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| T-20 Results TB Guidelines for the HIV Positive |
| From AIDS Treatment News
Contents: Record AIDS Funding from Outgoing Congress T-20 Results Published New TB Guidelines for Persons with HIV U.S. Testosterone Shortage: Call for Information Abacavir (Ziagen(TM)) Approval Recommended Induction/Maintenance Strategy Failed in U.S., French Trials Efavirenz (Sustiva(TM)) Available through Patient Assistance Program Amprenavir (Agenerase(TM)) Submitted for Approval National AIDS Treatment Advocates Forum, December 5-8, Philadelphia Glasgow Conference Reports on Web Lipodystrophy, Anemia, Resistance, Other Articles at Web Site Help Wanted, AIDS Treatment Writer, New York California: Medicaid Expansion Needs Quick Attention after the Election Youth Consent, Confidentiality for Counselors, San Francisco December 1
Record AIDS Funding from Outgoing Congress By John S. James
 AIDS funding received large increases for fiscal year 1999
(which started in October 1998). According to numbers
provided by the AIDS Action Council:
Comment The success of AIDS funding in this Congress was due to several lucky conditions, not all of which will be repeated. The federal government had an unexpected surplus, our legislative advocates were in place, and they could call on the community for grassroots support. But also, this Congress was heavily distracted by other affairs, and with money on its hands, threw it at a lot of things and went home. It would be a serious mistake to count on good fortune in the future. Instead we need to broaden our focus, and work more with other health constituencies. On non-funding issues, AIDS-related legislation was mostly negative or mixed. Congress not only prohibited Federal funding of needle exchange for an additional year, it also included language which threatens Federal funding for any organization which conducts needle exchange, even with private dollars. And it prohibited the local Washington D.C. government from funding needle exchange there. On another issue, the Senate confirmed the new FDA commissioner, Jane Henney. According to Biocentury Extra (October 22), she was confirmed moments before the Senate adjourned, and only after she had promised in writing not to seek a manufacturer of RU-486, (the "abortion pill" which may also be useful in treating breast cancer and other diseases). Also in its last-minute rush, Congress passed a law to federally regulate content of the Internet, to prevent pornography from reaching children. We do not yet know if it could threaten AIDS prevention information. Medical Marijuana
 On medical marijuana, Congress passed a compromise resolution
requiring the FDA to report in 90 days on efforts to have
marijuana considered for approval as a prescription drug.
This is progress, and the original resolution was much worse,
as it would have put Congress on record as opposing medical
marijuana entirely.
But we are concerned that the FDA is not set up to consider this issue well. The FDA institutionally favors chemical entities over plant parts, and drug approval typically requires studies taking years and costing millions of dollars--a largely pointless exercise when trying to measure subjective relief. Who will produce such data for marijuana? What is needed instead is flexibility now in letting patients find the relief that works for them--while researchers isolate and develop the (probably non-psychoactive) cannabis ingredients which are now suspected of providing much of the medical benefit of the plant. Eventually these will be developed as conventional new drugs, and in rich countries at least the need for medical marijuana will largely go away. The outgoing Congress had other ideas. It nullified in advance the November 3 Washington D.C. vote on medical marijuana, by forbidding the city's local government from spending any money to count the votes or certify the result; the ballots had already been printed, however, and we have heard that the votes will be counted automatically, although the election result cannot become law. Congress also authorized money to biologically engineer a fungus to destroy marijuana plants. T-20 Results Published By John S. James Complete results on the first multi-dose human trial of T-20 were published November 2 in Nature Medicine 1 with an accompanying editorial 2. In summary:
Comment This trial was first reported over a year ago (September 16), at the IDSA (Infectious Diseases Society of America) meeting in San Francisco3; we summarized that presentation in AIDS Treatment News issue #279, September 19, 1997. Unfortunately that report received little public attention, for several reasons. The technical details have not been published until now; the drug's mechanism of action is new and difficult to understand; the sponsoring company (Trimeris, Inc., in Durham, North Carolina) was in a "quiet period" at the time of the conference and could not publicize the results; and there were very few treatment activists at that particular conference. In this trial T-20 was administered intravenously twice a day. It is likely that the drug can be administered more efficiently subcutaneously, by a portable computerized infusion pump, like the pump widely used in diabetes treatment to administer insulin. This study has clearly established proof of principle for a drug with an entirely new mechanism of action (which means, among other benefits, that no cross-resistance is expected between T-20 and any treatment now in use). Viral resistance to T-20 does occur; it is not known how much problem it will cause in practice. It is possible that resistance might be managed by using T-20 to shut off viral replication almost completely--since blood levels can be much higher than necessary to prevent replication, and the infusion pump eliminates food, absorption, and peak-trough issues, and should greatly improve adherence. Other possible approaches for managing resistance include combining T-20 with other antiretrovirals, or creating a new version of T-20 to target the resistant virus. A new trial, TRI-003, is currently recruiting and about half filled as we go to press (see AIDS TREATMENT NEWS #300, August 7, 1998). It will obtain longer-term viral suppression data, and verify dosage for the infusion pump. It will also check to see if the body produces antibodies against T-20-- which might or might not be a problem in long-term use. Currently T-20 is difficult to produce in large quantities. But there is little doubt that efficient manufacturing methods can be developed. References 1. Kilby JM, Hopkins S, Venetta TM, and others. Potent suppression of HIV-1 replication in humans by T-20, a peptide inhibitor of gp41-mediated virus entry. NATURE MEDICINE. November 1998; volume 4, number 11, pages 1302-1307. 2. Richman DD. Nailing down another HIV target. NATURE MEDICINE. November 1998; volume 4, number 11, pages 1232- 1233. 3. Saag M, Alldredge L, Kilby M and others. A short-term assessment of the safety, pharmacokinetics, and antiviral activity of T-20, an inhibitor of gp41 mediated membrane fusion. IDSA 35th Annual Meeting, San Francisco, September 16, 1997 [abstract #771]. New TB Guidelines for Persons with HIV
On October 30 the U.S. Centers for Disease Control announced
published guidelines for prevention and treatment of
tuberculosis in persons with HIV. Some highlights of the
current guidelines:
All persons with HIV should be screened for tuberculosis, and treated if necessary. The TB drug rifampin should not be used together with protease inhibitors or non-nucleoside reverse transcriptase inhibitors, because it can seriously impair the effectiveness of those antiretrovirals. But another TB drug, rifabutin, can be used with antiretroviral treatment. There is now a two-month preventive treatment for persons who have been infected with tuberculosis, as an alternative to the traditional one-year isoniazid regimen. Copies of the document can be obtained by calling 404-639- 8063, or from various Web sites including http://www.healthcg.com/hiv. U.S. Testosterone Shortage: Call for Information By Tadd Tobias and John S. James There is a nationwide shortage of certain injectable testosterone products. At this time we do not know how serious the problem is.
How the Shortage Happened On September 10, 1998 the FDA moved against Steris Laboratories, Inc. (a division of Schein Pharmaceutical, Inc.), seizing large stocks of their drugs and ordering a halt in further production of all products at that facility; Steris, located in Phoenix, Arizona, laid off about 350 workers. The FDA has not said that any of the drugs are bad, but that the company had not followed required procedures for documenting quality assurance. Steris had been manufacturing all the generic testosterone cypionate and enanthate sold in the U.S., even that which is sold by other companies. On October 16, 1998, a "Consent Decree of Condemnation and Permanent Injunction" between the FDA and Steris allowed the company to resume distribution of some but not all of its products. The consent decree (which is public information) includes an "Exhibit C" of drugs which the FDA has determined are medically necessary. Steris will re-test the seized stocks of these drugs, and return them to the market if possible; also, it will resume manufacturing, when permitted, for these products. However, Exhibit C does not include any form of testosterone, apparently because the FDA believed that enough other companies were marketing equivalents of the drug; the FDA has approved about three dozen testosterone preparations of about a dozen different companies, but at this time does not know how many are currently on the market. Exhibit C also includes chorionic gonadotropin 5,000 U/vial and 10,000 U/vial (sometimes used to help restart endogenous testosterone production after discontinuation of testosterone therapy) and nandrolone decanoate 100 mg/mL and 200 mg/mL-- suggesting that if any shortages of these drugs develop, they should be temporary. Steris did list testosterone cypionate and enanthate 200mg/mL in Exhibit A (drugs it wants to resume manufacturing when possible). It lists a lower concentration of both testosterone cypionate and enanthate (100mg/mL)--and also nandrolone decanoate 50mg/mL--in Exhibit B (products it may withdraw from the market). Call for Information We have been told that no generic testosterone cypionate or enanthate is currently being manufactured for U.S. sale. Pharmacies and distributors may have inventory of enanthate, and manufacturing may be resumed. Most of the non-generics should remain available. If you have any additional information about supply of generic testosterone, non-generic testosterone, nandrolone, other anabolics, or chorionic gonadotropin, please let us know; contact Tadd Tobias at AIDS Treatment News, 415-255-0836 or ttobias@aidsnews.org. Abacavir (Ziagen(TM)) Approval Recommended On November 2 the FDA Antiviral Drug Products Advisory Committee recommended accelerated approval of abacavir (brand name Ziagen). The vote was 7-2. The most important trial compared abacavir plus AZT plus 3TC vs. indinavir plus AZT plus 3TC. In preliminary analysis at 16 and 24 weeks, the two groups looked very similar. This study is still blinded, so it is not known which group is receiving which combination. Extensive information about this drug will be available in a transcript of the meeting, which will be placed on the FDA Web site. For instructions on finding the transcripts there, see "Abacavir (Ziagen(TM)) Advisory Committee Meeting, November 2," in AIDS TREATMENT NEWS #304, October 2, 1998. Induction/Maintenance Strategy Failed in U.S., French Trials Two similar trials, one in the U.S. and one in France, tried switching patients to less-intensive treatment after triple combination therapy had reduced viral load to a relatively low level. In both cases, viral load returned more often in the patients who were switched to the less intensive regimens, than in those who remained on three drugs. But even for those switched to the less-intensive regimens, a majority did not have their viral load return by the time the study was stopped. In both trials, the patients started with indinavir (Crixivan®) plus AZT plus 3TC. In the U.S. study, they were randomized to either continue triple therapy, or switch to AZT plus 3TC, or to indinavir alone. In the French study, they were randomized to either continue triple therapy, switch to AZT plus 3TC, or switch to indinavir plus AZT. Both trials were first presented as late breakers at the 5th Conference on Retroviruses and Opportunistic Infections, Chicago, February 1-5, 1998. The full papers for both1,2, plus an editorial3, were published October 29 in the New England Journal of Medicine. References 1. Havlir DV, Marschner IC, Hirsch MS and others. Maintenance antiretroviral therapies in HIV-infected subjects with undetectable plasma HIV RNA after triple-drug therapy. New England Journal of Medicine October 29, 1998; volume 339, number 18. 2. Pialoux G, Raffi F, Brun-Vezinet F, and others. A randomized trial of three maintenance regimens given after three months of induction therapy with zidovudine, lamivudine, and indinavir in previously untreated HIV-1- infected patients. New England Journal of Medicine, October 29, 1998; volume 339, number 18. 3. Cooper, DA. Therapeutic strategies for HIV infection--Time to think hard. New England Journal of Medicine, October 29, 1998; volume 339, number 18. Efavirenz (Sustiva(TM)) Available through Patient Assistance Program
Several states, including California, Pennsylvania, and New
York, have not yet added efavirenz (Sustiva) to their AIDS
Drug Assistance Program (ADAP) formulary, due to concern that
a new wave of high drug prices could make it impossible to
assure uninterrupted supply of important medications. DuPont
Pharmaceuticals has assured the community that people who
need the drug will not be denied it. The company, like most
large companies in the pharmaceutical industry, has set up a
patient assistance program to locate possible sources of
reimbursement, and if necessary provide the drug to persons
who have no other way to pay for it.
For information about this program, physicians and patients can call 800-334-4486. Amprenavir (Agenerase(TM)) Submitted for Approval On October 16 Glaxo Wellcome announced that it has submitted the new protease inhibitor amprenavir (brand name Agenerase) for U.S. drug approval; four days later it also filed for approval in Canada and in Europe. Amprenavir was developed by Vertex Pharmaceuticals Incorporated, and will be marketed by Glaxo Wellcome under a partnership between the two companies. National AIDS Treatment Advocates Forum, December 5-8, Philadelphia The National AIDS Treatment Advocates Forum will be held this year from December 5-8, at the Crowne Plaza Philadelphia Hotel. It is being organized by the National Minority AIDS Council with the support of eight other AIDS service, information, and research organizations. The registration fee after November 9 is $175. This year's program will be organized in three conference tracks: Clinical Research and Drug Development; Research Policy and Legislation; and Treatment Education and Advocacy. For more information, contact Oscar Lopez, 202-483-6622x327, or olopez@nmac.org. Glasgow Conference Reports on Web
The 4th International Conference on Drug Therapies in HIV
Infection took place in Glasgow, Scotland, November 8-
12. Those who were unable go can find information on the Web:
There may be other Web coverage as well.  Lipodystrophy, Anemia, Resistance, Other Articles at
Web Site
Recent articles on the Healthcare Communications Group Web site include:
For more information about the Healthcare Communications Group Web site, http://www.healthcg.com/hiv, contact Edward King, eking@healthcg.com. Note: On October 29 Medscape announced that it would be acquiring Healthcare Communications Group. Medscape runs a free site, http://www.medscape.com, which currently has 800,000 registered members, including 150,000 physicians; the Medscape site has 18 specialty home pages, including one on AIDS. Users of the Healthcare Communications Group site should not be affected, since a major purpose of the merger is to apply that site's approach to other Medscape specialties as well. Medscape CEO Paul Sheils explained the thinking behind the merger: "Physicians are among the busiest professionals in the world. They need fast, practical answers to their tough clinical questions; and they rely on experts to tell them quickly and succinctly about the latest developments and new drug therapies. Clinicians require access to that critical information from wherever they are: the office, the hospital and home. Everything we do at Medscape is designed to satisfy those fundamental needs. By combining the comprehensive, original state-of-the-art programs from HCG with the depth and breadth of Medscape's comprehensive databases, into an easy-to-use, free site, accessible from any browser anywhere, we are able to provide physicians with the tools they need to get those answers fast and stay on the cutting edge of medicine." [AIDS Treatment News is publishing a series of short articles on major AIDS treatment Web sites, focusing on important new material on each. All these sites can be reached from the AIDS Treatment News link site, http://www.aidsnews.org; you only need to remember "aidsnews.org" to get to any of this information.] Help Wanted, AIDS Treatment Writer, New York Treatment Issues, the AIDS treatment newsletter published by Gay Men's Health Crisis in New York, urgently needs a new associate editor to start as soon as possible. "The ideal candidate will have a history of writing medical news articles and being familiar with AIDS treatment activism. A demonstrated ability to translate complicated pharmaceutical and medical data into popular language is essential. Salary is in the high 30s. Send applications, including resume, writing samples, and salary requirements, to CJ Bacino, Human Resources Dept., Gay Men's Health Crisis, 119 W. 24th St., New York, NY 10011 (fax: 212-367-1527)." California: Medicaid Expansion Needs Quick Attention after the Election By John S. James Medicaid, the government program for medical care for persons with low income, is today the largest provider of healthcare for persons with AIDS. But to be eligible for Medicaid, a patient needs not only a low income, but also an official diagnosis of "disability"; therefore persons with HIV who need medical care cannot get Medicaid, no matter how low their income, until they first get sick enough to qualify. It would certainly be better for them, and it may also cost less money, to start treatment earlier, before their illness has progressed enough that they are officially disabled. Vice President Al Gore took the lead in considering Medicaid expansion nationwide for persons with HIV. It did not happen, however, because it could not be proved to cost no more than the present system. Meanwhile, individual states can implement this policy in their own Medicaid systems. In California, a serious Medicaid-expansion effort was underway in the office of outgoing Republican Governor Pete Wilson, at the initiative of several AIDS organizations. The new Democratic governor, Gray Davis, is expected to be sympathetic. But it is important that the new administration hear from the AIDS community early, that this issue is important to us. A successful program in California would be very helpful in gaining similar access to care in other states, or in the U.S. as a whole. Youth Consent, Confidentiality for Counselors, San Francisco December 1 Two nationally recognized experts will speak on the often- problematic task of maintaining confidentiality when counseling young clients under California laws. Therapists are required to call law enforcement in some cases--if the minor has sex with an adult, for example--whether or not that is in the interest of the client. Also, parental consent is sometimes required. Addressing such issues will be Erica Monasterio, F.N.P., associate clinical professor, University of California San Francisco Division of Adolescent Medicine, and Catherine Teare, M.P.H., health policy analyst, National Center for Youth Law. This program is sponsored by Health Initiatives for Youth. The seminar will be held Tuesday, December 1, 2:00 p.m. to 4:30 p.m., at San Francisco State University Downtown Center, 425 Market Street, 2nd floor (at Fremont Street), rooms 8 and 9. There is no charge, but space is limited and you should reserve a place by calling Helen at Health Initiatives for Youth, 415-487-5777, ext. 17, by November 23, 1998. AIDS Treatment News Published twice monthly Subscription and Editorial Office: P.O. Box 411256 San Francisco, CA 94141 800/TREAT-1-2 toll-free U.S. and Canada 415/255-0588 regular office number Fax: 415/255-4659 E-mail: aidsnews@aidsnews.org
Editor and Publisher: John S. James Associate Editor: Tadd T. Tobias Reader Services: Tom Fontaine and Denny Smith Operations Manager: Danalan Richard Copeland Statement of Purpose: AIDS Treatment News reports on experimental and standard treatments, especially those available now. We interview physicians, scientists, other health professionals, and persons with AIDS or HIV; we also collect information from meetings and conferences, medical journals, and computer databases. Long-term survivors have usually tried many different treatments, and found combinations which work for them. AIDS Treatment News does not recommend particular therapies, but seeks to increase the options available. Subscription Information: Call 800/TREAT-1-2 Businesses, Institutions, Professionals: $270/year. Includes early delivery of an extra copy by email. Nonprofit organizations: $135/year. Includes early delivery of an extra copy by email. Individuals: $120/year, or $70 for six months. Special discount for persons with financial difficulties: $54/year, or $30 for six months. If you cannot afford a subscription, please write or call. Outside North, Central, or South America, add air mail postage: $20/year, $10 for six months. Back issues available. Fax subscriptions, bulk rates, and multiple subscriptions are available; contact our office for details. Please send U.S. funds: personal check or bank draft, international postal money order, or travelers checks. ISSN # 1052-4207 Copyright 1998 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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