AIDS Treatment New, no. 183

in concentrations of about 3 micromolar (not especially
good compared to other drugs), and it must be present
continuously to protect the cells. But it has been effective
against all strains of HIV-1 and HIV-2 tested, including
virus which is resistant to AZT or to the non-nucleoside
RT-inhibitor drugs. And plasma concentrations higher
than the effective anti-HIV concentration have been
achieved in animal studies.
The obstacle now to cosalane's development is making
enough for further tests. Only small quantities have been
synthesized in laboratories - not enough to finish animal
tests, let alone run a clinical trial. Efforts are now underway to scale up the fairly complex manufacturing process.
Little has been published about cosalane so far, although several papers have appeared about the work with
ATA which led up to it. Mark S. Cushman, Ph.D., presented the first technical information at a meeting of the
American Chemical Society, August 22-27, 1993. A nontechnical article about cosalane appeared in AIDS Weekly,
September 6.
MEGACE Now Approved
for AIDS: New Formulation
MEGACE (megestrol acetate), a drug long approved as
a palliative treatment for certain cancers, was approved by
the FDA on September 10 for treatment of unexplained
significant weight loss, or loss of appetite, in persons with
AIDS. Because of the large doses used with AIDS (which
are inconvenient to take with the MEGACE tablets previously approved), a new oral suspension form was also approved on September 10. It should be in pharmacies within
the next few weeks.
In controlled studies, weight increased by an average of
7.8 to 11.2 pounds in high-dose groups, and 4.2 pounds
with a lower dose, compared to a weight loss of about two
pounds with placebo. Also improved were appetite, caloric intake, and sense of well being. The weight gain was
shown to include lean body weight and muscle mass, not
just water.
However, a followup study a year later found no difference in survival between the treatment and placebo groups.
And impotence occurred in as many as 12 percent of the
patients at the highest dose; it appears to be reversible
when the drug is discontinued.
A suggested starting dose for most patients is 800 mg
per day, reduced to 400 mg after one month. In practice,

according to Jamie Von Roenn, M.D., lead investigator of
a MEGACE trial, patients are likely to start with the high

dose until they gain weight, then reduce the dose to
maintain the weight.
According to Bristol-Myers Squibb, the price to wholesalers will be $4.15 per day or less; we do not know what
dose was used for this computation. For patients who need
the drug but cannot pay, physicians can call 800/788-0123
to apply for free drug when no third-party options are
available.
Recent Journal Articles
Note: This section is new in AIDS Treatment News.
Usually we do not focus on articles published elsewhere,
but prefer in-depth reports which may come out months
before the journal articles (or months after, giving us a
chance to hear professional reaction). We have left reporting of recent articles to others. However, the most comprehensive sources on recent journals are either very expensive (AIDS Weekly) or often very technical (ATIN: AIDS
Targeted Information).
Our coverage will not be comprehensive. For every
article includedbelow, we examined abouttenotherrecent
AIDS treatment articles which we chose not to include -
mostly because we thought they would not be relevant to
our readers. Some of those we omitted are important for
physicians, but concern specialized areas which we could
not cover adequately.
Note that we cannot do the same in-depth investigation
for these reports as we do for major articles. The main
focus here is the fact that the article appeared. But sometimes we will include background to help readers understand the context.
We plan to focus on information which is practical now,
and also on information which helps readers understand
developments which may be important for the future. But
there are thousands of different medical journals, and we
can only scan a few. We will inevitably miss important
articles, and hope that readers will bring them to our
attention.
AZT: European-Australian Study Shows
Benefit, Especially in Early Treatment
The third large trial of AZT, by the European-Australian
Collaborative Group, was published in the July 29 New
England Journal of Medicine. The results are not new,
having been presented in conferences and known to physicians for some time, but the fully peer reviewed publica
tion provides an opportunity for a closer look. And no
matter how you look at the data, AZT showed some benefit
on the average, with disease progression in the AZT group
415/255-0588

AIDS Treatment News #183