10 ▼ juiM 21. 1090 ▼ ju s t o u t
news
A new option
The F D A admits nevirapine onto the AID S-drug roster,
New on the market...
while a herpes drug is nixed due to serious risks
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. R ENEFITS
I ATICA I
Please c a ll fo r m ore inform ation.
Gay Owned and Operated
Food and Drug Administration ad
visory panel unanimously recom
mended approval o f the AIDS drug
nevirapine at its June 7 meeting at
Silver Spring, Md. Final approval
seems assured, and the drug may be available in
pharmacies as early as the end o f June.
Nevirapine was developed by Boehringer
Ingelheim Pharmaceuticals and will be marketed
under the trade name Viramune. It disrupts the
HIV virus at the same point in its replication
cycle as do the nucleoside analogs (A ZT , 3TC,
d4T, ddl, ddC). But it is the first in a new class o f
drugs known as non-
nucleoside reverse
transcriptase inhibi-
tors. It binds to adif-
ferem
-*
*® *«**< K '
RNA to
cation.
C lin ic a l trials
show the drug to be
easily absorbed and
tolerated by the
body. The most sig
nificant side effect
is skin rash, though
it is seldom severe
enough to discon
tinue use. Resistance
q u ick ly d e v e lo p s
when used as a
monotherapy, as is
often the case with AIDS drugs. The drug is being
recommended for use in combination.
Trials o f nevirapine in triple combination with
A ZT and ddl have produced sustained elevations
in CD4 count and drops in viral load that approach
those o f combinations using protease inhibitors.
It appears to have its greatest effect on those with
a CD4 count between 50 and 350 and lesser
impact on either side o f that range.
There is no clinical data on combination use
with other nucleoside analogs. However, the
chemical profile o f nevirapine leads researchers
to believe it is safe and will have parallel synergy
in those combinations. There is, however, poten
tial for harmful drug interactions with protease
inhibitors. Patients and physicians are advised
not to try these combinations until clinical data
becom e available.
Martin Delaney o f Project Inform in San
Francisco called nevirapine “ another pathway
towards that goal o f undetectable virus, one that
has very low side effect risk.”
Spencer C ox o f the Treatment Action Group
in New York City called nevirapine “ an impor
tant option without very much information on
how to use it.” He believes that “ people are going
to be making decisions [on whether to use it or
not] based on everything from toxicity profile,
prior anti-viral history and cost.”
A
Delaney sees “ the issues are shifting away
from active therapies. Now the goal is to sort out
clinical management o f the disease.”
The company has not said how it will price the
new drug, but indications are that it will be
comparable to the nucleoside analogs and sig
nificantly lower than the protease inhibitors.
Ernest Hopkins o f the National Association
o f People with AIDS, calls it “ a significant fund
ing challenge. Health care access will be the issue
for us as more and more people begin to enroll in
treatment therapy.”
Delaney says, “ It will actually offer some
relief in the [govern
ment A ID S Drug
A ssista n ce
P ro-
grams]. There may
p r a ; be a way to get to the
___ goal o f suppressing
the virus without ini
tially incurring the
cost o f the protease
’ £&'■$ inhibitors.”
C ox warns, “ It is
probably going to
require some com
promise from activ
ists that we haven’ t
had to make in the
past— figuring out
when it is time to let
a drug fall o ff the
formulary, as well as
hopefully bringing in some new money to pay for
new products.” He cites the use o f expensive
growth hormone in people with very advanced
disease as “ a hard question that sounds mean just
[in] asking it.”
ai
O
n June 6 the panel considered and rejected
the application for Sorvudine, a treatment
for herpes zoster. The drug is as effective as
current medications and offers the convenienc
taking a pill once a day as opposed to four pills
five times a day.
The problem is a fatal interaction with an anti-
cancer drug. Experience in Japan, where the drug
is commercially available, has resulted in numer
ous cases o f patients obtaining the medications
from different physicians who were unaware o f
the other prescription. The patients died from the
drug interaction.
“ I know there were people in the community,
particularly the AIDS community, who were
looking forward to that one-dose drug,” said
N A PW A ’ s Hopkins. Buthe applauded the panel’ s
recommendation as appropriate. “There was no
way they could agree to put the drug on the
market because o f the potential for fatalities.”
The panel recommended further study to see
if there is a way to approve restricted distribution
so as to safeguard the public.
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