Gilead, Bristol-Myers Squibb To Develop Once-a-Day Pill for Treating HIV; Study Shows Drug Combination More Effective Than Standard RegimenGilead and Bristol-Myers Squibb say they jointly have developed a regimen for treating HIV that is effective in suppressing HIV viral loads with few side effects and could lead to the development of a one-pill, once-a-day treatment regimen, according to a study published on Thursday in the New England Journal of Medicine, the Washington Post reports (Gillis, Washington Post, 1/19). Joel Gallant of Johns Hopkins University and colleagues looked at 517 HIV-positive patients who had never received antiretroviral therapy and had HIV viral loads greater than 10,000 copies per milliliter (Gallant et al., New England Journal of Medicine, 1/19). The patients were randomly divided into two groups: one group received a combination of BMS' Sustiva and Gilead's Viread and Emtriva as separate components and the other group received a combination of Sustiva and GlaxoSmithKline's Combivir (Vollmer, Charlotte News & Observer, 1/19). Combivir, which is taken twice daily, is the standard treatment taken by one in five HIV-positive patients in the U.S., according to GSK (Tansey, San Francisco Chronicle, 1/19). After 48 weeks, researchers found "significantly greater responses" in the group receiving the Sustiva, Viread and Emtriva treatment, with 84% of patients in that group showing a reduced viral load compared with 73% in the other group. According to the study, patients taking the Sustiva, Viread and Emtriva treatment also experienced fewer side effects than those associated with the standard three-drug regimen (New England Journal of Medicine, 1/19). According to the Post, BMS and Gilead already have combined the three drugs into one pill (Washington Post, 1/19). Gilead plans to ask FDA to approve its once daily pill later this year, the Chronicle reports (San Francisco Chronicle, 1/19).
"I think it's a huge thing these companies are going to do," Nelson Vergel, an HIV/AIDS treatment activist in Houston, said, adding that with the "right price" in developing countries, the one pill, once a day, could become the "main treatment [for HIV] in the world" (Washington Post, 1/19). However, GSK in a statement questioned the value of the results of a single study, adding that Combivir has been tested in more than 50 studies and each time has been proven effective. Mark Shaefer, head of GSK's HIV drug development division, said, "We are always interested in learning more about existing treatments for HIV, but we realize the limited value of a single, open-label study to make comparisons among products" (Charlotte News & Observer, 1/19). Gilead and BMS plan to seek approval for the pill in the U.S. and Europe by the end of 2006 (Washington Post, 1/19).