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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