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AIDS Trestment News
October 1, 1999

Contents:


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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.



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].



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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 tomxix@ix.netcom.com, 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.]



ISSN # 1052-4207

Copyright 1999 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.




  
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