Zerit (d4T) Delayed; Parallel Track Extended

As reported in the previous issue of AIDS TREATMENT NEWS, the
newly approved HIV drug d4T (brand name Zerit),was expected
to be on pharmacy shelves in July. Due to production
problems, commercial availability has been delayed;
pharmacies are now expected to receive Zerit about mid
August. Because of this delay, the parallel track program is
being extended; new patients who are eligible can still
enroll in this program to receive the drug without charge.
Physicians can call 800/842-6036 to obtain information about
enrolling patients.

According to Bristol-Myers Squibb, parallel-track enrollment
will remain open until the drug is available through
pharmacies. Even after enrollment closes, those in the
program will still receive the free drug for another month.

Fortunately, new patients for whom Zerit is indicated
("adults with advanced HIV infection who are intolerant of
approved therapies with proven clinical benefit or who have
experienced significant clinical or immunologic deterioration
while receiving these therapies or for whom such therapies
are contraindicated") are also likely to be eligible for the
parallel track, so their treatment need not be affected by
the delay in commercial availability. (Persons eligible for
the parallel track must have a T-helper count under 300 and
have failed both AZT and ddI, either because they could not
tolerate those drugs, or because their condition continued to
worsen despite treatment with each of them.)

Those who want to use the drug "off label" will probably not
be eligible for the parallel-track program, and will need to
wait for commercial availability.