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Past Issues
Volume 16, number 12
December 2002
Contents
Late Nights at the FDA
Five new drugs take their final exams
The First Tree Falls
New York State ADAP comes under the ax
Save ADAP
AIDS organizations write to Congress
Joep to it!
An interview with the new IAS president
Advice for Umesh
Men, women and sex in an Indian village
Global Treatment Update
Gilead's plan for tenofovir plus
Short Course
Notes on drugs in development
Opinion
Gregg Gonsalves bashes back
Five
New Drugs Enter the Homestretch By Bob Huff
It's a busy season for the folks at the FDA who approve AIDS drugs.
At least five new products have passed or are soon to pass under
their scrutiny on the way to your medicine shelf. And while none
is expected to cause a treatment revolution, each new drug offers
something that will surely improve life for someone living with
HIV. The question is, "who?" Soon, with more than 20 products
to choose from, it will become harder to match up the right drugs
with the right people.
The U.S. Food and Drug Administration (FDA) is the federal agency
charged with assuring the public that its medicines are as safe
and effective as promised and that the claims made by prescription
drug makers reflect what the science shows. Before the FDA approves
a drug for sale in the U.S., it conducts a thorough review of all
the research results that the sponsor company has submitted from
human, animal and laboratory studies. After the Agency has received
the data (altogether known as an NDA, for New Drug Application),
it must review the application within 10 months or, as has often
occurred with HIV drugs, it may decide to grant a special six-month
priority review to help speed important new drugs into use.
The current crop of drugs contains a mixed bag ranging from a first-of-its-kind
fusion inhibitor that blocks HIV in a completely new way, to a kinder,
gentler protease inhibitor with (hopefully) fewer toxicity problems,
to a couple of renovated formulations that should give a new lease
on life to existing drugs. Throw in the merger of two small HIV
drug developers with synergistic product lines, and the outlook
looks brighter for serving people with diverse treatment needs with
ever more finely tailored options. Call it the boutiquing of HIV
therapy.
But while any advancement in tolerability and convenience is welcome,
there is still concern that further upstream the drug pipeline is
dry. Some of this concern comes from drug companies who perpetually
stir fears that research will cease unless prices continue their
upward march. There is also nervousness that rumored mergers between
huge pharmaceutical companies such as GlaxoSmithKline and Bristol-Myers
Squibb will kill the competitive drive to improve HIV treatment.
But while failure to innovate and take risks will certainly hurt
our chances of ever seeing another revolution like HAART, there
are signs that progress continues on drugs to attack new viral targets
such as integrase and that stronger and safer versions of current
generation drugs are coming.
In the meantime, here's what's on the FDA's docket right now.
Zerit XR
Zerit XR is an extended-release formulation of d4T that had Champagne
corks popping at Bristol-Myers Squibb (BMS or Bristol) when word
of FDA approval arrived on New Year's Eve last year. The company
is finalizing the label and ad copy in consultation with the agency.
Next comes the advertising blitz promising a carefree world of once-daily
dosing. But go slow: there are still a lot of questions that have
to be answered. More convenient dosing may well be the wave of the
future, but it may not be the right choice for everybody all at
once.
The recommended dose of Zerit XR is 100 mg once daily for individuals
weighing at least 132 pounds and 75 mg once daily for individuals
weighing less than 132 pounds. A comparison between extended release
Zerit and conventional Zerit in a clinical trial involving nearly
800 people demonstrated comparable efficacy and tolerability. While
the total amount of drug present in the blood over time obtained
from Zerit XR was similar to that obtained from immediate release
Zerit, the initial peak concentration that followed each dose of
the drug was lower with the XR version. This may be good news if
the drug's tolerability or toxicity (chiefly peripheral neuropathy)
profile can be improved by smoothing out those transient peaks of
overly high drug concentrations. On the worrisome side, we have
yet to see what happens to blood levels of Zerit XR between 24 and
48 hours after a dose. We still don't know if a skipped dose that
results in a full day of exposure to sub-therapeutic drug levels
will be more likely to allow resistance than 12 hours of inadequate
viral suppression.
The timing of Zerit XR is worth examining. With the first patents
on conventional Zerit expiring in 2008, this improved formulation
gives BMS a new lease on an old drug far beyond the six years they
had left. Remarkably, BMS also introduced the EC version of their
Videx product with only six years left on the original patent in
2000. Could these improved formulations have hit the market sooner?
Or does "extended release" carry more meaning than we
think?
Fuzeon
Fuzeon (T-20) is the Godot of HIV therapy. The long awaited, much
delayed, first agent of a completely new method of suppressing HIV
infection is definitely at the top of the FDA's to-do list for the
New Year. Accepted for priority review in October, the Agency has
to deliver a verdict by March. And despite T-20 being a difficult-to-manufacture
injectable drug, with inconvenient twice-daily dosing and unpleasant
injection-site reactions as a prominent side effect, its novelty
and unique value for people with resistance to all available regimens
means that approval of Fuzeon is virtually a sure thing.
But a green light from the FDA won't be the end of the wait for
some. Because of manufacturing difficulties, Hoffman La Roche (Roche),
the drug's sponsor, has announced that availability of Fuzeon will
be limited during the first year following approval. Allocating
the drug fairly may be a challenge since there seems to be a gap
between those in greatest need and those who might expect the greatest
benefit from the drug. In a large clinical trial, people who added
Fuzeon to a suite of other drugs active against their virus had
a much better response than those who took it on top of their worn-out
regimens. The catch here is that people with other options may not
want to go through the unpleasantries of twice-daily injection,
while those with no other options may not find Fuzeon the life preserver
they need.
Another block to the widespread use of Fuzeon may be its breakthrough
price. Rumors are rife that Roche will set a new record when pricing
T-20. Because of budget shortfalls in many states' AIDS Drug Assistance
Programs (ADAPs), it seems increasingly likely that coverage of
Fuzeon may be limited to those with private insurance willing to
pay for it. Some states have adopted a "budget neutral"
policy about adding new drugs to their formularies and if plugging
T-20 into the typical regimen means significantly boosting the cost
of treating HIV, then people dependent on state assistance may be
out of luck. Roche has promised that no one who truly needs Fuzeon
will go without, but details of their plan to patch over access
problems remain to be seen.
Atazanavir
Atazanavir is a nearly next generation protease inhibitor from BMS
making a big claim that may revitalize the class. The worrisome
cholesterol and triglycerides abnormalities that have hit most long-time
users of PIs seem blessedly absent in those who've received atazanavir
in clinical trials. Going straight for the competition, atazanavir
took on Sustiva (efavirenz), the once and future PI alternative,
in a nearly yearlong head-to-head comparison involving over 800
people starting HIV therapy for the first time. Of course, since
BMS subsequently bought Sustiva when it acquired DuPont Pharmaceuticals,
it has been in competition with itself, and the company clearly
hopes to find itself holding the premier agents in both the non-nuke
and PI classes of therapy. But that's not all. As the first daily-dosed
PI, atazanavir will climb aboard Bristol's unstoppable once-a-day
juggernaut, joining Sustiva, Videx EC and Zerit XR. Bristol filed
the paperwork for FDA approval in December and if they made a good
case for priority approval, atazanavir could be commercially available
by June.
In the trial, atazanavir proved comparable to efavirenz in its
ability to bring down viral load below 400 copies in most trial
participants. There are also some tantalizing early indications
that atazanavir may retain activity after resistance to other PIs
has developed — and even a suggestion that resistance mutations
to atazanavir may possibly increase viral sensitivity to other PIs.
While much more data is needed before making definite claims, it
may behoove people with extensive resistance who are considering
Fuzeon to wait a bit longer and add atazanavir at the same time.
For those who can't wait, see the sidebar about early
access programs.
Atazanavir holds no breakthrough in potency, since only about half
of those who had viral load suppressed below 400 copies also went
below 50 copies. And there is an apparently benign but unpleasant
side effect that raised bilirubin levels and turned some people
yellow with jaundice. Stopping the drug got the yellow out, but
that's a poor justification for treatment interruption. These may
be quibbling points in light of evidence that people with elevated
cholesterol due to HIV therapy saw numbers normalize after going
on atazanavir. Although long-term follow up must be conducted to
be sure, the promise alone that atazanavir might dramatically lower
the risk of heart disease or diabetes in people taking lifetime
HIV therapy could mean eager acceptance after approval. Still, one
nagging question returns, "What's up with that bilirubin?"
Fosamprenavir
On the same day in December that Bristol filed for FDA approval
of atazanavir, GlaxoSmithKline (GSK or Glaxo) submitted data to
support the approval of their PI hopeful, fosamprenavir (also known
simply as "908"). Although Glaxo surely petitioned the
Agency for priority review of 908, gaining that favor doesn't seem
likely, which would mean approval by as late as October.
Why the lack of enthusiasm? To begin with, fosamprenavir isn't
so much a new drug as it is a tricked-up version of Glaxo's Agenerase
with a VIP pass to get into the bloodstream more efficiently. Agenerase
(amprenavir) was approved by the FDA in 1999, but hasn't found many
converts, mainly because of the need to gag down eight big fat pills
twice a day. The problem is that very little of the drug in the
pill gets from the intestines into the blood. But fosamprenavir
is specially designed to be taken up by the gut and then immediately
processed into amprenavir before being sent to the bloodstream.
The "fos" means the difference between 16 pills a day
and only two pills a day. Factor in improved tolerability and fewer
side effects and it could be that amprenavir is finally ready for
prime time. But is this too little, too late?
On its own, fosamprenavir given twice a day can produce viral suppression
comparable to nelfinavir without the troublesome rise in triglycerides.
But once-a-day is all the rage, and 908 can go that route too —
with a little boosting from ritonavir. Unfortunately, ritonavir
brings more pills, elevated triglycerides and tolerability problems.
And with atazanavir looming, nelfinavir is no longer the benchmark
PI. Still, there may be benefits for some people lurking within
amprenavir's resistance profile, although what that might be remains
murky. There have been a few suggestions about a lack of cross-resistance
between atazanavir and amprenavir. If so, then the possible benefit
of using the two together should be explored for people with extensive
and complicated treatment histories. This drug may not be for everyone,
but those it helps will be happy to have it.
Coviracil
Coviracil (FTC) is another drug wending its way through the FDA.
Its maker, Triangle Phamaceuticals, filed for approval in September
and, under standard review, the drug should become available by
summer. But in a surprise, what went in as a Triangle drug is going
to come out under the brand of Gilead Sciences, the makers of recently
approved Viread, who announced the acquisition of Triangle in December.
Coviracil is difficult to distinguish from Glaxo's Epivir (3TC)
although some have detected a possible resistance advantage, and
in comparison with Zerit, Coviracil was shown more potent and less
toxic. But the exciting potential for Coviracil under Gilead's roof
is as part of a new once-a-day, all-in-one-pill alternative to Glaxo's
Combivir as the nucleoside analog backbone of choice. In other words,
no AZT.
The approval of Coviracil is step one. Already Gilead is said to
be working on performing the necessary studies that the FDA will
want to see when they are asked to approve a coformulated Viread/Coviracil.
Hopefully, this data will be in the Agency's in-box by next year.
Next Steps
Gaining FDA approval for this bundle of drugs will be a nice step
forward, but the story won't end there. We will have to wait to
see how doctors and people with HIV will actually use these new
drugs. Big budget ad campaigns in magazines and on bus shelters
will certainly have their say, but personal experience and the constantly
shifting consensus about therapy usually prevails. First, though,
more data from clinical trials are needed to develop our understanding
of these new options, and the next wave will come at February's
Retrovirus Conference in Boston. The conference halls will be buzzing
with opinions, but nothing is as convincing as research well done.
In the years ahead, as these newcomers become established, we can
expect them to be knocked down by newer — and merely newly
tweaked — drugs to come. One question still begging an answer
is, with twenty-plus HIV drugs to choose from in the U.S., what
does our embarrassment of riches mean to the 90 percent of HIV-positive
people in the world who have access to none?
| Expanded
Access Program for Atazanavir
Bristol-Myers Squibb is currently enrolling patients in
an Early Access Program (EAP) to provide the investigational
protease inhibitor, atazanavir, to eligible patients infected
with HIV. An EAP provides medicines to patients in need of
alternative therapy prior to the medicine's approval. Atazanavir
is in Phase III clinical development as a product to treat
HIV infection in combination with other antiretroviral agents.
HIV-infected patients who have experienced treatment failure
with other available antiretroviral agents and who require
alternative antiretroviral agent in order to construct a new
treatment regimen may be eligible to participate in the atazanavir
EAP. Reasons for treatment failure may also include antiretroviral
resistance, intolerance or adherence problems. Physicians
must use atazanavir in combination with two or more new or
recycled antiretroviral agents. In addition, patients must
meet other protocol-specified eligibility criteria. Pharmacokinetic
interaction and safety data on the use of atazanavir with
other antiretroviral agents (i.e., protease inhibitors, non
nucleoside reverse transcriptase inhibitors) are outlined
in the protocol.
Patients may be enrolled in the atazanavir EAP through physicians
only. U.S. physicians may call 1-877-7-BMS-EAP
(1-877-726-7327) or visit www.atveap.com
for more information on the atazanavir EAP.
No expanded access programs for Coviracil or fosamprenavir
have been announced. An expanded access program for Fuzeon
has closed to enrollment. |
First Wave of Cuts Hits NewYork's ADAP
The following is the text of a letter being sent to health
care providers in New York State concerning the first wave of cutbacks
to New York State's AIDS Drug Assistance Program (ADAP).
New York State's Uninsured Care Programs (ADAP) has grown rapidly
since 1996, with increasing enrollment, higher numbers of participants
using program services and increasing drug prices. The Program is
primarily funded with federal money. To make the best use of limited
resources available, we must take steps to make sure that the Program
is cost-effective and meets the highest priority needs.
The Uninsured Care Programs (ADAP) is making some changes that
will allow us to continue new enrollments and maintain core services.
The following changes are effective February 15, 2003.
Mandatory Generics — ADAP will stop paying
for brand-name drugs when there is an A-rated generic equivalent
for a brand-name drug. If you get a prescription that is Dispense
as Written (DAW), the participant will need to get a new prescription.
There will be no exception process for these medications (see the
list of affected medications enclosed with this mailing).
Maximum limit of 5 refills per prescription —
ADAP will pay for the first prescription and then five (5) refills.
This step will help ADAP reduce waste and save money by not refilling
prescriptions that have been discontinued. To assure that funding
is maximized for all participants, pharmacies should not automatically
refill and bill for medications without assurances from the participant
that they are still taking the medication.
New limit on nutritional supplements — The
maximum amount of nutritional supplements that ADAP will pay for
will be no more than three (3) cans per day or the equivalent amount
in other forms (e.g., powders, bars).
Maximum number of clinic visits each year — ADAP will pay
for up to thirty (30) clinic/threshold visits each year. Enhanced
fee visits (that have their own limits) are not counted toward this
30-visit limit (e.g., annual comprehensive exam, mental health visits
and dental visits).
Maximum number of dental visits — ADAP will
pay for no more than eight (8) dental visits per year.
Formulary Reduced — ADAP will no longer
pay for the following drugs.
Oxandrolone
Androgel
Octreotide
Famotidine (Pepcid)
Nizatidine (Axid)
Loratidine (Claritin)
Famciclovir
Quantity Restrictions on Zolpidem (Ambien) —
ADAP will pay for only 15 tablets of Ambien per month.
Prior Approval for atovaquone (Mepron) —
ADAP will require prior authorization through a physician to pay
for atovaquone (Mepron). Participants currently taking atovaquone
will receive a separate letter with the authorization form to bring
to their doctors.
We are sorry that we have to limit these services, but ADAP only
has the funds allocated to it each year and must adjust our services
to match our funding.
Please assist our participants in securing other health care coverage
options such as public entitlement programs that cover more drugs
and services than ADAP. These include Medicaid, Medicaid Spenddown,
Family Health Plus and Veterans Health Care Coverage. These programs
offer more comprehensive coverage.
As always, the New York State ADAP hotline staff are available
(1-800-542-2437) Monday to Friday 8:00 a.m. to 5:00 p.m. to answer
questions about the Program.
State ADAPs with waiting lists, client expenditure
caps and/or drug access restrictions:
Alabama — 175 people waiting
Guam — 4 people waiting
Idaho — Program closed to new enrollees
Indiana — 4 people waiting
Kentucky — 62 people waiting
Montana — 2 people waiting
Nebraska — Program closed to new enrollees
North Carolina — 60 people waiting
Oregon — 18 people waiting
Puerto Rico — 64 people waiting
South Dakota — 43 people waiting
Texas — ARV restrictions
Wyoming — Program closed to new enrollees
Washington — Program restrictions
Source: www.ATDN.org
|
Message to Congress: SAVE ADAP!
Dear Senator/Representative:
The undersigned organizations serving the needs of people living
with HIV write to ask that Congress provide a minimum of $162 million
in additional federal funding for AIDS Drug Assistance Programs
for FY 2003.
This year, 13 state AIDS Drug Assistance Programs (ADAPs) have
been forced to take steps to limit access to life-saving HIV medications
for uninsured and underinsured Americans due to inadequate funding.
Texas, for example, has recently announced that in order to close
its deficit, it will retroactively lower its income limits from
200% of the federal poverty level (300% with spend downs) to 140%.
That action will require the removal of 2500 presently enrolled
ADAP clients from the program by June 1, 2003.
New York must also address a $16 million structural deficit in
2003 and a projected $50 million deficit in 2004 if either state/and
or federal funding is not increased by that amount.
According to the most recent National Alliance of State and Territorial
AIDS Director's (NASTAD) Report, the following states have also
initiated waiting lists as of 12/5/2002: Alabama (175), Indiana
(34), Kentucky (62), Montana (2), North Carolina (60), Oregon (18)
and South Dakota (43). Idaho, Nebraska and Wyoming have closed to
new enrollees. In addition to New York and Texas, Colorado, Florida,
Georgia, Nevada and South Carolina have projected the need to impose
access restrictions in early 2003.
One major factor driving increased ADAP need is enrollment growth,
which is due to the success of the new drugs in decreasing deaths
and slowing progression to AIDS. Since the introduction of effective
combination HIV therapies in 1996, America's death rate from AIDS
has fallen by over 50%. Because people are staying alive longer,
they need ADAP longer and so enrollment continues to climb. While
this should be taken as a sign of the program's success, resources
flowing to ADAPs are not being increased to take care of the swelling
numbers of people that are being kept alive.
Ironically, attempting to save money in the short term may cost
taxpayers more money in the long term. Recent data presented by
the University of Alabama at Birmingham at the International AIDS
Conference in Barcelona demonstrates that the average cost of care
for a person with early HIV disease is approximately $14,000 a year
while waiting to treat that person until they are disabled costs
about $34,000 a year.
Fears of particularly serious problems for FY 2003 are exacerbated
by the expected arrival of new drugs that few programs in crisis
are likely to be able to afford. Fuzeon (T-20), the first fusion
inhibitor to reach the market, could provide urgently needed support
for patients whose anti-retroviral options have run out when it
is approved in early 2003, but the drug is expected to be expensive,
which could force ADAPs to ignore the need for the drug.
The second class of drugs that most ADAPs are unlikely to be able
to afford are those to treat HCV. While HCV has become the number
one cause of death among people with HIV, most states are resistant
to adding new classes of treatment when resources are scarce.
Finally, in order to make best use of ADAP funding we ask that
you fund required services provided under the Ryan White CARE Act
at the highest possible levels. Without the support services provided
by the CARE act, many ADAP clients would have no realistic access
to the medical care and auxiliary services they require to maximize
the usefulness of anti-HIV medical regimens.
We believe that it is imperative to provide life-extending AIDS
drugs to all Americans in need. We hope that you will agree.
Sincerely,
Partial listing: ADAP Working Group • African
Services Committee, New York, NY • AIDS Action • AIDS
Action Baltimore • AIDS Coalition of Texas Now! (ACT Now!)
• AIDS Council of Northeastern, NY • AIDS Foundation
of Chicago • AIDS Rochester • AIDS Services of Dallas
• AIDS Treatment Data Network • AIDS Vaccine Advocacy
Coalition • Alianza of New Mexico • AMASSI, Inc. •
Bailey House, New York, NY • Betances Health Center, New York,
NY • Boulder County AIDS Project • CARE Resource, Miami,
FL • Catholic Social Services of Mobile, Alabama • Center
for Community Alternatives • Families Connecting for Kids,
The Adoption Exchange • Florida AIDS Action • GMHC •
Hepatitis C Action & Advocacy Coalition, San Francisco •
Hepatitis C Advocate Network, Inc (HepCAN) • HIVandHepatitis.com
• IDC Research Initiative, Orlando, FL • International
AIDS Empowerment, El Paso, Texas • International Foundation
for Alternative Research in AIDS • Long Island Association
for AIDS Care (LIAAC) • Los Angeles County Office of AIDS
Programs and Policy • Los Angeles Family AIDS Network (LAFAN)
• Los Angeles Gay and Lesbian Center • Miami Beach Community
Health Center, Inc. • Milwaukee Lesbian, Gay, Bisexual, Trangender
Community Center • Montrose Clinic, Houston, TX • National
AIDS Treatment Advocacy Project • New York AIDS Coalition
• New York City AIDS Housing Network • North Carolina
Council for Positive Living • Nova Southeastern University,
College of Dental Medicine • Physicians' Research Network
• POZSeattle • Project AZUKA, Inc. • Project Inform
•Provincetown AIDS Support Group • San Mateo County
AIDS Program • Search for a Cure • Sierra Foothills
AIDS Foundation • Staten Island HIV C.A.R.E. Network •
Tarzana Treatment Centers • Tennessee AIDS Support Services,
Inc. • The Center for AIDS: Hope & Remembrance Project
• Title II Community AIDS National Network • Treatment
Action Group • Tucson Interfaith HIV/AIDS Network (TIHAN)
• United Foundation for AIDS v Vermont People with AIDS Coalition
• Williamsburg/Greenpoint/Bushwick HIV CARE Network
Interview
with Joep Lange
Reprinted from European AIDS Treatment News
A publication of the European AIDS Treatment Group (EATG) www.eatg.org
The International AIDS Society‘s (IAS) Governing Council
reads like a Who's Who of the HIV world. Robert Gallo, Tony Fauci,
Luc Montaigner and the late Jonathan Mann all at one time served
on the Council. Today, the IAS leadership is still composed of leading
scientists and physicians including Scott Hammer from the University
of Columbia, Souleymane Mboup and Elly Katabira, both respected
and established HIV advocates from Africa, and Helene Gayle, formerly
of the U.S. Centers for Disease Control (CDC) and now with the Bill
and Melinda Gates Foundation.
While the IAS may lack the gravitas of the World Health Organization
(WHO), the resources of the National Institutes of Health (NIH),
and the high-status prefix of UNAIDS, from an activist perspective,
the IAS is respected for its world conferences and for making itself
amenable and accessible to the activist community in Europe. Stefano
Vella, the former IAS President, before and during his presidency,
was no stranger to European AIDS treatment activists. His engagement
with AIDS activism has been a personal commitment and has helped
to establish an important liaison between advocates operating at
pan-European and international levels.
Joep Lange is the recently appointed President of IAS. While his
demeanor may be brusque and disarmingly forthright, his intellect,
integrity and dedication to fighting HIV on all its geographical
fronts, is without reproach. Lange is a rare individual who understands
the business of governance but does not respect the insidious imposition
of power. Entrenched positions of power, and abuse of it, he has
long claimed, have the potential to bring nations to a halt. Whether
the abuse of authority is the result of political machinations,
business greed or personal lethargy, it is always reprehensible.
On the eve of his inauguration as President of IAS, Lange shared
his thoughts on HIV, his presidency and what to do about AIDS in
Africa.
Professor Lange, how would you describe the HIV situation
in the developing world?
Well, I would begin by describing the scale of the situation. HIV
has devastated individuals, communities and populations on a proportion
that can only be expressed as a human tragedy. The suffering, misery
and total lack of hope that I witness when I travel to Africa is
beyond description. I would also illustrate the toll of HIV against
the stark reality of economics — since that is, and will continue
to be, the great motivator for many nations.
What specific efforts do you feel are essential to contain
and adequately address HIV in the developing world?
Treatment. All our breast-beating is futile. And our efforts to
date — 50 patients here, 50 patients there — are negligible.
Let's look at the figures, 28 million in Africa, 7 million in Asia.
We are told that 30,000 people are being treated in the developing
world. Well, that must be a lie — it is actually less than
this. Our commitment, no matter how well meant, has been fragmented.
We have not even begun to consolidate our own actions. What is needed
is concerted, responsible and sustainable intervention. Let's look
at it like this — we will need treatment, yes. But we will
also need to devise effective strategies for speeding up drug supply,
drug delivery, identify key players, develop clinical and technical
expertise. The Global Access Initiative launched here in Barcelona
is one way of sharing and building upon our resources and commitment.
We organized ourselves against smallpox eradication. Let's do it
for HIV.
Who is responsible for addressing this global tragedy?
Who are the key agents whose contribution will make a difference
— African governments, western governments, WHO, scientists,
physicians, pharmaceutical companies, international NGOs, activists?
There is so much to be done. So much intellect, resource, capital
and commitment is out there, yet no one seems to be playing together.
I have often said that we are fighting over Africa and Asia for
our own political and career interests, duplicating efforts and
obstructing real potential. Instead, let's divide the world amongst
those who have the resources and thus the responsibility to treat.
I proposed earlier that the NIH could be responsible for some part
of the world, the ANRS for another and so on. The WHO does have
a role. It's role is to lead — but it cannot deliver alone.
Bad governments impede our efforts. I have always been vocal on
this issue. People under a bad government are punished enough —
let's not punish them anymore by making them suffer a disease for
which we have treatment. There are operational issues and supply
issues to be addressed. Let's work positively and responsibly with
those who have the treatment resources — the pharmaceutical
industry and those who make generics. NGOs will remain essential
in this process. They can support, empower and vocalize. As Paul
Farmer so rightly said, "the community is part of the infrastructure."
What is your personal vision and aim as President of IAS?
To be an advocate. To take the lead. To overcome the issue of infrastructure
as an obstruction to treatment. Infrastructure is used incessantly
as an argument for not treating HIV. We have the WHO treatment guidelines
as a starting point. Let's establish treatment, scale-up and work
with countries to improve existing health care delivery systems
now.
The Vice-Chair of the EATG said in a press conference "scientists
are turning into politicians" and "activists are getting
angry again." How do you respond to that?
Unfortunately, scientists can't just stay scientists. Their resources
and skills are needed to mobilize treatments on a global scale.
Scientists and physicians have delivered astounding achievements
in this area. But we need to push them and their talents so that
research and clinical care are available and made meaningful to
those who need it the most. And yes, I have observed the community
getting angry again. That is a good sign. We need strong advocates
from both the developed and the developing world. Activists emerging
from Africa have already established historical landmarks.
My message to European treatment activists? Partner up with activists
and networks in the developing world, share with them what you know,
learn from them about their experiences of HIV, and build alliances
that will be supportive, challenging and formidable.
Interview conducted by Y Halima and R Camp, EATG
Written by Y Halima, EATG, UK
Our thanks to Professor Lange for sharing with us his candid
comments and views.
Intervention in a Village By Maitreya
Email correspondence from the AIDS-INDIA discussion list
Dear Umesh,
This is in response to your post requesting information on village-level
interventions for HIV prevention.
Your description of a village "having low literacy level,
low socio-economic status and totally male dominated," fits
more than 80 percent of Indian villages. Therefore we could say
that strategies adopted in most villages could be applicable in
your case also.
But I must say, you must start with "men as high-risk group"
and address them first exclusively. Usually health projects address
women first, as they are sitting ducks at home, but those projects
forget about power relations in sexual matters. So if you start
with women, all you will end up doing is creating more fear to go
along with their already powerless existence. Women may be easy
to approach and available, but make sure, as difficult it may seem,
that you address the men first.
Never talk to men in the language of fear and death, for they always
live dangerously in life situations and at work. Approach them first
with the idea of pleasure and then health. Tell them we need health
to sustain pleasure. You may encounter resistance among them about
using safe sex methods, especially condoms. Tell them there are
ways to wear condoms pleasurably by, say, asking your partner to
put them on. Slowly build the idea of health woven strongly with
the idea of pleasure, or else they may listen stoically but will
never practice.
Next, work out ways to bring up the topic of injustice in power
relations that exists between genders — point out how a submissive
and docile wife actually lessens the pleasure, and stress the aspect
that an active partner heightens pleasure. Also mention that this
is why men seek out sex workers. Under existing conditions it is
men who take the initiative in all sexual matters. Thus, once you
can build the idea of pleasure around all health aspects, men will
start to listen.
In short, first make men responsible for their acts.
Once this part is initiated then you can ask the village heads
to address the issue of HIV/AIDS broadly through awareness campaigns
and meetings.
Only after this, should you address women exclusively to show the
disparities in gender relations and tell them that they should ask
their spouses to use safe sex methods. This way the men won't feel
affronted when women dare to ask them. This way you can avoid a
lot of violence and bitterness among couples.
Don't stick to "condoms are the only method" to safe
sex practice. Make sure you teach them the pleasures of mutual masturbation,
using thighs, etc. Tell to avoid penetrative sex as far as possible
and, if need be, only then use condoms. Tell men that penetrative
sex is for making babies and that they don't have to push their
stick in all the encounters.
Now, we have to show that there are different sexuality groups
and there is nothing to hide or be shameful about. That sex between
consenting adults — between man and man, woman and woman,
man and intersex person, woman and intersex person or among intersex
persons — is permissible and "quite natural" also.
Also say that there are bisexual persons and there are different
shades of sexual orientation, and that there are confused persons
with their different sexual orientations, but all is okay, if it
is done on mutual agreement with respect and concern. Again show
them that there are different sexual practices and all are acceptable
with above agreement. What is wrong in sexual encounters is what
is forced and without consent. Tell men, even if that happens between
married couples, it is wrong.
In short teach sexuality in depth to bring about behavioral changes.
Only in a brothel set up one can demand the use of condom in sexual
encounters. All other relationships need mutual agreement, responsibility,
respect and concern, in short, love.
Men will ask about sexual matters, about pleasure and other details.
Talk about these in small, comfortable groups. But never create
literature to explain it, for there will be "moral morons"
around who will topple the apple cart. The fundamentalist business
will come into action, so don't leave anything for them to chew
upon. At any confrontation, deny everything, but if you leave anything
written, you will be in trouble. Police and the fundamentalist mafia
will make mincemeat of you. Sex and the politics of power goes together.
Make sure that condoms are available once you promote their use.
Easy availability increases use.
The most neglected issue concerns the treatment given to the AIDS
patients. You have to fight for the medicines with all the authorities.
This you should do with other NGOs at all levels. Start a care center
if there are any AIDS patients, but to treat them you need expert
people.
We also have to address the stigma around PLWHAs (People living
with HIV/AIDS). Make people sensitive about it. If possible include
in your team an HIV+ person. If there are already HIV+ people in
the village, this will help immensely. Moreover this will wipe out
fear and discrimination immediately. People see what is preached
as practiced.
Okay, these are some of the thoughts that crossed my mind. If you
ask on specific matters I may be able to answer them later. Say,
I may not know all the answers but all I am saying is I am ready.
Love,
Maitreya
Global Treatment
Update
By Bob Huff
Developing new drugs is one thing, but finding ways to get them
to the vast majority of people in the world who need them is proving
a lot tougher than hoped. Of course price has been and will continue
to be a problem, but the logistics of shipping, clearing customs,
transporting and storing medicines need attention too. Then come
issues of diagnosing, dispensing and monitoring therapy when doctors,
diagnostics and skilled staff are in short supply or lacking altogether.
Gilead Sciences, the makers of Viread (tenofovir) and soon-to-be
custodians of Coviracil (FTC), have announced a plan to distribute
tenofovir at no profit to organizations in every country in Africa
and in 15 other resource-challenged countries. Providing drugs at
cost or even for free is not a new idea. Other companies have launched
similar programs that have met with mixed success. Boehringer Ingelheim,
for example, has a program to provide free nevirapine for prevention
of mother to child transmission of HIV. Yet the required paperwork
was initially so convoluted and difficult to negotiate, that few
were successfully treated.
What sets the Gilead plan apart is the attention given to addressing
the problems of actually distributing and dispensing the drug. First,
Gilead plans to arrange for direct purchasing by treatment programs
in each country. Some small treatment programs have found that drugs
offered at an affordable price by a generic maker may have to pass
through a third-party wholesaler who can add on significant markups
or divert their shipment to another customer willing to pay more.
Next, the company has indicated a willingness to provide information
and technical assistance to organizations that are interested in
adding treatment to their services. The intention, the company says,
is to "take appropriate steps to ensure that Viread shipments
reach their intended destination and, to the extent possible…
monitor the recipient programs on an ongoing basis to ensure that
quality care is being provided."
Realizing effective programs will depend on continued research
into both the medical and the operational aspects of delivering
treatment in resource-limited settings. Gilead is also a participant
in the "Development of Antiretroviral Therapies" (DART)
study, a 3,000-patient clinical trial sponsored by the U.K. Medical
Research Council scheduled to begin this year in Uganda and Zimbabwe.
DART aims to investigate ways to optimize the provision of therapy
with simplified protocols and diagnostic tools.
There are more than a few stumbling blocks ahead, even with the
company's willingness to smooth the way. To date, no price has been
announced and it's possible that Gilead's "no profit"
price will exceed what many programs can afford. Then, cheap Viread
is fine, but one drug is not enough. What other drugs on what terms
will be available to programs that wish to begin offering treatment?
Gilead is in the process of acquiring Coviracil, which should prove
nicely compatible with Viread, but that won't be available for perhaps
another year — and still, the third leg is missing. If Gilead
is serious about making this program work, it should plan to act
as the "at-cost" middleman for a full combination, including,
say, Viread plus Epivir and Viramune or Sustiva in the package.
At the very least, Gilead should pledge not to disqualify or discriminate
against programs that plan to use generic versions of these other
drugs in their affordable combinations.
New Handbook for Organizations Seeking to Provide Treatment
Initiatives like the Viread distribution program could be an attractive
solution for employers, religious missions, health clinics, clean
water programs or any of a number of similar existing economic or
health development projects that would like to add HIV care and
treatment to the services they offer. But small community-based
organizations (CBOs) and non-governmental organizations (NGOs) interested
in dispensing HIV medicines have a lot to consider before taking
the plunge.
The International HIV/AIDS Alliance, along with the World Health
Organization (WHO) and UNAIDS, has developed a handbook entitled,
"Mobilising NGOs, CBOs and PLHA groups for improving access
to HIV/AIDS-related treatment." Intended as practical toolkit,
the handbook contains a series of training exercises designed to
prepare management and staff to deal with the full range of tasks
and issues that will accompany undertaking a treatment program,
including how to:
- Make decisions on involvement in treatment provision and drug
supply by providing a basic understanding of the main factors
involved in HIV/AIDS treatment;
- Gain access to and make use of existing local and national
drug supply systems where available; explore and use alternatives
to these systems and drugs where necessary and useful; understand
the uses of donated drugs and the constraints associated with
their management and use;
- Work with the practical issues involved in drug supply and
financing, with special regard to cost, quantification, quality
and sustainability in the context of the development of the epidemic
and in relation to other public health needs;
- Ensure good practice in the use of HIV/AIDS-related drugs,
including clinical requirements and the use of treatment protocols,
technical support (such as laboratory services) and psychosocial
support (such as confidentiality and counseling).
- Although the Handbook is designed to build practical skills
through interactive exercises, simply reading through the material
gives an overview and reality check about what treatment provision
can entail.
For copies of the Handbook, please click here.
| Short
Course Notes on HIV drugs in development Tipping
the Scales at 500 mg — Tipranavir!
Boehringer Ingelheim has announced that they have finally
settled on a dosage for their protease inhibitor, tipranavir.
Now, larger Phase III clinical trials of the drug can begin.
A recently completed Phase II study had compared three different
dose combinations of tipranavir plus ritonavir given twice
daily. A dosage of 500mg tipranavir plus 200mg ritonavir was
chosen as providing the best balance of adequate viral suppression
with the fewest side effects. The ritonavir acts to keep blood
levels of tipranavir higher, longer, by slowing its metabolism
through the liver.
The Phase II study was conducted in people with extensive
experience using multiple drugs in all classes of antiretroviral
therapy. Since tipranavir may be able to suppress multiple-PI
resistant and wild type virus with about equal efficacy, it
represents an urgently needed therapy for people who've run
out of treatment options. Even though primary resistance to
tipranavir itself seems to be slow to develop, people who
still have an array of treatment choices probably won't choose
tipranavir. Besides being a twice-a-day product, ritonavir
boosted tipranavir is likely to raise blood lipid levels and
cause drug interactions and tolerability problems. Unfortunately,
these are factors that will also limit its use among some
people who will desperately need it.
Having settled on a dose, Boehringer is now set to start
up a pair of large Phase III trials. One study (RESIST 1)
will be a 24-week trial in sites throughout North and South
America, and Australia. A 16-week trial (RESIST 2) will be
conducted exclusively in Europe. The time to approval of tipranavir
will depend on how quickly the Phase III studies are enrolled,
how much time the company needs to pull its data together
for the FDA, and how long the FDA needs to review the application.
Mid 2004 would be an optimistic guess.
As the Phase III trials get going, and with the approval
of T-20 (Fuzeon) expected in March, it becomes urgent to finalize
the details of a tipranavir expanded access program for people
with no other treatment options. We know that T-20 has the
best shot at working when it is accompanied by at least one
other drug active against an individual's viral strain, and
for many, tipranavir is the best candidate on the horizon.
With access to T-20, tipranavir and atazanavir opening up
in the next six months, things might start looking brighter
for the growing number of people who critically need an effective
third, fourth or fifth-line regimen.
|
Ring in the New... Now
By Gregg Gonsalves
As the New Year begins, it's time to take stock of where we've
been and where we're going. Around the world, only a fraction of
the people who need AIDS treatment get it and the virus continues
to spread like wildfire in Asia, Eastern Europe, and Africa. In
the United States, 13 state AIDS Drug Assistance Programs (ADAPs)
have already closed enrollment to new clients or limited access
to antiretroviral treatments. Adding expensive new drugs like T-20
or treatments for hepatitis C are out of the question for most ADAPs.
Meanwhile, the extreme right wing within the Bush Administration
continues to play politics with HIV prevention, pushing abstinence-only
prevention programs — despite evidence that suggests these
kinds of efforts are ineffective — and questioning the worth
of condoms, despite data that confirms their central role in protecting
people against HIV.
Soon, Congress, working with Draconian budget caps, the prospect
of more tax cuts, and a war in Iraq, will have nothing to spend
on domestic discretionary programs, including those for HIV/AIDS.
Nor will there be room for any real investment in international
efforts to combat the epidemic. Additionally, the doubling of the
NIH budget has come to an end, forcing some hard choices about the
future of AIDS research.
As Irish poet William Butler Yeats wrote 80 years ago, "the
best lack all conviction, while the worst are full of passionate
intensity." Since the advent of highly active antiretroviral
therapy (HAART) in the late 1990s, we've seen a waning of AIDS activism
here in the United States. It seems as if many of the activists
who fought for the programs and policies that we rely on today —
if they survived to see the drugs — considered their work
done and moved on. And although many new-generation AIDS activists
have focused their energies on vital international work, one wonders
if and when we'll see resurgence in the activism needed here at
home.
The passionate intensity of the Right is bent on destroying all
we have worked for during the past twenty years, yet people with
AIDS and their advocates in the U.S. seem strangely silent. Have
gay men in New York City and around the country forgotten what it
was like in the 1980s? Or have they decided, now that they've got
HAART and health insurance, and now that the epidemic has moved
into African-American and Latino communities, that HIV is not their
problem? Are there still some leaders in the African-American and
Latino communities practicing denial about the swath of destruction
that HIV has unleashed in their communities?
A few of our readers here at GMHC Treatment Issues have complained
that the newsletter has gotten "too political" over the
past couple of years. I happen to like our focus on treatment information,
policy and advocacy—it eloquently reflects the challenges
and opportunities of the next decade of the pandemic. In counterpoint,
I would maintain that a few of our readers have gotten "too
complacent" since HAART came on the scene.
Today, I can ask: where were you when your state's ADAP program
closed? Where were you when "just say no" abstinence-only
programs were instituted as the only HIV prevention efforts in your
teenager's high school? Soon, I'll be able to ask: where were you
when public funding for AIDS programs began to slide backwards?
Where were you when your local AIDS service organization started
cutting back services to those most in need due to lack of funding
from individuals and foundations? Where were you when the number
of people in the world infected by HIV — where, for the majority,
AIDS remains a death sentence — hit 70 million?
So, it's a New Year. Time to make your resolution. Pick up a pen
and write to the President, your members of Congress, your governor,
and your mayor. Check in with your local AIDS organization to see
what needs to be done, and then get to work. If every subscriber
to Treatment Issues did this, thousands of calls and letters would
flow to Washington, D.C., to the people who make the decisions that
affect our lives.
Yeats concluded his poem by asking, "what rough beast, its
hour come round at last, slouches towards Bethlehem to be born?"
Those of us living with AIDS don't need to ask; this terrible creature
lives in our bodies, swirling in our blood, and it links our fate
to all people with HIV, whether they are a subway ride away or a
world apart.
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