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Agouron and Immune Response to Commercialize Remune Immune-Based Treatmentby John S. James
Remune is the HIV treatment vaccine developed by the late Dr. Jonas Salk. It is currently in a phase III trial in which 2500 patients were randomized to receive the treatment or not once every three months -- in addition to standard antiretroviral therapy. The trial finished enrollment in May 1997, and is expected to be completed in April 1999.
Immune-based treatments have been difficult to test, because there is no surrogate marker (like viral load for antiretrovirals) which is well-established for quickly telling if a drug is working, and predicting long-term clinical benefit. Without a surrogate marker, trials must wait for "clinical endpoints" -- persons becoming ill -- to see if those with the new treatment do better than those without it. That is why a Remune trial with 2,500 volunteers is now being conducted.
Agouron decided to get involved after reviewing the data available, including "encouraging preliminary results from a small study of Remune taken in combination with highly active antiretroviral drugs -- results that will be presented at the upcoming 12th World AIDS Conference in Geneva later this month" (Agouron press release, June 11; the reference is to a report to be presented by Fred Valentine, M.D., of New York University).
12th World AIDS Conference, Geneva, June 28-July 3
How to Participate from Homeby John S. James
Those not going to Geneva can receive video coverage as well as detailed summaries on the World Wide Web, at any time 24 hours a day, during the conference and for months after. They can also participate in discussions of conference topics through email lists. In some ways it is possible to follow the news better through the Internet than by being in Geneva, since many sessions are simultaneous and it is hard to know in advance what will be important. But teams of experts will attend all the major sessions and write detailed reports of the most important talks; these will be available without charge around the world, often by the next day. And the Internet video will allow users to skip ahead in a lecture, switch to another one at any time, or look back to view a section which only later was recognized as important.
For those without a computer, expert review sessions are available by telephone, or by video in certain cities. And of course AIDS newsletters and other publications will have more extensive and reliable reports than the newspapers. (AIDS Treatment News will report on the Geneva conference mostly in our next two issues, #298 and #299. Issue #298 will be delayed a week and be mailed on July 10, since we will be in Geneva on the regular publication date.)
In addition there will be many local lectures providing expert reviews of the conference; check with AIDS organizations in your area to find out about these. For example, in San Francisco, the University of California AIDS Research Institute and Project Inform will present a Post Geneva Symposium, Monday July 22, 2-5 p.m. on the UCSF campus; for more information, see http://hivinsite.ucsf.edu.
Below are some of the major Web sites for following the results of the conference, official email discussion lists, and some other reviews by telephone or video. All of the information listed in this article is available without charge.
Those following the conference should be aware that it is divided into four major tracks:
In addition there are officially-recognized "satellite" sessions (in two categories, commercial and non-commercial), and many community and skills-building programs organized or recognized by the conference. There will undoubtedly be public meetings which are not part of the official schedule, but it is hard to learn about these in advance; we only know of a handful, all of them by pharmaceutical companies (which could afford to spread the word independently). We will watch for others through the general literature table at the conference.
Because Web users around the world could overload a single computer during the conference, the organizers have set up "mirror" sites, other computers with the same material. If you cannot get through at the address above, try one of the following:
Discussion Forums by E-mail
The 12th World AIDS Conference has set up six email discussion forums, giving those who cannot go to the conference a chance to participate and be heard. More than 500 people have signed up for one or more of these lists so far.
The six topics -- roughly in order of number of subscribers, with the most popular topics first -- are:
Also, there is an information list for journalists.
Anybody with email can join these lists to receive the messages, or send messages (including anonymous communications if desired). You can see an archive of the earlier messages on the Web.
Telephone and Video Reports
12th World AIDS Conference Updated CD-ROM
A CD-ROM with searchable abstracts plus slides of the major presentations may be available about 4-8 weeks after the conference. Besides the abstracts, it will have "slides and/or text of plenary talks and track symposia, updated extended summaries and key slides of other oral sessions" -- about 3,000 or more slides. It is expensive, about 150 Swiss franks if ordered before the conference, 250 if ordered later.
For more information, fax Congrex Sweden AB, Attn: AIDS 98, +46 8 661-8155.
Other Geneva Reports
This list is not complete, and many programs are poorly publicized. Watch for announcements of others, especially on Web sites or through local AIDS organizations.
Starting on June 15, the titles and authors of the abstracts can be read or searched on the official conference Web site, http://www.aids98.ch -- allowing attendees to begin planning their schedules in advance.
We asked the staff for other information which we did not find in the Pocket Programme or on the early Web site:
Metabolic Complications, Growth Hormone Treatment: New Studies Planned
On June 12 the Community Research Initiative on AIDS (CRIA), located in New York City, announced that it will begin two studies of metabolic disorders (fat redistribution, and blood sugar abnormalities) now being recognized more frequently in some persons with AIDS.
These studies are expected to begin in early July; more information will be available after the 12th World AIDS Conference, June 28-July 3 in Geneva. To find out about volunteering, call the Community Research Initiative on AIDS, 212-924-3934.
Ribavirin Approved for Hepatitis C Combination Treatmentby John S. James
On June 3 the FDA approved ribavirin capsules for use in combination therapy "for the treatment of chronic hepatitis C in patients with compensated liver disease who have relapsed following alpha interferon therapy." In the U.S., the drug will be called Rebetol, and marketed as a combination (called Rebetron) with interferon alpha-2b, by Schering- Plough Corporation. Schering is selling the ribavirin under license from ICN Pharmaceuticals, Inc. (See AIDS Treatment News issue #295 for two articles about this combination treatment for hepatitis C.)
Oral ribavirin has long been approved throughout the world as a broad-spectrum antiviral, but has been in limbo in the U.S. for over ten years, due to an old war between the former Commissioner of the U.S. Food and Drug Administration, Frank Young, and the head of ICN Pharmaceuticals, Milan Panic, concerning its use as an HIV treatment. Today, with viral load testing available, ribavirin should be re-evaluated as a possible element in modern antiretroviral combinations. The first step could be a review of the published and otherwise- available data about ribavirin and HIV, to see whether a new trial would be appropriate. An AIDSLINE search finds many recent studies which suggest that this drug might have considerable importance.
Note: also see "Ribavirin and Mortality: New Information," by this writer, published over ten years ago in AIDS Treatment News issue #52, March 11, 1988. (Back issues of AIDS Treatment News are available at the Immunet site on the World Wide Web, http://www.immunet.org/atn.)
Pediatric HIV Treatment: Federal Guidelines Discussed July 22
The U.S. Department of Health and Human Services has organized a two-hour discussion of the Federal Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. This discussion will be transmitted by satellite downlink broadcasts on July 22 from 1:00 p.m. to 3:00 p.m. Eastern time; a videotape may be available later. CME credit is available. As sites register to receive this program, their locations will be posted at www.tech-res-intl.com/hivaids.
Congress: How You Can Helpby John S. James
This summer may be especially important for AIDS research, treatment access, services, prevention, and public policies. No one knows what may come out of Congress; we have talked to both optimists and pessimists.
But everyone agrees that when Congress does move on AIDS funding this year, it will move very rapidly -- because action on the budget has been delayed due to other disputes, and yet politicians will be under pressure to leave early to campaign for the November elections. We can expect a last-minute rush and sloppy legislation, with very little time to address problems that may develop.
We need to prepare now so that people will be ready to call their senators and their representative immediately if necessary, even if there is only a day's notice.
Email is best for receiving action alerts (not for contacting Congress -- usually it's better to call their local office, which takes about one minute as the staff is busy and seldom has time to chat). If you do not have email, there may be a local organization which can send you rapid alerts by fax. Here are a few of the organizations which can send email action alerts on national AIDS issues:
Most of these email lists started only recently, so there could be glitches. You may want to sign up for more than one and see how they differ.
The biggest challenge for the organizations is to send alerts that work for people. You should be able to read about the issue in a page or less, then make a couple quick phone calls. And the issue should speak to those receiving the alerts, not only to insiders or professionals.
San Francisco: Six-Week Workshop on Returning to Work
"Going Back to Work If You Have HIV," presented by The Life Program and co-sponsored by Metropolitan Community Church, is a two-hour workshop every Thursday afternoon from July 9 to August 20, at the Metropolitan Community Church, 150 Eureka St., in San Francisco; in addition, in the week after there will be a job faire, probably downtown. There is no fee for this program.
Goals include developing your own plan for: "Maintaining a safety net, just in case; Identifying your job/career interests; Assessing your knowledge and skills; Improving any weaknesses; Finding a job that's right for you; and Your resume and interviews."
For more information, call the Life Employment Program, 415-537-3990.
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.