Advertisement
The Body: The Complete HIV/AIDS Resource
Follow Us Follow Us on Facebook Follow Us on Twitter Download Our App
Professionals >> Visit The Body PROThe Body en Espanol
Read Now: TheBodyPRO.com Covers AIDS 2014
  
  • Email Email
  • Printable Single-Page Print-Friendly
  • Glossary Glossary

AIDS Treatment News
May 16, 1997

Contents:

For subscription, donation and editorial information and to read our Statement of Purpose, visit Aids Treatment News' page here at The Body.

AIDS TREATMENT NEWS
Needs Your Support

by John S. James

Since we started publishing more than 10 years ago, AIDS TREATMENT NEWS has been supported by subscriptions. In the last year, tight finances have forced us to miss conferences, delay equipment upgrades, and spend time and attention on business that we would rather devote to our mission. Our current staff is half the size it was at its peak. We are asking assistance from readers who can help us continue what we do well.

Advertisement
Total expenses for AIDS Treatment News are $265,000 per year, which includes large fixed costs for rapid printing and first-class postage, as well as all salaries and benefits. Our basic subscription income pays 85% of the total, and has been stable (up 2% from first quarter 1996 to first quarter 1997). But we have relied on unpredictable income -- occasional gifts, bequests, and large orders -- for the rest. We have not increased the $100 per year subscription price since AIDS Treatment News began, although most expenses have increased modestly over the years. We do not accept pharmaceutical-company grants or contributions.

We are now working with the nonprofit AIDS Treatment News Associates to fund free subscriptions to AIDS Treatment News. We already send subscriptions at our expense to over 350 prisoners and prison staff, over 250 other people who cannot afford even the subsidized rates, and about 70 AIDS service organizations; reimbursement for these would close our funding gap. You can help us do our work by sending a tax- deductible contribution to: AIDS Treatment News Associates, 584-B Castro St., San Francisco, CA 94114-1465.


Clinical Trials and Viral Load:
Statement for FDA  Community Meeting May 16

by John S. James

Introduction

We wrote the following statement to suggest issues for discussion at the FDA community forum on May 16, concerning using viral load instead of "clinical endpoints" in certain trials of anti-HIV drugs (see announcement in AIDS TREATMENT NEWS #270). This introductory section provides background for readers who are not familiar with current debates and issues in clinical trial design.

In the early years of the epidemic, due to historical accident, clinical trials of AIDS drugs developed from the model of cancer trials. The traditional "gold standard" in cancer trials was five-year survival. Since five-year trials would clearly slow drug approval, there have been years of debate about whether substitute ("surrogate") cancer measures, such as tumor size, were an acceptable substitute for survival for drug approval.

In AIDS, the cancer standard of survival was quickly relaxed a little, and the traditional gold standard for AIDS drugs became improved survival or reduction of major disease progression (usually taken as the development of a new AIDS- defining opportunistic condition) for some unspecified period of time. These are the "clinical endpoint" trials referred to in the article below. In a clinical-endpoint trial, a new drug must prove that it is at least as good as some standard treatment in reducing death or major disease progression in some group of patients.

The first problem with clinical endpoint trials is that they commonly require over a thousand volunteers and take well over a year of actual time on treatment (plus more years to plan, set up, and recruit) to get statistical proof. And more recently, especially within the last year, a new problem has arisen. The importance of lowering viral load (especially to levels so low that it is undetectable) has become widely accepted. Since viral-load trials can be run much more rapidly than clinical-endpoint trials (and can usually get statistical proof with about a tenth as many volunteers as required for clinical-endpoint trials), it can quickly be learned that some of the treatment arms in clinical-endpoint trials are inferior to others in lowering viral load. It is now widely considered unethical to ask volunteers to stay on these virologically inferior treatments for years (see discussions in SCIENCE, April 25).

For many years there has been debate on whether anti-HIV drugs must go through clinical endpoint trials in order to be approved, or whether improvement in "surrogate markers" (especially viral load) would be enough. Several years ago the FDA started a system called "accelerated approval," which allows a drug to be approved based on surrogate markers (without having to wait years for clinical endpoint trials), provided that clinical endpoint trials are run later (to confirm that the surrogate-marker benefit translated into a real clinical benefit for patients). Today these confirmatory trials are creating intolerable problems, mainly because it is no longer considered ethical to keep patients on virologically inferior treatments, now that the importance of viral load has become much more accepted than it used to be.

During the last year and a half, the viral load measurement which has become widely regarded as most important is the proportion of volunteers whose viral replication can be essentially shut off (as shown by undetectable viral load in the blood plasma) for as long as possible. Other measurements, like the group average fall of viral load, are not considered as relevant. Our article below explores the surprisingly strong advantages of using the ability to maintain undetectable viral load as the primary way to judge an antiretroviral drug regimen in confirmatory trials.

Statement to May 16 FDA Community Meeting:

Clinical Trials and Viral Load: Complete Viral Suppression As Primary Endpoint for Confirmatory Trials

The ethical, practical, and scientific problems with the current regulatory requirements for confirmatory trials of antiretrovirals are well known. The biggest problem concerns trials with suboptimal treatment arms. These often try to show clinical-endpoint superiority of a regimen containing the drug being tested, compared to some other regimen which the trial designers or sponsors thought they could get away with -- but which must prove inferior through death or major illness for the trial to be a success. The need now is to articulate consensus and/or develop regulations to encourage workable trials which are ethical in the context of modern medical knowledge, yet provide the answers physicians need and can use.

It is now becoming widely accepted that instead of clinical endpoints, some degree of viral load suppression, for some period of time, should be required for final approval. (Formulating this agreement and providing specifics is the apparent mission of the mid-July meeting of the Antiviral Drug Products Advisory Committee.) Since the time required for showing durable viral suppression is likely to be a year or more, approval should not be delayed until completion of these trials. Therefore, the current system of accelerated approval, which has been successful, should be kept in place.

Complete HIV Suppression, and Trial Design: A Fortunate Synergy

Today it is widely agreed that antiretroviral therapy should aim for complete suppression of HIV replication (to undetectable levels of plasma viremia), sustained for as long as possible. Far from making it impossible to test new drugs, as some have feared, this modern view makes possible a new generation of very attractive confirmatory trials. The key is to use loss of complete viral suppression as the primary endpoint to define failure of the assigned treatment regimen for that individual -- that is, as long as a treatment completely suppresses the virus, it is regarded as successful, but when complete suppression stops, it is counted as having failed. In that case, the individual is immediately unblinded and offered new treatment options (which should usually include new randomizations, for further research). Drug failure due to toxicity or intolerance of the regimen would also lead to unblinding and new treatment options.

Especially near the beginning of treatment, and later as required, frequent viral load testing would be used to detect failing regimens quickly, and volunteers would be offered other options without delay.

"Treatment failure" would not be declared from a single viral load result, if only because of the possibility of testing errors. Exact criteria for virological failure -- either loss of complete suppression after it had been achieved, or inability to achieve it in the first place -- would be defined in the protocol.

Some advantages of this approach:

* Each trial volunteer always receives virologically optimal treatment (or is given the option of trying another therapy). No one need stay in any arm unless the therapy is suppressing viral replication to the greatest extent that can be measured. This attractiveness to patients and treating physicians should greatly help in recruiting.

* These randomized controlled trials would provide the data which is widely regarded today as most central: How well does a regimen prevent drug failure (due either to viral breakthrough, or to drug toxicities) in the patient population being tested?

* Failure of complete viral suppression is already in common use in drug trials, and is well regarded as a virological measure. (It has not yet been used as the primary endpoint for confirmatory trials, because the FDA has required clinical endpoints so far.)

* This trial design avoids most of the need to hide information. Volunteers are of course given their viral load results immediately (since the viral load must remain undetectable, or the volunteer will be unblinded and offered different treatment).

* There is much less need than with previous trials to conceal overall results as they develop, in order to avoid biasing the trial. This is because, regardless of the overall statistics of drug failure, each volunteer is either on a treatment which, virologically at least, is working perfectly for them (as far as can be measured), or is already changing to a different treatment. Participants are unlikely to abandon a (blinded or unblinded) regimen which works this well for them, in favor of a treatment which may not work, based on statistical results from other people.

* Long-term data on treatment success or failure are critically needed -- and this kind of trial can obtain such data much more easily than conventional designs. Trials could regularly be planned to run for five years or more. This is because participants are not kept on a treatment which is not working for them. Instead, their failure and abandonment of the treatment provide the data for measuring the effectiveness of the antiviral regimen. Therefore, the only volunteers who will be kept on a regimen for years are those for whom it is working very well. They will be unlikely to want to change.

Also encouraging long-term continuation of randomized controlled testing is the fact that results can be reported as they develop, with little fear of subsequent bias. There is no need to close the trial or risk its future integrity so that results can be published for general use.

For the same reasons, approval and marketing of the drugs should have little effect on these trials -- further encouraging the generation of long-term data from randomized treatment, regardless of when accelerated approval and final approval occur. The key difference from most current trial designs is that the only people on the long-term treatments are those who are doing very well, who therefore have no incentive to leave the study -- while those who left after treatment failure are not dropouts responsible for missing data, but instead reached a primary endpoint exactly as planned in the protocol.

And sponsors will be happy to pay for long-term followup for as many volunteers as possible, because that will mean that their drug is successful. The more people who stay on the treatment long term, the more valuable the drug is. This creates a strong economic incentive to collect long-term data.

* This kind of trial might reduce the bias which now occurs because volunteers who are more ill are less likely to report for study visits. Those who are doing poorly would probably already be recorded as treatment failures, so any appointments they miss will not affect the primary endpoint of the trial.

Followup after treatment failure -- even after leaving the protocol -- is also important. Especially those who have left the protocol need reimbursement for their time and expenses in study visits, since the drugs no longer serve as incentive. It is a great mistake to just drop people after they leave a protocol -- yet that is commonly what happens.

* Because virologic treatment failure (loss of complete suppression) is likely to occur much more rapidly than clinical endpoints -- with today's treatments at least -- these trials should require far fewer volunteers than clinical-endpoint confirmatory trials.

* When treatments improve enough that failure (either from viral breakthrough or drug toxicity) becomes rare, then these trials will keep more of their participants on their original randomized arms for a long time -- effectively becoming CLINICAL ENDPOINT trials, with increasing power as more volunteers remain on their assigned treatment for longer. This provides an ethical way to look for any unexpected disease progression in spite of complete viral suppression. In the most likely case -- that no such disconnect is found -- nothing is lost, since all of the volunteers will have received optimal treatment, all groups will have done well clinically, and the trial will have provided valuable assurances about the drugs.

Regulatory Oversight Needed

Several areas will need continuing FDA and public attention to ensure that confirmatory trials with virological endpoints best serve the public interest:

* What happens after treatment failure? Are volunteers just dropped because the sponsoring company has no further interest in them? Those who have participated in a trial should have assistance in finding a treatment strategy which works for them -- especially since the public could benefit greatly by knowledge obtained in this process.

The medical community needs to know what options are useful after certain drugs have failed -- both to treat those individuals successfully, and to learn how initial choice of therapy may limit future choices. In some trials, subsequent randomization options after failure of the initial antiretroviral regimen will be appropriate for obtaining this information. For various reasons, including the fact that drugs from different manufacturers are likely to be involved, a private sponsor may not want to do this research. It should be public policy to ensure that such studies are done as part of a drug's approval.

* At the very least, long-term observational followup should be part of most if not all antiretroviral trials. Safety and quality of life information is needed for all who are randomized to a treatment, even after they discontinue it.

* Antiretroviral drug development must include testing in advanced or heavily pretreated patients. Any new antiretroviral will be widely used by them. It is unconscionable to collect no data and test the drugs only where they are likely to look best.

* Physicians and patients need other data from the approval process -- data often neglected today. Small, rapid pharmacokinetic trials should be required, to establish:

- Doses for infants and children;

- Possible dose adjustments for sex, race, or body weight;

- More interaction data with other medications which patients being treated with the drug being tested are likely to use -- including illegal or recreational drugs -- when there is any reason to suspect an interaction;

- Per-patient variation in blood levels due to individual differences in absorption or metabolism -- and the effect of such variation on treatment failure.

Ending the previous generation of clinical-endpoint confirmatory trials will save enormous resources which are now mostly wasted. The FDA, supported by professional consensus, should require pharmaceutical companies to use some of the resulting savings to provide a rational package of information to the patients and physicians who will rely on their products.


1592: Small Distribution
Programs Begin June, July

On April 29 Glaxo Wellcome announced that it will begin three small compassionate-use programs for access to 1592, an experimental antiretroviral. A pediatric program is planned to start in June, and dementia and adult programs in July.

1592 is a nucleoside analog -- a drug in the same class as AZT -- but it appears to give much better viral suppression than AZT. Also, its resistance profile is different. About 250 people have been treated with 1592 so far. About 20 additional trials are planned, involving more than 2,000 people.

The three programs and their entry criteria are:

* Pediatric program (ages 90 days through 12 years): To enter, patients must have a viral load greater than 100,000 copies/ml, CD4 percent less than 15, and have failed at least one nucleoside analog drug (e.g. AZT, ddI).

* AIDS dementia complex (ages 18 through 65): Patients must have severe dementia (MSK grades 3-4) diagnosed by a neurologist. They must have had prior treatment with AZT (which is known to be effective in treating AIDS dementia in some cases).

* Other adults: Patients must have viral load greater than 50,000 copies, CD4 count under 100, and they must have previously failed at least two nucleoside analog drugs and one protease inhibitor.

The pediatric and dementia programs will have a central registration procedure; physicians will call to register patients. The other adult program will be conducted at centers in North America, countries in Europe which are currently running trials of 1592, and Australia. The list of centers is not yet final.

2,500 slots will be available in all three programs together worldwide.

Comment

There is widespread concern that 2,500 slots will be entirely inadequate -- that the adult program especially could fill up in days. In that case the drug will be available to those with connections and luck -- those whose physicians can have someone stand by the phone or fax to get them in line first.

There is also concern that the development of this drug has proceeded too slowly (see "Why Isn't Glaxo's New AIDS Drug Ready Yet" in THE WALL STREET JOURNAL , November 12, 1996, page B1). Current plans are to apply for FDA approval well into 1998. Glaxo hopes to have a larger expanded access program starting in early 1998.

The company has given two reasons for the small size of the current program: some supply limits due to unexpected difficulties in scaling up the production process to make large batches, and concern about distributing a drug very widely when it has been tested on few people so far.

1592 is expected to be most useful to people who have limited treatment options and need to find a combination which works for them to suppress HIV replication.


Indinavir (Crixivan(R))
Becoming  Available at Many Pharmacies

On May 14 Merck & Co. announced that its protease inhibitor indinavir will soon be available at 27,000 pharmacies. Until now the drug has been sold primarily through one source, Stadtlanders Pharmacy; this system was used so that patients could be counted, to make sure that supplies of the drug would not run out -- which would have forced interruption of therapy and increased the risk of viral resistance.

According to Merck, all pharmacies and clinics are eligible to participate in the new system, but they must register for it, and report the number of patients using the drug.

Patients may continue getting their Crixivan from Stadtlanders, as before. Or they may get a new prescription from their physician and fill it at another pharmacy. Patients can call 1-888-CRIXIVAN to find a participating pharmacy near them, or to ask other questions about the program.


AIDS Internet:
Treatment Information Online
Introduction to a Series

by Tadd Tobias and John S. James

The Internet's World Wide Web provides more choice of current AIDS treatment information than you can find in any other way. Almost all of it is free; and you can get to it any time, from any place with a telephone and computer (or from some public libraries, if you do not have a computer). Unlike sending away for information, you see what you request almost immediately; so if it is not what you want, you can keep looking and follow dozens of leads in one session. And the World Wide Web is so easy to use -- once the equipment and software have been set up -- that you can learn it almost immediately, with no need for training or documentation.

On the other hand, there is a glut of information on the Internet, and quality and credibility vary greatly. The World Wide Web can be pictured as about one million(1) bulletin boards connected throughout the world. Almost anyone who wants to post almost anything can find a place to do so -- and then it is immediately available to millions of people from anywhere in the world, if they are interested in the information, and know or can find out where to look for it. On the whole, quality is higher than one might expect -- probably because truly anonymous posting is difficult and unrewarding, and those who place their work in a public forum want it to look good. (But those with an axe to grind are often inclined to do so in public. For example, few if any sites misspell the names of AIDS drugs -- but some do advise rejecting medical care for AIDS and relying on clean living alone, or on someone's favorite remedy.)

We are organizing this article series around different kinds of AIDS information which readers might seek on the World Wide Web, or elsewhere on the Internet; most articles will focus on one or more major sites, and list others as well. For example, the article below looks at AIDS news, focusing on the AEGIS site. For beginners not already using the World Wide Web, we will publish hints on getting started later.

References

1. Internet Archive in San Francisco is saving a copy of most of the contents of the World Wide Web, for use by future historians and scholars. It has found about one million different Web sites, and an estimated 80 million separate Web pages as of January 1997. For more information, see "Crawling Towards Eternity" by Mike Burner, WEB TECHNIQUES May 1997, pages 37-40. Or see "Preserving the Internet" by Brewster Kahle (the founder of Internet Archive), SCIENTIFIC AMERICAN March 1997, pages 82-83.


AIDS News on the World Wide Web:
AEGIS (http://www.aegis.com) and Others

by Tadd Tobias and John S. James

The well-known AEGIS site (AIDS Education Global Information System), with over 350,000 documents online dealing with AIDS/HIV, is probably the most comprehensive single Web site for AIDS news and general information. Major strengths are (1) mainstream news reports, both current and archival; (2) the AEGIS library, with current and back issues of community newsletters and fact sheets, and government documents and databases; and (3) a clean user interface, and rapid, flexible search engine to find the information you want. AEGIS also allows you to do free AIDSLINE searches (which are available through other Web sites as well), and has a well- organized collection of links to other sites.

AEGIS has been given permission to reproduce many (not all) of the AIDS stories from major media, including THE WASHINGTON POST, THE WALL STREET JOURNAL, LOS ANGELES TIMES, CHICAGO TRIBUNE, SAN FRANCISCO CHRONICLE, SAN FRANCISCO EXAMINER, REUTERS, ASSOCIATED PRESS, BUSINESS WIRE, and AIDS WEEKLY PLUS. It also includes the AIDS DAILY SUMMARY from the U.S. Centers for Disease Control, which summarizes major news stories each weekday and makes the abstracts available for noncommercial use. The result is a huge, free, searchable clipping service of U.S. and some international media on all aspects of AIDS; you can have the stories delivered to you by email (which we will discuss in a separate article), or search on the AEGIS Web site for stories containing any words you specify.

While major newspapers and wire services seldom have information detailed or accurate enough to be useful in medical care, they do tell you that something has happened -- usually the publication of a journal article or conference presentation, or a statement by a major company or recognized expert. The stories probably include the names of potential treatments and/or the people involved -- a starting point for conversation with your physician, or for other research. When you hear part of a story on television or in a rumor, you can usually use AEGIS to find a longer press report; try to remember one or more names or key words to search for. But usually the date of the broadcast will be enough to locate more information on AEGIS about a national news story.

Treatment Newsletters on AEGIS

AEGIS has current and back issues of about 30 AIDS newsletters and other publications. You can search through all of these publications together, or any single one alone, for articles containing any words you specify. Usually AEGIS has all the issues of every newsletter, from #1 up to and including the current issue.

Newsletters on AEGIS include:

* AIDS INFORMATION NEWSLETTER (from the U.S. Veterans Administration)

* AIDS Treatment News

* AIDS TREATMENT UPDATE (published in the UK)

* AIDS WEEKLY PLUS (which has extensive coverage of scientific conferences and publications on AIDS treatments and scientific advances)

* BETA (BULLETIN OF EXPERIMENTAL TREATMENTS FOR AIDS, from the San Francisco AIDS Foundation)

* JOURNAL OF THE INTERNATIONAL ASSOCIATION OF PHYSICIANS IN AIDS CARE

* NOTES FROM THE UNDERGROUND (from PWA Health Group, New York's oldest buyers' club)

* TAGLINE (from the Treatment Action Group)

* TREATMENT ISSUES (from GMHC in New York)

* TREATMENT REVIEW(from the AIDS Treatment and Data Network)

* TREATMENT UPDATE (from CATIE in Canada)

* WOMEN ALIVE

There are also many newsletters, fact sheets, and publications from the U.S. Centers for Disease Control and other government agencies.

Always note the DATE of newsletter articles. We often hear from someone who has read a years-old article as if it were current.

AEGIS -- Other Strengths

* Religious links. AEGIS, started by Sister Mary Elizabeth of the Sisters of St. Elizabeth of Hungary, has a strong collection of links to Web sites of AIDS religious organizations, including Christian, Jewish, Islamic, Buddhist, and interfaith organizations.

* International involvement. AEGIS currently has links to Web sites in Australia, Canada, France, Israel, Malaysia, South Africa, and the United Kingdom. Also, some of its services are available through FidoNet, which connects computer bulletin boards in many parts of the world which do not have regular access to the Internet.

* AEGIS also has links to Web sites of over 20 scientific and medical journals, over 15 U.S. government agencies, and about 15 pharmaceutical companies. There are also links to general health resource Web sites, and separate categories for sites on tuberculosis, and on sexually transmitted diseases.

AEGIS Search Example: Sinusitis

To illustrate searching on AEGIS, we picked sinusitis as a sample topic. From the home page, click "Search" (either the "Search" button, or the underlined word "Search" -- both are exactly the same, which can be confusing at first).

We selected All (meaning to search all databases on AEGIS), entered "sinusitis" as our only search word, and started the search. Within 15 seconds the system found 233 documents which used the word "sinusitis" at least once, and returned titles of the first 10 of them (and a link to get to the next 10 titles, etc., if you want to see them). The system tries to list the most relevant documents first; however, this may or may not be what you want. The "search engine" used by AEGIS allows you to display the found documents in either of two ways: full text with the searched words highlighted, or excerpts from the text showing where the searched words appear. (In the case of medical-journal articles, the "full text" is usually only the abstract, as the full article is unlikely to be available online at all. For the AIDS newsletters and wire service stories, the entire article is usually on AEGIS.)

We looked at some of the 233 titles and documents, and most are indeed relevant, with medical information from around the world about AIDS-related sinusitis and its treatment. Do note the dates; while most of the articles we saw were 1997 or 1996, the first one listed was from 1992.

AEGIS allows a search to be limited to a particular day (for example, a search for "970512" [without the quote marks] will get all articles dated May 12, 1997; this can be used to find very recent documents, such as today's entries, or yesterday's, for example to follow up on a television or radio report). A search can also be limited to a month (for example, "sinusitis and 9701*" will find the sinusitis articles dated January 1997). However, limiting a search to a year (97*) does not work at this time; the system returns no documents, with a message saying that the search would be too expensive to complete.

Other AIDS News Sites

Here are news highlights from several other sites, which we listed in alphabetical order. These sites have much more than the news described here, and we will return to them in future articles.

We have not included news from AIDS conferences, nor newsgroups, nor Web search engines, as we will cover them separately.

ACT UP/Golden Gate

(http://www.actupgg.org)

Two news collections on this site are particularly useful. Most of the AIDS treatment articles written by the ACT UP/Golden Gate Writers' Pool, and published weekly in the BAY AREA REPORTER from 1995 through the present, are available. Also, the news releases (1996 and 1997) provide a history of the work of this leading treatment activist organization.

American Medical Association

(http://www.ama-assn.org/special/hiv/newsline/newshome)

This site, written primarily for physicians, includes: news briefings, current and archived, including REUTERS reports, the AIDS DAILY SUMMARY, and a link to SCIENCE NOW; special reports, in-depth articles from major professional sources; and Journal Scan -- postings of abstracts from major journals and related commentaries, sometimes with links to the full- text articles (which often require registration, however, and may not be free).

Critical Path AIDS Project

(http://www.critpath.org/bulletin.html)

Includes treatment and research news, and Federal, state, and local policy issues.

New York Academy of Medicine

(http://www.aidsnyc.org)

This site is host to many AIDS organizations in New York. A "What's New" link tells what has been posted recently on all of the sites, and the date of each posting. You get the benefit of over 20 different AIDS organizations bringing to the public what they feel is important. Also, upcoming AIDS forum announcements (generally for the New York City area) are posted.

Project Inform

(http://www.projinf.org)

Includes treatment and policy news, action alerts, and press releases.


Help Wanted:
Project Inform  Seeks Hotline Manager

Project Inform is hiring a manager for its AIDS treatment hotline. A resume and letter of interest should be sent by May 30 to HM Search, 1965 Market Street #220, San Francisco, CA 94103.

A detailed job description is available on the Project Inform web site, http://www.projinf.org If you do not have access to the Web, call the Project Inform office at 415/558-8669 to obtain a copy.


California: ADAP Program Adds
Cidofovir, Nevirapine, and Nelfinavir

Three drugs were recently added to the California ADAP (AIDS Drug Assistance Program) formulary. ADAP pays for certain medications for persons meeting income requirements. Although largely funded by Title II of the Federal Ryan White CARE Act, the program varies tremendously among different states -- and recently some states have denied drug access because ADAP financing has not kept up with the increasing interest in AIDS/HIV treatment.

Cidofovir (Vistide(R)) and nevirapine (Viramune(R)) were added to the California ADAP formulary on April 24, and nelfinavir (VIRACEPT(R)) was added May 12.

The current California ADAP drug list (generic names, not brand names) is: acyclovir, aerosolized pentamidine, alpha interferon, amphotericin B, atovaquone, azithromycin, bleomycin sulfate, cidofovir, clarithromycin, clindamycin, clofazimine, clotrimazole, cyclophosphamide, dapsone, dexamethasone, didanosine, doxorubicin, dronabinol, epoetin alfa, ethambutol, filgrastim, fluconazole, flucytosine, foscarnet, ganciclovir, indinavir, itraconazole, ketoconazole, lamivudine, leucovorin calcium, megestrol acetate, methotrexate, nelfinavir, nevirapine, nystatin, paromomycin, prednisone, pyrimethamine, rifabutin, ritonavir, saquinavir, stavudine, sulfadiazine, trimethoprim, trimethoprim/sulfamethoxazole, trimetrexate glucuronate, vinblastine sulfate, vincristine sulfate, zalcitabine, and zidovudine (AZT).


California: Seventh Annual  AIDS
Lobby Day, June 2

On Monday June 2 hundreds of persons from around California will meet in Sacramento to speak with their representatives or staffs about AIDS funding and other AIDS legislation in the state. AIDS Lobby Day is sponsored by the AIDS Budget Coalition, which includes half a dozen major AIDS service organizations.

For more information you can call the San Francisco AIDS Foundation (415/487-3080); or call AIDS Project Los Angeles (213/993-1365). Early registration is important so that appointments can be made with your representatives. AIDS Project Los Angeles is organizing a bus and hotel package for the trip, which will cost about $38. per person.


San Francisco: Lark Lands,
Other Experts to Speak on Nutrition,
Lean Body Mass, and Wasting, June 14

Healing Alternatives Foundation will sponsor a free public seminar on nutritional health and prevention of wasting, on Saturday afternoon June 14, 1:00 p.m. - 6:00 p.m., at the Metropolitan Community Church, 150 Eureka St. (between 18th and 19th Streets) in San Francisco. Scheduled speakers are:

* Carl Grunfeld, M.D., Ph.D., an expert on AIDS-related wasting, who will speak on metabolic dysfunction and wasting syndrome;

* Lark Lands, Ph.D., on using nutrients "to eliminate symptoms, reduce drug side effects, lessen infection risk, improve drug effectiveness, slow disease progression, and prevent internal damage and wasting"; and

* Michael Mooney from PoWeR (Program for Wellness Restoration) who will focus on anabolic steroids and exercise for restoring lean body mass in HIV.

Nutritional counseling and BIA testing (bioelectric impedance analysis, to assess lean body mass) will be available without charge.

For more information, call or come by the Healing Alternatives Foundation, phone 415/626-4053, 1748 Market St. Suite 205, San Francisco; hours are Tuesday through Friday 12-6, and Saturday 12-5.


Copyright 1997 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.





  
  • Email Email
  • Printable Single-Page Print-Friendly
  • Glossary Glossary

This article was provided by AIDS Treatment News.
 

Tools
 

Advertisement