Subject: AIDS Treatment News #328
From: "John S. James" <[email-masked]>
Date: Mon, 11 Oct 1999 15:52:03 -0700

AIDS TREATMENT NEWS #328, OCTOBER 1, 1999
   phone 800-TREAT-1-2, or 415-255-0588

[Note: Due to changes at our Internet service provider,
this message is being sent from a different email address.]

CONTENTS:

ABT-378 Early Access Program Begins

ICAAC Conference Reports on the Web

ICAAC: New Drugs in Late Breaker Session

New AmFAR Treatment Directory Now Available

Medicaid: You Don't Always Have to Be "Disabled"

***** ABT-378 Early Access Program Begins

On September 27 Abbott laboratories announced an Early Access 
Program to make ABT-378/r (which is the new protease 
inhibitor ABT-378, which is combined with a small amount of 
ritonavir) available to a small number of patients outside of 
clinical trials, in the U.S. and some other countries. 
Because of limited drug supply at this time, the initial 
entry criteria are very restrictive in order to get the drug 
to the sickest patients; later, the eligibility requirements 
will be expanded as more drug is available--probably by 
January 2000.

Right now, patients must have failed at least two protease-
inhibitor-containing regimens, and either have a CD4 count 
under 50, or have had an opportunistic infection while on 
highly active antiretroviral therapy. Because ABT-378/r 
includes low-dose ritonavir (to maintain blood levels of ABT-
378), it cannot be used together with drugs contraindicated 
for ritonavir; otherwise, most other medicines are OK--
including PMPA, T-20, and some other experimental 
antiretrovirals.

Because ABT-378/r is experimental, doctors will need approval 
from an IRB (institutional review board)--which could involve 
delays due to the scheduling of meetings. Abbott has a 
central IRB which is already familiar with the drug and can 
approve applications quickly, but medical centers which have 
their own IRB often require their doctors to use it.

Patients, doctors, and other medical professionals can call 
888-711-7193 (8:00 a.m. to 7:00 p.m. Eastern time) in the 
U.S. or Canada, or 00-800-49-68-59-90 outside North America, 
for more information about this program.

[Note: Patients considering this program may want to wait, if 
possible, for PMPA, T-20, or other experimental 
antiretrovirals, so that they can start the new drugs 
together. This is because those who qualify for ABT-378/r 
under the current criteria are probably already resistant to 
most or all approved antiretrovirals. Any antiretroviral, 
including ABT-378/r, should be started with at least one and 
probably two other antiretrovirals which are expected to be 
effective for the patient, to prevent development of 
resistance to the new drugs. Those who have no approved drugs 
likely to work for them may want to wait for at least one 
more experimental drug, to reduce the risk of losing ABT-378 
as well. AIDS treatment activists in the Coalition for 
Salvage Therapy have been through long, hard, and apparently 
successful negotiations to make sure that the various rules 
allow the use of the different experimental drugs together.]

[But those who cannot wait should apply immediately, because 
there are only about 300 slots in the U.S., and similarly 
limited access elsewhere, until more drug becomes available, 
probably in January 2000.]

***** ICAAC Conference Reports on the Web

About 15,000 people gathered this week in San Francisco for 
the 39th annual Interscience Conference on Antimicrobial 
Agents and Chemotherapy (ICAAC)--a major conference on 
infectious diseases and new antibiotics. In recent years 
ICAAC has been an important forum for AIDS biomedical 
researchers to present their findings. This year was more 
important than most, and had more good news than bad, 
although many of the developments were too technical to get 
much attention in the mainstream press.

Extensive coverage is available on the Web. We recommend 
checking at least the first three sites listed here, scanning 
the titles and reading the specific reports of interest.

* http://hiv.medscape.com
Coverage of 18 conference sections by a number of physicians. 
(You need to register the first time you use this site, but 
registration is free.)

* http://www.hivandhepatitis.com/conferences/ICAAC.html  
One to two paragraphs each on many news reports from the 
conference.

* http://www.thebody.com/confs/icaac99/icaac99.html
Reports by four leading physicians.

* http://www.asmusa.org/mtgsrc/ic99main.htm
The official ICAAC site, with searchable abstracts online, as 
well as other information written before the conference. You 
may need to register and use the "itinerary builder" to 
search the abstracts.

* http://www.ama-
assn.org/special/hiv/newsline/conferen/icaac99/icnews99.htm
Journal of the American Medical Association site. It has more 
than a dozen Reuters reports on HIV news from the conference. 
[Note: The dash after 'ama', above, is part of the Web 
address of this page.]

***** ICAAC: New Drugs in Late Breaker Session

by John S. James

At ICAAC and many other conferences, "late breakers" are 
important and very recent reports that could not be submitted 
by the regular conference deadline. Three of the late 
breakers at ICAAC concerned drugs that are or are soon likely 
to be available through limited early access programs.

ABT-378

This experimental protease inhibitor from Abbott Laboratories 
just became available outside of clinical trials to a few  
patients who urgently need it (see "ABT-378 Early Access 
Program Begins," above). This drug (which is always combined 
with a small amount of Abbott's approved protease inhibitor 
ritonavir, in order to slow the metabolism of the ABT-378 and 
keep it in the body longer), has a much greater margin than 
other protease inhibitors between the  level which inhibits 
HIV, and the lowest level maintained in the blood (about a 
30-fold therapeutic index for ABT-378, vs. 4-fold or less for 
approved protease inhibitors, for non-resistant "wild type" 
viruses)--allowing ABT-378 to suppress many viruses which are 
partially resistant.

ABT-378 is active against some but not all viral mutations 
which confer resistance to other protease inhibitors. But HIV 
can become resistant to ABT-378--so this drug (like all the 
others) must be used carefully, in effective combinations, to 
avoid the subtherapeutic regimens which allow resistant 
viruses to evolve. (For this reason, patients who have 
exhausted all approved antiretrovirals may want to consider 
waiting a few weeks or months, if possible, so that ABT-378 
can be combined with other new drugs such as PMPA or T-20, 
instead of being added as the only new drug to a currently 
failing regimen.)

Results presented at ICAAC(1) showed that ABT-378 combined 
with other antiretrovirals gave very good results in both 
treatment-naive and treatment-experienced patients at 36 
weeks--with few side effects known at this time.

PMPA (now named tenofovir)

This experimental drug being developed by Gilead Sciences is 
in the same class of adefovir (which is currently on expanded 
access), but appears to be both safer and more active against 
HIV. In a trial in almost 300 volunteers who were already on 
stable antiretroviral treatment but still had a viral load 
between 400 and 100,000 copies, those given the highest dose 
tested (300 mg once a day of an oral prodrug--a substance 
which becomes tenofovir in the body) had a median viral load 
decrease of 0.83 logs at week 24, vs. an increase of 0.28 
logs for those receiving a placebo. At 24 weeks, those on 
placebo were switched to the highest dose of the drug.

Only 24-week safety and activity data were reported at 
ICAAC(2), and at that time the drug appeared to be well 
tolerated.

T-20 in Highly Pretreated Patients

T-20 is the first of an entirely new class of drugs called 
fusion inhibitors, which block the process by which HIV 
attaches to and enters a cell. Because it is active against 
HIV infection in a fundamentally different way, no cross 
resistance with other antiretrovirals is expected (although 
resistance to HIV does develop). T-20 is difficult to 
manufacture in large quantities, so only limited supplies are 
available.

In the study reported at ICAAC(3), 55 volunteers were treated 
with T-20 in combination with other antiretrovirals. Because 
of their extensive experience with anti-HIV drugs (these 
patients had already received a median of 11 different 
antiretrovirals), resistance testing was used to decide what 
to combine T-20 with. The combination regimen reduced the 
viral load to below 400 copies in 20 of the 55 patients, and 
reduced the viral load by one log or more in 13 others.

The T-20 was given twice a day by self-administered 
subcutaneous injection.

References

1. Eron J, King M, Xu Y and others. ABT-378/ritonavir (ABT-
378/r) suppresses HIV RNA to <400 copies/mL in 95% of 
treatment-naive patients and in 78% of PI-experienced 
patients at 36 weeks. 39th Interscience Conference on 
Antimicrobial Agents and Chemotherapy, September 26-29, San 
Francisco [abstract LB-20].

2. Schooley R, Myers R, Ruane P, and others. A double-blind, 
placebo-controlled study of tenofovir disoproxil fumarate 
(TFD) for the treatment of HIV infection [abstract LB-19].

3. Lalezari J, Eron J, Carlson M, and others. Sixteen week 
analysis of heavily pre-treated patients receiving T-20 as a 
component of multi-drug salvage therapy [abstract LB-18].

***** New AmFAR Treatment Directory Now Available

The American Foundation for AIDS Research (AmFAR) has revived 
and changed its important HIV/AIDS Treatment Directory. 
Printed copies were distributed at the recent ICAAC 
conference, and a free copy can be obtained through the AIDS 
Clinical Trials Information Service, 1-800-TRIALS-A--or write 
to ACTIS, P.O. Box 6421, Rockville, MD 20849-6421 (be sure to 
ask for the AmFAR HIV/AIDS Treatment Directory, and include 
your mailing address). [Note: ACTIS is the U.S. AIDS Clinical 
Trials Information Service.]

A searchable online version will soon be available at 
http://www.amfar.org/td .

The Directory includes: "A to Z drug descriptions for HIV 
treatment and associated infections; New drugs in development 
and clinical study locations; Federal guidelines for HIV 
treatment; Federal guidelines for prophylaxis of 
opportunistic infections; HIV experimental vaccine directory; 
Reimbursement and drug assistance programs for patients, and 
HIV treatment information resources worldwide." Also included 
is a guide to understanding your lab test results, phone 
numbers of state AIDS Drug Assistance Programs and 
pharmaceutical company drug assistance programs, and an 
extensive resource directory. The current edition (volume 10, 
number 1, summer 1999) also has articles on results of the 
AmFAR observational database 1990-1993), and long-term 
effects of antiretroviral treatment.

***** Medicaid: You Don't Always Have to Be "Disabled"

By Thomas P. McCormack

[Note: Medicaid provides health care for about half of 
persons with AIDS in the U.S. Benefits expert Thomas P. 
McCormack explains entry criteria for this program.]

How many times have we read that you have to be disabled to 
be eligible for Medicaid (Medi-Cal in California), that if 
you are "only" HIV-positive you cannot qualify--and that 
changing the rules to cover persons who are not yet disabled 
would by itself fix the problem? In fact the truth is more 
complicated.

In all states, Medicaid now covers poor persons who are: over 
age 65; under age 18; pregnant; blind; members of families 
with children (including--in almost all states--the father if 
he is at home); and those found disabled by SSA (the U.S. 
Social Security Administration). So, in reality, Medicaid 
covers six different kinds of poor persons--and the disabled 
are only one of those six.

It is true that many persons do qualify for Medicaid in the 
"disabled" category--but many others get it through the other 
five category routes. SSA generally accepts an AIDS diagnosis 
as disabling if it actually prevents substantial work, but it 
also accepts persons who are 'only' HIV-positive as disabled, 
if their medical conditions prevent work. Most of the first 
AIDS patients were childless, sighted gay men in the prime of 
life, whose route to Medicaid--indeed, whose only possible 
route to Medicaid--was as disabled. And so the myth grew that 
only AIDS patients found disabled by SSA could get Medicaid. 

Medicaid has been available all along--and has been awarded 
to thousands of other poor persons who are "only" HIV-
positive--because they were under 18; over 65; blind; 
pregnant; or members of families raising minor children. And 
in addition, almost all of the larger, wealthier states use 
their own money--without federal help--to give similar 
medical assistance to poor persons who don't fit in any of 
the six federal Medicaid categories. Most notably, this does 
include not-yet-disabled, childless adults in the prime of 
life.) 

In fact, since AIDS emerged in the early 1980s, federal 
Medicaid has been broadened to cover childless, not-yet-
disabled adults in several ways:

(1) States can pay COBRA premiums (to keep health insurance 
from one's former job in force for 18 or even 29 months after 
leaving work) with federal Medicaid money, for anyone with 
countable income under the national poverty level ($707 
monthly for the unemployed, $1,458 for those working), even 
those who are not disabled or members of the other five 
Medicaid categories.

(2) States can get waivers under federal law to cover needy, 
"pre-disabled" persons who are not in any Medicaid category 
through their Medicaid programs--but only if they can show 
that federal costs will not be increased. (While this "budget 
neutrality" rule is tough to meet, Oregon and Tennessee have 
already done it and expanded their Medicaid programs, and 
Maine, Massachusetts and other states are now trying to do so 
also.)

(3) States can already offer Medicaid with federal support, 
at small premiums, to working persons with medically 
disabling conditions (whom SSA cannot consider "disabled" 
because they are actually working) with incomes up to about 
$43,000 a year. Alaska, Iowa, Massachusetts, Minnesota, 
Oregon, Vermont, and Wisconsin have already done this--and as 
this article went to press, a bill was on Governor Gray 
Davis' desk for California to do so too.

(4) One little-noticed result of the 1996 welfare reform law 
was that states gained the right to define what constitutes a 
family for Medicaid coverage purposes. Under the old AFDC 
welfare system, families with fathers at home could only be 
eligible if he had been laid off after long employment, or if 
he met state "incapacity" rules  (temporary disability less 
strict than SSA's). Now, under the reformed TANF welfare 
system, almost all states have dropped these limits and cover 
all poor families with children--no matter what the father's 
status.                       

(5) Under the state Child Health Insurance Program (CHIP) 
created by the 1997 Balanced Budget Act, children under age 
19 with family incomes under 200% of poverty [currently 
meaning incomes under $22,400 per year for a family of two, 
$27,700 for three, $33,400 for four, or $39,000 for five] are 
eligible for Medicaid or similar CHIP health insurance even 
if they are not disabled. The law even gives states the 
right, in some case, to give this coverage to the children's 
parents--whether or not they are disabled. Vice President 
Gore has called for making the parental coverage standard in 
this program, and for increasing the income level as well.

But there will be even more about to be offered to states 
under the bipartisan Work Incentives Improvement Act (S. 
331/H.R. 1180)--not currently law, but expected to clear 
Congress in the fall of 1999:

(6) On a demonstration project basis, many states that take 
the option to cover the working disabled can then also give 
Medicaid, under the same income rules, to "pre-disabled" 
persons who are at risk of becoming fully disabled without 
early Medicaid treatment. These states would get extra 
federal money for doing so, too.

(7) And states which cover the working disabled can also 
include those working persons who have recovered from their 
disabilities but still have a potentially serious condition 
like HIV. Here, too, extra federal money can help states do 
this.

States need to take the working disabled coverage option--and 
then go on to take the sub-options of covering those at risk 
of becoming disabled and those who have recovered but still 
have serious underlying conditions. Both the "pre-disabled" 
and the "ex-disabled" could then get Medicaid with incomes up 
to about $43,000 yearly. 

Without this, "waiving" the disability rule alone won't do 
much good. The fact is that non-disabled persons are likely 
to be employed, even if at menial jobs. Someone earning as 
little as the minimum wage gets an income of about $950 
monthly. That is far, far above the Medicaid level for a non-
disabled person, which averages about $350 in even the most 
generous states (through the "General Assistance" programs 
which many but not all states have). And it's even above the 
levels for those who are disabled--$500 in most states, $676 
in the most generous state (California).  

So waiving the disability rule won't do much alone. It will 
take careful, thoughtful advocacy at the state level to enact 
the Medicaid coverage choices which states already have--and 
the new ones they will shortly get.

[Thomas McCormack, email [email-masked], wrote the AIDS 
BENEFITS HANDBOOK (Yale University Press) and handled 
Medicaid eligibility policy at the federal Department of 
Health and Human Services. He has done benefits advocacy for 
several AIDS and disability groups and now serves as policy 
consultant for the Title II Community AIDS National Network. 
These opinions are his own, and not those of any 
organization.]

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Treatment News does not recommend particular 
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