Drugmakers Bristol-Myers Squibb, Gilead Sciences, and Merck on Sunday announced that the companies have begun work on the development of a once-daily, fixed-dose pill that contains three anti-HIV drugs made by the firms. The single pill would contain a full day's dosing of Gilead's nucleoside reverse transcriptase inhibitor Emtriva, its nucleotide reverse transcriptase inhibitor Viread, and the nonnucleoside reverse transcriptase inhibitor Sustiva, which is marketed in the United States by BMS and in many other countries by Merck. The companies also are considering copackaging options for the three individual medications. Gilead has already filed for Food and Drug Administration approval of a single-tablet combination of Viread and Emtriva.
AIDS caregivers say that because HIV patients need to take up to 95% of their antiretroviral medications on time to avoid the development of drug-resistance virus, regimens that are simpler to stick to--such as once-daily pills--are an important tool in HIV treatment. The three-drug pill being discussed would be available in both developed and developing nations, company officials say. "Given the complexities of this disease and the unique challenges in delivering care and treatment in resource-limited settings, we recognize the need to work together and combine our expertise to find innovative solutions," said BMS chairman and CEO Peter R. Dolan. There was no indication by the companies as to when a three-drug pill would be ready for human testing or to when they hope to submit the pill for FDA marketing approval.