AIDS Treatment News Issue #379, April 12, 2002
phone 800-TREAT-1-2, or 215-546-3776

Contents

** Retroviruses Conference: Some New Drugs in the Pipeline
Some of the experimental drugs discussed at the Retroviruses
conference: TMC125, DPC-083, tipranavir, atazanavir, BMS-806,
SCH-C, T-20, and S-1360.

** Measles Found to Suppress HIV
Measles appeared to cause almost a 100-fold drop in HIV viral
load, in this study of children who were hospitalized with
measles and also had HIV. After they recovered from measles,
their HIV viral load went back up. Could this finding suggest
ideas for new drug or other treatments for HIV?

** New Cancer Drugs Might Help Treat HIV -- But Research Not
Done
A class of drugs now approved and used in cancer treatment
also showed anti-HIV activity in laboratory tests. But due to
complications in licensing the HIV rights, which were held by
the U.S. government, no one has done any human test to see if
these drugs might help reduce viral load.

** Bone Problems: Overview Article Available
An article in the current issue of POZ magazine looks at bone
complications -- especially osteonecrosis, which is causing
an increasing number of persons with HIV to need hip
replacements. No one knows if HIV drugs, the disease itself,
or both are responsible.

** Alert: International Epidemic, Disease Control
The key issue now in international AIDS is political
commitment -- especially funding for controlling AIDS and
other infectious epidemics. People anywhere can help by
letting their political representatives know that AIDS and
other global epidemics are important to them.

** Medical Privacy Rule Changes: Public Comments Due April 26
The Bush Administration has proposed changes to the Clinton
Administration rules on the privacy of medical records, rules
that have not yet gone into effect.

** Medical Marijuana Action Alert
Legislation is widely favored in Vermont, but the governor
may block it.


***** Retroviruses Conference: Some New Drugs in the Pipeline

by John S. James

Here are some of the experimental antiretroviral treatments
(not yet approved for general use) that were discussed at the
Retroviruses conference, February 24-28, 2002, in Seattle. We
organized them by drug class.

Non-Nucleoside Reverse Transcriptase Inhibitors

* TMC125

This is a very active antiretroviral of the NNRTI class (non-
nucleoside reverse transcriptase inhibitor -- the same class
as efavirenz, nevirapine, and delavirdine, the three NNRTI
drugs currently approved in the U.S.). But TMC125 was
rationally designed to overcome the main problem of this
class of drugs, the development of viral resistance. This was
accomplished, in part, by making the molecule flexible, so
that it can still fit in the "pocket" (the active site) of
the reverse-transcriptase enzyme, even when HIV mutates to
change the shape of that site.

In patients, TMC125 caused a faster drop in HIV viral load
than has been seen with any other single drug so far (in a
small, 12 patient study) -- an almost 2-log drop in only one
week from this drug alone, in treatment-naïve patients.(1) In
that week the median CD4 increase was 119. No one knows why
the drug worked so well. [Note: short, small clinical trials
like this are used to estimate the antiviral potency, by
measuring how fast the virus disappears from the blood in the
days after the drug is started. This kind of study gives an
idea of the antiviral activity of the new drug by itself,
without giving the virus much time to develop resistance to
it.]

TMC125 also works in patients who are highly resistant to
other NNRTIs. Another small study tested the drug for one
week in patients who were failing either efavirenz or
nevirapine, who had resistant virus with at least 10-fold
reduced sensitivity to the drug they were using (all of these
patients were at least 35-fold less sensitive to nevirapine).
After one week of using TMC125, the median viral load had
decreased 0.9 logs, and was still going down.(2)

These trials used an early phase I formulation of TMC125,
which required the volunteers to take many pills per day. The
formulation has been improved since then, though more work is
needed. Drugs of this class tend to be difficult to dissolve
because of their chemical nature (the molecule needs to bind
to a pocket in the viral enzyme with non-polar bonds), but
this problem can be overcome.

TMC125 was developed by Tibotec-Virco, a company
headquartered in Belgium that uses high-tech methods to
develop new drugs, especially antivirals (including treatment
for hepatitis C). It also offers HIV phenotypic resistance
testing (the Antivirogram) under the name Virco. Many of the
principals in the company have a background in tropical
medicine. On March 22 it was reported that Johnson & Johnson
had bought Tibotec-Virco -- probably good news, as it was
widely believed that Tibotec-Virco did not have enough money
to develop the drug quickly.

But because of the slow pace of drug development generally,
it is unlikely that the company will be able apply for
approval for TM125 before 2004, even if everything works as
well as possible.

* DPC-083

This NNRTI is related to efavirenz (Sustiva(R)), but is
active against many viruses that are resistant to efavirenz
and other approved NNRTIs.(3,4) It seems to cause less of a
problem with the mental changes that trouble some patients
when they start efavirenz.

Protease Inhibitors

* Tipranavir

Tipranavir, developed by Boehringer Ingelheim
Pharmaceuticals, is the first of a new class of "non-
peptidic" protease inhibitors (PIs) -- giving it a different
resistance profile from the approved PIs. It is active
against HIV that is heavily resistant to the approved drugs.
(As with the protease inhibitor Kaletra, a low dose of
ritonavir has to be used with tipranavir to keep the body
from rapidly destroying the drug.)

Forty one patients who were failing their second protease-
inhibitor regimen, were NNRTI naïve, and had a viral load
over 5,000 were given tipranavir along with other
antiretrovirals (including the NNRTI efavirenz). They had
average viral load reductions of more than 2 logs at 48 weeks
and beyond. Most of them (35 of 41) remained fully
susceptible to tipranavir at 48 weeks. One patient had been
resistant to tipranavir at baseline.(5)

The difference in the resistance profile of tipranavir can be
seen by comparing how resistant these patients were to
various protease inhibitors. For saquinavir, for example, the
average resistance was 17.4 fold (meaning it took about 17
times as much of the drug to suppress this resistant HIV,
compared to HIV that had not developed resistance. By this
measure, the average resistance to saquinavir was 17.4,
nelfinavir 27.8, indinavir 17.1, ritonavir 48.5, amprenavir
3.7, and tipranavir 1.5.

The development of this drug has been seriously delayed in
the past, and patient groups are starting to seek an
expanded-access program as soon as possible for those who
have no other viable option.

* Atazanavir

In 48-week data presented at the Retroviruses conference,
this protease inhibitor did not increase blood cholesterol,
LDL cholesterol, or triglycerides in treatment-naive
patients(6) -- suggesting that it may be useful in developing
HAART treatment regimens with fewer side effects.

And in a study of patients who were failing therapy, the
combination of atazanavir and saquinavir worked well at 48
weeks, both in blood lipid levels and in viral load
reduction.(7)

Atazanavir is now in phase III trials. It should soon be
available on expanded access for patients who cannot
construct viable treatment regimens otherwise. It will
probably be the next protease inhibitor approved.

Entry Inhibitors

Note that there are three different mechanisms of inhibiting
viral entry into cells -- mechanisms that are used by drugs
being developed today. BMS-806 blocks the first step -- the
binding of gp-120 of the virus with the CD4 receptor on the
cell. A later step is the binding with a co-receptor on the
cell (usually CCR5 or CXCR4); this step is the target of SCH-
C, described below. Then the final step is fusion of the
viral and cell membrane, which brings the viral genes into
the cell; this step is targeted by T-20, a drug well advanced
in clinical trials.

* BMS-806

This compound blocks entry by binding to gp-120 on HIV --
preventing the virus from binding to CD4 and then entering
cells.(8,9) It is new and has not yet been tested in
patients.

* SCH-C

This drug blocks viral interaction with the CCR5 co-receptor
on the cell. The low dose studied so far produced an average
of about a 0.7 log viral load decline by day 10.(10) Higher
doses will be studied next.

* T-20

We plan to cover this important drug in a later issue.

Integrase Inhibitors

* S-1360

This integrase inhibitor was synthesized by Shionogi & Co.
Ltd. in Japan, and is being developed in the U.S. in
partnership with GlaxoSmithKline. It is a small molecule that
is orally bioavailable(11) and is now being tested in
patients. Activists and others at the conference were
encouraged that an integrase inhibitor has finally progressed
this far.

Integrase inhibitors (like entry inhibitors) have a different
viral target than any currently approved drug. Therefore all
the viral resistance that has developed so far is unlikely to
affect these new drugs. HIV will be able to become resistant
to them, however, so the new drugs will have to be used
carefully in appropriate combinations. Their importance will
be in providing new kinds of treatment options -- as protease
inhibitors did when they were introduced.

References

1. Sankatsing S, Weverling G, van 't Klooster G, Prins J,
and Lange J. TMC125 monotherapy for 1 week results in a
similar initial rate of decline of HIV-1 RNA as therapy with
a 5-drug regimen. 9th Conference on Retroviruses and
Opportunistic Infections, Seattle, February 24-28, 2002
[abstract # 5].

2. Gazzard B, Pozniak A, Arasteh K and others. TMC125, a
next-generation NNRTI, demonstrates high potency after 7 days
therapy in treatment-experienced HIV-1-infected individuals
with phenotypic NNRTI resistance. 9th Conference on
Retroviruses and Opportunistic Infections, Seattle, February
24-28, 2002 [abstract # 4].

3. Ruiz N, Nusrat N, Lauenroth-Mai E and others. Study DPC
083-203, a phase II comparison of 100 and 200 mg once-daily
DPC 083 and 2 NRTIs in patients failing a NNRTI containing
regimen. 9th Conference on Retroviruses and Opportunistic
Infections, Seattle, February 24-28, 2002 [abstract #6].

4. Ruiz N, Nusrat N, Lazzarin A and others. Study DPC 083-
201: A phase II double-blind (DB) comparison of 3 once daily
doses of the NNRTI DPC 083 vs 600 mg efavirenz (EFV) in
combination with 2 NRTIs in HIV antiretroviral (ARV)
treatment-naïve patients. 9th Conference on Retroviruses and
Opportunistic Infections, Seattle, February 24-28, 2002
[abstract # 7].

5. Schwartz R, Kazanjian P, Slater L and others. Resistance
to tipranavir is uncommon in a randomized trial of
tipranavir/ritonavir (TPV/RTV) in multiple PI-failure
patients (BI 1182.2). 9th Conference on Retroviruses and
Opportunistic Infections, Seattle, February 24-28, 2002
[abstract # 562-T].

6. Piliero PJ, Cahn P, Pantaleo G and others. Atazanavir: A
once-daily protease inhibitor with a superior lipid profile -
- results of clinical trials at week 48. 9th Conference on
Retroviruses and Opportunistic Infections, Seattle, February
24-28, 2002 [abstract # 706-T].

7. Haas D, Zala C, Schrader S, Thiry A, McGovern R and
Schnittman S. Atazanavir plus saquinavir once daily favorably
affects total cholesterol (TC), fasting triglyceride (TG),
and fasting LDL cholesterol (LDL) profiles in patients
failing prior therapy (trial AI424-009, week 48). 9th
Conference on Retroviruses and Opportunistic Infections,
Seattle, February 24-28, 2002 [abstract # 42].

8. Lin P-F, Robinson B, Gong Y-F and others. Identification
and characterization of a novel inhibitor of HIV-1 entry --
I: Virology and resistance. 9th Conference on Retroviruses
and Opportunistic Infections, Seattle, February 22-28, 2002
[abstract #9].

9. Lin P-F, Guo K, Fridell R, Ho H-T, Yamanaka G, and Colonno
R. Identification and characterization of a novel inhibitor
of HIV-1 entry -- II: Mechanism of action. 9th Conference on
Retroviruses and Opportunistic Infections, Seattle, February
24-28, 2002 [abstract # 10].

10. Reynes J, Rouzier R, Kanouni T and others. SCH C: Safety
and antiviral effects of a CCR5 receptor antagonist in HIV-1
infected subjects. 9th Conference on Retroviruses and
Opportunistic Infections, Seattle, February 24-28, 2002
[abstract # 1].

11. Yoshinaga T, Sato A,, Fujishita T, and Fugiwara T. S-
1360: in vitro activity of a new HIV-1 integrase inhibitor in
clinical development. 9th Conference on Retroviruses and
Opportunistic Infections, Seattle, February 24-28, 2002
[abstract #8].


***** Measles Found to Suppress HIV

A study in Africa found that viral load was apparently
reduced by almost two logs during acute measles infection in
children. After they recovered from measles, the HIV viral
load came back.(1)

Interpretation was complicated by the fact that no baseline
viral loads were available for the children before they came
down with measles. Instead, researchers measured viral load
in children who had been hospitalized with measles, and found
it surprisingly low -- a median of 5,339 copies. This
compared to 387,000 copies in the same children at a one-
month followup, after they had recovered from measles. A
comparison group of children with HIV but without measles or
other acute illness had a median viral load of 228,000.

This reduction was all the more remarkable since an illness
like measles would be expected to raise the viral load if it
did anything -- due to increased immune activation.

Comment

At least one other disease -- scrub typhus -- has also been
found to suppress HIV, but only in some patients.(2)

Clearly we need research to identify the exact mechanism of
viral suppression by measles or certain other diseases. It
might be possible to use this knowledge to design a new class
of treatment for HIV.

References

1. Moss WJ, Ryon JJ, Monze M, Cutts F, Quinn TC, and Griffin
DE. Suppression of human immunodeficiency virus replication
during acute measles. THE JOURNAL OF INFECTIOUS DISEASES.
2002; volume 185, pages 1035-1042.

2. Watt G, Kantipong P, de Souza M, and others. HIV-1
suppression during acute scrub-typhus infection. THE LANCET.
August 5, 2000; volume 356, pages 475-479.


***** New Cancer Drugs Might Help Treat HIV -- But Research
Not Done

by John S. James

A new class of cancer drugs -- topoisomerase inhibitors -- is
now in use in the United States for treating certain cancers.
But despite laboratory studies and other reason to believe
that these drugs might also work as antiretrovirals, they
have never been tested in people for treating HIV. An
activist who investigated the situation found that the U.S.
government owns the rights to use at least some of these
drugs for HIV, and licensed exclusive rights to a small
company that was unable to get funding to start human
research. And the big companies that are selling the drugs
for cancer are not interested in testing for HIV -- either
because of the exclusive license, or for other reasons.
Similar licensing problems could be blocking development of
other drugs that we have not heard about.

AIDS activist Eric Goldman investigated this situation and
published a short article in the current issue of Positively
Aware ("An HIV Treatment the World May Never See," by Eric
Goldman with David Scondras, Positively Aware March/April
2002, http://www.tpan.com -- click on POSITIVELY AWARE).

Comment

The current organization of AIDS medical research makes it
very difficult to get a new drug into the first human
testing, to establish a proof of principle that it might
work. Industry is reluctant to do this -- not so much because
it is expensive (industry does pay for the large clinical
trials needed for drug approval, which cost much more), but
because the reward is too distant. Once there is positive
human data, it is much easier to raise money and interest for
further research.

The case of topoisomerase inhibitors is unusual in that these
drugs have gone through the entire approval process for
cancer. Therefore, the first human trial for HIV would be
much less expensive, since formulation, tolerable dosing,
toxicity, and some long-term safety issues have already been
worked out. Still this work wasn't done, and no one is doing
it today.

Since these drugs are already in use, it would be quick and
easy to see if there is an effect on viral load in persons
treated for cancer who also happen to have HIV. If a major
reduction in viral load could be documented, it would much
easier to get further research started. Then the next step
could be a small trial in which the drugs were prescribed for
selected patients. (The first topoisomerase inhibitors are
given by injection, but a new one -- Orathecin, formerly
named Rubitecan -- now waiting for FDA approval for
pancreatic cancer, is taken orally. All can have serious side
effects. It is not known whether smaller doses could be used
in HIV treatment. Indeed, since the research has not been
done, no one knows whether these drugs, in any doses, could
have any value in treating HIV.)

We also need more investigation into the problems in
licensing policies and elsewhere that block early human
research that would be strongly in the public interest. As
Goldman points out in his article, there may not be any
single villain in this story -- each company and government
agency may have done what it was supposed to do. Lack of a
villain can make it harder to mobilize public interest for
reform. Still, the system is not working -- and is costing
many lives, if any of the drugs that should have been tested
would in fact be useful.

As a lawyer who works in intellectual property in the
entertainment industry, Goldman had the background to be
among the first to investigate the complicated tangle of
legal rights that has blocked these drugs and probably others
from being tested as they should. Now that he has shown the
way, other activists without this specialized background can
help develop the investigation.

A major problem in AIDS treatment today is that many patients
need new drugs, and the "pipeline" of potential new
antiretrovirals is disappointing. The biggest single block in
the pipeline -- the obstacles to the small human trials that
could establish proof of principle -- needs much more
attention.


***** Bone Problems: Overview Article Available

An overview of the growing problem of bone disease --
especially avascular necrosis (also called osteonecrosis, or
aseptic necrosis), which is requiring an increasing number of
hip replacements in persons who have had AIDS and been on
HAART for many years, was published in the April 2002 issue
of POZ ("Hip to the Future," by Anne-christine d'Adesky, page
28-31 and 39).

Avascular necrosis (which is different from osteopenia or
osteoporosis, caused be loss of bone minerals) occurs when
blood vessels that supply the bone constrict, cutting off
blood supply and causing bone death. No one knows the cause,
although there are many theories. The condition can be hard
to diagnose early, and it is not known how many people are
affected.

Finding the Article

Many AIDS service organizations and medical practices have
copies of POZ, often available free or available for
photocopying. Some newsstands may have copies.

Unfortunately the Web site, http://www.poz.com, does not have
the last six months of issues online (it does have back
issues older than six months). If you want to get the article
before it is online and cannot find a copy locally, you can
purchase the April 2002 POZ by calling 800-9-READPOZ (toll-
free from the U.S.), or 815-734-4151 (from anywhere).


***** Alert: International Epidemic, Disease Control

by John S. James

Every day 8,000 people die of AIDS, thousands more of
tuberculosis, and thousands more of malaria. Leading experts
agree that all three could be effectively controlled around
the world with a total investment of about $10 billion per
year, and the political will to match. This is not much money
compared to the global economy; in theory at least, a number
of individuals could write the check themselves.

But last year President Bush proposed $200 million for the
Global Fund for AIDS, Tuberculosis, and Malaria (later raised
to $300 million) -- about a tenth of the U.S. share of the
total cost to control these diseases, based on the size of
the U.S. economy. This year Bush proposed $200 million again.
Coming from the world's only superpower, this has set the bar
low, and donor countries and others around the world have
followed accordingly. If the U.S. does not take global
infectious disease seriously, other rich countries are
unlikely to do so. (Total U.S. foreign aid for all purposes
is about 0.1 percent of the U.S. gross domestic product -- a
fraction of what European countries contribute. Recently
President Bush called for increasing this by 50% over several
years -- an important positive development.

Also, conservative Senator Jesse Helms recently called for an
additional $500,000 from the U.S. for international AIDS
control, especially targeted for prevention of mother to
infant transmission. (We have not heard criticism of this
targeting, probably because mother-to-infant transmission is
indeed a major part of the epidemic, and there is no doubt
that the money could be well spent there. And some of these
programs treat the whole family.)

Later this month (April 2002), the Global Fund will have to
turn down many of the more than 300 projects from developing
countries that have requested funds in the current cycle. The
requests from the first round of proposals total about $1.15
billion now, or $5 billion if five-year commitments are made
-- and the Global Fund has only about 15% of that currently
available. And these initial requests were done under great
time pressure, and under pressure to scale back the amounts
asked for.

Comment

Political mobilization to get a reasonably adequate U.S.
response for the control of these major infectious diseases
is completely doable. There is lots of potential public
support. What then are the obstacles that have kept it from
happening so far? We see the following:

* Widespread public mobilization has been slow. For example,
church groups are natural sources of support, but AIDS
activists have been slow to get them involved. Some churches
even have staff or volunteers assigned to look for
opportunities to help in the world, but usually no one has
prepared them on this issue or explained that what is most
important is letting Congress, the media, and others know
that many Americans care about illness and death in
developing countries.

* After September 11, many government officials are serious
only about war.

* The pharmaceutical industry is not on the same page. Its
major concern is intellectual property, and any precedents
that might be set abroad that might someday limit its freedom
to charge high prices in the U.S. So it has leaned toward
charity programs negotiated separately and usually secretly
between each company and country (where the countries of
course give up freedom of action) -- and also toward
selective price reductions where companies make no profit
according to their own accounting, then wash their hands --
establishing a case that they are not profiteering, instead
of working together to solve the problem. There is nothing
like the U.S. domestic program where company and patient
representatives have gone to Congress together to support
funding for treatment access in the U.S. (Incidentally, we
believe that developing or manufacturing treatments for
developing countries *should* be profitable -- though clearly
the U.S. model of making the patient pay will not work. But
companies could work together with communities, officials,
and others to raise government and other monies to pay for
the needed drugs and medical infrastructure.)

* Donors and communities alike want assurance that money is
well spent on programs that work. But measuring results is
difficult -- not only here, but in nonprofit programs in all
fields.

Of all these obstacles, the biggest one so far has been lack
of public mobilization. Members of Congress need to hear that
their constituents care about global health and infectious
diseases. You can help by writing or calling your
representatives, especially when these issues are in the news
or have come to Congress for a vote.


***** Medical Privacy Rule Changes: Public Comments Due April
26

The Bush Administration has proposed significant changes in
the Clinton Administration's rules on medical privacy. The
proposed rule is open for public comment for a short period
of 30 days.

The WASHINGTON POST summarized the changes as follows: "The
proposal would alter the requirement, put in place by the
Clinton administration, that patients give their written
permission before their medical records may be disclosed to
doctors, hospitals, pharmacies and insurance companies. In
the new requirements, those who use their records must at
some point notify patients of their privacy rights."
("Medical Privacy Changes Proposed; Bush Plan Would Lessen
Patients' Say on Records," by Amy Goldstein, WASHINGTON POST,
March 22, 2002). The long version of the proposed changes --
40 pages of small print in the FEDERAL REGISTER -- is
available through the link below.

A government site, favoring the changes, is:
http://www.hhs.gov/ocr/hipaa/

Arguments pro and con can be found in the WASHINGTON POST
reference above, and in THE NEW YORK TIMES, "Bush Acts to
Drop Core Privacy Rule on Medical Data," also March 22, 2002.

Comment

We have not had time to fully analyze the changes and do not
intend to submit comments. But we want our readers to know
about the option.

We have mixed feelings about opposing the changes, because we
fear that in practice, the right to give consent before one's
medical records are used will be theoretical, not real. We
fear that in reality, patients will just have more paperwork
thrust at them to read and sign before they can get treatment
at all, from any facility. Since most people who have sought
medical care do not have a good option to just walk out and
abandon the quest, this is not a real choice.

The basic concern motivating opposition to the Bush
Administration proposal -- how can personal sovereignty be
maintained in a world of huge institutions that seldom
respect people -- is one of the central issues of our time.
But creating formal rights that are not practical to use
could discredit this quest and do more harm than good. We
need to find other ways to proceed.


***** Medical Marijuana Action Alert

We received the following press release from the Marijuana
Policy Project on March 29. On April 2, ACT UP New York wrote
an open letter to Vermont Governor Dean in support of the
bill to legalize marijuana for medical purposes, H. 645.

"A bill to legalize use of marijuana for medical purposes --
similar to laws already on the books in Alaska, California,
Colorado, Hawaii, Maine, Nevada, Oregon and Washington --
passed the Vermont House of Representatives March 15.
Vermont's Senate will consider the bill in April.

"The biggest obstacle to passage appears to be Vermont
Governor Howard Dean. Vermont newspapers have reported that
Dean, a physician, opposes the bill and is pressuring his
fellow Democrats, who control the Senate, to kill it before
it reaches his desk.

"Dean, who has been making strong political overtures to the
gay and lesbian community in preparation for a possible run
for president, is said to believe that more research is
needed. But research is not the issue. Everyone wants more
research, but because of government foot-dragging, progress
has been slow. There is no reason that those who benefit from
marijuana now -- for example, those who use it to ease the
nausea often caused by antiretroviral drugs -- should have to
risk arrest and jail while waiting for research to go
forward.

Letters are urgently needed -- by mail or fax -- to:
Gov. Howard Dean, M.D.
109 State Street, Pavilion
Montpelier, VT 05609-0101
Fax: 802-828-3339


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