AIDS TREATMENT NEWS Issue #382, August 9, 2002
phone 800-TREAT-1-2, or 215-546-3776

CONTENTS

** Barcelona Conference: New Online Report
An excellent collection of articles, written mainly for HIV
medical professionals, summarizes some of the important medical
information from the Barcelona conference.

** Barcelona Conference Daily News Links
These sites have short reports, usually published within a day or
two and focusing on a single medical presentation. You can quickly
scan what's available, then read what you need.

** ACTG 384 at Barcelona: The Bottom Line
Unexpected early results from a major clinical trial will change
some treatment decisions.

** Nandrolone: Generic Now in Stock
On June 28 we reported that the anabolic steroid nandrolone
suddenly became unavailable in the U.S. (except perhaps for a
compounded version). Since then a new generic product has reached
some pharmacy shelves.

** "Save ADAP" Campaign Starts August 12 -- What You Can Do Now
An excellent instruction kit for advocacy is available.

** National AIDS Treatment Advocates Forum (New Orleans, December
2002): Scholarship Deadline Aug. 16
Financial assistance deadline for NATAF is Friday of this week.

** Barcelona Comments
What do we see as most important from the conference -- or missing
from it? Besides new drugs, we look at how vaccines could be
developed much faster -- and at leadership (and lack of it) in
controlling a global epidemic that is becoming much worse than was
expected even recently.


***** Barcelona Conference: New Online Report

by John S. James

On August 9 an excellent in-depth summary of what HIV medical
professionals and well-informed patients most need to know from
the XIV International AIDS Conference (July 7-12 in Barcelona,
Spain) was published on the Medscape Web site,
http://hiv.medscape.com It consists of four articles, and a test
that physicians, pharmacists, and RNs can take for continuing
medical education (CME) credit (but anyone can read the articles
or take the test for their own information). [Note: The first time you
use this site you will probably need to register, but registration is
free.]

The articles are:

* Initial Antiretroviral Therapy: Further Insights on When to
Start and What to Use, by Joseph J. Eron Jr., M.D.,

* Antiretroviral Therapy in Treatment-Experienced Patients, by
William A. O'Brien, M.D., M.S.,

* Update on Lipodystrophy...Or Is It Just Lipoatrophy?, by Donald
P. Kotler, M.D., and

* Opportunistic Infections and Coinfections: Focus on Fungi and
Hepatitis, by William G. Powderly, M.D.

Many patients will find one of the first two articles most
important, because they discuss some of the newer options in
antiretroviral treatment. The lipodystrophy article is the most
complex, because our basic understanding of HIV-related
lipodystrophy may be changing. In addition to these four articles,
there is some optional material that is not required for CME
credit.

This CME course is available at:
http://hiv.medscape.com, and will remain online for one year.

Comment

The first reports from Barcelona were next-day coverage of
individual sessions, which were published by several different
organizations. Now, a month after the conference, we are getting
reports that summarize information from many conference sessions
and from other sources as well, outlining how our understanding
has changed due to the findings presented at the meeting.

We missed the Barcelona conference unexpectedly (see AIDS
TREATMENT NEWS #381) -- and especially missed the many informal
conversations in hallways and other informal meetings that help to
put the whole conference in perspective. Fortunately these
conversations continue by email -- although this medium would be
more useful if people would learn to communicate better when
sending email to large groups (for example, by making each message
coherent to others who may not be as involved as the sender in the
background and context of that message).

The official conference site,

http://www.aids2002.org, leaves much to be desired -- although
fortunately it does allow searching for any word in the abstracts,
important for locating specialized information.

So far, the Medscape CME is the best summary we have seen of the
clinical importance of this conference. It is likely that several
comparable reports will be published over the coming months.


***** Barcelona Conference Daily News Links

The next-day reporting from the conference had to focus on
individual meetings instead of broader perspectives. Still, some
of these reports may be the best source available for particular
information you need. You can use these links to read quickly
through the dozens of titles, to find what is important for you.

Note: Web sites often get reorganized, so some of these links may
not work when you try them. In that case, go to the home page of
the site (usually the part of the address through the .com or
.org), and look for the reports from there.

The annotations in brackets below are our own.

* Medscape [information for medical professionals and patients]
http://www.medscape.com/viewprogram/1980 also see
http://www.medscape.com/pages/editorial/newsbeats/aids

* Kaiser Family Foundation [general conference news widely
syndicated on other sites]
http://www.kaisernetwork.org/aids2002/

* Health & Development Networks [important international coverage]
http://www.hdnet.org/home2.htm

* The Body [focus on new drugs and other medical news]
http://www.thebody.com/confs/aids2002/aids2002.html

* International Association of Physicians in AIDS Care (IAPAC),
http://www.iapac.org/ [Choose IAPAC AIDScan for their daily
newsletter on the conference.]

* HIV and Hepatitis.com [many news reports]
http://www.hivandhepatitis.com

* National AIDS Treatment Advocacy Project [occasional medical
articles, also strong on hepatitis]
http://www.natap.org/

* For a short (6 pages single spaced) overview of the conference,
focusing on medical information that will affect patient care over
the next several years, see "A Roundup of Barcelona" by Pablo
Tebas, available at:
http://www.thebody.com/confs/aids2002/tebas10.html
From the Roundup: "The science -- at least the clinical part --
was very good this time, much better than in Durban or in
Retrovirus this year. Major trials like ACTG 384, INITIO, Gilead
903, and the TORO trials were presented during the Barcelona
conference. These trials will mark the next months if not years of
HIV treatment."


***** ACTG 384 at Barcelona: The Bottom Line

by John S. James

ACTG 384 is a large clinical trial by the U.S. Institute of
Allergy and Infectious Diseases, which enrolled over 900
treatment-naive volunteers. Shortly before the Barcelona
conference, one of the six different treatment regimens tested was
found to be clearly better than the others. So volunteers will be
told which regimen they were on, and advised on options for
changing therapy when appropriate.

Letters were written to study volunteers before the conference;
however, local IRB (institutional review board, intended to
protect volunteers in clinical trials) for most of the study sites
required that they review the letters before they could be
distributed. Since the reviews had to wait for the IRB process,
few volunteers received the news before the Barcelona meeting.

Two abstracts on this study were presented at late breakers at
Barcelona (numbers LbOr20A and LbOr20B). These hard-to-read
abstracts can be found by a search on the official conference
site, probably reachable at:
http://www.aids2002.org/Search/AbstractSearch.asp (be careful to
use the Abstract Search, not the Quicklinks search confusingly
placed above it); you can search for the abstract numbers.

But what matters most is:

1. Efavirenz plus AZT plus 3TC was a better starting regimen than
the other five tested in this trial;

2. Regimens including d4T plus ddI had more toxicity than others;
and

3. There are questions about how to apply these results to
treatment today (see article by Peter Ruane, M.D., at:
http://www.medscape.com/viewarticle/438430).

Comment

1. This is an important trial -- despite issues of whether the
questions it was designed around will ever be answered, or were
the best questions to ask. The comparisons between regimens do not
generalize to drug classes (whether it is better to start with a
protease inhibitor or an NNRTI, for example), but apply mainly to
regimens chosen from those available several years ago. Still, the
trial is important because it collected good-quality data after
randomized treatment assignments -- data likely help in many ways
to improve HIV care. We will be hearing much more from this trial
over the next few years.

2. The local IRB review of the researchers' recent letter to the
volunteers, which delayed its delivery to most participants, made
no sense. The local IRBs will not change this letter, nor stop it
from going out. So the whole exercise was empty process. We
hope the current dysfunctional relationship between local and
national IRBs will be part of the badly needed review of
protection of volunteers in medical research. Perhaps national
studies should be reviewed by national IRBs that can be trusted --
with local IRBs able to block the study initially, but not
routinely involved when it is too late to make any contribution.


***** Nandrolone: Generic Now in Stock

In June we reported that nandrolone was no longer regularly
available in the U.S.; generic versions had disappeared three
years ago, and the more expensive brand name Deca Durabolin had
just been withdrawn from the market by the manufacturer. In late
July we learned that a generic version is now available through at
least some pharmacies. The Schein brand was found in a New York
pharmacy at a retain price of $13 per vial (1 ml, 200 mg/ml). This
is close to the old generic price.

There may be more information on the nandrolone situation at
http://www.medibolics.com or at http://www.houstonbuyersclub.com
(On the Medibolics site, you might search the home page for 'Deca'
or 'nandrolone', using the search in your own Web browser).


***** "Save ADAP" Campaign Starts August 12 -- What You Can Do Now

About 10,000 Americans eligible for AIDS treatment are now on
waiting lists for the AIDS Drug Assistance Program (ADAP), because
of lack of funds. As we go to press, the AIDS Treatment Activist
Coalition is about to release an action alert on what you can do
now, especially in August and September. It includes clear,
accurate instructions for writing to your Representative and two
Senators, for writing to local newspapers on this issue, and for
attending any local meetings your representatives in Congress have
with their constituents.

If you do not get the alert through an AIDS email list, look for
it at http://www.atac-usa.org You can also email Ryan Clary at
Project Inform rclary@..., and ask for a copy of the
Save ADAP alert.


***** National AIDS Treatment Advocates Forum (New Orleans,
December 2002): Scholarship Deadline Aug. 16

The National AIDS Treatment Advocates Forum, sponsored by the
National Minority AIDS Council (NMAC), brings together about 400
treatment advocates from the U.S. and other countries for skills
building to help assure the continued success of the treatment
advocacy movement. This year's NATAF meeting will be held in New
Orleans, LA, on December 8-11, 2002.

Scholarships (which can include the $150 registration fee, the
hotel, and a $100 travel credit) are available. The deadline for
scholarship applications is Friday, August 16. You can apply
online at:

http://www.nmac.org/nataf/2002/scholarship.htm You will need
information about yourself and your agency, so it's best to check
the application form ahead of time, and submit it online later.

The mission of NATAF includes:

"Updating participants on the latest treatment and research
information;
Providing opportunities to build advocacy skills;
Providing opportunities to develop inclusive strategies to
advocate for people living with HIV/AIDS;
Promoting collaboration, networking and mentoring among all
participants."


***** Barcelona Comments

by John S. James

The XIV International AIDS Conference, July 7-12 in Barcelona,
Spain, was the biggest AIDS conference ever, with more than 15,000
people and more than 10,000 research, program, and other reports
presented. Some have wrongly concluded that little important
medical or scientific information was included. But it can be hard
to find what you need, so we will continue to point to the best
and most accessible reviews as new ones become available.

But first, here are some (not all) of the important take-home
messages, as we see them:

* Clinical care. Lots of information will affect treatment of
patients over the next several years -- including new drugs,
better ways to use existing drugs, and better understanding of why
HIV treatment is difficult. For example, the approved drugs
efavirenz and tenofovir, and T-20, which should be approved within
a year, continue to look good. For a link to in-depth clinical
information, see "Barcelona Conference: New Online Report" in this
issue.

Incidentally, T-20 is expensive to manufacture -- and there are
likely to be serious equity issues in who gets access within the
U.S. But we doubt that there will be major access issues in
developing countries. This is because T-20 is injected twice a
day, and therefore is likely to be used only by those who need it
because they have developed extensive viral resistance to other
HIV drugs. So few people in developing countries have received any
antiretroviral treatment that there is not likely to be much need
for T-20 for several years. By that time there should be other new
antiretrovirals that can be provided more easily.

* Vaccines -- What's Missing on Faster Testing? The discussion we
have seen from the Barcelona conference has missed what may be the
most important practical fact about vaccine development -- that by
far the fastest way today to develop a preventive vaccine is to
test candidates as therapeutic vaccines first. This is because
therapeutic vaccines can be tested in weeks in a handful of HIV-
positive volunteers during structured treatment interruptions, to
see if they show any anti-HIV effect by delaying the return of the
virus humans. But getting any idea of whether a preventive vaccine
works takes thousands of people in trials that run for years.
(There were a handful of presentations on therapeutic vaccines in
Barcelona -- including DermaVir, a vaccine designed to be applied
to the skin, that could begin human trials this fall.)

Eventually the development paths for preventive and therapeutic
vaccines may diverge. But this has not happened yet, because so
much is still unknown about immune protection from HIV.

Scientists now can measure a seemingly endless number of potential
immune responses -- and often can stimulate these responses in
human volunteers with vaccine-like treatments. The problem is that
we don't know which immune responses actually help to protect
against HIV (and we may know less after the Barcelona conference
than we thought we knew before). If we had a vaccine that would
greatly reduce the return of viral load after antiretroviral
therapy was stopped, that would not prove it would protect against
initial infection; additional tests would still be required. But
such a vaccine would be a much better candidate for a preventive
trial than any we now have. Therapeutic vaccine testing can
quickly screen many ideas, allowing for successive improvements in
basic science and in products alike, greatly advancing the search
for a preventive vaccine.

And although it is clearly a setback for vaccine development, we
are not too worried by the news that a person's immune response to
HIV infection may not protect against another HIV infection.
Clearly the immune system does largely contain the virus in
early infection, so immune control of HIV is possible. And
vaccines can be engineered to produce many immune responses that
natural infection usually does not produce.

* Global epidemic. The biggest need now is to prevent India,
China, Indonesia, Eastern Europe, and other large population
centers from developing major epidemics like the one in Africa,
which could ultimately kill a quarter of the population or more --
especially parents, and workers in their most productive years.
These epidemics are already in their early stages. They could be
mostly stopped if the proper steps are taken now -- but while
proven prevention programs exist, they are not being scaled up in
most countries, due to lack of leadership and the resulting lack
of resources. If current trends continue, the number of people
killed or otherwise affected will be far larger than in Africa,
because the population is greater.

For an in-depth look at a world epidemic much worse than many
people thought even recently see the UNAIDS publication, REPORT ON
THE GLOBAL HIV/AIDS EPIDEMIC, JULY 2002. Epidemics that were
thought to be leveling off because they were running out of new
people to infect have instead increased to levels that were not
thought possible. (Links to this report and other UNAIDS
information are at:
http://www.unaids.org/whatsnew/newadds/index.html The links are
in chronological order; this report is one of several published
July 2, 2002.)

Also from the United Nations, an expert panel recently convened by
UNAIDS and WHO estimated that just expanding the prevention
successes already achieved in some countries could prevent two
thirds of new infections save 29 million lives by 2010. But a
three-year delay in acting would reduce the effectiveness by 50%.
(The report, "Can We Reverse the HIV/AIDS Pandemic with an
Expanded Response," was published in THE LANCET, July 6, 2002. A
July 3 press release and link to a downloadable copy are at:
http://www.unaids.org/whatsnew/press/eng/pressarc02/Lancet_040702.
html These can also be reached through the "whatsnew" link
above.)

* Treatment access. Only 30,000 people in Africa are now receiving
antiretroviral treatment (less than 1% of those who clearly need
it). On the positive side, many new programs are expected to start
in the coming year, so this number should be considerably higher
next year. Also good news is the strong consensus that treatment
needs to be part of prevention, which gives people a reason to be
tested and to fight against the stigma that stops so much of what
needs to be done. Most experts now agree that condemning almost
everyone with HIV in developing countries to death on the grounds
that prevention is more cost-effective than treatment will not
work as prevention in the real world. (A less obvious factor is
that the great majority of those who need treatment will not get
it anyway, no matter what we do; for example, most of those who
are infected do not know it, and do not want to be tested.
Policies can give or deny hope without suddenly requiring enormous
resources for treatment.)

* Leadership and Resources. By different groups' estimates, the
public money needed to control AIDS, tuberculosis, and malaria
around the world would be about ten billion dollars
($10,000,000,000) per year. This is less than Africa alone pays on
debt service every year (which is over $14,000,000,000). The share
of this money needed from the U.S. and other rich countries to
control these three epidemics worldwide would be about the cost of
a movie and a bag of popcorn for each person once a year. People
are willing to pay this but world leaders are not ready to move.
So opportunities to control HIV epidemics in their early stages
are being lost forever.

Also, despite much progress, intellectual-property rules and trade
restrictions do remain a problem on the ground, and are still
keeping treatment away from many people in Africa and elsewhere
who would otherwise have a possibility of getting it -- a human
sacrifice which in this case does not add one dollar to the
funding of research for new treatments in the future, the reason
cited for justifying the pharmaceutical patents in the first
place. Other major access problems include unworkable distribution
systems, uncoordinated regulatory requirements throughout much of
the world, and of course lack of medical infrastructure.

The greatest disappointment from Barcelona is that most of the
governments of the world, led by the U.S. government, are still
not serious about dealing with the epidemic. President Bush set
the tone for the U.S. (and therefore other rich countries) shortly
before the Barcelona meeting, by killing a serious effort in
Congress to move forward on global health -- replacing it with a
speech about saving babies by preventing mother-to-child
transmission, which everyone already supports. It is generally
believed that most European and other countries use the U.S.
government's seriousness (or lack of it) as a benchmark for their
own commitment on the worldwide epidemics of HIV and other
diseases. There is widespread concern that once again, top leaders
will downplay the problem until the bodies pile up, and as much as
a third of the population in some of the worlds' largest
population centers already has an incurable infection.

Could we do better at asking for resources? At organizing
grassroots support everywhere for AIDS control around the world?
Of course.

Former presidents Nelson Mandela and William Clinton addressed
political issues in their talks during the closing ceremony. Both
focused most (and in different ways) on the problem of AIDS
stigma. But here we selected short quotes focusing mainly on
leadership.

Mandela

"There is no doubt that strong leadership is the key to an
effective response in the war against AIDS. Leadership starts at
the top. When the top person is committed, the response is much
more effective.

"This means not only political leaders, but also business leaders,
union leaders, religious leaders, traditional leaders, and the
leaders of NGOs. One has to make special mention of the role
played by NGOs and the leadership in those organizations. These
are often small organizations with meager resources that have made
an impact far beyond what would have been expected from their
size. One is often moved to reflect that, if only the big
institutions of government and business had made a similar effort
proportionately, we might very well already have turned the tide
of the AIDS pandemic." (Former president Nelson Mandela,
Barcelona, July 12, 2002.)

Clinton

"The first responsibility of leaders in the AIDS epidemic, in my
view, before they seek new funding, or launch new initiatives, or
expand treatment and prevention -- their first obligation is to
make the case loudly and repeatedly that AIDS is not a threat
against people of a particular group or country or continent; AIDS
is a threat against all of us. The AIDS epidemic has been so
devastating so quickly because it has exploited our worst human
instinct -- the instinct that demonizes, or at best is indifferent
to, people we see as different. We were slow to act on AIDS
because the wealthier, more powerful people in the world saw
people with AIDS as different. They're sex workers; they're drug
addicts; they're poor; they're gay; they're from another country,
another continent, another race. We're not from another race;
we're from the same race -- the human race. We need to get this
right today. Tomorrow may be too late." (Former president William
J. Clinton, Barcelona, July 12, 2002.)

Recordings and transcripts of both talks are at:
http://kaisernetwork.org/aids2002/webcast_12_a.cfm


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