                           Being Alive Newsletter
                                 April 1996


TABLE OF CONTENTS

     Getting and Using Protease Inhibitors: Problems and Questions
     by Walt Senterfitt

     Notes From The Director
     By Gary E. Costa

     Medical Update-March 18, 1996
     presented by Mark Katz MD and reported by Jim Stoecker

     Critical Information About Ritonavir and Indinavir
     a special alert from Project Inform

     Notes on Current Advances in Clinical HIV/AIDS Management
     by Robert S. Jenkins, MD, David Hardy, MD and Cyril Gaultier, MD

     AIDS Drug Assistance Programs (ADAPs)
     by Christopher Griffin

     After Eye Surgery: Life with a Ganciclovir Implant
     by Christopher Griffin

     Dead Doctors Don't Lie
     by Jennifer Jensen, MS, RD

     3rd Conferencia Anual sobre Retrovirus y Enfermedades Oportunistas
     Jim Stoecker-Traduccin y Adaptacin: Rubn Gamundi

     AIDS and the Law: Recent Developments
     by John Alan Cohan

     Commission on HIV Health Services
     by Christy Cowell

     Chiropractic and HIV

     Bits and Pieces
     by Fran Mcdonald

     AIDS Memorial Quilt Display in Washington D.C.

     People with PacifiCare-Update
     by Leonard E. Wojtyna



_____________________________________________________________
Getting and Using Protease Inhibitors: Problems and Questions
by Walt Senterfitt

As a service to our readers, we are printing the Special Alert from Project
Inform titled "Critical Information about the Availability and Use of
Indinavir (Crixivan) and Ritonavir (Norvir)" (see page 4). Though this
alert is not comprehensive, we believe its basic thrust is well-founded. It
gives information as to where to find further and future answers. My only
caveat is that Project Inform has always been strongly in favor of drug
treatment for HIV infection, providing advice and critical commentary about
the best possible drugs and combinations available. Those who tend to be
more skeptical or slow about initiating "state-of-the-art therapy" may well
want to add as many "grains of salt" as they find helpful, and balance or
supplement P.I.'s opinions with other sources.

To that end, let me contribute, for what they are worth, nine points I have
gleaned from other sources including Internet comments of smart people,
experiences of my friends and initial conversations with a few HIV
physicians. One valuable source is Jules Levin, of the National AIDS
Treatment Advocacy Project (NATAP) in New York City. Jules has devoted most
of the last two years to following protease inhibitor development very
closely, writing about it and acting as a community advocate with
government and industry sources. Being Alive and NATAP have organized a
major all-day forum in Los Angeles on protease inhibitors, which
unfortunately is due to occur a few days after we go to the printer. We
will bring you new information in forthcoming issues.

Protease Inhibitors are works in progress: be prepared for an uncomfortable
level of uncertainty. Critical information is lacking to make decisions
which many of us have to make anyway before complete data are available. If
you feel you need to act soon to incorporate these promising drugs in your
life, you will have unanswered questions and will have to take risks. Some
of these key uncertainties are amplified below. Those of us involved in
treatment advocacy must work with others to demand the focused research as
rapidly as possible, while continually putting forth the best of what we
know at a given point. Keep up with the evolution of our knowledge.

Beware of drug-drug interactions. The most urgent caution is not to combine
saquinavir (Invirase) and ritonavir (Norvir) on your own. In lab tests,
ritonavir was found to increase the blood level of saquinavir by 290 times
(29,000%)! This fact may prove to be very helpful in increasing the
problematic bioavailability of saquinavir, but right now taking both at the
recommended doses is dangerous. Critical Path AIDS Project reported last
week calls from four Philadelphia PWAs who were given this combination by
an insufficiently informed physician and developed serious and
life-threatening reactions.

Secondly, ritonavir has potentially adverse reactions with dozens of other
commonly-used drugs. These include Seldane, Hismanal, Rifampin, Halcion,
Valium, Tranxene, Xanax and Versed, and many more too numerous to list. The
package insert lists many of them, but not all are yet known. Abbott, the
manufacturer, maintains an 800 number for both providers and patients that
can give you the latest information on drug interactions: 800.441.4987. The
Project Inform hotline can also provide their frequently-updated Drug
Interaction Fact Sheet.

Indinavir can increase the blood availability of rifabutin, and should be
accompanied by a rifabutin dose reduction to ward off possible eye
problems. Indinavir may also require dose modification of anti-fungal
medications like ketaconazole, itraconazole, and the like.
Saquinavir may require dose modifications in rifabutin, rifampin, and the
same "azole" anti-fungals.

Short-term side effects can be horrible, but seem to become tolerable after
a while for most people. Ritonavir has the worst buzz so far, but many are
willing to try it because its use is supported by the best data that it
actually prolongs survival. Activist Carlton Hogan of Minneapolis wrote on
the "sci.med.aids" Internet forum, "I...had quite spectacular nausea and
vomiting, numbness running all the way down my throat, and taste
perversion. Of all the drugs I have ever taken, this one feels the most
similar to toxic waste." The company is now distributing a different, gel
cap formulation which may help. Others have found that tapering up the
dosage to full strength over a few days helps reduce the side effects. Many
people recommend taking it on a full stomach, after a high-protein,
high-fat meal. Yogurt may help some. A little ibuprofen seems to help.
Usually the symptoms go away in two weeks or less, but some have reported
that it took up to three months for symptoms to go away "95%." Overall, as
many as 25% of people who try it are not able to tolerate it.

Indinavir seems to be better tolerated, but causes gastro-intestinal
problems in some people and may cause kidney stones. However, the
relatively frequent reports of kidney stones in earlier studies may have
been mostly attributable to dehydration in fairly sick people. Drinking a
lot of water (or taking it IV if you have to) is essential with this drug.

Longer term toxicities, like liver function abnormalities, will have to be
closely observed. As is too typical, we know too little about whether there
are some gender differences in toxicities and side effects that may pose
special cautions for women.

Use the experience of others, but don't rely on just one. In reading
Internet exchanges and talking to friends, I realize that there are more
individual differences than there are uniformities, especially in the
experience of side-effects. Anecdotal experiences of friends and
support-group members and waiting-room acquaintances can be very helpful in
picking up tips of what to expect and what to do about it. The danger,
however, is being put off trying something that may help you based on the
experiences of someone else which may turn out not to apply to you.

Resistance and cross-resistance are problems. We know that resistance
(growth of strains of HIV that are immune to the effect of a drug) will
develop in all known protease inhibitors; we just don't know how soon, how
severely and what is the best strategy to minimize or counteract it. We do
know that protease inhibitors should only be used as part of combination
therapy. (Of course that's not to say you shouldn't try monotherapy if
you're desperate and can't take or benefit from anything else, but all
evidence showing effectiveness of this class of drugs is based on
combinations with other antiviral drugs.) The best combinations we don't
yet know. Inform yourself and consult closely with your provider.

Cross-resistance means that if you take one protease inhibitor, you can
become resistant to a second protease inhibitor without ever having taken
the second drug. Both Abbott and Merck agree that prior treatment with
either ritonavir or indinavir will cause a large degree of cross-resistance
to the other. If you use either one for a significant period, you may not
benefit from later use of the other one, based on what we now know.

The story with saquinavir is more controversial. Roche (maker of
saquinavir) and Merck (maker of indinavir or Crixivan) disagree. Merck
believes that if one has used saquinavir first, one may develop resistance
to indinavir more quickly. Roche says it ain't so. At FDA and community
insistence, the two companies have agreed to conduct a special study to
answer this question.

The same problem may occur with saquinavir and ritonavir, but for now
establishing the safety of this combination is the first order of business
in current studies. Ritonavir's manufacturer Abbott believes that the two
drugs may have complementary resistance profiles that will produce a
synergistic benefit in using them in combination, once they figure out the
best and safest doses.

There is a potential for reversing resistance to protease inhibitors, as is
believed to occur with the AZT/3TC combination (where it is believed that
3TC may reverse resistance to AZT which occurred earlier). Some reports say
that another protease inhibitor in particular, one being developed by
Glaxo-Wellcome, may have this ability. We will have to see, and to push
Glaxo to investigate this possibility quickly and soundly.

When should you start taking a protease inhibitor? The answer is clear for
those with high or rising viral loads as well as others no longer getting
benefit from current regimens: as soon as possible. In earlier stages of
disease, one has to go on the beliefs of you and your provider because they
haven't yet been well-studied in people with higher T-cell counts (the
clinical trials used for FDA approval were in people with no higher than
300 T-cell counts, usually much lower). A logical scientific argument can
be made for including a protease inhibitor in a combination regimen started
as early as possible, but this remains to be proven in the concrete. Other
physicians recommend starting with other combinations and saving protease
inhibitors for later. Whichever path is chosen, use of viral load tests can
help you and your provider decide early on if your regimen seems to be
working.

Other protease inhibitors are in the pipeline. Agouron's Viracept has been
getting good reviews from many observers and the company may file for FDA
approval this fall. The Glaxo-Wellcome Vertex protease inhibitor is also
interesting. Pharmacia/Upjohn, among others, is also still hopeful about
its candidate. You may want to hold off for further choices and more
experience with the various drugs, if you are doing well with whatever you
are taking (or not taking) right now.

Access: how can we all get 'em if we want 'em? The timing is a bear. These
promising (if problematic) new drugs come out just as special funding for
AIDS care has topped out and begun its decline, and all other forms of
health care funding are under attack or being "downsized and economized."
NATAP's Jules Levin has crystallized it well. The wholesale prices for a
year's supply of these drugs are ritonavir-$6300, indinavir-$4380 (Merck
decided to come in with a lowball price), saquinavir-$5800. This compares
to a price range of $2000 to $3000 a year for each of the older, nucleoside
analog drugs (AZT, ddI, ddC, d4T, 3TC). If one takes three-drug combination
therapy that is now recommended, the cost easily exceeds $10,000 a year.
Even with competition, the retail markup adds another 15-40%. Monitoring,
especially with the new viral load tests that are expected to be
FDA-approved very soon and thus widely available at $200 or more a pop,
will add another two or three thousand a year at least.

About 30% of people with HIV are not insured and another 40% are covered
under Medicaid (Medi-Cal in California). The AIDS Drug Assistance Programs
(ADAP) serves about 20% of people in care for HIV, those uninsured or whose
insurance does not pay for any or all drugs. Both Medicaid and ADAP are
under attack; some state ADAP programs are already bankrupt and nearly all
others are threatened. It is estimated than an additional $200 million will
be needed for just the next fiscal year for adding protease inhibitors to
the regimens of those who now use ADAP. Clinton has asked for an additional
$52 million, which has passed the Senate but faces rougher sledding in the
House. At the state level, Pete Wilson is refusing to ask for or release
more funds for ADAP (it's about half state-funded and half federally
funded). Good ol' Pete hasn't heard enough noise from us yet.

Some Medicaid and HMO formularies are refusing to add protease inhibitors
until more is known about their optimal use or unless some other drugs are
removed from the formulary (which means an approved list of drugs that a
physician can prescribe and the patient can obtain, in a particular system
or institution). We obviously have to fight for access or else a big chunk
of us will never have the option of figuring out the best individualized
drug therapy.

Get involved and keep yourself and others informed. Our efforts to provide
the latest information to our community will be greatly assisted if you
will send in your own experiences, observations and ideas about how to get
and use protease inhibitors. We can then compile the information of our own
direct constituency as well as that of researchers and advocates
nationwide. Also, there are numerous urgent targets for public policy
advocacy right now. We at Being Alive are gearing up our own unique
advocacy voice and apparatus. Please call me or the office if you are
interested.

P.S. I hope I haven't discouraged too many of you with all these problems
and uncertainties. There is, of course, the possibility that the hope of
protease inhibitors will turn to ashes, or be no more real in the long run
than the hopes for AZT when it first came out. I don't think so, but we
have to do the work implied above if we are to give these (and future) new
drugs a chance to prolong our lives and energies.

-----------------------
Notes From The Director
by Gary E. Costa

We begin the spring season at Being Alive each year by unveiling our annual
operating budget and program plan for the new fiscal year which commences
April 1. The new budget and plan were drafted and submitted to the Board of
Directors after meeting with various program leaders and members. The
$672,526 expense budget calls for a 23% increase in spending over last
fiscal year's budget. On the income side, the organization plans to take in
$698,370 in grants, donations and other revenues, which is a 31% increase
over 1995-96. The budget was adopted at the March 27 meeting of the Board
of Directors. The complete budget and income plan, along with other
financial information, will be printed in the May 1996 issue of the Being
Alive Newsletter.

While few specific new programs are planned for the new fiscal year, staff
and volunteers are working on a plan to strengthen the existing programs by
consolidating efforts with other programs, expanding the frequency of
others, and finding creative approaches to making all programs and services
of Being Alive accessible to the increasing number of people with HIV
regardless of race, gender, religion, HIV treatment beliefs, or
socioeconomic class. As always, Being Alive needs your support and
participation to remain a true coalition, the voice of people with
HIV/AIDS.

Key Program Changes

Support Groups: This program plans to continue to offer more weekly support
groups than ever before. We currently offer over 23 weekly groups. Groups
addressing the needs of special populations are always welcomed. If you see
a special need that is currently not being addressed by our support groups,
please feel free to contact us. New facilitators are always needed and
trainings will be provided.

Medical Updates: Plans are to change the location of these monthly forums
facilitated by Mark Katz MD to some other venue that would be easily
accessible, safe, and comfortable. If you have any suggestions on how to
improve the updates, feel free to contact Ron DiLiberto at the West
Hollywood office. Remember, these are your medical updates and we want you
to get the most out of them.

Library: The treatment library at the Silverlake location has had a
complete overhaul recently, and is now more user-friendly. Stop by or call
one of our many helpful librarians to assist you in accessing the latest
information on treatments, clinical trials, and policies. Plans this year
call for expanding the Spanish language materials section and computerized
data bases.

Monthly Newsletters: This year the newsletter staff plans to do more
original reporting and less reprints from other sources, a policy that was
started last year. All other treatment periodicals where reprints
originated are still available through the treatment library. Plans are to
increase the availability of the newsletter by expanding the list of access
points. If a clinic, physician, bookstore, coffeehouse, or other venue that
you frequent does not usually have a stack of newsletters available in the
lobby when you visit, please let us know. We will contact them to see if
they would like to become a distribution point.

Women Alive: With the opening of the new drop-in women's center last month,
expect to see more support groups, social activities and treatment
workshops for women being offered through this program this year. The
women's treatment advocacy program is currently being revamped with a new
emphasis and structure. Stay tuned!

Town Hall Meetings: Being Alive will be working more closely with other
AIDS organizations to provide more timely responses to new treatment and
policy issues. Expect bi-monthly forums with guest speakers from around the
world.

B.A. Pal: This social support program will expand to include more weekly
on-site social events and parties, plus road trips to local museums,
theaters, and picnic outings. This program will also begin regular hospital
and home visits to our members who are unable to attend events. If you
would like to be a pal call the Silverlake office and ask for Larry.

Sunday Socials: These popular weekly events will continue, with some weeks
featuring great entertainment, new food menus, and a more coffee-house like
atmosphere. Beer and wine will only be served on special occasions.

Volunteer Parties: Two events designed to honor our volunteers will be held
this year; one in the summer and one in the winter at new exciting
locations to be announced.

Latina Newsletter: Ecos Femininos is a new bi-annual Spanish language
treatment newsletter targeted to our Latina members. Written of, by and for
Latinas with HIV and Latinas at risk. The premier issue will be released in
May. A distribution list is being created now. More information is
available through the Women Alive office.

West Hollywood: Our location in West Hollywood is seeking new volunteers to
expand the peer-counseling program at that location. Social events and
monthly treatment forums will be expanded there as well.

Silverlake Annex: Additional office space is being sought near the
Silverlake office to house some of the administrative functions of Being
Alive to allow more room at the main office for support activities. This
new space will house some support groups and fundraising activities as
well.

Ten Year Anniversary: As we enter our tenth year as an organization, the
Being Alive Board of Directors has formed an anniversary committee to plan
events and functions to celebrate, acknowledge, and reflect on our past ten
years. Please contact me if you are interested in serving on this
committee.

Communications Committee: A new committee comprised of volunteers from the
advertising, graphic design, and entertainment industries will be working
on a plan to create appropriate materials to assist Being Alive in our fund
raising, outreach, and advertising efforts. If you have similar experience,
we welcome your involvement.

-----------------------------
Medical Update-March 18, 1996
presented by Mark Katz MD and reported by Jim Stoecker

Physician Experience and PWA Survival

A few years back we talked about a study that showed survival for
hospitalized people with AIDS increased with the experience that the
hospital had with treating PWAs. Now a report in the New England Journal of
Medicine (March 14, 1996) looks at the impact that a primary care
physician's experience with treating AIDS has on the survival of his/her
patients with AIDS.

Group Health in Seattle, a large managed care organization, conducted a
retrospective study of the patients of some 125 primary care physicians.
Patients were grouped according to whether they were their doctor's first
patient with AIDS, their doctor's second to fifth such patient, or greater
than their physician's fifth patient with AIDS. Survival from time of
initial consultation after diagnosis was then calculated for the three
groups of patients. The researchers found that the median survival for
patients who were their doctor's first experience with AIDS was only 14
months. For the second to fifth patient with AIDS, median survival time
increased to 21 months. And if the patient was over the fifth PWA that the
doctor had treated, median survival was calculated to be 26 months.

Researchers suggested that the more experienced physicians were more likely
to call in specialists for consultations and were also more likely to
advocate prophylaxis for PCP and other opportunistic infections. Whatever
the explanation, the data do show that there is a learning curve for
primary care physicians in treating people with AIDS. HIV+ people need to
be aware of this and choose their physicians accordingly.

Low CD4 Count and Survival

Researchers will soon publish a study of survival time for people with HIV
after their CD4 count falls below 50. Several hundred PWAs were included in
the data, and this study calculated a median survival time of 19.7 months
after CD4 count has dropped to less than 50. This median survival time is
in contrast to previous studies that showed around 12 or 16 months. The new
data reinforces what we have known for some time: people with HIV infection
are living longer than in the earlier years of the epidemic. It is
important to keep in mind that a low CD4 count does not necessarily mean
that the end is at hand.

Low CD4 Count and Protease Inhibitor Therapy

As you probably know, Abbott Laboratories' protease inhibitor, ritonavir,
was recently approved by the FDA. One of the studies used in seeking this
approval involved over one thousand PWAs with less than 100 T-cells. The
study participants could be on any antiviral regimen and could continue
that regimen during the course of the study. Participants were given either
ritonavir or a placebo. Median baseline CD4 counts were calculated to be 18
in the ritonavir arm and 22 in the placebo group. Median follow-up was 6.1
months. Researchers found that in this time 26 or 4.8% of the participants
on ritonavir had died, while 46 or 8.4% of those on placebo had died. What
these data suggest is that even at a low CD4 count, antiviral therapy that
combines the right drugs can make a difference in survival.

Another RT Inhibitor

Glaxo-Wellcome, manufacturer of AZT and 3TC, is developing a new reverse
transcriptase (RT) inhibitor that is currently only identified as 1592U89.
This drug is reportedly synergistic with all the other RT inhibitors (AZT,
3TC, ddI, ddC and d4T) and protease inhibitors; this means that it enhances
the antiviral effect of these other drugs. Researchers also report that
1592U89 has good central nervous system penetration and thus may prove
useful in cases of dementia. In very early studies, viral load reduction
was 2.1 logs after 12 weeks, with an average CD4 increase of 122. Stay
tuned for further developments on this latest RT inhibitor.

Another Protease Inhibitor: Nelfinavir

Nelfinavir (brand name Viracept) is the name of the protease inhibitor
being developed by the drug company Agouron. Early data suggest that this
is a potentially powerful antiviral. Thirty patients, with baseline viral
loads ranging from 50,000-60,000 copies per ml., were involved in the
dose-ranging studies. The higher doses proved to be the most efficacious.
Ninety per cent of the participants receiving 2250 mg per day showed at
least a 1.5 log drop in viral load; 60% of this dosage group showed no
detectable viral load. Diarrhea was a common side effect of the drug;
however, most cases were treatable with antidiarrheals.

Protocol 511 is part of the continuing studies of nelfinavir. Study
participants need to have a baseline viral load of greater than 15,000
copies per milliliter of blood; there are no CD4 count restrictions.
Participants also cannot have had any previous antiviral therapy, with the
exception of less than one month on AZT. The study will last for 24 weeks,
with subjects able to get the drug for six months more. All participants in
protocol 511 will get AZT and 3TC. One-third of the participants will also
get 1500 mg per day of nelfinavir and another third will add 2250 mg of
nelfinavir daily.

Locally, there are two sites for this study: AIDS Research Alliance
(310.358.2423) and Kraus Medical Partners (213.930.2324). You can also call
Agouron directly for trial information at 800.501.2474.

Summary: Six Axioms of Antiviral Therapy

Over the years, I have developed axioms for making decisions concerning
antiviral therapy. With all we know today, here are my current axioms:

   * if the viral load is found to be greater than 100,000 copies per cubic
     milliliter, you should be on some form of antiviral therapy;
   * in most situations, the use of two drugs for antiviral therapy is
     preferable to the use of just one;
   * in combination therapy, you should use two reverse transcriptase
     inhibitors, one of which should be AZT for its superior ability to
     penetrate the central nervous system;
   * a protease inhibitor should never be used alone;
   * once you begin antiviral therapy with a protease inhibitor, you should
     stay on that particular drug and follow the dosing regimen faithfully;
   * you should start using a protease inhibitor in your antiviral regimen
     if you are already using two reverse transcriptase inhibitors and the
     viral load remains high.

--------------------------------------------------
Critical Information About Ritonavir and Indinavir
a special alert from Project Inform

Most people in HIV/AIDS care believe that these two new protease inhibitors
are the most potent compounds yet for the treatment of HIV infection.
However, there are important issues associated with the use of these drugs
that must be emphasized.

The most important message about the use of protease inhibitors is that you
may have only one chance to get the maximum benefit from these drugs. If
they are used correctly, they may produce a large and long-lasting benefit.
Used incorrectly, they may only produce a short-term benefit followed by
the rapid development of multi-drug cross-resistance, rendering the whole
category of protease inhibitors ineffective.

Who Can Benefit?

Early studies show that ritonavir increased survival in people with
advanced disease, but it has not yet been tested in people with early
disease. The recommended dose of ritonavir is 600mg twice daily (12
gel-caps). (Editor's note: due to pronounced side effects often associated
with ritonavir, some physicians are recommending that their patients start
with a reduced dose of only 200mg twice daily, and then work their way up
to the higher dosage as tolerance allows.)

The data supporting the use of indinavir are limited to studies which
showed large improvements in surrogate markers (viral load and CD4+ cell
counts). The indinavir data span both advanced and early disease. It is
still unknown whether indinavir will delay disease progression or prolong
survival, but surrogate marker improvements of the type demonstrated by the
drug have been linked to such benefits in other studies. Those studies are
ongoing and results should be known by early 1997. The recommended dose of
indinavir is 800mg every eight hours.

Side Effects

Side effects for ritonavir include nausea, headache, diarrhea, vomiting,
weakness, and elevated liver function tests. Although these effects were
reported widely in early trials, this may have been due to a poor liquid
formulation of the drug. It has since been replaced by a gel cap
formulation, which avoids some of the unpalatable taste associated with the
liquid formulation. It is unclear how frequently these side effects will
occur with the new formulation.

Indinavir has generally been well tolerated in clinical studies. Some of
the side effects that have been noted in a small minority of users includes
nausea, headache, diarrhea, vomiting, insomnia, weakness, abdominal pain
and back pain. One of the more serious side effects has been referred to in
the media as "kidney stones." This description may be misleading, since
only a very few people have actually seen anything like a small kidney
stone appear. The side effect occurs in the form of flank pain or pain in
the urinary tract. This pain is caused by small undissolved crystals of the
drug which are being removed by the kidneys. In most instances, this
problem has occurred in people with advanced disease who are dehydrated.

The solution seems to be to make sure a person using the drug takes
adequate liquids along with the drug. People who take indinavir should
drink at least 48 ounces of water (about 8 glasses) a day to reduce the
risk of developing kidney stones. Indinavir should be taken one hour before
or two hours after a meal to increase absorption. Foods with no fat such as
toast (no butter), skim milk and corn flakes should not affect the
absorption of indinavir and can be taken at the same time. Additionally,
ddI (Videx) should be taken on an empty stomach one hour before or one hour
after taking indinavir.

How to Use These Drugs

All protease inhibitors run the risk of triggering the development of viral
resistance. Moreover, once people become resistant to one of these drugs,
they are likely to be resistant to the others as well. The existing studies
of ritonavir show that this problem can best be minimized by adhering to
the following guidelines:

   * Stick to the recommended dosage at all times; reducing the dose, or
     skipping doses, increases the risk of developing resistance. If side
     effects occur, it is better to temporarily stop using the drug than to
     lower the dose. If it becomes necessary to stop and then restart the
     drug, start again at the full normal dose. Do not restart with a
     reduced dosage.
   * Use these drugs as part of a three-drug combination: existing data
     suggest that both monotherapy use and two-drug combinations are less
     effective in suppressing viral load and increasing CD4 counts. The
     three-drug combinations should also minimize the development of viral
     resistance.
   * Combine with drugs which are known to be active. Drugs which have been
     used for a very long time and which no longer appear to be working are
     not ideal candidates for playing a role in a three-drug combination.
   * Establish a careful strategy for combining drugs: do not simply add
     indinavir or ritonavir to whatever else you're doing, unless you're
     confident your existing therapies are still effective.

Drug Interactions

People using ritonavir should be extremely careful to read the package
insert, which lists dozens of drugs which can have interactions with
ritonavir. This includes many drugs commonly used by people with advanced
HIV disease. This list of potential drug interactions with ritonavir is too
large to list here, but it warrants great caution in the use of this drug.

People who take indinavir should not use the following drugs: terfenadine
(Seldane), astemizole (Hismanal), rifampin (Rifadin, Rifamate or Rimactin),
cisapride, triazolam (Halcion) or midasolam (Versed). Additionally, for
people taking indinavir and rifabutin (Mycobutin), the dose of rifabutin
should be decreased. People taking indinavir and ketoconazole (Nizoral)
should consider the effect on their dose of indinavir.

Ritonavir is routinely available by regular prescription from pharmacies.
For questions about payment assistance and reimbursement for ritonavir,
call 1.800.659.9050. Indinavir supplies might not be able to meet the
demand for the next six months, and this drug will only be available
through Stadtlanders Pharmacy. To purchase the drug (or to ask questions
about payment assistance and reimbursement) you and/or your doctor will
have to call Stadtlanders at 1.800.927.8888.

(Project Inform will publish complete results from the ritonavir and
indinavir studies in its upcoming PI Perspective #18. For more information,
or to order a copy of PI Perspective, contact the Project Inform AIDS
Treatment Information Hotline at 1.800.822.7422.)

---------------------------------------------------------
Notes on Current Advances in Clinical HIV/AIDS Management
by Robert S. Jenkins, MD, David Hardy, MD and Cyril Gaultier, MD

[The first section of these notes were prepared and sent to us by Dr. David
Hardy of UCLA and Dr. Robert S. Jenkins of Pacific Oaks following a meeting
in early March hosted by Dr. Steven Miles (also of UCLA) and Dr. Hardy.
This meeting sought to disseminate information on the current advances in
antiviral therapy (the various newly-available protease inhibitors and
combination therapies), some newer approaches to opportunistic infection
prophylaxis, and advances in the clinical use of HIV quantification
techniques (the measurement of viral load).

This meeting dealt primarily with the three protease inhibitors now
available by prescription: saquinavir (Invirase), ritonavir (Norvir) and
indinavir (Crixivan). Discussion focused specifically on the clinical use
of these protease inhibitors, alone or in combination with reverse
transcriptase inhibitors (AZT, ddC, ddI, d4T, 3TC.) The following notes
constitute the significant conclusions arrived at by those participating in
the discussions.]

Bioavailability of Saquinavir

The bioavailabilty of saquinavir (the amount of drug that is absorbed into
the blood stream) when taken as a single agent is very low (4%). Thus, its
effectiveness as a single agent is limited.

The bioavailability of saquinavir can, however, be increased by one of
several means: by combining saquinavir with ritonavir (see next paragraph);
by taking Nizoral along with saquinavir (Nizoral inhibits the enzyme that
breaks down the saquinavir, thereby allowing more of the drug to be left in
the blood stream); and by coming up with a better formulation of saquinavir
(which is in the works and will probably be a liquid formulation in
soft-gelatin capsules), allowing for better absorption.

The combination of saquinavir and ritonavir may be toxic to the liver. This
combination requires extreme caution because of the lack of any controlled
clinical data and very little clinical experience with this combination. A
hypothetical (but not confirmed) dosing regimen might be: 600 mg of
ritonavir twice a day combined with very low dose saquinavir (200&shyp;400
mg per day). High blood levels of saquinavir may be achieved in this
manner, because the cytochrome P450 (CYP) isoform which is responsible for
extensively inhibiting the metabolism of saquinavir is itself inhibited by
ritonavir, thereby resulting in increased saquinavir plasma concentrations.

Cross-Resistance

Cross-resistance may develop between protease inhibitors (that is, HIV
could become resistant to both drugs at the same time). Data from clinical
trials suggests, however, that saquinavir and ritonavir might not develop
cross-resistance, and therefore might be a useful combination. This issue
of cross-resistance is not settled, and the use of these two agents in
combination for the sole purpose of preventing cross-resistance would be
premature.

Viral Loads: Keep Them Low

There was a fair amount of discussion about the use of viral loads, Roche's
HIV RNA PCR in particular. The goal of HIV therapy should be to keep viral
loads as low as possible. Viral loads greater than 5000 copies per
milliliter are predictive of more rapid clinical progression of disease and
death. Even patients who have only recently converted their HIV status (for
example, those who converted within the last year) and have viral loads
above 5000 should probably be on therapy, despite high CD4 cell counts.

Also discussed was the proper preparation of blood samples drawn for viral
load testing: immediate centrifugation and freezing of the plasma is
crucial to achieving accurate test results. It was also noted that a
patient who stops his/her antiviral therapy for even a few days before the
test is done might show a significantly higher viral load than if he/she
had remained on antivirals.

d4T/ddI Combination Therapy

Results of a recently completed pilot study of d4T/ddI combination show
that this combination appears to be as efficacious as AZT/3TC in decreasing
viral load and increasing CD4 cells, and does not provoke a significant
increase in side effects.

Oral Gancycolvir: CMV Prophylaxis?

The use of oral ganciclovir as prophylaxis for CMV retinitis remains
somewhat controversial. In one study 38% of patients not on oral
gancycolvir and with less than 23 CD4 cells developed CMV end organ disease
(retinitis, colitis) compared to 18% of patients who were on prophylaxis.
This is a statistically significant difference, but one must also consider
that there are serious side effects involved with the use of oral
ganciclovir (bone marrow suppression). The cost of ganciclovir
($1200/month) and the quantity of capsules required (12 capsules/day) may
also represent obstacles. Thus, there is no clear-cut consensus on whether
to prophylax against CMV or not.

MAC Prophylaxis with Azithromycin

The use of azithromycin (Zithromax) at 1250 mg once a week has been shown
to be successful as MAC prohpylaxis. This dosage, however, might prove to
be hard on some individuals' GI systems, so 500 mg of azithromycin three
times a week is proposed as an alternative. Azithromycin has been found to
be superior to rifabutin (Mycobutin) as MAC prophylaxis, but has not been
compared to clarithromycin (Biaxin).

The use of azithromycin (as opposed to the other forms of MAC prophylaxis)
also presents two other benefits to the patient. First, the dosing regimen
(1250 mg once a week or 500 mg three times a week) is far more convenient
and tolerable than the twice-daily regimen of rifabutin or Biaxin. And
second, azithromycin prohpylaxis is significantly lower in cost. The
average cost per patient per year for the prevention of MAC infection using
prophylaxis is as follows:

   * Rifabutin (Mycobutin): $20,000/person
   * Clarithromycin (Biaxin): $11,700/person
   * Azithromycin/Rifabutin combo: $14,668/person
   * Azithromycin (Zithromax): $3,310/person

Clearly there is compelling evidence to consider azithromycin as the main
MAC prophylaxis, on both economical and ease-of-administration grounds.

(Robert S. Jenkins, MD is in practice at Pacific Oaks Medical Group in
Beverly Hills, 310.652.2562. David Hardy, MD practices at UCLA and can be
reached at 310.206.3474. Cyril Gaultier, MD can be reached at the Wilshire
Blvd. Pacific Oaks office, 310.358.5660.)

-------------------------------------
AIDS Drug Assistance Programs (ADAPs)
by Christopher Griffin

The federally funded AIDS Drug Assistant Programs serve to provide free
AIDS drugs to people with low or moderate income who are not eligible for
Medicaid coverage and who do not have prescription drug coverage under
private health insurance. (ADAP funds come primarily from the Ryan White
CARE Act.) These programs are available in all fifty states-over 50,000
people with HIV or AIDS are enrolled-although eligibility requirements vary
state to state, as do drug formularies (the drugs covered by the program).
Some states' formularies cover most AIDS-related medications, while other
states have restrictive programs that cover only a handful of the most
obvious drugs (AZT, aerosolized pentamidine and Bactrim).

California ADAPs

In California, the formulary covers most established AIDS-related drugs,
but does not yet provide coverage for 3TC or any of the new protease
inhibitors. (Also not on the formulary are Doxil, the newest and often
highly effective drug for treating Kaposi's sarcoma, nor Zofran, a highly
effective anti-nausea drug.) These omissions constitute a very serious
problem: these are the drugs that have shown the most potency and promise
in combating HIV and associated conditions, and yet they are currently only
available to people who have private prescription coverage or the financial
resources to purchase them. This problem is quickly becoming one of the
most important policy issues for AIDS community groups and activists.

In California, ADAP can be used by people whose health insurance does not
cover prescription drugs, or for whom their co-payment is a financial
hardship. Medi-Cal recipients cannot use ADAP unless they are unable to
meet their monthly share of the cost of medications. Anyone with an income
of less than $50,000 can qualify for ADAP, but people who make more than
$29,440 a year will be responsible for a co-payment.

How to Apply for Enrollment in ADAP

California's ADAPs are administered by the county Departments of Health.
People with HIV/AIDS who wish to apply for ADAP coverage should contact the
ADAP coordinator at the California Department of Health office in their
county.

In Los Angeles County the process of applying for ADAP has been made
considerably easier by the creation of Community Unity for AIDS Care
(CUAC). Founded jointly by the Los Angeles Gay and Lesbian Community
Services Center and Stadtlanders Pharmacy, this first-of-its-kind program
brings together 20 HIV community-based organizations across Los Angeles
County to improve access to medications through California's ADAP (call
Being Alive for information 213.667.3262).

Each participating CUAC organization has staff members on-site to assist
clients in enrolling in ADAP. Clients no longer have to travel long
distances or to several different agencies to enroll; the application
process can be done at the most convenient of the sites.

Moreover, CUAC clients can choose between picking up their ADAP medication
at the pharmacy within the LA Gay and Lesbian Community Services Center (at
the Jeffrey Goodman Clinic) or having their medications delivered to them
by the Stadtlanders Pharmacy mail service program.

ADAPs in Crisis

Across the country ADAPs are facing a funding crisis. A recent survey by
the National Association of State and Territorial AIDS Directors (NASTAD)
discovered that 19 state ADAPs had or will have funding shortfalls this
fiscal year. Two state ADAPs (Missouri and Colorado) have actually run out
of money, and others are cutting services, limiting enrollment,
establishing waiting lists, or canceling or delaying formulary expansions.

The highly promising antiviral therapies that have just recently become
available-3TC and the protease inhibitors-are going to be putting
additional financial pressure on these programs. These drugs, while
offering powerful new options for people with HIV/AIDS, do not come cheap.
The cost of 3TC (which is now commonly used in combination with AZT) is
estimated at about $2200 per year; the protease inhibitors are even more
costly, perhaps $7000 per year. As triple drug therapy (AZT, 3TC and a
protease inhibitor) becomes the "standard of care," the annual cost of HIV
treatment is estimated to be $12,000 to $18,000 per patient.

It is clear that current ADAP funding levels will not cover the expense of
providing access to these drugs. NASTAD and other groups are lobbying
stridently for an increase in the CARE Act appropriations for ADAP, but the
Republican-controlled Congress may prove unwilling to provide the increases
necessary. The Health Resources Services Administration, the federal office
that administers Ryan White programs, is developing a national "core
formulary" for ADAPs; their aim is to standardize ADAP coverage in all
states so that an even level of service can be provided nationwide. Among
other things, this would allow for more accurate planning, and thus be more
economical. This "core formulary" is expected by summer.

Unfortunately, these budget woes are fueling our ever-evolving and
increasingly unbalanced health care system, where people with HIV/AIDS who
rely on government health care or managed care plans may find that the
newer therapies will not be reimbursed. The most potent antivirals and
other new drugs will be available to only those who have top-of-the-line
insurance coverage or who can afford to purchase them. Lobbying efforts
must focus on maintaining or creating ways for people with low or moderate
incomes to gain access to protease inhibitors and other innovative HIV
treatments. Will we reach a point at which there are valuable AIDS
therapies available, but only to certain people? Will the fortunate ones
with strong insurance coverage look on idly as the less fortunate suffer
and die?

--------------------------------------------------
After Eye Surgery: Life with a Ganciclovir Implant
by Christopher Griffin

(Last month Christopher reported on his experience of having a ganciclovir
implant surgically placed in his eye. Since then the implant has been
approved by the FDA and is generally available for the treatment of CMV
retinitis. This issue he writes about how having the implant has reshaped
his day-to-day experience.)

It's now three months since I had the implant surgery, stopped IV drug
therapy, and started oral ganciclovir. My eye remains clear of CMV
retinitis lesions, and except for some minor floaters I have no visual
disturbance whatsoever. My greatest fear, that the oral ganciclovir would
not control gastro-intestinal CMV, has proven to be unfounded; my
intestinal tract seems just fine.

It's hard to overstate the impact having the implant has made upon my
experience of day-to-day life. Before the implant became available, the
only way to control a CMV infection was with intravenous drugs, either
ganciclovir or foscarnet. IV therapy requires a permanent indwelling
catheter, most commonly a PICC-line.

For seven months, starting the day I was diagnosed with CMV retinitis and
had a PICC-line installed, I had been infusing one drug or another at least
once a day, often twice. Ganciclovir infusions had only taken an hour, but
it soon developed that I could not tolerate the drug, and I switched to
foscarnet, which takes three hours to infuse. During those weeks when I was
on induction dose (twice a day) a full six hours of my day was spent hooked
to a pump. And although I got myself a little fanny pack that contained the
pump and the bag of drug, so that I could be ambulatory (I could go to the
theater, see a movie, go out to dinner, all the while infusing away), I
nonetheless was forced to plan my life around my infusions.

In order to keep the PICC-line free of infection, I was fastidious about
keeping the site clean and dry. The dressing covering the line was changed
once a week, requiring (since I live alone) the help of a home-care nurse.
I had to take showers with my arm covered by a long plastic glove and with
my hand held high over my head, to prevent getting the insertion site wet.
I no longer went into the pool or the steam room at the gym.

This is the matter-of-fact reality of daily life for many people with AIDS
who have needed, for one reason or another, to have an IV line installed in
their body. And I do not mean to suggest that it is an overwhelmingly grim,
disastrous reality (although it does take some getting used to). I adjusted
quite well to this new life, as well I must, for I fully expected to be
infusing one or another of the IV drugs for the rest of my life. I took on
this new version of experience like a trooper, refused to let it get me
down, insisted on going to the gym and trying to maintain a semi-normal
life. Still, this was heavy going for a man who loves the water, who loves
standing under a shower for the sheer pleasure of feeling the water course
over the body, who could swim before he could walk and whose greatest
pleasure in life is swimming in the ocean.

And that is why the implant had such a profound effect upon me. For two
weeks following the surgery, I kept my PICC-line, in case the implant
failed or I needed some other IV therapy. But through those two weeks I
could see the future ahead of me: I could almost taste the freedom that
losing the PICC-line would bring. And I decided to make the absolute most
of that freedom. Two days after I had the PICC-line removed, I flew to
Hawaii, where, for three weeks, I indulged my passion for the tropics and
the ocean. I went scuba diving every other day (a mere two weeks after eye
surgery!), spent hours on the beach, swam in the ocean with abandon, and
soaked up as much of that kind of life as I could-knowing that this calm in
the storm could be transitory, that any moment it could all be snatched
away from me yet again. Talk about carpe diem.

The intensity of that sense of freedom has diminished a bit over time, but
not a day goes by that I do not pause to internally express my gratitude
for this hiatus from IV therapies. I know only too well how temporary this
freedom could prove to be. Make the most of it while I can, that's become
my mantra.

Until recently the implant was available only through clinical trials, and
in order to be enrolled in the trials one had to have failed (or been
intolerant of) both IV ganciclovir and foscarnet. Now that it has been
approved by the FDA, IV drug failure is no longer a necessary criterion.

There are several ophthalmologists in the Los Angeles area who are
experienced in performing the implant surgery; your primary care giver is
probably familiar with at least one of them. This procedure, however, does
not come cheap. The device itself costs $4,000; add the fees of the
hospital and the surgeon and the overall cost for the procedure will
probably be around $7,000 to $8,000 per implant (which might need to be
replaced within six to eight months). The cost of oral ganciclovir needs to
be factored in as well, around $1200 per month. Expensive as this is, it
may prove to be cheaper than ongoing IV therapy, which in my experience
averaged around $6500 per month (which included the cost of the drugs, the
home nurse visits, the pole and/or pump rentals).

Clearly, given the potential for financial savings and an improvement in
the quality of life, the implant represents an incredibly attractive
treatment option. Yet in many medical circles the ganciclovir implant is
still considered a therapy of last resort, because eye surgery (and its
concomitant risks) is necessary. I would argue strongly that the
ganciclovir implant be considered a first defense against CMV retinitis
(perhaps two weeks of induction therapy with IV drug, using a temporary
peripheral IV line, then the surgical implant combined with oral
ganciclovir). Long-term IV therapy so changes a person's life and
experience, I feel the longer a medical team can keep that option at bay,
the better.

----------------------
Dead Doctors Don't Lie
by Jennifer Jensen, MS, RD

This is the title of an audio tape from a charismatic "doctor"-a real
down-home sounding guy, talking all about mineral deficiencies killing just
about anyone who dies. He talks about life-spans of up to 200 years. He
even tells us that an 80-year old man fathered ten children-before he was
100. And all due to good mineral intake in order to live that long and
still get it up to make new babies. (Presumably the mothers were younger).

The product the "Dead Doctors" tape is promoting is "colloidal minerals." A
colloid is a liquid suspension containing particulate matter. Minerals are
being touted in this scam as the particulate matter, and we aren't told
what liquid they're suspended in, or which minerals and how much of them
are included in each dose (32 doses per bottle). There's no ingredient
list, but the tape claims that it works and saves lives that would
otherwise be lost due to mineral deficiencies.

I've received eight copies of this tape: two from distant friends, four
mailed to my office and two sent to my home. It makes me wonder when, not
if, you'll get your own copy. Then you can "be your own boss" and "own your
own company." They'll tell you all about how to do it. Supportive
documentation, from current pyramid toppers, has income reports that run
from $4,000 to $34,000 per month.

This is called pyramid marketing or multi-level distribution; they're
synonymous. "Business owners" don't really sell products so much; they
further the scam to "help" their friends feel better, remain alive, and
make the Big Bucks. These friends are supposed to follow and set up their
friends, etc. The "owners" get kickbacks from all the distributors they
manage to collect from among their own friends, friends of friends, and
their friends, etc. Will you get to the top of the pyramid, to that $34,000
a month? If you believe this, I have some low-cost beach-front property in
Montana to sell you-for when you retire as a millionaire!

How to spot a pyramid: The first thing to look for is a line stating "not
available in stores." Another is that we really don't have to pay top
dollar for the miraculous prophesies-we get the goods for free after we've
become distributors with lots of "friend action." The pyramid grows
bottom-heavy as our friends find other scam victims to make percentages on
what they sell. Do we ever get to the top? Sure, when that Montana
beachfront property becomes a real hot land deal.

Dead Information

Stating that the life-expectancy of a doctor is age 58, the tape would have
us believe that the young doctors all died of mineral deficiencies. If you
have Alzheimer's, there's a mineral deficiency at cause (selenium). If your
heart gives out on you, it's a mineral deficiency (selenium, copper,
chromium, iron, magnesium, etc.). The list goes on. Mineral-deficiency
killers include some of the most ridiculous notions I've ever heard. The
diseases caused by most of the stated mineral deficiencies have nothing
whatever to do with most of what this (apparently alive) "doctor" states.
Of course, some of what he says is true. Wrapping truths around falsehoods
has been going on since entrepreneurism was invented. The tape continually
mixes up fact and fiction. If you don't believe me, come to my office and
I'll show you a few biochemical textbooks and other medical literature that
will absolutely disprove the numerous false statements in these tapes. All
of them. Heading for Montana?

Supplementation

I recently wrote "the first necessary thing to say [about minerals] is
don't ignore them" (July 1995 issue). They really are important, but with
these colloidal minerals, at two doses per day (as recommended), one bottle
will only last 16 days. A bottle of 100 tablets from the best, most
absorbable multimineral I've found, even double dosing, will last you
nearly two months and the cost is only $6.

The "Dead Doctors" tape is not specifically targeted to an HIV audience. In
fact, neither HIV nor AIDS is mentioned in the tape. However, I suspect
that it won't be long before word-of-mouth on this "hot-new-product" grabs
hold of the HIV community. And that's why I'm issuing this warning now!

Selenium and HIV

The supportive written documentation that comes with the tape does
(correctly) list HIV/AIDS in the selenium deficiency category. (This is the
only mineral they associate with HIV/AIDS, though zinc might have,
correctly, been included-I can't begin to imagine why it isn't.) As it
happens, I also wrote about selenium last July for HIV/AIDS use and I think
it's so important that I'll repeat myself here.

Selenium is hot and will probably get much hotter as further time and study
happens. First, Selenium is an antioxidant that works with vitamin E. This
benefit may be independent of other "hot-stuff" on Selenium. A study first
reported a year ago by Dr. Will Taylor in the Journal of Medicinal
Chemistry suggests that "HIV slowly depletes the body's store of selenium.
The hope: This can lead to specific ways of using selenium supplements to
help AIDS patients keep their virus in check. Many AIDS patients have low
selenium levels, and some already take supplements. It had been reported
that AIDS patients had trouble absorbing the nutrient from food.

"The new theory: HIV produces proteins that consume the body's supply of
selenium. HIV needs selenium (which normally preserves the elasticity of
body tissue) to grow. Once the virus exhausts the selenium in an infected
cell, it breaks out in search of more, spreading the infection to other
cells."

If this is true, then why not take colloidal selenium? I've always
suggested a three-question method for decisions on any "alternative"
treatment: "Can it cause harm? Will it help? and Can I afford it?" If it
can cause harm, we must decline: this is an absolute. And colloidal
minerals do not pass this test. If you don't know what you're taking,
there's always a potential for harm.

Suppose colloidal minerals help-a real stretch if you believe me so far.
Again, not knowing what minerals are there, and in what doses, and costing
a lot, there's more than sufficient evidence that this product should be
avoided. Don't believe the "Live Doctors!" And don't waste good money on an
unknown of possible harm: Spend about the same amount of money on an
appointment with me or another well trained HIV-nutrition expert. That will
help you understand minerals, and you won't get scammed.

Again, do no harm. If any of this advice is, or seems to be connected to
adverse consequences, contact your primary healthcare provider and/or your
nutritionist.

(Jennifer Jensen, MS, MBA, RD, CNSD is in private practice. Call her
anytime at 310.450.5581, or E-Mail at NutPower@aol.com.)

------------------------------------------------------------------
3rd Conferencia Anual sobre Retrovirus y Enfermedades Oportunistas
Jim Stoecker-Traduccin y Adaptacin: Rubn Gamundi

El 7 de Febrero de 1996, Being Alive y Shanti patrocinaron un panel donde
se present informacin acerca de lo expuesto en la Tercera Conferencia
Nacional sobre Retrovirus y Enfermedades Oportunistas. El doctor Mark Katz
actu como moderador.

El Dr. Katz anunci que la conferencia gener una atmsfera de optimismo en
la lucha contra el VIH.

Pruebas de Carga Viral

El Dr. Scott Hitt habl acerca de la importancia de las pruebas de carga
viral. Estas incluyen las pruebas de laboratorio PCR del laboratorio Roche
y bDNA del laboratorio Chiron. Las mismas miden la cantidad de virus que se
encuentra en la sangre de un individuo.

En el pasado, slo disponamos del conteo de clulas T4 para establecer el
estado de enfermedad de un individuo infectado con el VIH. El conteo de
clulas T4 no nos informa qu tan activo est el VIH. En la opinin del Dr.
Hitt, el conteo de clulas T4 es bueno para determinar cuando una persona
debe comenzar terapia profilctica en contra de enfermedades oportunistas.
Las pruebas de carga viral nos sirven para determinar cundo comenzar o
cambiar de terapia antiviral.

El Dr. Hitt dijo que es importante saber que existen fluctuaciones diarias
en los resultados de pruebas de carga viral. Por lo tanto, una sola prueba
no sera suficiente para determinar cul es la verdadera carga viral de un
individuo. Para poder hacer buenas decisiones de tratamiento es conveniente
repetir las pruebas de carga viral peridicamente despus de comenzar o de
cambiar un determinado rgimen de medicamentos.

Hoy se cree que una carga viral de 10.000 copias (confirmado por ms de una
prueba) indicara baja actividad viral y por lo tanto progresin lenta de
la enfermedad. Pruebas repetidas que muestren cargas de ms de 10.000
copias indicaran la necesidad de comenzar o de cambiar terapia antiviral.
Se puede medir la efectividad de los antivirales observando la cada o
reduccin de los valores de carga viral. La magnitud y duracin de dicha
cada es lo que importa (la cuals es expresada en logaritmos, una unidad de
medida. Una cada de 1 logaritmo indica que la cantidad de virus disminuy
un 90%; por ejemplo, un individuo con 300.000 copias que despus de terapia
antiviral llega a una carga viral de 30.000. Podemos decir que una
reduccin de 1 logaritmo se considera importante. Esto tambin nos dice que
dicha terapia antiviral est funcionando. Por otra parte, una disminucin
de menos de 1 logaritmo, no sera tan importante e indicara que otras
medidas debern tomarse.

El Dr. Hitt termin su charla indicando que todava se necesitan hacer ms
estudios para determinar cmo podemos utilizar mejor las pruebas de carga
viral. Estas pruebas nos permiten evaluar la efectividad de terapias
antivirales con rapidez. Tambin dijo que quizs en personas que no tienen
enfermedad avanzada, no sea necesario hacer un conteo de clulas T4 pero si
pruebas de carga viral cada 3 meses.

Patognesis del VIH

Marty Majchrowicz, de la Universidad de California, Los Angeles, habl
acerca de cmo es que el VIH causa enfermedad (Patognesis). Se sabe que
los ganglios linfticos son sitios donde el virus es atrapado y tambin
donde se multiplica. En el curso de la enfermedad, los ganglios linfticos
van perdiendo su estructura y funcionalidad en forma gradual y no logran
mantener al VIH atrapado. Por lo tanto, altos niveles de VIH pueden ser
detectados en la sangre.

Investigaciones recientes tambin demuestran que hay varios subtipos de
clulas T4. Estos subtipos cumplen roles diferentes en el sistema inmune.
Pareciera que el VIH hace disminuir a estos subtipos de clulas T4 de una
manera diferente en cada individuo. Esto significa que dos individuos con
el mismo nmero de clulas T4, quizs tengan diferentes subtipos. Esto
ayudara a explicar porque una persona con 100 clulas T4 progresa ms
rpidamente que otra con el mismo nmero de clulas. Tambin demuestra la
limitacin que presentan el conteo de clulas T4.

Estudios de Inhibidores de Proteasa

Uno de los aspectos ms importantes de la conferencia fue la informacin
dada a conocer acerca de los resultados de estudios clnicos con
inhibidores de la proteasa. La doctora Karen Sandler de Kraus Medical
Partner dio a conocer dichos resultados.

Dos estudios clnicos (039 y 020) investigaron la eficacia de Indinavir
(tambin conocido como Crixivan). El estudio 039 incluy 97 personas con
conteos de clulas T4 de 50 a 400. Todos los participantes haban usado AZT
por lo menos 6 meses antes de comenzar el estudio. Los participantes fueron
divididos en tres grupos: indinavir solo, AZT+3TC o AZT+3TC+indinavir. A
pesar de que el estudio no estaba completamente terminado, la informacin
preliminar fue muy alentadora. Treinta y tres personas tomaron la
combinacin triple. Se presentaron resultados de 7 de esas 33 personas.
Seis de esos siete participantes experimentaron una disminucin en la carga
viral que lleg a menos de 500 copias. Esta cifra es considerada
"indetectable". El aumento promedio de clulas T4 fue de 146.
El estudio 020 incluy 78 personas con menos de 500 clulas T4 y que nunca
haban tomado AZT. Los participantes fueron divididos en tres grupos:
indinavir solo, AZT+ddI o los tres medicamentos juntos. Nuevamente, la
combinacin triple fue la que demostr mejores resultados. En el grupo de
individuos que tom la combinacin triple se vieron reducciones en la carga
viral de 2.9 logaritmos. Esta es una reduccin muy importante. El 59% de
los participantes en este grupo experiment una reduccin de la carga viral
por debajo de los niveles de deteccin. El aumento promedio de clulas T4
fue de 90. La doctora Sandler aclar que ninguno de estos estudios incluy
el anlisis de mejora clnicas (como el desarrollo de enfermedades o
muerte).

Tambin se dio a conocer informacin acerca de dos estudios con ritonavir
(Norvir). En el estudio M94-247 se enrolaron 1090 personas con menos de 100
clulas T4. Los participantes permanecieron tomando los antivirales
recetados antes del estudio y a los cuales se les agreg ritonavir o
placebo. Despus de 16 semanas, el grupo que tom ritonavir experiment un
aumento de 50 clulas T4 y una reduccin en la carga viral de casi 1
logaritmo. En este estudio se vieron mejoras clnicas en el grupo que tom
ritonavir, donde hubo 26 muertes comparadas con 46 en el grupo que us
placebo.

El estudio M94-208 enrol 21 personas y fue llevado a cabo en Francia.
Estos participantes nunca haban recibido terapia antiviral con
anterioridad y tenan un conteo de clulas T4 de 50 a 250. Todos los
participantes fueron puestos en un rgimen que incluy ritonavir+AZT+ddC.
Despus de seis meses se registraron aumentos en el conteo de clulas T4 de
156 a 303.

En lo que respecta a la aparicin de resistencia y durabilidad de la
eficacia, todava se necesitan ms estudios para que esto sea determinado.
Sabemos que aquellas personas que desarrollen resistencia a ritonavir,
tambin sern resistentes a indinavir. Tambin sabemos que si los
inhibidores de proteasa no se toman en las dosis y manera adecuadas, la
posibilidad de aparicin de resistencia aumenta.

Novedades acerca de la Terapia Antiviral

El Dr. Katz explic que lo importante de esta conferencia es que ya no
debera usarse monoterapia (tratamiento con un solo antiviral) en personas
con VIH. Adems, basndonos en la informacin que hoy tenemos, parecera
estar indicado comenzar a usar antivirales en un estadio ms temprano de la
enfermedad. Los estudios de combinacin de medicamentos demostraron que los
participantes que menos se beneficiaron con la terapia fueron aquellos con
menos clulas T4. Adems, aquellos que comenzaron terapia con un conteo
bajo de clulas T4, experimentaron ms efectos indeseables. Esto sugerira
que cuanto ms temprano se empiece terapia antiviral, mayores son las
posibilidades de beneficiarse con la misma.

En la conferencia tambin se dieron a conocer resultados acerca de la
combinacin de ddI con d4T. Los resultados de estos estudios son similares
a los vistos con AZT+3TC (otra combinacin potente). Adems se vio que la
combinacin ddI+d4T no provoc aumentos en la incidencia de neuropata
perifrica como se haba pensado.

Todava no hay respuesta a la pregunta de cul es la mejor combinacin para
usar.

Enfermedades Oportunistas

El Dr. David Hardy de UCLA dio informacin acerca de los ltimos avances en
enfermedades oportunistas. Dijo que debido al uso de profilaxis contra
enfermedades oportunistas hoy se ven ms casos de CMV. Hay alguna evidencia
que el ganciclovir oral podra ser eficiente en la prevencin de CMV. En
cuanto al tratamiento de CMV, se ha visto que el uso de implantes
intraoculares se est haciendo ms popular para tratar esta infeccin.
Los investigadores tambin estn analizando la posibilidad de combinar
infusiones de ganciclovir y foscarnet para tratar la retinitis por CMV. Los
resultados de esta combinacin parecen ser mejores que los que se ven
usando una droga sola. No hay que olvidarse de que el uso de esta
combinacin disminuye la calidad de vida de las personas ya que las mismas
se deben someter a dos o cuatro infusiones al da.

Finalmente el Dr. Hardy report resultados de estudios comparando rifabutin
con clarithromycin o la combinacin de los dos en la prevencin de MAC.
Clarithromycin demostr ser ms efectivo que rifabutin e igual que la
combinacin de los dos. El problema que se presenta con el uso de
clarithromycin unicamente, es la aparicin de resistencia.

-------------------------------------
AIDS and the Law: Recent Developments
by John Alan Cohan

Medicaid Coverage for Nutritional Supplements

Even though a doctor might prescribe over-the counter supplements to treat
AIDS-related malnutrition Medicaid is not available for payment, according
to a recent federal ruling in Maine. The ruling notes that, while a state
"may not arbitrarily deny or reduce the scope of a required service solely
because of the diagnosis or type of illness," nonetheless a "required
service" does not apply to over-the-counter drugs such as nutrition
supplements. This is an exceedingly disappointing and unfair ruling because
Medicaid pays for supplements used for patients with end-stage renal
disease, but not AIDS.

ADA Suit Settled

A New Jersey patient with HIV was awarded $82,000 against a dentist who
refused to treat him. The ruling was based on state disability laws and on
the Americans with Disabilities Act as it pertains to public
accommodations. The court emphasized the importance of encouraging HIV+
people to seek important medical services.

AIDS Discrimination Cases

Nearly one-half of AIDS discrimination cases filed by the EEOC have been
settled out of court, often within weeks of the lawsuit being filed,
according to Ken Morse of the General Counsel's office in Washington, D.C.
Of the 50,000 claims processed by the EEOC since 1992, 903 involved HIV.
The agency currently has approximately 26 cases pertaining to AIDS.

These cases involve the following circumstances: employers placing a
lifetime cap on medical benefits for AIDS but not other illnesses;
employers asking whether a plaintiff has AIDS and terminating him based on
his disability; failure to accommodate employee's request for a cool
working environment and disclosing to other workers that plaintiff has
AIDS; employer refusing to grant flexible work schedule to employee with
AIDS to accommodate medical treatments; refusing to grant plaintiff a
different position with less travel, as his doctor had recommended; refusal
to hire plaintiff based on HIV+ results on pre-employment physical exam;
failure to correct hostile work environment and failure to grant
plaintiff's request to transfer; breaching confidentiality by discussing
employee's medical condition with other employees, and failing to keep
medical records separate from personnel file.

No Generic AZT

The Supreme Court rejected a challenge by generic drug companies to the
patent rights to AZT, the AIDS drug which since 1987 has provided a
profitable monopoly to the Burroughs Wellcome Company (now Glaxo Wellcome).
In 1991 the National Institutes of Health licensed a generic-drug company,
Barr Laboratories, to produce the drug in return for paying royalties to
the government. This license was justified on the grounds that a government
scientist, Dr. Samuel Broder, was a joint inventor of the drug, and the
government therefore had the right to grant other companies a license to
make the drug. Burroughs sued and won a patent infringement suit in 1994.
A group of generic drug companies sought Supreme Court review, arguing that
Burroughs was not in a position to apply for a patent in the first place
because it had not conceived of AZT as a treatment for AIDS. It was Dr.
Broder, working for the government, who conceived of an experiment that
demonstrated AZT's potential in treating AIDS in humans. Therefore
Burroughs did not have a "complete conception" of the drug under patent law
terminology, and was not entitled to a patent. Now that the appeal is
exhausted, the monopoly on AZT will be protected until the year 2005. For
the average patient, the annual cost of the drug is about $3,000, a price
the generic drug companies had said they could cut in half.

(John Alan Cohan practices law in Century City and can be reached at
310.557.9900.)

---------------------------------
Commission on HIV Health Services
by Christy Cowell

Upcoming Membership Vacancies on the Commission

The terms for a number of seats on the Commission on HIV Health Services
will be ending in June, and we will be seeking people to fill these
vacancies. Many of these seats are specifically designated for HIV+ people.
The Commission would also like to increase its membership of Latinos and
women, to more accurately reflect the AIDS epidemic and the population
demographics in LA County. These upcoming Commission membership positions
will include: HIV+ representatives of several communities (Asian/Pacific,
Gay/Bisexual Men, Latinos/Latinas, American Indians); HIV+ representatives
of HIV+ residents in Supervisorial Districts Three, Four and Five;
representatives of Supervisorial Districts (First through Fourth);
representatives of Women's Caucus; and advocates for the incarcerated, for
housing, and for mental health.

We would like to encourage all Being Alive members to consider nominating
themselves and/or other individuals whom they think are qualified for one
of these Commission membership positions. For more information please call
Patricia Ramirez, Commission staff, at 213.351.8130.

Managed Care Representatives

The Commission has recently initiated a Managed Care Committee, whose
primary focus is the incorporation and delivery of HIV services within
managed care systems. The Committee is looking for three additional members
to serve as Consumers and Consumer Advocates so that its decisions and
recommendations always include these perspectives. The Committee is seeking
members who have experience (successful or unsuccessful) in navigating
managed care systems, particularly women of color with children who are
self-disclosed as HIV-infected and are receiving their health care in a
managed care system. They also seek one member who can play an advocate and
information sharing role with other HIV-infected communities, and a third
member to serve as a consumer at large. For more information about these
membership seats, please call Michael Higgins at 213.351.8125.

--------------------
Chiropractic and HIV

Los Angeles College of Chiropractic offers chiropractic services by senior
interns under the supervision of a licensed chiropractor on Fridays at the
Silverlake and West Hollywood locations of Being Alive (1&shyp;5 pm in West
Hollywood and 8am-noon in Silverlake).

While many clients complain of back, neck, and shoulder tension, pain and
strain, others come for support to their immune system.

Some recent preliminary studies indicate a possible link between spinal
adjusting and a boost in the immune system as measured by increased white
blood cell counts and immune-related blood chemical levels.

In 1993, James J. Allen reviewed every report of research that attempted to
answer the question, "Does spinal manipulation have an effect on the immune
system?" Ten studies reported the following:

   * Apparent increases in B and T lymphocytes, but the study group was
     statistically too small to allow generalization to the larger
     population;
   * Increases in IgA, IgG, and. IgM antibodies in three out of four
     patients;
   * Stimulation of white blood cells; again, a small study;
   * Increased endorphin (natural pain killers) levels.

A separate study in 1994 showed an apparent increase in CD4 levels over six
months following spinal manipulation. Again, the subject count was not
statistically significant, but a study to include 200 patients is being
prepared.

While none of this "proves" that chiropractic boosts the immune system, it
does indicate a possible link. Chiropractors use skilled touch and
movements to restore motion to dysfunctional spinal joints. It may well be
that the release you feel when your back is "popped" is indeed bringing a
burst of positive energy to your immune system.

---------------
Bits and Pieces
by Fran Mcdonald

TB and HIV/AIDS

Many of you are aware of the resurgence of tuberculosis as a serious health
threat among both HIV-negative and positive people, but did you know that,
according to the United Nations World Health Organization, about 266,000
HIV+ people are expected to die from TB worldwide this year?

Dr. Arata Kochi, Director of the WHO Global Tuberculosis Program, says that
up to two-thirds of all HIV+ people seeking treatment are either being
misdiagnosed or treated improperly, and that proper treatment can add more
than two years of healthful life to a patient. The best way to achieve this
is to pursue a directly-observed, short-course treatment called DOTS: The
health worker watches each patient swallow a specific regimen of TB
medication for a six month period. (The regimen includes anti-TB medicines
that specifically do not cause serious side effects in HIV+ people; note
that the inexpensive drug thiacetazone is still being prescribed in AIDS
endemic areas, and that this drug can be lethal to an HIV+ person). The
DOTS strategy has been nearly 100% effective in curing TB in TB/HIV
hotspots such as New York City.

According to WHO, TB is the leading opportunistic infection to kill HIV+
people, so I hope that you will take the TB threat seriously. If you'd like
a copy of the press release from WHO, give me a call.

Patients' Rights

Part of taking care of yourself involves being an informed patient, knowing
what your rights are and when to draw a line and put your foot down. The
American Hospital Association has a "Patient's Bill of Rights" that can
help by offering good advice and sound facts. This brochure discusses many
things to which a patient is entitled, including treatment with respect and
dignity, privacy (both personal and of medical records), clear explanations
of procedures and medications and any risks involved, and the option to
refuse any procedure, test, or drug.

If you'd like a copy of this brochure, call the Association at 312.422.2000
or call me.

Food Safety

It may seem sometimes as if the subject of safe handling of food is being
beaten to death, but considering the possible serious consequences of
unsafe handling of food, it's information that bears repeating. The U. S.
Department of Agriculture has a brochure, "Plating it Safely," prepared in
conjunction with various related agencies, public and private, that seems
to me the best of the lot.

One of the best features is its brevity-truly a brochure, just two
folds-while at the same time it contains a wealth of information. The
brochure points out that in spite of the U. S. food supply being one of the
safest in the world, more than thirty million Americans suffer some type of
foodborne illness each year and that most of this illness is a result of
unsafe food handling by the consumer.

Along with The Joy of Cooking, no kitchen should be considered complete
without a brochure like this one. If you'd like a copy, call me.

(Fran McDonald has been in Social Services for 24 years and welcomes your
calls at 213.664.4772.)

---------------------------------------------
AIDS Memorial Quilt Display in Washington D.C.

From October 11 to 13, just four weeks before national elections, the NAMES
Project will stage the largest AIDS awareness event in history. The entire
AIDS Memorial Quilt-45,000 individual memorial panels, 30 football fields
of fabric-will be unfolded on America's front lawn in an effort to focus
the attention of the nation and its leaders on the urgency of the AIDS
crisis.

Since its last Washington showing in 1992, the Quilt will have doubled in
size. Hundreds of eight-person teams from all over the U.S. will unfold the
Quilt in the early hours of Friday, October 11. According to the NAMES
Project, an estimated 750,000 visitors are expected, including 50,000
school children.

More Than 10,000 Volunteers

Two thousand readers-elected officials, sports figures, celebrities,
community and religious leaders, educators, people with AIDS, family
members, friends-will be reading out the names of those memorialized in
Quilt panels. In all, 70,000 names will be read aloud during the three day
display, more names than are carved in the nearby Vietnam War Memorial.
More than 10,000 volunteers will be participating in this three-day display
of the Quilt. If you are interested in becoming a volunteer, contact the
NAMES Project in San Francisco at 415.882.5569.

Deadline for Submitting New Panels

If a memorial quilt panel is to be included in the Washington display, it
must be received by the NAMES Project Foundation in San Francisco or by a
local chapter of the NAMES Project by May 31. The NAMES Project
headquarters in San Francisco is located at 310 Townsend Street, Suite 310,
San Francisco, CA 94107. For more information call 415.882.5569.

Panel-Making Workshops

There are at least five workshops being conducted by the NAMES Project in
the Los Angeles area (one in Spanish) to help people construct their panels
for the Quilt. For information on these workshops, please call
213.653.6263.

NAMES Project Los Angeles: New Panel Dedication

Newly created panels for the AIDS Memorial Quilt from Southern California
will be dedicated on Sunday, April 28. The ceremony, hosted by The NAMES
Project Los Angeles, will take place from 3&shyp;4 pm at the Hollywood
United Methodist Church, 6817 Franklin Avenue, Hollywood. NAMES Project LA
will begin accepting new panels for this ceremony at 1:30 pm in the church
courtyard. Volunteers will be on hand to assist all panelmakers. For more
information or to volunteer, call 213.653.6263 or contact Bob Ames at
818.763.0589.

-----------------------------
People with PacifiCare-Update
by Leonard E. Wojtyna

People with PacifiCare (PWPC) participated in an energy charged fourth
meeting of PacifiCare's HIV Committee held at the PacifiCare offices in
Cypress. Our first order of business was to evaluate the initial draft of a
survey that PacifiCare (PC) will conduct of its California provider medical
groups regarding HIV issues. We decided that further work on the survey
questions was necessary.

Next we considered the prescription drug formularies now employed by health
maintenance organizations including PC. A formulary is a list of approved
drugs from which the physician can prescribe. PC acknowledged that seven of
the forty-three drugs now covered under the AIDS Drug Assistance Program
(ADAP) were non-formulary drugs. Those seven also did not include Invirase
(saquinavir) and Lamivudine (3TC). PWPC proposed that PC follow the FDA
lead and expedite their approval process for new drugs. In the interim, if
you are advised that a prescription is not on PC's formulary, advise your
physician or case manager to appeal with PC.

PC's Case Management brochure is now in the final revision process. This
brochure is given to all new plan enrollees and defines AIDS as one of the
qualifying medical conditions necessary to be eligible for Case Management.

Participation by the Senior Medical Director and Vice president of
Operations confirmed PacifiCare's commitment to have decision making
executives in attendance at these meetings. Representation by various
PacifiCare departments, as well as Being Alive and APLA, assured that all
avenues of the issue were explored.

We pointed out that our discussions still have not yet revealed a solution
to the problem of choosing a primary care physician and medical group
knowledgeable about HIV from the information provided by the HMO. We all
acknowledged that, while there are no easy solutions to that issue, we
would continue to search for them.

People with PacifiCare meets on the third Saturday of each month at the
offices of Being Alive, 3626 Sunset Blvd. in Los Angeles from 12 to 2 pm.
Call 1.800.990.8990 for information.


-------------------
Newsletter Masthead

     In memory of Fred Clark and Gilbert Cornilliet

     Circulation: 11,000

     Newsletter Staff:

     Mark Allen-Smith, Tony Arn, Patrick Edington, Ruben Gamundi, Daniel F.
     Chan, Sam Raygoza, Walt Senterfitt, Jim Stoecker

     Please direct all correspondence to Christopher Griffin E-mail:
     cgrffn@aol.com

The Being Alive Newsletter is produced and published by Being Alive,
People with HIV/AIDS Action Coalition, which is solely responsible
for its content. Distribution of the Newsletter is supported by our
many subscribers, and by generous donations from Screen Actors Guild
Foundation, The Foundation for Educational Research and the City of
West Hollywood.

If you have articles you would like to submit to the Being Alive
Newsletter or if you just want to help, please contact the Being
Alive office during regular hours.

Please note: Information and resources included with your Newsletter
are for informational purposes only and do not constitute any
endorsement or recommendation of, or for, any medical treatment or
product by Being Alive, People with HIV/AIDS Action Coalition.

With regard to medical information, Being Alive recommends that any
and all medical treatment you receive or engage in be discussed
thoroughly and frankly with a competent, licensed, and fully
AIDS-informed medical practitioner, preferably your personal
physician.

Being Alive and Being Alive Coping Skills Support Groupx are
trademarks of Being Alive, People With HIV/AIDS Action Coalition,
Los Angeles.

Opinions expressed in various articles in the Newsletter are not
necessarily those of Being Alive's membership.

Any individual's association with Being Alive or mention of an
individual's name should not be, and is not, an indication of that
person's health status.

The staff of the Being Alive newsletter wishes to express its very
deep appreciation to both Wes Kashiwagi and Rich Grzesiak for their
valuable assistance in volunteering their energy for maintenance of
this Home Page on the Internet.

c 1996 by Being Alive, Inc. All Rights Reserved, including permission
to reprint.  Distributed by AEGIS, your online gateway to a world of
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