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AIDS Treatment News
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Glossary
Viral Immunology Advances Suggest Treatment Strategiesby John S. James |
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Two practical consequences have been suggested by a number of researchers: (1) Effective antiretroviral treatment early enough -- probably during primary infection with a regimen including protease inhibitors -- may allow the specific anti-HIV responses to be preserved, as they seem to be in long-term nonprogressors. Early experience from treatment of patients during primary infection supports this possibility. (2) Later in HIV disease, antiviral treatment which results in undetectable viral load generally does not lead automatically to the return of these specific anti-HIV T- helper cells. However, there is reason to believe that they still could be induced by vaccination while the infectious virus is suppressed by antiretrovirals. Several approaches -- killed-virus vaccine, certain HIV antigens produced by genetic engineering, or DNA vaccines -- are feasible to try now. References
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New Meeting on Immune Surrogate MarkersBaltimore, January 9-11 |
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The "First Annual Immune Function and Surrogate Markers: Setting the Goal Line" will take place at the University of Maryland, Baltimore campus; rooms have been reserved at the Hyatt Regency Baltimore. Conference registration is $200 for academic registrants, $300 for corporate. Registration is requested if possible by December 15. For more information, including the program and the registration form, contact Jeffrey Meshulam, Institute of Human Virology, 410-706-8614, fax 410-706-1952, email ihvinfo@umbi.umd.edu. |
FDA Approves New Kind of Lymphoma Treatmentby John S. James and Greg Dubs, Ph.D. |
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Rituximab works by killing B-cells, both normal and cancerous; the body can replace the normal cells after several months. B-cells produce antibodies for fighting certain infections, but no increase in infections has been found so far. Side effects of this treatment are usually much less than with conventional chemotherapy. In one trial in 166 patients with relapsed or refractory low- grade non-Hodgkin's lymphoma (those with large tumors were excluded from this study), 6% of the volunteers had a complete response, and 42% had a partial response.1 In another trial, 46% of patients responded to rituximab treatment after they had failed conventional therapy; of the 17 responders, 14 had partial remission and three had complete remission.2 Combination use with chemotherapy seemed to work especially well in another trial.3 Forty volunteers with low-grade lymphoma were entered, 80% of them with no prior therapy. Of the 35 who completed the treatment, the response rate was 100% (60% complete response and 40% partial response). Of the other five, two did not receive treatment, and the three others had a partial response. In addition, there is laboratory evidence that the antibody may re-sensitize tumor cells that had become resistant to the chemotherapy.4 There is concern that rituximab might be dangerous if used as initial therapy if there is a high tumor burden, because of possible toxicity from killing too many B-cells at once. To avoid this, other treatment may be used first to reduce the tumor burden. There is interest in not waiting for the chemotherapy to fail (as the officially approved indication suggests), but instead using the antibody sooner. The approved rituximab treatment is four doses over a 22-day period -- because this is what was used most in the important clinical trials. Unfortunately, the drug price to physicians for the four-course treatment is about $11,000; it is expected that insurance will pay in some cases, but be a problem in others. Rituximab was discovered by IDEC Pharmaceuticals Corp., and developed by IDEC and Genentech Inc. It is being marketed in the U.S. by Genentech. Genentech has established a toll-free number to help with reimbursement problems, and has an Uninsured Patients Assistance Program to "provide assistance to patients whose physicians recommended treatment with Rituxan, regardless of the patients' economic or insurance status." We do not have the phone numbers or additional information at press time. A newly formed Lymphoma Action Group began shortly before the approval. It will be working especially on increasing access to the drug, particularly for persons with HIV or others with high-grade lymphoma (who may need the most help with access, since the official indication is for low grade). To contact the group, leave a message at 415-790-5716. References
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Major AIDS Institute Inaugurated in San Francisco |
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"The next generation of answers requires a deeper level of collaboration," said Thomas Coates, Ph.D., director of the Institute, and professor of medicine, epidemiology, and statistics at UCSF. "The important answers will come at the interface of the sciences. It's clear we cannot answer clinically important questions without bringing people together." The AIDS Research Institute will provide "both financial and practical support for a broad range of initiatives, including vaccine research, development of new therapies, studies of transmission dynamics, prevention science, AIDS policy and ethics research, a new clinical virology and immunology lab, and international and community studies. It will also provide the mechanism for meetings of scientific minds through town hall forums, peer review sessions, focus groups and 'targeted action groups,' in which a dozen or so researchers will meet to plan multidisciplinary studies." The executive committee consists of Haile T. Debas, M.D. (Chancellor and Dean of the School of Medicine at UCSF), Margaret A. Chesney, Ph.D., Thomas J. Coates, Ph.D., Warner C. Greene, M.D., Ph.D., John S. Greenspan, B.Sc., B.D.S., Ph.D., Jay A. Levy, M.D., Paul A. Volberding, M.D., and Diane W. Wara, M.D. For more information, see the UCSF AIDS Web site, http://hivinsite.ucsf.edu/ari |
Protease Inhibitor InformationFDA Fact Sheet Available |
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The current edition, last updated in October, includes information on dosage, relation to food, storage requirements, warnings and precautions, most frequent adverse effects, pediatric use, medications that should not be used with each protease inhibitor, and drug interactions requiring dose adjustment. There is also a list of suspected interactions, especially with ritonavir (suspected due to the metabolism of the drugs, although clinical trials to check for these interactions have not been done), and advice on reducing risk if these combinations must be used. Some information on dosing when using two protease inhibitors simultaneously is provided in this section. The reading level is appropriate for medical staff or informed patients. Comment: This authoritative and non-promotional publication will help patients understand their options, and also help assure that instructions provided with protease-inhibitor prescriptions are correctly understood. Failure to follow instructions for use of drugs is a major problem in medicine, and the consequences are especially serious with HIV treatments, particularly protease inhibitors. Sometimes the instructions are not followed because the patient never understood them. And sometimes instructions are wrong, as when drugs are combined incorrectly. This brochure will help assure that patients understand the instructions, and may bring potential errors to the attention of medical staff. The Protease Backgrounder is available on the World Wide Web under FDA's HIV/AIDS Therapeutic Index, found at: http://www.fda.gov/oashi/aids/piindex.shtml, or by calling the FDA Office of Special Health Issues at 301-827-4460. |
Protease Inhibitor Failure TrialCombination 1592, 141W94, and Efavirenz |
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Volunteers are 13 or older, with viral load over 500 copies despite treatment including a protease inhibitor. They must have been receiving the same protease inhibitor(s) for the most recent 12 weeks and continuing until the start of the study medication. They must not have used 1592, 141W94, or efavirenz (also called SUSTIVA™, or DMP-266) before; also, certain other treatments must not have been used within 30 days. There are other criteria, including no AIDS-defining opportunistic infection or malignancy except Kaposi's sarcoma, and a negative pregnancy test for women. This is an open-label study, meaning everyone receives the three medications. There is no randomization or control group. The goal is to study the antiviral activity of the drug combination, and also its safety and tolerability, when existing regimens do not fully control the virus. Each of these drugs has side effects. For each one, rash is the most common reason for which the drug has had to be discontinued. |
New AIDS Bookstore on World Wide Webby John S. James |
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This site is also noteworthy as an example of a kind of online business and community structure which we believe will become much more important over the next few years, and which is likely to have other uses in AIDS, including buyers clubs and possibly pharmacies. How to Use the SiteFrom the Immunet home page, select the Online Bookstore; most users will then search for books by one or more keywords. As a test, we entered "nutrition" and found 36 books on AIDS and nutrition; a search on "pathogenesis" found 27 books. Most of the books we found have reviews available. You can also search for author by entering a last name as a keyword.For each book, you can read the review if any, and can obtain ordering information, including price and an estimate of how long it will take to be shipped (usually a few days, but if delivery is likely to be delayed, you know that before placing the order). The reviews are provided by the AIDS Book Review Journal, of the University of Illinois. Orders are processed and shipped by Amazon.com, a large and well-known online bookstore. It is no accident that most of the books which were found in our searches do have reviews. This is because the search will examine the title, and also the review if there is one; and it is more likely that the exact word being sought will occur somewhere in a lengthy review of a relevant book, than in the much shorter title. The "nutrition" search, for example, found 24 books that were reviewed and 12 that were not; all of the books that were not reviewed had "nutrition" (or "nutritional") in the title, or they would not have been found. This system works for most users, because presumably the most important books are likely to be reviewed, and yet the others can be found as well. As of December 2 the list of non-reviewed AIDS books is preliminary and appears to have been computer generated. Suggestions for improvement -- especially books that should be listed but are missing -- can be sent to Gary Schaff, gschaff@immunet.org, or to Tony Brooks, tbrooks@immunet.org. Comment: Community BuildingA major key to successful Web sites is community building. Large merchandising organizations are seldom good at that. On the other hand, community-based or specialized interest groups are seldom effective at running a large business efficiently (processing orders, shipping books, building relationships with suppliers, etc.); this is not what they want to do. Unlike other media, the World Wide Web allows orders to be passed from the community organization to the merchandiser with zero cost and zero delay.All the parties can benefit. The community group earns a referral fee for orders it generates (5 to 15%, according to Immunet's press release), without having to process or ship the orders -- creating a fundraising tool for organizations. The merchandiser receives orders with guaranteed profit, as there is no up-front cost for advertising or promotion. Customers can use a site built around their needs and interests, and still receive discounts and pay no more than if they placed their orders elsewhere. Ultimately the negotiating leverage rests with the community organizations, not the merchandisers, even when the latter are much larger entities. For as the online market develops, there will be a number of competing merchandisers, all offering about the same prices and services. A community group can take its business to any of them; there is no "Microsoft effect," no natural monopoly based on a mutual benefit in everybody using the same system. But while merchandisers are generic, each community is unique; whoever brings the people has the controlling advantage. This dynamic can provide some antidote to the increasing centralization and remoteness of modern institutions. We believe that this kind of arrangement could be important for AIDS or other buyers' clubs -- which could offer huge selections at low prices by referring fulfillment of routine orders to selected commercial suppliers, while shipping the most specialized orders themselves. |
Revised Federal Antiretroviral Treatment Guidelines |
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The new Web site of the University of California San Francisco, http://hivinsite.ucsf.edu/, has links to the new draft, both the official release with the original graphics, and also in a Web format more convenient for many users. In addition, it has links to about a dozen other major AIDS- related treatment guideline documents. A review of the changes, by Edward King of AIDS Treatment Update in London, is available at http://aids.miningco.com/library/weekly/aa111697.htm |
FDA Reform Signed into Lawby John S. James |
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Also, there can always be "sleepers," inconspicuous phrases which are added by special interests and become law by surprise. Today it is common that neither the public nor members of Congress know exactly what is in a major bill when the final vote is taken. The bill will probably not fix the very serious delays early in the development process, when an experimental drug is first entering clinical trials. This issue unfortunately dropped out of the discussion early on, and has never received sustained national attention. It is hard to build political momentum around events which occur early, before a compound has become a therapeutic option for people. Most AIDS organizations and activists have not been involved in the discussion and debate about this bill. Of those who were involved, most were strongly opposed; they worked through a new group called the Patients' Coalition. One organization, the Log Cabin Republicans, strongly supported the bill. CommentWe doubt that the new law will have a major near-term impact on AIDS drug development, since the fast-track provisions mostly legislate what the FDA has done already for the most clearly important AIDS drugs. The law should, however, encourage more attention to surrogate markers for drugs other than antiretrovirals -- for AIDS and other serious illnesses as well.The other big change, allowing limited promotion of off-label uses, has become framed as a debate between consumer protectionists and industry. ("Off-label" use means that a drug approved by the FDA for one use is prescribed by doctors for another purpose. It has long been recognized as legal and proper for physicians to do this; however, pharmaceutical companies could not promote such uses. They could give doctors peer-reviewed articles if asked, but could not take the initiative to provide them, even to a doctor.) Opponents say that the new law will allow companies to profit from uses not proved safe and effective, will remove incentive for companies to get their drugs approved for new uses, and will result in more prescriptions not being covered by insurance. They fear that companies could start promoting new uses just by announcing that they will file an IND, doing the minimal paperwork, and repeating the process whenever necessary; the law requires an IND (so that the offlabel uses will be researched and, if proven, come onto the label), but cannot stipulate that the IND be a credible one. On the other side, industry sees the new revenue streams from off-label uses as particularly important to small biotech companies which can only afford to go for one approval at a time. What needs more attention is the apparently large number of people with serious health problems which could be successfully treated with available drugs, but who are never told that by their doctors, even though credible evidence has been published. The number of cases of people who learn by happenstance, through friends, newsletters, or noticing a story in the news, suggests that there are probably hundreds of thousands, possibly millions, who could benefit substantially from known off-label uses of available drugs, but who are not receiving that help today. Most doctors will not bring up treatments which are outside the mainstream and are not promoted. In recent years the FDA has made it easier for companies to get these new indications approved, which is commendable; but many valid uses will never be submitted for approval (with or without the new legislation), especially if they are inexpensive and therefore will not generate revenue to cover development costs. The new law may have created the first institutional incentive to bring such treatments into use. Hopefully industry will use this new power responsibly -- and medical and public-service organizations will be ready to call companies on any abuses. |
Press Must Register Now to Cover February Retroviruses MeetingDecember 29 Deadlineby John S. James |
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"5th Conference on Retroviruses and Opportunistic Infections, Press Registration Information:"Press registration applications will be reviewed by members of the Scientific Program Committee. Applications from community newsletters will be reviewed by the Community Liaison Subcommittee. All press must preregister. There will be no on-site registration. "Who May Register "Representatives from the following media may register as press:
"Medical communications companies, financial press, biotechnology newsletters, public relations firms, and noneditorial staff such as publishers and representatives of sales, marketing, or advertising departments are not eligible for press registration. Individuals, agents, or contractors providing coverage for or being sponsored by industry may not register as press. "Freelance writers should provide proper credentials as well as a letter of assignment from a publication. Unassigned freelance writers may not register as press. "Any publication, supplement, or electronic product devoted exclusively to the coverage of the conference must have prior written approval of the Scientific Program Committee (e.g., meeting highlights, on-line conference proceedings/reporting, audio conferences, etc.). Media campaigns at the conference and distribution of company-sponsored press releases (both at the conference and off-site) are not permitted preceding or during the meeting dates. "How Many May Register "Press registration is limited to 180. Up to two reporters per publication, publication group or electronic news-media service may register as press. Applications for a second reporter will be considered after all other requests have been received, and registration privileges will be provided if the limit has not already been reached. Additional badges (above the allotment of 2 per media outlet) providing admittance to press conferences will be available for television crews. "How To Register "Requests for press registration should be submitted (preferably on the attached registration form) along with the materials listed below: "Press who have been credentialed for the conference in the past 2 years should include: "1. a letter from the editor (or masthead with reporter's name listed) "2. sample of a recent article (preferably from the last Retrovirus Conference, demonstrating previous coverage, and with a byline) "Press who have not registered for previous Retrovirus Conferences should include: "1. a letter from the editor "2. copy of one recent article (published within the past year and preferably with a byline) "3. sample publication "Send the above materials to: "Deadline "The deadline for press registration is December 29, 1997 (or until the press block has filled, whichever occurs sooner). All applications will be handled on a first-come, first- served basis. Within two weeks of receipt of press application and after press credentials have been reviewed and approved, a confirmation letter and housing information will be sent. A press kit and final program and abstracts book will be sent two weeks prior to the Conference to all preregistered press."
The 5th Conference on Retroviruses and Opportunistic Infections "is sponsored by the Foundation for Retrovirology and Human Health and is held in scientific collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention (CDC)." The secretariat is the Westover Management Group, 703-684-4876, fax 703-684-4841. |
Correction:
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December Deadline for Charitable Giving and Tax Reliefby John S. James |
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One charity we suggest is AIDS Treatment News Associates, 584-B Castro Street, San Francisco, CA 94114. A 501(c)(3) organization, ATNA reimburses free subscriptions for persons who cannot afford to pay for AIDS Treatment News. Contributions to ATNA relieve us of a serious financial burden, since AIDS Treatment News has never turned people away but sends free subscriptions at our expense when necessary. And to guard our independence we do not accept pharmaceutical-company contributions, even for charitable purposes. The changing epidemic during the last several years has meant that more people who need and request this information cannot pay even the cost of printing and mailing their newsletter; we have become payers of last resort. We need assistance to avoid spending more and more time working around financial constraints, time we could better devote to our work. For more information, contact me at AIDS Treatment News, or at 415-255-6259.
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. |
This article was provided by AIDS Treatment News. It is a part of the publication AIDS Treatment News.
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