1991 marks the beginning of the second decade of the HIV epidemic and its related illnesses. Every sector of society is called upon to intensify its efforts in the areas of education, advocacy, and direct service. There is no room for complacency. In the United States alone, one person dies every eleven minutes from the complications of AIDS. Others who are ill are cared for in health facilities or at home. Homeless persons with HIV/AIDS and run-away youth fend for themselves and go without treatment, care or shelter. Tens of thousands of persons will be diagnosed with AIDS this year and many more will learn they have been infected with HIV. Family members and loved ones will begin the life-changing, soul wrenching process of learning to live with HIV infection and AIDS. Hopes for a cure and more effective and affordable therapeutic agents will intensify as the need for them grows greater.
The nation's learnings to date constitute important lessons for the future. The HIV epidemic will leave an indelible imprint on the social and medical histories written about this period. The following highlights some of the struggles and achievements of the past which are instructive regarding the challenges ahead.
Organization, Education and Determination
The HIV epidemic has given rise to highly motivated, high profile
AIDS advocacy groups and hundreds of thousands of self-
determined, self-educated consumers who have HIV infection and
related illnesses.
These individuals share a common fight for their lives and the
lives of those they love. They have become a social and
political force affecting every decision-making process,
structure and institution which has a role to play in the
HIV/AIDS crisis.
Allegiances between AIDS primary care physicians and those they
treat have fostered mutual dialogue and decision-making regarding
treatment regimes and case management. Former injection drug
users have challenged community attitudes and programs which have
denied drug treatment to persons with HIV infection. They have
gone to the streets to teach HIV prevention to drug users and
have recommended strategies to slow the spread of HIV infection.
Haitian organizations have protested government policies
restricting the donation of blood based on country of origin.
Persons with handicapping conditions, their advocate groups and
AIDS advocates worked for passage of the Americans with
Disabilities Act of 1990 which extends federal protection to
persons with HIV infection (including asymptomatic infection),
and a host of individuals and groups lobbied successfully to
change immigration policies regulating the entry of persons with
HIV/AIDS and homosexuals.
Individuals from the communities of color, gay men and lesbians,
women, parents of children with HIV/AIDS, and persons who have
been imprisoned have formed their own advocate groups and
networks to address critical issues regarding AIDS funding,
prevention education, access to experimental drugs, community-
based care, insurance, discrimination and other human rights
issues.
Denominational groups, interfaith organizations, and national and
world councils of churches have joined to provide education,
pastoral ministries and direct services. The determination of
secular and religious groups to work on the front line to address
the needs of individuals, communities and the nation has been
impressive.
Overall, however, those who are involved in sustained work to
address the realities and demands of the epidemic are a numerical
minority. A good many of the epidemic's finest leaders are
persons who themselves have AIDS or a related illness. Others
have grown tired and weary of the struggle. Others who have
cared for and buried their loved ones and colleagues find they
are unable to go on any longer.
Organizations at the community and state levels are struggling
for funds. Some foundations which have invested heavily in
prevention education and services are receiving pressure to move
on to fund other causes.
A major challenge of the decade of the 90's will be to motivate
additional individuals, community groups, churches, and direct
service providers to become involved and to stay involved.
Expanding Access to Drug Trials and Treatment
AIDS activists, persons with HIV/AIDS and their physicians have
challenged the cumbersome bureaucratic processes of the U.S.
Federal Drug Administration and, in some instances, have taken
matters into their own hands in an attempt to make therapeutic
agents available to ever larger numbers of persons. Some have
traveled to other countries in search of treatments; others have
turned to underground buyers' groups; while others have organized
to make drug research and approval processes more responsive to
current needs. One of these most notable groups, ACT-UP, has
successfully challenged the slow, laborious drug research and
approval process and laid the groundwork for expanded access to
drug trials and investigational new drugs.
Through the protestations of ACT-UP and others, expanded access
advocates are addressing the dual concerns of: 1) access to a
variety of trials with more flexible protocols, as well as 2)
access for those who have been notably absent from drug trials to
date.
The American Foundation for AIDS Research reports in its Fall
1990 Report that 45 Community-Based Clinical Trial (CBCT) Centers
are conducting more than 20 clinical trials with many more trials
about to begin.
"CBCT's involve community-based physicians and their patients in
the design and conduct of clinical trials. They accelerate the
pace of AIDS clinical research, while providing access to
populations traditionally under represented in AIDS clinical
trials--including women, children, African Americans, Latinos, IV
drug users and gay men living in smaller cities." (AmFAR Report,
Fall 1990, p. 1.)
Early Intervention and Treatment
Over the past two years there has been a pronounced recognition
of the importance of early detection and treatment of HIV
infection in order to delay, and perhaps even prevent, the onset
of opportunistic infections and cancers, as well as to decrease
the severity of these complications should they occur.
Advocates of early intervention and treatment are aware of a
number of immediate and long-range concerns. Anonymous HIV
testing sites are not readily accessible to many people who would
like to use them and who will not seek testing otherwise.
AIDS primary care specialists are nonexistent in some areas and
some, when found, will not accept persons on Medicaid. Though
early intervention treatment is one reason for recommending HIV
testing, many persons who test positive and who might qualify for
drug trials will find themselves excluded because of the distance
they live from a study center.
Living close to a trial site, on the other hand, is no guarantee
of acceptance if one does not meet the inclusion criteria. In
addition, insurance and Medicare and Medicaid coverage for drug
therapies differ from state to state. Persons who receive
experimental drugs free through clinical trials, treatment IND
protocols, compassionate use programs, and community research
initiatives might find they are unable to pay for these drugs
after the research period is completed.
Managing Chronic Degenerative Illnesses in Large Numbers of
Children, Youth and Middle Age Persons
With increased intervention and treatment of HIV infection in its
earliest stages and with the development of more effective, less
toxic, long term therapeutic drugs and drug combinations for
persons already diagnosed with clinical AIDS, expectations are
high that persons with HIV-related illnesses will live longer and
better. Of equal importance, the duration and severity of acute
illnesses will become more manageable and affordable.
Short of a cure being perfected and readily available during the
next ten years, AIDS primary care physicians, community-based
organizations, family members and in home care providers will be
challenged with the longer term management of chronic illnesses
and conditions (including central nervous system and neurological
impairment) among larger and larger numbers of children, youth
and middle age persons.
How and where care will be provided, by whom, and how it will be
funded and paid for are among the most critical questions facing
individuals, families, communities and the nation as a whole.
The Americans with Disabilities Act of 1990 provides invaluable
protection against discrimination for persons with HIV infection
in the public and private sectors. Translating ADA-90 into
practice will assure access to greatly needed services and
supports for persons with HIV-related illnesses.
Supporters of ADA-90 and AIDS advocates are well aware that
attitudes against persons with HIV infection might harden and
increase as the public and private sectors find themselves
compelled to work with, serve, employ, accommodate, and transport
persons whom they found reasons to ignore and avoid previously.
The Changing Demographics of HIV Infection and Related Illnesses
Much is being written about the changing demographics of the HIV
epidemic and the disproportionate burden of suffering being
experienced by the communities of color, injection drug users and
their sexual partners, high risk youth, women and children.
In every instance this disproportionate burden of suffering is
compounded by disproportionate burdens of discrimination which
are lethal with regard to HIV and AIDS.
In the December 1990 edition of Focus: A Guide to AIDS Research
and Counseling, a monthly publication of The AIDS Health Project,
affiliated with the U. Of California San Francisco, emphasizes
that "society has not adequately responded to the needs of women
with HIV disease. Women comprise 'only' 9 percent of frank AIDS
cases in the U. S. Four years ago, 'only' 4 percent of these
cases were among women. In fact, women proportionately represent
the fastest growing segment of people with AIDS in the U.S. This
increase has included women who have had sexual contact with
bisexual or intravenous (I.V.) drug using men, as well as women
who have been I.V. drug users themselves. At the same time,
women remain undereducated about HIV risks and their HIV antibody
status, and are vulnerable to misdiagnosis by medical
practitioners who remain ignorant of the clinical manifestations
of HIV disease in women which can include vaginal infections,
pelvic inflammatory disease (PID), and cervical dysplasia."
(Focus, Volume 6, Number 1, December 1990, p. 1.)
The Cost of Caring for Persons and Families with HIV/AIDS
The per patient and total costs of caring for persons with
HIV/AIDS can vary significantly. Care costs are affected by
factors which complicate care and necessitate extended use of
acute facilities, effective case management, and the existence of
community-based services and supports which assure effective
quality care both prior to and after the need for
hospitalization. Access to comprehensive HIV/AIDS primary care
and a personal primary care physician are critical with regard to
early intervention, treatment and disease management.
As more and more babies are born with HIV infection, HIV/AIDS
will be seen as impacting families as a whole. In the vast
majority of instances, HIV infection in an infant indicates that
the infant's mother is infected as might be the child's father
and some of the infant's siblings.
The reality of HIV infection in children speaks to the need for
family-wide services, community-wide HIV prevention education for
all age groups, and effective drug prevention treatment programs
which are sensitive to ethnic/racial and language group concerns
and which are designed to serve women and youth, as well as men.
Insurance coverage for pediatric HIV/AIDS varies from state to
state with a significant number of children and women having no
insurance or being dependent on Medicaid.
Having and maintaining adequate health insurance coverage is
essential to good care and treatment, to easier access to AIDS
primary care physicians and specialists, to the development of
comprehensive mutually agreed upon treatment plans, and greater
access to the latest developments in HIV research and care.
Without universal access health insurance many persons, including
those women and children who have the greatest needs, drug users,
persons who are poor, and those who are unemployed or
underinsured will be denied access to adequate care.
It is to be hoped that early intervention and treatment will have
a significant long-term impact on an individual's health status
and life quality. Whether health insurance plans and other
reimbursement programs will cover the cost of caring for HIV-
infected persons, including those who are asymptomatic, is
another matter. Care of this type has the potential to keep down
care cost over the long term, but too often falls under
categories of care which insurance plans and federal and state
sources will not cover.
The foregoing points are but a few of the learnings from the past
which provide lessons for the future if universal access health
insurance and health care are to meet the needs of the million
and a half persons who are estimated to be infected with HIV in
the United States and those hundreds of thousands who are
presently in need of care. Access to care, including early
intervention and treatment of HIV infection and related
illnesses, is a matter of self-determination and a human right
which ought never to be denied.
Information is provided below about findings from a placebo-
controlled study regarding the benefits of using low dose AZT
with persons with asymptomatic HIV infection.
Also included below is an outline of "Things For Institutional
And Direct Service Ministries To Keep In Mind In Response to the
HIV/AIDS Epidemic".
Share "Things . . . To Keep in Mind" with church-related
direct care service providers in your community.
STUDY FINDINGS ON USE OF LOW DOSE AZT FOR PERSONS WITH
ASYMPTOMATIC HIV INFECTION --- A Medical Update by Gabriel
Torres, MD
The following information is being reprinted with permission in
response to requests received in the HIV/AIDS Ministries Network
Office for information about the use of low dose AZT by persons
with asymptomatic HIV infection.
AZT has been recommended by the National Institutes of Health for
persons with asymptomatic HIV infection and fewer than 500 T4
cells, based on the results of a large placebo-controlled study.
That trial demonstrated a significant reduction in progression to
advanced ARC or AIDS in the group receiving AZT after a mean
follow-up time period of 55 weeks. The lowest dose used in the
study (500 mg per day or 100 mg capsule every four hours while
awake) produced rises in T4 cells and reduction in p24 antigen
levels similar to those achieved with high dose AZT (1500
mg/day), but with less toxicity. The only adverse side effect
experienced by the low dose group was nausea (3.3%).
Recently, a study comparing two doses of AZT (1200 mg/day vs. 600
mg/day) in patients with AIDS who have had one episode of
Pneumocystis carinii pneumonia (PCP) was published by Dr.
Margaret Fischl in the New England Journal of Medicine (NEJM),
showing that the low dose group had improved survival (63% versus
52%) after 18 months of follow-up. The 600 mg dose appeared as
effective as the higher dose, and was also associated with less
blood toxicity. No differences were observed in rates of
opportunistic infection development, or changes in T4 cell counts
or p24 antigen levels.
These studies have led to reduction of the dose of AZT from 1200
mg to 500 mg per day by most practitioners treating HIV-infected
patients. They have also spurred interest in studying still
lower doses (100-300 mg/day) to determine the least toxic dose
that produces optimal clinical benefits with the lowest risk of
resistance developing over long term use. Dr. Douglas Richman
from the University of San Diego showed with in vitro studies
that HIV strains isolated from patients on higher doses of AZT
are more likely to be resistant to the drug than those isolated
from patients on lower doses.
Lower doses of AZT in combination or alternating with related
drugs, such as ddI or ddC, are less likely to induce resistance,
thus allowing for a sustained inhibitory effect. A pilot study
comparing 300 mg, 600 mg and 1500 mg of AZT alone or in
combination with high dose acyclovir was published in NEJM in
October by Dr. Ann Collier of the University of Seattle,
demonstrating similar clinical, immunological and virologic
effects with the lowest dose as with higher doses. The study
involved patients with ARC who had T4 cell counts between 200 to
500 and detectable p24 antigen or positive HIV plasma cultures.
Patients assigned to the 300 mg AZT dose showed the greatest T4
cell count rise (from 321 to 421 after 12 weeks) and gained the
most weight. The addition of acyclovir was well tolerated but
did not enhance AZT's antiviral effects. This study has received
much attention and has led many physicians to reduce the dose
from 500 mg to 300 mg per day. It must be noted, however, that
the patient population studied was a very select group whose
initially high T4 cell counts and p24 antigen levels may not
compare to the patient population at large.
At the 10th AIDS Clinical Trials Group Meeting Dr. Richman
reported on a study comparing high and low doses of AZT and ddC
in combination that found the lower doses of both drugs less
effective in lowering p24 antigen levels than the high doses.
Effects on T4 cell counts or clinical events were not
significantly different. Also of concern has been the effect of
lower doses of AZT on HIV infection in the central nervous
system. One report from St. Mary's Hospital in London described
five cases of an acute encephalopathy (brain disorder)
characterized by headache, neck stiffness and confusion that
occurred after the dose of AZT was reduced from 1200 mg/day.
Three patients had a prior history of HIV-associated dementia
that had improved on high dose AZT. The "rebound" effect
associated with dose reduction was probably related to the
recurrence of HIV replication in the central nervous system.
Conclusion: Lower doses of AZT (300-600 mg/day) seem to be
effective in inhibiting HIV replication and boosting T4 cell
counts with significantly less toxicity than higher doses of the
drug. Conveniently for patients, the cost and number of capsules
taken would be reduced by half. Researchers and clinicians are
still uncertain, however, as to the optimal dose, especially in
relation toeffects on HIV in the central nervous system. Further
study of reduced dosages in imminent to resolve this issue with
such vast practical implications. (From The Volunteer:
Newsletter for Volunteers and Supporters, Jan/Feb 1991, Vol 8,
No. 1, p 6.)
Focus Paper readers should keep in mind The AIDS Clinical Trial
Information Service (a Public Health Service Project) which puts
callers in touch with health specialists regarding clinical
trials. Call: 1-800-TRIALS-A. Deaf and hearing impaired persons
using a telecommunications device for the deaf (TDD) may call: 1-
800-243-7012.
