ju s t ou« ▼ fo b ru ary 2 1 . 1 9 9 7 T I S
REASONS FOR HOPE
V iral L oad T ests A vailable
For individuals who do not have health cover
age that pays for viral load tests and cannot afford
to pay for them, Roche Diagnostics, the makers o f
the Amplicor PCR test, has a program which may
enable you to access coverage for the tests or to
get them free. There are, however, limitations on
the number o f free tests the company gives away
in any particular month. To apply, you or your
doctor should call 1-888-837-8727.
IV/AIDS
R emember
to
R efrigerate
R itonavir
The protease inhibitor ritonavir, marketed by
Abbott Laboratories under the trade name Norvir,
must be kept refrigerated to retain its potency.
The liquid form may be left unrefrigerated for up
to 8 hours, however the more popular capsules
should always be kept cold.
W hile most users of ritonavir have kept this in
m ind, there are concerns
about a small number of phar
m acies w here o rd e rs for
ritonavir, once filled, are left
unrefrigerated in out baskets
while awaiting pickup. If this
happens, you should refuse
that bottle and ask for a re
frigerated one. If you or your
p h arm acist has particular;:
questions about a bottle left;:;
unrefrigerated, you may call
Abbott at 1-800-441-4987.
W hile most pharmacists un
derstand the importance o f
keeping such a product cold, it can ’t hurt to
remind the pharmacy to keep it refrigerated when
you call in your order.
P rotease E xpanded A ccess
for
A dults
Agouron Pharmaceuticals, the m aker o f the
new protease inhibitor nelfinavir (trade name
Viracept), has been busy with announcements
since it applied for FDA approval. W hen Agouron
originally announced its expanded access pro
gram in October, it was viewed as too restrictive
by most treatment advocates. Among the recent
announcements are new guidelines for the pro
gram. Any HIV-positive adult who has ever had
a T-cell test under 100 (cells per cubic millimeter)
and who is unable to take indinavir (Crixivan)
and/or ritonavir (Norvir) will be eligible to re
ceive nelfinavir without charge. This applies to
people who have an intolerance for either of these
products or who have previously failed one or
both o f them. Information on this Viracept Ex
panded Access Program is available by calling
1-800-621-7111.
This is a significant im provem ent over the
original program, which only applied to individu
als who tested under 50 T cells and who could not
take any o f the three already approved protease
inhibitors.
P rotease I nhibitor
for
C hildren A vailable
A nother A gouron announcem ent concerned
the oral pow der form ulation o f nelfinavir for
children, w hich can be m ixed w ith m ilk, fo r
m ula or soft foods. It is being offered free o f
charge to any H IV -positive child betw een the
ages o f 2 and 13 from now until the product is
approved for m arketing. For inform ation on
this Pediatric Expanded Access Program , call
1-800-621-7111. C urrently there are no p ro
tease inhibitors approved for pediatric use, how
ever, early studies have indicated that nelfinavir
is safe and w ell-tolerated in children. P relim i
nary results o f a pediatric study were announced
at the 4th Annual R etrovirology C onference
held in W ashington, D.C., in January and will be
reported in the next “Reasons for Hope” column.
Gas, Electric
Oil, Heat Pumps
Air Conditioning
Hot Water Heaters
^
Agouron has also announced that nelfinavir
will be tested in a clinical trial for people with fewer
than 100 T cells conducted by the Community
Programs for Clinical Research on AIDS. The trial
is considered consumer friendly because it has no
inferior therapies where participants might get an
antiviral or antiviral combination not up to current
standards. This trial will randomly assign partici
pants to receive either nelfinavir plus nucleoside
analogues or ritonavir plus nucleoside analogues.
The trial o f 1,300 participants will last for one year.
F o r e n ro llm e n t and site in fo rm atio n , call
1-800-TRIALS-A (1-800-874-2572). People who
are unable to take saquinavir (In verase) are eligible
: : :
for tfoe trial, but those who
cannot take either indinavir
(C rix iv a n ) o r rito n a v ir
(Norvir) are not eligible, and
should instead consider the
Expanded Access Program
discussed above.
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N ucleotide
A nalogue T rial
Another type of trial con
sidered consumer friendly in
volves allowing participants
to continue to use their normal regimen o f anti
retrovirals while being randomly assigned either
to add another product or a placebo. One such
trial, sponsored by Gilead Sciences, tests a new
type o f product known as a nucleotide analogue.
Nucleotide analogues are similar to nucleoside
analogues (or nukes) such as AZT or ddl, but
these drugs have been further processed. The
particular product in this trial, known as GS 840
(adefovir dipivoxil), has only lowered viral loads
by modest amounts, but so far has not had any
resistant strains of the virus emerge. Adding it to
an already powerful combination may prove use
ful. People with 200 T cells or more are eligible
for this trial. Another study o f GS 840, which will
evaluate its impact on CMV, is open to individu
als with fewer than 100 T cells. For information
about enrollment and sites for either study, call
1-800-TRIALS-A (1-800-874-2572).
‘S alk I mmunogen ’ T rial
The therapeutic vaccine Remune (commonly
known as the Salk HIV Vaccine) is also in a trial
which allows participants to continue to use their
desired anti-retroviral combination while being
randomly assigned to either receive Remune or a
placebo. Individuals who have never had an AIDS-
related opportunistic infection and whose T-cell
count is between 300 and 549 are eligible for the
trial. For information on sites and enrollment, call
1 -800-684-8624. Those not eligible for the trial
may ask about an open-label protocol. The data
on Remune, while positive, has not been over
whelming. However the logic o f attempting to
increase some forms of HIV 1-specific immunity
has a solid basis.
Reported by the Boston AIDS Writers Group,
which consists o f Robert Folan and Lou Pesce
o f ACT UP Boston; David Scondras, Robert
Krebs, Derek Libby and Larry Bresslour from
Search fo r a Cure; and Jeff Terry.
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