therapy using pegylated
interferon alfa-2a (Pegasys) plus ribavirin after the initial 2-week dosing
period.
The results presented at the AASLD meeting focused on the final 3 cohorts,
consisting of patients who received the higher-dose twice-daily regimens. Data
from the initial lower-dose cohorts were previously reported at the European
Association for the Study of the Liver (EASL) meeting this past April.

Results
  All patients receiving twice-daily RG7128/RG7227 regimens experienced a
continual decline in HCV RNA during the study period, with viral decline showing
a biphasic pattern.
  The highest response rate at day 13 -- 88% with viral load below the lower
limit of quantification (LLOQ, <43 IU/mL) and 63% below the lower limit of
detection (LLOD, <15 IU/mL) -- was seen in treatment-naive patients receiving
1000 mg RG7128 plus 900 mg RG7227 twice-daily.
  In previous null responders receiving the same doses, the corresponding
response rates were 50% below LLOQ and 25% below LLOD.
  In the 1000/900 mg dose cohorts, HCV RNA fell by a median -5.1 log10 IU/mL for
treatment-naive participants and -4.9 log10 for prior null responders.
  Participants who received the lower 600 mg dose of RG7227 plus 1000 mg RG7128
had lower response rates, 50% below LLOQ and 13% below LLOD.
  However, there were also no significant differences between twice-daily and
3-times-daily dosing.
  Patients with HCV genotype 1a and 1b also responded similarly.
  1 patient who received a lower dose (500/200 mg) of RG7128/RG7227 experienced
viral rebound, but had no identified resistance mutations and went on to achieve
undetectable viral load on standard-of-care therapy.
  The RG7128/RG7227 combination was generally well-tolerated.
  No treatment-related serious adverse events, dose modifications, or drug
discontinuations were reported.
  The most commonly reported adverse events were headache, nausea, and diarrhea,
which occurred with a frequency similar to that seen in the lower-dose cohorts.
  No emergent resistance to RG7128 or RG7227 was observed during the study
period.

Based on these findings, the researchers concluded that the combination of
RG7128 and RG7227 for up to 14 days "provided significant antiviral potency in
treatment-naive and experienced patients, sustained viral reductions, and
appears safe and well-tolerated as a twice-daily oral regimen."
"The results from this study of the RG7227/RG7128 combination raise hopes that
we can deliver an interferon-free regimen for our patients in the future," said
lead investigator Edward Gane, MD, in a press release issued by InterMune.
"Current HCV therapy includes up to 12 months of weekly interferon injections
which can be associated with significant side effects. In addition, not all
patients can take interferon due to intolerance or contraindications. We look
forward to the results of additional studies with these potent compounds."
The collaborating companies announced that Roche will initiate a Phase 2 trial
program in the first quarter of 2010. INFORM-2 will assess rapid virological
response (undetectable HCV RNA after 4 weeks of therapy) in prior non-responder
genotype 1 patients receiving twice-daily RG7128/RG7227 alone and in combination
with pegylated interferon alfa-2a, ribavirin, or both. Longer-term studies
evaluating sustained virological response (undetectable HCV RNA 24 weeks after
completing therapy) are anticipated for the first half of 2010.
Roche, Palo Alto, CA; Intermune, Brisbane, CA; Pharmasset, Princeton, NJ;
Auckland Clinical Studies, Auckland, New Zealand; The Alfred, Melbourne,
Victoria, Australia; Christchurch Clinical Studies, Christchurch, New Zealand;
Austin Hospital, Heidelberg, Victoria, Australia; Royal Adelaide Hospital,
Adelaide, SA, Australia.
11/10/09


Reference
EJ Gane, SK Roberts, CA Stedman, and others. Combination Therapy with a
Nucleoside Polymerase (R7128) and Protease (R7227/ITMN-191) Inhibitor in HCV:
Safety, Pharmacokinetics, and Virologic Results from INFORM-1. 60th Annual
Meeting of the American Association for the Study of Liver Diseases (AASLD
2009). Boston. October 30-November 1, 2009. Abstract 193. (Slides available
online).

S Le Pogam, M Chhabra, S Ali, and others. Combination Therapy with Nucleoside
Polymerase R7128 and Protease R7227/ITMN-191 Inhibitors in Genotype 1 HCV
Infected Patients: Interim Resistance Analysis of INFORM-1 Cohorts A-D. 60th
Annual Meeting of the American Association for the Study of Liver Diseases
(AASLD 2009). Boston. October 30-November 1, 2009. Abstract 1585.

PN Morcos, R Kulkarni, D Ipe, and others. Pharmacokinetics/Pharmacodynamics
(PK/PD) of Combination R7227 and R7128 Therapy from INFORM-1 Demonstrates
Similar Early HCV Viral Dynamics when R7227 is Combined with either
PEG-IFN/Ribavirin (SOC) or R7128. 60th Annual Meeting of the American
Association for the Study of Liver Diseases (AASLD 2009). Boston. October
30-November 1, 2009. Abstract 1594.

Other Sources
InterMune. INFORM-1 Results: Robust Antiviral Suppression Achieved with
Combination of Nucleoside Analog Polymerase Inhibitor RG7128 and Protease
Inhibitor RG7227. Press release. November 3, 2009.
AASLD. INFORM Study: HCV Protease R7227+HCV Nucleoside R7128; Twice Daily Oral
Medication Shows Promise in Treating Patients with Hepatitis C. Press release.
November 2, 2009.

http://www.hivandhepatitis.com/2009icr/aasld/docs/111309_b.html


HIV and Hepatitis.com Coverage of the
60th Annual Meeting of the American Association
for the Study of Liver Diseases (AASLD 2009)
October 30 - November 3, 2009, Boston, MA


Entecavir (Baraclude) and Tenofovir (Viread) Rescue Therapy for Chronic
Hepatitis B Patients with Advanced Fibrosis and Prior Treatment Failure


SUMMARY: A "rescue therapy" regimen combining entecavir (Baraclude) and
tenofovir (Viread) is safe and effective for chronic hepatitis B patients with
advanced liver disease who have experienced past treatment failure or developed
extensive drug resistance, according to a study presented this month in Boston
at the 60th Annual Meeting of the American Association for the Study of Liver
Diseases (AASLD 2009).

By Liz Highleyman


In this open-label cohort study, investigators from 8 referral centers in Europe
assessed the efficacy and safety of tenofovir plus entecavir in
treatment-experienced hepatitis B patients with advanced liver disease.


Past treatment with single nucleoside/nucleotide analog drugs as sequential
monotherapy has left many patients with hepatitis B virus (HBV) that harbors
multiple resistance mutations, the researchers noted as background. Drug
resistance renders older therapies less effective or ineffective, putting
patients with advanced liver fibrosis or cirrhosis at risk of further damage due
to hepatic "flares," or episodes of worsening disease.


Of the 39 study participants, more than half were hepatitis B "e" antigen
(HBeAg) positive. They had multidrug resistant HBV or a history of only partial
response to previous treatment. The median age was 48 years, and patients had
used an average of 3 (range 1-6) past treatment regimens. At baseline, the
median ALT level was 1.2 x upper limit of normal (ULN) and the median HBV DNA
level was 1.7 x 10(4) IU/mL.



Results

The median treatment duration after initiating combination therapy was 10.5
months (range 1-42 months).

During this period, no significant clinical side effects were observed.

The median HBV DNA level dropped significantly after starting the combination
regimen, by 3.5 log (range 0-8 log; P < 0.0001).

Nearly 80% (31 of 39 patients) achieved undetectable HBV DNA (< 80 IU/mL).

HBV DNA decline was accompanied by a significant ALT decrease (median 0.68 x
ULN; P = 0.001).

All patients with detectable HBV DNA were treated for less than 6 months.

3 patients experienced HBeAg loss (after 18, 21, and 24 months).

1 person showed hepatitis B surface antibody (HBs) seroconversion.

Patients with liver cirrhosis at baseline did not develop clinical
decompensation.

However, 2 patients with cirrhosis who had undetectable HBV DNA nevertheless
developed hepatocellular carcinoma.

There was no significant decrease in adherence among patients taking the 2
medications.


Based on these findings, the investigators concluded, "Rescue therapy with
entecavir and tenofovir in HBV monoinfected patients harboring complex viral
resistance patterns or showing only partial antiviral responses to preceding
therapies was highly efficient, safe, and well tolerated in patients with
advanced liver disease."


However, they added, "More data are certainly needed to judge about the
long-term safety, efficacy and prevention of emergence of new viral mutations in
this difficult to treat patient population."


Asklepiosklinik St. Georg, Liver Center Hamburg IFI Institute, University of
Hamburg, Germany; University Hospital Hamburg Eppendorf, Hamburg, Germany; Hotel
Dieu Hospital Lyon, Lyon, France; University Hospital Hamburg Eppendorf,
Hamburg, Germany; University Medical Center, Rotterdam, Netherlands; Charite
University Medical Center, Berlin, Germany; Fondazione IRCCS Maggiore Hospital,
University of Milan, Italy; Service d Hepato-Gastroenterologie, Universite
Pierre et Marie Curie, Paris, France; Hospital Vall de Hebron, Barcelona, Spain;
Goethe University Hospital, Frankfurt, Germany.


11/13/09


Reference
J Petersen, M Lutgehetmann, F Zoulim, and others. Entecavir and Tenofovir
combination therapy in chronic Hepatitis B: Rescue therapy in patients with
advanced fibrosis and multiple previous treatment failures. Results from an
international multicenter cohort study. 60th Annual Meeting of the American
Association for the Study of Liver Diseases (AASLD 2009). Boston. October
30-November 1, 2009. Abstract 405.

http://www.ncbi.nlm.nih.gov/pubmed/19885876

Hepatology. 2009 Aug 31. [Epub ahead of print]

Severe sepsis in cirrhosis.

Gustot T, Durand F, Lebrec D, Vincent JL, Moreau R.

Institut National de la Santé et de la Recherche Médicale (INSERM), U773, Centre
de Recherche Bichat-Beaujon CRB3, Paris 75018, France.


Sepsis is physiologically viewed as a proinflammatory and procoagulant response
to invading pathogens. There are three recognized stages in the inflammatory
response with progressively increased risk of end-organ failure and death:
sepsis, severe sepsis, and septic shock. Patients with cirrhosis are prone to
develop sepsis, sepsis-induced organ failure, and death. There is evidence that
in cirrhosis, sepsis is accompanied by a markedly imbalanced cytokine response
("cytokine storm"), which converts responses that are normally beneficial for
fighting infections into excessive, damaging inflammation. Molecular mechanisms
for this excessive proinflammatory response are poorly understood. In patients
with cirrhosis and severe sepsis, high production of proinflammatory cytokines
seems to play a role in the worsening of liver function and the development of
organ/system failures such as shock, renal failure, acute lung injury or acute
respiratory distress syndrome, coagulopathy, or hepatic encephalopathy. In
addition, these patients may have sepsis-induced hyperglycemia, defective
arginine-vasopressin secretion, adrenal insufficiency, or compartmental
syndrome. In patients with cirrhosis and spontaneous bacterial peritonitis
(SBP), early use of antibiotics and intravenous albumin administration decreases
the risk for developing renal failure and improves survival. There are no
randomized studies that have been specifically performed in patients with
cirrhosis and severe sepsis to evaluate treatments that have been shown to
improve outcome in patients without cirrhosis who have severe sepsis or septic
shock. These treatments include recombinant human activated C protein and
protective-ventilation strategy for respiratory failure. Other treatments should
be evaluated in the cirrhotic population with severe sepsis including the early
use of antibiotics in "non-SBP" infections, vasopressor therapy, hydrocortisone,
renal-replacement therapy and liver support systems, and selective
decontamination of the digestive tract or oropharynx. (HEPATOLOGY 2009.).

PMID: 19885876 [PubMed - as supplied by publisher]

http://aje.oxfordjournals.org/cgi/content/abstract/kwp375

American Journal of Epidemiology Advance Access published online on November 12,
2009
American Journal of Epidemiology, doi:10.1093/aje/kwp375

American Journal of Epidemiology © The Author 2009. Published by Oxford
University Press on behalf of the Johns Hopkins Bloomberg School of Public
Health. All rights reserved. For permissions, please e-mail:
journals.permissions@....
--------------------------------------------------------------------------------
Original Contribution

Molecular Sequence Data of Hepatitis B Virus and Genetic Diversity After
Vaccination

W. Marijn van Ballegooijen*, Robin van Houdt, Sylvia M. Bruisten, Hein J. Boot,
Roel A. Coutinho and Jacco Wallinga
* Correspondence to Dr. W. Marijn van Ballegooijen, RIVM, National Institute for
Public Health and the Environment, PO Box 1, 3720 BA Bilthoven, the Netherlands
(e-mail: marijn.van.ballegooijen@...).

Received for publication December 8, 2008. Accepted for publication August 21,
2009.


The effect of vaccination programs on transmission of infectious disease is
usually assessed by monitoring programs that rely on notifications of
symptomatic illness. For monitoring of infectious diseases with a high
proportion of asymptomatic cases or a low reporting rate, molecular sequence
data combined with modern coalescent-based techniques offer a complementary tool
to assess transmission. Here, the authors investigate the added value of using
viral sequence data to monitor a vaccination program that was started in 1998
and was targeted against hepatitis B virus in men who have sex with men in
Amsterdam, the Netherlands. The incidence in this target group, as estimated
from the notifications of acute infections with hepatitis B virus, was low;
therefore, there was insufficient power to show a significant change in
incidence. In contrast, the genetic diversity, as estimated from the viral
sequence collected from the target group, revealed a marked decrease after
vaccination was introduced. Taken together, the findings suggest that
introduction of vaccination coincided with a change in the target group toward
behavior with a higher risk of infection. The authors argue that molecular
sequence data provide a powerful additional monitoring instrument, next to
conventional case registration, for assessing the impact of vaccination.


--------------------------------------------------------------------------------
Editor's note: An invited commentary on this article appears on page 000, and
the authors’ response is published on page 000.

From:
  Therapeutics Daily (news@...)

Sent:
Wed 11/11/09 8:07 AM

















Valeant Pharmaceuticals Highlights Taribavirin Phase IIb End of Study Data
Presentation
From PR Newswire US - Nov 03, 2009
Valeant Pharmaceuticals today announced that results from the week-72 analysis
for its Phase IIb  dose-finding clinical trial for taribavirin, a prodrug of
ribavirin which is in development for  the treatment of chronic hepatitis C in
conjunction with a pegylated interferon, were presented  at the American
Association for the Study of Liver Disease 60th Annual Meeting in Boston.
  Read Full Article      Article Summary



Idenix Pharmaceuticals Initiates Phase II Trial of IDX184 in Combination With
Pegylated Interferon and Ribavirin for HCV
From PR Newswire US - Nov 03, 2009
CAMBRIDGE, Mass., Nov. 3 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc.,
a biopharmaceutical company engaged in the discovery and development of drugs
for the treatment of human viral diseases, announced today that it has initiated
a Phase II clinical trial evaluating IDX184, a liver-targeted nucleotide prodrug
candidate for the treatment of HCV, in combination with pegylated interferon and
ribavirin, in treatment-naive hepatitis C genotype 1-infected patients.
Antiviral activity, safety and tolerability of the triple combination will be
assessed at 14 days.
  Read Full Article      Article Summary




TapImmune Signs License Agreement With Crucell N.V.
From GlobeNewswire - Nov 04, 2009
TapImmune Inc., a biotechnology company specializing in the development of
immunotherapeutic vaccines for cancer and infectious diseases, has signed a
license agreement with Crucell N.V.  Under the license TapImmune may use the
proprietary PER.C6 cells in its development programs.
  Read Full Article      Article Summary




Scynexis' SCY-635 Demonstrates Positive Antiviral Activity in Combination with
Approved and Investigational Anti-HCV Agents
From Business Wire NewsExpress - Nov 03, 2009
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Nov 3, 2009 - Drug discovery
company Scynexis,  Inc. today presented positive data from an in vitro study
evaluating the antiviral activity of  SCY-635 in combination with approved and
investigational non-nucleoside polymerase inhibitors, nucleoside polymerase
inhibitors, protease inhibitors, ribavirin and interferon alpha 2b.
  Read Full Article      Article Summary




Idera Pharmaceuticals Presents Preclinical Data on IMO-2125,at Liver Meeting
2009
From Business Wire NewsExpress - Nov 03, 2009
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov 3, 2009 - Idera Pharmaceuticals, Inc.
today presents  preclinical data on the mechanism by which IMO-2125 was shown to
induce immune activation through  Toll-like Receptor 9 (TLR9). Two presentations
are being made today at the 60th Annual Meeting of  the American Association for
the Study of Liver Diseases being held in Boston, MA.
  Read Full Article      Article Summary


[Non-text portions of this message have been removed]

http://www3.interscience.wiley.com/journal/122670911/abstract?CRETRY=1&SRETRY=0

Journal of Viral Hepatitis
Volume 16 Issue 12, Pages 833 - 843
Published Online: 2 Nov 2009
© 2009 Blackwell Publishing Ltd


Management of chronic hepatitis C patients who have relapsed or not responded to
pegylated interferon alfa plus ribavirin

D. T. Dieterich 1 , M. Rizzetto 2 and M. P. Manns 3

1 Mount Sinai School of Medicine, New York, NY, USA ;   2 Division of
Gastro-Hepatology, Ospedale S. Giovanni Battista (Molinette), Torino, Italy ;
and   3 Department of Gastroenterology, Hepatology, and Endocrinology, Medical
School Hannover, Hannover, Germany
Correspondence to Professor Douglas T. Dieterich, Professor of Medicine Division
of Liver Disease, Director of CME, Mount Sinai School of Medicine, 1425 Madison
Ave, LC 01 MC Level, New York, NY 10029. E-mail:
Douglas.Dieterich@...

Copyright © 2009 Blackwell Publishing Ltd

ABSTRACT
Summary. Development of therapeutic strategies for patients with chronic
hepatitis C who experience virological breakthrough, relapse or nonresponse lag
behind those for treatment-naïve patients. The probability of a previously
treated patient responding to re-treatment depends on the nature of the previous
regimen, the magnitude of the response to previous treatment and the patient's
characteristics. Relapsers have higher sustained virological response rates than
nonresponders when re-treated with pegylated interferon plus ribavirin.
Re-treatment of nonresponders to pegylated interferon plus ribavirin with the
standard 48-week regimen resulted in an approximate 6% sustained response rate
in the EPIC-3 program. In the REPEAT trial, the sustained response rate was
significantly higher in nonresponders to pegylated interferon alfa-2b (12 kD)
plus ribavirin randomized to 72 weeks of peginterferon alfa-2a (40 kD) plus
ribavirin, compared with a 48-week regimen (16%vs 8%, P = 0.0006). Based on
available data, extended treatment is the best option for these individuals.
Undetectable viral RNA at week 12 is an important criterion for re-treatment in
the REPEAT and EPIC studies. Maintenance therapy with pegylated interferon is
generally ineffective in nonresponders and cannot be recommended. Directly
acting antivirals may increase response rates and the burden of adverse events
when combined with the standard of care, but will not be available for some
years. In conclusion, after careful evaluation of an individual's benefit–risk
ratio, a 72-week regimen is the preferred strategy for optimizing sustained
response rates in patients who have not responded to the standard of care,
provided that viral RNA is undetectable at week 12 of re-treatment.

--------------------------------------------------------------------------------
Received June 2009; accepted for publication July 2009
DIGITAL OBJECT IDENTIFIER (DOI)
10.1111/j.1365-2893.2009.01218

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> the Study of Liver Disease. During this conference
> many issues were addressed that clinicians face
> when they care for patients with chronic hepatitis
> B infection including:
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> are the optimal antiviral therapies and treatment strategies?
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> is a liver biopsy needed and are any of the non-invasive approaches to
detecting
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Patients With More Difficult to Treat Forms of Hepatitis C are Half as Likely to
Treat the Disease
11/09/2009

A new study by Mount Sinai researchers has for the first time found that
patients with more difficult to treat forms of hepatitis C are half as likely to
initiate treatment for the disease, when compared to patients with hepatitis C
that is easier to treat. Marital status also affected whether patients chose
treatment, as did whether or not they had other diseases. The study is published
in the Nov. 1 issue of Journal of Health Care for the Poor and Underserved.
“Overall, only about 30 percent of hepatitis C patients choose to initiate
treatment for the disease,” said Thomas McGinn, MD, senior study author and
chief of general internal medicine at Mount Sinai School of Medicine. “It’s a
huge problem that needs to be addressed. This study confirms that genotype is a
major barrier to treatment. We hope these findings will lead to changes in how
physicians approach patient care in a way that increases the rate of treatment
initiation.”
Researchers analyzed all patients referred to Mount Sinai’s Primary Care
Treatment and Screening Program for Hepatitis C between January 2003 and May
2007. The analysis included all hepatitis C clinic patients who were eligible
for treatment and to whom treatment was offered.
Of the 168 treatment-eligible patients, 41 began treatment and 127 chose not to.
Patients with genotypes 1 and 4 of the disease, which are less responsive to
treatment, were less likely to initiate treatment, as were unmarried patients
and patients with multiple diseases, or medical comorbidities. Age, gender,
language, race, and other risk factors were not found to be significant in the
study. Researchers found that:

-- Only 21 percent of individuals with genotypes 1 and 4 initiated treatment,
compared to 42 percent of patients with genotypes 2 or 3.
-- 46 percent of patients who chose treatment were married, as opposed to just
19 percent of the patients who declined treatment.
-- Patients who chose treatment had an average of 2.9 medical comorbidities,
while patients who did not treat their hepatitis C had an average of 5.2 medical
comorbidities.
“More research is needed to determine why these factors affect treatment
initiation,” said McGinn. “Because of existing studies on other diseases, we
were not surprised that marital status and comorbidities were contributing
factors to low treatment rates. However, this is the first study to associate
hepatitis C genotype with lower rates of treatment initiation.
“Duration of treatment may be a factor,” said McGinn. “Genotypes 1 and 4 of the
disease require longer treatment courses, about 9 to 12 months, versus an
average of 6 months for genotypes 2 and 3. It’s possible the longer duration
discourages patients from choosing treatment. Furthermore, patients with
genotypes 1 and 4 often need a liver biopsy, which many patients incorrectly
think are extremely painful. As a result of this study, Mount Sinai has started
a program called ‘Biopsy Buddies,’ in which a patient who has already undergone
a liver biopsy consults with a patient who needs one. We’re hopeful that by
building more support systems for patients we will increase the likelihood that
they will choose to receive treatment.”

> U.S. Department of Health and Human Services
> NATIONAL INSTITUTES OF HEALTH NIH News
> National Center for Research Resources (NCRR) <http://www.ncrr.nih.gov/>
> Embargoed for Release: Tuesday, November 10, 2009, 11:00 a.m. EST
>
> CONTACT: Cindy McConnell, 301-435-0888, <e-mail:info@...>
>
> NIH ANNOUNCES FIRST NATIONAL RESEARCH STUDY RECRUITMENT REGISTRY
> Nationwide Registry to "Match" Volunteers with Researchers
>
> Individuals who want to participate in research studies now can connect online
with researchers nationwide through the first disease-neutral, volunteer
recruitment registry.
>
> <ResearchMatch.org> is a not-for-profit secure Web site, designed to provide
people who are interested in participating in research the opportunity to be
matched with studies that may be the right fit for them.
>
> ResearchMatch offers an easy-to-use, free and safe way for volunteers to
connect with thousands of researchers who are conducting research on a wide
range of diseases.
>
> The site is a collaborative effort of the national network of medical research
institutions affiliated with the Clinical and Translational Science Awards
(CTSAs). The CTSA program, which is led by the , a part of the National
Institutes of Health, is focused on enhancing local and national efforts to
enhance the translation of laboratory discoveries into treatments for patients.
>
> "Participant recruitment continues to be a significant barrier to the
completion of research studies nationwide - recent NIH data indicates that just
4 percent of the U.S. population has participated in clinical trials," said NCRR
Director Barbara Alving, M.D. "ResearchMatch is a tool that can improve the
connection and communication between potential participants and researchers
providing opportunities for the public to contribute to advancing new
treatments."
>
> The convenient and user-friendly registry employs a familiar research matching
model that is complementary to Clinicaltrials.gov. One key difference is that
ResearchMatch places the burden of connecting the right volunteers with the
right study on the researchers, whereas Clinicaltrials.gov asks volunteers to
identify the trials that could work for them.
>
> "ResearchMatch offers a convenient solution to the complex, competitive and
often costly participant recruitment system," said Gordon Bernard, M.D.,
principal investigator of the Vanderbilt CTSA, which hosts the national
registry. "NIH data indicates that 85 percent of trials don't finish on time due
to low patient participation, and 30 percent of trial sites fail to enroll even
a single patient. We aim to help combat these challenges with ResearchMatch."
>
> HOW RESEARCHMATCH WORKS
>
> ResearchMatch will match any interested individual residing in the United
States with researchers who are approved to recruit potential research
volunteers through the system. After an individual has self-registered to become
a volunteer, ResearchMatch's security features ensure that personal information
is protected until volunteers authorize the release of their contact information
to a specific study that may be of interest to them. Volunteers are notified
electronically when they are a possible match and then make the decision
regarding the release of their contact information. It also will promote choice
as there are no obligations on the volunteer to participate in studies.
>
> For the first year of the project, only researchers affiliated with
participating CTSA institutions are eligible to use ResearchMatch. However,
plans are in place to make ResearchMatch available beyond the CTSA consortium by
2011. Currently 52 individual institutions associated with 40 CTSA sites are
part of the ResearchMatch network. A list of these institutions may be viewed
here
(http://ncrr.nih.gov/clinical_research_resources/clinical_and_translational_scie\
nce_awards/researchmatch).
>
> To learn more about ResearchMatch and to register as a volunteer, visit:
<www.researchmatch.org>.
>
> ABOUT THE CTSA CONSORTIUM
>
> The CTSA consortium is a national network of 46 medical research institutions
working together to improve the way biomedical research is conducted across the
country. The consortium, funded through Clinical and Translational Science
Awards (CTSAs), shares a common vision to reduce the time it takes for
laboratory discoveries to become treatments for patients and to engage
communities in clinical research efforts. It also is fulfilling the critical
need to train a new generation of clinical researchers. The CTSA program is led
by the National Center for Research Resources, part of National Institutes of
Health.
>
> Launched in 2006, this network now includes awardees in 26 states. When the
program is fully implemented, it will support approximately 60 CTSAs across the
nation.
>
> For more information about the CTSA program, visit <www.ncrr.nih.gov/ctsa>.
The CTSA consortium Web site, which provides information on the consortium,
current members and new grantees, can be accessed at <www.CTSAweb.org>.
>
> The National Center for Research Resources, part of NIH, provides laboratory
scientists and clinical researchers with the resources and training they need to
understand, detect, treat and prevent a wide range of diseases. NCRR supports
all aspects of translational and clinical research, connecting researchers,
patients and communities across the nation. For more information, visit
<www.ncrr.nih.gov>.
>
> The National Institutes of Health (NIH) -- The Nation's Medical Research
Agency -- includes 27 Institutes and Centers and is a component of the U.S.
Department of Health and Human Services. It is the primary federal agency for
conducting and supporting basic, clinical and translational medical research,
and it investigates the causes, treatments, and cures for both common and rare
diseases. For more information about NIH and its programs, visit <www.nih.gov>.
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> ##
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IAC Express
Immunization news from the Immunization Action Coalition

More than 35,000 subscribers read IAC Express.
Subscribe to IAC Express and our other free publications at
  http://www.immunize.org/subscribe

A web page version of this issue is available at
  http://www.immunize.org/express/issue833.asp

The September 2009 issue of Needle Tips, including Ask the
Experts, is now online. Visit http://www.immunize.org/nt

***Combined Federal Campaign (CFC)***
Federal employees, including military, may contribute to IAC
by using code #10612 on their pledge cards.
===========================================================

Issue Number 833
November 9, 2009

CONTENTS OF THIS ISSUE

1. CDC updates its H1N1 web section with information on
vaccine supply, dosage, administration, and storage--and
much more
2. Leading physician groups urge pregnant women to get both
seasonal and 2009 H1N1 influenza vaccines
3. MMWR publishes article on fatal case of human rabies in
Missouri in 2008
4. Healthy pregnant women mount a robust immune response
after receiving one dose of 2009 H1N1 influenza vaccine
5. HHS orders intravenous antiviral influenza medication to
help patients hospitalized with 2009 H1N1 influenza
6. Health Alert Network (HAN) Info Service Message advises
clinicians about antiviral treatments for 2009 H1N1
7. AAP offers information on coding for influenza vaccine
and its administration
8. IAC's Video of the Week--"Sneezing 101"--shows how a
simple hygiene step can keep you and others healthy
9. "CDC Features" educate the public about issues related to
2009 H1N1 influenza
10. Keep vaccinating against seasonal influenza!
11. Immunization Techniques video (DVD or VHS) offers a great
way to give staff high-quality vaccination training
12. CDC's two new flyers educate healthcare providers and
parents about the Vaccines for Children program
13. October issue of CDC's Immunization Works electronic
newsletter recently released
14. Correction: IAC Express amends statistic on annual number
of meningitis cases reported among U.S. infants
15. Notice: November 17 teleconference on infant
meningococcal diseases has been postponed
16. Laminated seasonal influenza vaccine pocket guides--
FREE!--from the National Influenza Vaccine Summit
17. VISs for 2009 H1N1 influenza vaccines available in 12
additional languages
18. VIS translation: VIS for PPSV vaccine now available in
Turkish
19. Pediatrics publishes "Recommendations for Screening,
Monitoring, and Referral of Pediatric Chronic
Hepatitis B"
20. MMWR publishes article on 2009 human vaccinia infection
after contact with raccoon rabies vaccine bait in
Pennsylvania
21. Physician toolkit for adolescent immunization ready for
downloading
22. Summary report of ACIP's special July meeting on H1N1
influenza is now online
23. National Conference on Immunization and Health Coalitions
set for May 26-28 in Chicago; abstracts due February 1

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