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Fuzeon
approved
Fuzeon (T-20) was approved
by the U.S. Food and Drug Administration (FDA) in March. The
twice-daily injections were approved for people with HIV drug
experience whose antiviral therapy is failing to work for
them. Fuzeon is the first in a new class of anti-HIV drugs
to hit the market: fusion inhibitors. It literally prevents
HIV from infecting (fusing to) cells. The best use would be
in someone who also has another active drug to add to their
regimen along with the Fuzeon. People taking Fuzeon are advised
to seek medical evaluation immediately if they develop signs
or symptoms suggestive of pneumonia, such as cough with fever,
rapid breathing and shortness of breath. They should also
beware of an allergic reaction. Fuzeon is a peptide, which
is expensive and difficult to produce. As a result, there
are two major access problems: cost (more than $20,000 per
year) and production. See the January/February Annual HIV
Drug Guide for more information.
Send
unused drugs abroad
…through the Starfish
Project of New York-Presbyterian Hospital and Cornell University.
The program is approved by the U.S. Food and Drug Administration
(FDA). Medications are sent to Africa. Contact www.thestarfishproject.org
or call (212) 746-4180. In Chicago, drugs may be dropped off
at Howard Brown Health Center, 4025 N. Sheridan Rd. Bottles
may be opened or unopened. The name comes from the story of
the girl throwing some of the hundreds of starfish back into
the sea. When asked what difference she could make, she replies,
“It makes a difference to this one.”
Nkosi’s
orphanages
Positively Aware did
not find information on the Nkosi Johnson AIDS Foundation
before presstime for the orphans resource list in the March/April
issue. The website is http://nkosi.iafrica.com.
Nkosi Johnson is the South African child who spoke at the
2000 International AIDS Conference and died of AIDS, but not
before helping to start an organization that would help other
orphans.
New
Detroit program
The Detroit LIGHT House now
has a specialized substance abuse treatment program (intensive
outpatient with home visits) for people with HIV. The program
focuses on African Americans and men who have sex with men
(MSM). Services include one-on-one and groups dealing with
topics such as emotional management and recovery (drug use,
relapse prevention, health, depression, anxiety and AIDS).
Free housing provided to eligible clients. Legal and financial
counseling is available. For more information, call (313)
832-1300.
Poz
HeteroCruise
The Center for Positive Connections
is hosting its 6th annual Poz HeteroCruise October 12–19th,
leaving from San Juan, Puerto Rico. Reservations must be made
by May 12, or as soon as possible. Payments must also begin
the sooner the better. For more information call tollfree
(888) POS-CONN (767-2666) or visit www.positiveconnections.org.
TCPC, located in Miami, is an organization for HIV-positive
heterosexuals.
Resistance
database
Scientists have started a
non-profit database of HIV drug mutations, the HIV Resistance
Response Database Initiative. It hopes to collect data from
doctors around the world. Efforts include responding to clinician
inquiries. RDI was founded by Brendan Larder. Members include
Julio Montaner of the British Columbia Centre for Excellence
in HIV/AIDS, Victor DeGruttola of Harvard University and Scott
Wegner of the U.S. Military HIV Research Group. Visit www.hivrdi.org.
Women’s
website
The United Nations Development
Fund for Women (UNIFEM) with UNAIDS (United Nations Programme
on HIV/AIDS) has developed a comprehensive website on women
and HIV/AIDS. UNIFEM notes that, “Programmes on HIV/AIDS are
beginning to mainstream gender…. Best practices are being
identified. And women are increasingly being regarded as active
participants in bringing about change, rather than helpless
victims.” Visit www.GenderandAIDS.org.
AIDS
vaccine fails
The first AIDS vaccine to
reach an advanced stage of research (Phase III) showed no
difference when compared to placebo (fake drug). Overall,
people in the study were infected with HIV whether or not
they received the vaccine (about 6% each). Results are out
to three years with more than 5,000 people at high risk of
infection.
VaxGen, the manufacturer
of AIDSVax, reported that the vaccine seems to have protective
ability for African Americans and Asians. However, the numbers
of these people in the study were so small, they were basically
irrelevant until much more research takes place. The statement
served to mislead people, some of whom called the claim of
ineffectiveness of the vaccine “racist.” Gay Men’s Health
Crisis, an HIV-service organization in New York City, called
the company’s statement “grossly premature.”
VaxGen can, of course, continue
studies to see if the vaccine may indeed protect certain populations.
Raising money for this may be difficult with the disappointing
results of this trial. However, many vaccine advocates were
optimistic. They noted that while the results were poor, the
importance of the effort was huge.
AIDSVax was supposed to stop
HIV from reproducing by blocking one of its proteins, gp120.
There are more HIV vaccines in development which work in different
ways. The company has another vaccine in the works, in Thailand,
with results also expected this year.
“Safer”
Smallpox
The U.S. Department of Health
and Human Services (DHHS) awarded two grants for the search
of a smallpox vaccine that can be used by people with a compromised
immune system. Such a group includes people with HIV and those
on cancer chemotherapy. Preliminary results may come as early
as this year.
Bush
backslides
It was hard to believe that
President Bush could really be an advocate for people with
HIV, despite his pledge of $15 billion for fighting AIDS in
Africa and the Caribbean during his January State of the Union
address. Sure enough, the President basically took back his
pledge later by saying that only organizations that do not
perform or advocate for abortions can receive money. This
makes it virtually impossible for medical clinics and other
organizations that help people with HIV get money for AIDS
treatment as outlined in the President’s proposal. The President
said organizations can get money by setting up separate facilities
for AIDS work. This too is virtually impossible.
News
from the 10th Conference on Retroviruses and Opportunistic
Infections, held in Boston in February
Prisoners
and HIV
Researchers noted that “as
many as 20% of HIV-infected persons in the U.S. enter and
leave a correctional facility each year.” Lead researcher
Dr. David Wohl told Reuters news service that areas of the
country with high rates of HIV also have high rates of incarceration,
“and we were wondering if this is more than just a coincidence.”
The researchers talked with 80 prisoners, more than half of
them women, and again after they were released (83% of them
at the time of the report). They found that half of the ex-inmates
had sex within a week after leaving prison. Although most
of the people getting out of prison (64%) had a main partner
without HIV or with unknown HIV status, 24% of them had unprotected
sex with the partner. (In the year before incarceration, 78%
had unprotected sex with the partner.) The University of North
Carolina research team reported that, “Given their current
sex behavior 31% of releasees felt that it was very likely
or somewhat likely that they would infect their HIV-negative
main partner.”
Other research has found
a high risk of HIV infection among partners of former prisoners.
The health risks are thought to be so high, one Chicago blood
bank refuses donations from anyone ever locked up for 48 hours.
908/fos-Amprenavir
Final 48 weeks results from
the NEAT study are in for the new formulation of Agenerase.
GW433908 (908 for short) is a protease inhibitor with a low
pill burden—two tablets twice a day. It was compared to Viracept
(five tablets twice a day), both given with Epivir and Ziagen.
908 twice a day “showed evidence
of greater efficacy” than Viracept. In people who had more
than 100,000 viral load at the start of treatment (half of
the participants), 67% of the 908 group had less than 400
viral load, compared with 35% of the people on Viracept.
Overall, the number of people
who went below 400 viral load was 66% for 908 and 48% for
Viracept. (Under 50 copies, it was 908 - 58% and Viracept
- 42%.)
Half of the group of 249
participants had less than 200 T-cells. Both drugs increased
T-cells by 200. TheBody.com reported that the drop-out rate
was more than 30% for 908 and 46% for Viracept. The report
noted that perhaps the advanced disease stage of so many of
the patients made therapy more difficult to tolerate. Many
participants were from poor countries in Central and South
America, although most were from the U.S.
908 is expected to be dosed
once a day with Norvir. It’s also hoped that 908 is active
against resistant virus.
908
vs. Kaletra
Now here’s a drug to beat.
Kaletra is a potent protease inhibitor, even for people with
extensive drug resistance.
In the CONTEXT study, Kaletra
and 908 both showed a strong response in people who had already
experienced viral load failure on therapy (defined as more
than 1,000). About half of the participants had advanced disease—less
than 260 T-cells. These are preliminary results from six months
of treatment.
Using intent-to-treat analysis
(a strict standard), the percentage of people getting below
50 viral load at 24 weeks was 48 for Kaletra, 42 for 908 once
daily and 40 for 908 twice daily. T-cell increases were around
65 for all groups.
In this study, 908 was given
with a small dose of Norvir, either once or twice a day. Two
nucleoside drugs (the class of drugs that includes Retrovir
and Ziagen) were added with the use of resistance testing,
to make sure the nukes were effective in the participants.
The 320 people in the study were from 13 countries, most from
the U.S.
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