Treating
HIV disease could become a lot easier for many people who
are on a medication regimen. Two of the world's pharmaceutical
giants--Bristol-Myers Squibb and Gilead Sciences--have teamed
up to create the so-called holy grail of treatment: a single
pill containing an entire day's worth of antiretroviral medications.
If approved by the U.S. Food and Drug Administration, the
proposed once-a-day pill containing Sustiva, Viread, and Emtriva
would be the simplest anti-HIV regimen available.
AIDS treatment advocates have longed for easier-to-take courses
of anti-HIV drugs since the early days of combination therapy--when
25 to 30 pills a day could be typical. Even today's simplest
regimens require two to four pills daily, which some experts
say still makes it burdensome to achieve near-perfect adherence.
And recent studies have shown that these medications can lose
their effectiveness if taken less than 95% of the time.
"I personally see a lot of patients with new infections
and treatment-naive patients, and people want to start with
the easiest possible dosing regimen," says Tony Mills,
MD, an HIV specialist in Los Angeles who is gay and HIV-positive
himself. "The easier the dosing regimen, the more likely
you are to be adherent. The better you adhere, the more likely
it is that your viral load will remain undetectable in the
long term."
BMS spokesman Eric Miller calls the first-of-its-kind collaboration
between pharmaceutical rivals an "important milestone"
in HIV treatment. "It grew entirely from the companies
responding to meet the growing need for increased treatment
options," he says.
Because each of the component drugs in the new pill have
already been approved individually by the FDA, the new combination
treatment could zip through the government approval process,
according to the manufacturers, and hit the market as soon
as the second half of 2006.
MILESTONES
1984 Researchers discover HIV; it is three years since the
first U.S. AIDS cases were reported
1987 AZT is the first medication approved to treatment HIV
1995 invirase is the first protease inhibitor approved for
treatment; the era of combination therapy begins
1996 Viramune, the first drug in the third class of antiretrovirals,
is approved
1997 Combivir, the first pill to combine two anti-HIV medications,
is approved
2000 New medication Trizivir combines three nucleoside analogs
into one pill
2002 The first one-pill-a-day formulation of one antiretroviral,
Sustiva, is approved
2003 Fuzeon is the first approved medication in the fusion
inhibitor class
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