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Reyataz
on its way
The first-ever once-a-day
protease inhibitor (with only two pills in that dose) was
recommended for approval in May by an advisory panel of the
U.S. Food and Drug Administration (FDA). Such preliminary
approval generally leads to full FDA approval soon after.
Reyataz (generic name atazanavir) should be in the drug stores
by the time this issue comes out. The drug might not raise
cholesterol levels as most of the other protease inhibitors
do (Agenerase is the other exception). Unfortunately, a few
people have experienced a rise in their bilirubin blood levels.
While not leading to illness, the increased bilirubin sometimes
gives a jaundiced appearance that one doctor called “another
visible sign of AIDS.” However, another doctor said some
of his patients simply appeared tan. (You need a bilirubin
level above 3.5 to see jaundice.) Positively Aware
medical consultant and columnist Dr. Daniel Berger says that
of the many patients he put on Reyataz during clinical trials,
none developed jaundice. He also noted that, “The bilirubin
elevations are minimal at best and often revert to normal
not too long after.”
New
Viracept dose
Also in May, a new dose of
Viracept was approved. Viracept can now be taken as two 625
mg tablets twice a day. One pharmacist said the new white
pill looks almost like a tiny Volkswagen bug, complete with
the signature Viracept “V”. The previous dose was
five tablets of 250 mg each, twice a day. This advancement
should make it easier for people to take Viracept, and in
turn have better results. The new dose also provides greater
bioavailability (basically, it’s better absorbed). Unfortunately,
according to the FDA, the drug’s infamous diarrhea problem
may be even more common with the new dose. However, preliminary
results from a study of 82 people who took the new dose for
a month—most of whom had been switched after two weeks
on the old dose—found less diarrhea than among those
who continued taking the 250 mg tablets. Moreover, none experienced
severe diarrhea. The results were presented at the 4th International
Workshop on Clinical Pharmacology of HIV Therapy held in March
in Cannes, France. Study results looking at people switching
from the 250 mg to the 625 mg pills are expected in September.
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Viracept
and food
In the May 2003 Hopkins
HIV Report (from Johns Hopkins University), Drs. Adriana
Andrade and Charles Flexner criticized the finding that high-fat
food intake increases the effectiveness of Viracept. They
write that, “Though nelfinavir bioavailability substantially
increased with higher caloric and fat intake, one has to wonder
how practical it is to recommend that patients consume such
large amounts of fat twice daily for long periods of time.
These results reinforce the fact that nelfinavir is a drug
with suboptimal pharmacokinetic properties. While pharmacokinetics
can be improved with an extraordinary (and unhealthy) diet,
the real value of this study might be in promoting the search
for a new formulation of nelfinavir that would produce higher
concentrations without the fat.” (See “Bon
Appetite,” this issue).
Prison
Book Program
The Prison Book Program has
new contact information. In addition to sending books free
to prisoners nationwide, the project also offers the National
Prisoner Resource List, a booklet of resources available for
prisoners, and a resource list specific to lesbian, gay, bisexual
and transgender prisoners. Contact: Prison Book Program, c/o
Lucy Parsons Bookstore, 110 Arlington St., Boston, MA 02116.
Call (617) 423-3298 or visit www.prisonbookprogram.org.
HIV
prevention
The U.S. Centers for Disease
Control and Prevention (CDC) in April announced a new direction
in its tackling of the epidemic. According to CDC officials,
nearly 25% of HIV funds will focus on four aspects: making
HIV testing a routine part of medical care; using rapid HIV
tests in non-medical settings with no requirement for pre-test
counseling; engaging HIV-positive people and their partners
in care, prevention, and testing services; and establishing
HIV testing for pregnant woman without requiring informed
consent or counseling. Many HIV advocates feel that because
most people will test negative for HIV, it’s the counseling
aspect that’s most important, in order to keep them negative.
Moreover, the initiative’s move away from distribution
of condoms and clean syringes can also be expected to harm
people at high risk of infections. Advocates were in an uproar.
HIV
research
Meanwhile, HIV researchers
talked to the press about pressure from the National Institutes
of Health (NIH). According to reports in the New York Times,
the Chronicle of Higher Education and others, the researchers
were warned against applying for money to study prevention
using any of the following words in their applications: anal
sex, men who have sex with men, transgender, needle exchange
and sex workers.
HIV
and anthrax
Down at the National Institute
of Allergy and Infectious Diseases (NIAID, part of the NIH),
money was shifted from AIDS research to pay for anthrax vaccines.
This was according to the AIDS Vaccine Advocacy Coalition
(AVAC), located in New York City. AVAC sent a letter protesting
the shift, signed by several other organizations. The letter
said that the U.S. Office of Management and Budget should
get the bucks from somewhere else.
HIV
and the Surgeon General
In Washington, D.C., Advocates
for Youth praised the U.S. Surgeon General Dr. Richard Carmona
for advocating comprehensive sex education that includes discussion
of condoms. In a press release, Advocates for Youth President
James Wagoner said that, “The Surgeon General realizes
that comprehensive sex education—education that covers
abstinence and contraception—is critical in protecting
the health and lives of America’s youth in the era of
AIDS. It is stunning that the administration [President Bush
and staff] is exporting [through a global AIDS initiative]
an unproven approach that has failed to gain the support of
the nation’s leading public health official.” Advocates
for Youth praised Dr. Carmona and criticized the President’s
“abstinence-only-until-marriage” program. The Associated
Press quoted Dr. Carmona as saying that, “As part of
comprehensive education, we should be talking about all of
the issues.” That’s our kind of doctor.
AIDS
activist recognized
The European edition of Time
magazine named AIDS activist extraordinaire Zackie Achmat
as one of 36 “extraordinary heroes.” Three other
AIDS activists were also recognized: French countess Albina
du Boisrouvray, Irish rock star Bono and geologist Sergei
Kostin of Ukraine. Achmat, 41, is also one of the winners
of the Jonathan Mann Award for Global Health and Human Rights,
from the Global Health Council, the Association Francois-Xavier
Bagnoud and Doctors of the World. The honors led to profiles
published around the world, including the Boston Globe
and the Associated Press.
Achmat co-founded the Treatment
Action Campaign (TAC) in South Africa four years ago to fight
for antivirals. He is a filmmaker and a life-long activist,
formerly with labor, anti-apartheid and gay rights struggles.
TAC successfully sued to force the South African government
to provide Viramune to HIV-positive pregnant women, to prevent
mother-to-infant transmission. Another struggle made the pharmaceutical
giants back off from their attempts to stop the importation
and production of less-expensive generic HIV meds. TAC members—especially
Achmat—have smuggled generic drugs into the country to
help people with HIV. Today he’s widely recognized as
the activist who’s dying because he refuses to take anti-HIV
drugs available through his private medical insurance until
his government agrees to provide antivirals to its people
living with HIV. Achmat was diagnosed with HIV in 1990. Time
reported that, “he said he was so sore he felt as if
his body had been used as a punching bag. One week before,
he was struggling with a serious chest infection that kept
him in bed for days.”
To see the speech he delivered
to the World AIDS Conference (by satellite, because he was
too ill to travel), see the September/October
2002 Positively Aware. Visit www.tac.org.za.
He
said what?
“If the Supreme
Court says that you have the right to consensual (gay) sex
within your home, then you have the right to bigamy, you have
the right to polygamy, you have the right to incest, you have
the right to adultery. You have the right to anything,”
Senator Rick Santorum, a Republican from Pennsylvania, said
in a recent interview, fuming over a landmark gay rights case
before the high court that pits a Texas sodomy law against
equality and privacy rights. “All of those things are
antithetical to a healthy, stable, traditional family,”
Santorum said. “And that’s sort of where we are
in today’s world, unfortunately. It all comes from, I
would argue, this right to privacy that doesn’t exist,
in my opinion, in the United States Constitution.”—Charles
E. Clifton
Price
Freeze for ADAP
Boehringer Ingelheim Pharmaceuticals
announced a two-year price freeze on its non-nuceleoside reverse
transcriptase inhibitor HIV drug Viramune (nevirapine). This
price freeze is coupled with the discount that Boehringer
Ingelheim (BI) currently provides to ADAPs (AIDS Drug Assistance
Programs). Other manufacturers have also put a price freeze
on their HIV drugs, including Agouron Pharmaceuticals (Viracept)
and GlaxoSmithKline (Combivir, Ziagen and others). In addition,
BI continues to provide Viramune at no cost to patients with
a demonstrated need through its Patient Assistance Program.
Please call 1 (800) 556-8317 more information on this program.—Charles
E. Clifton
Staying
Alive
The National Association
of People with AIDS (NAPWA) hosts its 20th annual Staying
Alive conference August 15–17 in Denver, organized by
and for people living with HIV. For more information, call
(202) 898–0414 or visit www.napwa.org.
On-line
database
Test Positive Aware Network
has added a searchable online database for its Chicago
Area HIV Services Directory (in English and Spanish).
Visit http://www.tpan.com/publications/services_directory/
services_directory.html
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