The third time
seems to be the charm for drugmakers Bristol-Myers Squibb
and Gilead Sciences, who struck out in two previous attempts
to craft a single-pill, once-daily antiretroviral
regimen. The companies on Monday announced
they've successfully combined the drugs Sustiva and
Truvada into a single formulation. Truvada is already
a combination pill containing Emtriva and Viread. The
companies plan to file for Food and Drug
Administration approval of the resulting single-pill regimen
in the second quarter of 2006. Should the FDA approve
the pill, it would be the only one-pill, once-daily
full antiretroviral regimen available in the
United States. The medication could be available to
consumers before the end of the year.
"The
advancement of our fixed-dose regimen represents an
important step forward in the further simplification
of HIV treatment," said John C. Martin,
president and chief executive officer of Gilead Sciences in
a press statement. "Gilead and Bristol-Myers
Squibb share a commitment to the treatment of HIV, a
disease for which significant unmet medical need
continues to exist, and we look forward to working with
regulatory authorities."
Gilead and
Bristol-Myers Squibb 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. The new pill
uses bilayering technology to incorporate the drugs
into a single fomulation, and studies show it has the
same bioequivalence as the individual medications.
Health and Human
Services guidelines recommend the combination of Sustiva
and Truvada as a preferred nonnucleoside reverse
transcriptase inhibitor-based regimen for
treatment-naive HIV-positive adults. (Advocate.com)
