One Pill a Day on the Way?
February 17 2006 1:00 AM ET
The third time must be the charm for drugmakers Gilead Sciences and Bristol-Myers Squibb in their quest to craft a once-daily pill that contains a full antiretroviral regimen. After two unsuccessful attempts in 2005 to merge Gilead's Truvada'which itself is a combination of Emtriva and Viread'and BMS's Sustiva, company officials announced in January that a new technology enabled their third effort to succeed. They plan to file for Food and Drug Administration approval of the one-pill regimen this spring.
In addition to the three-drug combination being recommended by U.S. Department of Health and Human Services for treatment-naive patients, a study published in The New England Journal of Medicine found that the combo leads to superior viral suppression with fewer side effects than a regimen including Combivir and Sustiva.
BMS and Gilead announced the joint venture in December 2004, but the first two combinations they developed were not as powerful as the individual medications when dosed separately. Researchers finally settled on what's known as bi-layering technology'through which each drug is pressed onto the other.
Antonio E. Urbina, a physician at St. Vincent's Comprehensive HIV Center in New York City, calls the potential once-a-day pill the 'holy grail of HIV treatment.' He and other HIV experts say that the fewer daily doses patients have to take, the more likely they are to adhere to their treatment properly. Studies have shown that adherence rates of 95% are needed to keep HIV in check and to avoid the development of drug resistance.
Gilead executive vice president Norbert Bischofberger says the companies' one-pill regimen is a significant improvement over the earliest antiretroviral regimens, which 'were almost impossible to comply with in the long term. And now we're down to one pill, once daily,' he says. 'I think that's pretty impressive progress.'