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Past Issues
Volume 18, number 9/10
September/October 2004
One Step Forward...
Reflections by HIV/AIDS advocates around the world
You're Not Listening
Steven James on his impatient doctor relationship
Planet Queue
Brian Varner on flu shot rationing during wartime
HIV Advocates Tackle TB
Olayide Akanni on the community response to a killer
The Tipping Point
Tipranavir's large efficacy trials reported in Glasgow and DC
The Rage of Reason
Mark Milano targets creeping fundamentalism
Change and Rumors of Change
By Bob Huff
In nearly every corner of the globe, HIV treatment advocates are
working for people living with HIV/AIDS, helping them to get the
care they need and the respect they deserve; helping them to get
the most out of whatever medications are available; to understand
what is happening with the virus in their bodies and to learn what
they can do to maintain and improve their health. In the U.S. the
job may involve getting a client who needs an unaffordable drug
for their salvage regimen admitted to a patient assistance program.
In one part of Kenya, it may be getting a client access to free
tuberculosis treatment and drugs to prevent pneumonia in the hope
that serious illness can be forestalled until antiretroviral (ARV)
drugs finally become available. While in another part of Kenya,
the challenge may be helping a patient who has failed her free
first-line regimen get transportation to the U.S. financed PEPFAR
clinic so she can start a second-line set of drugs. In Pakistan,
the advocate's work may be counseling family members of a person
diagnosed with HIV to relieve the stigma, thereby preserving the
only source of care and support he has. In Argentina, the challenge
may be to refill a prescription for free government-provided drugs
when the nearest clinic is 1,000 miles away.
Despite the wide range of resources and problems that treatment
advocates deal with, they often face a common set of challenges.
All too often the doctors their clients rely on are poorly trained,
dismissive or simply unwilling to provide information or care that
goes beyond handing out pills. Everywhere that antiretroviral drugs
are available, and in many places where they are merely anticipated,
the prime adherence message about taking the drugs consistently
is being taught. In addition to such basic treatment literacy,
people with HIV worldwide are learning about nutrition, side effects
and the healing community that can form when people speak out about
their illness and embrace life.
All over the globe, things are changing for people with HIV/AIDS.
Mostly the changes are improvements; stigma is lessening; free
ARVs are becoming available; resources from international donors
are starting to flow; lives are being saved and hope is coming
alive. In many regions, though, change is slow to come and oppressive
conditions are lingering or getting worse. In several countries,
conditions seem poised for change, but are stalled by corruption
and the unwillingness or inability of the Global Fund to Fight
AIDS, Tuberculosis and Malaria to follow through with promised
grants.
Recently, 26 HIV advocates from around the world were asked what
changes they had seen in the past 12 months; and what changes they
hoped to see in the coming year.
Eid Muhammad Shamas, Pakistan
It is a very tough situation for someone with HIV in Pakistan.
There is a lot of stigma and discrimination — not only in
the general community but in doctors' attitudes. When a person
goes to the hospital he faces discrimination. He fears to seek
treatment because the doctors often ask embarrassing questions
like "how many times have you had sex with females." Because
sex is a taboo issue in Pakistan culture, people don't talk about
sex openly. So when a person faces these kinds of questions,
he feels fear, feels shame, and feels guilty. And he faces great
difficulty maintaining his health because the doctors don't cooperate
with him.
When people with HIV come to us, our doctor examines them and
can get them to the government hospital for drugs and testing but
not ARVs. People don't want to go to the hospital because they
are afraid their status will be told to their family members and
friends. But when they come to us we counsel them to reduce their
guilt and shame and then we do counseling with his family so he
won't be rejected. The majority of families will be accepting once
they are counseled.
Elie Bertrand Gaston Kampoer, Cameroon
The stigma about HIV among the medical personnel is less now in
the cities but it is still bad in the rural areas. Anywhere the
NGOs (non-governmental organizations) are not present, the discrimination
is bad. If you have a choice, you get better care from private
doctors, but it is too expensive. In the past year, the fight
against AIDS is getting stronger and moving more into the rural
zones. But they are still not working enough on treatment.
We are hoping that the Global Fund will bring a big change in
how people are treated for both HIV and tuberculosis. But I'm afraid
that what is written on paper is not always the case in reality.
Lydia Mungherera, Uganda
In the past year there has been an increase in the awareness of
treatment. A few years ago we focused on having a healthy life
and told people how to care for themselves and how to have safe
sex. And now, we are gearing the NGOs and CBOs (community-based
organizations) towards treatment, saying, "There are lifesaving
drugs and everybody needs access to them." And that's a change.
At the moment, most of the funding for ARV is coming from the
donors. But I hope that in one year's time the government will
also put some effort towards treatment. Most of the money we have
goes towards defense. If we could put more into the health facilities
and human resources, we could do a lot.
Tesfalidet Debesay, Ethiopia
Awareness about HIV/AIDS has improved in the last year. Awareness
is good, actually. Some research studies say that 95 to 97 percent
of the population are aware of HIV/AIDS. But what matters is
the behavioral change, because we still see people doing risky
behaviors. Awareness is good, but behavioral change progress
is very slow. And I think that the prevalence of HIV is increasing
and Ethiopia is a country hard hit by HIV as well as tuberculosis.
We are a high burden country on both diseases.
The changes we need are not for the next year, but Ethiopia needs
to work for the coming two or three decades to tackle these diseases.
It is not a simple disease to tackle within five or six years because
nearly 3 million people are living with HIV/AIDS in Ethiopia. It
is one of the hardest hit countries next to South Africa and Nigeria.
We need three or four decades to reverse the situation.
Precious Jackson, U.S.A.
Not much has improved in the past year. I'd say they are getting
worse. For example, I hear from women who go to the AHF (AIDS
Healthcare Foundation) clinics that they are not being treated
the way they are supposed to. The problem is, there are so many
cases, the doctor doesn't have time to actually sit down and
talk to the women and answer the necessary questions they have.
A lot of the women are having side effects, and they tell their
doctors, but sometimes the doctors ignore them until it's too
late. Women call me and tell me this and sometimes I have to
go with them because they don't feel like they are being heard.
So we go in support to assure that her voice is heard.
I think that doctors really need to take women seriously. They
need to listen to them. If they say, "I have a pain in my leg and
I know there's something wrong," don't ignore it or say, "Oh, it's
probably just arthritis." Because arthritis is a valid complaint
and something needs to be done about it. My thing is just to listen
and to know what the person is saying is valid.
Julia Vinckler, Estonia
There is stigma about HIV in the medical profession but it is becoming
better. Two years ago they didn't know anything about it, but
now a lot of information has been coming. In the prisons, when
we came there, there was a separate block for the positive persons;
now that doesn't exist. As the prisoners become more educated
they also educate the staff. Outside the prisons, the city government
decided to organize low threshold centers for drug users, which
is a big step forward. There are also more needle exchange places.
So, step-by-step, slowly we are moving forward.
The next steps will be to have more possibilities for the rehabilitation
of the drug users. We have methadone treatment for free, but it
is not enough; we need rehabilitation.
Mohammed Farouk Auwalu, Nigeria
In terms of HIV/AIDS, I think a lot has changed in the past year,
because more people are getting on treatment now, and some people
who are very sick are getting better now because they are taking
medications. And PLWHAs who are activists are gradually coming
out of their shells, you know, breaking the silence and trying
to do advocacy and activism in terms of addressing specific issues
that have relevance to the lives of infected and affected people
in Nigeria.
The biggest change that has to happen, first and foremost, has
to do with the issue of transparency and accountability. That's
key. Because, I can tell you that in Nigeria, if you read the last
report from Transparency International, Nigeria is the most corrupt
country in the world. And I can tell you that HIV/AIDS is not excluded.
We have seen a lot of people become AIDS millionaires overnight.
So for me the key issue now is that activism has a lot to do in
terms of transparency and accountability. We have to hold our leaders
accountable for whatever they have said. And first and foremost
we have to hold ourselves accountable, because you don't start
attacking somebody if you can't look at yourself. If you're straight
up, you can look at anybody and tell him he's not straight up.
Francisco Rosas, Mexico
Not much has changed in the past year. People are dying in Mexico,
especially children, young people and women. They have access
to drugs but, in my opinion, they need access to quality care.
It is not the same to have access to treatment and comprehensive
care. It is not the same, to receive drugs each month and to
receive quality of care.
We have to create new leaderships among HIV-positive people because
the existing networks are so few and many of the leaders are dead
now. Another big problem is that drug companies condition these
leaders to do some kinds of work and not others. For example, the
drug companies said to these leaders, "Don't talk about generic
drugs and oppose the local production of generic drugs." But the
drug companies bring their organization's money. I think one important
problem in Mexico is corruption among leaders.
Lucy Chesire, Kenya
To be really honest, things have really changed. Five years ago
when we started the clinic, you'd get someone coming into the
clinic, she walks in and there's a big waiting room outside and
she doesn't want to sit there. So she goes into a different room
and says, "Lucy, when it's my turn to see the doctor, please
come and call me." But nowadays, you get someone walking into
the clinic and it's not an issue, because they already know it's
an HIV clinic and they don't find it's an issue. You find them
sitting there outside waiting and they want to know, "When is
my time coming so I can get attended to and I go." It's not a
big problem. So that's a big, big change and that is what has
contributed to the big numbers that are actually coming into
the clinic now. The stigma within the hospital does not exist.
And people have understood that we are moving into a new building
because the number of patients has become too large.
Still, free ARVs are not yet everywhere in the country. We are
funded by PEPFAR and Global Fund and also Indiana University, which
has really played a big role. But it is a big country.
ARVs in Nigeria
The government of the fair Republic of Nigeria started a
national antiretroviral program which was to treat 15,000
patients. The program has been there two or three years now.
The program has not been working well. The situation is that
there are a lot of patients on that program who have already
grown resistant and we don't have the second-line treatments,
which is a major, major issue for us. And that's why, as
activists, we were happy when PEPFAR came up. PEPFAR said
they were going to treat more patients in Nigeria — and
not only treat the patients, but they are going to provide
a comprehensive level of treatment, which has been lacking
in the government program, because the government just brings
the ARVs and gives them to the patient at a subsidized rate.
But the question is, do you give the patient a subsidy when
the patient does not even have the money to get the laboratory
tests and find out if indeed these drugs are working or not?
Mohammed Farouk Auwalu
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Sunil Pant, Nepal
We now have 25 people on ARV who started this year; otherwise not
that much has changed. The press has been very friendly this
year on HIV/AIDS; they wrote a lot of articles. A few organizations
also sponsored a few radio and TV programs. So that's good, but
we do not have that commitment for education from the political
leadership and Nepal's situation is very poor: the political
situation; the security situation is bad. Because the security
presence is so strong in Nepal now; in Kathmandu it is everywhere.
Every street has a checkpoint and patrolling, so the metis (feminized
males) and sex workers going in the night for sex or for earning
money or something, they get checked and raped or blackmailed
or cheated by security forces.
The situation for access to health care and treatment should be
improving, but it is something pretty hopeless to think about in
Nepal, because the Global Fund granted a second round proposal
but they haven't been able to send any money, and the government
is corrupt — they don't really think about the community.
And the Global Fund sort of says, "Oh, we have made the grant." But
Global Fund needs to tell government, "Either you take it or not.
If you are not able to do it, they we'll give it to the NGOs." They
should start working with us and stop waiting, waiting for the
government to get their act together, which never happens.
Fatima Koshokova, Kyrgyzstan
The main route of transmission is injecting drug use. Our city
is situated on the drug traffic that goes from Afghanistan and
Pakistan to our CIS (Central Independent State) countries and
then to Eastern Europe. And drugs are very cheap in my area,
for example, for one package of heroin, it costs about 10 dollars.
That's why it's one of the most used drugs in my area and most
drug users are injecting drug users.
If you compare HIV/AIDS stigma and TB stigma, HIV/AIDS is stronger.
At the moment, only one person in my country came out with his
HIV-positive status. As for TB stigma, it depends on the community
where the person lives. For example, injecting drug users are not
afraid of TB stigma; if they have TB, it's not a big deal. But,
for example, if a person works at the university, it will be a
stigma. People don't want other people to know they have TB. They
will avoid contact with the person, so they won't get TB.
Beverley Figaji, Namibia
The CD4 count for eligibility to the government ARV program has
been raised from 250 to 300 and more people are going on treatment.
I think that's also due to our voluntary counseling and testing
center. The positive clients coming out know that they can go
to the ARV clinic because we're referring them straightaway.
It's not people wandering around aimlessly not knowing where
to go anymore.
I would like to see our center becoming a one-stop-shop. I would
like to have everything there. If you come out positive, you could
go straight onto treatment. No need to walk or take a bus. Our
public transport service is not good; it's expensive for people.
You can't just jump onto a train or a tram or a bus. You have to
pay a taxi and it's expensive, or you walk. So it should be a one-stop
shop. And other progress that's been made is that government has
decided to go for rapid tests now. So if a person is positive,
then we should be able to then give their CD4 count and give the
treatment all in one place on the same day.
Matt Sharp, U.S.A.
Despite the complexity of all the new medications that are coming
out, in general I'm seeing people in better health; their overall
health status has improved. It seems that, at the very least,
people are more stable. I still see some deaths occurring, but
they are all unrelated, there's no pattern to why they are happening.
Maybe a suicide or things like that. I don't see that the deaths
are related necessarily to HIV.
I'm a big proponent of educating people. I still see a big gap
when talking to people about what's going on in their lives with
treatments and with their doctors. There's a big misconception
in the community that puts doctors on a pedestal and we're trying
to break down that misconception and say, "You have to be able
to speak to them on your level." I see that as a big area of work
for me.
MacBain Mkandawire, Malawi
Within the catchment area where I am working, I wouldn't say there
have been many changes in terms of care. One key problem is there
was a tendency to say HIV is a medical problem. And for those
of us who are not coming from the medical background, and are
trying to change that notion, it has really been a hassle.
We want to see the community members themselves take action and
care for the sick. The hospital should be the last resort. I mean
the hospital should be for purely medical situations and not things
that have got to do with nursing care. Like 70 percent of the bed
space in the hospital, you could actually see that these are TB
and HIV cases. So, what we are saying is, that if there was a better
mechanism for care and support, and if we make progress against
stigma, then people who are sick can get back to the community
without being harassed or intimidated and we would be able to see
a positive development among the people who are sick. But also
taking into consideration that those who are sick have got children,
and as they get stigmatized, we stigmatize the whole family and
the children, and the growing up of those children becomes horrible.
In our area, there is no one receiving ARVs through a government
program. But in other areas, there are. We have been told that it's
going to start soon and that's why we want to do advocacy on the
education and treatment programs so that they should be ready. We
know when they start getting ARVs, the issue of nutrition will be
very critical.
But in the meantime people continue to get sick and die and there
is nothing we can do about that because it is a government program — you
know the bureaucracies of government — and because about 50km
from where we are there is a hospital that actually administers
ARVs. But when we went there with some of our clients, we were
told, "No, you are not in our catchment area, so we can not give
them to you."
Elizabeth Anyango, Kenya
We've seen an improvement in acceptance in the past year. The peer
educators who have accepted their condition have been influencing
the others to seek medical care. People see that those who were
very sick, now walk. Because some people are sick with TB and
after the TB has been sorted out, they're able to work and they're
able to walk. So, the other people feel that since so-and-so
is able to come back and work, I too can seek health care. So
that is something that we have seen. Also, our government promised
a roll-out of ARVs. They released medicines in one of our district
hospitals. But they only can take about five persons and they
are showing about 400 persons on the waiting list. So they don't
even take the five because how can they select the five? So they
are using the medicines for their prophylaxis for the health
care workers — when they are treating, they are going to
get exposed — so that's what they are using for medicine.
So, the impact of that has not translated into anything.
I hope to strengthen our community strategy, in terms of strengthening
treatment literacy. We hope that with the PEPFAR support the ARVs
will be able to reach more people than they are reaching now. We
also wish to reach other funders that work in this field because
they don't provide ARVs. So we are hoping to influence them to
provide the ARVs to people that are in dire need, because, in one
of our secondary schools, we lost six teachers within eight months
this year. These are graduate teachers. We lost them because of
the TB/HIV/AIDS problem. So we feel that these other funders — we
have the CDC working in the area — we feel that they need
to do more.
Joshua Formentera, Philippines
First, there are more people aware that the intervention of care
and treatment and advocacy is a stepping stone for people to
get involved. So a lot of people are making a change in their
way of thinking now. Second is the availability of generic medications.
A lot of our people who could not afford to buy medications before
are accessing these drugs.
Care and treatment has to be set as a priority. People come around
voluntarily when you say there is a treatment available. Some health
workers never talk about ARV, because there's an issue of not knowing
about it, and it is so expensive, which adds additional depressions
to people who are ready to access it.
Rene Roa-Flores, Argentina
Nothing has changed. Nada. We have antiretrovirals and we even
have the latest generation of them — in the cities; in the
country, where we work, it is a different story. These are not
covered by the public national health program, but we do have
a private national health program that covers them. But what
has happened is that the economy has gotten much worse; nutrition
has gotten much worse; and that quality of life has gotten much
worse.
We work in the rural areas. In Argentina, someone could be 400km
away from an HIV clinic. We need to improve their quality of life
and find ways to get to the people we're concerned with. We don't
have the money to accomplish the necessary logistics. We need an
airplane.
Heidi Nass, U.S.A.
For treatment na•ve people, the simplification of regimens is a
big deal. Sometimes I hear people dismiss those issues in community
advocacy meetings, but when you talk to people in the exam room,
they ask how many pills, and how big are they; are they capsules
or tablets; do I have to take them with food? There are very practical
concerns that I think we sometimes undervalue.
We've got to come up with much better ways to manage salvage therapy.
It's astounding. In our clinic, we are seeing double-boosted PIs
(protease inhibitor), which seem to have come into vogue. I certainly
see physicians using it in their salvage situations. It's really
a tough thing when you've got someone with a really low CD4 count
and then the good news is you get a response, but the bad part
is you start having to look for all the immune reconstitution effects,
which we see. And then you have to start treating all of these
sometimes very intense and violent OIs (opportunistic infections)
that appear. At the same time the person is on a regimen that,
frankly, is difficult to manage in the best of circumstances, and
even then getting a mediocre response. For people who are assessing
a lot of issues, including quality of life, what is worth what?
It's really frustrating to watch. Now that I work in a clinic I
see people over and over. A lot of people, unfortunately, are coming
to our clinic several times a week, given what's going on with
them. The more up close you are to somebody in that situation,
the more frightening it is, because you can watch it become more
and more tenuous before your eyes. And it's one person after another
after another. Salvage is a really difficult one.
Nelson Vergel, U.S.A.
I've seen improvements in treatment advocacy. We're including more
people like me around the table when we talk to drug companies.
I think the introduction of Fuzeon and now tipranavir is expanding
the possibilities for salvage patients. So is a renewed interest
in that field. I think the lipoatrophy field has changed, with
Sculptra coming in. People want to talk to me a lot about that.
But a lot has gotten worse, like funding, the waiting lists for
ADAPs (AIDS Drug Assistance Programs), and no new drugs have
been approved this year.
I want to push the salvage agenda; teaching patients that going
on sequential monotherapy is not the right thing to do. That's
a big goal for me. With the entry of Tibotec, I'm very excited
because we're going to have a company with two new agents for use
in salvage therapy. And personally, my main goal will be to educate
people about multi-drug resistant HIV and about their options.
Rajiv Kafle, Nepal
Treatment has started in the past year. There are also more groups
coming out and more groups being formed. At the same time we
who are based in the cities and have some reach with the policy
makers and the donors are pressurizing the donor communities
and the funding mechanisms to put more money on the smaller groups
so that they can be sustained.
The scaling-up of treatment as well as care and support groups
being funded are priorities. The people who know how to create
support groups live in the city, but Nepal is many regions and
we need to get support groups funded all over Nepal.
Anjan Amatya, Nepal
In the past year I see a great deal more involvement of people
living with HIV/AIDS in workshops, seminars and meetings. Also
we see many more NGO and donor agencies in Nepal asking for workshops
on HIV and we have many more people living with HIV involved
in those.
In the next year, I hope to see more of the same but moving out
of the city to the rest of the country.
Ramkumar Thankiah Selva, India
The HIV prevalence has been reduced in my area. In my particular
district, in the past year, we can strongly say, only one person
we found positive. We ran a large VCT campaign last year among
sex workers and we took a random sample of 300 and only 3 were
HIV positive. Also, the stigma is reduced and the local people
are understanding that we can support them.
Still we need some support for the children. The local people
are doing some support but we need more.
Dario Abarca, Ecuador
In the last year the political view has changed, but nothing more.
They have changed what they say, but nothing has really changed.
The Global Fund proposal was approved in 2002, but in 2004, we
have no money. Sex workers maybe have better access to health
services now. They also have better access to condoms and information.
That's very good.
The NGOs and the Global Fund should go away. It's not good with
them in Ecuador. There is constant fighting between the NGOs over
everything and with everybody. Also, Ecuador is a very corrupt
country. We are afraid of what is going to happen with the Global
Fund, because the NGOs also have the same problem of corruption.
Yulia Chorna, Ukraine
Our achievement in the past year is that our clients coming to
our needle exchange point do not use dirty needles. For example,
almost all of the clients that we work with for more than a year
always try to have clean needles and condoms, and that is our
influence on these clients. New people that become injection
drug users, of course, at first they do not understand. But our
workers try to explain to them and make them understand why it
is very dangerous. Our achievement is that our clients do not
use dirty needles.
Shirke Rajendra Arjun, India
Government has started training programs and they have been involving
positive people in decision making. Most of my colleagues are
on the governing boards of the government policy making groups.
I think the media campaign the government did previously was absolutely
wrong. They have to come up with a good strategy involving positive
people. There are things the government should be doing to help
the positive people's organizations. They are afraid that if positive
people become strengthened, then tomorrow they will stick out their
heads and make demands. So they don't want that.
Tamara Gvaramadze, Georgia
People are talking about HIV/AIDS more; the general population.
They are more interested and less afraid. And that's great because
that's how knowledge and understanding work. This is so important
for people who are infected because they have to face these problems
everyday... everyday. And when they feel things improving, they
will be encouraged to start getting better.
I think most urgent would be to start connecting TB with HIV because
this is at zero level, so far. There are no NGOs working on this;
there is no information about TB co-infection. We did not discuss
it in our communities; we were not aware of it. We need to talk
about it to our target populations next year then start talking
about it to the general public.
U.S. advocates were interviewd at a meeting of the AIDS Treamtent
Activists Coalition (ATAC), in Washington, D.C., on October 29,
2004. International advocates were interviewed at the 3rd International
TB/HIV Community Mobilization Workshop, in Paris, France, from
October 24 to October 28.
Repression of Blue Diamond Society in Nepal
We started Blue Diamond Society in 2001 to support the human
rights of homosexuals and sexual minorities in Nepal. But
this year it has been very tough. It is because we are becoming
more successful and more visible and a lot of people joined
us and we are also being more visible. Usually, attacks on
metis (feminized males) or gay men are not premeditated or
coordinated by the police. It is usually a few police officers
on the street corner somewhere who take advantage of people
unfairly. But this year there were 39 people from Blue Diamond
Society who were rounded up and arrested. This was well-planned
and coordinated by the police. It means they don't want homosexuals
coming out and demanding their rights. They think it is an
anti-cultural and anti-social sort of activity and they think
it should be suppressed and kept down. So our people were
taken and kept for 13 days, detained without any charge.
Sunil Pant
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What my Doctor Didn't Know
and Didn't Ask
By Steven James
Not too long ago, I met my new doctor. As he went over my lab
numbers he immediately started discussing medication. I stopped
him and proposed waiting until I had permanent housing. Reluctantly,
he agreed and we decided to meet again in a month. It seemed we
were off to a good doctor/patient relationship.
After a month of ambivalence and stress, it was time for my follow-up
visit. That morning I awoke feeling weak and tired. I could barely
muster enough energy to make it to the clinic. I thought about
canceling, but I knew that I had to "show up for life."
I came to the appointment apprehensive about taking medication.
My fears were running rapid. I was afraid of the unknown and of
the side effects that might occur as a result of the drugs. The
doctor looked at his computer screen, read off my numbers and a
list of drugs. It felt like I wasn't in the room. But, Doctor,
I have questions.
I was seeking reassurance and empathy, but what I received was
impatience and intolerance. I came seeking answers to my questions,
so my ignorance and fears would not hinder what I knew was necessary
treatment. I was seeking a doctor who would listen to me. But as
it became clear we were quickly heading in two different directions,
my doctor suddenly and abruptly said, "Goodbye," and walked out
of the room.
I sat there in disbelief. He was supposed to schedule me to see
the adherence counselor, which I requested. He was supposed to
write a prescription for multi-vitamins, which I suggested. Had
he listened, he would have realized I had some immediate issues
that needed attention.
Instead he felt challenged by my hesitation and became frustrated.
I was supposed to be the good patient, who arrives, receives his
recommendations, agrees to everything and lets him move on to the
next case, delivering the same impersonal medical jargon.
Well, how could he successfully treat me if he doesn't know me
or take the time to understand my fears and my day-to-day struggles?
If you don't listen to me, I can't actually believe that you care
about me and my health. For him, all the answers were on his computer
screen. So, I left feeling physically and emotionally drained.
Now, my fears were really heightened and validated. Still, I knew
that I would have to begin treatment, soon. My recent history in
Atlanta convinced me the time had come.
* * *
The year 2004 has been horrific for me. I started out comfortably
residing in Atlanta, working for MCI, when my life and my health
took a sudden turn for the worse. I lost my job and weeks later
I became homeless. As my fall from grace continued, I soon lost
all my possessions. I began frequenting soup kitchens, various
churches and homeless agencies in order to receive food, clothes,
and medical attention. In no time, I went from "living well" to
sleeping in a shelter with drug addicts, criminals, and many health
risks. I thought for sure, God had left my side or was playing
some type of trick on me. But, when I thought my life had sunk
to its lowest, it got worse.
My health deteriorated. Before this awful year, I had never had
an opportunistic infection; I had hardly been sick at all. First,
I came down with shingles (a disorder in which a rash of small
blisters develops on the skin, caused by varicella-zoster virus,
the same virus that causes chicken pox. The rash of blisters, usually
confined to one side of the body, erupts when dormant virus particles
reproduce in the nerves supplying the skin). I looked horrible.
My left eye was almost completely shut and I had blisters all over
that side of my face. The slightest pressure caused my head to
begin burning. The pain would be so great, I would fall to the
ground in excruciating pain as my spine and neck tensed up.
To make matters worse, I had no insurance and no moral or emotional
support. For several weeks I had to walk a mile to receive medical
attention with my eye and the left side of my face covered to hide
the lesions. For treatment, I was given pain pills and sleeping
pills. Yet I could not rest and recover at the shelter where I
was staying. They could only offer me a hard chair in the waiting
room, since their policy did not allow the comfort of bed rest
during the day.
A couple of weeks later, I came down with my second opportunistic
infection. While enduring the hot and humid weather of Atlanta,
I became dehydrated. In seeking air conditioning, I somehow came
down with pneumonia. I walked around for days dehydrated and feverish;
my body felt like a wilting piece of lettuce. I thought my HIV
had finally caught up with me. I thought I was going to die in
that shelter. At the worst point, I could feel myself passing out,
but then my will to live kicked in as I began to pray to my higher
power, and through God's grace, I made it through the evening.
The next day I was off to the hospital.
I was immediately admitted to the emergency room. I was terrified
as I was put in isolation, feeling like a leper. I couldn't believe
my fate. One moment I was a healthy, muscular jock and now I was
this sickly individual lying in a hospital bed with HIV. I could
no longer escape the fact that I contracted a disease that could
kill me, especially without medication. I knew then that I had
put off what I could no longer ignore. It was time. So, I immediately
made plans to leave Atlanta and head to New York, where I felt
I had a fighting chance.
When I arrived in New York I was directed to the clinic I now
attend. There was a delay at first; I left so suddenly I didn't
have my CD4 and viral load numbers with me, and so we had to wait
for them to arrive. But when I saw my recent blood work, I felt
the same inescapable conclusion; it was time to begin treatment.
And that's how I ended up in an exam room with the doctor peering
into his computer screen and telling me to take three pills during
the day and two during the night.
So, why am I so apprehensive about beginning my regimen? Well,
it's a life changing, disciplined practice I must follow for the
rest of my days. And if I don't get it right or fall off or stop,
then I will lessen my chances of survival. This is scary for me;
ultimately, I realize I have no choice. It's treatment or death.
Its nausea and morning sickness or death. Its tingly and numb sensations
in my foot or death. It's taking medication regularly and at the
scheduled time or death. Though, there are so many choices and
treatments today, ultimately I have only one. My CD4 count is below
300 and my viral load count has climbed from 150,000 to over 500,000.
It's time.
But now that I have decided to begin treatment, I need for my
doctor to realize that I'm not overwhelmed with joy and anticipation.
I don't hunger to be reminded of my HIV status on a daily basis,
no matter how many or how few pills I have to take. One is way
too many.
So, here we are: me and my new doctor; my ambivalence and his
indifference. I don't want to be ignored and taken for granted
again just as I'm sure he wants a compliant patient who is ready
to further his life expectancy and improve his health. How can
we meet each other halfway or get on the same page? I suggest we
talk. I have to believe that good treatment must begin with knowledge
of your patient. Not his physical health history only, but also
his emotional state. This lets your patient know that you care
and that you respect his will to live, and not simply his benefit/insurance
card that helps supplement your income.
So, trust is necessary for a good doctor/patient relationship,
along with honest and open communication, as well as education
about the different treatments and medicines available. So, on
my next appointment, after seeing the resident adherence counselor,
I will hopefully be ready to begin my lifetime/lifesaving regimen.
But, will my doctor ask me anything personal? Will he ask me how
I'm feeling today? Will he begin to take the time to know me? Will
he realize my life may lie in his judgment?
Or will he ask me nothing; make his pronouncements, then abruptly
leave the room with a cold and final, "Goodbye." Will he even realize
his empathy and emotional support may be the medicine I really
need? I have come so far and I know that I still have a long way
to go. I just wonder if this doctor will make the time to take
this journey with me. But, if he can't, I will find one who will.
My Flu Shot Story
Rationing During Wartime
By Brian Varner
Well, I got it, but it took considerable effort on the part of
Mom, the Health Department and the staff of Kroger's to get the
job done.
The day began at 3:00 a.m.— not my favorite hour to crawl
out of bed. I hit the snooze button at least twice and at 3:30,
the phone rang.
It was Mom, calling to make sure I was up and ready to go to Kroger's
in Fountain City, Tennessee to get in line for a flu shot. I told
her I'd be ready to go by the time she got to my house. She hadn't
slept much the day before because, well, she was worrying about
one of her kids. At 41, I don't feel much like a kid anymore, but
at 71, mom still thinks of me as her "baby."
There was little traffic at 4:00 on Monday morning, but Mom punched
the accelerator at every light like a horse starting the Kentucky
Derby. She was determined to make good time and beat the crowd,
pushing her 16-year-old, four-cylinder Honda Accord to the limit.
As we turned in the parking lot, she sighed, "Just look at all
the cars!" I've been legally blind for 8 years, but Mom still forgets
that I can't see much — especially at 4:00 in the morning.
That's okay; sometimes I forget that she's been deaf in one ear
since birth and is becoming hard of hearing in the other.
I was number 56 in line, according to the number on the chair
I took. Mom took number 57. The chairs were lined up facing each
other along an aisle where the "feminine products" and Depend undergarments
were neatly stacked. Once seated, we engaged in small talk with
the folks around us, most of whom qualified for their own numbered
chair by virtue of being at least 65 years old.
Soon, the stories began to circulate — stories of family
members and friends, local politics, life in retirement homes,
and stories of others going through the ordeal of obtaining, or
in some cases, being denied this season's scarce flu shot. I knew
how long Mom had waited in line to get her flu shot the previous
week, but we didn't want to bring that up for fear that someone
would ask her to give up her seat. If that happened, I'd need to
depend on the kindness of others to help me navigate the line and
fill out the paperwork. I didn't want to ask a stranger to check
the box that indicated my need for a flu shot: "weakened immune
system." That one always raises an eyebrow.
As the hours passed, I began reflecting on the experience as a
classic dilemma in medical ethics. After all, this was an exercise
in allocating scarce medical resources, an issue I had written
about in grad school.
As a person with AIDS, access to health care is a big issue for
me. Before I contracted HIV in the '90s, I remember hearing about
activists in the '80s demonstrating for early access to AZT in
the streets of New York, Atlanta and San Francisco, so that they
and other people with HIV might live a few short months or years
longer. I have often thought of those early AIDS activists as soldiers
who took the first and worst casualties in the war for access to
HIV health care — and how I likely owed my life to them. Now
that I've joined their ranks, I have a better appreciation for
their sacrifices and how hard they worked to knock down the social,
cultural and economic barriers that stood in their way. I also
have a greater appreciation for how much work still needs to be
done.
As I sat sipping coffee among these people roughly twice my age,
I listened to their own struggles with health and health care.
The man next to me was diabetic. A lady across from me had palsy.
Several people down the line had heavy coughs. The man next to
mom complained of severe neuropathy down his right side. He was
a tall, fit, 75-year-old, who, up until last month, had worked
out every day, doing bench presses and arm curls with heavier weights
than I ever lifted when I was a young, healthy, weight-lifting,
ball-playing jock. He had stopped lifting after his doctor told
him that such strenuous workouts could make his neuropathy worse.
I had read a lot about neuropathy, so I talked to him about how
the nerve cells are covered in a fatty, insulating sheath, much
like electrical wires are coated with plastic or rubber. In neuropathy,
when this protective coating is damaged, our nerves "short-circuit" and
cause us to feel sensations like bee stings or needle sticks. He'd
been suffering from this considerably.
As we talked, I mentioned how this flu shot experience brought
up the ethical issues of allocating scarce medical resources that
I had studied. I outlined the various systems used to administer
rationing, such as the principle of medical necessity, the "lottery
method," and "first-come-first-served." Waiting in a series of
numbered chairs seemed to fit the latter model. He also figured
that anyone who could afford to plunk down $500 would likely have
no trouble obtaining a shot. No doubt.
Then he told me about his son — a disabled Vietnam veteran — who
had recently waited in a long line for a flu shot but was turned
down because he wasn't elderly and didn't "fit" any of the other
acceptable risk categories — like having a weakened immune
system.
I was speechless for a moment. No longer proud of what I knew
about medical ethics or neuropathy, I was shocked to hear that
such basic medical care had been denied to a disabled veteran.
I said, "That's a crying shame."
His story reminded me of another, often theoretical, criterion
for allocating scarce medical resources — moral worth. While
a person's demonstrated moral worth is often discussed as a possible
criterion to consider in divvying up limited resources, it's generally
thrown out of the mix as ethically problematic: How do we determine
a person's moral worth? By how hard they work? By how much they
contribute to charity? By how often they attend church? Okay, but
if these criteria are used, only those able to work hard, give
to charity, or frequent churches would be able to access needed
health care, leaving the poor and infirmed and incarcerated out
of the running. Where's the justice?
Mom got up to get more coffee and pastry. She returned with two
half-filled cups of coffee, and one sweet roll, cut in two. She
said they were rationing the refreshments to make sure there was
enough to go around.
I was reminded of the '70s, a decade I can remember, when gas
was rationed. I was reminded of World War II, a time I never knew,
when the whole country was forced to ration coffee, gas, and other
staples for the war effort. My grandmother's stories of the Great
Depression came to mind. I looked at Mom and asked, "Wasn't World
War II the last time we had to ration goods in this country?" She
laughed.
After waiting nearly five hours in line, I finally made it to
the nurses who were taking forms and deciding who would and wouldn't
get their flu shot. One nurse noted my white cane and guided me
to the folding chair next to her table. She asked me if I had been
blind since birth. I informed her that I had only been blind since
1996. She said, "Okay," and continued examining my form. I realized
she didn't have all the information as she needed to make a decision,
so I leaned closer to her. In a low voice, I explained that my
loss of sight was due to CMV retinitis related to HIV. She immediately
put down the form. She asked me if I was feeling okay today. I
said "Yes." She asked me if I was allergic to eggs. I said, "No." She
asked me if I had ever gotten a flu shot before. I said, "Yes." She
swabbed my arm, administered the shot and stuck on a band-aid.
Why did I feel guilty after I got my shot? Maybe it was because
I hadn't always worked hard, or contributed to charity, or gone
to church, like many of those around me had. Maybe it was because
I had never served in the armed forces. Maybe it was because I
saw a woman, about my age, with no apparent medical condition putting
her into a "high-risk category," get turned away just before I
stepped up for my shot.
* * *
Today, I heard that 20 million more flu shots are going to be
made available. Health Secretary Tommy Thompson is telling senior
citizens not to wait in lines anymore, but instead, to ask their
doctors for the shot, when it gets here, from Canada, in a month
or two, or three.
I wish I knew how many "people years" of experience were in the
line yesterday at the Kroger's in Fountain City, and I wish I could
take all that wisdom and transplant it into the minds of our leaders
so they'd think and act in a more proactive and responsible way.
Nevertheless, I want to thank all the Health Department workers
and the folks at Kroger's who have been getting up in the wee hours
of the morning to help ensure access to basic health care — for
those who "qualify." I also want to thank all the healthy people
who are giving up their shot for not-so-healthy folks, like me,
and I offer them my hope for a mild flu season.
And, last, but not least, thanks to Mom, who, by the way, gave
her place in line to a lady in a wheelchair.
TB/HIV Advocates Demand
Political Commitment
By Olayide Akanni, Nigeria-AIDS eForum Correspondent
Treatment advocates from across the globe have challenged national
governments and multi-lateral agencies to demonstrate greater political
will and commitment in their response to the dual epidemics of
tuberculosis (TB) and HIV.
The advocates warned that the apathy demonstrated in the addressing
the TB epidemic could grossly undermine efforts to address HIV,
as both are inextricably linked.
They also identified poor funding of TB programs, slow pace of
operational research into newer drugs and diagnostics for TB management
and poor standard of care for clients with TB and HIV as key issues
which national governments must prioritize, if the global TB/HIV
burden is to be reduced.
Over 40 advocates from 32 countries issued the call on October
29, 2004 at the end of the 3rd International TB/HIV Community Mobilization
Workshop, held in Paris, France.
Designed to update participant's knowledge on recent developments
in TB and HIV research, the workshop provided an avenue for sharing
of country experiences, defining the advocacy agenda and planning
of appropriate advocacy strategies to strengthen AIDS and TB control
programs in their respective countries.
The workshop also provided a platform for treatment advocates
to participate in the Working Group meetings of the STOP-TB Partnership
of the World Health Organization (WHO), 35th International Union
Against Tuberculosis and Lung Disease (IUATLD) World Conference,
held from October 28 to November 1, where they voiced several concerns
about the inadequate involvement of people living with HIV/TB (PLWH/TB)
in policy making decisions affecting their lives.
Two diseases in one patient
"TB is the main killer of people living with HIV (PLWH). The diagnosis of TB
has not changed in the last 100 years and management of the disease is not patient
centered," said Lillian Mworeko of the National Forum of PLWH Networks in Uganda.
Dr. Lydia Mungherera of The AIDS Support Organization (TASO) Uganda,
observed that although political commitment is a key element of
the World Health Organization's strategy for controlling TB, this
is still often times non-existent in many countries.
"Many TB patients still can not receive the quality treatment
and care they need. If 70 percent of PLWH who are worst hit with
TB cannot get treatment, then how do governments expect to provide
antiretroviral drugs," she queried.
But Ezio Santos Filho of Gruppo Pela Vidda, a PLWH based group
in Brazil cautioned that making treatment available alone without
advocacy for the implementation of TB/HIV collaborative policies
would not address the dual TB/HIV epidemics effectively.
He observed that despite Brazil's leading role in the manufacture
of generic antiretroviral drugs and the existence of a free TB
treatment policy, the lack of political will and a poor policy
implementation process continue to make TB a major health problem
in Brazil.
Mohammed Farouk Auwalu of the AIDS Alliance, a PLWH support group
in Nigeria, also stressed the need for the emergence of a strong
civil society movement, which would hold national governments accountable
to commitments made.
"In April 2001, African Leaders at the Abuja Summit committed
to spending 15 percent of their annual budget on health and particularly
to addressing TB, HIV and Malaria. Our leaders need to show us
their score card of how they have fared with respect to this commitment," he
said.
Participants noted that the huge amounts of money spent by developing
countries on debt service, coupled with the strict macro-economic
policies of the World Bank and the International Monetary Fund
(IMF) places a major limitation on the health sector's inability
in these countries to secure qualified manpower and personnel to
adequately respond to TB, which is a disease of the poor.
Several regional and global advocacy strategies were proposed
by participants at the end of the various break-out meetings held
during the four-day workshop.
These advocacy strategies aim at strengthening TB/HIV collaborative
activities within countries, advocating for the adoption and implementation
of the WHO interim Collaborative TB/HIV Policy at country levels
as well as advancing operational research into newer drugs and
diagnostics for TB.
Email: olayide@nigeria-aids.org
Drug News
By Bob Huff
There is a growing need for new anti-HIV medications for people
who have developed resistance to available drugs in every class
of therapy and are no longer able to construct a suppressive regimen.
These so-called salvage patients are part of an expanding population
who, whether because of improper prescribing, inadequate pharmacokinetics,
or poor adherence, find themselves chronically awaiting the next
ARV to enter the marketplace. It is now understood that simply
adding the latest drug down the pipeline to a failing regimen — a
practice called serial monotherapy — will quickly result in
resistance to the newcomer as well, and that unless at least two
new active ARV agents are added to a salvage regimen, the chain
of virologic failure due to resistance can not be broken.
The next investigational HIV agent likely to hit this treadmill
is a protease inhibitor (PI) called tipranavir. The drug has been
specifically developed by its sponsor, Boehringer-Ingelheim, to
address the urgent need for new agents in salvage therapy for people
with limited treatment options due to multi-drug resistance. Tipranavir
is active against many strains of HIV that have developed resistance
to currently available PIs. At the 44th annual ICAAC meeting in
Washington, DC, in October 2004, Charles Hicks, of Duke University,
reported on a planned, 24 week, interim analysis of a phase III
clinical trial of tipranavir, dubbed RESIST-1. The trial enrolled
620 patients in the U.S., Canada and Australia.
In the randomized RESIST-1 study, tipranavir was added to a physician-selected,
standard-of-care regimen that was prescribed for all participants
at entry. At 24 weeks, regimens that added tipranavir outperformed
the comparator regimens, producing a treatment response (defined
as a > 1.0 log drop in HIV RNA) in 41.5% of patients, compared
to an equivalent response in 22.3% of those who did not add tipranavir
to their "best available" regimens (p < 0.0001). Viral load was
suppressed below 400 copies/mL in 34.7% of those receiving tipranavir
versus 16.5% of patients in the comparator arm (p<0.001) and
fell below 50 copies/mL in 25.1% and 10.0% of patients in these
respective groups (p<0.001). The median viral load drop was
-0.88 log copies/mL in the tipranavir arm compared to -0.26 log
copies/mL in the control group (p<0.001). Changes in CD4 cell
counts at 24 weeks were modest, with a median rise of 36 cell/mm3
experienced by those receiving tipranavir versus an added 6 cells/mm3
by those in the comparison arm (p<0.001).
The RESIST-1 patients had been exposed to drugs from three classes
of HIV therapy and had taken a median of 4 prior PIs, 2 prior NNRTIs
and 6 prior NRTIs. Participants had to have been failing their
latest regimen with viral load in excess of 1,000 copies for at
least 1 month. There was no restriction on CD4 count for entry
into RESIST. The study offered expert analysis of baseline genotype
data to help physicians construct a best possible regimen, although
it is not clear how many treating clinicians took advantage of
this assistance. Lopinavir was selected as a PI component of the
standard-of-care regimens in 61% of the patients; saquinavir was
used in 20.6% of regimens; and amprenavir in 14%. The injectable
fusion inhibitor, enfuvirtide, was used in 36.1% of the regimens.
Due to popular demand, Dr. Hicks revealed one bit of data about
the role that enfuvirtide may have played in contributing to treatment
success in this trial. In those who added enfuvirtide to tipranavir,
47.1% had viral load suppressed to <400 copies/mL compared
to 34.7% in the overall tipranavir group.
Grade 3 or 4 adverse events were more common on the tipranavir
arm, mainly due to increased rates of nausea, and there were more
discontinuations due to adverse events than in the comparator arm.
Grade 3 or 4 elevations of ALT were 3 times more frequent on the
tipranavir arm than the comparator regimen (6.9% vs. 1.3%) although
ALT and AST elevations were reported as asymptomatic and not resulting
in discontinuations. The incidence of elevated cholesterol (4.2%
vs. 0) and triglycerides (21.0% vs. 12.5%) were also significantly
more common in those receiving tipranavir.
At the 7th International Congress on Drug Therapy in HIV Infection,
held in Glasgow in November 2004, preliminary 24-week results were
presented from a sister study to RESIST-1. RESIST-2 was conducted
in 863 subjects in Europe and Latin America. Not surprisingly,
its results served to reinforce the findings reported in RESIST-1.
In RESIST-2, adding tipranavir produced a >1.0 log drop in HIV
RNA in 41.0% of subjects compared to only 14.9% of those in the
comparator arm (p<0.001). Viral load was suppressed below 400
copies/mL in 33.6% of those receiving tipranavir versus 13.1% of
patients in the comparator arm (p<0.0001) and fell below 50
copies/mL in 22.5% and 8.6% of patients in these respective groups
(p<0.0001). The median viral load drop was -0.72 log copies/mL
in the tipranavir arm compared to -0.22 log copies/mL in the control
group (p<0.001). Changes in CD4 cell count in RESIST-2 were
also similar to the modest changes seen in RESIST-1. The impact
of using enfuvirtide in combination with tipranavir in this study
was less impressive than in RESIST-1, with only 38.5% of subjects
who used the two drugs together achieving viral load suppression
below 400 copies.
As in RESIST-1, patients receiving tipranavir in RESIST-2 had
significantly greater incidence of grade 3 or 4 laboratory abnormalities
than those receiving the comparator regimens; these included ALT
(5.2% vs. 2.2%), cholesterol (2.5% vs. 0.5%) and triglycerides
(20.1% vs. 10.2%).
The sponsor had previously reported serious drug-drug interactions
between tipranavir and other protease inhibitors, which will likely
make using this drug as part of a dual boosted PI strategy quite
tricky. BI says it plans to deliver a comprehensive analysis of
the best way to use — and not use — tipranavir in salvage
therapy at the next annual Retrovirus Conference in February 2005.
An expanded access program is slated to begin soon, although limitations
on using other investigational drugs while receiving tipranavir
may mean in effect that, if adding enfuvirtide is not an option,
then many individuals may have no second active drug to add to
their salvage regimen, thus perpetuating serial monotherapy and
the attendant risks of new resistance. If all goes well, FDA approval
could come as soon as mid-Spring 2005. Due to the likely complexity
of using this drug in very advanced patients with few options,
the FDA is urged to convene an advisory committee meeting to discuss
tipranavir and air these issues before approval.
Po-drug
Gilead Sciences announced in October 2004 that it was abandoning
the development of its protease inhibitor (PI) candidate, GS
9005 due to lack of bioavailability. While the drug itself was
not revolutionary — it offered a resistance profile similar
to that of tipranavir — it was meant to serve as the payload
for Gilead's novel prodrug technology that specifically targets
drug molecules to lymphocytes — the cells that HIV prefers
to infect. The idea is that when the prodrug complex (comprised
of the targeting molecule joined to the drug molecule) enters
a lymphocyte, it is cleaved by a host enzyme specific to those
cells, which releases and activates the drug precisely where
it can do the most good. Meanwhile, other types of cells are
spared from any collateral toxicity. At least that is the idea.
Gilead proved the concept with a prodrug version of tenofovir,
but looked to protease inhibitors as the therapeutic class that
could most benefit from the reduction in toxicity and boost in
effective concentration expected with more precise targeting. Unfortunately,
the PI molecule they selected turned out to be too large to efficiently
make it past the gut and into the bloodstream. In a proof-of-concept
study of GS 9005 in people with HIV, no significant viral load
reduction was seen. Although a similar study of GS 7340, a Viread
version of the prodrug, was successful, the company thinks there
is little to be gained by tweaking tenofovir. The search is on
now for a PI candidate better suited for this novel approach. The
disappointing outcome of this agent demonstrates why many companies
are reluctant to talk about drug candidates before they have proved
themselves in people. But as community treatment advocates have
become more sophisticated about the drug development process, we
have learned to season our optimism with the salt of caution.
Cautious Combo
It increasingly appears that there is something not quite right
about combining ddI and tenofovir. However, exactly what that
is, isn't clear. It's been known for some time that tenofovir
can raise blood levels of ddI, which (unless managed with ddI
dose reduction) can cause characteristic ddI toxicities. Recently,
some small studies have identified early virologic failure in
patients taking the drugs together. One theory for this is that
tenofovir may cause inadequate metabolism of ddI, possibly by
inhibiting PNP, an obscure enzyme in the gut that metabolizes
ddI, thereby eliminating one active drug and allowing viral failure.
Still other groups have recently reported that HIV-infected patients
combining ddI with tenofovir may experience a paradoxical decline
in CD4+ T cell count despite achieving complete viral suppression.
This interpretation, reported by Vincent Soriano, from Hospital
Carlos III, in Madrid, and presented at the 44th ICAAC in Washington
DC, found that T cell loss began to be evident by about 6 months
on the combination and increased over time. The paradoxical T
cell loss continued for some patients despite initiating or switching
to a lower dose of ddI.
The investigators conducted a chart review of 570 patients who
had initiated a PI-sparing regimen between September 2002 and June
2003 and who had maintained viral load below 400 copies/mL for
at least a year. Changes in CD4+ cell counts were analyzed by treatment
experience status and by whether the third drug in the regimen
was an NNRTI or another nucleoside. The impact of ddI and tenofovir
when used separately was also evaluated.
Dose reduction of ddI from 400mg per day to 250mg per day has
been recommended when used in combination with tenofovir due to
a drug-drug interaction that raises ddI levels and has been observed
to produce characteristic ddI toxicity. Yet the drug combination
remains attractive because both agents are regarded as potent antiretrovirals
with a high genetic barrier to resistance and offer convenient
once daily dosing.
By 12 months of ddI/tenofovir therapy, CD4+ cell declines greater
than 50 cells/mm3 had occurred in 78 of 175 (45%) treatment experienced
patients who were also taking an NNRTI. About a third of this group
had CD4+ cell counts reduced by over 100, and 14% had losses greater
than 200 cells/mm3. Patients on their first NNRTI-containing regimen
fared better; 20% lost at least 50 cells and none lost as many
as 200. Yet the CD4 loss was dramatically worse for patients employing
a third nucleoside in their regimens: 91% of treatment experienced
patients on triple NRTIs that included ddI and tenofovir had CD4
losses in excess of 100 and 64% lost more than 200 cells/mm3. No
treatment naïve patients received a triple nucleoside/nucleotide
combination.
With regard to ddI dose, 38% of treatment experienced patients
on a NNRTI-containing regimen who received a lower dose of ddI,
experienced CD4 cell loss greater than 50 cells/mm3. However, this
proportion is not dramatically different from the equivalent degree
of CD4 cell loss observed in 30% of treatment experienced patients
on an NNRTI who did not combine ddI with tenofovir. Nevertheless,
of the 8 patients who experienced a change in absolute CD4 count
from over 350 cells/mm3 to below 200, 2 had received a lower dose
of ddI, which suggests caution in using this combination, particularly
in patients with extensive treatment experience and low baseline
CD4 counts.
However, several prominent researchers are said to have doubts
about the existence of a paradoxical loss of T-cells despite viral
suppression. Indeed, two studies presented at the Glasgow meeting
found fault with the ddI/tenofovir combo for not adequately suppressing
viral load. Based on these two studies, Bristol-Myers Squibb issued
a Dear Doctor letter warning not to use ddI EC tablets in combination
with tenofovir and either nevirapine or efavirenz. This situation
is rife with contradictions. Until someone can definitively explain
what is going on with these drugs, the prudent thing may be to
consult a specialist HIV physician before starting or continuing
this combo.
References
Hicks C, et al. RESIST-1: A Phase 3 randomized, controlled, open-label
multicenter trial comparing tipranavir/ritonavir (TPV/r) to
an optimized comparator protease inhibitor/r (CPI/r) regimen
in antiretroviral (ARV) experienced patients: 24-week data,
44th Interscience Conference on Antimicrobial Agents and Chemotherapy;
October 31 – November 2, 2004, Washington, D.C. Abstract
H-3726
Cahn P, et al. 24-week data from RESIST-2: Phase 3 study of
the efficacy and safety of either tipranavir/ritonavir (TPV/r)
or an optimized ritonavir (RTV)-boosted standard-of-care (SOC)
comparator PI (CPI) in a large randomized multicenter trial in
treatment-experienced HIV+ patients, 7th International Congress
on Drug Therapy in HIV Infection; November 14 – 18, 2004,
Glasgow, U.K. Abstract: PL 14.3
Barrios A, Negredo E, Rendon A, et al. Paradoxical CD4+ T-cell
decline in patients with complete virus suppression under tenofovir
plus didanosine combinations. Program and abstracts of the 44th
Annual ICAAC Meeting; October 30 – November 2, 2004; Washington,
DC. Abstract H-1132
One Size Does Not Fit All
The TB drug rifampicin is known to lower blood levels of
efavirenz. So there is an open question about the proper
dose of efavirenz in people who are being treated for TB.
A study in Thailand looked at this question by randomizing
70 patients taking rifampicin at least once a month to receive
an HIV regimen containing efavirenz at either 600mg or 800mg
per day. Blood levels of efavirenz were measured on day 14
and viral load and CD4 counts were measured through week
48. Another important factor to consider is that, on average,
the Thai patients in this study weighed about 110 pounds
(50kg), which is much less than the mean body weight of the
people in which the original dosing studies for efavirenz
were done. So there are two competing factors at work that
could affect concentrations of efavirenz: rifampicin could
be lowering blood levels of EFV, but in these Thai patients,
EFV blood levels might be relatively high to begin with.
The study reported very little difference between 600mg
and 800mg of EFV daily, either in blood levels at day 14
or in virological response. Adverse events were also equivalent
between the arms. The authors suggest that EFV 600mg may
be suitable for patients with bodyweight around 50kg.
References
Manosuthi W et al. A randomized controlled trial of efavirenz
600 mg/day versus 800 mg/day in HIV-infected patients
with tuberculosis to study plasma efavirenz level, virological
and immunological outcomes: A preliminary result. Fifteenth
International AIDS Conference, Bangkok, abstract MoOrB1013,
2004.
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Why I Will Continue to Fight
By Mark Milano
As I watched the election returns, I felt a profound sense of
despair and hopelessness. If the accusations of voter fraud were
not true, the American people had chosen to re-elect one of the
worst administrations in history, in spite of the debacle of the
last four years. How could this have happened? What were they thinking?
And then I saw the exit polls: people cited "moral values" as
one of the top reasons they voted for Bush. Even those who felt
that the war in Iraq was wrong and that Bush had hurt the economy
still voted for him because of his "strong moral beliefs."
At first I thought about leaving the country or giving up on activism
altogether. But then I realized that this election was a wake-up
call.
Battle lines had been drawn. Those of us who think that government
(indeed, people in general) should make decisions based on reason
and enlightenment were beaten by those who think decisions should
be based on religion — specifically, fundamentalist religion.
But it goes beyond this election. I feel that fundamentalist belief
systems are inherently damaging to the individual and to society.
I know this because I once was a born-again Christian (I even prayed
in tongues). I know that when you adhere to a rigid set of beliefs
that allows for no questioning or individual thought, things become "clear" in
dangerous ways. It's one of the reasons Islamic fundamentalists
have been able to recruit terrorists to do the horrible things
they've done. And make no mistake — fundamentalists in America
are enacting their own form of terrorism, albeit without physical
violence.
We've all watched the fundamentalist movement grow in America.
We've seen creationism returning to schools; efforts to replace
sex education with "abstinence only" programs that falsely claim
condoms don't work; efforts to censor textbooks and TV shows; Halloween "Hell
Houses" that use high-tech theater to scare teens into thinking
that everyone who is gay will die of AIDS and go to hell; the list
goes on and on.
A 1997 poll found that 43 percent of Americans who believe in
heaven also believe there are harps there! The possibility that
those people are taking over our country is frightening. If this
movement continues to snowball, it could throw us back into another
Dark Ages. The Age of Reason could be coming to an end, replaced
by an Age of "Faith" — rigid, uncompromising, intolerant faith
that leaves no room for debate or discussion.
Those of us who believe in freedom of thought and empowerment
must accept that this is war. The radical right has known it for
years and has even said as much. But we've been too timid to call
it that, for fear of sounding elitist and trampling on people's
right to their beliefs.
But I'm saying it now: fundamentalism, whether Christian, Jewish
or Muslim, is dangerous and wrongheaded. It prevents people from
doing what we are all here to do: to learn, to grow, to become
more enlightened. It blocks the flow of information to people who
need it — and AIDS activists know that the main weapon in
our battle has always been education and self-empowerment.
So from this day forward, I dedicate myself to fighting any belief
system that prevents the human race from moving forward. Anything
less, and we risk a return to the time when superstition and magic
prevailed over science and reasoning.
Let me be clear: I am not advocating a war on organized religion
or spiritual beliefs. This is a call to stop the kind of fundamentalism
that reduces people to sins rather than seeing them as human beings.
It is a non-violent call to arms against the kind of "moralism" that
used the bible to support slavery and the oppression of women.
It is not, I repeat, an attack on religion in general.
Where do we start? Well, we have one weapon in our arsenal: the
truth.
Many people who voted for Bush didn't know the facts: 70 percent
thought there was "clear evidence" that Saddam Hussein worked closely
with Al Qaeda; a third thought that WMDs had been found in Iraq.
We know how ignorance has harmed people with HIV; now we're seeing
how it can harm our country. Let's fight back with the facts on
every issue.
I'm sure others have more ideas. So let s start the discussion — maybe
we can turn this increasingly "faith-based" country back into a
reality-based one.
Email: marknyc@email.com
© 2004 Gay Men's Health Crisis
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