Anticipating the once-a-day pill: a new daily anti-HIV pill is likely to become available later this year. Some patients can't wait, some are happy to stick with what they've got, and many won't have an option.
But things have been getting easier for the 46-year-old gay man from Orlando, Fla. Recently he was able to simplify his regimen to just two pills a day. And now a new once-a-day HIV pill is promising an even better life. "It's going to be sweet," says Robin, who travels a lot for work. "It's going to be a lot easier to have one pill to remember to bring with me on my trips, and one pill to remember to take every day."
Drugmakers Bristol-Myers Squibb and Gilead Sciences announced in January that they've successfully layered BMS's Sustiva into a single pill with Gilead's Truvada, which itself is a combination of the drugs Viread and Emtriva. The companies plan to file a marketing application with the Food and Drug Administration in the second quarter; if approved as expected, the pill could be available by the end of the year. HIV treatment experts say the combination pill will be a godsend for those like Robin whose virus can be controlled by its three component drugs and for newly diagnosed HIVers whose first regimen will now be simple to take.
But the new pill won't be the HIV-treatment fix-all some have imagined. In fact, many of the patients currently taking anti-HIV drugs will not be able to switch to the once-daily therapy. "For our patient population, the major consideration is going to be whether their virus still responds to the meds in the once-a-day pill," says Michael Gottlieb, a Los Angeles-area physician who reported the nation's first AIDS cases in 1981.
"If they've already been through several regimens, as many of them have, it's not going to be a choice available to them."
That's the case for Paul Kusler, 41, a gay resident of Montclair, N.J. Currently he's on what's known as a "salvage" regimen that includes a boosted protease inhibitor and the injectable fusion inhibitor Fuzeon--drugs he can't give up if he hopes to keep his virus under control. "I'd love to be able to take just one pill a day, because right now treatment is like a ball and chain that's always with me," Kusler says. "But I'm not expecting to be able to switch."
Tom Emerson Jr., a 41-year-old gay man living in Garnett, Kan., isn't sure if he's going to be able to switch to the one-pill regimen. But the idea of once-daily therapy is enormously appealing to him, particularly because of the slipups he's had on more complex regimens. "We talk about adherence like it's only stupid people who don't take all their pills," Emerson explains. "But I have a law degree, for chrissake, and I know how to take my pills. But I still sometimes forgot. People just forget. It just happens."
While a missed dose here or there may not sound like a big deal, AIDS experts say adherence to most anti-HIV drugs needs to be nearly perfect--95% or better--to prevent the virus from mutating and developing resistance to the medication and sometimes even to an entire class of antiretroviral drugs.
Because a single-pill regimen should significantly reduce missed doses, the combination treatment will be ideal for newly diagnosed HIV patients, says physician Cal Cohen, a research director for the Community Research Initiative of New England. Research also has shown the combination to be highly effective in suppressing HIV, so much so that the U.S. Department of Health and Human Services endorses the three-drug combination as a preferred first-line regimen.
There are others for whom the drug combination will not be an option, including women who could become pregnant, those with a history of mental illness or depression, and patients with kidney problems. And some, like gay Long Beach, Calif., HIVer Drew Faber, have no desire to abandon a regimen that is working for them. "The goal for me has been to get my viral load as low as possible, not to get my pill burden as low as possible," says Faber, who is on a five-drug regimen.
The key, says Gottlieb, is to work with your doctor to see if the new pill--or another simplified regimen--is a good option for you. "And if we can't do something for you now, maybe we will in the future," Gottlieb notes, "as hopefully this kind of collaboration [between Bristol-Myers Squibb and Gilead Sciences] is not going to be the first and last of its kind."
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|Publication:||The Advocate (The national gay & lesbian newsmagazine)|
|Date:||Apr 11, 2006|
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