LiverHope
VOLUME 6, ISSUE 3 March 2004
LiverHope
VOLUME 6, ISSUE 3 March 2004
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March
21st, 2004 -
In This Issue
APRICOT Study: Combination Treatment and
HIV/HCV Coinfection
Vioxx Prevents Reduction in Platelets During
Pegasys Therapy for HCV: Short Term Pilot Study
Doctors broach idea of selling body organs
VA Revises Priority for Doctor Visits
02/06/2004 Veritas Medicine Viewpoint
Chinweike Ukomadu, M.D., Ph.D.
Instructor in Medicine, Harvard Medical School
In an upcoming article in
Gastroenterology, investigators report on their observations from over 600
patients who had failed prior treatment for chronic hepatitis C infections. The
investigators studied the response of this group of patients who had failed
therapy with alfa interferon alone or in combination with ribavirin. Most of the patients were infected with
genotype 1 virus. Treatment was with Pegasys 180 mcg subcutaneously every week
and ribavirin between 1000 mg-1200 mg a day.
The investigators found that
after 20 weeks, 35% of patients had no detectable virus. This group was treated
for a further 28 weeks and then evaluated 24 weeks after treatment. They noted
that 18% of the retreated group achieved sustained virologic response (SVR).
Prognostic data on who would
benefit from retreatment was mostly as expected 1) patients who were previously
treated with interferon monotherapy 2) patients infected with genotype
2 or 3 virus 3) patients
without cirrhosis 4) patients with viral loads of less than 1.5 million copies.
What was unexpected and what
this writer feels is an extremely important observation is the effect of dose
reduction of pegylated interferon and ribavirin on SVR.
The investigators noted that
dose reduction of pegylated interferon as is usually done for side effects of
neutropenia (low white blood cells) or thrombocytopenia (low platelets) did not
affect SVR. However, reduction of ribavirin dose (usually done for anemia)
before the 20th week of treatment resulted in lower SVR.
The importance of this last
finding if validated is that our current thinking of side effect management
will change. It implies that growth factors currently given to patients with
neutropenia (e.g. Neupogen) to help maintain interferon dose may be unnecessary
while such growth factors given to reverse anemia (e.g. Procrit, Epogen) may be
absolutely essential to prevent ribavirin dose decreases.
Reference: Mitchell L Shiffman
, Adrian M Di Bisceglie , Karen L Lindsay, Chihiro Morishima , Elizabeth C Wright et al. Peginterferon
alfa-2a and ribavirin in patients with chronic hepatitis c who have failed
prior treatment. Gastroenterology, In press
APRICOT Study: Combination Treatment and HIV/HCV Coinfection
New York, Feb. 12
/PRNewswire/ -- A Mount Sinai School of Medicine researcher reported results
from a study with a drug combination that showed the highest hepatitis C
treatment response rates ever reported in patients infected with hepatitis C
and HIV virus on Tuesday, February 10 at the 11th annual Conference on
Retroviruses and Opportunistic Infections (CROI).
The multinational APRICOT
(AIDS PEGASYS® Ribavirin International Co-infection Trial) study found that the drug combination
of Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin) were much more
effective than the previous generation of hepatitis C therapy standard
interferon and ribavirin. Efficacy was
measured as the sustained virological response (SVR) rate, which is defined by
the absence of detectable HCV RNA in the serum for at least six months after
treatment. Dr. Douglas Dieterich, Professor of Medicine, Mount Sinai School of
Medicine, New York City, and lead investigator on the APRICOT trial presented the
study results at the meeting. The study
was funded by Roche, the developers of Pegasys.
HCV and HIV are the two most
prevalent blood-borne infections in the United States. Of the nearly one million people estimated
to have HIV in the U.S., approximately 300,000 are believed to be co-infected
with HCV. It can take 10 to 20 years
following infection with hepatitis for a person to progress to end stage liver
disease. However, in patients with HIV,
the disease progresses far more quickly.
With advances in HIV therapy prolonging the life expectancy of HIV
patients, hepatitis C is now a major threat to people with HIV.
"The results from this
trial are very exciting news for the hundreds of thousands of Americans who are
living with hepatitis C and HIV," said Dr. Dieterich. "They prove that, through treatment
with Pegasys and Copegus, these patients can be treated successfully for their
HCV -- without compromising their HIV status."
Results from the study report
40 percent overall efficacy among co-infected patients and, when analyzed by
genotype, 62 percent efficacy in patients with genotypes 2 and 3, and 29
percent in those with genotype 1. Genotype 1 is typically the most difficult
strain of HCV to treat. Four times more
genotype 1 patients cleared the hepatitis C virus with Pegasys in combination
with Copegus than with those treated with standard interferon/ribavirin
combination therapy (29% vs. 7% respectively). Additionally, Pegasys
monotherapy showed superior efficacy to treatment with standard interferon and
ribavirin (20 percent vs. 12 percent), which is important for patients who
cannot tolerate ribavirin.
The randomized, partially
blinded international trial had a total of 868 HCV/HIV co-infected patients in
19 countries, and is currently, the largest study conducted among this patient
population. All patients were HCV
positive, had compensated liver disease, a CD4+ count greater than 100
cells/mL, and stable HIV disease, with or without antiretroviral therapy.
Patients were randomized to 48 weeks of treatment with interferon three times a
week plus 800 mg/day of ribavirin, 180 mcg of Pegasys once weekly plus placebo,
or 180 mcg of Pegasys once weekly with 800 mg/day of Copegus. Sustained
virological response (SVR) was accessed at the end of 24 weeks of
treatment-free follow up (week 72).
Negative predictability
ranged from 98 to 100 percent at 12 weeks. Negative predictability means that
patients can determine by week 12 if they are unlikely to respond to therapy
with Pegasys so decisions about the continuance of treatment can be made in
that time. In addition, HIV viral
levels were not negatively impacted by treatment with Pegasys and Copegus
combination therapy, and no new safety concerns were reported with this study.
Pegasys is a well-tolerated medication, even with the addition of full doses of
ribavirin. In this study, the most
commonly reported side effects were fatigue, fever and headache.
Co-authors on the study include J. Torriani, University
of California, San Diego, CA; J. Rockstroh, University of Bonn, Bonn, Germany;
M. Rodriguez- Torres, Fundacion de Investigacion de Diego, Santurce, Puerto
Rico; E. Lissen, Virgen del Rocmo University Hospital, Seville, Spain; J.
Gonzalez, Hospital La Paz, Madrid, Spain; A. Lazzarin, San Raffaele Vita-Salute
University, Milan, Italy; G. Carosi,
University of Brescia, Italy; J. Sasadeusz, Royal Melbourne Hospital,
Australia; C. Katlama, Groupe Hospitalier de la Pitie Salpetriere, Paris,
France; J. Montaner, University of British Columbia, Vancouver, Canada; H.
Sette, Instituto de Infectologia Emilio Ribas, Sao Paulo, Brazil; F. Duff,
Roche, Nutley, NJ, USA , J. DePamphilis, Roche, Nutley, NJ, USA; U. M. Schrenk,
Roche, Basel; Switzerland.
Vioxx Prevents Reduction in Platelets During Pegasys Therapy for HCV: Short Term Pilot Study
Reported by Jules Levin NATAP
54th AASLD Meeting - Oct
25-29, 2003 - Boston, MA
David H. Van Thiel and
researchers at University Medical Center, Maywood, IL reported at AASLD (Oct
2003) on seeing increase of platelets during treatment for HCV with Pegasys. In
order to improve tolerability for HCV IFN/RBV therapy non-steroidal
ant-inflammatory medications are often used, such as Motrin, Tylenol, Advil,
etc. Vioxx is an anti-arthritis drug sometimes often used by doctors for the same
purpose, to reduce the body aches, arthralgia and myalgia, associated with
IFN/RBV therapy. This pilot study reports for the first time that Vioxx may
also improve platelet count reductions associated with IFN/RBV therapy, called
thrombocytopenia.
Thrombocytopenia (reduced
platelet count) is a major limiting factor in the treatment of chronic
hepatitis C with interferon preparations. This is particularly true for
individuals with advanced disease because of a combination of factors that
include: 1) reduced thrombopoietin production by the diseased liver, 2)
hypersplenism and 3) actions of interferon per se.
The use of a Cox II inhibitor
like Vioxx (rofecoxib) is known to inhibit the inflammatory and
vasoconstriction actions of prostacyclin but has little or no effect on
prostaglandin production and any adverse effect on iNOS and the production of
NO, actions that are inhibited by nonselective NSAIDS.
The aim of the present
short-term pilot study was to define the effect of Vioxx combined with Pegasys
as compared to Pegasys therapy alone for chronic hepatitis C on platelet
numbers and the expected decline in platelet numbers associated with Pegasys
therapy.
Eighteen subjects with
chronic hepatitis C documented by positivity for anti-HCV, HCV-RNA and abnormal
liver injury tests and a liver biopsy consistent with chronic hepatitis C were
treated with Pegasys 180ug SQ weekly plus daily oral Vioxx (12.5mg/day) or
Pegasys alone for 8 weeks.
The changes in Hgb, WBC,
platelet count, serum ALT, AST, BUN, creatinine and viral load were assessed
weekly in both groups.
No differences in the levels
of Hgb or WBC counts were evident between the two groups treated with Pegasys.
Similarly, no change in the serum ALT, AST, BUN and creatinine levels were
observed between the 2 groups.
In contrast, the platelet
count declined from a mean baseline value of 193±13 in the group treated with
Pegasys and Vioxx such that at 8 weeks, the value was 162±12, a 16% decline.
The decline in platelet count in the group not using Vioxx was 41% with a
reduction in platelets from 166 ±18 to a value of 89±11.
These data demonstrate that
Vioxx, when used in combination with Pegasys to treat advanced chronic
hepatitis C, results in a highly significant reduction in the decline in
platelet numbers associated with Pegasys therapy.
Importantly, this platelet
sparing effect of Vioxx is not associated with an alteration in the values for
Hgb, WBC, BUN or creatinine.
This suggests that patients
with advanced disease (stage 3 or 4), who have baseline thrombocytopenia,
should be treated with Vioxx (rofecoxib) as well as Pegasys in an effort to
avoid high-grade thrombocytopenia that might limit the dose or duration of
Pegasys therapy when used alone to treat chronic hepatitis C.
Doctors broach idea of selling body organs
Poor people might be the primary
donors, but they would make money and save lives
By Helen Altonn
Honolulu Star-Bulletin – 2-14-04
Many transplant patients are
dying while waiting for organs that could be supplied through organ sales, some
doctors suggest.
The two controversial ideas
were aired at an International Bioethics Conference attended by more than 250
medical professionals, attorneys and bioethics experts on February 12 and 13,
2004, at St. Francis Medical Center in Honolulu.
Dr. Arthur Matas, University
of Minnesota Renal Transplant Service director, said paying unrelated living
donors for kidneys, now a federal crime, would be cost-effective compared with
extended dialysis.
He advocates a regulated
system with specified centers; a fixed, tax-free price for kidneys; and
allocation to patients the same as it is done now.
Matas acknowledged ethical
concerns about selling body parts and the likelihood that most sales would be
by poor people. But they would benefit from the income, and fewer people would
die waiting for transplants, he said.
Dr. S.Y. Tan, conference
co-chairman and director of the St. Francis International Center for Healthcare
Ethics, supported an organ-sales program, saying, "We should save
lives."
Another approach is
"presumed consent," he said.
Adults who die would be
presumed to have agreed to donate their organs for transplantation unless they
"opt out" with a registered refusal, he said. This would result in a
lot of organs for transplant operations, he said, "but there are critics
aplenty."
Critics say mistakes are
inevitable, problems would occur in registering and transmitting a person's
objection, and the system undermines individual autonomy and the right to
delegate decisions to family members, he said.
Tan said Singapore has
progressive policies on organ donations, including a presumed-consent law for
anyone except Muslims, and donations have increased sevenfold.
Only an average of 12 organs
are donated in Hawaii every year, he said, while as of January, 344 patients
were waiting for kidneys, 23 for livers, four for hearts and two for a kidney
and pancreas.
"Setting Limits to
Healthcare: The Time Is Now" was the theme of the conference, with
speakers exploring health care reforms and rationing to control skyrocketing
costs.
Dr. Lawrence Schneiderman,
professor of family and preventive medicine, University of California-San
Diego, said managed health care has failed to control costs and put doctors in
"a true ethical dilemma."
Their responsibility is to
serve the best interests of the patients, but managed care bases their income
on giving less care, he said, adding that this has eroded patients' trust in
doctors.
Canada, Britain and Singapore
also are grappling with health system problems, speakers explained.
For example, Canada gives
everyone access to health care, but patients have to wait months to years for
consultations and procedures unless it is an emergency, said neurologist Dan
Krushelnycky, St. Francis International Center for Healthcare Ethics fellow.
Canadians want the kind of
health care Americans have, with speed and access to technology, and Americans
want what the Canadians have with basic coverage for all people, he said.
"I think we will see a
convergence," he said.
VA Revises Priority for Doctor Visits
By Suzanne Gamboa
The
Associated Press
Saturday,
January 3, 2004
WASHINGTON - Veterans needing
medical help about health problems stemming from their military service will be
scheduled first for nonemergency appointments under new rules announced by the
Department of Veterans Affairs.
Appointments for such
veterans must be scheduled within 30 days of the request. When an appointment
is unavailable, the VA must arrange for care at another VA facility or contract
out for it, VA Secretary Anthony Principi said in a statement Friday.
Any veteran needing emergency
care still will be treated immediately. The new rule changes a policy in which
veterans with service-connected health issues, such as a war injury or certain
cancers related to Agent Orange exposure and who are not severely disabled,
waited with other veterans for appointments.
Last October, Principi gave
priority for appointments to veterans with 50 percent or more disability
ratings. Such severely disabled veterans also get priority for nonservice-related
health problems.
"If a veteran cannot see
a doctor in a timely manner, then we have failed that veteran," Principi
said.
Veterans have been enduring
waits of up to two years for appointments since demand increased after the VA
opened its medical facilities to all veterans in 1998. The VA has made
some progress toward reducing
waiting times. Principi hoped that by the end of 2003, veterans would need to
wait no more than 30 days to see a primary care physician.
Phil Budahn, a VA spokesman,
said that in July 2002 more than 300,000 veterans had been waiting more than
six months for primary care appointments at VA institutions. The list has
dropped to about 30,000, he said.
John Brieden, the American
Legion's national commander, said the new rule shows that the VA health care
system is so burdened that it cannot handle the demand and should get more
money.
"What they are doing is
admitting they can't do it for everybody they are supposed to do it for, so
they must put priority on some folks and tell others, “Gee, we can't see you
right now,'" Brieden said.
The House has passed a
spending bill containing $28.6 billion for veterans' health care, $2.8 billion
more than last year's allocation. The Senate should take up the bill when it
reconvenes Jan. 20. Brieden said the additional money should relieve some of
the demand, but it won't be enough to allow higher-income veterans eliminated
from VA health care last year to re-enter the system.
Last January, Principi barred
new enrollment of higher-income veterans in the VA health care system without
health problems related to their military service. He's required by law to
re-evaluate that decision this year.
On the Net: Veterans Affairs:
http://www.va.gov
Source: washingtonpost.com
A group of students were
asked to list what they thought were the present "Seven Wonders of the
World." Though there were some disagreements, the following received the
most votes:
1.
Egypt's
Great Pyramids
2.
Taj
Mahal
3.
Grand
Canyon
4.
Panama
Canal
5.
Empire
State Building
6.
St.
Peter's Basilica
7.
China's
Great Wall
While gathering the votes,
the teacher noted that one student had not finished her paper yet. So she asked
the girl if she
was having trouble with her
list. The girl replied, "Yes, a little. I couldn't quite make up my mind
because there were so many."
The teacher said, "Well,
tell us what you have, and maybe we can help."
The girl hesitated, then
read, "I think the 'Seven Wonders of the World' are:
1.
To
See
2.
To
Hear
3.
To
Touch
4.
To
Taste
5.
To
Feel
6.
To
Laugh
7.
And
to Love."
The room was so quiet you could have heard a pin drop. The things we
overlook as simple and ordinary and that we take for granted are truly
wondrous! A gentle reminder -- that the most precious things in life cannot be
built by hand or bought by man.
Co-Facilitators
Email: info@liverhope.com
Fax: (763) 566-0589
Website: www.liverhope.com
Helen: (952)
933-0932 – helen@liverhope.com
Pat: (763) 566-3839 – pat@liverhope.com
[1] Janet Durfee is a
Nurse Practitioner at the Chronic Hepatitis Clinic at the Minneapolis VA
Medical Center. She is an adjunct
professor at the University Of Minnesota School Of Nursing. Ms. Durfee has
served in United States Navy Nurse Corps for 11 years, with 4 years active duty
and 7 years in the Reserves. She has
served at military bases worldwide. Ms.
Durfee received her BA degree from Concordia College in Moorhead, MN and went
on to graduate school at George Washington University in Washington DC where
she earned her Masters Degree as an Adult Nurse Practitioner. She is a member of numerous societies and
nursing organizations and has contributed to various publications related to
hepatitis C.