The Washington AIDS Conference: New Hope On Treatments (Part I)

The "III International Conference on AIDS", June 1-5 in Washington D.C., the major scientific conference of the year,
may become a watershed event for AIDS treatments.

As expected, no dramatic breakthroughs were announced. AIDS research proceeds with informal discussions among professionals, seldom by sudden surprises. Few if any of the treatments discussed at the Conference were brand new to the scientific community.

But the Conference did mark the growing optimism among scientists and physicians on the possibility of effective
treatments. Dr. Samuel Broder of the National Cancer Institute, one of the leading U.S. AIDS researchers, summarized
the change of attitude:

"Two years ago you could find 1,000 fine doctors who would say you could never stop the natural progression of this virus. Now you can hardly find anyone." (Quoted in The Washington Post, June 6, 1987).


Treatment Listing

Below is an overview of some of the treatment information presented at the Conference.

Note the limitations of this listing. We have omitted most of the treatments for opportunistic infections. Even the
list of treatments for HIV cannot be complete. No one could attend every session -- many were simultaneous -- nor absorb everything at the sessions one did attend. Some of the most current information comes from conversations in the aisles, which may not reflect all sides of an issue. This writer has not had time to research the background of all these treatments, or to call the researchers involved. This listing can only be suggestive, not authoritative or comprehensive.

The Conference had over 250 papers presented, plus over 1000 "poster sessions"; 700 others were turned down for lack of time and space. The presentations were recorded, and the public can order audio tapes from the address below. The poster sessions were displayed on long rows of bulletin boards in the exhibit area, each for one day, with the researcher there for part of that time to answer questions. Each paper or poster session had a short abstract, submitted in advance and passed out to all Conference attenders in a bound volume of over 1200 abstracts. Unfortunately no additional copies of this Abstracts Volume are available; the volume has no copyright notice so presumably anyone could reprint copies. Meanwhile this writer will provide copies of those abstracts which are referenced in this article.

The treatment section below refers to the the abstracts by the same numbering system used in the Abstracts Volume. The first letter or letters gives the day of the week: 'M', 'T', 'W', 'TH', or 'F'. For poster sessions, a 'P' follows the day-
of-week abbreviation. For example, "M 5.1" (which is a talk on Peptide T) refers to Monday, session number five, talk number one in that session. "MP 24" (a poster session on D- Penicillamine) refers to Monday's poster number 24.


Treatment Summaries

*** DDC (dideoxycytidine). This antiviral works on the same theory as AZT, providing a false building block for the
virus; it may be more effective. For laboratory studies, see THP 8, and TP 1. Human trials are currently being conducted and DDC appears less toxic than AZT; the biggest problem seems to be a skin rash which is temporary and usually not severe. At least 20 people are getting DDC in a scientific trial at this time, but it is too early to tell whether the drug will be clinically useful.

DDC has the same kind of institutional push behind it as AZT did, and it will probably move relatively quickly through
testing if it continues to look good.

Underground supplies have developed, but at this time people are waiting until more is known.

*** AMPLIGEN (mismatched double-stranded RNA). This antiviral and immune modulator is getting considerable
interest. A poster session at the Conference (MP 216) reported a test with eleven AIDS and ARC patients. No toxicity was found, and there were many improvements; for example, all patients had been anergic on multiple skin tests before
treatment, and all reversed this condition. However one AIDS patient developed pneumocystis for a second time and died, after having received the treatment for seven weeks.

A new trial with 200 patients has now begun.

Another poster session (MP 5) presented laboratory results suggesting that Ampligen would work well with AZT, and might allow AZT to be used in a fifth or less of its usual dose to get the same effect as the full dose of AZT without Ampligen.

A report is being published this month in The Lancet.

*** AME (amphotericin methyl esther). AME was easy to miss at the Conference but is generating considerable interest among researchers who know about it.

AME, a water-soluble derivative of the antifungal medicine amphotericin B, has been effective against HIV in several ways in laboratory tests. In humans, AME was tested in the U.S. about 10 years ago as an antifungal; apparently it is much less toxic than amphotericin B. But during the testing some of the doses were too high, and people were hurt seriously enough to sue the manufacturer, which then abandoned the product. The importance of this earlier testing is that dosage and toxicity are now known. We have heard that AME is available today in some countries.

The researchers who presented the poster session (MP 226) are now trying to get clinical trials started for AIDS or ARC. AME might be combined with AZT; the researchers suspect that only a tenth the usual dose of AZT may be required.

*** AZT (Retrovir). More papers reported research on AZT than on any other treatment -- not surprisingly since only AZT is officially approved. Most of the published abstracts do not provide much new information. They confirm the picture we already have -- that AZT can help some people, but also that it can have serious side effects.

The most important new development with AZT seems to be the possibility of combining it, usually in low doses, with
other drugs, such as DDC or AME.

This writer did not attend the AZT talks or panel, however, and could not obtain the tapes by press time. Those
who want more information on AZT could purchase these tapes (see below).

Burroughs-Wellcome also presented a special meeting on AZT for physicians, closed to the press. According to one of the attenders, the data analyzed so far shows a one-year survival rate of 90 percent in the experimental group originally on AZT, much less in the group originally on placebo and switched to AZT later. Other points were that side effects go down in time; and AZT is helping with neurological problems. Burroughs-Wellcome also produced an AZT videotape which it recently mailed to physicians.

Another viewpoint will become available through Project Inform in San Francisco, which has just obtained extensive
documentation on the approval of AZT through a Freedom Of Information Act request. This documentation is now being
analyzed.

Whatever the medical judgment on AZT, this drug has had an important role in overcoming the fatalism about AIDS
treatments, thereby opening the door to serious efforts to save lives instead of just preparing people for death. Many
professionals cannot take a treatment seriously unless it is approved; others cannot unless it makes money. AZT has made these people aware that treatment for AIDS is possible. AZT may save more lives by this political effect -- opening the door to other research -- than by its direct medical use.

*** Alpha Interferon. A number of papers reported studies of this treatment, often in combination with AZT. No clear
picture emerged from the published abstracts.

*** Peptide T. This possible treatment, which has had a very limited clinical trial, has become the focus of a major
scientific controversy.

Peptide T (TH 1.3, M 5.1 -- also see Sentinel January 16, 1987) mimics a part of the AIDS virus which, some scientists
believe, makes the initial attachment to the receptor site on the T-helper cell. Some studies have found that peptide T
prevents infection of these cells, in the laboratory and in humans. However, most researchers have been unable to
reproduce the laboratory results -- only one other team has recently done so -- and the human trial, in Sweden, involved
only four patients. Recently the FDA approved further clinical trials in the U.S.

At this time the scientists are divided on peptide T, and most appear skeptical. But even if this particular drug
doesn't work, the line of research which produced it may have great value. Already one team which failed to get results with peptide T produced another peptide which inhibited the AIDS virus in the laboratory without harming cells (WP 6).

*** Ribavirin. The bitter disputes around this drug became more bitter during the week of the Conference, with the
FDA and others accusing the manufacturer, ICN Pharmaceuticals of Costa Mesa, CA, of unethical conduct. Meanwhile, ICN sued a securities company in a separate dispute.

These conflicts aside, what do we know about whether the drug works?

The major clinical study of ribavirin and HIV gave 800 mg daily, 600 mg, and placebo, to two separate groups of patients; one group had lymphadenopathy syndrome (LAS), and the other was more seriously ill with ARC. On January 9 of this year, ICN released results of the LAS patients, reporting that none using the 800 mg dose progressed to AIDS, while 10 in the placebo group did (see Sentinel, January 16).

But later it became known that a number of patients had been accepted by the study even though they were too ill to
qualify under the study's rules. And the great majority of these more seriously ill patients ended up in the placebo
group. Many of them progressed to AIDS, distorting the study's results. There is a bitter dispute over whether the ribavirin data showed any effectiveness after this error had been adjusted for (see T 8.5).

Meanwhile, results of the ARC patients were presented last week at the Conference (T 8.6). Ribavirin in the doses tested showed no effectiveness. In fact, more people died in the treatment groups than with the placebo, apparently by random chance.

At the same time, however, some small clinical studies continued to show effectiveness (TP 226, WP 224). And many
persons continue to be convinced that ribavirin is saving their lives.

The study which failed to show effectiveness of ribavirin used doses only up to 800 mg per day. The ribavirin
underground has long said that this dose is marginal or ineffective; but ICN chose to bend over backwards for safety
when designing the study.

Some of the leading researchers want to test ribavirin in higher doses. But meanwhile it is clear that this drug came
out of the Conference with considerably less credibility than it had going in.


Other Treatments

Scientists also reported about the following treatments and potential treatments, among others, at the Conference. For space reasons we must cover these in future issues.

*** Aerosol pentamidine (TP 217)
*** AL 721 (M 5.6, TP 223)
*** Avarol and avarone (MP 1)
*** Bestatin (WP 229)
*** Castanospermine (T 4.3)
*** Diethylcarbamazine (MP 3)
*** D-Penicillamine (MP 24, TP 220)
*** DTC (Imuthiol, diethydithiocarbamate) (MP 227)
*** Foscarnet (TH 8.1, THP 13, THP 237, THP 238)
*** Glycosylation inhibitors (TP 23)
*** Granulocyte-Macrophage Colony Stimulating Factor (MP222)
*** HPA-23 (WP 216, WP 218)
*** Imreg-1 (MP 218, THP 241)
*** Isoprinosine (MP 132)
*** Milk from hyperimmune cows (THP 148)
*** Naltrexone (WP 227)
*** Phosphorothioate analogs (T 4.4)
*** Rifabutin (ansamycin) (THP 228, THP 233)
*** Tumor Necrosis Factor (T 4.5)
*** Vaccines (many papers)

We may also comment on several treatment approaches notably absent from the Conference, although they should have been there. Examples are DNCB, herbal and Oriental therapies, and nutrition.


For More Information

Most of the 250 presentations were taped. Anyone can order the audiotapes from InfoMedix, 12800 Garden Grove
Boulevard, Suite F, Garden Grove, CA 92643, (714) 530-3454, or (800) 992-9286 from California, or (800) 367-9286 from other states. Ask for program number T205. Most tapes cost $7.50 for one session, which often includes several related talks. There are no tapes for the poster sessions. The complete set of tapes can be ordered for about $400, or you can get a catalog of the tapes to order individually. (For example, tape number T205-T8, "Clinical Trials -- AZT and Ribavirin", includes six talks, T 8.1 through T 8.6, and costs $7.50.)

Since the Abstracts Volume (containing about 1250 abstracts for both the presentations and the poster sessions)
is not available, this writer will supply a copy of all the abstracts referenced in this article. For these abstracts, send $2. to cover cost to: John S. James, P.O. Box 411256, San Francisco, CA 94141.