The announcement by Gilead Sciences and Bristol-Myers Squibb in July that the Food and Drug Administration had approved Atripla'their once-daily anti-HIV pill'was very good news for Robin Haftman of Orlando, Fla. Already taking the component drugs of the newly approved pill, Haftman plans to quickly move to Atripla, the first one-pill, once-a-day full antiretroviral regimen available in the United States [see more details on page 36 of Treatment Guide].
Since he travels three weeks each month for his job as a consultant for a software firm, 'one pill a day is going to be terrific!' Haftman says enthusiastically. 'It's going to be a lot easier to have one pill to remember to take with me when I travel and only one pill to have to remember to take every day.'
Ease of use to enable better adherence rates is precisely the goal of the single-pill regimen, according to Gilead and BMS officials. Having only one pill to take each day should cut down on forgotten or skipped doses, which can lead to the development of drug-resistant virus. 'Many of these patients will take medication for the rest of their lives,' Gilead spokesman James Loduca says, 'so anything that makes it easier is a big advance.'
But as important as the single-pill regimen will be for newly diagnosed HIV patients and those able to switch to the combination, many won't be able to take it'and some eligible candidates, like New Yorker Paul Teixeira, will choose not to.
Teixeira had previously taken the component medications in Atripla (BMS's Sustiva and Gilead's Truvada) but had to change regimens because of Sustiva's psychological side effects'particularly, vivid and disturbing dreams that left him feeling exhausted, irritable, and anxious. 'I would not want to switch back,' he says, 'even if it was just one pill I had to take each day.'
And people who are resistant to the drugs included in the combo pill simply can't take it, according to Michael Gottlieb, a Los Angeles physician who helped identify the first U.S. AIDS cases in 1981. In addition, he adds, 'women who are at risk of becoming pregnant are not candidates'unless they have foolproof birth control'because Sustiva has been associated with birth defects in animals [see also 'Mother's Day' on page 24]. This is not something for everybody, and I think that's important for people to understand.'
Still, the development of a single-pill full regimen is a huge psychological boost for all HIVers, Gottlieb says, even for those who won't be able to switch to Atripla.
'This is certainly symbolic that the movement is afoot to simplify treatment,' he says, noting that the earliest triple-drug regimens often required upwards of 20 pills taken throughout the day and night. 'As the industry moves more and more toward cooperation, you're likely going to be able to take advantage of those collaborations. And we're all hoping that [the development of Atripla] is not the last of that kind of cooperation.'