Health News
2006-04-28
One-pill HIV
regimen submitted for FDA review
Single pill would
provide a full day's supply of anti-HIV drugs
Gilead Sciences
and Bristol-Mye
Gilead Sciences
and Bristol-Myers Squibb on Thursday submitted for review
to the Food and Drug Administration their once-daily
anti-HIV pill that contains a full three-drug regimen.
The tablet contains a full day’s dosing of
Gilead’s drugs Viread and Emtriva—already
packaged in a combination pill called
Truvada—and BMS’s Sustiva. If approved by the
FDA, it would be the first one-pill, once-daily complete HIV
treatment available in the United States.
Gilead and BMS
announced in December 2004 that they planned to
collaborate on a venture to combine Gilead’s Truvada
with Bristol-Myers Squibb’s Sustiva into a
single pill that would be taken just once daily. The
first two attempts to combine the medications were
unsuccessful, as the resulting combination pill did
not have the same bioequivalence of the drugs dosed
separately. But the companies announced in January 2006
that using bilayering technology to incorporate the drugs
into a single formulation was successful, and studies
showed the combination pill had the same
bioequivalence as the individual medications.
The U.S.
Department of Health and Human Services lists the
combination of Truvada and Sustiva as one of the
preferred nonnucleoside reverse transcriptase
inhibitor–based regimens for treating newly diagnosed
HIV patients.
A decision by the
FDA could come before the end of the year.
“The
partnership between Bristol-Myers Squibb and Gilead was
founded on the companies’ shared commitment to
addressing the needs of people living with
HIV,” said John C. Martin, Gilead president and CEO,
in a statement. “Significant progress in
science and medicine has been achieved since the
advent of the first combination regimens 10 years ago, but
more work is needed, and we view this partnership to
create the first-ever once-daily single tablet regimen
for HIV as an important step toward further
simplifying dosing of HIV therapy for physicians and
patients.” (The Advocate)
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